Gardasil – HPV Vaccine – The Injured Continue To Pile Up

FOR IMMEDIATE RELEASE  PRLog (Press Release)Apr 25, 2011

by Leslie Carol Botha
Vice President Public Relations, SANE Vax Inc.

It is becoming hard to comprehend why the United States government; FDA, CDC and the NCI have blatantly turned their backs on the thousands of families whose daughters and sons have been severely injured by Merck’s Gardasil vaccination. GlaxoSmithKline is not off the hook on this either as mounting injuries from Cervarix (approved in the US in 2009) are now being reported to VAERS. How many deaths and how many injuries is it going to take before these vaccines are taken off the market?

The latest VAERS reports include:

•   376 abnormal pap smears post HPV vaccination
•   108 reports of anogenital warts found after HPV vaccination
•   224 reports of papillomavirus infections found after HPV vaccination
•   41 reports of cervical cancer after HPV vaccination
•   21,634  Adverse Events
•   95 Deaths

The numbers reflect approximately, 1 to 10% of the adverse event population reporting.  Medical consumers and physicians do not often think that vaccinations harm people – and therefore injuries and illnesses are not immediately associated with the vaccine.

HPV vaccines have been administered to adolescent girls and boys whose parents believed in the government’s vaccine program.  They followed their physician’s advice – and have been deceived.  What does that say about a government ‘for the people’?

SANE Vax, Inc. is outraged at the injustice shown to these families who now suffer from loss of life or diminished quality of life; outraged by their financial helplessness as they pay for mounting medical bills not covered by health insurance companies.

It is apparent in this country – the only one’s innocent until proven guilty are the government and corporations – who have protected themselves from liability.  For the rest of us – well, we are guilty until proven innocent – and the burden of proof lies on our shoulders.

SANE Vax, Inc.  has prepared a Global Concerns about HPV Vaccines Fact Sheet that includes the peer reviewed analysis, research documents and data that prove the culpability of Merck, GlaxoSmithKline, the CDC, FDA, and NCI in regards to fast tracking the HPV vaccines to medical consumers.  The SANE Vax Team believes it is time to hold them accountable for their actions. The Fact Sheet is posted on the SANE Vax, Inc. web site at

http://sanevax.org/news-blog/2011/04/sanevax-presents-gl …The HPV Vaccine Fact Sheet was created so that it could be shared globally with politicians, physicians, the media and anyone looking for an overview of the concerns about the Gardasil and Cervarix travesty.

We are hoping readers will post the fact sheet to their Social Media Network sites and circulate the fact sheet far and wide.  If we cannot get through to our government – then we, the people, need to make it our responsibility to educate other innocent medical consumers to prevent the Grim Reaper from striking down more innocent adolescents.

SANE Vax Inc. is dedicated in our efforts to remove Gardasil and Cervarix from the market until independent studies on their safety and efficacy are conducted.  We have become internationally recognized and known for the research and work we have done on this issue.  Conversely, we are now being contacted by more mothers whose daughters have been adversely affected by HPV vaccines.  Most of these injuries have not been reported to VAERS. We have even heard of a new death – another previously healthy teenage girl who went to bed on a Sunday night and never got up to go to school the next morning.

Read the comments from mothers and other innocent girls affected by HPV vaccines.  The government and Big Pharma must be held accountable for the innocent lives they have destroyed. Government agencies and pharmaceutical companies have become the Grim Reaper.

“My 15 year old autistic daughter was given all three Gardasil injections in 2009, and hasn’t been well since. She’s struggled her entire life with development delay, OCD, stuttering, and a seizure disorder that hasn’t reared its head since she was 9, so we’re not unfamiliar with hardships. Shortly after her last Gardasil injection, she began to have chronic vaginal itching, low grade fevers, severe headaches, abdominal pains, dizziness, leg pains, heart racing, heightened sense of her heartbeat and blood flow, fatigue, and an overall feeling of illness. I’m sure there are other symptoms that I’ve passed off as growing pains, hormones, you name it. I’m relieved to find this group, and join the ranks as another frustrated, determined mother, who is ready to see the makers and distributors of this “vaccine” be accountable for what they have done to our daughters.”

“My daughter who has just turned 14 years old has been unable to attend school due to fatigue and nausea and other symptoms since last December 2010. When I took her to her G.P. and had all the usual blood tests done they returned as normal. I did mention to the doctor that my daughter had had her second HPV injection at school just before she began to feel sick, but she dismissed any connection. The third vaccination injection is due this Thursday and I have decided to not allow my daughter have this final injection. Is this o.k. for her not to complete the vaccination programme as I am now suspecting that there may be a connection between the vaccination and her illness? My daughter has just started back to school this week after an absence of over three months. She is attending for only a few hours per day as she is too fatigued to manage any more than that.”

“I just had an MRI completed for my lower lumbar spine; I had a minor sports injury. Results read “bladder distention was noted.”  I completed my Gardasil vaccine over a year and a half ago, and two months after started noticing extra pressure and pain in my abdomen, and enlarged lymph nodes. Prior to the vaccine, I never experienced any of my “symptoms” and Gardasil is the biggest regret of my life. It was pushed upon me by my 3 doctors for years, promising it was safe, and there were no side effects associated. After I started complaining about tiredness and abdomen pain, major side effects were being brought to my attention. I feel deceived, lied to, and tricked. I experience discomfort and occasional pain when I am intimate with my partner. I have trouble urinating, and urinate frequently now. I am 24 years old, and devastated about my experience and findings. I am depressed and fearful of other complications it may cause in the future and can only be hopeful that I didn’t damage and will not pass on any complications to a child.”
“I am writing to u because I was also affected by Gardasil. I now have limbic encephalitis, which is the swelling of the brain, along with heart palpitations which don’t let me sleep, extremely bad headaches, body pain every morning, bone problems, anxiety problems, the list goes on forever. If you can please contact me, I would really appreciate it.”

# # #
SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.
Leslie Carol Botha,
Vice-President Public Relations, SANE Vax, Inc.
Health Educator, Broadcast Journalist

Internationally Recognized Expert on Women’s Hormone Cycles
Holy Hormones Honey -The Greatest Story Never Told!
http://holyhormones.com/
http://sanevax.org

US Government Concedes Hep B Vaccine Causes Systemic Lupus Erythematosus

Here we present the US Federal Court’s decision and order in full below.

The claimant in this case was dead when the damages were awarded. Tambra Harris died on November 9, 2009. Tambra’s mother and Administratix of her estate, Louvonia Deniece Harris, was substituted as petitioner, and an amended petition was filed on October 15, 2010.

Hepatitis B vaccine is given to US infants at birth for a disease which they are not at risk of.

Why? At risk groups are intravenous “recreational” drug abusers and those who practice unsafe sex – which rules out new born babies.

Whilst the risk factors for babies have changed little, there is now impressive evidence that for a preventive measure, hepatitis B vaccine is remarkable for the frequency, variety and severity of complications from its use. The toxicity of this vaccine is so unusual that, even if crucial data are regrettably concealed or covered by Court order, scientific evidence is already far higher than normally needed to justify severe restrictive measures.

Quote from French expert Dr. Marc GirardSee CHS article below for full details: UK Government Caught Lying On Baby Hep B Vax Safety.  Whilst other evidence is embargoed by the French Courts, Dr Girard has been able to publish a scientific review of the unembargoed evidence from the French Courts of the vaccine’s hazards (Autoimmun Rev 2005; 4: 96-100). Dr Girard shows that French health authorities suppress studies demonstrating serious risks. Hepatitis B vaccine has been shown in many peer reviewed research papers [including from Harvard University - detailed references at end] to be associated with numerous infant deaths in the USA and Europe, multiple sclerosis and numerous chronic auto-immune disorders [see below for more details].

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 01-499V
(E-Filed: March 23, 2011)

TO BE PUBLISHED -  Stipulated Damages; Hepatitis B Vaccine; Alleged Injuries Include Systemic Lupus Erythematosus (SLE)

_______________________________________
LOUONIA DENIECE HARRIS,
Administratrix of the Estate of TAMBRA
HARRIS,

Petitioner,

v.

SECRETARY OF THE DEPARTMENT OF
HEALTH AND HUMAN SERVICES,

Respondent.
______________________________________

STIPULATED DAMAGES DECISION1

On August 29, 2001, Tambra Harris (“petitioner”), filed a petition for compensation alleging that she suffered certain injuries as a result of receiving a vaccination. 2

Among the injuries petitioner alleged that she had suffered as a result of receiving a hepatitis B vaccination was systemic lupus erythematosus (SLE).  She sought an award under the National Vaccine Injury Compensation Program 3

On March 22, 2011, counsel for both parties filed a stipulation, stating that a decision should be entered awarding compensation. The parties stipulated that petitioner shall receive the following compensation:

A lump sum of $ 475,000.00 in the form of a check payable to petitioner as Administratrix of the Estate of Tambra Harris. This amount represents compensation for all damages that would be available under 42 U.S.C. §300aa-15(a);

and

A lump sum payment of $ 9,914.00 in the form of a check jointly payable to petitioner and the State of Mississippi Division of Medicaid, Attn: Ms. Carolyn Hall Williams, Third Party Liability Unit, 550 High Street, Walter Sillers Building, Suite 1000, Jackson MS 39201, for reimbursement of Mississippi’s Medicaid expenses related to Tambra’s care.

Stipulation ¶ 8(a) and ¶ 8(b).

The undersigned approves the requested amount for petitioner’s compensation. Accordingly, an award should be made in the form of a check payable to petitioner as Administratrix of the Estate of Tambra Harris in the amount of $ 475,000.00.   In addition, an additional award should be made in the form of a check payable jointly to petitioner and the State of Mississippi Division of Medicaid in the amount of $ 9,914.00. In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the court SHALL ENTER JUDGMENT in accordance with the terms of the parties’ stipulation. 4

IT IS SO ORDERED.
s/Patricia E. Campbell-Smith
Patricia E. Campbell-Smith
Special Master.

1 Because this decision contains a reasoned explanation for the undersigned’s action in this case, the undersigned intends to post this decision on the United States Court of Federal Claims’ website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). As provided by Vaccine Rule 18(b), each party has 14 days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, “the entire” decision will be available to the public. Id. (the Act or the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-1 to -34 (2006) (Vaccine Act or the Act). All citations in this decision to individual sections of the Vaccine Act are to 42 U.S.C. § 300aa.

2 Tambra Harris died on November 9, 2009. Tambra’s mother and Administratix of her estate, Louvonia Deniece Harris, was substituted as petitioner, and an amended petition was filed on October 15, 2010.

3 The National Vaccine Injury Compensation Program is set forth in Part 2 of the Program). 42 U.S.C. §§ 300aa-1 to -34 (2006).

4 Pursuant to Vaccine Rule 11(a), entry of judgment is expedited by the parties’ joint filing of notice renouncing the right to seek review.

___________________________________________________________________

UK Government Caught Lying On Baby Hep B Vax Safety

Posted on April 13, 2009

The British Government has been caught lying this week in news reports in two British Sunday newspapers about a proposal to give 8 week old British babies Hepatitis B vaccinations.

A Department of Health spokesman was quoted claiming:-

The safety of children is always paramount whenever decisions are taken regarding what vaccines are included as part of the child vaccination programme.: New vaccination fears over plan to give hepatitis jabs at eight weeks old Mail on Sunday 12th April 2009, Vaccination fears over plan for Hepatitis B jabs for babies : Sunday Telegraph 12 Apr 2009.

Only cost and not safety is legally permitted to be an objection under the UK New Labour Government’s new law in effect from April 1 this year [full details below].  Whilst 8 week old babies are not at risk from Hepatitis B, they are from the vaccine [full details below].  And six five EU Hepatitis B vaccines have lost their marketing authorisations since 2000, the latest being last week – GlaxoSmithKline’s Hepatitis B Energix B vaccine [full details below].

Hepatitis B vaccine has been shown in many peer reviewed research papers [including from Harvard University - detailed references at end] to be associated with numerous infant deaths  in the USA and Europe, multiple sclerosis and numerous chronic auto-immune disorders.  These latter include Guillain-Barre syndrome, lupus, rheumatism, blood disorders and chronic fatigue.  The only potential claimed infant risk group is alleged to be babies born in the UK to mothers from countries with claimed-to-have high rates of infection.  Around 2000 British born infants are already being vaccinated annually in the UK.  At risk groups are intravenous “recreational” drug abusers and those who practice unsafe sex – which rules out 8 week old babies.

There has been a criminal judicial investigation in France into the adverse effects of this vaccine.  France was the first country to introduce universal Hepatitis B vaccination and saw effects  which included the first ever seen and harrowing cases of childhood multiple sclerosis in France.

Research also shows that the prevalence of Hepatitis B is low in the UK, consistent with previous estimates and suggesting that many infections were acquired outside the UK. This all suggests Government should concentrate its efforts on effective treatment rather than vaccination of infants against a disease which does not affect them. Proponents of the vaccination claim rates of Hepatitis B infection are “spiralling” but based on “estimates”. Regrettably “estimates” can be “pulled” in one direction or another depending on which direction those responsible for the “estimates” are more interested in seeing them move.  And in these circumstances, they can never be justification for vaccinating all babies to protect adult drug abusers and practitioners of unsafe sex.

Additionally, UK and EU authorities have withdrawn marketing licences for 6 5 Hepatitis vaccines claiming a lack of efficacy in some cases, voluntary withdrawal by the applicant in others and denying in one case [Hexavac] any association with 6 infant deaths in Germany. The deaths were reported in a 2005 research paper as possibly caused by the vaccine: Unexplained cases of sudden infant death shortly after hexavalent vaccination.” Zinka B, Rauch E, Buettner A, Rueff F, Penning R. – Vaccine. 2005 May 18.

The most recent vaccine to lose its authorisation was last Last week the UK Medicines  and Healthcare Products regulatory Agency withdrew required recall of a batch of GlaxoSmithKline’s Hepatitis B Engerix B vaccine marketing authorisation with Professor Kent Woods, chief executive of the MHRA stating:-

The safety of the vaccine is not in question, but it is suspected to be ineffective.” MHRA recalls GSK’s Hepatitis B vaccine - 07 Apr 2009 - Regulatory Affairs – Hays Pharma News

The other most recent vaccine to lose its European marketing authorisation was  Quintanrix [also from GSK] in August last year. The other vaccines are: Infanrix [GSK], Hepacare [Celltech] and Primavax [Aventis Pasteur].

So if ‘The safety of children is always paramount’ why the British Department of Health is even contemplating such a vaccine for 8 week old babies is beyond comprehension.”

And do vaccines cause autistic conditions?  If you read nothing else we strongly recommend you read this: PDF Download – Text of May 5th 2008 email from US HRSA to Sharyl Attkisson of CBS News].  In it the US Health Resources Services Administration [HRSA] state to CBS News reporter Sharyl Attkisson

We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.

After the Hannah  Poling story broke in the USA in February 2008 [see CHS article here] under the media spotlight numerous US health officials and agencies conceded on broadcast US nationwide TV news from CBS and CNN. Full details with links to the original sources can be found in this CHS article: Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines. Hannah developed an autistic condition after 9 vaccines administered the same day.

But there is worse to come and it shows the UK’s New Labour Government has been irresponsible handing recently from 1st April 2009 legal power to dictate vaccination policy exclusively to the Joint Committee on Vaccination and Immunisation: UK Government Hands Drug Industry Control of Childhood Vaccination.  The JCVI regrettably has a demonstrable track-record of recklessness on safety up to and including the present day, as shown in FOI documents: British Government’s Reckless Disregard for Child Health Safety and UK Government Hands Drug Industry Control of Childhood Vaccination.

The DoH statement published in The Mail on Sunday is also untrue because:-

  • Under the new law The Health Protection (Vaccination) Regulations 2009 which came into effect on 1st April for England only, the Secretary of State has no power on the grounds of safety to refuse to implement or reverse any Joint Committe on Vaccination and Immunisation recommendation
  • the JCVI expressly has no remit to take safety into account in its decision-making
    • [that role is supposedly the MHRA's but regrettably they seem to rubber stamp a great deal of what the drug industry come up with - as has been shown time and again and not just with vaccines, but drugs like Seroxat - the "anti-depressant" shown not to work compared to placebo in some trials and which causes adolescents to be 3 times more likely to commit suicide in others.]
  • the only consideration the Secretary of State can take into account in rejecting JCVI recommendations is cost-effectiveness – not safety
  • contrary to the UK Department of Health claims, no childhood vaccines used on British children have ever been tested according to the gold standard of evidence – randomised placebo controlled clinical trials.
  • health officials refuse to ensure large scale studies of total health outcomes between vaccinated and unvaccinated individuals are carried out.  These should show differences in overall health between these groups and some medical professionals believe this is because the studies would reveal the unvaccinated are healthier overall and high levels of chronic diseases in vaccinated individuals.
  • there is no clinical benefit to infants from Hepatitis B vaccine but infants are put at risk of the known and unknown adverse effects
  • this also means doctors and nurses are being expected to behave unethically and possibly criminally – because no caring parent will consent to a vaccine administered to an 8 week old baby on being told there are risks but no benefits

The main reason for the new drive to more and more vaccines – and this is well published in the trade press – is that the drug industry has been changing its business model.  The financial markets have known for many years the old model would fail – that of patented “blockbuster” drugs:-

  • the drug industry have made vaccines the new growth area because they are highly lucrative
    • they are drugs everyone gets – it is the same business model of Bill Gates’ Microsoft – pretty much everyone has to have Windows software – pretty much everyone gets vax’d
    • and the drug industry has been working hard behind-the-scenes to pursuade everyone – especially legislators – that they are vital when they are not and lobbying for changes in law just like this new law – which was introduced without Parliamentary debate and appears to be unlawful per se: UK Government Hands Drug Industry Control of  Childhood Vaccination

Dr Marc Girard, a specialist in the side effects of drugs and commissioned as a medical expert by French courts in the French criminal investigation into the introduction of universal Hepatitis B vaccination in France, suggests that even in high-endemic countries, the risk/benefit ratio of what he describes as “this unusually toxic vaccine” must be carefully re-assessed.

Regarding the health situation in the UK Dr Girard says the conclusion not to vaccinate is obvious. France was the first country to implement universal hepatitis B vaccination in 1994.

Whilst other evidence is embargoed by the French Courts, Dr. Marc Girard has also been able to publish a scientific review of the unembargoed evidence of the vaccine’s hazards (Autoimmun Rev 2005; 4: 96-100). Dr Girard shows that French health authorities suppress studies demonstrating serious risks.

Dr Girard has previously said:

Whilst the risk factors for babies have changed little, there is now impressive evidence that for a preventive measure, hepatitis B vaccine is remarkable for the frequency, variety and severity of complications from its use. The toxicity of this vaccine is so unusual that, even if crucial data are regrettably concealed or covered by Court order, scientific evidence is already far higher than normally needed to justify severe restrictive measures.

______________________________________

REFERENCES

UK & EU MARKETING AUTHORISATION WITHDRAWALS

  • MHRA recalls GSK’s Hepatitis B vaccine - 07 Apr 2009 - Regulatory Affairs – Hays Pharma News
  • Public Statement on Quintanrix (Common name: diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b conjugate vaccine) Withdrawal of the Marketing Authorisation in the European Union – 29/08/08 – EMEA/424484/08
  • EMEA announces recommendation for suspension of the marketing authorisation for HexavacEMEA/297369/2005
  • EMEA Withdrawal of the Marketing Authorisation for the Medicinal Product Hepacare (Triple hepatitis B recombinant vaccine)EMEA/32933/02- 20/12/02
    • Public Statement on Hepacare (Triple hepatitis B recombinant vaccine)17/12/02 – EMEA/32933/02
  • Withdrawal of the Marketing Authorisation for the Medicinal Product Primavax (Diptheria, Tetanus, and Hepatitis B vaccine) – 04/12/00 – EMEA/H/2681/00

______________________________________

DEATHS, MULTIPLE SCLEROSIS AND OTHER ADVERSE EFFECTS

  • “Unexplained cases of sudden infant death shortly after hexavalent vaccination.” Zinka B, Rauch E, Buettner A, Rueff F, Penning R. – Vaccine. 2005 May 18

Vaccinations are considered to be the most effective and safe method preventing infectious diseases. Although hexavalent vaccines like Hexavac((R)) and Infanrix Hexa((R)) are assumed to be well tolerated and safe regarding the rate of immunity  [Liese JG, Stojanov S, Berut F, Minini P, Harzer E, Jow S, et al. Large scale safety study of a liquid hexavalent vaccine (D-T-acP-IPV-PRP-T-HBs) administered at 2, 4, 6 and 12-14 months of age. Vaccine 2002;20:448-54; Mallet E, Fabre P, Pines E, Salomon H, Staub T, Schodel F, et al. Immunogenicity and safety of a new liquid hexavalent combines vaccine compared with separate administration of reference licensed vaccines in infants. Pediatr Infect Dis J 2000;19:1119-27], it was noticed that several cases of death occurred shortly after the vaccination. We report six cases of sudden infant death that occurred within 48h after hexavalent vaccination. At post-mortal examination, those cases showed unusual findings, especially in the brain and in laboratory tests. Crude calculations of local epidemiology are compatible with an association between hexavalent vaccination and unusual cases of sudden infant death. If confirmed in systematic studies, our findings would have potentially serious clinical implications.

Neonatal Deaths After Hepatitis B Vaccine – The Vaccine Adverse Event Reporting System, 1991-1998 – Arch Pediatr Adolesc Med. 1999;153:1279-1282

Results: Of 1771 neonatal reports, there were 18 deaths in 8 boys and 9 girls (1 patient unclassified). The mean age at vaccination for these 18 cases was 12 days(range, 1-27 days); median time from vaccination to onset of symptoms was 2 days (range, 0-20 days); and median time from symptoms to death was 0 days (range, 0-15 days). The mean birth weight of the neonates (n = 15) was 3034 g (range, 1828-4678 g). The causes of death for the 17 autopsied cases were sudden infant death syndrome for 12, infection for 3, and 1 case each of intracerebral hemorrhage, accidental suffocation, and congenital heart disease. Conclusion: Few neonatal deaths following HepB vaccination have been reported, despite the use of at least 86 million doses of pediatric vaccine given in the United States since 1991. While the limitations of passive surveillance systems do not permit definitive inference, these data suggest that HepB immunization is not causing a clear increase in neonatal deaths.

Recombinant hepatitis B vaccine and the risk of multiple sclerosis

NEUROLOGY 2004;63:838-842

A prospective study

Miguel A. Hernán, MD, DrPH, Susan S. Jick, DSc, Michael J. Olek, DO and Hershel Jick, MD

From the Department of Epidemiology (Dr. Hernán), Harvard School of Public Health, Boston; Boston Collaborative Drug Surveillance Program (Drs. Susan S. Jick and Hershel Jick), Boston University, Lexington, MA; and Department of Neurology (Dr. Olek), College of Medicine, University of California, Irvine.

Background: A potential link between the recombinant hepatitisB vaccine and an increased risk of multiple sclerosis (MS) hasbeen evaluated in several studies, but some of them have substantialmethodologic limitations.

Methods: The authors conducted a nested case-control study withinthe General Practice Research Database (GPRD) in the UnitedKingdom. The authors identified patients who had a first MSdiagnosis recorded in the GPRD between January 1993 and December2000. Cases were patients with a diagnosis of MS confirmed throughexamination of medical records, and with at least 3 years ofcontinuous recording in the GPRD before their date of firstsymptoms (index date). Up to 10 controls per case were randomlyselected, matched on age, sex, practice, and date of joiningthe practice. Information on receipt of immunizations was obtainedfrom the computer records.

Results: The analyses include 163 cases of MS and 1,604 controls.The OR of MS for vaccination within 3 years before the indexdate compared to no vaccination was 3.1 (95% CI 1.5, 6.3). Noincreased risk of MS was associated with tetanus and influenzavaccinations.

Conclusions: These findings are consistent with the hypothesisthat immunization with the recombinant hepatitis B vaccine isassociated with an increased risk of MS, and challenge the ideathat the relation between hepatitis B vaccination and risk ofMS is well understood.

Received March 31, 2004. Accepted in final form May 8, 2004.

“Multiple sclerosis and hepatitis B vaccination: Adding the credibility of molecular biology to an unusual level of clinical and epidemiological evidence” Comenge Y; Girard M (Med Hypotheses, doi 10.1016/j.mehy.2005.08.012)

“Autoimmune hazards of hepatitis B vaccine” Girard M (Autoimmun Rev 2005; 4:96-100) (Text available in electronic form on request.)

______________________________________

Low Prevalence in The UK of Hepatitis B and Infections acquired abroad

The prevalence of hepatitis B infection in adults in England and Wales – Epidemiology and Infection (1999), 122:133-138 Cambridge University Press

Cost effectiveness analyses of alternative hepatitis B vaccination programmes in England and Wales require a robust estimate of the lifetime risk of carriage. To this end, we report the prevalence of infection in 3781 anonymized individuals aged 15–44 years whose sera were submitted in 1996 to 16 microbiology laboratories in England and Wales. One hundred and forty-six individuals (3·9%) were confirmed as anti HBc positive, including 14 chronic carriers (0·37%). The prevalence of infection and carriage was higher in samples collected in London and increased with age. No increased risk of infection was seen in sera from genito-urinary (GUM) clinics. Only 15 sera positive for hepatitis B were also positive for hepatitis C. Our results confirm the low prevalence of hepatitis B in England and Wales, are consistent with previous estimates of carriage and suggest that many infections were acquired while resident outside the UK. Future prevalence studies should determine the country of birth and other risk factors for each individual in order to confirm these findings.  (Accepted September 14 1998)

Paul Offit – Liar “Doctor of Vaccine Profit” Voted His Patented Vaccine For US Children When On Vaccine Safety Committee

After a Congressional investigation the lying spokesman for the US drug industry on vaccine safety Dr. Paul Offit, of the Childrens’ Hospital of Philadephia, was named in a formal Congressional report for voting himself rich as a member of the US Advisory Committee on Immunization Practices (ACIP).  Crooked Offit voted for his own patented vaccine Rotavirus to be introduced into the US childrens’ vaccine schedule when he was meant to be looking out for the health and safety of US children.  [So no change there then].  Offit has made millions of dollars from the patent for the vaccine which he held in partnership with vaccine maker Merck.

And governments pretend they do not understand when the public do not believe them.  And they still keep appointing some crooked “experts” like this to their oversight panels.

Offit has already been caught lying publicly twice about vaccine safety issues – see CHS article here:  Paul Offit – “Doctor of Vaccine Profit” Caught Lying – Again – Orange County Register

He has also claimed children can withstand 100,000 vaccines administered at once when the US government has paid out a settlement of US$20m to Hannah Poling who developed an autistic condition caused by receiving 9 vaccines in one day: US Government In US$20 million Legal Settlement For Vaccine Caused Autism Case

The full text of the Congressional investigation report is set out at the end of this article.

It shows Offit voted “yes” three times for including Rotavirus vaccine on the US childhood vaccine schedule and abstained only once for a vote to rescind the recommendation of Wyeth’s vaccine after it had been found to cause adverse events.  Dr. Offit began his tenure on ACIP in October of 1998.

The Report shows Dr. Offit:-

  • had already been awarded the patent on the Rotavirus vaccine which he shares in development with Merck
  • received a $350,000 grant from Merck for Rotavirus vaccine development
  • acts as a consultant to Merck.
  • out of four votes pertaining to the ACIP’s rotavirus statement, he voted yes three times, including voting for the inclusion of the rotavirus vaccine in the VFC program.
  • Dr. Offit abstained from voting on the ACIP’s rescission of the recommendation of the Wyeth rotavirus vaccine for routine use when serious adverse reactions were being reported. He stated at the meeting, “I’m not conflicted with Wyeth, but because I consult with Merck on the development of rotavirus vaccine, I would still prefer to abstain because it creates a perception of conflict.″

The Report mentions Offit by name several times:

C. Problems Identified During the Committee’s Investigation

The Committee staff’s review of the ACIP’s consideration of the rotavirus vaccine identified serious weaknesses in the CDC’s policing of conflicts of interest on this advisory committee. On June 25, 1998, the ACIP voted to recommend the rotavirus vaccine for routine use in infants. In reviewing the minutes of ACIP meetings and the financial disclosure forms of the ACIP members, the Committee staff identified a number of troubling issues:

1. ACIP Members Do Not Fully Disclose Conflicts of Interest

Examination of ACIP members’ financial disclosure forms reveals that many members do not fill them out completely. CDC ethics officials conceded to Committee staff that they have been lax in compelling the ACIP members to provide complete and thorough information.[lxv]

………..

c. Dr. Paul Offit
Dr. Offit lists that he is a consultant to Merck on an attachment to his OGE 450, but does not disclose whether or not he received any remuneration for his services. (Exhibit 39)

And here:-

3. ACIP Members are Allowed to Vote on Vaccine Recommendations, Even When They Have Financial Ties to Drug Companies Developing Related or Similar Vaccines

……..

While ACIP members with ties to Wyeth-Lederle were not allowed to vote on recommendations for the rotavirus vaccine, those with ties to Merck and Smithkline-Beecham were allowed to vote. This stands in stark contrast to the policies of the FDA. In discussions with FDA staff on this specific issue they informed the Committee staff that when the VRBPAC is deliberating the licensure of a vaccine, a company is considered affected [an affected company is one with a direct interest] if they are direct competitors of the manufacturer of the vaccine being considered. They further clarified that that this policy was in place because of the competing interest of the affected company and not because of concerns about the release of proprietary information. Moreover, if a VRBPAC member has a direct interest with a competing firm they are automatically disqualified from participation.

At ACIP meetings from February 11, 1998, through June 17, 1999, there were eight votes related to the their approval of the rotavirus vaccine for routine use. Three of these votes were particularly notable. They include: (1) June 25, 1998 – The ACIP approved the statement recommending the rotavirus vaccine for routine use, (2) October 22, 1998 – The ACIP recommended the rotavirus vaccine be added to the Vaccines for Children Program, and (3) October 22, 1999-the ACIP rescinded its earlier decision to recommend the rotavirus vaccine.

………

b. Dr. Paul Offit (Exhibits 38-41)
Dr. Offit shares the patent on the Rotavirus vaccine in development by Merck and lists a $350,000 grant from Merck for Rotavirus vaccine development. Also, he lists that he is a consultant to Merck.

Dr. Offit began his tenure on ACIP in October of 1998. Out of four votes pertaining to the ACIP’s rotavirus statement he voted “yes” three times, including, voting for the inclusion of the rotavirus vaccine in the VFC program.

Dr. Offit abstained from voting on the ACIP’s rescission of the recommendation of the rotavirus vaccine for routine use. He stated at the meeting, “I’m not conflicted with Wyeth, but because I consult with Merck on the development of rotavirus vaccine, I would still prefer to abstain because it creates a perception of conflict.”[lxvii]

FULL TEXT OF US CONGRESSIONAL REPORT

Conflicts of Interest in Vaccine Policy Making
Majority Staff Report
Committee on Government Reform
U.S. House of Representatives
June 15, 2000

Section I
Introduction

In August 1999, the Committee on Government Reform initiated an investigation into Federal vaccine policy. Over the last six months, this investigation has focused on possible conflicts of interest on the part of Federal policy-makers. Committee staff has conducted an extensive review of financial disclosure forms and related documents, and interviewed key officials from the Department of Health and Human Services, including the Food and Drug Administration and the Centers for Disease Control and Prevention.

This staff report focuses on two influential advisory committees utilized by Federal regulators to provide expert advice on vaccine policy:
1. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC); and
2. The CDC’s Advisory Committee on Immunizations Practices (ACIP).

The VRBPAC advises the FDA on the licensing of new vaccines, while the ACIP advises the CDC on guidelines to be issued to doctors and the states for the appropriate use of vaccines.

Members of the advisory committees are required to disclose any financial conflicts of interest and recuse themselves from participating in decisions in which they have an interest. The Committee’s investigation has determined that conflict of interest rules employed by the FDA and the CDC have been weak, enforcement has been lax, and committee members with substantial ties to pharmaceutical companies have been given waivers to participate in committee proceedings. Among the specific problems identified in this staff report:

§ The CDC routinely grants waivers from conflict of interest rules to every member of its advisory committee.

§ CDC Advisory Committee members who are not allowed to vote on certain recommendations due to financial conflicts of interest are allowed to participate in committee deliberations and advocate specific positions.

§ The Chairman of the CDC’s advisory committee until very recently owned 600 shares of stock in Merck, a pharmaceutical company with an active vaccine division.

§ Members of the CDC’s advisory Committee often fill out incomplete financial disclosure statements, and are not required to provide the missing information by CDC ethics officials.

§ Four out of eight CDC advisory committee members who voted to approve guidelines for the rotavirus vaccine in June 1998 had financial ties to pharmaceutical companies that were developing different versions of the vaccine.

§ 3 out of 5 FDA advisory committee members who voted to approve the rotavirus vaccine in December 1997 had financial ties to pharmaceutical companies that were developing different versions of the vaccine.

A more complete discussion of specific conflict of interest problems identified by Government Reform Committee staff can be found in Sections 4 and 5 of this report. To provide focus to the discussion, this report examines the deliberations of the two committees on one specific vaccine — the Rotavirus vaccine. Approved for use by the FDA on August 31, 1998, the Rotavirus vaccine was pulled from the market 13 months later after serious adverse reactions to the vaccine emerged. Financial disclosure forms and waivers granted to committee members who participated in these meetings were analyzed, along with their votes and actions taken during the meetings.

Section II
Laws and Regulations

Laws Governing Advisory Committees
Federal law requires that advisory committees be balanced in terms of points of view of their members and that they conduct their business in public. The law also requires that advisory committee members disclose their financial interests and recuse themselves from matters in which they have an interest. The following is a brief description of the requirements of these laws:
1. Federal Advisory Committee Act (FACA)[i]:
The FACA, signed into law by President Richard Nixon in 1972, regulates advisory committees, task forces and councils established by either the President, the federal agencies or Congress. These increasingly influential advisory bodies have been considered by many to be the A fifth branch of government.[ii] It is important to note, however, that the FACA does not address the conflict of interest of committee members; these are addressed in a separate statute and dealt with by individual agencies in the Code of Federal Regulations.[iii] The FACA’s most significant requirements fall into three basic categories:

a.) Scope of Committees: The statute clearly states that the function of advisory committees is to be Advisory only. They provide advice and recommendations that may or not may be adopted. The final determination is to be made by the official or agency involved.[iv]

b.) Requirement of Openness: The second important issue addressed by the FACA is the need for openness in the proceedings of advisory committees. With very few exceptions, all advisory committee meetings are to be open to the public and the materials distributed at the meetings, including working papers, studies agendas, etc…, are to be made available to the public for inspection.[v]

c.) Balanced Representation: Perhaps the most controversial provision of the FACA is the need for a membership that is Afairly balanced in terms of the points of view represented and the functions of the committee.[vi] The statute specifically forbids the committees to be inappropriately influenced by special interests.[vii]

2. Conflicts of Interest Statutes [viii]:

The ethics guidelines for the advisory committees are set by the agencies in accordance with federal statute, specifically 18 U.S.C. ”202-209. Under the statute, advisory committee members are considered ASpecial Government Employees (SGEs). SGEs provide temporary services to the U.S. government, not to exceed 130 days a year. As SGEs, advisory committee members must comply with Federal conflict of interest laws. 18 U.S.C. ”202-209 broadly prohibits employees, including SGEs, from participating in a decision-making process when they have a personal interest in the matters discussed, absent a waiver from the relevant parties .[ix] The types of waivers found in the statute are:

a.) (b)(1) waivers: The employee may participate when the appointing official determines that the financial interest is not substantial as to be deemed likely to affect the integrity of the services that the Government may expect.[x]

b.) (b)(2) waivers: Employee may participate if the interest is so remote or inconsequential that it will not have a special or distinct effect on the employee or his employer.[xi]

c.) (b)(3) waivers: specifically applicable to advisory committee members, this waiver will allow them to participate in matters for which he would have been disqualified, if it is determined that the need for the employees services outweigh the potential conflict of interest created by the employees financial interest.[xii] Factors that may be considered include: type of interest, identity of the person, uniqueness of the individuals qualifications, difficulty of locating a similarly qualified individual without a disqualifying interest, the dollar value of the interest- including its value relevant to the members assets, and the extent to which the financial interest will be affected by the actions of the committee.

3. Code of Federal Regulations (CFR) & Office of Government Ethics (OGE):
Since most advisory committee members are considered special government employees, the provisions in 18 U.S.C. ”201-219 that address conflicts of interest apply to them. However, the statute only provides broad guidelines, so that it is up to the individual agencies to provide the specific rules governing conflict of interest.[xiii] In the case of the Department of Health and Human Services (DHHS), these regulations can be found at 5 C.F.R. ” 2635 and in 5 C.F.R. ”2640. Under the DHHS regulations, an advisory committee member may not participate, absent a waiver, in matters in which they have a financial interest. These are divided into the following categories:

a.) Particular matter: includes matters that involve deliberation, decision, or action focused on the interests of specific persons, or a discrete and identifiable class of persons.[xiv]

b.) Particular matter involving specific parties: the code defines this term to include proceedings, applications, requests for determination, contracts, claims, controversies and/or investigations involving specific parties. The term typically involved a specific proceeding affecting the legal rights of the parties, or an isolatable transaction or related set of transactions between identified parties.[xv] This term will generally refer to the particular issue, vaccine and or company that will be directly affected by the advisory committee discussions.

c.) Particular matter of general applicability: the code defines this term as a particular matter that is focused on the interests of a discrete and identifiable class of persons, but does not involve specific parties.[xvi] This definition becomes relevant in the discussion of companies that may be indirectly affected by the proceedings of an advisory committee. In this report, the companies under this category will be referred to as affected companies.

d.) A direct and predictable effect on their financial interest: a direct effect on a financial interest is defined as a close causal link between any decision or action to be taken in the matter and any expected effect of the matter on the financial interest.[xvii] According to the CFR, the effect may actually be considered direct even though it does not occur immediately. However, the CFR also specifies that the link will not be direct in instances where the chain of causation is attenuated or is contingent upon the occurrence of events that are speculative.[xviii] On the other hand, predictable is defined in the code as a situation where there is a real possibility that the matter will be affected.

e.) Affected interests: according to the CFR, the disqualifying financial interests include: salary, indebtedness, job offer, or any other similar interests that could be affected by the matter discussed.[xix] It also includes the interests of persons other than the advisory committee members, such as a spouse, children, general partner, place of employment, organizations where the advisory committee member serves as officer, director and/or trustee, and prospective employers.[xx]

f.) Interests in securities: The CFR specifically addresses the potential conflicts that may arise out of interests in securities, such as stock holdings. The guidelines provided for in the CFR include:

(1) De minimis exemption: This exemption applies to publicly-traded or long-term Federal/municipal securities. The CFR states that persons having holdings in the specific parties involved of $5,000 or less or holdings in the affected companies of $25,000 or less will be allowed to participate in the proceedings of the advisory committee. (Exhibit 53) These financial interests are deemed to be of low involvement and do not require a waiver, but a simple disclosure on the forms required by the particular agency or department.

(2) Employment exemption: Under the DFR, SGEs may participate in the advisory committee discussions on matters of general applicability so long as the otherwise disqualifying financial interest arises only from the committee members non-Federal employment or prospective employment and so long as the matter does not have a special or distinct effect on the employee or employer other than as part of a class. In other words, under these circumstances, employees will be granted an automatic waiver.

g.) Teaching, speaking and writing on subject of meeting: SGEs are prohibited from receiving compensation for teaching, speaking, and writing on subjects related to the employees official duties in the advisory committee.[xxi]
The Code also stipulates that an SGE may not participate in matters that are likely to have a direct and predictable effect on the financial interests of …a person with whom he has a covered relationship,  including members of his household, close friends or employer.[xxii] This type of conflict requires that the member disclose the potential conflict and that said conflict be waived by the agency designee.

Section III
The Rotavirus and the Rotashield Vaccine

A. What is Rotavirus?
Rotaviruses cause acute gastroenteritis. Rotavirus gastroenteritis is a self-limiting, mild to severe disease characterized by vomiting, watery diarrhea, and low-grade fever. Infantile diarrhea, winter diarrhea, acute nonbacterial infectious gastroenteritis, and acute viral gastroenteritis are names applied to the infection caused by the most common and widespread “Group A rotavirus.”

Person-to-person spread through contaminated hands is probably the most important means by which rotaviruses are transmitted in close communities such as pediatric and geriatric wards, day care centers and family homes. Group A rotavirus is endemic worldwide. It is the leading cause of severe diarrhea among infants and children, and accounts for about half of the cases requiring hospitalization.

It is estimated that over 3 million cases of rotavirus gastroenteritis occur annually in the United States. In temperate areas, it occurs primarily in the winter, but in the tropics it occurs throughout the year.

Group B rotavirus, also called adult diarrhea rotavirus or ADRV, has caused major epidemics of severe diarrhea affecting thousands of persons of all ages in China. Group C rotavirus has been associated with rare and sporadic cases of diarrhea in children in many countries. However, the first outbreaks were reported from Japan and England.

The incubation period ranges from 1-3 days. Symptoms often start with vomiting followed by 4-8 days of diarrhea. Temporary lactose intolerance may occur. Recovery is usually complete. However, severe diarrhea without fluid and electrolyte replacement may result in severe diarrhea and death.

Childhood mortality caused by rotavirus is relatively low in the U.S. Estimates of death resulting from complications of rotavirus are from 20[xxiii] to 100 deaths per year. From 1979 through 1985, an average of 500 children died annually from diarrhea disease in the United States; an estimated 20% of these deaths were caused by rotavirus infection. Death rates for diarrhea disease were highest in the South and among black children less than 6 months of age. Many deaths and hospitalizations may be prevented by the aggressive use of oral rehydration therapy, which is underused. Children 6 months to 2 years of age, premature infants, the elderly, and the immuno-compromised are particularly prone to more severe symptoms caused by infection with Group A rotavirus. Outbreaks of Group A rotavirus diarrhea are common among hospitalized infants, young children attending day care centers, and elder persons in nursing homes.[xxiv]

B. Rotavirus Vaccine Development
Wyeth Lederle Vaccines and Pediatrics, a subsidiary of American Home Products was the first pharmaceutical company to come to market with a rotavirus vaccine. The Rotashield was approved by the Food and Drug Administration on August 31,1998. It was a Rhesus monkey-based live oral vaccine. Merck was also developing a rotavirus vaccine that was based on bovine cells. The National Institute of Allergy and Infectious Diseases was conducting research in rotavirus vaccine development. Smith Kline Beecham was also working on a rotavirus vaccine.

Wyeth-Lederle Vaccines and Pediatrics first filed their Investigational New Drug Application in August of 1987 for the Rotashield vaccine. This vaccine had an overall relative efficacy of 49% to 83% for four strains of rotavirus.

C. Timeline for Vaccine Approval and Universal Use Recommendation
Date Individual or Organization Action August 1, 1987 Wyeth Lederle Filed Investigational New Drug (IND) Application to the FDA December 9, 1994 Fred Clark, Paul Offit, Stanley Plotkin (Inventors); Wistar Institute of Anatomy and Biology and Children’s Hospital of Pennsylvania (Assignees) Filed U.S. Patent for Rotavirus reassortant vaccine. Application number 353547 June 1, 1995 Fred Clark, Paul Offit, Stanley Plotkin (Inventors); Wistar Institute of Anatomy & Biology and Children’s Hospital of Philadelphia (Assignees) Filed U.S. Patent for rotavirus reassortant vaccine. Application number 456906 May 6, 1997 Fred Clark, Paul Offit, Stanley Plotkin (Inventors); Wistar Institute of Anatomy and Biology and Children’s Hospital of Pennsylvania (Assignees) Awarded U.S. Patent # 5,626,851 for Rotavirus Reassortant vaccine. December 12, 1997

VRBPAC (FDA) The committee voted to recommend that the FDA license the Rotashield vaccine. February 11, 1998

ACIP (CDC) The committee voted to include the statement “Routine Vaccination” in the ACIP statement. June 25, 1998

ACIP (CDC) The committee voted to include the short version of the ACIP statement regarding post-marketing surveillance. August 31, 1998 FDA

FDA approved the Rotashield vaccine. October 1, 1998 Wyeth-Lederle

Distribution of the Rotashield began. October 21-22, 1998

ACIP (CDC) The committee voted to add the rotavirus vaccine to the Vaccines For Children Program. January 15, 1999

CDC

ACIP published its recommended immunization schedule in the Morbidity and Mortality Weekly Report (MMWR). February 17-18, 1999

ACIP (CDC) The committee voted in favor of recommending immunization of infants who have diarrhea at the time presented for immunization. February 17-18, 1999

ACIP (CDC) The committee voted to include infants born prematurely under guidelines for routine immunization with a precaution to insure the infant was at least six weeks of age, leaving a nursery or no longer hospitalized, and clinically stable. March 19, 1999

CDC
CDC officially adopted recommendation for routine use of rotavirus vaccine as published in MMWR. May 1999

FDA
Ten cases of intussusception reported through the VAERS System. June 17, 1999

ACIP (CDC) The ACIP discussed intussusception reports to the Vaccine Adverse Event Reporting System (VAERS) July 16, 1999

CDC
MMWR published request to suspend use of Rotashield until further analysis of existing reports of intussusception. October 15, 1999 Wyeth-Lederle

A subsidiary of American Home Products Manufacturer voluntarily removed Rotashield from the U.S. market. October 22, 1999 ACIP (CDC) The Committee voted to rescind the Recommendation of the Rotashield Rotavirus Vaccine.

D. Severe Bowel Obstructions Tied to Rotashield Vaccine
A little more than one year after the Rotashield rotavirus vaccine was licensed by the Food and Drug Administration as a safe and effective vaccine, it was removed from the market due to adverse events. More than 100 cases of severe bowel obstruction, or intussusception, were reported in children who had received the vaccine were reported.

Rotashield was licensed by FDA on August 31, 1998. Distribution began on October 1, 1998. On January 1, 1999 there were zero cases of intussusception on the Vaccine Adverse Events Reporting System (VAERS). In May 1999 there were ten cases of intussusception reported in the VAERS. Data was received from the Northern California Kaiser active surveillance system and from statewide data case control in Minnesota in early June that supported a relationship between the Rotashield vaccine and intussusception. Dr. Jeffery P. Koplan, Director of the CDC was briefed for the first time on June 11, 1999. A subsequent meeting was held with Dr. Koplan and the CDC at which a decision was made to postpone any further use of the vaccine until further analysis was conducted. This was published in MMWR on July 16, 1999.

As of October 15, 1999, 113 cases of intussusception had been received. Nine of these reported cases were determined not to be intussusception. Of the remaining 102 cases of intussusception, 57 had received the vaccine. Of these, 29 required surgery, seven underwent bowel resection, and one five-month-old infant died after developing intussusception five days after receipt of the vaccine.[xxv] A case study was conducted that estimated that the risk of intussusception was increased by sixty percent among children who received the Rotashield.

It is alarming that it was known during clinical trials and the licensing process that there were increased incidences of intussusception in vaccinated infants. The topic was raised at a VRBPAC meeting and a reference to intussusception is listed in the ACIP recommendation, however, the committee apparently determined that the reported rate of 1 in 2010 was not to be statistically significant. The CDC continues to provide inconsistent information on their web site. One fact sheet, the Rotavirus Q & A, has not been updated since July 16, 1999 and does not provide a link to a more recent fact sheet. The fact sheet significantly plays down the seriousness of the adverse event and asserts that no association has been made.[xxvi] Another Rotavirus Vaccine Fact Sheet was updated on February 2, 2000 that indicates that the FDA and CDC confirmed the association between Rotashield and intussusception.

During the clinical trials, five children out of a total of 10,054 subjects suffered intussusception.[xxvii] If confirmed, the rate of intussusception would be 1 in 2010 children. According to the manufacturers package insert, the adverse event was considered statistically insignificant at 0.05%. Intussusception had not previously been associated with natural rotavirus infection.

Rotashield rotavirus vaccine was removed from the U.S. market in October 1999. Development of other rotavirus vaccines continues by Merck and others.

Section IV
Food and Drug Administration
Vaccines and Related Biological Products Advisory Committee

A. Vaccines and Related Biological Products Advisory Committee:

1. Description of the Committee:
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) advises the Commissioner of the Food and Drug Administration in discharging her responsibilities as they relate to helping ensure safe and effective biological products, including vaccines.[xxviii] It reviews and evaluates the data concerning the safety, effectiveness, and the appropriate use of vaccines and related biological products. In short, the VRBPAC advises the FDA on whether or not to license new vaccines for commercial use.

2. Membership of the Committee:
The VRBPAC has 15 voting members, including the Chair, who are selected by the Commissioner of the FDA or her designee. The FDA seeks members who are “authorities” in the fields of immunology, pediatrics, infectious diseases and related fields. The charter also suggests that there be a member who is identified with consumer interests. VRBPAC meets approximately 6 times a year.

3. Terms:

VRBPAC members serve overlapping terms of four years. A member may serve after the expiration of the members term until a successor has taken office. Under the DHHS policy, members may not serve continuously for more than four years or more than eight years within a twelve year period. Additionally, members may not serve on more than one committee within the agency at the same time. Vacancies are announced at least once a year in the Federal Register. The selections are made by Dr. Linda Suydam, Senior Associate Commissioner of the FDA, who also considers and grants all conflict of interest waivers.

4. Temporary voting members:
Members of other scientific and technical FDA advisory committees — not to exceed 4 members (Exhibit 54) — may vote on the VRBPAC when: a.) expertise is required that is not available among current voting members or, b.) their presence is needed to comprise a quorum.

B. Conflict of Interest Review and Waivers by the FDA
1. Scope:
As discussed in Section I of this report, conflict of interest statutes and regulations generally prohibit the participation of advisory committee members in official matters where that person has a financial interest and their participation will have a direct and predictable effect on that interest.[xxix] Many factors are considered by the Department in determining whether a conflict of interest exists and, if it does, whether it may be waived to allow participation. A conflict may either be an actual or apparent conflict. An actual conflict is the situation where a direct, identifiable conflict exists. An apparent conflict is where there is an appearance of a lack of impartiality.[xxx]

2. Procedure:
There are many steps in the FDA’s procedure to clear potential conflict of interests in VRBPAC.

They include:
a. Prior to a scheduled VRBPAC meeting, FDA officials will review the agenda and other assignments. Entities with a financial interest in the matter to be discussed are identified by the staff of the Center for Biologics Evaluation & Research, as are the products to be used in conjunction with the product being reviewed, and competing products.
b. Advisory committee members are required to fill out a Confidential Financial Disclosure Statement (FDA form 3410) prior to each meeting.
c. FDA staff compares financial disclosure information compiled for each VRBPAC member with the issues on the agenda for the upcoming meeting to determine who has conflicts. Based on the information provided, the member can be found to have: a.) no conflict of interest, b.) a conflict of interest that is minimal and thus, justifiable, or c.) a conflict of interest so substantial than recusal or a waiver is the only course of action. If there is a substantial conflict of interest, it must be detailed. Some of the factors and criteria used in determining whether a waiver is appropriate include:

(i.) Agenda topic: Where the subject of the meeting is of Ageneral scientific presentations and not of particular products or to review research with no direct or predictable effect on outside interests, waivers are not needed.[xxxi]
(ii.) Net worth of member: The amount of the financial interest will be considered in relation to the net worth of the SGE.[xxxii]
(iii.) Employment: Situations where the SGE’s university employer has a grant or a contract with either the sponsoring company or any other affected companies will be taken into consideration during the waiver process.[xxxiii]
(iv.) Amount of grant or contract: The amount of the grant or contract given to the university employer of a member, as well as the member=s involvement (i.e. principal investigator, department chair) will be considered in whether the financial interest arises to the point of conflict. (Exhibit 53).
(v.) Competing products: The member’s financial interest in competing products or otherwise affected companies will be taken into consideration by the agency in determining whether a waiver may be granted.[xxxiv]
(vi.) Potential effect of committee recommendation: Members may not vote on any matter where a committee recommendation could benefit financially either the member or his/her immediate family. A waiver may not be granted where the member’s own research is involved.
(vii.) Industry consultant or advisor: The level of involvement of the member with either a sponsoring or an affected company, as measured by the amount of compensation received, will also be considered. (Exhibit 53).
(viii.) Patents, royalties and trademarks: As in the previous categories, the level of involvement of the particular member will be measured by the amount of compensation received from the sponsoring or affected companies. (Exhibit 53).
b. If the Director of the division determines that the member’s services are too important, despite a substantial conflict of interest, he must provide the necessary justification for a waiver. Where the financial interest is relatively large it is essential that the justification be particularly strong.[xxxv]
c. If a waiver is contemplated, it must be reviewed by FDA’s ethics staff who will make a recommendation to the approving official regarding the waiver. They may also consult with the Office of General Counsel in the Department or the Office of Government Ethics.
d. Final approval of waivers is given by Dr. Linda Suydam, Senior Associate Commissioner of the FDA. In addition to a full participation waiver, the Department may also grant:
i.) Limited Waivers: This waiver places restrictions on the member’s participation, such as no right to vote.[xxxvi] Potentially, a limited waiver could also restrict a member’s participation to answering factual questions about the matter being discussed by the committee.
ii.) Disclosure: In cases where the financial interest is not deemed to be substantial, it will be disclosed in the public record with the expectation that other participants will take them into consideration as they evaluate the opinions expressed by the member. The Agency in some cases deems that such disclosure is sufficient in addressing the potential for an actual or apparent conflict of interest.[xxxvii]
iii.) Recusal: Finally, members are expected to recuse themselves from the committee proceedings in cases where they deem that the financial interest may interfere with their ability to be impartial.

C. Problems identified with VRBPAC:
The Committee conducted an in-depth investigation of the VRBPAC from 1995 to present. As noted above, the approval and recommendation of the Rotashield vaccine for the treatment of rotavirus was chosen as a good example of the concerns that arise from the use of waivers by advisory committees. For the purposes of this report, we chose the VRBPAC’s December 12, 1997, meeting, at which the Rotashield vaccine received its initial approval.

This meeting was attended by 5 VRBPAC committee members, 5 temporary voting members and at least 3 consultants, in addition to both the FDA and the sponsor company’s representatives. Although Wyeth-Ayerst Laboratories (Wyeth Lederle Vaccines and Pediatrics) was the sponsoring company for the Rotashield vaccine, several other companies were deemed to be AAffected Companies by the FDA. These include: Merck, Virus Research Institute, and National Institute on Allergy and Infectious Diseases (NIAID). Advisory committee members, temporary voting members and consultants were screened for potential financial conflicts of interest with either the sponsoring or the affected companies. The decision to recommend approval of the license for the Rotashield was unanimous. The Government Reform Committee’s investigation of the VRBPAC’s Rotashield vaccine approval meeting raised several concerns:

1. Unanimous vote despite concerns raised: At the VRBPAC meeting, several members raised concerns about adverse effects that occurred at the rotavirus clinical trials. These included: intussusception, infant’s failure to thrive, and febrile reactions among others.

A statement by Dr. Fleming, a temporary voting member, summarizes the statements of many of the other voting members. He stated: “And as a result, I would ask the FDA to work with the sponsor to further quantitate what these serious side effects are — specifically the adverse effects, driven in particular by febrile illness — is inducing hospitalizations and what is that level of access. I still don’t feel like I have a good grasp of that at this point.” He proceeded to vote for the approval recommendation.[xxxviii]

2. Potential conflicts of interest of VRBPAC members: Four out of five members had conflicts of interest that necessitated waivers. Perhaps one of the major problems contributing to the overall influence of the pharmaceutical industry over the vaccine approval and recommendation process may be the loose standards that are used by the agency in determining whether a conflict actually exists. (Exhibit 53). In many cases, significant conflicts of interest are not deemed to be conflicts at all.

For this particular meeting, two members of the VRBPAC were excluded from the committee deliberations:

a.) Dr. Harry Greenberg: Dr. Greenberg was excluded from the deliberations as he is a patent holder of the Rotashield, the actual vaccine discussed at the meeting. He may have been present at the VRBPAC meeting, but it is not apparent that he participated in any way, including the open public session.

b.) Dr. Clements-Mann: It is not clear from the waiver process why she was excluded from participating in the proceedings.[xxxix] However, while Dr. Clements-Mann did not vote, she was present and did participate in the public session of the committee deliberations. Dr. Clements-Mann works for the Johns Hopkins University.

Five members out of fifteen members of the advisory committee were present in the deliberations:

c.) Dr. Patricia Ferrieri, Chair: She directed the discussion on the Rotashield vaccine. At the time of the proceedings, Dr. Ferrieri owned at about $20,000 of stock in Merck, an affected company and manufacturer of an upcoming rotavirus vaccine. This conflict was waived by the FDA as it was deemed to be of low involvement (Exhibit 56). Also, Dr. Ferrieri received a $135,000 NIAID grant for unspecified research on rotavirus[xl] for 1998-1999, after the committee voted to approve the Rotashield vaccine. It is not certain whether this grant was in negotiations at the time of the VRBPAC vote on Rotashield. Dr. Ferrieri received a full participation waiver.

d.) Dr. Caroline Hall: At the time of the VRBPAC meeting for approval of Rotashield, Dr. Hall’s employer, the University of Rochester, had a $9,586,000 contract with the NIAID for a rotavirus vaccine. As the original developer of the rotavirus vaccine, the NIAID subsequently licensed to Wyeth the rights to further develop the Rotashield vaccine. According to the conflict of interest waiver forms, neither Dr. Hall nor the principal investigator of the NIAID contract have evaluated the specific Rotashield vaccine. However, the same form states that it is unknown which rotavirus vaccine was licensed to Wyeth from NIAID. Dr. Hall was allowed to fully participate in the meeting.

e.) Ms. Rebecca Cole: The consumer representative on the VRBPAC committee at the time, Ms. Cole has been an ardent advocate for increased vaccinations after her son died of complications from his asthmatic condition and the chicken pox. As an advocate for vaccines, she has received both travel expenses and honoraria from Merck, the developer of the chicken pox vaccine, to appear in discussions advocating its use. Under the FDA standard, Ms. Cole did not need a waiver for participation.

f.) Dr. Kathryn Edwards: Dr. Edwards received a contract from Wyeth Lederle for $255,023 per year from 1996 to 1998 for the study of pneumococcal vaccines. She also had numerous grants and contracts with the NIAID, an affected company, for the following amounts: $206,750 per year from 4/1/95 to 3/1/98 to study TB vaccines; $673, 373 a year from 1996-2003 to study mucosal vaccines; and $86,279 from 1997-1998 to study acellular pertussis/cell mediate immunity. These contracts and grants were deemed to potentially appear to be a conflict, but were subsequently waived. Dr. Edwards was allowed full participation in the meeting.

g.) Dr. Mary Estes: At the time of the Rotashield approval meeting, Dr. Estes’ employer, Baylor College of Medicine, was receiving a large amount of funds for the development of rotavirus vaccines, including a $75,000 grant from American Home Products, the parent company of Wyeth-Lederle Vaccines and Pediatrics, and from the NIAID for $404,000 from 8/93 to 7/98. The FDA determined that the amount of funding is not large and represent[ed] a small portion of the University’s research budget. (Exhibit 61) Accordingly, this conflict was waived. Dr. Estes was also listed as the principal investigator for a grant from Merck for the development of a rotavirus vaccine. This conflict was also waived and Dr. Estes was given a full participation waiver for the meeting.

3. Use of temporary voting members:
An additional concern was raised by the liberal use of temporary voting members, particularly in the Rotashield approval meeting of VRBPAC. Of the ten (10) members allowed to vote in this meeting, only half (5) were standing members. The other half were temporary voting members. The VRBPAC charter states that the number of temporary members is normally not to exceed four members.[xli] This is bothersome as a meeting where a quorum cannot be constituted from the duly appointed members should be canceled until the quorum can be achieved. The temporary voting members appointed for this meeting were:

a.) Dr. Claire Broome: Senior Advisor to the Director for Integrated Health Information Systems at the Centers for Disease Control.
b.) Dr. Dixie Snider: Associate Director for Science at the Centers for Disease Control. Dr. Snider was, at the time, the Executive Secretary of the CDC’s Advisory Committee on Immunization Practices (ACIP).
c.) Dr. David Karzon: Professor at Vanderbilt University. Dr. Karzon is a frequent consultant and/or temporary voting member to the VRBPAC, voting on a variety of issues. While no apparent conflicts of interest were reported by Dr. Karzon, his employer, Vanderbilt University, receives extensive grants and contracts from pharmaceutical companies.
d.) Herbert DuPont: Professor at the University of Texas in Houston. No apparent conflicts of interest were reported.
e.) Thomas Fleming: Chair of Biostatistics at the University of Washington, Dr. Fleming has also been a frequent temporary voting member or consultant to the VRBPAC.

4. Conflicts of interest of consultants:
At least three consultants participated in the discussion of the Rotashield vaccine on December 12, 1997. They were:

a.) Dr. Neal Halsey: Dr. Halsey has been one of the leading investigators and advocates in the area of vaccines. In addition to numerous grants and contracts from different vaccine manufacturers, Dr. Halsey has received frequent reimbursements for travel expenses and honoraria from companies such as Merck. Importantly, at the time of the Rotashield approval meeting, Dr. Halsey was seeking start-up funds from most of the vaccine manufacturers for the establishment of an institute for vaccine safety at Johns Hopkins University, where he works. He has already received $50,000 from Merck and was awaiting funds from Wyeth Lederle (Exhibit 56). Dr. Halsey also participated in the rotavirus working group of the ACIP.[xlii] Also, Dr. Halsey was the Chair of the Committee on Infectious Diseases and representative of the American Academy of Pediatrics which, in conjunction with the CDC, sets and advertises the recommendations for schedules and dosages of immunizations. He was granted a waiver for participation,[xliii] participated during the morning session and then recused himself at the beginning of the afternoon session due to conflicts that were not disclosed in the minutes for the meeting. Finally, Dr. Halsey’s employer, Johns Hopkins University, is also the employer of Dr. Clements-Mann, who was excluded from the discussions.

b.) Dr. Yvonne Maldonado: No apparent conflicts were listed for Dr. Maldonado.

c.) Dr. John Modlin: At the time of the Rotashield approval meeting, Dr. Modlin owned approximately $26,000 in Merck stock, an affected company. He has also served on Merck’s Immunization Advisory Board from 1996 to the present. These financial interests were waived and he was allowed to extensively participate in the meeting although, as a consultant, he was not allowed to vote. Also, Dr. Modlin was at the time the Chairman of the ACIP and its rotavirus working group.

5. Balanced representation:
As previously discussed, the statutory requirement of balanced representation is one of the most controversial provisions of the FACA. The FDA has interpreted “balance” as diversity of geography, ethnicity, disciplines and gender. While it is questionable whether this standard guarantees the balance of points of view represented expressly required by the statute, it was interesting to see the high concentration of professors in pediatrics represented on the VRBPAC committee, particularly during the Rotashield discussion (Dr. Ferrieri, Dr. Karzon, Dr. Edwards, Dr. Modlin, and Dr. Halsey). Also, two of the voting members work for Vanderbilt University (Dr. Edwards & Dr. Karzon), while one member Dr. Clements-Mann (who, although excluded from voting, was able to participate in the open public hearing part of the meeting) and Dr. Halsey, both come from Johns Hopkins University. Two of the voting members (Dr. Broome and Dr. Snider) are CDC Federal employees. The overwhelming majority of members, both voting members and consultants, have substantial ties to the pharmaceutical industry.

6. Recurrent membership:
A troubling pattern is the recurrence of members, temporary voting members and consultants, year after year, despite term limits, which greatly limits the diversity of opinion that is sought in this type of committee.[xliv] After reviewing the VRBPAC rosters of members and consultants for the past few years, it becomes apparent that many of the members have frequently participated in committee proceedings for many years. Also, it is evident that there is a significant number of people who frequently participate in proceedings at both the FDA and the CDC, despite a policy that prohibits the simultaneous participation of members in more than one advisory committee within the agency.[xlv] In this particular meeting, at least four of the members (Dr. Broome, Dr. Snider, Dr. Modlin and Dr. Halsey) were intrinsically involved in the development of recommendations for the CDC. In other words, these persons influence the process of vaccine approval and recommendation. Dr. Halsey also chaired the American Academy of Pediatrics committee which helps set and advertise the schedule and dosage of recommended vaccines. Also, several of the temporary voting members frequently participate in VRBPAC’s meeting, without actually becoming members, thus severely limiting the diversity of participation and opinion.[xlvi] Other members are retained as temporary voting members and/or consultants once their four year term on the advisory committee has expired.[xlvii]

7. Timing of the proceedings:
A particularly troubling aspect of the deliberations on the Rotashield vaccine is the sequence of events. The ACIP Committee voted to recommend universal vaccinations of infants before the FDA licensure of the vaccine. Officials of the CDC acknowledge that they knew of no other instance where this has happened. As discussed before, during the December 12, 1997, VRBPAC vote to recommend the licensure of the Rotashield vaccine, a number of concerns were raised by some of the members with regard to the vaccine and its possible adverse effects. Although the VRBPAC unanimously approved the vaccine recommendation, some of the committee members votes were conditioned on the FDA’s ability to successfully resolve the areas of concern. However, before the FDA final licensure of the Rotashield vaccine in August 1998, the ACIP committee – as will be discussed in the ACIP section of this report- had already voted to recommend the mandatory universal use of the vaccine. This is troubling, not only because the vaccine had not yet been approved by the FDA, but because there were several areas of concerns that may not have been successfully addressed by the FDA, at the time of the ACIP vote.

Section V
Centers for Disease Control and Prevention
The Advisory Committee on Immunizations Practices

A. Practices and Procedures of the Advisory Committee on Immunization Practices (ACIP)

1. Purpose of the ACIP
ACIP provides advice and guidance on vaccine policy to the Secretary of DHHS, the Assistant Secretary for Health, and the Director of CDC. The ACIP develops written recommendations, subject to the approval of the Director of the CDC, for the routine administration of vaccines to the pediatric and adult populations, along with schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the vaccines.

The recommendation for routine use of a vaccine is tantamount to a Federal mandate for vaccine use. HHS regulations require that all grants for childhood immunizations are subject to the States’ implementation of procedures to ensure routine vaccination. To receive federal funding the States must, among other things, require a plan to systematically immunize susceptible children at school entry through vigorous enforcement of school immunization laws.[xlviii]

Additionally, the ACIP has been given a mandate from Congress by the Omnibus Budget Reconciliation Act of 1993, to establish and periodically review and, as appropriate, revise a list of vaccines for administration to children in the Vaccine For Children Program (VFC), along with schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the pediatric vaccines.[xlix] The VFC program provides for public purchase of vaccines for children without health insurance coverage. Under the VFC program, $474 million has been obligated to pay for the purchase of vaccines in fiscal year 2000.

2. Membership of the ACIP
The ACIP has three different categories of membership consisting of voting members, ex-officio members and liaison representatives.

a. Voting Members of the ACIP
The ACIP has twelve voting members, including the Chair, all approved by the Secretary of DHHS or his designee.[l] The ACIP members are selected based upon their expertise in the field of immunization practices.[li] The membership consists of U.S. citizens that have multi-disciplinary expertise in public health, and expertise in the use of vaccines and immunologic agents in both clinical and preventive medicine. The ACIP membership is required by FACA and agency guidelines to be fairly balanced in terms of point of view represented and the committee’s function. Specifically, the CDC attempts to select members from diverse backgrounds including geographic areas, gender, ethnic and minority groups, and the disabled.

(i.) Procedure for nomination to the ACIP
New members are nominated to the ACIP on an annual basis. Suggestions for membership to the committee are sought from a variety of sources including current and former ACIP members, professional societies, vaccine manufacturers and the general public. A panel of government officials screens the candidates for nomination to the committee and submits a slate of possible nominees to the director of the CDC. With approval of the CDC director, a nomination package is prepared for the Secretary of DHHS who makes the official appointments to the committee.

Committee members are nominated to serve for overlapping four-year terms. Members may serve after the expiration of their terms until their successors have taken office.[lii]

b. Ex Officio Members of the ACIP
The ACIP charter designates seven non-voting ex officio members to the committee from the following federal agencies:

1. Deputy Director, Division of Vaccine Injury Compensation, Bureau of Health Professions, Health Resources and Services Administration
2. Deputy Director for Scientific Activities, Office for the Assistant Secretary of Defense
3. Under Secretary for Health, Department of Veterans Affairs
4. Director, National Center for Drugs and Biologics, Food and Drug Administration (FDA)
5. Medical Advisor, Medicaid Bureau, Health Care Financing Administration (HVFA)
6. Director, Microbiology and Infectious Diseases Program, National Institute of Allergy and Infectious Diseases, HHS
7. Director, National Vaccine Program Office, CDC[liii]

Generally, designees of the officials listed above hold the ex officio positions. In contrast to regular voting members, who are expected to voice their personal opinions, ex-officio members are expected, to the extent possible, to represent the position and views of their sponsoring organizations.[liv]

c. Liaison Members:
In addition to the voting members and ex-officio members, the ACIP charter specifies 16 additional non-voting liaison representatives from professional societies and organizations responsible for the development and execution of immunization programs for children and adults. Like ex officio members, liaison members are expected, to the extent possible, to represent the positions and views of their sponsoring organizations. Liaison members are expected to contribute to committee discussions when issues of importance to their organizations are being discussed. These members can serve as appointed consultants to working groups and subcommittees to provide expert advise and apprise the working group of the position their organization endorses.[lv]

The liaison representatives to the ACIP consist of representatives from the following organizations:
1. American Academy of Family Physicians
2. American Academy of Pediatrics
3. American Association of Health Plans
4. American College of Obstetricians and Gynecologists
5. American College of Physicians
6. American Hospital Association
7. American Medical Association
8. Association of Teachers of Preventative Medicine
9. Canadian National Advisory Committee on Immunization
10. Hospital Infection Control Practices Advisory Committee, CDC
11. Infectious Diseases Society of America
12. National Medical Association
13. Pharmaceutical Research and Manufacturers of America
14. National Vaccine Advisory Committee
15. Biotechnology Industry Organization
16. Secretario de Prevencion y control de Enfermedades, Mexico

3. Decision-Making Process of the ACIP
a. Working Groups of the ACIP
When deemed appropriate by the Executive Secretary and the Chair of the ACIP, working groups may be formed to prepare draft policy recommendations to be submitted to the full ACIP for its consideration. The working groups must: 1) include one or more regular voting members, 2) include CDC staff members, 3) may include ex officio members and liaison representatives and other consultants. Vaccine manufacturer’s official representatives may not serve on working groups but, at the discretion of the chair, may be consultants to a working group.[lvi]

Generally, working groups range from six to fifteen members.[lvii] The working group is charged with reviewing all pertinent information relative to the recommendation for use of a vaccine. No notice is given to the public of working group meetings and discussions of the group are held in private. No minutes are taken at the meetings.

Upon drafting a proposed recommendation, the chair will submit the draft proposal to the ACIP for consideration. The ACIP members review the proposal and suggest revisions to the working group. This process is generally repeated numerous times. The process for making a final recommendation to the full ACIP generally takes eighteen to twenty-four months. The work that the working group does contributes in large part to the recommendations for use of a vaccine submitted to the Director for approval.

b. Full Meetings of the ACIP
Regularly scheduled meetings are usually held three times a year, at the discretion of the CDC, with meeting dates announced six to twelve months in advance. Notices of each meeting, along with agenda items that may be discussed, are published in the Federal Register in accordance with the requirements of FACA. Potential topics for ACIP consideration can be suggested by anyone, but are most often proposed by CDC program staff, ACIP members, and vaccine manufacturers.[lviii]

The meetings of the ACIP are held in public and are widely attended by representatives from government, industry, and other interested parties. Frequent votes are taken to decide on a given policy matter at hand. Whenever six or more members are not eligible to vote by reason of financial conflict or interest, the Executive Secretary has the authority to temporarily designate the ex-officio members as voting members.

c. Final Recommendations for Vaccine Use
ACIP recommendations are submitted to the agency for approval. Upon acceptance by the agency, ACIP recommendations are published in the Morbidity and Mortality Weekly Report Recommendations and Report published by the CDC. While the recommendations by the ACIP to the CDC are subject to agency approval, longtime CDC officials do not remember an ACIP recommendation that was not approved by the agency.[lix]

B. The ACIP Conflicts of Interest Resolution Process
1. Disclosure Requirements for ACIP Members As an SGE, every member of the ACIP is required to file the standard OGE form 450 confidential financial disclosure report once a year.[lx] New members of the ACIP must file a new entrant report no later than 30 days after assuming their position. All reports must cover the 12 months preceding the date of filing.
Members must report specific sources of earned income over $200 for the filer and $1,000 for the filer’s spouse. ACIP members must report all honoraria received in excess of $200, along with the date services were provided. The $1,000 threshold for spousal earned income does not apply to honoraria, because of special concerns about that form of income.[lxi] They must also report all assets held for investment or the production of income with a fair market value greater than $1,000 at the end of the reporting period. The filer does not have to report the dollar amount or values for any asset or income.[lxii]

2. Reviewer’s Responsibilities
The ACIP Deputy Ethics Officer, Mr. Joseph Carter, is responsible for ensuring that the OGE 450 is completely and properly filled out. Specifically, the reviewer is required by the OGE to check for the completeness of the financial disclosure form and that each asset and source of income are listed separately.

3. ACIP Waiver Process
Waivers are granted to each and every member of the ACIP whether or not they have conflicts of interests listed on their OGE 450. The ACIP issues “limited” 208 (B)(3) waivers on an annual basis to members who have potential conflicts of interest. The waivers allow members to participate in all matters that come before the ACIP, with the provisos that: (1) members recuse themselves from voting on matters involving vaccine-related entities where they have a current direct financial interest and (2) that they publicly disclose all relevant financial interests at the beginning of each ACIP meeting.

The waiver states that under Section 208(a) the members are under statutory obligation to refrain from participating in any deliberation that involves a particular matter having a direct and predictable effect on a financial interest attributed to them. They provide that the deputy ethics counselor has the authority under 18 U.S.C. §208(b)(3) to grant a waiver permitting the ACIP member to participate in such matters as deemed appropriate.[lxiii]

Waivers are requested by the Executive Secretary of the ACIP, Dr. Dixie Snyder, Jr. CDC Legal Counsel Kevin Malone concurs that the waiver is appropriate and the Deputy Ethics Counselor, Mr. Joseph R. Carter, is responsible for approving the waiver. In interviewing these individuals, the Committee staff was told, “we generally give them to everyone…we give them out freely.” The CDC representatives explained, it is “the nature of the industry that they will have conflicts…we will allow you to participate if you disclose your conflicts…we will let you discuss but not vote.”[lxiv]

4. Work Sheets
The Executive Secretary prepares a work sheet prior to every ACIP meeting detailing the conflicts of interest that members may have pertaining to the topics on the agenda. The work sheet is only for his use and is not disclosed to the public. The documents are considered informal and are not saved by the CDC.

C. Problems Identified During the Committee’s Investigation

The Committee staff’s review of the ACIP’s consideration of the rotavirus vaccine identified serious weaknesses in the CDC’s policing of conflicts of interest on this advisory committee. On June 25, 1998, the ACIP voted to recommend the rotavirus vaccine for routine use in infants. In reviewing the minutes of ACIP meetings and the financial disclosure forms of the ACIP members, the Committee staff identified a number of troubling issues:
1. ACIP Members Do Not Fully Disclose Conflicts of Interest
Examination of ACIP members’ financial disclosure forms reveals that many members do not fill them out completely. CDC ethics officials conceded to Committee staff that they have been lax in compelling the ACIP members to provide complete and thorough information.[lxv]
a. Dr. Mary (Mimi) Glodé (Exhibits 3-15)
Dr. Glodé lists reviews of medical legal cases on her OGE 450 for 1996, 1997, 1998, 1099 at 5 per year for her and her spouse, but does not detail the law firms or clients for whom they do the legal work. She only discloses that the maximum income allowed by University of Colorado is $10,000 per year.

Dr. Glodé and her spouse have attended numerous conferences and received honoraria for their attendance. However, she does not list who the sponsors were in 1995, 1996, 1997, 1998, 1999. She states only that the honoraria given was from $500-$750 Per occurrence and were limited to five per year; her spouse does 5-10 per year as well.

On her 1996 FDA financial disclosure form she lists that she was a co-principal investigator on an $84,500 grant from Chiron to study the MGNIN C Vaccine, $10,000 of which was a part of her salary. The study lasted for fifteen months from 10/96-3/98. But on her CDC financial disclosure forms for 1997, 1998, and 1999, this funding was not mentioned as required. Furthermore, the conflict was not mentioned on the waivers granted to her by the CDC for the same years. According to the Federal conflict of interest statutes she would not be able to participate in any deliberations regarding Chiron before the ACIP.

b. Dr. Marie Griffin
Dr. Griffin doesn’t fill out a new form each year. She references previous year’s forms instead and adds any new items to the current year’s form. (Exhibit 18)

She lists “publicly traded stock,” but not the specific companies on her 10/6/94, 2/95, 6/9/96, and 10/20/97 OGE 450. This is not sufficient under the law. (Exhibit 16)

c. Dr. Paul Offit
Dr. Offit lists that he is a consultant to Merck on an attachment to his OGE 450, but does not disclose whether or not he received any remuneration for his services. (Exhibit 39)

d. Dr. Richard Clover
Dr. Clover lists legal fees paid by the law firm of O’Bryan, Brown, and Toner, but not their client. (Exhibit 1)

The CDC informed the Committee staff that they have been unhappy with the OGE 450 and are working on a supplemental form. They stated that they wanted a form that was more specific and easier to fill out. Two years ago at the June 24-25, 1998, ACIP meeting, CDC Legal Counsel Kevin Malone stated his concerns to the ACIP:
“The 450 is a very frustrating form. All of us use the same form too and it is very difficult to even figure out what it is you should be disclosing. One of the things we’ve talked about is producing a supplementary form that would more explicitly lay out types of issues because certainly if we’re going to be in a position that we have to be announcing these interests, we would also need to feel a little bit more confident, I think that everything is being reported.”[lxvi]

However, two years later, the supplemental form has yet to be put into use.

2. Every Member of the ACIP is Granted a 208 (B) Waiver for the Entire Year
The CDC grants blanket waivers to the ACIP members each year that allow them to deliberate on any subject, regardless of their conflicts, for the entire year. In contrast, the FDA grants waivers on a meeting by meeting basis, taking into consideration the issues on the agenda and the affected companies discussed. Moreover, the FDA provides a list of parties that will be affected by their vote so their members clearly understand when they can not participate.

The CDC’s policy of issuing annual waivers creates an environment where people do not take the conflict of interest issue as seriously as they should. This policy, in concert with sloppy monitoring of the completeness of members’ financial disclosure statements, allows for a clubby environment where ethical concerns are downplayed.

3. ACIP Members are Allowed to Vote on Vaccine Recommendations, Even When They Have Financial Ties to Drug Companies Developing Related or Similar Vaccines

Members of the ACIP are allowed to vote on a recommendation for one company’s vaccine even if they have financial ties to a competing firm developing a similar vaccine. For example, in the case of rotavirus vaccine, the vaccine before the advisory committee was developed by Wyeth-Lederle. However, Merck and Smithkline-Beecham had rotavirus vaccines under development. A recommendation for Wyeth-Lederle’s vaccine would help pave the way for future recommendations for the products of Merck and Smithkline-Beecham.

While ACIP members with ties to Wyeth-Lederle were not allowed to vote on recommendations for the rotavirus vaccine, those with ties to Merck and Smithkline-Beecham were allowed to vote. This stands in stark contrast to the policies of the FDA. In discussions with FDA staff on this specific issue they informed the Committee staff that when the VRBPAC is deliberating the licensure of a vaccine, a company is considered affected [an affected company is one with a direct interest] if they are direct competitors of the manufacturer of the vaccine being considered. They further clarified that that this policy was in place because of the competing interest of the affected company and not because of concerns about the release of proprietary information. Moreover, if a VRBPAC member has a direct interest with a competing firm they are automatically disqualified from participation.

At ACIP meetings from February 11, 1998, through June 17, 1999, there were eight votes related to the their approval of the rotavirus vaccine for routine use. Three of these votes were particularly notable. They include: (1) June 25, 1998 – The ACIP approved the statement recommending the rotavirus vaccine for routine use, (2) October 22, 1998 – The ACIP recommended the rotavirus vaccine be added to the Vaccines for Children Program, and (3) October 22, 1999-the ACIP rescinded its earlier decision to recommend the rotavirus vaccine.

a. Dr. John Modlin-Chair beginning 2/11/98 (Exhibits 35-37)

Dr. Modlin owned 600 shares of stock in Merck as listed on his OGE 450. He serves on Merck’s Immunization Advisory Board but receives no remuneration. Dr. Modlin informed committee staff that he divested his shares in Merck some time in 1999.

Dr. Modlin was the Chairman of the Rotavirus working group. He voted yes on eight different matters pertaining to the ACIPs rotavirus statement, including recommending for routine use and for inclusion in the VFC program.

b. Dr. Paul Offit (Exhibits 38-41)
Dr. Offit shares the patent on the Rotavirus vaccine in development by Merck and lists a $350,000 grant from Merck for Rotavirus vaccine development. Also, he lists that he is a consultant to Merck.

Dr. Offit began his tenure on ACIP in October of 1998. Out of four votes pertaining to the ACIP’s rotavirus statement he voted “yes” three times, including, voting for the inclusion of the rotavirus vaccine in the VFC program.

Dr. Offit abstained from voting on the ACIP’s rescission of the recommendation of the rotavirus vaccine for routine use. He stated at the meeting, “I’m not conflicted with Wyeth, but because I consult with Merck on the development of rotavirus vaccine, I would still prefer to abstain because it creates a perception of conflict.”[lxvii]

c. Dr. Fernando Guerra (Exhibits 30-31)
Dr. Guerra lists a Contract with Merck Vaccine Division from 2/99-8/99 on his OGE 450, and a donation of $25,000 by Merck, Pasteur Merieux Connaught, and Medimmune (5/11/99 supplement to OGE 450). Also, he has a Contract with Smithkline-Beecham as a Principal Investigator (pending 7/99).

Dr. Guerra voted yes on eight different matters pertaining to the ACIP’s rotavirus statement, including recommending for routine use and for inclusion in the VFC program.

d. Dr. Marie Griffin (Exhibits 16-29)
Dr. Griffin lists consultant fees (3/21/97) and a salary from Merck relating to her position as Chair of Merck’s Endpoint Monitoring Committee on her OGE 450 (5/12/98 & 1/22/98).

She also lists consulting fees and travel expenses paid by Merck. (Exhibit 22)
Her spouse is a consultant for American Cyanamid (5/12/98 disclosure). American Cyanamid and Wyeth-Lederle are Subsidiaries/divisions of American Home Products Corporation.

Dr. Griffin voted on seven different matters (yes six times and no once) pertaining to the ACIPs rotavirus statement, including recommending yes for routine use and for inclusion in the VFC program.

d. Dr. T. Chinh Le (Exhibits 32-34)
Dr. Le’s employer, Kaiser Permanente, is participating in vaccine studies with Merck, Wyeth-Lederle, and Smithkline-Beecham. Additionally, Dr. Le owns stock in Merck as reported on his OGE 450. Dr. Le abstained from voting on all but one issue related to the Rotavirus.

e. Dr. Richard Clover (Exhibits 1-2)
Dr. Clover lists educational Grants from Merck and Smithkline-Beecham on his OGE 450. He voted on seven different matters (six times and no once) pertaining to the ACIPs rotavirus statement, including recommending voting yes for routine use and for inclusion in the VFC program.

4. Members Who are Not Allowed to Vote on a Recommendation Due to Financial Conflicts are Allowed to Fully Participate in the Discussion Leading up to a Vote
The “limited” 208(B)(3) waiver process enacted by the CDC allowing for discussion in all matters before the ACIP by conflicted members appears to be in direct contradiction to common practice at other DHHS agencies.

As stated succinctly by the Congressional Research Service, “Clearly, the influence on Government policy from advice and persuasion during a “discussion” of a particular recommendation, immediately preceding a vote on that recommendation, is significant and is equal under the law, to participating in a particular recommendation by way of voting for or against that recommendation.”[lxviii]

a. Inappropriate Statements by ACIP Members Undoubtedly Influence the Process
This is evidenced by several exchanges between Dr. T. Chinh Le and members of the ACIP. At one point during deliberations on the rotavirus vaccine, he said, “if I were to vote for this, I would vote for this routine immunization” and went on to encourage a two-dose regimen for the vaccine.[lxix] Moreover, at the June 1998 ACIP, meeting during which they approved the statement for routine use of the rotavirus vaccine, he said he “feels very privileged to be able to participate in a discussion that he cannot vote on . . . Hopefully, that perhaps what I will say will influence the people who can vote [referring to ex officio members] for me if I cannot vote.” When Committee staff queried CDC ethics officials regarding these statements, they acknowledged that they were inappropriate, and that they had discussed the issue with Dr. Le.

Dr. Le abstained from all but one vote related to the rotavirus vaccine because of significant conflicts of interest as stated earlier in this report. He did, however participate extensively in deliberations on the rotavirus vaccine and was a member of the rotavirus working group.

CDC conflict of interest policies are contrary to those of both the FDA, as cited earlier in this report, and that of the National Institutes of Health (NIH). The Office of Federal Advisory Committee Policy (OFACP) at NIH clearly states that a 208 (B)(3) waiver “is considered a ‘general’ waiver, in that it allows participation in matters that affect all institutions, or types of institutions, similarly. Even with a general waiver, however SGEs must disqualify themselves from participation in all matters that specifically and uniquely affect their [particular] financial interest.”[lxx]

5. Liaison Representatives Don’t have to Disclose Financial Conflicts of Their Organizations
Liaison representatives to the ACIP are not considered SGEs by the CDC.[lxxi] As such, they are exempted from the Federal conflict of interest statues the financial disclosure process. In the process of investigating events leading up to the approval of the rotavirus vaccine, the Committee staff has learned that the relationship between liaison members and the ACIP is substantially more formal than described by the CDC.

ACIP liaison members provide more than the just the opinions of their organization to the advisory committee’s process. Their role of the liaison representatives is more like that of a de facto SGE than an advisory representative. They are central to the process of creating recommendations for vaccine use by the ACIP. As official voting members of working groups that write draft recommendations for the committee’s consideration, they are under routine supervision by CDC staff and have meetings in government offices. Moreover, their advice is solicited frequently by CDC personnel on issues where their organization has a financial interest.
In a cursory review of publicly available references and an internet search, the Committee staff was able to find that the following organizations that the ACIP liaison representatives represent have ties to numerous vaccine manufacturers.

a. American Academy of Family Pediatrics
Abbott Laboratories, American Home Products Corporation, Aventis, Bayer Corporation, bioMerieux, Boehringer Ingelheim Chemicals Co., Bristol-Myers Squibb Company, Eli Lilly and Company, Forest Laboratories, G.D. Searle & Co., Glaxo Wellcome plc, Janssen Pharmaceutica, Lederle Laboratories, Merck & Co., Muro Pharmaceuticals, Novartis, Novo Nordisk A/S, Ortho-McNeil Pharmaceuticals, Otsuka America Pharmaceutical, Inc., Pasteur Merieux Connaught, Pfizer, Inc., Pharmacia, Schering AG, Schwarz Pharma, Inc., SmithKline Beecham, Solvay S.A., Warner-Lambert Company, and Wyeth-Ayerst Laboratories .[lxxii]

b. American Academy of Pediatrics
Abbott Laboratories, Astra, Merck & Co., Pasteur Merieux Connaught, Pfizer, Inc., and SmithKline Beecham.[lxxiii]

c. American College of Obstetricians and Gynecologists
Berlex Laboratories, Eli Lilly and Company, Novartis, Ortho McNeil Pharmaceutical, Pharmacia, Schering AG, and Wyeth-Ayerst.[lxxiv]

d. American Medical Association
Aventis, Glaxo Wellcome plc, Merck & Co., Pfizer, and Shering AG.[lxxv]
e. Infectious Disease Society of America
Aventis and Bristol-Myers Squibb Company.[lxxvi]

f. Biotechnology Industry Organization
Merck & Co., Wyeth-Ayerst and many other pharmaceutical companies.[lxxvii]

g. Pharmaceutical Research and Manufacturers of America

6.The Use of Working Groups is Contrary to the FACA (Exhibit 71)
a. Members of the Rotavirus Working Group of the ACIP
The ACIP rotavirus work group was responsible for creating the statement recommending universal use of the rotavirus vaccine. The working group has ten members, seven of whom have identifiable conflicts of interest with vaccine manufacturers or vaccine interest groups. The group’s meetings were held in private with no minutes or records of the proceedings taken. It appears that members who were not allowed to vote because of conflicts of interest with Wyeth-Lederle, such as Dr. Le, were allowed to work extensively on the recommendation for a long period of time in the working group.
The broad ability to grant waivers from the federal conflict of interest statutes was specifically enacted because of the statutory requirements and safeguards of the FACA. FACA requires that advisory committees hold public meetings, except in unusual circumstances. As such, deliberations of advisory committees are open to the most exacting public scrutiny. These requirements are to ensure public scrutiny of advisory committees operations and ensure that it is not a secretive or hidden vehicle for special interest influence.[lxxviii] The ACIPs prolific use of working groups to draft vaccine policy recommendations outside the specter of public scrutiny opens the door to undo special interest access.

i. John Modlin, M.D., Chairman
Chinh T. Le, M.D.
David W. Fleming, M.D
ACIP Voting Members
Dr. Le has conflicts with Wyeth Lederle and Smithkline-Beecham and Dr. Modlin has a conflict with Merck as described in this report.

ii. Roger I. Glass, M.D., Ph.D.
Joseph S. Bresee, M.D.
Centers for Disease Control and Prevention
National Center of Viral and Rickettsial Diseases
National Center for Infectious Diseases

iii. Margaret Rennels, M. D.
Department of Pediatrics, University of Maryland
Her employers website states that she participated in virtually all phases of the testing of the licensed rotavirus vaccine[lxxix] Also, she is affiliated with U.S. Rotavirus Efficacy Group[lxxx]

iv. Richard Zimmerman, M.D.
American Academy of Family Physicians (AAFP)
The AAFP has conflicts with numerous vaccine manufacturers as described in this report.

v. Neal A. Halsey, M.D.
American Academy of Pediatrics
At the time of the rotavirus approval meeting, Dr. Halsey was seeking start-up funds from most of the vaccine manufacturers for the establishment of an institute for vaccine safety at Johns Hopkins University, where he works. He has already received $50,000 from Merck and was awaiting funds from Wyeth Lederle. (Exhibit 56) He has received frequent reimbursements for travel expenses and honoraria from companies such as Merck.

Dr. Halsey Serves on the advisory board to the Immunization Action Coalition, an advocacy group funded by vaccine makers including: Aventis Pasteur, Chiron Corporation, Glaxo Wellcome, Merck & Co., Nabi, North American Vaccine, SmithKline-Beecham, Wyeth-Lederle Vaccines.[lxxxi]

vi. Peter Paradiso, Ph.D.
Lederle-Praxis Biologicals Division
Wyeth-Lederle Vaccines and pediatrics

vii. Florian Schodel, M.D.
Office for Clinical Vaccine Research
Merck Research Labs

7. ACIP is not Fairly Balanced in terms of the Points of View Represented
According to section 5 of FACA, membership on an advisory committee must be “fairly balanced in terms of points of view represented and the functions to be performed . . . ” and the advice and recommendations of the advisory committee cannot be “inappropriately influenced by the appointing authority or by any special interest.”

The absence of any consumer advocates on the ACIP has resulted in an advisory committee that is inherently not “fairly balanced.” It is clear to the Committee that the intent of the FACA was for individuals who are affected by the work of the ACIP, in this case vaccine recipients, to have significant representation on the committee.

The ACIP’s use of ex officio members, who are all government employees, in a voting capacity contradicts the notion of an advisory committee. Advisory committees are intended to provide independent information and advice to the government. In discussions with CDC staff, the Committee was informed that there are no records of an ex officio member ever voting no on an issue before the ACIP. This policy encourages a system where government officials make crucial decisions affecting American children without the advice and consent of the governed.

Congress sought to eliminate “the danger of allowing special interest groups to exercise undue influence upon the Government through dominance of advisory committees which deal with matters in which they have vested interests.”[lxxxii] However, the extensive use of working groups, in which conflict of interest procedures do not appear to be implemented, and the automatic waivers given to every advisory committee member, along with the absence of consumer representation, appear to thwart this goal.

Section VI
Recommendations
As a result of the review of the ACIP and VRBAC practices, the following Committee has the following recommendations to the Department of Health and Human Services:
1. Individuals who serve on advisory committees involving vaccines should have no financial ties to vaccine manufacturers.

2. Public participation on ACIP and VRBAC needs to be increased substantially.

3. Conflict of Interest waivers should be used more stringently.

4. A balance of policy perspectives should be incorporated into consideration of appointments of committee members.

5. Any level of stock ownership in vaccine manufacturers should not be allowed by committee members.

6. Department personnel need to insure that all documentation is fully and adequately completed.

7. Full explanation of participation as expert witnesses in legal cases needs to be a part of financial disclosures.

8. Individuals who have patents for vaccines for the same disease under discussion should not be allowed to participate in the discussion or vote of ACIP or VRBAC.

9. Individuals who are developing vaccines for the same disease under discussion should be not be allowed to participate in the discussion or vote of ACIP and VRBAC.

10. Working groups should be replaced by fully constituted Subcommittees on both the VRBAC and ACIP.

11. Individuals should not be allowed to participate on two DHHS advisory committees at the same time.

12. Individuals should not serve excessively long terms on a committee.

13. The FDA should reconsider its policy on using temporary voting members.

14. ACIP should not consider making a recommendation on a vaccine until it has been licensed by the FDA.

15. CDC should follow the same policy in identifying affected companies for vaccine discussions as the FDA does and exclude participation of any individual who has a conflict.

16. Organizations who send liaison members to participate in council meetings, should offer full disclosure of ties to the pharmaceutical industry.

17. The Department should review its policies and practices regarding conflicts of interest, participation on advisory committees, and terms of service, public participation, and balance of views and expertise.

[i] 5 U.S.C. app. II (1994).
[ii]Ensuring Coverage, Balance, Openness and Ethical Conduct for Advisory Committee Members Under the Federal Advisory Committee Act, 5 Admin. L.J. 231, Mary Kathryn Palladino, Spring, 1991.
[iii]5 U.S.C. app. II ’7(c). The guidelines for the Food and Drug Administration=s advisory committee are set forth in 5 C.F.R. ’2640 (1994)
[iv]5 U.S.C. app. II ’2(b)(6) (1994).
[v]5 U.S.C., ’10 (b).
[vi]5 U.S.C., ’5 (b)(2).
[vii]5 U.S.C., ’5(b)(3).
[viii]18 U.S.C. ”202-209.
[ix]18 U.S.C. ’208.
[x]18 U.S.C. ’208(b)(1).
[xi]18 U.S.C. ’208(b)(2).
[xii]18 U.S.C. ’208(b)(3).
[xiii]FACA amendments of 1989
[xiv]5 C.F.R. ’2640.103(a)(1).
[xv]5 C.F.R. ’2640.102(l).
[xvi]5 C.F.R. ’2640.102(m).
[xvii]5 C.F.R. ’2640.103(a)(3).
[xviii]Id.
[xix]Id. at (b).
[xx]Id. at (c)(5).
[xxi]5 C.F.R. ‘ 2635.807.
[xxii]5 C.F.R. ’2635.502.
[xxiii] Minutes of ACIP meeting, October 22, 1999 at 51.
[xxiv] Bad Bug Book, U.S. Food & Drug Administration, Center for Food Safety & Applied Nutrition, Foodborne Pathogenic Microorganisms and Natural Toxins Handbook, Chapter 33

http://vm.cfsan.fda.gov/~mow/chap33.html.

[xxv] Minutes of ACIP meeting, October 22, 1999, 56-57.
[xxvi] CDC’s Rotavirus Q&A http://www.cdc.gov/nip/Q&A/genqa/Rotavirus.htm.
[xxvii] Rotashield Package Insert, Wyeth-Ayerst, 13.
[xxviii]VRBPAC charter, DHHS, 12/21/99.
[xxix]5 C.F.R. ’2640.103(a).
[xxx]Waiver Criteria Document 2000, FDA, 2. (Replacing the AWaiver Criteria Document (1994).@)
[xxxi]Id. at 19.
[xxxii]Id. at 23.
[xxxiii]Id. at 20. Where the grant or contract relates to the subject matter of the committee discussion, an actual conflict may arise. In situations where the grant or contract is unrelated to the product at issue, an appearance problem may arise. In either situation the conflict of interest may be waived and the member allowed to participate.
[xxxiv]Id. at 17.
[xxxv]Policy and Guidance, Handbook for FDA Advisory Committees, 12.
[xxxvi]Waiver Criteria Document (2000), FDA, 19.
[xxxvii]Id.
[xxxviii] VRBPAC “Rotashield” rotavirus vaccine approval meeting transcript, page 210, December 12, 1997.
[xxxix]A copy of the waiver forms have not been provided to the Committee.
[xl]The NIAID is the original developer of the Rotashield and other rotavirus vaccines. According to the FDA, as stated in Dr. Caroline Hall’s Conflict of Interest Waiver form, Wyeth received the rights to further develop the Rotashield from NIAID and it is unknown which rotavirus vaccine was licensed to Wyeth by the NIAID.
[xli]Please see VRBPAC Charter. Exhibit 54
[xlii]See further discussion of the ACIP rotavirus working group in the ACIP section of this report. Section IV
[xliii]Consultants may be allowed to participate in the committee’s discussion, but may not vote, unless designated a temporary voting member in advance of the meeting.
[xliv]According to the DHHS policy, members cannot serve for more than eight combined years within a period of 12 years.
[xlv]Letter from Mr. David Doleski, FDA, to the Government Reform Committee (March 30, 2000), stating that the DHHS policy states that Federal advisory committee members will not: ..serve on more than one committee within an agency at the same time.
[xlvi]Some of the frequent temporary members and consultants in the past few years include: Dr. Fleming (at least 4 meetings from 7/96 to 12/97); Dr. Karzon (at least 5 meetings between 4/96 until 9/99); Dr. Snider (at least 4 meetings in 1997, before becoming a standing member in 1998); Dr. Broome ( 8 meetings from 4/96 to 12/97); Dr. Diane Finkelstein (consultant in at least 5 meetings from 4/96 to 12/97, when she became a standing member); Dr. Theodore Eickhoff (consultant on at least 8 meetings from 4/96 to 9/99); Dr. Rob Breiman (4 meetings from 11/98 to 9/99).
[xlvii] For example, Dr. Ferrieri (at least 4 meetings past her appointment ); Dr. Gregory Poland (at least 2 meetings past his appointment); Dr. Alison O’Brien ( at least 3 meetings past her appointment) and Ms. Rebecca Cole (1 meeting past her appointment).
[xlviii] 42 C.F.R. §51b.204
[xlix] Section 1928 of the Social Security Act (42 U.S.C. § 1396s), as added by Section 13631 of the Omnibus Budget Reconciliation Act of 1993
[l] ACIP Charter, May 3, 1998 as approved by Claire Broome, Acting Director CDC (Exhibit 72)
[li] ACIP Charter, May 3, 1998 as approved by Claire Broome, Acting Director CDC, 2
[lii] ACIP Charter, May 3, 1998 as approved by Claire Broome, Acting Director CDC, 3
[liii] ACIP Charter, May 3, 1998 as approved by Claire Broome, Acting Director CDC, 2
[liv] The Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention, Policies and Procedures for Development of Recommendations for Vaccine Use and for the Vaccines for Children, January 2000, 4 (Exhibit 73)
[lv] ACIP Charter, May 3, 1998 as approved by Claire Broome, Acting Director CDC, 4
[lvi] The Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention, Policies and procedures for Development of Recommendations for Vaccine Use and for the Vaccines for Children, January 2000.
[lvii] Telephone interview of Dr. John Modlin (June 9, 2000).
[lviii] The Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention, Policies and Procedures for Development of Recommendations for Vaccine Use and for the Vaccines for Children, January 2000.
[lix] Interview of Dr. Dixie Snider, Mr. Kevin Malone and Mr. Joe Carter (June 1, 2000).
[lx] 5 C.F.R. § 2634.904(b).
[lxi] OGE Form 450: A review Guide, U.S. Office of Government Ethics, 15 (September 1996).
[lxii] OGE Form 450: A review Guide, U.S. Office of Government Ethics, 15 (September 1996).
[lxiii] Cited from a several examples of waivers provided by the CDC to the Government Reform Committee.
[lxiv] Interview of Dr. Dixie Snider, Mr. Kevin Malone and Mr. Joe Carter (June 1, 2000).
[lxv] Interview of Dr. Dixie Snider, Mr. Kevin Malone and Mr. Joe Carter (June 1, 2000).
[lxvi] ACIP Meeting June 24, 1998, 41.
[lxvii] ACIP Meeting, October 22, 1999.
[lxviii] Conflicts of Interest and the Disqualification of Federal Advisory Committee Members, Congressional Research Service Memorandum, June 6, 2000.
[lxix] ACIP Meeting Minutes, February 11 and 12, 1998.
[lxx] Ethics Rules for Advisory Committee Members, for committee members appointed to serve on HHS advisory committees as SGEs, NIH Office of Federal Advisory Committee Policy (OFACP), 4, http://www1.od.nih.gov/cmo/sge.htm.
[lxxi] Interview of Dr. Dixie Snider, Mr. Kevin Malone and Mr. Joe Carter (June 1, 2000).
[lxxii] http://www.aafp.org.
[lxxiii] http://www.aap.org.
[lxxiv] http://www.acog.org; http://www.figo2000.com/sponsors.cfm.
[lxxv] http://www.ama-assn.org.
[lxxvi] http://www.idsociety.org/pd/grants_toc.htm.
[lxxvii] http://www.bio.org.
[lxxviii] Conflicts of Interest and the Disqualification of Federal Advisory Committee Members, Congressional Research Service Memorandum, June 6, 2000.
[lxxix] http://som1.umaryland.edu/research.html.
[lxxx] ACIP Meeting, February 13, 1997.
[lxxxi] http://www.immunize.org/admin/funding.htm.
[lxxxii] FAC Standards ACT, supra note 10, at 6, reprinted in FACA Source Book, supra note 2, at 276, citing Hearings on H.R. 4383 Before the Legal and Monetary Affairs Subcommittee. Of the House Comm. On Government Operations, 92 Cong., 2d Sess., at 13-55 (1971), reprinted in 1972 U.S. Code Cong. & Admin. News 3434-76.

Committee on Government Reform
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Washington, DC 20515
(202) 225-5074

US CDC Experimenting On Kids – Admits Harm From Multiple Vaccines Not Known

In May 2004 under Director Julie Gerberding, the CDC admitted in an expert report [full details below] that it had no clue what problems multiple vaccines were causing – and they still don’t know – they are carrying out unethical mass experiments on US kids with the vaccines. The report was quickly deleted from their website.  Gerberding walked into the job of Merck’s Director of Vaccines Division after her sacking when Obama was elected.

What is the Federal Bureau of Investigation doing about all the organized crime in the drug industry milking health budgets worldwide of billions of dollars?  Nothing.

US Prosecutors sit on their hands whilst some children die and autism, diabetes, asthma and allergy rates soar along with much else ill-health.

If the US were a signatory to the Rome Statute there might have been the outside possibility of a criminal prosecution by the International Criminal Court, but the US has never signed [which helps keep US government Human Rights abuses going - US officials will not be hauled before the Court].

The Now Vanished May 2004 Blue Riband Report – Admits Harms Not Known

Committee Chairman and vaccine promoter Prof Louis Cooper stated in a CDC report [emphasis added]:-

However, concern was expressed that ……. there are not enough studies of possible adverse effects of new vaccines in combination with existing vaccines. Therefore, as the number of vaccines increases, the number of unresolved hypotheses which need new studies might also increase. Who will be responsible for prioritizing and doing these studies? Another point raised was that post-marketing research results may not necessarily be included in the vaccine package insert unless they are submitted for FDA review by the manufacturer.”

An independently archived copy of the report can still be read here:-

Blue Ribbon Panel Meeting, Summary Report, June 3 and 4, 2004

Chairman vaccine promoter Professor Louis Z Cooper

And full details are in this CHS article:-

The Liars in Government Agencies – 60 YEARS OF DISASTER & THE ‘EXPERTS’ STILL SCRATCH THEIR HEADS

And does the CDC know today?  No:-

US CDC Actively Investigating Vaccines As A Cause of Autistic Conditions

FDA Halts HPV Vaccine Roll-Out – SaneVax News Release

SANEVax – Our Daughters Should Not Be Experiments for The Drug Industry

And the EU is doing the same kinds of experiments on kids:-

EU Takes Emergency Measures Over Glaxo’s ‘Flu Vaccine – Causes Narcolepsy in Children

US CDC Actively Investigating Vaccines As A Cause of Autistic Conditions

CDC Autism/Disability Study: Mercury and Vaccines Are “High Priority” Targets

Critics of a possible vaccine-autism connection continue to insist that vaccines have been completely cleared as a possible trigger of regressive autism, and that any further study is being done merely to “appease” parents who think vaccines may be implicated in a subset of children.

They are wrong on both counts.  The following extracts are taken from the US SEED study FAQs document published by the US CDC:  SEED FAQs

SEED stands for the Study to Explore Early Development.  It is being conducted by  six study sites and a data coordinating center called the Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) Network.

The Centers for Disease Control and Prevention is currently conducting the study which:-

will help identify what might put children at risk for autism spectrum disorders (ASDs) and other developmental disabilities,” according to the CDC.”

SEED is looking at a variety of genetic, environmental and socioeconomic factors that might increase risk of autism spectrum disorders (ASD), including: infection and immune function; including autoimmunity; reproductive and hormonal features; GI abnormalities; genes that control immune function; and “select mercury exposures.

There are several studies, including studies funded by the government, looking at environmental exposures related to autism including mercury,” the CDC says. “We chose to look at information on vaccines and other types of medical procedures that may have mercury exposure that we can get through medical records.” The SEED study also asks parents about possible mercury exposures they may have had at work.

We designated each of the factors as high priority,” the CDC says.

That bears repeating: the CDC has identified thimerosal and mercury as “high priority” factors in autism research.

Are pushy parents shouting for more studies responsible? Hardly.

We selected these research factors after an extensive review of the literature,” the CDC states, “based on the how strongly they seemed to be associated with ASD and what new information we needed to collect about each factor.”

Mercury exposures that SEED is looking at include

vaccines that the mom received during pregnancy, the child’s vaccine exposures after birth and specific other factors such as RhoGAM treatment in pregnancy if the mom has developed an immune response against the fetus that can harm it,” the CDC says

And there is more:

Will the study include vaccines as a potential cause of autism?

Yes, the study will include vaccines.

Will CDC find out if thimerosal causes autism?

It is too soon to speculate on the results of the study. We hope the study will give us a better idea of which of the risk factors that we will be looking at seem to be the most important in causing autism.

If the study shows that thimerosal is a cause of autism, will CDC report the data? What guarantees does the public have that the findings won’t be covered up?

We will report all the findings of the study by following the normal scientific review process as soon as possible.

Call for FDA Ban on Glaxo Weight-Loss Drug – Public Citizen Group Petitions FDA

April 14, 2011

Weight-Loss Drugs Alli and Xenical Should Be Removed From the Market, Public Citizen Tells FDA

Xenical and Alli Can Cause Severe Injury to Liver, Pancreas, Kidneys

WASHINGTON, D.C. – The over-the-counter weight-loss drug Alli and its prescription form Xenical should be removed from the market immediately because they not only can damage the liver, but also, based on new information obtained from FDA adverse reaction files, have been associated with 47 cases of acute pancreatitis and 73 cases of kidney stones, Public Citizen said today in a petition to the Food and Drug Administration (FDA).

 Both drugs are forms of orlistat; Xenical has 120 milligrams (mgs) and Alli has 60 mgs. Their serious risks greatly outweigh their benefits, which are questionable, because neither has been shown to be much more effective than diet and exercise.

“Any one of these serious risks alone would be sufficient basis for banning Xenical and Alli,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “These drugs have the potential to cause significant damage to multiple critical organs, yet they provide meager benefits in reducing weight loss in obese and overweight patients. For this reason, the FDA should tell the manufacturers of these drugs, Hoffman-LaRoche and GlaxoSmithKline, to pull Xenical and Alli, respectively, from the market immediately.”

This is Public Citizen’s second petition to have Xenical taken off pharmacy shelves. In April 2006, Public Citizen urged a ban of Xenical because research in rats had demonstrated that orlistat caused the formation of pre-cancerous lesions in the colon. The FDA rejected that petition.

U.S. physicians have been writing fewer prescriptions for Xenical, even long before over-the-counter Alli was available, because of its serious risks and marginal effectiveness. Prescriptions for Xenical in the U.S. declined 81 percent from 2.6 million in 2000, when Xenical first became available in the U.S., to just 490,000 in 2007. By 2009, the number of Xenical prescriptions in the U.S. further decreased to 110,000 prescriptions, representing only 4 percent of its peak in 2000, but still exposing tens of thousands of patients to a drug with serious risks that greatly outweigh its meager benefits.

Meanwhile, sales of Alli plummeted from $145 million in the first year of marketing (mid-2007 to mid-2008) to $84 million between mid-2009 and mid-2010, the latest years for which data are available.

The weight lost by users of both prescription and the over-the counter-strength orlistat was minimal, Public Citizen said in the petition. For example, people taking Xenical while dieting and exercising for one year (in contrast to those just altering their diet and exercise) lost only 5.6 additional pounds from the 60-mg dose and seven additional pounds from the 120-mg dose compared to the group that engaged only in diet and exercise. Similarly, those in a four-month study of Alli lost only two to four more pounds than those who solely changed their diet and exercise routines.

But the biggest problem with the drugs is their potential to cause serious injuries and death.

On May 26, 2010, the FDA issued a warning about “severe liver injury” resulting from using orlistat. The agency identified 12 foreign reports of severe liver toxicity associated with Xenical and one domestic case for Alli. Two of the patients died of liver failure and three required liver transplants.

Another serious adverse effect of taking Xenical or Alli is acute pancreatitis, which may be especially difficult to diagnose since orlistat’s most common side effects, including abdominal pain and nausea, are also typically symptoms of pancreatitis. Public Citizen’s research of FDA MedWatch adverse reaction reports found 47 cases of pancreatitis associated with Xenical or Alli. Thirty-nine of those patients required hospitalization and one died.

 Public Citizen’s analysis of FDA’s MedWatch reports also identified 73 cases of kidney stones associated with Xenical or Alli use, of which 23 required hospitalization. In a review of the medical literature, Public Citizen also identified at least three patients taking orlistat who developed acute kidney failure because tiny calcium salt crystals formed throughout the kidneys. In one reported case, the patient required dialysis and ultimately died.

Other risks of these drugs include interference with the absorption of fat-soluble vitamins and drugs, fecal urgency, gas with discharge and abdominal pain.

###
Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.

SANEVax – Our Daughters Should Not Be Experiments for The Drug Industry

SANEVax News Release

Parents of Daughters & Women Injured from Gardasil
React to FDA Decision

Why are medical consumers the medical experiments?
Safety and efficacy studies should be conducted for all intended age intended before market release.

On April 7, 2011 the media broke the news about the U.S. FDA’s ruling against Merck’s supplemental biologics license application (sBLA) for an indication to use GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in women ages 27-45. This was Merck’s 4th request to expand Gardasil use to an older population of women.

 According to a report in MedPage Today,

‘The decision was based on a trial in 3,253 women ages 27 to 45. Although the vaccine appeared to prevent persistent HPV infection, no significant benefit was found for more important outcomes such as high-grade neoplastic lesions or cervical cancer when all participants were included irrespective of baseline HPV status.’

Within days the news of the FDA’s decision traveled across the country and across the world.  SANE Vax Inc. asked parents whose daughters have been injured by the vaccine as well as victims themselves to comment on the decision. 

Instead of protecting her life, it took her life.

I am thankful that the FDA did not give Merck a license to provide Gardasil for women over the age of 26 to 45 years.  That is only one small step when in my opinion the FDA has made many errors with this program of vaccination.  My 14 year old daughter died after having her second shot of Gardasil.  She was in perfect health until she received this vaccination.  We were told that we had to be responsible parents and that it was important that she have this vaccine.  Instead of protecting her life, it took her life.  The FDA still dares to suggest that this program is safe and effective and the benefits outweigh the risks.  That is not true in my case or in the cases of all those who have lost their daughters, and even their sons, to this vaccine; and not forgetting the many thousands who have also been injured. There can never be a benefit when there is the death of a child. 

Linda Morin, Quebec, Canada

With over 20,000 adverse injuries reported and around 100 deaths,
why is nothing being done to pull the vaccine from the market?

I am very disappointed in the FDA and CDC in general regarding Gardasil and the monitoring of adverse reactions.  The FDA recently rejected Merck’s 4th request to expand Gardasil use to women 26 years and older.  I think this was a very good decision on their part, but the fact that they have left the vaccine on the market for females 25 and below is appalling.    My 12 year old daughter was disabled by the Gardasil vaccine and missed almost an entire year of school.  2 ½ years later, she still suffers from the adverse effects of the vaccine.  With over 20,000 adverse injuries reported and around 100 deaths, why is nothing being done to pull the vaccine from the market? 

I have personally seen the damage the vaccine can do to a young, healthy girl.  I feel it is justified to not allow the vaccine to be marketed for older women.  I personally would never consider this vaccine for my 18 year old son or for myself as one who falls in the older age bracket.  I wish I had known of the adverse effects and Gardasil prior to my daughter’s vaccine injury.    

I would like the FDA to explain how Gardasil is acceptable in younger women when they say it has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age.  What is the difference?  How can it be accepted as safe in the younger group but not in the older group?

Rosemary Mathis, North Carolina

U.S. FDA has rejected the use of Gardasil in women between 27-45 years old.
The problem in Spain is that the vaccine is recommended for women older than 26.
How can it be effective for women in one country and not the other?

All our suffering cannot be paid with all the money they are losing. Money is just money; they will earn or lose it. However our daughters will never recover the years they have lost suffering the side effects of a vaccine that has been on the market without enough evidence of its efficacy. The governments around the world should do something to prevent these things from ever happening again.

Health Authorities around the world should inform parents about the risks of this vaccine, so that parents can make an informed decision about their daughter´s health. I wish I had known all the dangers this vaccine had before vaccinating my daughter – but the only information I received was (1) the vaccine protects women from getting cervical cancer – not true- and (2) the vaccine may only produce local effects such as pain or swelling on the site of the injection – not true either.

When my daughter was in hospital we wrote a press release to the International Scientist Community asking for help and the answer we received from Spanish Health Authorities was that the only two cases of seizures in Spain and Europe were the Valencian girls; one is my daughter. We felt hopeless when we learned all the incidents of seizures reported to VAERS before February 2009 when my daughter received her second shot.
Now the FDA has rejected the use of Gardasil in women between 27-45 years old. The problem we have in Spain is that the vaccine is recommended for women older than 26. How can it be effective for women in one country and not the other? I do not understand how these things can happen in the world.

Alicia Capilla, Spain

Why me? I was 25 & 4 months when I received the first vaccine and became injured.
Why is my genetic make up – or whatever it was that lead to this reaction -
so different than if I was 8 months older?

I was given the first dose of Gardasil by my GP in Australia in May 2008. I advised him that I had recently separated from my husband (in March 2008), and was convinced of his infidelity. As such, I requested a pap smear and full women’s wellness test, which to my knowledge, included blood samples to be taken for STI’s. The first dose of Gardasil had been administered prior to receiving the results which were negative. My GP was also aware that my immune system was severely lowered due not only to my separation, but moving house and changing employment. Exactly two weeks after receiving the vaccine, I fell and snapped a bone in my foot. Once I was off crutches, I went to the GP as recommended to receive my second shot. I advised them that my walking was a bit funny due to getting off crutches. No warning was given, I was administered the shot, and not required to wait the mandatory waiting time. I was allowed to leave and drive. A few weeks later, everything started to deteriorate. This led to paralysis and my cerebellum to shut down. Prior to this, I was fit and healthy and had no health concerns. My question is: Why me? I was 25 & 4 months when I received the first vaccine. Why is my genetic make up – or whatever it was that lead to this reaction – so different than if I was 8 months older? It does not make sense. If there is something in an individual’s genetic make up, should they not receive some sort of screening or testing prior to being vaccinated? We need to fill out pages of information to give blood (i.e. specimen coming out of our bodies), but this is not the same for something that goes into our body’s, and may stay there for a lifetime. Furthermore, it may change our lives forever. I struggle every single day to accomplish seemingly simple every day tasks, and there is no saying that this will change. And I am one of the lucky ones.

We are guinea pigs. We place our lives in the hands of those who we believe are there to protect our health, and that sense of trust seems to be overwritten by money. Furthermore, not only was I a victim of Gardasil, the treatment to save my life – which is supplied by CSL Laboratories – was ultimately purchased by my parents to save my life as CSL would not donate it.

Kristin Clulow, Australia

What the heck is the difference in approving it for those who are one year younger!

As a parent dealing with a 20 year old daughter badly damaged by Gardasil I can say whilst it is pleasing to see that the FDA has not approved Gardasil for women over 26, I guess the question that everyone  would now be asking is, what the heck is the difference in approving it for those one year younger!

Stephen Tunley, Australia

SANE Vax Inc., believes that if Gardasil has not been demonstrated to prevent CIN 2/3 or worse in older women the same applies for women younger than 26 years of age. Clinical trials used an endpoint insufficient to clearly demonstrate efficacy in this arena. Therefore, we believe that Gardasil needs to be taken off the market until an independent study on the vaccine’s safety and efficacy is conducted.  

  • The SaneVax Team and medical consumers around the world demand scientific proof that Gardasil® is safe, effective and necessary for the approved age groups.
  • The SaneVax Team and medical consumers around the world, once again request the FDA rescind their approval of Gardasil® until studies are conducted with appropriate endpoints.

The FDA has opened the door of doubt confirming our worst fears; Gardasil is a potentially dangerous vaccine fast-tracked into the medical consumer market without adequate testing. Medical consumers should never become medical experiments for the profit of the pharmaceutical industry or the government.  SANE Vax, Inc. will continue our global campaign on behalf of the parents whose daughters and sons have been injured or who have died post-vaccination, until the vaccine is taken off the market.

 

Leslie Carol Botha,
Vice-President Public Relations, SANE Vax, Inc.
Health Educator, Broadcast Journalist

Internationally Recognized Expert on Women’s Hormone Cycles
Holy Hormones Honey -The Greatest Story Never Told!
http://holyhormones.com/
http://sanevax.org
 

Amazing US News Report – Part III – Autism’s Causes: How Close Are We to Solving the Puzzle?

Part III of this six part PBS series by reporter Robert MacNeil is disappointing.  Preview tonight’s episode – watch it below online, listen on a download mp3 file or read the transcript. 

This episode fails to touch on what we already know.  Vaccines have been admitted by US Government officials and agencies and the US Federal Court to cause autistic conditions.  If you read nothing else we strongly recommend you read this: PDF Download – Text of email from US HRSA to Sharyl Attkisson of CBS News].  In it the US Health Resources Services Administration [HRSA] state to CBS News reporter Sharyl Attkisson

We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.

Despite all the lies and deceit by health official worldwide, the question “do vaccines cause autism” was answered when the Hannah  Poling story broke in the USA [see CHS article here].  Hannah developed an autistic condition after 9 vaccines administered the same day.  Under the media spotlight numerous US health officials and agencies conceded on broadcast US nationwide TV news from CBS and CNN. In the US Federal Court children have been compensated after findings they developed autism and other injuries. Full details with links to the original sources can be found in this CHS article: Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines.

One thing seems clear – if it is left to the medical doctors MacNeil interviews in this broadcast, no one will ever “find” the “causes of autism”.

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Autism’s Causes: How Close Are We to Solving the Puzzle?

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Autism’s Causes: How Close Are We to Solving the Puzzle?

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Live Chat: Join a discussion about autism Wednesday at 1 p.m. ET

ROBERT MACNEIL: As we’ve reported, autism now affects one American child in a 110. Last month, a committee convened by public health officials in Washington called it a national health emergency. The dramatic rise in official figures over the last decade has generated a surge of scientific research to find what is causing autism.

Among the centers for such research is here, the University of California, Davis MIND Institute in Sacramento. Here and around the country, we’ve talked to leading researchers about where that effort now stands. Among them is the director of research at the MIND Institute, Dr. David Amaral.

DR. DAVID AMARAL, MIND Institute: Well, I think we’re close to finding several causes for autism. But there’s — I don’t think there’s going to be a single cause.

ROBERT MACNEIL: The science director of the Simons Foundation in New York, Dr. Gerald Fishbach; Dr. Martha Herbert, professor of neurology at Harvard Medical School; and Dr. Craig Newschaffer, professor of epidemiology and biostatistics at Drexel University in Philadelphia. First, I asked, how close are we to discovering the cause of autism?

DR. GERALD FISHBACH, Simons Foundation: I think we’re much closer now than we were five years ago. There’s been a tremendous amount of new information and discoveries. But with any disorder as complicated, as multifaceted as autism, I’m reluctant to say how close.

DR. DAVID AMARAL: Everything we know about autism is that there are multiple genes that confer risk. The children have various co-morbid problems. And everything we know looks like this is a multitude of disorders all under the umbrella that we call autism spectrum disorders.

DR. CRAIG NEWSCHAFFER, Drexel University: To begin with, I think there probably is no cause of autism. We’re probably talking about multiple causes. And I think we already have identified some causal components on the genetics front. But if I can interpret your question as complete understanding of all of these complex causes of autism, I think we’re still quite a ways away.

ROBERT MACNEIL: Some people we’ve talked to say we are on the verge of big discoveries. Others say we’re just scratching the surface. Where do you think we are?

DR. GERALD FISHBACH: I think we’re scratching the surface of big discoveries.

RELATED INFORMATION

(LAUGHTER)

DR. MARTHA HERBERT, Harvard Medical School: I think it’s somewhere in between. At the brain level, I think in the last five years, we’ve figured out that there’s a coordination problem of the different parts of the brain not hooking up in as synchronized of a fashion. The question for me is why is that happening?

ROBERT MACNEIL: The autism puzzle is proving to be immensely complex. But I asked what hunches they have on where the answer will be found.

DR. DAVID AMARAL: Clearly, 30 years ago, we didn’t know any genes that conferred risk of autism. Now, we know that there’s at least 20 or more that seem to be associated with autism. The interesting thing, though, is that any particular gene that you might find that is related to autism is only related to about 1 to 2 percent of the cases of autism. So there — I think what’s clear now is that there’s not going be a single autism gene. But there are many, many.

DR. GERALD FISHBACH: Well, I think many people feel that autism is a problem in communication between cells in the brain. Now that’s saying an obvious truth. The brain is a communicating organ. We take in sensory information. We put out motor actions. And in between, there’s the whole phenomena of perception, understanding and digestion of that information. It’s the phenomenon of synaptic transmission. And my belief is we will find root causes of autism at particular synapses in the brain.

DR. CRAIG NEWSCHAFFER: Well, I think it’s going to be a combination of continued good work on the genetic side of things. I also believe, however, that there are going be causal components that are nonheritable genetics, things that we refer to as environmental causes, with a capital E, environment-encompassing lifestyle factors — exposures, things of that nature. And those were, by the way, we’re still at the very beginning stages.

DR. MARTHA HERBERT: I don’t think there’s any one cause of autism. I would lay money that we will not find one thing. We certainly haven’t found one gene; we’re finding hundreds of genes. We’re finding boutique genes. We’re finding genes that kids have and the parents don’t have — their own parents. I think that there are a lot of things environmentally that are overwhelming our ability to cope, metabolically, that are overwhelming our immune system. And the synergy — the collective impact of that is to deplete our protective systems. And I think that’s what’s causing autism.

DR. CRAIG NEWSCHAFFER: But I think the emphasis on genetics probably has been correct, at least as we think about the unfolding of our understanding of what causes autism. And I think over time, we realized that in addition to these genetic components, there is room for and probably just cause for investigating the environmental. So we’re swinging around.

DR. GERALD FISHBACH:  First, there’s no question that autism is a genetic disorder. That does not mean the environment is not tremendously important, because it is also clear that the genetics are complex. We’re looking at the Simons Foundation for what are called de novo mutations — mutations that arise anew in the germ cells of one or the other parent, sperm or egg. Because it appears that these de novo mutations have a very big effect, a very profound effect. If you have the mutation, you have a great risk of developing autism.

DR. MARTHA HERBERT: I think that what you have is, yes, definitely a question of toxics and toxics in our environment, that some of them act like our own molecules, like hormones, for example. That’s called endocrine disruption. Some of them get confused with neurotransmitters. Some of them damage our cell membranes. Many, many of them damage our mitochondria, our energy factories in our cells.

DR. CRAIG NEWSCHAFFER: Something that I think is important in thinking about these complex causes is thinking about the window of vulnerability. When are these causes most likely to act? And again, I believe that that prenatal, intrauterine period is going be very, very important. So things from maternal diet, infections that mothers may be exposed to in pregnancy, exogenous chemicals, chemicals in the environment that could be neuro-developmentally significant. All these are things — I think these things are likely to play a role. How large, how small, I think, is yet to be determined.

DR. GERALD FISHBACH: I don’t think this is an either-or effort. The issue is ideas and hypotheses. The genetics will facilitate work on the environment.

ROBERT MACNEIL: One issue science considered settled for years won’t go away: the parental belief that vaccines cause autism. Public health officials have steadily maintained there is no valid, scientific evidence of such a connection; all epidemiological studies have proved negative.  But now, bowing to public opinion, the body that sets priorities in autism research, The Inter Agency Coordinating Committee, has recommended studies to determine whether small subgroups might be more susceptible to environmental exposures, including vaccines.

DR. GERALD FISHBACH: Despite many, many, many epidemiological studies, no evidence that current vaccines in their present form have triggered autism. There are two prevalent things going on here: vaccination and autism. But trying to correlate those two have failed to date.

DR. DAVID AMARAL: So I think it’s pretty clear that, in general, vaccines are not the culprit. If you look at children that receive the standard childhood vaccines. If anything those children are at are at slightly less risk of having autism than children that aren’t immunized. It’s not to say, however, that there is a small subset of children who may be particularly vulnerable to vaccines if the child was ill, if the child had a precondition, like a mitochondrial defect. Vaccinations for those children actually may be the environmental factor that tipped them over the edge of autism. And I think it’s — it is incredibly important still to try and figure out what, if any, vulnerabilities in a small subset of children might make them at risk for having certain vaccinations.

DR. MARTHA HERBERT: I think it’s possible that you could have a genetic subgroup. You also might have an immune subgroup. There are a variety of subgroups. But the problem with the population studies is they don’t they aren’t necessarily designed to have the statistical power to find subgroups like that if the subgroups are small.

DR. DAVID AMARAL: I think more importantly what the whole vaccine issue has done is has opened our eyes again to the idea that the immune system is an important component of autism.

DR. MARTHA HERBERT: The brain and the immune system and the gut are intimately related. The cells in those systems have common features. They work together seamlessly, and when you disregulate one, you disregulate all the others. And systems biology is a way of looking at how we work as an integrated whole. I think that’s 21st century biology. Is the brain miswired, or is it misregulated? And I’ve come to think the brain is misregulated. And there are several reasons for that. Short-term, dramatic changes in the functional level of people with autism. One of them is the improvements you see with fever. A child who gets a fever will start to make eye contact, be interactive, will relate. A child who would have been really out of touch will become connected, and then it will go away.

DR. DAVID AMARAL: You know, vaccines are only one of the things that we do to ourselves. But there are myriad other kinds of– toxic chemicals that we’re putting into the environment.

I don’t think there’s enough research on environmental factors. Frankly, I think it’s very expensive. It’s difficult research to do. Because again, you start trying to develop a list of how many new things there are in the environment now, from 30 years ago. And it’ll be a very long list.

DR. MARTHA HERBERT: When we were having this explosion of our chemical revolution, we didn’t have any way of knowing the subtle impacts on cellular function. We thought if it doesn’t kill you, it’s probably okay. But now we’re learning that it can alter your regulation way before it kills you.

ROBERT MACNEIL: There are many other areas of focus that researchers are pursuing.

DR. GERALD FISHBACH: Parents are having children at later ages. And there is a lot of evidence that children born of parents in the late 30′s and 40′s have a higher likelihood of developing autism.

DR. DAVID AMARAL: We’re trying to chart the course of the — of brain development in autism. And what we’ve found is that there are certain parts of the brain — the frontal lobe, right behind the forehead, in particular — as well as a small structure that’s about two inches in from your ear, called the amygdala. Both of these structures actually grow too quickly. They get to the adult size too quickly in children with autism.

There’s a bunch of kids who probably have autism right from the get-go. Right– you know, right from conception or — very early on. There’s another group of kids who, at 12 months old, they look fine. They’re communicating, they’re having — engaging socially. But then sometime between 18 and 24 months, they lose social behavior. They lose language. And they regress back into autism. But now we’re showing that the kids who regress into autism, for whatever reason, are the ones who have the rapidly growing brains. So that’s a clue.

I mean, it — it doesn’t tell us all that much. And it doesn’t tell us how to treat those two kids differently, but it’s beginning to provide evidence that there really are biologically different subsets of kids with autism. And I think once we actually define that there are different subsets, we can start going after the causes of each one of those subsets.

ROBERT MACNEIL: Are you at all discouraged that after so much effort, investment, some of the best minds in the world on this, that — that autism is still so baffling?

DR. GERALD FISHBACH: I’m not discouraged at all about that. I think we’re addressing one of the most profound problems in not only all of medicine but in all of human existence. We’re talking about the ability to relate to other people, to empathize in a certain way and to comprehend. And I think it’s the most worthwhile, most challenging effort in science that I’ve ever been involved in. So I’m not discouraged at all.

Paul Offit – “Doctor of Vaccine Profit” Caught Lying – Again – Orange County Register

It looks like this is the reason we now have Seth Mnookin to replace Paul Offit as liar-in-chief.  [And wasn't one of the reasons for Wakefield losing his licence alleged dishonesty?  The CEO and Board of The Children's Hospital of Philadephia seem to need to do some spring cleaning of their resident liars?].

The Orange County Register has published: April 18, 2011 the correction [text below in full] regarding lies told by Dr Paul Offit the “Doctor of Vaccine Profit” of the Childrens’ Hospital of Philadelphia.

Paul Offit is an inveterate liar, and will say just about anything to quell parents’ fears that vaccines are causing all this autism.  Aside from this new episode of lying Offit lied in one of his books about JB Handley the founder of Generation Rescue. Handley sued him, and Offit was forced to correct his book, write Handley a letter of apology and acknowledgement, and donate money to Jenny McCarthy’s second-favorite (behind GR!) charity at UCLA.

Here is the Orange County Register correction [emphasis added]:-

An OC Register article dated Aug. 4, 2008 entitled “Dr. Paul Offit Responds” contained several disparaging statements that Dr. Offit of Children’s Hospital of Philadelphia made about CBS News Investigative Correspondent Sharyl Attkisson and her report.

Upon further review, it appears that a number of Dr. Offit’s statements, as quoted in the OC Register article, were unsubstantiated and/or false. Attkisson had previously reported on the vaccine industry ties of Dr. Offit and others in a CBS Evening News report “How Independent Are Vaccine Defenders?” July 25, 2008. 

Unsubstantiated statements include: Offit’s claim that Attkisson “lied”; and Offit’s claim that CBS News sent a “mean spirited and vituperative” email “over the signature of Sharyl Attkisson” stating “You’re clearly hiding something.”

In fact, the OC Register has no evidence to support those claims.

Further, Offit told the OC Register that he provided CBS News “the details of his relationship, and Children’s Hospital of Philadelphia’s relationship, with pharmaceutical company Merck.”

However, documents provided by CBS News indicate Offit did not disclose his financial relationships with Merck, including a $1.5 million Hilleman chair he sits in that is co-sponsored by Merck.

According to the CBS News’ documentation recently reviewed by the OC Register, the network requested (but Offit did not disclose) the entire profile of his professional financial relationships with pharmaceutical companies including: The amount of compensation he’d received from which companies in speaking fees; and pharmaceutical consulting relationships and fees.

The CBS News documentation indicates Offit also did not disclose his share of past and future royalties for the Merck vaccine he co-invented. To the extent that unsubstantiated and/or false claims appeared in the OC Register and have been repeated by other organizations and individuals, the OC Register wishes to express this clarification for their reference and for the record.

The CBS News revelations about Offit

And his undeclared financial interests in promoting vaccines on behalf of the drug industry:

For years some parents and scientists have raised concerns about vaccine safety, including a possible link to autism and ADD. Many independent experts have sided with government officials and other scientists who say there’s no possible connection. But how “independent” are they? CBS News investigative correspondent Sharyl Attkisson shares here’s what she found.

They’re some of the most trusted voices in the defense of vaccine safety: the American Academy of Pediatrics, Every Child By Two, and pediatrician Dr. Paul Offit.

But CBS News has found these three have something more in common – strong financial ties to the industry whose products they promote and defend.

The vaccine industry gives millions to the Academy of Pediatrics for conferences, grants, medical education classes and even helped build their headquarters. The totals are kept secret, but public documents reveal bits and pieces.

A $342,000 payment from Wyeth, maker of the pneumococcal vaccine – which makes $2 billion a year in sales.

A $433,000 contribution from Merck, the same year the academy endorsed Merck’s HPV vaccine – which made $1.5 billion a year in sales.

Another top donor: Sanofi Aventis, maker of 17 vaccines and a new five-in-one combo shot just added to the childhood vaccine schedule last month.

Every Child By Two, a group that promotes early immunization for all children, admits the group takes money from the vaccine industry, too – but wouldn’t tell us how much.

A spokesman told CBS News: “There are simply no conflicts to be unearthed.” But guess who’s listed as the group’s treasurers? Officials from Wyeth and a paid advisor to big pharmaceutical clients.

Then there’s Paul Offit, perhaps the most widely-quoted defender of vaccine safety.

He’s gone so far as to say babies can tolerate “10,000 vaccines at once.”

This is how Offit described himself in a previous interview: “I’m the chief of infectious disease at Children’s Hospital of Philadelphia and a professor of pediatrics at Penn’s medical school,” he said.

Offit was not willing to be interviewed on this subject but like others in this CBS News investigation, he has strong industry ties. In fact, he’s a vaccine industry insider.

Offit holds in a $1.5 million dollar research chair at Children’s Hospital, funded by Merck. He holds the patent on an anti-diarrhea vaccine he developed with Merck, Rotateq, which has prevented thousands of hospitalizations.

And future royalties for the vaccine were just sold for $182 million cash. Dr. Offit’s share of vaccine profits? Unknown.

There’s nothing illegal about the financial relationships, but to critics, they pose a serious risk for conflicts of interest. As one member of Congress put it, money from the pharmaceutical industry can shape the practices of those who hold themselves out to be “independent.”

The American Academy of Pediatrics, Every Child By Two and Dr. Offit would not agree to interviews, but all told us they’re up front about the money they receive, and it doesn’t sway their opinions.

Today’s immunization schedule now calls for kids to get 55 doses of vaccines by age 6.

Ideally, it makes for a healthier society. But critics worry that industry ties could impact the advice given to the public about all those vaccines.

The Liars in Government Agencies – 60 YEARS OF DISASTER & THE ‘EXPERTS’ STILL SCRATCH THEIR HEADS

Vaccines are safe they kept telling us. We are the experts. You know nothing. The risks are negligible.

Well that is not what the following documents from the US Centers for Disease Control (CDC), Institute of Medicine (IoM), National Vaccine Advisory Committee (NVAC) and the Interagency Autism Coordinating Committee (IACC) tell us.

First A Document The US CDC has deleted from their website

Here are extracts of a 2004 published document the US CDC removed from the web several years ago – it is a very embarrassing document for them.  It tells us they just did not know the extent of the harms they were doing by promoting universal vaccination programmes.  The author and chairman of the CDC committee concerned is Professor Louis Z Cooper, a man who insisted publicly at the time that vaccines are fine and promoted them and no doubt still does.  We are posting what remains publicly available of the full text at the end so you can see the extent of the US CDC’s ignorance of vaccine hazards in 2004 [CDC - OCSO - Blue Panel Meeting Summary Report]. Here are extracts [emphasis added]:

US Centers for Disease Control
Office of the Director, Office of the Chief Science Officer

Blue Ribbon Panel Meeting, Summary Report, June 3 and 4, 2004 – [missing weblink = http://www.cdc.gov/od/ads/brpr/brprsumm.htm%5D  But full document can still be seen here:-

http://replay.web.archive.org/20060620191520/http://www.cdc.gov/od/ads/brpr/brprsumm.htm

“Additional questions focused on the perceived increase in national morbidity from chronic diseases—and the role, if any, that vaccines may play regarding such conditions as asthma, neuro-developmental and learning disabilities, diabetes and autoimmune disorders. While CDC does conduct research on chronic diseases, it was not completely clear what the roles are for the agencies in conducting research on chronic diseases that could be linked to a vaccine and/or drug (i.e. product/drug-induced disease) and whether this type of research should fall only within the purview of FDA, since it is a regulatory agency. The challenge of determining whether a chronic disease is product-induced was recognized. There is great difficulty in determining whether a valid signal exists for a relationship between vaccines and chronic conditions. Some participants questioned the sensitivity of existing vaccine safety tools, such as VAERS and VSD in picking up signals around chronic diseases.

and

“However, concern was expressed that most monitoring/surveillance systems are not specific to a particular vaccine and there are not enough studies of possible adverse effects of new vaccines in combination with existing vaccines. Therefore, as the number of vaccines increases, the number of unresolved hypotheses which need new studies might also increase. Who will be responsible for prioritizing and doing these studies? Another point raised was that post-marketing research results may not necessarily be included in the vaccine package insert unless they are submitted for FDA review by the manufacturer.”

and

There was a clear sense that vaccine safety activities are under-funded within the federal government.

The Liars Just Did Not Know Before and They Still Do Not Know Now

And now in 2011 they still do not know as these documents show – and please download them and pass them around for comment.  These documents [links below] show there is only now in 2011 an effort being made to look into a wide range of adverse events [ie. kids getting very sick] associated with them being given vaccines.

Recently it was announced that the following agencies would be conducting research on vaccine side effects and susceptible groups of children:

National Vaccine Advisory Committee (NVAC),

US Department of Health and Human Services (HHS),

Interagency Autism Coordinating Committee (IACC),

Health Resources and Services Administration (HRSA),

Vaccine Injury Compensation Program (VICP),

Office of Immunization Safety (OSI),

US Centers for Disease Control and Prevention (CDC).

The CDC is convening a panel to look at the feasibility of a study of vaccinated and unvaccinated children to compare autism rates.

In truth the science isn’t in and the question of a link is still open.  These are the links to upcoming federal studies on vaccine safety, including a link to autism in susceptible groups of children.

The 2011 Interagency Autism Coordinating Committee Strategic Plan for Autism Spectrum Disorder Research – January 18, 2011

Centers for Disease Control and Prevention’s Immunization Safety Office Scientific Agenda Immunization Safety Office, Division of Healthcare Quality Promotion National Center for Emerging and Zoonotic Infectious Diseases – February 2011

US Institutes of Medicine COMMITTEE TO REVIEW ADVERSE EFFECTS OF VACCINES WORKING LIST OF ADVERSE EVENTS TO BE CONSIDERED BY THE COMMITTEE

National Vaccine Advisory Committee (NVAC) Recommendations on the Centers for Disease Control and Prevention Immunization Safety Office Draft 5-Year Scientific Agenda Approved by NVAC on June 2, 2009

Do Vaccines Cause Autistic Conditions – The Question Has Already Been Answered

If you read nothing else we strongly recommend you read this: PDF Download – Text of email from US HRSA to Sharyl Attkisson of CBS News].  In it the US Health Resources Services Administration [HRSA] state to CBS News reporter Sharyl Attkisson

We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.

Despite all the lies and deceit by health official worldwide, the question “do vaccines cause autism” was answered when the Hannah  Poling story broke in the USA [see CHS article here].  Hannah developed an autistic condition after 9 vaccines administered the same day.  Under the media spotlight numerous US health officials and agencies conceded on broadcast US nationwide TV news from CBS and CNN. In the US Federal Court children have been compensated after findings they developed autism and other injuries. Full details with links to the original sources can be found in this CHS article: Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines.

Full Text of US CDC Blue Riband Panel Meeting Summary Report June 3 and 4, 2004

 CDC Home Search Health Topics A-Z

Office of the Director
Office of the Chief Science Officer

Blue Ribbon Panel Meeting
Summary Report
June 3 and 4, 2004

In March 2004, Dr. Julie Gerberding, Director of the Centers for Disease Control and Prevention (CDC) requested that a diverse group of individuals be convened to review the vaccine safety monitoring and research activities at CDC. At a two-day meeting in June 2004, the participants engaged in frank and wide-ranging discussion of current vaccine safety programs and perceptions about the safety of immunizations. The participants accepted Dr. Gerberding’s charge to report back on CDC’s longstanding commitments in vaccine safety monitoring, research and communication. The discussion highlighted that vaccine safety is a subject that requires much broader governmental and public involvement in keeping with the evolving epidemiology of disease and expanding clinical and laboratory science. In addition, community expectation for vaccine safety standards increases as the burden of disease decreases as a result of successful immunization programs.

Links on This Page:


CDC BACKGROUND

Rationale for convening this meeting:

Vaccines are cited as one of the greatest achievements of biomedical science and public health in the 20th century. This achievement is based on the remarkable success in controlling numerous infectious diseases which used to be widely prevalent in the United States. While there has been great progress in reducing the number of cases of vaccine-preventable diseases such as polio, measles, rubella and meningitis, the threats posed by these diseases remain because the organisms that cause them have not been eliminated.

The public health importance of immunizations cannot be disputed; however, an equally important aspect of the immunization program is ensuring the safety of all vaccines, particularly because they are sometimes administered to entire populations and are often mandatory. CDC recognizes its role in collaboration with FDA and other partners in ascertaining the risks involved in vaccinations as well as its responsibility to communicate these risks to the public. Public confidence in the immunization program is essential and must be based on understanding and communicating the benefits and risks of immunization. At the same time, it is critical that public health officials listen to and understand concerns that are expressed by the public around vaccine safety.

Although CDC is not solely responsible for the complex issue of vaccine safety, it has a unique role in surveillance, monitoring and engaging in and supporting research on immunization. Respect and confidence in the quality and integrity of these scientific efforts is an essential component of our national immunization program. CDC is actively involved in detecting and investigating vaccine safety concerns and supporting a wide range of vaccine safety research to address safety questions. Given this role, CDC is deeply committed to ensuring that vaccine safety monitoring and research is undertaken with the highest degree of integrity and scientific quality. CDC recognizes its dual roles in promoting immunization to prevent disease and ongoing assessment of vaccine safety. In addition, given the concerns some have expressed about potential conflicts of interest in fulfilling these roles, CDC appreciates that the assessment of immunization risk warrants both adequate resources and appropriate oversight.

Therefore, Dr. Gerberding made the important decision to convene a group of individuals who have been engaged in the area of vaccine safety and who could provide individual opinions on a variety of issues related to the vaccine safety program at CDC. By holding this meeting and encouraging an open and honest exchange of ideas on vaccine safety, CDC hoped to demonstrate its commitment to strengthen the collaboration between public health agencies, public interest, professional and advocacy groups, industry and the general public. Furthermore, CDC hoped the discussion among the participants will continue to provide a foundation upon which further trust and confidence can be established on these very important public health issues.

Meeting Participants:

The group consisted of 17 individuals (see , Meeting Participants) from a variety of professional organizations, public interest and advocacy groups, government advisory committees, and government agencies. In an effort to create balance among the participants, including complementary skill sets, diverse points of view, and general interest in safety issues (specifically in area of vaccine safety) while maintaining a size that would promote productive and manageable discussion, the following guidelines were utilized to choose participants:

  • Broad understanding and knowledge of risk assessment, risk management, and quality assurance and/or,
  • Interest and/or knowledge of vaccine safety issues and/or,
  • Partners with diverse perspectives who work with CDC on vaccine safety issues and its research agenda and/or,
  • Partners with diverse perspectives who work with CDC in an advocacy role for public health issues and/or have engaged CDC in discussions on this issue and/or,
  • Individuals who actively seek credible vaccine safety information which include healthcare providers, consumers, other federal agencies, industry, professional groups and others.

Unfortunately, many key stakeholders who have been deeply involved and dedicated to issues around vaccine safety were not invited to participate in the meeting. The primary reason for not inviting additional groups and/or individuals was not to exclude any particular points of view but simply to maintain a smaller group of individuals to allow for productive discussion. This summary report will be posted on the CDC website for public comment and we invite those who were not able or invited to participate in this meeting to provide their comments. The public comments along with the summary report will be provided to the Director of CDC.

OBJECTIVES FOR THE MEETING PARTICIPANTS:

The meeting participants were asked to review and discuss three objectives during their two-day meeting. The purpose of providing objectives for the participants was to assist them in discussing the vaccine safety program at CDC on a broader level; therefore, they were not convened to discuss specific vaccine safety studies such as the thimerosal issues, the recent IOM report or other more specific details of the vaccine safety program.

Individuals were asked to provide individual opinions on the following three objectives:

  1. Review the structure, function, credibility, effectiveness, efficiency and support of CDC’s vaccine safety program and assess how it can be maximized and sustained.
    • Assess the program’s ability to detect emerging or rare adverse events.
    • Assess the capacity of the program to provide comprehensive monitoring of the growing number of vaccines.
  2. Review the intramural and extramural collaborative activities of the vaccine safety program and determine their effectiveness and efficiency.
    • Assess additional steps CDC can institute to enhance coordination with other federal agencies and partners, including consumer and advocacy groups.
  3. Determine the optimal organizational location for vaccine safety activities within the CDC to ensure scientific objectivity, transparency and oversight while at the same time ensuring that program priorities are appropriately established and are relevant to the immunization program and other stakeholder needs.
SUMMARY OF MEETING:

The two-day meeting took place in Atlanta, Georgia on June 3 and 4, 2004. Prior to the meeting, the participants were provided with a notebook of informational materials and an agenda for the meeting. To ensure a productive meeting, the participants were asked to review the materials prior to the meeting. Specifically, the notebook consisted of supplemental materials and recommended sources for other information on vaccine safety. While the meeting was not open to the public, the discussions of the meeting were transcribed.

June 3, 2004:

On the first day of the meeting, the Chair, Dr. Louis Cooper as well as CDC’s Chief of Science, Dr. Dixie Snider, provided opening remarks to the participants. Then, each individual present, including CDC staff attendees, offered a personal introduction. Finally, the objectives for consideration by the participants were reviewed and the meeting continued with presentations given by CDC and other Department of Health and Human Services (DHHS) staff.

The presentations by the staff ranged in topic, beginning with a broad overview of the vaccine safety activities in the DHHS coordinated through the National Vaccine Program Office (NVPO). There were presentations on CDC’s overall activities in vaccine safety and then the focus of the presentations narrowed to specific overviews of the National Immunization Program (NIP) and its activities in vaccine safety. The Immunization Safety staff presented on specific functions and activities within the immunization program which involve surveillance, monitoring and research in vaccine safety. Specifically, activities such as the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) Project were outlined and there was background given on other efforts such as the Clinical Immunization Safety Assessment (CISA) Network and the Brighton Collaboration. There was a presentation on CDC’s Data Sharing Program and finally, to stimulate thinking and further discussion, options were presented regarding the current and potential organizational location for vaccine safety activities within CDC.

The range of topics presented was intended to give the participants a sense of the depth and complexity of the issues that CDC and specifically, the Immunization Safety staff tackle on a daily basis. Throughout the day, while presentations were given, the participants were encouraged to ask questions of the staff. The questions and comments from the participants were direct and at times constructively critical of the vaccine safety monitoring and research activities at CDC. The immunization staff’s honest and direct answers stimulated additional substantive and productive discussion.

The discussion demonstrated the complexity of the issues and often revealed sources of tension between CDC and some members of the public as well as among CDC staff. At times, it was clear that some of the staff have experienced a great deal of stress and frustration, including personal harassment, while dealing with the vaccine safety issues and allegations by some of loss of public trust in CDC’s work. However, the pride and dedication that the immunization staff have regarding their effort in vaccine safety was equally clear and impressive to the participants.

Overall, the presentations given by the staff and questions asked by the participants generated frank dialogue on important and challenging aspects of vaccine safety by a unique, diverse group of individuals, including the CDC and NIP staff, representatives from parental and advocacy groups, vaccine manufacturers, professional organizations, advisory committees and government officials. Although disagreement was clear on some issues, the interaction underscored a common theme, a clear dedication to the safety of vaccines and the importance of broad public and professional understanding about the benefits and risks of immunization.

For additional details, the presentations and discussions can be reviewed in the official transcript.

June 4, 2004:

The second day of the meeting was reserved for discussion among the participants regarding the three objectives (mentioned earlier) as well as specific considerations dealing with vaccine safety activities at CDC. With the exception of senior staff who were asked to remain as resources, other CDC staff were excused from this session, allowing the participants the entire day to engage in thorough and open discussion regarding the objectives as well as the issues presented the previous day.

To begin the discussion, Dr. Cooper asked all participants to share their most important impressions and views following the June 3rd session. The participants each provided insightful and direct remarks concerning, but not limited to the presentations and the interactions with the immunization staff. An emphasis was placed on vaccine safety issues where improvement is feasible and critical.

Following the opening remarks, the participants continued the discussion on the three objectives but also considered some other specific questions/issues regarding vaccine safety. Again, the participants were encouraged to speak freely and openly regarding their views and as a result, the discussion was extremely thoughtful. The comments made during both the opening remarks and the remaining session seemed to revolve around very specific themes. As a result, even though the participants were not convened to come to a consensus and/or make recommendations as a group regarding what CDC should do to improve the vaccine safety activities at CDC, these themes seemed to resonate throughout the day. Individuals did not restrict their comments solely to the role of CDC, but directly mentioned other governmental entities, industry, the provider community and the public. Some of the themes are highlighted in this report as a framework for moving forward to make improvements in the area of vaccine safety. (These themes are not prioritized.)

There is a tremendous need for strategic planning for vaccine safety research and for greater coordination and collaboration among federal agencies and community leaders.

Vaccine safety research and monitoring is not just an activity at CDC. Therefore, collaboration is considered critical if the activities around vaccine safety are going to be improved and strengthened. The collaboration, however, must occur on many levels. It is important to harness the strengths of all stakeholders in the vaccine safety arena which translates into not only involving the federal government agencies such as FDA, CDC, National Institutes of Health (NIH), Health Resource and Services Administration (HRSA), Department of Defense (DOD), and others but allowing for public and community leaders and/or key advocates to be an integral part of the process. Additionally, the advisory committees, manufacturers, and other partners who have important stakes in vaccine safety need more clearly defined roles in this process.

There is a need for a more formalized process to coordinate activities and promote collaboration and priority setting among all federal agencies working in vaccines, specifically CDC, FDA, NIH, HRSA, DOD, and others. Some of the participants mentioned that NVPO could assist a great deal more in the coordination of vaccine safety activities, particularly among the federal government agencies; however, it was acknowledged that NVPO lacks the resources and the authority to drive such activity. Some participants expressed the need for creating an interagency coordinating group to review the vaccine safety activities and/or a scientific advisory board for research. Others suggested that a Task Force on vaccine safety to include NIH, CDC, FDA, HRSA, and others should be formalized. The participants were reminded that at one time, there was a Task Force on Childhood Vaccines that could be reactivated with clear definition of its role in vaccine safety. Currently, it should be noted that there is an Interagency Group on Vaccines (IAVG) comprised of senior staff from many of the agencies noted above; and it convenes via teleconference every two weeks. Overall, participants expressed the tremendous need to strengthen coordination on vaccine safety activities. More importantly, the discussion highlighted the need for defined roles of responsibility and accountability for resource allocation and plan implementation across the various federal government agencies. These activities must be accompanied by an ongoing review of results to ensure further responsibility and accountability.

The discussion around collaboration revealed that a strategy for setting the agenda on vaccine safety research is critical but that it must be done in a way that is coordinated and incorporates the strengths of each participating agency and/or partner. Again, NVPO, with additional resources and a clearer definition of authority was mentioned as an appropriate key player in the process of providing more formal collaboration on the development of a strategy for looking at vaccine safety issues.

When speaking to the strengths of the various agencies, CDC’s strengths in epidemiological studies and outbreak investigations were acknowledged. However, it was emphasized by many that epidemiology is not the only scientific research that should occur around vaccine safety. There was a discussion about NIH and its’ focus and strength in basic and clinical research. Additionally, there was acknowledgment that the genetic component of any chronic disease must be studied as well as the genetic predisposition to any serious adverse event (acute or chronic). Again, NIH has the potential to bring additional strength and expertise to conduct such research.

Regarding vaccine safety monitoring, there was a strong support for CDC’s role in surveillance and epidemiology; however, there was less clarity regarding differentiation of CDC’s role and FDA’s role in vaccine safety research matters such as post-licensure trials.

Once it was recognized that a need exists for a formalized collaboration across the agencies and beyond, another theme emerged which demonstrated that the specific roles of each agency within the federal government are not as clearly defined when it comes to vaccine safety research. It is certainly a cross-cutting issue with tremendous overlap and at the same time, some gaps.

FDA is responsible for the regulatory oversight and review of pre-licensure studies conducted by manufacturers and the question came up as to who is responsible for post-licensure studies? Currently, within the federal government, both CDC and FDA are involved in these types of studies. As part of a post-licensure commitment, FDA may request that a manufacturer conduct certain post-licensure studies, and FDA is also responsible for the regulatory oversight and review of these studies. Although this process seems to be working and must continue, it can also be improved. There was a sense among the participants that there is real need for improvement in post-licensure research. It was mentioned that some manufacturers have an active role in conducting post-marketing trials, both on their own initiative as well as in response to agreements with FDA.

CDC and FDA have important functions in surveillance and some participants emphasized that the performance has generally been strong in this area. However, concern was expressed that most monitoring/surveillance systems are not specific to a particular vaccine and there are not enough studies of possible adverse effects of new vaccines in combination with existing vaccines. Therefore, as the number of vaccines increases, the number of unresolved hypotheses which need new studies might also increase. Who will be responsible for prioritizing and doing these studies? Another point raised was that post-marketing research results may not necessarily be included in the vaccine package insert unless they are submitted for FDA review by the manufacturer.

Additional questions focused on the perceived increase in national morbidity from chronic diseases—and the role, if any, that vaccines may play regarding such conditions as asthma, neuro-developmental and learning disabilities, diabetes and autoimmune disorders. While CDC does conduct research on chronic diseases, it was not completely clear what the roles are for the agencies in conducting research on chronic diseases that could be linked to a vaccine and/or drug (i.e. product/drug-induced disease) and whether this type of research should fall only within the purview of FDA, since it is a regulatory agency. The challenge of determining whether a chronic disease is product-induced was recognized. There is great difficulty in determining whether a valid signal exists for a relationship between vaccines and chronic conditions. Some participants questioned the sensitivity of existing vaccine safety tools, such as VAERS and VSD in picking up signals around chronic diseases.

There is a need for external oversight and community/public involvement in setting the research agenda.

Another key theme that emerged is the underlying need to involve the public to a greater extent in the decision-making process on vaccine safety research. The public has a critical stake in the vaccine safety research agenda and therefore, could play a larger role in this process. Some participants stated that in the current environment, there is controversy about vaccine safety research and some of this may stem from the lack of trust that some members of the public have towards those setting and monitoring the research agenda. If coordination of vaccine safety activities could be improved and public participation could be enhanced in this process, the trust could be strengthened between the government and the public. Some individuals felt strongly that the process whereby the Advisory Committee on Immunization Practices (ACIP) and the Institute of Medicine (IOM) make recommendations for research priorities is working well and must continue, but might be strengthened with the addition of greater public participation. Others believed more substantive changes within and outside these existing relationships would be necessary to reduce what some perceive as inherent conflicts of interest.

A consistent message in the discussion supported the value of an integrated research effort to answer research questions. Some views were expressed that highlighted the desire by independent researchers to conduct research different from that research which the government is funding. For example, while there have been some changes implemented in the past several years (i.e. movement from whole cell pertussis to acellular pertussis as well as from oral polio to inactivated polio), there is a feeling among some participants that CDC can sometimes seem unaware of some concerns among the public and even at times dismissive of new ideas. This was another key reason why some participants believe that more public participation in setting research priorities will be a step towards additional collaboration and trust around these issues. The biases mentioned included:

  1. Extramural investigators whose hypotheses or initial findings raised questions about the safety of certain vaccines did not get a fair review of grant applications from any government agency.
  2. Vaccine safety research, in general, has no strong advocates involved in prioritization and allocation of resources and thus, does not seem to be a priority at NIH, the major source for biomedical research within the federal government.
  3. An exception has been made for funds related to vaccines considered to be useful for protection against bio-terrorism. Anthrax and Smallpox are examples, including National Institute of Allergy and Infectious Disease’s recent creation of centers to study atopic disease associated with smallpox vaccine.
  4. Funding for long-term studies of vaccine safety is very limited or not available.
  5. Clear mechanisms are too limited for rapid responses to new concerns around vaccine safety. The public’s role in evaluating the level of concern and prioritization for limited resources has been even more limited.

Additionally, the peer review process for government-funded research was questioned and there were suggestions that the research needs to be more results-oriented and customer-directed. An external prior peer review process is critical to evaluate the technical merit of proposed research protocols and also to assess the competence of the investigators to perform the research. Some participants believe that an additional external peer review process to assess research results should include people with different disciplines than the “usual suspects” with the technical expertise. Other members encouraged external peer review for both intramural and extramural research.

Some participants felt that the public should be involved throughout the process. Whereas, others felt that the technical review should be left to those scientists with the expertise and the public can contribute with the scientific community in recommending vaccine policy. Furthermore, it was mentioned that different patterns of review are needed. When new issues arise around vaccine safety, it should be possible to re-evaluate and do additional follow-up research as needed. Some suggested that while the CDC has demonstrated the ability to respond to signals, sometimes the response does not appear to be appropriate to the significance of the signal. Some believe that this demonstrates peer review of research results alone does not represent a final answer on a scientific issue. If there were more public participation in the process of setting research priorities, some felt that that this would reduce the risk of research being terminated “prematurely” in areas viewed as problematic.

Finally, once a research agenda has been set, there needs to be an external oversight process in place to monitor the research being conducted by the various agencies and others to ensure that ideas raised by members of the public are being addressed and the scientific integrity of the research is maintained. Additionally, and some believed most importantly, external oversight is needed to protect the science. While there are currently oversight mechanisms in place, some participants who noted that there is a need for improvement around the quality of the oversight. Others expressed concern that if an independent advisory board is set up to provide oversight to management, there is a risk that decision-making could effectively come to a halt. It was apparent that external oversight was essential if the results are to have the high credibility that the modern era of consumerism and evidence-based medicine demands.

There is a need for greater transparency in terms of how research priorities are set, how research designs are developed, how and what research is being conducted, how data are being analyzed, and how those data are used for policy making. This transparency could help the public understand what research is being done and why it is being done – this knowledge may help create a greater sense of participation in the process itself.

As the participants discussed the need for increased participation by the public in the process of setting the research agenda for vaccine safety, there seemed to be a sense that almost as important is the need for greater transparency into the research being done within the federal government. It was expressed by some that in the current environment, it is unclear who decides the priorities of vaccine safety research, how this research is funded and who ultimately does it. These are fundamental issues into which some members of the public would like to have more insight.

There were some concerns raised that it already seems as if some of the research being done in vaccine safety has been in response to political pressures, inaccurate public perception of the vaccine safety issues and other external factors. Given these issues, some of the participants believe that many of the research priorities are being set in a reactive versus proactive mode. There was concern expressed by some participants that research is being determined in response to external criticisms that are not based on science. These criticisms pose serious risks to priority-setting for use of limited resources. Responsiveness to public concern is important, but a mechanism must be implemented to balance these concerns with protection of science and the scientists. Some comments supported the importance of allowing science to drive the research agenda. While it was also expressed that the government research agenda should be driven by the health needs of the general public, the driving force for the research agenda should be based upon the “best science.” Oversight, regardless of where it is based, should utilize measurable objectives that are consonant with the needs of the general public. Otherwise, oversight alone tends to lead to micro-management and stifles creative outreach for solutions.

There were also comments regarding the need for the peer review process to have increased transparency. Overall, transparency in the governmental planning and implementation process in setting our nation’s vaccine safety agenda could potentially lead to increased public confidence.

Data access for external review and research is critical. Recommendations were varied as to how public access could be increased safely but there was agreement that data access needs to be increased. Additionally, this access would allow for increased extramural research.

Providing additional access to vaccine safety data to external researchers for the purpose of conducting vaccine safety research was another recurring theme. Some participants believe that the data must be publicly posted as this would increase public confidence in CDC’s credibility and accountability in these issues, while others place greater emphasis on audits. While a data sharing mechanism to allow access to the Vaccine Safety Datalink (VSD) Project data has been in place at CDC since 2002, some expressed their continued interest in having broader access to the VSD database to allow outside researchers to replicate and validate the studies that have already been done by CDC. However, others emphasized that CDC should more fully assess the current mechanism before expanding access. Some participants felt that in providing transparency and public participation in the research process, access to data is a key aspect of strengthening the trust around these issues.

Adequate safeguards for data must be in place to ensure the health plans’ willingness to continue participating, and to protect the privacy of both patients and the participating health plans. It was recognized that the health plans involved in the VSD Project can choose at anytime to discontinue participation and this would be an irreplaceable loss to vaccine safety research. During the discussion, it was emphasized that CDC and HHS must define conditions that protect the health plans and their patients, maintain the integrity of the science and continue to allow public access to the data. The participants all recognized that achieving these objectives was technically, legally and logistically challenging.

The Vaccine Adverse Event Reporting System (VAERS) is not sufficient to detect signals due to underreporting and doesn’t have the granularity needed to identify who is affected. There is a need to bolster and improve VAERS.

In reviewing some of the specific processes in place dealing with vaccine safety, concerns were raised regarding VAERS, a system collaboratively managed by both CDC and FDA. It was not clear to all participants that VAERS was designed only to identify signals, not respond to them. Nevertheless, several participants expressed little confidence in VAERS. Even if CDC can respond rapidly to signals, some participants perceive that CDC cannot respond adequately. Others expressed that VAERS has been sensitive in detecting signals and that CDC has demonstrated the ability to respond rapidly and decisively to clear-cut signals of vaccine adverse events. There was considerable discussion around what constitutes a signal and what represents a reasonable response. Intussusception following vaccination with the rotavirus vaccine was reviewed as an illustrative example.

Concerns were expressed that there may be important signals missed due to under-reporting; and therefore some participants questioned whether VAERS has the breadth and depth of signal reporting to allow for an appropriate response. Some expressed the opinion that in order to have a system that is truly effective, there would need to be mandatory reporting of adverse effects to VAERS by those who administer vaccines. Others discussed the importance in determining who does not report to VAERS and why they are not reporting. This latter concern was related to special or under-represented populations that may be at differential risk, due to genetic and/or environmental factors. Examples mentioned were racial and ethnic minorities, immigrants and the poor. Some thought that there may be additional ways to encourage reporting to VAERS and that this is another area where external input can be beneficial. Programs to educate the public and professionals about the importance of VAERS were proposed as potential ways to improve the sensitivity of signal detection by VAERS.

There were recommendations for structural changes at CDC (i.e. where to locate vaccine safety activities), ranging from very specific to very diffuse.

One question which continued to be discussed throughout both days of the meeting had to do with the placement of vaccine safety programs– both within CDC as well as outside of CDC. Opinions varied on where vaccine safety activities should be placed within CDC and how vaccine safety activities should be organized. Although options were presented by Dr. Wharton as to where vaccine safety might be placed within CDC, including pros and cons provided for each option, there seemed to be a tacit understanding by the participants that the placement of vaccine safety activities is largely a management decision. It was hoped that the tone of discussion would be useful to management as it reviews options for placement of vaccine safety activities.

One overarching issue that was raised had to do with CDC’s expertise in outbreak investigation and the necessity to continue to have the best science. Opinions were expressed by some that the vaccine safety activities must remain within the purview of skilled scientists and not be distorted by passions of the moment, current public trends or perceived conflict of interest. It was acknowledged that all individuals have biases and that conflicts of interest are inherent. Oversight structures, which can include external participation, may offer helpful approaches for managing and balancing these conflicts.

Strong sentiment was expressed to “do no harm” to the good work currently being done in any decision regarding where vaccine safety will be placed organizationally. CDC has a different role than NIH or FDA in responding to emergencies and there was an expressed desire to not jeopardize this ability with any changes that are instituted. Recognition of the need for CDC to maintain a workforce both interested in and desirous of responding to emergencies as well as doing safety research was also discussed. It was also noted that currently little support exists for only a small cadre of scientists with particular skills in the pharmaco-epidemiology of vaccines and the nascent field of pharmaco-genetics.

CDC must be able to detect potential safety problems quickly and address them systematically and effectively. Some believe that CDC should maintain leadership of the vaccine safety program while others felt the vaccine safety program should be moved outside of CDC. It was also noted that criticism of some study results will still exist regardless of where vaccine safety programs are placed. Other participants believe that the vaccine safety activities are best located where they are within the NIP and that additionally, there must be a formal enhancement of coordination of activities.

Comments were expressed concerning strong, positive interactions between policy, surveillance and research, thus making a case for continuing to house these activities together. There were comments that moving the vaccine safety monitoring outside of NIP could create more problems and there was a question of how public health benefits by moving the vaccine safety activities. Specifically, there were several remarks on the placement of the risk management, risk assessment and risk communication activities at CDC. Some participants questioned whether risk management for vaccine safety belongs in FDA (or outside of CDC) but they felt that it should not remain in NIP. Some noted that public perception must be considered and that generally, maintaining the management of risk and assessment of risk in same location would continue to raise questions. Some believe that while these two areas dealing with the assessment of risk and the management of risk should be separated, there are other ways to achieve this separation other than reorganization. There were suggestions that risk communication should be moved outside the Immunization Safety Branch or the NIP.

Strong concern was expressed that the CDC scientists and their research work need to be protected from undue outside influences. From the presentations, it was clear that there are many personnel issues around vaccine safety. One issue includes high levels of stress due to increased public criticisms of CDC’s vaccine safety research and other vaccine safety activities. Another issue is the number of people with the expertise to do this type of work is limited and the incentives to keep people in the field are limited. Other personnel issues of concern included recruitment, training and retention and the career ladders for personnel with appropriate training and skill sets in vaccine safety. It was further noted that regardless of the placement of vaccine safety activities, the staff in the broader immunization program and in the Immunization Safety Branch must have the support of the Director of CDC.

Overall, there seemed to be a sense among some that the work CDC and the immunization safety staff have been doing in this area has been very good. Some participants were extremely impressed with the breadth and depth of accomplishments presented by the staff. It was noted that there is tremendous respect for the Immunization safety staff. On the other hand, some noted that while the staff presented accomplishments with great pride, this expression of pride can often be misinterpreted by some in the public as arrogance and/or a lack of openness to listening.

There was a clear sense that vaccine safety activities are under-funded within the federal government.

The lack of funding dedicated to vaccine safety may have been the most common th

Amazing US News Report – Part II – US Reporter Bob MacNeil – Autism more serious for US children than cancer, diabetes and AIDS combined

Measles is nowhere as serious as autism now is.

Here you can preview Part II of Bob MacNeil’s six part seriestonight’s full show – of this extraordinary series by US reporter Bob MacNeil on the links below to the broadcast, the transcript and a link to listen on mp3:-

See on tonight’s show:

ROBERT MACNEIL:  Autism now affects more American children than childhood cancer, diabetes and AIDS combined. In the last decade, the numbers of children diagnosed on the autism spectrum have risen rapidly. The Centers for Disease Control now puts the rate at one in 110. Tonight, we look at what these rising numbers mean.

CHS covered Part I here: Amazing US News Report – Autism Strikes US Reporter Bob MacNeil’s Grandson After MMR & Other Vaccines.

In the second report in his Autism Now series, Robert MacNeil investigates why the number of children with autism is increasing in the U.S. He meets children at different points on the autism spectrum and gets several views on the increase in prevalence — from better diagnosis to a variety of environmental factors.

But here is the answer to the question Bob MacNeil does not address in his show.  Do vaccines cause autistic conditions? If you read nothing else we strongly recommend you read this: PDF Download – Text of email from US HRSA to Sharyl Attkisson of CBS News].  In it the US Health Resources Services Administration [HRSA] state to CBS News reporter Sharyl Attkisson

We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.

Despite all the lies and deceit by health official worldwide, the question “do vaccines cause autism” was answered when the Hannah  Poling story broke in the USA [see CHS article here].  Hannah developed an autistic condition after 9 vaccines administered the same day.  Under the media spotlight numerous US health officials and agencies conceded on broadcast US nationwide TV news from CBS and CNN. In the US Federal Court children have been compensated after findings they developed autism and other injuries. Full details with links to the original sources can be found in this CHS article: Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines.

Watch, Listen, Read Transcript Of Tonight’s Show

Listen on mp3:  Autism Now: Exploring the ‘Phenomenal’ Increase in U.S. Prevalence

Read the Transcript – full text after video of show below.

Watch the to-be-broadcast show:Autism Now: Exploring the ‘Phenomenal’ Increase in U.S. Prevalence

Full show transcript:-

ROBERT MACNEIL:  Autism now affects more American children than childhood cancer, diabetes and AIDS combined. In the last decade, the numbers of children diagnosed on the autism spectrum have risen rapidly. The Centers for Disease Control now puts the rate at one in 110. Tonight, we look at what these rising numbers mean.

This is the face of autism.

PERIN RAPP: I’m Perin. I’m 9 years old.

ROBERT MACNEIL: But so is this.

Would you tell me your name? Would you tell me your name? I think your name is Juliana, and I think you’re 8. Is that right? Is that right, Julie?

And so is this.

LOGAN HENDERSON: My name is Logan Henderson, and I’m 8 years old.

ROBERT MACNEIL: Each so different, yet it’s all called autism.

You can see the differences more dramatically when you visit their schools. They learn differently.

Juliana Hernandez doesn’t talk. Although her teacher’s says she is very smart, she’s in a special-needs class, and at 8, she’s still learning to count the days of the month.

Logan Henderson attends second grade at another elementary school. He’s in a mainstream class but needs an aide to manage any kind of change, although her support is almost invisible in class. But in the playground as Logan plays alone, his social disability is more obvious.

Like Logan, Perin Rapp can talk, but he’s profoundly different in other ways. Perin attends what is called a communication-handicap program for children who need to go at a slower pace, although he’s learning at grade level in other areas.

PERIN RAPP: Can I read quietly?

TEACHER: Do you need a break? Are you asking me for a break? Do you want to read this story quietly? Is that what you’re asking me?

PERIN RAPP: Mm-hmm.

TEACHER: OK, two minutes, and then you have to come back to…

PERIN RAPP: Wait, wait, I want to …

SALLY ROGERS, MIND Institute: Hi, feet. You like that, huh? OK. I’ll rub your feet.

ROBERT MACNEIL: Sally Rogers is a professor of psychiatry and behavioral sciences at the MIND Institute in Sacramento. MIND stands for Medical Investigation for Neurodevelopmental Disorders. It was established with state funds at the University of California, Davis in 1998. Sally spent some time playing with Juliana, Logan and Perin, who are among the thousands of children with autism who’ve been evaluated at the MIND Institute.

LOGAN HENDERSON: No. I do not autism.

SALLY ROGERS: No. You don’t want to talk about autism?

LOGAN HENDERSON: No.

SALLY ROGERS: OK. No autism. I got that. Would you rather have some Play-Doh?

LOGAN HENDERSON: No.

SALLY ROGERS: Or some bubbles or something?

LOGAN HENDERSON: No. Nothing.

SALLY ROGERS: No. Nothing. You don’t want anything today. OK. I know how that feels.

They all have common threads. None of those three children interact with me as a typical 8-year-old would. None of them converse with me as a typical 8-year-old would. And none of them really use the materials and the situation in the room like a typical 8-year-old would. But each of them showed their symptoms in a very different profile.

Do you know Shrek’s girlfriend’s name, Perin?

PERIN RAPP: (INAUDIBLE)

SALLY ROGERS: What is it?

PERIN RAPP: (INAUDIBLE)

SALLY ROGERS: Venera?

PERIN RAPP: Mm-hhm.

SALLY ROGERS: Oh, boy I didn’t know that.

Each of them wanted a different relationship with me. Logan didn’t want any interaction with me. Perin wanted a lot of interaction with me. And Julie wanted access to the materials and was happy to interact with me but doesn’t have a good way of starting or maintaining interaction because she doesn’t have language to use. But we used nonverbal communication.

ROBERT MACNEIL: Like?

SALLY ROGERS: Well, she followed my cues, my gestures. We figured out what each other wanted. We don’t need language for that.

ROBERT MACNEIL: Describe how differently you see each of those three children. Where do they – where do you put them on the spectrum?

SALLY ROGERS:  Well, autism has affected Julie particularly severely in her language and communication skills. She showed that she had some awareness of print. You know, when I was writing her name and she was copying it, I said some letters, and she could write them. So, it’s clear that she knows more than she can share through words.

Perin certainly has lots of skills. He can write. He could write names. He could figure out how to spell my name. He creates symbolic materials. He can carry on a conversation. But it’s kind of a one-sided conversation, you know?

ROBERT MACNEIL: And Logan?

SALLY ROGERS: And Logan, Logan was so uncomfortable in the whole situation. And fortunately Logan has language and knows how to use language to express his feelings. He didn’t have to have a tantrum or be destructive or aggressive. He could communicate with his speech, which is a great gift to be able to share your feelings.

LOGAN HENDERSON: All I would like is alone time, and I would like to get out of here.

SALLY ROGERS: You’d like some alone time? OK, you got it.

ROBERT MACNEIL: Logan has two older brothers, Jason, 10, and Matthew, 12. And, remarkably, they both have autism, too. In fact, although they share the same genetic inheritance, in their diversity, the three Henderson brothers almost represent the breadth of the autism spectrum. Each boy’s symptoms are quite different, as their dad, Rick Henderson, describes.

RICK HENDERSON: You know, Matthew, for an example, my 12-year-old is extremely shy, very passive in terms meeting people and being in different environments.

ROBERT MACNEIL: Matthew is high-functioning on the…

RICK HENDERSON: He is high-functioning on the spectrum. He is our highest-functioning child. And does very well. He is mainstreamed in school.

ROBERT MACNEIL: Good verbal skills?

RICK HENDERSON: Very good verbal skills. My 10-year-old, Jason, who is what they would call mid-moderate to severe in the spectrum. Very limited verbal communication, but at the same time very social.

JASON HENDERSON: What is your name?

CAMERAMAN: Hi, my name’s Jason.

JASON HENDERSON: What’s your name?

CAMERAMAN: Jason. We have the same name.

RICK HENDERSON: His name’s Jason. He’s Jason, and you’re Jason.

JASON HENDERSON: What’s your name?

CAMERAMAN: I’m Robert.

RICK HENDERSON: Jason especially has been a real challenge, where his mind will wake up at 3 in the morning, and he thinks it’s the middle of the day. And he’s up playing and doing his laughing and giggling and turning on TVs and, you know, just really thinking it’s the middle of the day. And you can’t shut that off. And so we’re up all night with him, ensuring to keep him safe and trying to prevent him from waking up the other two. And that happens at least once a week.

And then my youngest son, Logan, he’s what we call our politely defiant one. He is considered to be high-functioning but not quite as high as where Matthew is.

“I see it as progress. I really see it as an achievement to be able to identify these kids who previously were either misdiagnosed or maybe had no diagnosis at all.”

- Richard Grinker, George Washington University

ROBERT MACNEIL: How can the Henderson brothers and the other children all be so different yet diagnosed with the same condition? The answer to that question is where scientists disagree about what the rising numbers of autism diagnosis mean. Anthropologist Richard Grinker, a professor at George Washington University, says it’s because we have widened the definition of autism.

RICHARD GRINKER, George Washington University: It’s where somebody who previously had the identical symptoms now is conceptualized differently. And so, if you went back 30, 40 years, and you looked at people who were diagnosed with mental retardation or who were diagnosed with what was then called childhood schizophrenia, you would find that those people, 30 years ago, would qualify for the diagnosis of autism today. And I suspect that we may see the prevalence of autism continue to increase, not because there are more cases. They were there all along, perhaps, but because we’re getting better at locating them, finding them and delivering services to these children and adults who really need help.

ROBERT MACNEIL: But a majority of the researchers we talked to believe that wider diagnosis explains only part of the increase in autism numbers. The rest remains the object of much scientific speculation. Among others, Dr. Irva Hertz-Picciotto, who heads the Division of Environmental and Occupational Health at UC-Davis, sees many possible environmental factors.

IRVA HERTZ-PICCIOTTO, University of California, Davis: There is a group that did look at the diagnostic substitution explanation. They thought that maybe explained a quarter to a third. But in addition to that, there has probably been an environmental contribution for a long time.  We, in fact, know that some of the potential environmental causes do include, for example, infectious agents.

ROBERT MACNEIL: Do you have candidate factors for those factors that may be fresh in the environment?

IRVA HERTZ-PICCOTTO: I have a lot of candidate factors, actually. And they include nutritional factors, infectious agents, chemicals in our environment, including chemicals in the household products that we use every day. There are a variety of factors that could be influencing development, and they may play a role at different points in development. But I think multiple factors contribute not just across the population but within any one individual. So when I say that I think autism is multifactorial in its causation, I think that applies to even at the individual level so that it might take two or three susceptibility genes combined with two or three environmental factors at critical junctures.

ROBERT MACNEIL: Which might explain why individuals with autism are so different, even though they share some obvious symptoms.

IRVA HERTZ -PICCOTTO: Exactly. Exactly.

RICHARD GRINKER: And I say, “OK, there’s this big prevalence increase in autism. That’s undeniable. There’s a prevalence increase.” Whether it means that there’s an increase in the real number of people with autism or not, there’s a prevalence increase. But I see it as progress. I really see it as an achievement to be able to identify these kids who previously were either misdiagnosed or maybe had no diagnosis at all.

ROBERT MACNEIL: Sally Rogers has first-hand experience of the rising numbers as she works to identify and treat children with autism at the earliest possible age.

SALLY ROGERS: In my experience, the number of children who have autism has increased enormously. I remember 30 years ago when I started working with young children with autism in a real focused way. And I remember when I saw the first child in 1982, a 2-year-old with autism.  Two years later I saw another. Three years later I saw another. And now in the last two years, we’ve recruited 50, 70 2-year-olds with autism just here in this city. It’s a phenomenal change from a clinician’s experience in the prevalence of autism.

ROBERT MACNEIL: Whatever is happening to the numbers, there is a saying among those who know autism well: “When you’ve seen one child with autism, you’ve seen one child with autism.”

The prevalence of autism is intimately linked to what causes autism, and that’s our subject tomorrow night: the causes of autism.

From America – A Personal Story of Parental Love for Son’s Life Destroyed By Vaccines

Here, CHS republishes from the USA another personal tale in video of the horror vaccination has brought  not just to a child but to a family and of the devotion and love of parents in caring for their child, whose health, normality and childhood has been taken by the medical profession’s religious belief in the religion of vaccinology. 

This follows CHS’ publication today of  father Giorgio Tremante’s account from Italy of his and his wife’s years of love and devotion to a now adult son whose health and normality was similarly taken away in childhood, but not before the lives of a twin child and also of a sister were also taken from Giorgio and his wife: From Italy – A Father’s Personal Tale of Parental Love and Medical Horror – Courtesy of An Anti-Child-Safety Medical Profession

From Italy – A Father’s Personal Tale of Parental Love and Medical Horror – Courtesy of An Anti-Child-Safety Medical Profession

Here is a detailed account in a video and also in his own words from Italy by Giorgio Tremante a father telling his story of his and his wife’s absolute love for their children and a long fight to give and keep life for the disabling horrific injuries to a surviving adult son.

The sadness is deepened by the knowledge this severely injured child’s brother’s and sister’s lives were taken away in infancy by the needle happy religious beliefs of the medical professions. 

Those are professions which leave child health safety out of the list of considerations in the religion of compulsory universal vaccination for all.  This is a profession which knowingly and steadfastly ignores individual safety and refuses to screen out children at risk of injury and death from vaccinations. 

Here is the video and below is the account in his own words Giorgio posted on ChildHealthSafety today.  His account in limited English may not explain as well as he might in his mother tongue of Italian but this is a man whose tenacity and love for his son spills out for us to tell a story which might help others.  Please help it be better known. 

We, CHS are publishing it here, as posted by the father of a now adult child from Italy as testimony for others to see and share of the harm doctors and health officials cause to our children – all our children across the world.

Shame.  The Greatest of Shame on them – all of them.

Comment from Giorgio Tremante – Submitted on 2011/04/18 at 8:02 am

I’M ALIVE
Dedicated to all the victims of vaccines.
http://www.facebook.com/l.php?u=http%3A%2F%2Fwww.youtube.com%2Fwatch%3Fv%3DpQK_qhOdUcI&h=19e02

Comment from Giorgio Tremante – Submitted on 2011/04/18 at 8:01 am

When will ‘this genocide?

Brief description of our tragedy
To show how evil can do the vaccinations, used so indiscriminately on families from all over the world, I think it’s my duty by telling my story, but specifies that unfortunately my story is not considered a unique case in itself sporadically but it is only the tip of an iceberg that is trying to unmask the category of “scientism” that terror still require the use of vaccination practices.
The tragedy that struck my family, has hit three of my four children.
I state that my three children are affected by the reaction from the vaccine, were born perfectly healthy and that the manifestations of a disease may have appeared only after the first vaccine Sabin. A Mark, my firstborn, the folder was described the clinical symptoms that appeared after the Antipolo Sabin. The disturbances occurred (ocular nystagmus, tremors and defects to the word) had been made in relation to the pediatrician by Sabin, while other doctors had assumed various diagnoses such as brain tumor or degenerative encephalopathy, never confirmed by any analysis performed on the child. He died in 1971 at six years. The second son, born in 1970, there were problems. But the drama returns with the birth, which occurred in 1976, of two twins monovular. Despite my opposition to an iron law that I have imposed a mandatory absurd and dangerous, without any prior investigation, were vaccinated and the next day already began to emerge the first signs of any alteration. Submitted the medical records of the first shelters suffered by my children at various Universities: United States, England and even in Russia, in the latter country is speculated disease on immune deficiencies that would have confirmed the specific responsibility of the vaccinations. In my city, Verona, was placed the diagnosis of type metacromatic Leukodystrophy, a degenerative disease of the nervous system, this diagnosis was never confirmed by genetic tests also that we are submitting. Later Andrea, one of the twins, it is aggravated and was hospitalized for dehydration, despite my recommendation not to use drugs immune-suppressor, because the child was immune-compromised, of cortisone was used in a vein in five hours and my creature died. Later I came to know that the same drug was given to my first child before death. Even with the autopsy were able to have useful information to save the life of twin remained because there was denied the presence of a medical legal part, so that examination could not be trusted with our research. At one month after the death of Andrea, Alberto, was the sister, had to be hospitalized. Despite the opinion of doctors was to let it die, it was brought at our request, in resuscitation and asked a virologist of Naples, who previously had examined the child, they advised us of immune-stimulant. Subjected to treatment with interferon, the child began to improve slowly. After six months in hospital the baby was brought home with no letter of resignation. Sometime later, the requested medical records, I realized that they were different from those who copied each day during hospitalization. That is a statement presented to the judiciary. As a consequence of this was done by a judge issued a court notice to the Director at the Health Office in which he had been admitted to the child, later extended to primary pediatrics for “Fake ongoing public. At the end of this proceeding was filed.
Many other shelters suffered Alberto, both in the same hospital in Verona than in other resuscitation: the Polyclinic of Milano, Merate in the province of Como, a Melegnano, near Milan, and finally was transferred automatically from the Polyclinic of Melegnano Verona. During all the different shelters my task was to ensure that treatments were applied immune-stimulant that we had given the first positive results. These therapies we were always advised by Professor Tarro of Naples, who was a pupil of Professor Sabin. It was always difficult if not impossible to apply this type of therapy to Alberto, as the doctors had ruled compact now that my son had to die. This was supported because discovery was not the responsibility of the vaccinations used on a subject, partially immune-compromised. Although our case had concerned the then President of the Republic, Sandro Pertini, putting pressure because the Health Minister Renato Altissimo established a Ministerial Commission, this without ever having seen a report drawn Alberto fake to hide the truth of the damage suffered by the vaccines. The last shelter Alberto had to suffer at the Polyclinic in Verona, where, in the opinion of health care, my son had to die a short time. I tried desperately to bring home my child, was seen as their way of thinking because the only solution of the problem for them was the culmination of the whole nefarious affair. At that juncture, because I could not survive in order to make my creature, even I did remove the “parental authority” by the Judge of children in Venice, to whom I addressed just to make them understand that he was committing a gross error. I managed to convince him to reinstate me in the parental responsibility, starting as early the now 1984 to manage my child at home, creating me resuscitation room “where previously arranged our master bedroom. During hospitalization all my wife Franca Alberto has always remained with him day and night to protect it from any abuse that the medical profession sought to implement.
Many others had to suffer harassment by the Health, even if Alberto had not set foot in a hospital, controversy of any kind from the health institutions because they do not want to admit that the vaccinations were the cause of his illness and death of his brothers.
Finally, in 1995, making recourse to law 210 of 1992, recognized by the state saw the “causation” of the damage suffered by subjecting our children to mandatory vaccinations.
During all these years I efforts to establish associations in Italy to aggregate people like me who have suffered damage from the vaccine practices;
also tried to pass a law that had developed with the Parliamentarians, to waive the obligation of these practices, but this goal in Italy has not been achieved because, in my opinion, the health policy that is implemented is left thumb yet the power of corporations of drugs. All this is proving that even in this area, some pseudo science, with the arrogance of his scientism, devoid of any scruple, trample continuously, with action in most cases illegal, every human right and civil matters. It imposes its power based on speculation that interest their progress based not on an open and accurate information, but rather on a complete and deliberate disinformation to get even the Occult of certain realities and impersonating preventing these practices prophylaxis that may, except to prevent anything.
http://www.facebook.com/album.php?profile=1&id=100000877344712#!/photo.php?fbid=181193258586584&set=p.181193258586584&notif_t=photo_comment

Comment from Giorgio Tremante – Submitted on 2011/04/18 at 8:03 am

WHEN YOU BECOME A MEMBER “MURDERESS”?
WHEN COMING TO THE ATTENTION OF COUNTLESS SERIOUS NEGATIVE EFFECTS CAUSED by the indiscriminate use of certain practices, INSTEAD ‘makes it clear, He hides them and retains the obligation on those pseudo-HEALTH highly dangerous, not even bothering to PREPARE FINDINGS FOR QUOTES CAN BE AVOID POSSIBLE CONSEQUENCES Tragedy.
http://www.facebook.com/photo.php?fbid=1017122520708&set=a.1017113160474.2003342.1604470486&ref=fbx_album

EU Takes Emergency Measures Over Glaxo’s ‘Flu Vaccine – Causes Narcolepsy in Children

GlaxoSmithKline’s ‘Flu vaccine causes four-fold increase of cases of narcolepsy in children and adolescents (below 20 years of age) who received Pandemrix compared with unvaccinated people  of the same age according to preliminary results of the Swedish registry study from October 2009 to December 2010 on Pandemrix.  

Clearly this vaccine was not properly tested, like many other childhood vaccines.

Full Text of EMEA news release 15 April 2011 below.  Download links below to French and Swedish agencies’ reports on the narcolepsy problem.

And do vaccines cause autistic conditions? If you read nothing else we strongly recommend you read this: PDF Download – Text of email from US HRSA to Sharyl Attkisson of CBS News].  In it the US Health Resources Services Administration [HRSA] state to CBS News reporter Sharyl Attkisson

We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.

Despite all the lies and deceit by health official worldwide, the question “do vaccines cause autism” was answered when the Hannah  Poling story broke in the USA [see CHS article here].  Hannah developed an autistic condition after 9 vaccines administered the same day.  Under the media spotlight numerous US health officials and agencies conceded on broadcast US nationwide TV news from CBS and CNN. In the US Federal Court children have been compensated after findings they developed autism and other injuries. Full details with links to the original sources can be found in this CHS article: Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines. [Blue Text added 10 April 2011]

_____________________________

News Release

European Medicines Agency recommends interim measures for Pandemrix – 15/04/2011

Updated prescribing advice highlights preliminary results from epidemiological studies on narcolepsy; further research needed

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Pandemrix should be amended to advise prescribers to take into account preliminary results from epidemiological studies on Pandemrix and narcolepsy, and to perform an individual benefit-risk assessment when considering the use of Pandemrix in children and adolescents. This is an interim measure pending the outcome of the European review, expected to conclude in July 2011.

The CHMP reviewed all available data, including new findings from Sweden and France on the suspected link between narcolepsy in children and adolescents and Pandemrix. The CHMP concluded that, following the earlier results of an epidemiological study from Finland, the new evidence strengthened the signal in children and adolescents, but that the data had methodological limitations. The relationship between Pandemrix and narcolepsy is still under investigation.

Preliminary results of the Swedish registry study from October 2009 to December 2010 on Pandemrix vaccination and the risk of narcolepsy indicates a four-fold increase of cases of narcolepsy in children and adolescents (below 20 years of age) who received Pandemrix compared with unvaccinated people of the same age. The additional risk corresponds to an additional 3-4 narcolepsy cases per 100,000 vaccinated subjects. These results are broadly in line with the study results from Finland indicating an association between Pandemrix and narcolepsy in children and adolescents. The study did not identify any increased risk in adults. The CHMP concluded that the study was well conducted, although it has inherent limitations.

An analysis of narcolepsy reports in France provides some further evidence.

The lack of a clear increase in reports of narcolepsy following Pandemrix in other EU and non-EU countries may point towards the influence of other unknown factors affecting the trend seen in some countries. Also, there is currently no clearly identified biological plausibility for an association between Pandemrix and narcolepsy, and further non-clinical studies, especially in the juvenile setting, are needed.

The CHMP considers it important to gather more data on the use of Pandemrix and related vaccines in a variety of countries to further assess this concern. A variety of research efforts are now ongoing. These include an epidemiological study of narcolepsy and pandemic vaccines conducted by the European Centre for Disease Prevention and Control (ECDC) through a network of research and public health institutions (VAESCO) in nine European Union Member States, and an epidemiological study conducted by Glaxo Smith Kline (the marketing authorisation holder of Pandemrix) in Canada. Preliminary results of the VAESCO study and of the Canadian study are expected by July 2011.

The CHMP is working with experts from across the EU to assess the possible safety concern and any impact on the benefit-risk balance of Pandemrix. The CHMP plans to hold an expert meeting with participation of international experts, the World Health Organization (WHO) and ECDC.

The European Medicines Agency will provide updates as new information becomes available.

Notes

  • The exact wording to be included in the Pandemrix product information reads as follows:“Preliminary reports form epidemiological studies in two countries (Sweden and Finland) have indicated a 4-9-fold risk increase of narcolepsy in vaccinated as compared with unvaccinated children/adolescents, corresponding to an absolute risk increase of about three to four additional cases in 100 000 vaccinated subjects. This risk increase has not been found in adults (older than 20 years). Similar epidemiological studies have not yet been conducted in other countries.The relationship between Pandemrix and narcolepsy is still under investigation.When considering the use of Pandemrix in children and adolescents, an individual benefit risk assessment should be performed taking this information into account.”
  • Narcolepsy is a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly. Its precise cause is unknown, but it is generally considered to be triggered by a combination of genetic and environmental factors. Narcolepsy occurs naturally at a rate of around 1 case per 100,000 people every year.
  • Pandemrix, an (H1N1) v influenza vaccine, has been authorised since September 2009, and was used during the 2009 H1N1 influenza pandemic in at least 30.8 million Europeans.
  • The H1N1 influenza strain continues to be the predominant strain in this season.
  • The review of Pandemrix and the occurrence of cases of narcolepsy was initiated at the request of the European Commission under Article 20 of Regulation (EC) No 726/2004, on 27 August 2010, following an increased number of reports on narcolepsy in Finland and Sweden. Related press releases dated 27 August 2010, 23 September 2011 and 18 February 2011 are available on the Agency’s website.
  • The report from the Swedish registry study can be found on the website of the Swedish Medicines Agency (MPA).
  • The report from the French observed expected study can be found on the website of the French Medicines Agency.
  • More information about the network of research, public-health institutions and regulatory agencies VAESCO, funded by the European Centre for Disease Prevention and Control, can be found on its website.

News Stories From Google

European Regulators: Weigh Potential Narcolepsy Risk of Glaxo’s Pandemrix

Wall Street Journal (blog) - Katherine Hobson - ‎14 hours ago‎
Since last August, European regulators have been investigating reports that GlaxoSmithKline’s H1N1 vaccine, Pandemrix — which isn’t approved for use in the US — may be tied to the sleeping disorder narcolepsy in some children and

EU agency flags narcolepsy risk on GSK flu shot

Reuters - ‎17 hours ago‎
By Ben Hirschler LONDON (Reuters) – European regulators have recommended changes to the product label for GlaxoSmithKline’s pandemic flu vaccine Pandemrix to highlight the potential risk of narcolepsy in children or adolescents.

EU Panel Recommends Pandemrix Product Information Be Amended

Wall Street Journal - Ian Walker - ‎21 hours ago‎
LONDON (Dow Jones)–The Committee for Medicinal Products for Human Use, or CHMP, said Friday it has recommended that the product information for Pandemrix (Influenza vaccine (H1N1)) (split virion, inactivated, adjuvanted), from GlaxoSmithKline

Glaxo Pandemic Flu Vaccine’s Narcolepsy Risk Highlighted

Fox Business - ‎19 hours ago‎
By Sten Stovall LONDON -(Dow Jones)- European regulators have recommended changes to the product label for GlaxoSmithKline PLC’s (GSK) pandemic flu vaccine Pandemrix to reflect a potential higher risk of the sleeping disorder narcolepsy in children or

European Medicines Agency Recommends Interim Measures For Pandemrix

Medical News Today (press release) - ‎20 hours ago‎
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Pandemrix should be amended to advise prescribers to take into account preliminary results from epidemiological


Amazing US News Report – Autism Strikes US Reporter Bob MacNeil’s Grandson After MMR & Other Vaccines

See the same old story of a mother describing how her child developed autism after 7 vaccines in one day – the MMR and other vaccines [like the Hannah Poling case - 9 vaccines in one day: US Government In US$20 million Legal Settlement For Vaccine Caused Autism Case]. 

What is different is that this video with transcript is about the grandson of a US reporter and is from his TV show – see Robert MacNeil’s Public Broadcasting Service show: Autism Now: Robert MacNeil Shares Grandson Nick’s Story – REPORT AIR DATE: April 18, 2011

STOP PRESS – View listen and read transcript of Part II – Tonight’s Show April 19 here:

Amazing US News Report – Part II – US Reporter Bob MacNeil – Autism more serious for US children than cancer, diabetes and AIDS combined.

Robert MacNeil, is co-founder of the PBS NewsHour. Until his retirement in October 1995, MacNeil was executive editor and co-anchor of The MacNeil/Lehrer NewsHour, a 20-year nightly partnership with Jim Lehrer on PBS.

And do vaccines cause autistic conditions? If you read nothing else we strongly recommend you read this: PDF Download – Text of email from US HRSA to Sharyl Attkisson of CBS News].  In it the US Health Resources Services Administration [HRSA] state to CBS News reporter Sharyl Attkisson

We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.

Despite all the lies and deceit by health official worldwide, the question “do vaccines cause autism” was answered when the Hannah  Poling story broke in the USA [see CHS article here].  Hannah developed an autistic condition after 9 vaccines administered the same day.  Under the media spotlight numerous US health officials and agencies conceded on broadcast US nationwide TV news from CBS and CNN. In the US Federal Court children have been compensated after findings they developed autism and other injuries. Full details with links to the original sources can be found in this CHS article: Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines.

Transcript

ROBERT MACNEIL: In recent years, the diagnosis of autism has shown startling growth, now affecting one in 110 American children. For over two decades, parents desperate for answers and feeling slighted by the medical community have helped force to create services for their children, raise money for research and campaign for wider awareness of autism and for support from the government.

Today the picture is changing. Researchers now believe there is no simple genetic cause, that autism may involve multiple genetic pathways, and toxic materials in the environment may trigger the symptoms of autism. Autism once was considered only a brain disorder. Now, more doctors say it often involves serious physical illness.

And that’s our first story tonight. Frankly, I have a personal motive in telling it, because it’s about my grandson Nick, who is 6 and lives in Cambridge, Mass.

It’s not easy connecting with Nick. We live in different cities. All my grandchildren are a little shy when we first meet again. But Nick’s shyness is different.

One of the marks of autism is difficulty making eye contact and communicating, even with family members.

I’ve been a reporter on and off for 50 years, but I’ve never brought my family into a story, until Nick, because he moves me deeply. Also because I think his story can help people understand his form of autism and help me understand it better.

This was Nick when he was 9 months old, a healthy, alert and engaged baby with no apparent medical problems. Now at 6, my grandson seems like a different child, showing the classic symptoms of autism, a disorder in development, his difficulty connecting. Nick struggles with language, the rigidity and resistance to change Nick shares with other children with autism.

“I think pain in a child with autism is a very difficult thing to assess because a child with autism can’t vocalize that. He will very often not come to you and say, ‘I’ve got a bellyache.’ He can’t use those words.”

- Dr. Timothy Buie, Massachusetts General Hospital

NICK: Now go home.

ROBERT MACNEIL: A tendency to suddenly appear absent, to withdraw into an emotionally detached inner world of his own.

Those symptoms are characteristic of the autism spectrum — severe to mild — in Nick’s case, relatively mild. But beyond such mental difficulties, Nick has serious physical illness: in his digestive system, his mitochondria, the energy needed by his cells for normal activity, plus frequent small brain seizures, and extreme sensitivity to light and sound. How Nick was transformed from that healthy boy to Nick today is still devastating to his mother, my daughter Alison.

ALISON MACNEIL: When Nick was diagnosed, I actually hired a babysitter so that I could go sit in my car in a parking lot and cry because I couldn’t do it here with the kids.

ROBERT MACNEIL: Alison was trained as a psychiatric social worker, but like many parents, has made virtually a new career of caring for her son with autism.

ALISON MACNEIL: I remember one day I was sitting at the computer, and he was about 16 months old. And I caught out of the corner of my eye that he was spinning one of Neely’s doll’s plates. And I’d never seen a child play that way before — ever.

And I went in to interrupt him, and he wouldn’t stop. And there was an intensity about it. And I had this sinking feeling in the pit of my stomach, because I knew something was wrong.

ROBERT MACNEIL: That worry sent Alison to a developmental pediatrician who confirmed their fears: Nick had autism.

ALISON MACNEIL: Nick was irritable, crying, inconsolable and now is not on track developmentally at all. He’s gone backward.

So we went from a 15-month appointment where this child was A-OK, supposedly, and given the MMR, the DTaP and the Hib vaccines.

People say to me, Alison, it’s a coincidence. Alison, how do you know this happened? Well, it’s impossible for me to know. But what I will say is this: It was not a coincidence that my child was diagnosed with autism at the same time that his whole system shut down. Something happened to my child.

ROBERT MACNEIL: I understand Alison’s suspicion, but public health authorities say there is no scientifically valid evidence that vaccines cause autism. And Alison found little support from the developmental pediatrician.

ALISON MACNEIL: When I said to her this child has not had a formed bowel movement since the 15-month shots, she said children with autism have diarrhea.

When I said that he was crying inconsolably, she said this is part of autism. They can’t regulate their emotions. So it was all lumped under, “yes, we always see that with autism. It’s just autism.”

ROBERT MACNEIL: Nick’s complex problems demanded a broader view of autism. Some call it a new paradigm, or a systemic illness, or a whole-body experience. One of the leaders of that new thinking is Dr. Timothy Buie, a pediatric gastroenterologist at Massachusetts General Hospital.

DR. TIMOTHY BUIE, Massachusetts General Hospital: Six months ago, he was so lethargic and so out of it that he came into the office and literally laid on the chair for a 30- or 40-minute visit. He never moved.

He wouldn’t interact. He wouldn’t give you any eye contact whatsoever. And at the end of the appointment, Mom picked him up and took him out and went home.

ROBERT MACNEIL: Dr. Buie found changes in the lower GI tract he called lymphoid-nodular hyperplasia — inflammation and damage in his small intestine.

How does that affect the life of a child like Nick? For instance, does it give him pain?

DR. TIMOTHY BUIE: I think it can give pain. And I think pain in a child with autism is a very difficult thing to assess because a child with autism can’t vocalize that. He will very often not come to you and say, “I’ve got a bellyache.” He can’t use those words. So he may exhibit that as a child who doesn’t sleep well. He may exhibit that as a child who has a lot of increased agitation or hyperstimulatory-type behaviors.

And part of the problem with that is that we’ve accepted that those are behaviors that we often see in children with autism, and we’ve written it off to their autism. So it’s very difficult to think through whether that’s a marker for pain in some of those kids if we’re unwilling to look for other reasons.

(Nick laughs)

ALISON MACNEIL: You’re not leaving yet, come on. You’re going to come here. No.

DR. TIMOTHY BUIE: He’s looking remarkably better. He’s active. He’s happy. He’s playful. He’s turning off the lights, which some people would find to be a negative challenge. I don’t think so. I think that’s a child who’s testing. And I think it’s really interesting to see. And he walked right over happily, smiling, sat down — a much different child.

ROBERT MACNEIL: Do you think the medical community and your contact with it understands this wider definition of autism?

ALISON MACNEIL: Emphatically no. They can’t just refer these kids to early intervention and consider this a psychiatric or neuropsychiatric situation. They’ve got to stay involved and help the family get referrals for gastroenterology, to neurologists to look at whether or not there’s seizure activity.

ROBERT MACNEIL: From its lowest ebb two years ago, Nick’s condition has greatly improved as Alison found different doctors to diagnose and treat his other problems. But achieving even that level of progress, Nick’s autism is having a profound effect on the family. All of their lives ultimately revolve around his needs. Certainly, that’s how his 10-year-old sister, my granddaughter Neely, sees it. She’s in a different kind of pain.

NEELY: I just don’t like how autism affects the family. It just – it seems like it takes up too much time, and you usually get really bored of autism, because it’s in your life all the time.

ROBERT MACNEIL: What things would you do if you didn’t have a brother with autism?

NEELY: It just seems that a lot of money is spent on Nick’s vitamins and Nick’s doctors’ appointments and Nick’s everything, and it would change if we didn’t have to get all that stuff.

ROBERT MACNEIL: I see. Are you worried about Nick?

NEELY: Yes.

ROBERT MACNEIL: Tell me what you’re worried about, about him.

NEELY: Well, if he’s going to stay autistic for the rest of his life.

ROBERT MACNEIL: Yes. And what would that mean, if he were?

NEELY: I don’t know. It would get harder when he gets older, and there wouldn’t be as much services to help him. Sometimes I worry that he might get lost because he doesn’t really know what to do.

ROBERT MACNEIL: When you think about the future with Nick, what do you feel about that?

NEELY: Well, I hope that I — I hope that he doesn’t have to stay with me, kind of, and that I hope that he gets healed soon. Sometimes when other people, they — their lives seem perfect, and when yours — when yours — you have to do something that you don’t like, you don’t usually want to do it, and though your autistic sibling does, and it seems unfair. And it seems like they get what they want and you don’t.

ROBERT MACNEIL: Well, one of the things about life is that we all learn we have to do things we don’t want to do, whether there’s autism around or not.

NEELY: Yes, but it seems like it happens too much. I mean, there’s going to be a few times when that happens, but it seems with an autistic brother or sister, it always happens.

ALISON MACNEIL: I don’t know. I can’t take the autism out of her life. You know? We try to make things — you know, we try to do the best we can with it. But she’s right, you know. In some ways, this is really unfair.

I would have to say that every family living with an autistic child makes massive sacrifices in every way. It takes a phenomenal amount of teamwork. And I think Dave and I have been pleasantly surprised to find that it has brought out probably the best in us. It doesn’t leave a lot of energy left over.

ROBERT MACNEIL: Like the energy Nick’s father, Dave, expends every evening.

DAVE: Hey Nick. What do you want to do do?

NICK: Go on buses.

DAVE: In a little bit, sure. Can I get a high five?

NICK: We have to go on the 72.

DAVE: OK.

ROBERT MACNEIL: Nick loves to ride on buses.

NICK: We have to go on the bus.

DAVE: Yes, we might do that. We might go some other places, too.

NICK: After the 72 bus.

ROBERT MACNEIL: So every day after work as a senior account executive at a public-relations agency, Dave devotes 90 minutes to a bus outing that Nick yearns for all day.

NICK: 72 to Belmont.

DAVE: Yes, we can go on the Belmont if you want.

ROBERT MACNEIL: On our day there, we change Nick’s schedule so we can all go to the park before dark.

NICK: No. Go to Harvard Station.

ALISON MACNEIL: Yes, and you’re going to go to Harvard Station later with Dad.

NICK: After?

ALISON MACNEIL: After we’re done at the playground.

NICK: A bus ride?

ALISON MACNEIL: Yes, you’re going to have one with Dad.

NICK: Sad.

ALISON MACNEIL: I know you’re sad, sweat pea.

ROBERT MACNEIL: For exercise, they walk from their apartment the half mile to Harvard Square to wait, but not just for any bus.

NICK: We’re going to go on the 72 bus.

ROBERT MACNEIL: The 72 takes them on a 20-minute loop through Cambridge and back to Harvard Square for the walk home. But tonight the 72 doesn’t come and doesn’t come.

NICK: That’s the 71.

DAVE: Nope, that’s the 73.

ROBERT MACNEIL: The eager little boy scans each arriving bus as though it carries all his happiness. And still it doesn’t come.

DAVE: Want to go on the 73?

NICK: No.

ROBERT MACNEIL: After nearly an hour of waiting, looking sadder and sadder.

Nick, if the 72 doesn’t come, should we take another bus?

NICK: Another bus.

ROBERT MACNEIL: He’s persuaded with no tantrum to take another bus home.

Part of his improved physical condition has brought more patience, more tolerance for change.

DAVE: Alright, Nick. High five, bud.

ROBERT MACNEIL: We made a promised trip to the toy store.

So which one is Thomas?

Here you can see the disconnect between us.

Nick, which one is Thomas?

For me, the father of four children with four other grandchildren, seeking connection with Nick is a very poignant experience. To have a grandson who can tune me out or simply ignore me like this, make no eye contact for long stretches of time, gives me a strange and painful feeling.

ALISON MACNEIL: Say thank you to Grandpa.

NICK: Thank you to Grandpa.

ALISON MACNEIL: OK, there we go.

ROBERT MACNEIL: Thank you.

It warms my heart that Nick’s physical problems are improving, and I’m lost in admiration for the patience and courage Alison and Dave bring to his constant care. I see my daughter, like many autism mothers, not only perplexed but sometimes amused and always intrigued by what may be going on in her son’s mind.

Anti-Vaccine-Safety Blogs Desperate Over Thorsen/US CDC Autism Research Fraud

The rabid anti-vaccine-safety loons on Kev Leitch and Matt’s anti-vaccine-safety blog LeftBrainRightBrain have desperately republished a list of studies compiled by the American Association of Pediatrics in a vain attempt to counter the damaging revelations of the alleged fraud by autism-vaccine researcher Poul Thorsen: [US Prosecutors Seek Extradition of Madsen MMR/Autism Denmark Study Author for US$1m MMR & Mercury Autism Research Fraud]

LBRB and the AAP claim the published studies are evidence there is no causal association between vaccines and autistic conditions: [pdf download  AAP List of Studies]

Unfortunately for the AAP and LeftBrainRightBrain, the very first study cited in the AAP list is the Budzyn study from Poland.  It is a study even LeftBrainRightBrain admitted when originally published is junk research.  This also raises serious questions about the reliability of the AAP and their ability to discern valid from invalid research. The Budzyn paper is Lack of Association Between Measles-Mumps-Rubella Vaccination and Autism in Children: A Case-Control Study Mrozek-Budzyn D, Kiełtyka A, Majewska R. Pediatr Infect Dis J. 2010 May;29(5):397-400.

This is what LBRB said about the Budzyn dud paper when it first came out:-

To be honest, I don’t think these results are consistent with previous, large population studies of MMR and autism. An odds ratio of 0.17 (meaning you are six times more likely to be autistic if you didn’t get the MMR) should have been picked up.”

And the LBRB reviewer “Sullivan” added in the comments:-

If you look at only the kids who were never vaccinated for Measles—8 children (8%) in the autism group were never vaccinated for MMR. Only 1 in the control group (0.5%). If one were to use those numbers alone, the uncorrected “odds” of autism associated with MMR would be 16:1.”

Additionally, all the papers are cited as evidence of no association between MMR vaccination and autistic conditions.  But we now know as a result of admissions by US Government Officials and decisions of the US Federal Court that it is not just MMR vaccine but all vaccines which can and do cause autistic conditions.

If you read nothing else we strongly recommend you read this: PDF Download – Text of May 5th 2008 email from US HRSA to Sharyl Attkisson of CBS News].  In it the US Health Resources Services Administration [HRSA] state to CBS News reporter Sharyl Attkisson:

We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.

Despite all the lies and deceit by health official worldwide, the question “do vaccines cause autism” was answered after the Hannah  Poling story broke in the USA in February 2008 [see CHS article here].  Hannah developed an autistic condition after 9 vaccines administered the same day.  Under the media spotlight numerous US health officials and agencies conceded on broadcast US nationwide TV news from CBS and CNN. Full details with links to the original sources can be found in this CHS article: Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines. [Blue Text added 10 April 2011]

US Prosecutors Seek Extradition of Madsen MMR/Autism Denmark Study Author for US$1m MMR & Mercury Autism Research Fraud

Reuters reports that US prosecutors have indicted and seek the extradition of Aarhus University, Denmark’s MMR/mercury & autism researcher Poul Thorsen 49, on  13 counts of wire fraud and nine counts of money laundering.  This relates to monies paid to Thorsen by the US Centers for Disease Control including for research into the relationship between autism and exposure to vaccines.    Thorsen used the stolen money to buy a home in Atlanta, a Harley Davidson motorcycle and two cars, prosecutors said.

Denmark scientist accused of stealing autism research money.[ATLANTA | Wed Apr 13, 2011 7:35pm EDT]

[Read more: Dane indicted for defrauding CDC | Atlanta Business Chronicle ]

The real question is when will US prosecutors investigate the fraudulent commissioning and funding by CDC officials of studies they knew would produce the result they wanted.  An example is the Tozzi paper reported by CHS here: US Research Fraud, Tax Dollars And Italian Vaccine Mercury Study

What Did Thorsen Do?

Thorsen was a visiting researcher at the Atlanta-based CDC in the 1990s who obtained US$11m in research grants for two Danish government agencies.  Thorsen was in charge of administering the research funds to study the relationship between autism and exposure to vaccines.   It is alleged Thorsen submitted false invoices and arranged for Aarhus University where he was employed to transfer the funds to his personal account at the CDC Federal Credit Union in Atlanta.  It is said the university thought it was transferring the funds to a CDC account.

Here you can download the full set of US Grand Jury charges: CRIMINAL   INDICTMENT: UNITED   STATES  OF  AMERICA v. POUL  THORSEN NO·1:  11- C R – 194 [Blue Text Added 19 April 2011]

Thorsen’s Questionable Research

Thorsen was an author of the now notorious US CDC funded New England Journal of Medicine Madsen study of 500,000 Danish children which was used worldwide to claim there was no relationship between MMR vaccine and autistic conditions.  Thorsen was also involved in publishing studies claiming there was no link between the mercury additive thiomersal in vaccines, autistic conditions and developmental disorders in children.

Numerous irregularities were subsequently revealed in the Madsen study and rates of autistic conditions in fact rose in Denmark contrary to the claims of the authors of the Madsen study:  A Population-Based Study of Measles, Mumps, and Rubella Vaccination and Autism Kreesten Meldgaard Madsen, M.D., Anders Hviid, M.Sc., Mogens Vestergaard, M.D., Diana Schendel, Ph.D., Jan Wohlfahrt, M.Sc., Poul Thorsen, M.D., Jørn Olsen, M.D., and Mads Melbye, M.D.   N Engl J Med 2002; 347:1477-1482 November 7, 2002.

According to US vaccine safety organisation Safeminds some of the research Thorsen engaged in, substantial numbers of diagnosed autism cases disappeared annually from the data Thorsen and colleagues relied on.  Thorsen engaged in email correspondence with the US Centers for Disease Control about how to produce results which showed a more favourable safety profile for vaccines.  SafeMinds is calling for an independent federal investigation of these studies for data manipulation and scientific misconduct.

From August to October of 2003, three articles on the autism-mercury controversy were published in close succession, all of which used data from a Danish registry for psychiatric research to assess the relationship between autism trends and the use of thimerosal. SafeMinds accessed the registry at the time and reported that a large percentage of diagnosed autism cases are lost from the Danish registry each year and that most of those lost cases were older children. Since the studies were  based on finding fewer older thimerosal-exposed children than younger unexposed children, the validity of their conclusion exonerating thimerosal in autism was questionable and likely a result of missing records rather than true lower incidence rates among the exposed group.

In addition, internal emails obtained via FOIA document discussion between the Danish researchers and Thorsen which acknowledge that the studies did not include the latest data from 2001 where the incidence and prevalence of autism was declining which would be supportive of a vaccine connection.

The emails also include requests from Thornsen to CDC asking that the agency write letters to the journal Pediatricsencouraging them to publish the research after it had been rejected by other journals.

A top CDC official complied with the request sending a letter to the editor of the journal supporting the publication of the study which they called a “strong piece of evidence that thimerosal is not linked to autism.”

Further background information on these studies, the charges against Dr. Thorsen, and documents obtained through the Freedom of Information Act that support SafeMinds’ concerns are available on their website, www.safeminds.org.

Similarities to the Professor Christopher Gillberg Scandal

The Thorsen affair has undertones of the Gillberg scandal. [NB. The "editors" of Wikipedia medical topics have ensured the following historical data is not readily available to readers.]

Swedish psychiatrist and autism researcher Professor Christoper Gillberg was a scientific board member of US organisation Cure Autism Now, a professor of child and adolescent psychiatry at Gothenburg University in Gothenburg, Sweden, and an honorary professor at the Institute of Child Health (ICH), University College London.  He was a member of and advised numerous boards responsible for providing research funding.

Gillberg destroyed 100,000 pages of research material filling 22 metres of shelf space on a 25 year study when ordered by a Swedish Court to make it available for scrutiny in the light of suspected fraudulent scientific research.  The study was a 25-year follow-up of 42 children diagnosed as having a condition invented by Gillberg called “DAMP” [Deficits in attention, motor control and perception]. DAMP was roundly criticised by English psychiatrist Professor Michael Rutter in expert Court evidence.   Gillberg was already notorious for admitting privately his children had not been vaccinated, while declaring no link between vaccines and autism.

On the basis of this study, 3,000 Swedish children were prescribed amphetamines (Ritalin) and Gillberg and his colleagues argued that another 70,000 children were in need of it.  Amphetamines can have serious adverse effects.

Leif Elinder, a paediatrician in Uppsala and Eva Kärfve, a sociologist at the University of Lund identified unusual features of Gillberg’s study including:

  • Nearly all the patients were recorded as attending during the study for comprehensive examinations but received no diagnosis or treatment;
  • the dropout rate of the study [3 out of 42] was very low, when expected to be high in such a study covering 25 years;
  • the number of participants appeared to have increased over the course of the study;
  • DAMP, like autism, affects far more boys than girls. However, while more than half of the control group consisted of girls, most of whom came from stable families and prosperous homes, 75% of the DAMP children were boys from dysfunctional families in run-down areas with poor housing;

Details of papers published by Poul Thorsen can be found with the following Google search.

_______________________

CLICK HERE FOR GOOGLE SCHOLAR SEARCH – AUTHOR P THORSEN

Following are 1st 100 hits.

[PDF] from safeminds.org…, D Schendel, J Wohlfahrt, P Thorsen… – New England Journal …, 2002 – nejm.org
We conducted a retrospective cohort study of all children born in Denmark from January 1991
through December 1998. The cohort was selected on the basis of data from the Danish Civil
Registration System, which assigns a unique identification number to every live-born
Cited by 383Related articlesBL DirectAll 26 versions

[HTML] from oxfordjournals.org…, E Agerbo, D Schendel, P Thorsen… – American Journal of …, 2005 – Oxford Univ Press
Research suggests that heredity and early fetal development play a causal role in autism. This
case-control study explored the association between perinatal factors, parental psychiatric
history, socioeconomic status, and risk of autism. The study was nested within a cohort of
Cited by 182Related articlesAll 15 versions

[PDF] from pkids.org…, MB Lauritsen, CB Pedersen, P Thorsen… – Pediatrics, 2003 – Am Acad Pediatrics
Objective. It has been suggested that thimerosal, a mercury-containing preservative in
vaccines, is a risk factor for the development of autism. We examined whether discontinuing
the use of thimerosal-containing vaccines in Denmark led to a decrease in the incidence
Cited by 148Related articlesBL DirectAll 33 versions

MJ Silverberg, P Thorsen, H Lindeberg… – Obstetrics & …, 2003 – journals.lww.com
Wolters Kluwer Health may email you for journal alerts and information, but is committed to maintaining
your privacy and will not share your personal information without your express consent. For more
information, please refer to our Privacy Policy. Skip Navigation Links Home > April
Cited by 125Related articlesAll 8 versions

P Thorsen, IP Jensen, B Jeune, N Ebbesen… – American journal of …, 1998 – Elsevier
Attempts to identify infections in the lower genital tract in women as one of the causes of pathologic
pregnancy outcome have been made throughout several decades. Recently, efforts have been
concentrated on the condition of BV as described by Amsel et al. 5 The diagnostic criteria
Cited by 97Related articlesBL DirectAll 4 versions

[HTML] from endojournals.orgK Erickson, P Thorsen, G Chrousos… – Journal of Clinical …, 2001 – Endocrine Soc
Increased CRH secretion by the placenta of pregnant women has been associated with preterm
birth. Certain indices of risk, both medical and psychosocial in nature, have been linked to preterm
delivery. Levels of total, bound, and free CRH, CRH-binding protein (CRH-BP), and
Cited by 80Related articlesBL DirectAll 5 versions

[HTML] from clinchem.orgK Skogstrand, P Thorsen… – Clinical …, 2005 – Am Assoc Clin Chem
Background: Inflammatory reactions and other events in early life may be part of the etiology
of late-onset diseases, including cerebral palsy, autism, and type 1 diabetes. Most neonatal screening
programs for congenital disorders are based on analysis of dried blood spot samples
Cited by 75Related articlesBL DirectAll 5 versions

C Floridon, CH Jensen, P Thorsen… – …, 2000 – Wiley Online Library
Abstract Fetal antigen 1 (FA1) is a circulating EGF multidomain glycoprotein. FA1 and its
membrane-associated precursor is defined by the mRNAs referred to as delta-like (dlk), preadipocyte
factor 1 (pref-1) or zona glomerulosa-specific factor (ZOG). Using a polyclonal antibody
Cited by 64Related articlesBL DirectAll 4 versions

…, P Thorsen, A Curry, P Sandager… – Acta obstetricia et …, 2005 – Wiley Online Library
Among symptomatic women, the likelihood ratio (LR+) for the prediction of PTD was found to
be greater than 10 using amniotic fluid (AF) interleukin-6 (IL-6), AF Ureaplasma urealyticum,
as well as a multi-marker consisting of cervical IL-6, cervical IL-8, and cervical length
Cited by 55Related articlesAll 7 versions

IP Jensen, P Thorsen, B Jeune… – … of Obstetrics & …, 2000 – Wiley Online Library
Objectives To estimate the incidence of human parvovirus B19 among pregnant women before
and during an epidemic, to elucidate possible sociodemographic and medical risk factors during
pregnancy and to estimate the association between parvovirus B19 infection and
Cited by 53Related articlesBL DirectAll 4 versions

…, KM Madsen, J Wohlfahrt, P Thorsen… – JAMA: the journal of …, 2004 – Am Med Assoc
Author Affiliations: The Danish Epidemiology Science Centre, Department of Epidemiology and
Social Medicine, Aarhus University, Aarhus (Drs Vestergaard, Madsen, and Olsen), The Danish
Epidemiology Science Centre, Department of Epidemiology Research, Statens Serum
Cited by 51Related articlesBL DirectAll 6 versions

IP Jensen, P Thorsen… – Lancet, 1997 – ncbi.nlm.nih.gov
1. Lancet. 1997 Feb 1;349(9048):329-30. Sensitivity of ligase chain reaction assay of urine from
pregnant women for Chlamydia trachomatis. Jensen IP, Thorsen P, Møller BR. Comment in: Lancet.
1997 Apr 5;349(9057):1024-5. Lancet. 1998 Jan 31;351(9099):341-2. Lancet.
Cited by 48Related articlesBL DirectAll 6 versions

GB Hvilsom, P Thorsen, B Jeune… – Acta obstetricia et …, 2002 – Wiley Online Library
Methods. The present study is a prospective nested case-control study including 84
singleton, preterm deliveries (cases) and 400 singleton, term deliveries (controls), based at the
Odense University Hospital, Denmark. These cases were identified from a cohort of 2846
Cited by 43Related articlesBL DirectAll 8 versions

[HTML] from shouxi.net…, M Vaeth, E Ernst, LF Nielsen, P Thorsen – Pediatrics, 2006 – Am Acad Pediatrics
METHODS. A population-based, cohort study, including all live-born singletons and twins born
in Denmark between January 1, 1995, and December 31, 2000, was performed. Children conceived
with in vitro fertilization (9255 children) were identified through the In Vitro Fertilization
Cited by 42Related articlesBL DirectAll 8 versions

…, A Schuchat, P Thorsen – Mental retardation and …, 2002 – Wiley Online Library
Cerebral palsy is the most common neuromotor developmental dis- ability of childhood, affecting
as many as 8,000 to 12,000 children born in the US each year (corresponding to a prevalence
rate of between 2 and 3 per 1000 children). Recent improvements in neonatal care have
Cited by 42Related articlesBL DirectAll 3 versions

[PDF] from dbac.dkCS Benn, P Thorsen, JS Jensen, BB Kjoer… – Journal of allergy and …, 2002 – dbac.dk
Background: Infants with wheezing and allergic diseases have a microflora that differs from that
of healthy infants. The fetus acquires microorganisms during birth when exposed to the maternal
vaginal microflora. It is therefore conceivable that the maternal vaginal microflora might
Cited by 41Related articlesView as HTMLBL DirectAll 6 versions

…, S Dalsgaard, PH Thomsen, P Thorsen – Archives of Pediatrics …, 2007 – Am Med Assoc
You are seeing this message because your Web browser does not support basic Web
standards. Find out more about why this message is appearing and what you can do to make
your experience on this site better. Add to CiteULike Add to Connotea Add to
Cited by 33Related articlesBL DirectAll 5 versions

DR Feikin, P Thorsen, S Zywicki, M Arpi… – American journal of …, 2001 – Elsevier
*1 Supported by the Danish Health Insurance Foundation; the Institute of Clinical Research,
University of Odense; the Foundation of Reproductive Biology, Odense University Hospital; the
National Fund for Research and Development; the Danish Ministry of Health; the Medical-
Cited by 33Related articlesBL DirectAll 5 versions

[HTML] from pnas.org…, SS Jeffrey, T Thorsen… – Proceedings of the …, 2001 – National Acad Sciences
2 (Upper) and showed a significant difference in the frequency of TP53-mutated tumors
among the subclasses (P < 0.001, two-sided). 3 A, P < 0.01), with the basal-like and
ERBB2+ subtypes associated with the shortest survival times.
Cited by 3379Related articlesBL DirectAll 38 versions

K Povlsen, P Thorsen… – European Journal of Clinical Microbiology …, 2001 – Springer
Page 1. Eur J Clin Microbiol Infect Dis (2001) 20:65–67 Q Springer-Verlag 2001 Note Relationship
of Ureaplasma urealyticum Biovars to the Presence or Absence of Bacterial Vaginosis in Pregnant
Women and to the Time of Delivery K. Povlsen, P. Thorsen, I. Lind
Cited by 28Related articlesBL DirectAll 5 versions

…, H Simhan, K Ryckman, L Jiang, P Thorsen… – American journal of …, 2006 – Elsevier
We hypothesize that genetic variations (single nucleotide polymorphisms-SNPs) in the tumor
necrosis factor-α (TNF-α), TNF receptors (TNFRI and TNFRII), interleukin-6 (IL-6) and IL-6 receptor
(IL-6R) genes predict high-risk status for spontaneous preterm birth (sPTB) in European-
Cited by 29Related articlesAll 7 versions

S Cauci, J McGregor, P Thorsen, J Grove… – American journal of …, 2005 – Elsevier
Vaginal pH ≥4.7 or pH ≥5 by itself was not associated with LBW or prematurity.
Conversely, combination of pH ≥5 and high sialidase activity demonstrated OR 17 (CI
1.8-150) for LBW; OR 31 (CI 1.8-516) for VLBW; along with OR 18 (CI 1.6-204) for preterm
Cited by 27Related articlesAll 4 versions

…, B Jacobsson, C Svaerke, P Thorsen – Archives of Pediatrics …, 2009 – Am Med Assoc
You are seeing this message because your Web browser does not support basic Web
standards. Find out more about why this message is appearing and what you can do to make
your experience on this site better. Add to CiteULike Add to Connotea Add to
Cited by 26Related articlesAll 6 versions

SR Wann, PT Thorsen… – The Journal of Organic …, 1981 – ACS Publications
0 1981 American Chemical Society Page 2. 2580 J. Org. Chem., Vol. 46, No. 12, 1981 Wann,
Thorsen, and Kreevoy Table 11. SOC. B 1970, 1780-1783. (11) Wang, Y. Ph.D. Thesis, University
of Minnesota, 1976, p 64. (12) Yaks, K.; Stevens, JB Can. J. Chem. 1965,43,529-537.
Cited by 25Related articles

I Vogel, P Thorsen, VK Hogan… – Acta obstetricia et …, 2006 – Wiley Online Library
Objective. To examine associations of vaginal Ureaplasma urealyticum (UU) and bacterial vaginosis
(BV) with preterm delivery (PTD), small for gestational age (SGA), and low birth weight
(LBW). Material and methods. A population-based, prospective cohort study of 2,927
Cited by 24Related articlesBL DirectAll 7 versions

M Kaivola, P Thorsen… – Physical Review A, 1985 – APS
Dispersive line shapes have been observed in the population of the intermediate level of a
three-level Λ configuration in a fast beam of metastable 40 Ca * atoms. A steady-state calculation
in the weak-probe approximation is used to identify the main physical processes in the
Cited by 24Related articlesAll 5 versions

P Thorsen, DE Schendel… – Paediatric and …, 2001 – Wiley Online Library
The overall objective of the current study is to assess whether specific markers of infection (primarily
interleukin (IL) 1β, tumour necrosis factor (TNF) α, IL-6, and IL-10) obtained from maternal blood
during pregnancy, alone or in combination with other risk factors for PTD, permit
Cited by 23Related articlesBL DirectAll 5 versions

MJ Silverberg, P Thorsen, H Lindeberg… – … – Head and Neck …, 2004 – Am Med Assoc
You are seeing this message because your Web browser does not support basic Web
standards. Find out more about why this message is appearing and what you can do to make
your experience on this site better. Add to CiteULike Add to Connotea Add to
Cited by 23Related articlesBL DirectAll 3 versions

[HTML] from nih.govS Cauci, P Thorsen, DE Schendel… – Journal of clinical …, 2003 – Am Soc Microbiol
A nested case-control study of low birth weight and preterm delivery was performed with singleton
women. Immunoglobulin A (IgA) against the Gardnerella vaginalis hemolysin (anti-Gvh IgA) and
sialidase and prolidase activities were determined in vaginal fluid at 17 weeks of
Cited by 23Related articlesBL DirectAll 13 versions

[PDF] from psu.eduMA Unger, HP Chou, T Thorsen, A Scherer… – Science, 2000 – sciencemag.org
194, 163 (1998). ↵: P. Gravesen,; J. Branebjerg,; OS Jensen. , J. Micromech. Microeng.
Seven-layer devices have been produced by this method; no obvious limitations exist to limit
the number of layers. ↵: JC Lötters,; W. Olthuis,; PH Veltink,; P. Bergveld. , J. Micromech. Microeng
Cited by 1499Related articlesBL DirectAll 25 versions

R Menon, DR Velez, P Thorsen, I Vogel… – Human …, 2006 – content.karger.com
Spontaneous preterm birth (PTB, birth before 37 weeks gestation) is a primary risk factor for neonatal
morbidity and mortality in the US. The rate of PTB is 12.2% in the United States, representing
an increase of 15% over the past decade [1, 2] . There is also a docu- mented difference
Cited by 22Related articlesBL DirectAll 5 versions

DR Velez, R Menon, P Thorsen… – Annals of Human …, 2007 – Wiley Online Library
Preterm birth (PTB) is a significant neonatal health problem that is more common in African-Americans
(AA) than in European-Americans (EA). Part of this disparity is likely to result from the differing
genetic architectures of EA and AA. To begin assessing the role of these differences,
Cited by 19Related articlesBL DirectAll 2 versions

[HTML] from nih.gov…, SA McDonald, A Das, D Schendel, P Thorsen… – Pediatrics, 2009 – Am Acad Pediatrics
METHODS. For 1067 extremely low birth weight infants in the Neonatal Research Network of
the National Institute of Child Health and Human Development, levels of 25 cytokines were measured
in blood collected within 4 hours after birth and on days 3, 7, 14, and 21. Stepwise
Cited by 19Related articlesAll 5 versions

R Menon, SJ Fortunato, P Thorsen… – Journal of the Society …, 2006 – rsx.sagepub.com
Ramkumar Menon, MS, Stephen J. Fortunato, MD, Poul Thorsen, MD, PhD, and Scott
Williams, PhD KEY WORDS: Genetic association, prematurity, single-nucleotide
polymorphisms, Inultilocus analysis, MDR. 1. Twin studies supporting a genetic
Cited by 19Related articlesBL DirectAll 4 versions

HO Atladottir, MG Pedersen, P Thorsen… – Pediatrics, 2009 – Am Acad Pediatrics
METHODS: The study cohort consisted of all of the children born in Denmark from 1993 through
2004 (689 196 children). Outcome data consisted of both inpatient and outpatient diagnoses
reported to the Danish National Psychiatric Registry. Information on ADs in parents and
Cited by 17Related articlesAll 6 versions

AG Mikos, AJ Thorsen, LA Czerwonka, Y Bao… – Polymer, 1994 – Elsevier
A particulate-leaching method was developed to prepare highly porous biodegradable polymer
membranes. It involves the casting of polymer/salt composite membranes followed by the dissolution
of the salt. Poly(l-lactic acid) porous membranes of controlled porosity, surface/volume
Cited by 618Related articlesBL DirectAll 5 versions

U Nielsen, O Poulsen, P Thorsen… – Physical review letters, 1983 – APS
A novel technique combining the advantages of the laser-rf double-resonance scheme and
fast-beam collinear laser spectroscopy has been applied to a detailed study of the hyperfine
structure of 235 UI I. The experimental results are analyzed with use of ab initio
Cited by 15Related articlesAll 5 versions

BR Møller, FV Kristiansen, P Thorsen… – Acta obstetricia et …, 1995 – informaworld.com
Actu O hm Gwerol Scund 1995, 74: 216-219 Printed in Denmark – ull righls reserved Acta
Obstetricia et Gynecologica Scandinavica ISSN 0001-6349 BIRGER R. MDLLER, FRANK
v. KRISTIANSEN, POUL THORSEN, LARS FROST AND S0REN c. MOGENSEN
Cited by 15Related articlesBL DirectAll 5 versions

R Menon, P Thorsen, I Vogel, B Jacobsson… – American journal of …, 2008 – Elsevier
Median TNF-α concentration was associated with preterm birth when whites and blacks were
analyzed together, with cases having higher values (191.5 pg/mL) than controls (68.9
pg/mL; P < .001). There were no significant associations with sTNFR1 or sTNFR2
Cited by 15Related articlesAll 10 versions

…, DE Schendel, P Thorsen – Archives of Pediatrics and …, 2008 – Am Med Assoc
You are seeing this message because your Web browser does not support basic Web
standards. Find out more about why this message is appearing and what you can do to make
your experience on this site better. Add to CiteULike Add to Connotea Add to
Cited by 14Related articlesAll 4 versions

[PDF] from uniklinikum-jena.deK Skogstrand, CK Ekelund, P Thorsen… – Journal of …, 2008 – Elsevier
The interests in monitoring inflammation by immunoassay determination of blood inflammatory
markers call for information on the stability of these markers in relation to the handling of blood
samples. The increasing use of stored biobank samples for such ventures that may have
Cited by 14Related articlesAll 7 versions

…, WD Flanders, DM Hougaard, P Thorsen – Journal of reproductive …, 2008 – Elsevier
Few studies have assessed longitudinal changes in circulating cytokine levels during normal
pregnancy. We have examined the natural history of maternal plasma cytokines from early- to
mid-pregnancy in a large, longitudinal cohort. Multiplex flow cytometry was used to
Cited by 13Related articlesAll 4 versions

…, EJ Pedersen, ES Shabanova, PA Thorsen… – Physical Review B, 1994 – APS
Department of Solid State Physics, Riso National Laboratory, DK-4000 Roskilde, Denmark E.
Jonas Pedersen, Elizaveta S. Shabanova, and Peter A. Thorsen Chemical Institute 2. 15 624
50 NMR SPECTRA OF PURE 13C DIAMOND Hd = /LO E p- [Ii *Ij-3(Ii *rij)(Ij *rij)] (1) where
Cited by 13Related articlesBL DirectAll 4 versions

…, C Pearson, K Ortiz, N Porta, P Thorsen… – Pediatrics, 2009 – Am Acad Pediatrics
RESULTS. The 27 biomarkers could be classified into 1 of 3 groups: (1) biomarkers increased
in preterm birth (interleukin [IL]-2, IL-4, IL-5, IL-8, IL-10, monocyte chemoattractant protein 1, macrophage
inflammatory protein [MIP]-1 , MIP-1β, soluble IL-6 receptor , tumor necrosis factor ,
Cited by 13Related articlesAll 5 versions

R Menon, MC Camargo, P Thorsen… – American journal of …, 2008 – Elsevier
In this study, 321 amniotic fluids from cases (preterm birth 36 or fewer weeks’ gestation) and
controls (normal term delivery longer than 37 weeks’ gestation) were collected (147 cases [49
blacks and 98 whites] and 174 controls [85 blacks and 89 whites]) at the time of active
Cited by 13Related articlesAll 6 versions

I Vogel, J Grove, P Thorsen… – … of Obstetrics & …, 2005 – Wiley Online Library
*Correspondence: Dr I. Vogel, North Atlantic Neuro-epidemiology Alliances (NANEA) at Department
of Epidemiology and Social Medicine, Aarhus University, Vennelyst Boulevard 6, 8000 Aarhus
C, Denmark. Objective To evaluate whether soluble CD163 (sCD163) and C-reactive
Cited by 13Related articlesAll 3 versions

P Thorsen, I Vogel, J Olsen… – Journal of Maternal …, 2006 – informahealthcare.com
Results. At enrolment, 13.7% had BV. BV was not associated with an increased risk of spontaneous
preterm birth (crude OR 0.8 (0.5–1.5)). Nulliparity was found to affect birth weight to such a degree
that this variable was used for stratification. In nulliparous women BV was associated with
Cited by 13Related articlesBL DirectAll 5 versions

…, S Dalsgaard, PH Thomsen, P Thorsen – …, 2007 – journals.lww.com
Wolters Kluwer Health may email you for journal alerts and information, but is committed to maintaining
your privacy and will not share your personal information without your express consent. For more
information, please refer to our Privacy Policy. Skip Navigation Links Home > March
Cited by 12Related articlesBL DirectAll 3 versions

…, D Hougaard, J Olsen, P Thorsen – Acta obstetricia et …, 2007 – Wiley Online Library
Background. Few studies have investigated the relationship between inflammation and spontaneous
preterm delivery (sPTD) in women before preterm labour. The authors examine whether
mid-pregnancy plasma cytokine levels are associated with sPTD, and whether
Cited by 12Related articlesBL DirectAll 8 versions

…, LT Jensen, SA Ladefoged, P Thorsen… – Molecular …, 1998 – Wiley Online Library
Mycoplasma hominis contains a variable adherence-associated (vaa) gene. To classify variants
of the vaa genes, we examined 42 M. hominis isolates by PCR, DNA sequencing and
immunoblotting. This uncovered the existence of five gene categories. Comparison of the
Cited by 12Related articlesBL DirectAll 4 versions

DR Velez, S Fortunato, P Thorsen… – American journal of …, 2009 – Elsevier
The most significant associations were in the maternal interleukin (IL)-15 (rs10833, allele P =
2.91 × 10 −4 , genotype P = 2.00 × 10 −3 ) gene and the fetal IL-2 receptor B (IL-2RB)
(rs84460, allele P = 1.37 × 10 −4 , genotype P = 6.29 × 10 −4 ) gene. The best models for
Cited by 13Related articlesAll 7 versions

[PDF] from aace.com…, M Glavind‐Kristensen, P Thorsen… – … of Obstetrics & …, 2002 – Wiley Online Library
Setting Calculated sample size was reached over a two-year period, during which 9507 women
gave birth. Of these, 157 healthy women were eligible for the study as they were admitted with
symptoms of delivery before 34 weeks of gestation. Ninety-three women were included.
Cited by 11Related articlesAll 6 versions

[HTML] from nih.gov…, C Holzman, P Senagore, P Thorsen… – Journal of reproductive …, 2008 – Elsevier
Some spontaneous preterm deliveries (PTD) are caused by occult infections of the fetal membranes
(histologic chorioamnionitis [HCA]). High levels of infection-related markers, including some
cytokines, sampled from maternal circulation in mid-pregnancy have been linked to PTD,
Cited by 11Related articlesAll 6 versions

[HTML] from pnas.org…, D Roach, AT Woolley, T Thorsen… – Proceedings of the …, 1998 – National Acad Sciences
CrossRef. ↵: Woolley AT,; Mathies RA. (1995) Anal Chem 67:3676–3680, pmid:8644919.
Medline. ↵: Woolley AT,; Hadley D,; Landre P,; deMello AJ,; Mathies RA,; Northrup MA.
(1996) Anal Chem 68:4081–4086, pmid:8946790. Medline.
Cited by 245Related articlesBL DirectAll 11 versions

I Vogel, AR Goepfert, P Thorsen… – Journal of reproductive …, 2007 – Elsevier
This study aimed to analyze the associations between serum and cervicovaginal inflammatory
markers and recurrent spontaneous preterm birth in a cohort study of 62 pregnant women with
≥1 prior early spontaneous birth. Serum samples and cervicovaginal swabs from the
Cited by 11Related articlesAll 5 versions

P Thorsen, BR Møller… – Acta obstetricia et …, 1991 – informahealthcare.com
Semen specimens from 21 men with urethral infection with Chlamydia truchomutis were tested
for the presence of the organism before and after cryopreservation for 3 weeks of storage at -
196°C. Five specimens were chlamydia-positive before preservation and four of them
Cited by 11Related articlesAll 5 versions

K Mestan, Y Yu, P Thorsen, K Skogstrand… – 2009 – informahealthcare.com
Objective. In current, neonatal practice, clinical signs of intrauterine infection (IUI) are often
non-specific. From a large panel of immune biomarkers, we seek to identify cord blood markers
that are most strongly associated with the fetal inflammatory response (FIR), a specific
Cited by 11Related articlesAll 4 versions

[CITATION] Glas-Greenwalt and T. Astrup

P Thorsen – Thromb. Diath. Haemorrh, 1972
Cited by 10Related articles

…, AT Jacobsen, H Madsen, P Thorsen… – Ugeskrift for …, 2001 – ncbi.nlm.nih.gov
INTRODUCTION: Urinary incontinence is a common problem for adult women, and the need
for assessment and treatment of incontinence is expected to increase in the future. The aim of
this study was to elucidate the general practitioners’ (GPs) knowledge about and attitude
Cited by 10Related articlesAll 2 versions

…, S Lundqvist, PA Thorsen – US Patent App. 10/925,203, 2004 – Google Patents
3,2005 (54) WAVELENGTH MODULATION SPECTROSCOPY METHOD AND SYSTEM (76)
Inventors: Rikard Larking, Floda (SE); Stefan Lundqvist, Askim (SE); Per-Arne Thorsen, Ojersjo
(SE) Correspondence r- /6 fl fn n/ i P /A Lr ) 10 A 1 12 32 24 23^ -Cone ^ 22 21 19J 20 Y
Cited by 10Related articlesAll 3 versions

[HTML] from plos.orgDR Velez, SJ Fortunato, P Thorsen, SJ Lombardi… – PloS one, 2008 – dx.plos.org
Spontaneous preterm birth (<37 weeks gestation—PTB) occurs in ∼12% of pregnancies in the
United States, and is the largest contributor to neonatal morbidity and mortality. PTB is a complex
disease, potentially induced by several etiologic factors from multiple pathophysiologic
Cited by 10Related articlesCachedAll 6 versions

…, HK Poulsen, B Teisner, P Thorsen… – European Journal of …, 1993 – Elsevier
Three low-dose oral contraceptives Trinordiol ® , Gynatrol ® , and Marvelon ® , containing ethinylestradiol
(EE) in combination with triphasic levonorgestrel (LNg), monophasic levonorgestrel, and monophasic
desogestrel (DSG), respectively, were given to 65 healthy women, n = 21–22 in each
Cited by 10Related articlesAll 7 versions

P Thorsen, I Vogel, K Molsted… – Acta obstetricia et …, 2006 – Wiley Online Library
Background. No larger population-based study of bacterial vaginosis in pregnancy has previously
been available. The objective of this study was to examine risk factors for bacterial vaginosis
in pregnancy. Design. From a prospective population-based cohort of 3,596 eligible
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…, K Skogstrand, P Thorsen… – Obstetrics & …, 2009 – journals.lww.com
From the 1 Perinatal Center, Department of Obstetrics and Gynecology, Institute of Clinical
Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital/East, Göteborg, Sweden;
the 2 Imperial College, Institute of Reproductive and Developmental Biology, Queen
Cited by 9Related articlesAll 4 versions

…, A Madan, S Saha, D Schendel, P Thorsen… – Pediatric …, 2010 – journals.lww.com
Supported by The National Institutes of Health (General Clinical Research Center grants M01
RR30, M01 RR32, M01 RR39, M01 RR70, M01 RR80, M01 RR633, M01 RR750, M01
RR997, M01 RR6022, M01 RR7122, M01 RR8084, and M01 RR16587), the Eunice
Cited by 9Related articlesAll 5 versions

…, JL Thomsen, T Ovesen, P Thorsen – … –Head and Neck …, 2007 – oto.sagepub.com
We were able to identify 380 (61.2%) of these children in the NHR. There was no
significant difference in the severity of hearing loss between the Copenhagen children
who were found in the NHR vs those who were not (P = 0.16).
Cited by 9Related articlesAll 8 versions

R Menon, P Thorsen, I Vogel, B Jacobsson… – Placenta, 2007 – Elsevier
The objective of this study is to examine TNF-α and its soluble and membrane bound receptors
in fetal membranes derived from blacks and whites in response to in vitro infectious stimulus,
and the balance between TNF-α and the receptors. Fetal membranes collected from black
Cited by 10Related articlesAll 8 versions

…, K Skogstrand, P Thorsen… – Scandinavian …, 2007 – informahealthcare.com
IGF-I is primarily produced in the liver and mediates the anabolic effects of growth hormone
(GH). IGF-I and IGF-II are bound to six high-affinity IGF binding proteins (IGFBP-1 to
IGFBP-6) which act as carriers as well as modulators of IGF action [4]. In the circulation,
Cited by 9Related articlesBL DirectAll 7 versions

…, C Wilken‐Jensen, P Thorsen… – … of Obstetrics & …, 1994 – Wiley Online Library
How to Cite. Henriques, CU, Wilken-Jensen, C., Thorsen, P. and Møller, BR (1994), A randomised
controlled trial of prophylaxis of post-abortal infection: ceftriaxone versus placebo. BJOG: An
International Journal of Obstetrics & Gynaecology, 101: 610–614.
Cited by 9Related articlesBL DirectAll 5 versions

S Thorsen, P Glas-Greenwalt… – Thrombosis et diathesis …, 1972 – ncbi.nlm.nih.gov
1. Thromb Diath Haemorrh. 1972 Aug 31;28(1):65-74. Differences in the binding to fibrin
of urokinase and tissue plasminogen activator. Thorsen S, Glas-Greenwalt P, Astrup T.
PMID: 4672651 [PubMed - indexed for MEDLINE] MeSH Terms:
Cited by 147Related articles

…, G Røsland, F Thorsen… – … journal of cancer, 2008 – Wiley Online Library
Volume 122, Issue 4, pages 761–768, 15 February 2008. Additional Information. How to Cite.
Wang, J., Sakariassen, P. Ø., Tsinkalovsky, O., Immervoll, H., Bøe, SO, Svendsen, A., Prestegarden,
L., Røsland, G., Thorsen, F., Stuhr, L., Molven, A., Bjerkvig, R. and Enger, P. Ø.
Cited by 139Related articlesBL DirectAll 4 versions

[HTML] from biomedcentral.com…, C Wiuf, O Mors, M Didriksen, P Thorsen… – BMC …, 2009 – biomedcentral.com
Identification of disease susceptible genes requires access to DNA from numerous well-characterised
subjects. Archived residual dried blood spot samples from national newborn screening programs
may provide DNA from entire populations and medical registries the corresponding
Cited by 8Related articlesCachedAll 9 versions

…, T Lundström, SD Berkowitz, P Nyström… – JAMA: the journal of …, 2005 – Am Med Assoc
15-19 Kaplan-Meier estimates of the cumulative risk and the corresponding variance according
to the Greenwood formula were used when calculating the CI and the corresponding P values.
All reported P values are 2-sided; P<.05 was considered statistically significant.
Cited by 130Related articlesAll 10 versions

…, PL Thorsen – The High School Journal, 1985 – JSTOR
Both my wife Sandie and I (SPM) teach at a Christian liberal arts college. We both are ex- cited
about and revel in this vocational choice. However, it has placed us where we regularly deal
with the interaction between dogmatism on the one hand and developing a thoughtful
Cited by 8Related articles

[CITATION] Vanishing embryo syndrome

…, M Vaeth, E Ernst, L Nielsen, P Thorsen – IVF/ICSI. Hum Reprod, 2005
Cited by 8Related articles

…, I Vogel, K Skogstrand, P Thorsen… – Journal of reproductive …, 2008 – Elsevier
Pregnant women admitted with symptoms of threatening PTD and delivering before 34 weeks
of gestation had significantly lower levels of IL-18 compared to women delivering at or after 34
weeks of gestation (medians: 14.5 versus 26.6 pg/ml; p = 0.035). IL-12 levels were not
Cited by 8Related articlesAll 6 versions

PA Thorsen… – Materials Science and Engineering: A, 1999 – Elsevier
A more detailed discussion of the grain boundary structure effects that must be considered in
a modified theory has been given by Bilde-Sørensen and Thorsen [27]. Acknowledgements.
References. [1] OA Ruano, J. Wadsworth and OD Sherby, Acta Metall. 36 (1988), p. 1117.
Cited by 8Related articlesAll 3 versions

SL Hansen, P Thorsen, K Dybdal… – Photonics …, 1993 – ieeexplore.ieee.org
Abstract-The gain tilt responsible for second-order distortion generated by EDFA’s in AM
TV-systems is shown to be funda- mentally different from previous belief. The relevant gain-tilt
should be measured under locked-inversion conditions. It in- creases with signal
Cited by 8Related articlesBL DirectAll 4 versions

…, R Menon, DR Velez, P Thorsen… – American journal of …, 2008 – Elsevier
In white patients, multilocus interactions in maternal DNA between single nucleotide polymorphisms
at −7227 (interleukin-6), 22,215 (interleuki-6 receptor) and −3448 (tumor necrosis
factor-alpha) was predictive of approximately 59.1% (P < .02; odds ratio, 2.3 [95% ...
Cited by 8 - Related articles - All 8 versions

[HTML] from rbej.com…, SM Williams, SJ Fortunato, P Thorsen – Reproductive Biology …, 2009 – rbej.com
This is an Open Access article distributed under the terms of the Creative Commons Attribution
License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use,
distribution, and reproduction in any medium, provided the original work is properly cited.
Cited by 8Related articlesCachedAll 10 versions

HO Atladóttir, P Thorsen, L Østergaard… – Journal of autism and …, 2010 – Springer
Abstract Exposure to prenatal infection has been sug- gested to cause deficiencies in fetal
neurodevelopment. In this study we included all children born in Denmark from 1980, through
2005. Diagnoses of autism spectrum disorders (ASDs) and maternal infection were
Cited by 9Related articlesAll 6 versions

…, BH Bech, J Olsen, P Thorsen – Paediatric and …, 2008 – Wiley Online Library
In a previous study, we found that infants transferred to a neonatal ward after delivery had an
almost twofold increased risk of being diagnosed with infantile autism later in childhood in spite
of extensive controlling of obstetric risk factors. We therefore decided to investigate other
Cited by 8Related articlesAll 3 versions

[CITATION] Untitled

MA Unger, HP Chou, TA Thorsen, A Scherer… – US Patent 6,408,878, 2002
Cited by 118Related articles

P Kuban, A Engström, JC Olsson, G Thorsén… – Analytica chimica …, 1997 – Elsevier
17124 New interface for coupling nowinjection and capillary electrophoresis Petr Kuban, Anders
Engstrom, Joanna C. Olsson, Gunnar Thorsen, Robert Tryzell 00032670 97 S17.00 Copyright @
1997 Eisevier Science BV AI) rights reserved ‘ S00032670(96)00339X 118 P. A’uan
Cited by 111Related articlesBL DirectAll 4 versions

…, NP Bent, C Sværke, P Thorsen – Obstetrics & …, 2008 – journals.lww.com
From the 1 Department of Clinical Biochemistry, Statens Serum Institut, Copenhagen,
Denmark; 2 NANEA at Department of Epidemiology, Institute of Public Health, University of
Aarhus, Aarhus, Denmark; the 3 National Center on Birth Defects and Developmental
Cited by 7Related articlesAll 3 versions

S Lundqvist… – US Patent 7,193,718, 2007 – Google Patents
20, 2007 (54) WAVELENGTH MODULATION SPECTROSCOPY METHOD AND SYSTEM (75)
Inventors: Stefan Lundqvist, Askim (SE); Per-Arne Thorsen, Ojersjo (SE) (73) Assignee of origin
in the 5 non-linearity of the laser IP characteristics (I is the injection current and P is the
Cited by 7Related articlesAll 2 versions

NP Thorsen… – US Patent 5,033,713, 1991 – Google Patents
United States Patent Thorsen et al. [19] [ii] Patent Number: [45] Date of Patent: 5,033,713 Jul.
23, 1991 [54] TEMPERATURE-SENSITIVE ACTUATING APPARATUS FOR A SERVO-APPARATUS
[75] Inventors: Niels P. Thorsen, Sydals; Bjarke Hallenslev, Nordborg, both of Denmark
Cited by 7Related articlesAll 2 versions

[HTML] from oxfordjournals.org…, M Væth, E Ernst, L Nielsen, P Thorsen – Human …, 2005 – ESHRE
BACKGROUND: In a Danish population-based cohort study assessing the risk of cerebral palsy
in children born after IVF, we made some interesting observations regarding ‘vanishing
co-embryos’. METHODS and RESULTS: All live-born children born in Denmark from 1
Cited by 7Related articlesBL DirectAll 6 versions

[CITATION] Racial Disparity in Amniotic Fluid Tumor Necrosis Factor-α and soluble TNF Receptor Concentrations in Spontaneous Pretrem Birth: Evidence for Incresed …

R Menon, P Thorsen, I Vogel, B Jacobsson… – American Journal of …, 2008 – unknown
Cited by 7Related articles

[HTML] from nih.gov…, DJ Dudley, DE Schendel, P Thorsen – American journal of …, 2008 – Elsevier
Presented at the 14th Annual Meeting of the Psychoneuroimmunology Research Society,
Arcachon, France, May 30 through June 2, 2007. 6 National Center on Birth Defects and Developmental
Disabilities, Centers for Disease Control and Prevention, Atlanta, GA.
Cited by 7Related articlesAll 7 versions

[PDF] from clinchem.org…, B Norgaard-Pedersen, P Thorsen… – Clinical …, 2007 – Am Assoc Clin Chem
Programs to screen newborns for congenital disorders are based on analysis of dried blood
spot samples (DBSS), which have proven to be robust and convenient for collection,
transport, and storage. Because blood samples are collected with no selection, and
Cited by 7Related articlesBL DirectAll 4 versions

[PDF] from csic.es…, F Saborido-Rey, PR Witthames, A Thorsen… – 2003 – digital.csic.es
PR Witthames Centre for Environmennt, Fisheries and Aquaculture Science, Lowestoft
Laboratory Lowestoft, Suffolk NR33, 0HT, England A. Thorsen Institute of Marine Research,
PO Box 1870 Nordnes, Nordnesgaten 50, N-5817 Bergen, Norway
Cited by 72Related articlesView as HTMLAll 10 versions

[PDF] from sgmjournals.orgLT Jensen, P Thorsen, B MOsller… – Journal of medical …, 1998 – Soc General Microbiol
J. Med. Microbiol. – Vol. 47 (1998), 659-666 ( > 1998 The Pathological Society of Great Britain
and Ireland MOLECULAR I DENTI FICATION AND EPI DEM IOLOGY LlSE T. JENSEN,
P. THORSEN*, B. M0LLER*, S. BIRKELUND and G. CHRISTIANSEN
Cited by 6Related articlesBL DirectAll 4 versions

[PDF] from mit.eduJP Urbanski, T Thorsen, JA Levitan… – Applied physics letters, 2006 – link.aip.org
Fast ac electro-osmotic micropumps with nonplanar electrodes. [Applied Physics Letters 89,
143508 (2006)]. John Paul Urbanski, Todd Thorsen, Jeremy A. Levitan, Martin Z. Bazant. Abstract.
Author to whom correspondence should be addressed; electronic mail: thorsen@mit.edu
Cited by 72Related articlesBL DirectAll 9 versions

MV Hollegaard, J Grove, P Thorsen… – Genetic Testing and …, 2009 – liebertonline.com
Aims: The aim of this study was to investigate if dried blood spot (DBS) samples stored in the
Danish Neonatal Screening Biobank (DNSB) and the Danish National Birth Cohort (DNBC) repository
are useful for Illumina single- nucleotide polymorphism (SNP) genotyping. Genomic DNA (
Cited by 6Related articlesAll 2 versions

[PDF] from au.dkI Vogel, P Thorsen, HH Hundborg… – European Journal of …, 2006 – Elsevier
In the women with a subsequent preterm delivery the relaxin level decreased by 0.9% per week
as compared to 1.9% per week (t-test, p = 0.004) in the women with term deliveries. From the
cohort the course of S-relaxin during pregnancy in both preterm and term deliveries were
Cited by 6Related articlesAll 7 versions

[HTML] from fasebj.org…, M Hjelstuen, PERȖ ENGER, F Thorsen… – The FASEB Journal, 2002 – FASEB
MARTHA CHEKENYA * , MARI HJELSTUEN ‡ , PER ØYVIND ENGER * , FRITS THORSEN * ,
ANNE L. JACOB * , BEATRICE PROBST * , OLAV HARALDSETH § , GEOFFREY PILKINGTON
II , ARTHUR BUTT ¶ , JOEL M LEVINE ** and WT (P<0.001) and control cells (P<0.05).
Cited by 64Related articlesBL DirectAll 3 versions

…, SJ Hamilton-Dutoit, S Thorsen… – European journal of …, 1991 – ncbi.nlm.nih.gov
and prognostic features. Pedersen C, Gerstoft J, Lundgren JD, Skinhøj P, Bøttzauw
J, Geisler C, Hamilton-Dutoit SJ, Thorsen S, Lisse I, Ralfkiaer E, et al. Department
of Infectious Diseases, Hvidovre Hospital, Denmark. All 51
Cited by 61Related articlesAll 2 versions

H Alfredson, D Bjur, K Thorsen… – Journal of …, 2002 – Wiley Online Library
In this investigation the microdialysis technique was used to study the concentrations of lactate
in Achilles tendons with painful chronic tendinosis and in normal pain-free tendons. In four patients
(mean age 40.7 years) with a painful thickening localized at the 2-6 cni level in the
Cited by 63Related articlesAll 6 versions

P Nordström, K Thorsen, G Nordström, E Bergström… – Bone, 1995 – Elsevier
This study was conducted to evaluate the association between muscle strength of the thigh, different
body constitutional parameters, and bone mineral density (BMD) in adolescents. The subjects
were 26 healthy adolescent boys, age 15.9 ± 0.3 years, not training for more than 3 h per
Cited by 56Related articlesBL DirectAll 8 versions

[PDF] from safeminds.org…, D Schendel, J Wohlfahrt, P Thorsen… – New England Journal …, 2002 – nejm.org
We conducted a retrospective cohort study of all children born in Denmark from January 1991
through December 1998. The cohort was selected on the basis of data from the Danish Civil
Registration System, which assigns a unique identification number to every live-born
Cited by 383Related articlesBL DirectAll 26 versions

[HTML] from oxfordjournals.org…, E Agerbo, D Schendel, P Thorsen… – American Journal of …, 2005 – Oxford Univ Press
Research suggests that heredity and early fetal development play a causal role in autism. This
case-control study explored the association between perinatal factors, parental psychiatric
history, socioeconomic status, and risk of autism. The study was nested within a cohort of
Cited by 182Related articlesAll 15 versions

[PDF] from pkids.org…, MB Lauritsen, CB Pedersen, P Thorsen… – Pediatrics, 2003 – Am Acad Pediatrics
Objective. It has been suggested that thimerosal, a mercury-containing preservative in
vaccines, is a risk factor for the development of autism. We examined whether discontinuing
the use of thimerosal-containing vaccines in Denmark led to a decrease in the incidence
Cited by 148Related articlesBL DirectAll 33 versions

MJ Silverberg, P Thorsen, H Lindeberg… – Obstetrics & …, 2003 – journals.lww.com
Wolters Kluwer Health may email you for journal alerts and information, but is committed to maintaining
your privacy and will not share your personal information without your express consent. For more
information, please refer to our Privacy Policy. Skip Navigation Links Home > April
Cited by 125Related articlesAll 8 versions

P Thorsen, IP Jensen, B Jeune, N Ebbesen… – American journal of …, 1998 – Elsevier
Attempts to identify infections in the lower genital tract in women as one of the causes of pathologic
pregnancy outcome have been made throughout several decades. Recently, efforts have been
concentrated on the condition of BV as described by Amsel et al. 5 The diagnostic criteria
Cited by 97Related articlesBL DirectAll 4 versions

[HTML] from endojournals.orgK Erickson, P Thorsen, G Chrousos… – Journal of Clinical …, 2001 – Endocrine Soc
Increased CRH secretion by the placenta of pregnant women has been associated with preterm
birth. Certain indices of risk, both medical and psychosocial in nature, have been linked to preterm
delivery. Levels of total, bound, and free CRH, CRH-binding protein (CRH-BP), and
Cited by 80Related articlesBL DirectAll 5 versions

[HTML] from clinchem.orgK Skogstrand, P Thorsen… – Clinical …, 2005 – Am Assoc Clin Chem
Background: Inflammatory reactions and other events in early life may be part of the etiology
of late-onset diseases, including cerebral palsy, autism, and type 1 diabetes. Most neonatal screening
programs for congenital disorders are based on analysis of dried blood spot samples
Cited by 75Related articlesBL DirectAll 5 versions

C Floridon, CH Jensen, P Thorsen… – …, 2000 – Wiley Online Library
Abstract Fetal antigen 1 (FA1) is a circulating EGF multidomain glycoprotein. FA1 and its
membrane-associated precursor is defined by the mRNAs referred to as delta-like (dlk), preadipocyte
factor 1 (pref-1) or zona glomerulosa-specific factor (ZOG). Using a polyclonal antibody
Cited by 64Related articlesBL DirectAll 4 versions

I Vogel, P Thorsen, A Curry… – Acta obstetricia et …, 2005 – Wiley Online Library
Among symptomatic women, the likelihood ratio (LR+) for the prediction of PTD was found to
be greater than 10 using amniotic fluid (AF) interleukin-6 (IL-6), AF Ureaplasma urealyticum,
as well as a multi-marker consisting of cervical IL-6, cervical IL-8, and cervical length
Cited by 55Related articlesAll 7 versions

IP Jensen, P Thorsen, B Jeune… – … of Obstetrics & …, 2000 – Wiley Online Library
Objectives To estimate the incidence of human parvovirus B19 among pregnant women before
and during an epidemic, to elucidate possible sociodemographic and medical risk factors during
pregnancy and to estimate the association between parvovirus B19 infection and
Cited by 53Related articlesBL DirectAll 4 versions

…, KM Madsen, J Wohlfahrt, P Thorsen… – JAMA: the journal of …, 2004 – Am Med Assoc
Author Affiliations: The Danish Epidemiology Science Centre, Department of Epidemiology and
Social Medicine, Aarhus University, Aarhus (Drs Vestergaard, Madsen, and Olsen), The Danish
Epidemiology Science Centre, Department of Epidemiology Research, Statens Serum
Cited by 51Related articlesBL DirectAll 6 versions

IP Jensen, P Thorsen… – Lancet, 1997 – ncbi.nlm.nih.gov
1. Lancet. 1997 Feb 1;349(9048):329-30. Sensitivity of ligase chain reaction assay of urine from
pregnant women for Chlamydia trachomatis. Jensen IP, Thorsen P, Møller BR. Comment in: Lancet.
1997 Apr 5;349(9057):1024-5. Lancet. 1998 Jan 31;351(9099):341-2. Lancet.
Cited by 48Related articlesBL DirectAll 6 versions

GB Hvilsom, P Thorsen, B Jeune… – Acta obstetricia et …, 2002 – Wiley Online Library
Methods. The present study is a prospective nested case-control study including 84
singleton, preterm deliveries (cases) and 400 singleton, term deliveries (controls), based at the
Odense University Hospital, Denmark. These cases were identified from a cohort of 2846
Cited by 43Related articlesBL DirectAll 8 versions

[HTML] from shouxi.net…, M Vaeth, E Ernst, LF Nielsen, P Thorsen – Pediatrics, 2006 – Am Acad Pediatrics
METHODS. A population-based, cohort study, including all live-born singletons and twins born
in Denmark between January 1, 1995, and December 31, 2000, was performed. Children conceived
with in vitro fertilization (9255 children) were identified through the In Vitro Fertilization
Cited by 42Related articlesBL DirectAll 8 versions

…, A Schuchat, P Thorsen – Mental retardation and …, 2002 – Wiley Online Library
Cerebral palsy is the most common neuromotor developmental dis- ability of childhood, affecting
as many as 8,000 to 12,000 children born in the US each year (corresponding to a prevalence
rate of between 2 and 3 per 1000 children). Recent improvements in neonatal care have
Cited by 42Related articlesBL DirectAll 3 versions

[PDF] from dbac.dkCS Benn, P Thorsen, JS Jensen, BB Kjoer… – Journal of allergy and …, 2002 – dbac.dk
Background: Infants with wheezing and allergic diseases have a microflora that differs from that
of healthy infants. The fetus acquires microorganisms during birth when exposed to the maternal
vaginal microflora. It is therefore conceivable that the maternal vaginal microflora might
Cited by 41Related articlesView as HTMLBL DirectAll 6 versions

…, S Dalsgaard, PH Thomsen, P Thorsen – Archives of Pediatrics …, 2007 – Am Med Assoc
You are seeing this message because your Web browser does not support basic Web
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DR Feikin, P Thorsen, S Zywicki, M Arpi… – American journal of …, 2001 – Elsevier
*1 Supported by the Danish Health Insurance Foundation; the Institute of Clinical Research,
University of Odense; the Foundation of Reproductive Biology, Odense University Hospital; the
National Fund for Research and Development; the Danish Ministry of Health; the Medical-
Cited by 33Related articlesBL DirectAll 5 versions

…, H Simhan, K Ryckman, L Jiang, P Thorsen… – American journal of …, 2006 – Elsevier
We hypothesize that genetic variations (single nucleotide polymorphisms-SNPs) in the tumor
necrosis factor-α (TNF-α), TNF receptors (TNFRI and TNFRII), interleukin-6 (IL-6) and IL-6 receptor
(IL-6R) genes predict high-risk status for spontaneous preterm birth (sPTB) in European-
Cited by 29Related articlesAll 7 versions

S Cauci, J McGregor, P Thorsen, J Grove… – American journal of …, 2005 – Elsevier
Vaginal pH ≥4.7 or pH ≥5 by itself was not associated with LBW or prematurity.
Conversely, combination of pH ≥5 and high sialidase activity demonstrated OR 17 (CI
1.8-150) for LBW; OR 31 (CI 1.8-516) for VLBW; along with OR 18 (CI 1.6-204) for preterm
Cited by 27Related articlesAll 4 versions

…, B Jacobsson, C Svaerke, P Thorsen – Archives of Pediatrics …, 2009 – Am Med Assoc
You are seeing this message because your Web browser does not support basic Web
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Cited by 26Related articlesAll 6 versions

I Vogel, P Thorsen, VK Hogan… – Acta obstetricia et …, 2006 – Wiley Online Library
Objective. To examine associations of vaginal Ureaplasma urealyticum (UU) and bacterial vaginosis
(BV) with preterm delivery (PTD), small for gestational age (SGA), and low birth weight
(LBW). Material and methods. A population-based, prospective cohort study of 2,927
Cited by 24Related articlesBL DirectAll 7 versions

[HTML] from nih.govS Cauci, P Thorsen, DE Schendel… – Journal of clinical …, 2003 – Am Soc Microbiol
A nested case-control study of low birth weight and preterm delivery was performed with singleton
women. Immunoglobulin A (IgA) against the Gardnerella vaginalis hemolysin (anti-Gvh IgA) and
sialidase and prolidase activities were determined in vaginal fluid at 17 weeks of
Cited by 23Related articlesBL DirectAll 13 versions

MJ Silverberg, P Thorsen, H Lindeberg… – … – Head and Neck …, 2004 – Am Med Assoc
You are seeing this message because your Web browser does not support basic Web
standards. Find out more about why this message is appearing and what you can do to make
your experience on this site better. Add to CiteULike Add to Connotea Add to
Cited by 23Related articlesBL DirectAll 3 versions

P Thorsen, DE Schendel… – Paediatric and …, 2001 – Wiley Online Library
The overall objective of the current study is to assess whether specific markers of infection (primarily
interleukin (IL) 1β, tumour necrosis factor (TNF) α, IL-6, and IL-10) obtained from maternal blood
during pregnancy, alone or in combination with other risk factors for PTD, permit
Cited by 23Related articlesBL DirectAll 5 versions

[HTML] from nih.gov…, SA McDonald, A Das, D Schendel, P Thorsen… – Pediatrics, 2009 – Am Acad Pediatrics
METHODS. For 1067 extremely low birth weight infants in the Neonatal Research Network of
the National Institute of Child Health and Human Development, levels of 25 cytokines were measured
in blood collected within 4 hours after birth and on days 3, 7, 14, and 21. Stepwise
Cited by 19Related articlesAll 5 versions

R Menon, SJ Fortunato, P Thorsen… – Journal of the Society …, 2006 – rsx.sagepub.com
Ramkumar Menon, MS, Stephen J. Fortunato, MD, Poul Thorsen, MD, PhD, and Scott
Williams, PhD KEY WORDS: Genetic association, prematurity, single-nucleotide
polymorphisms, Inultilocus analysis, MDR. 1. Twin studies supporting a genetic
Cited by 19Related articlesBL DirectAll 4 versions

HO Atladottir, MG Pedersen, P Thorsen… – Pediatrics, 2009 – Am Acad Pediatrics
METHODS: The study cohort consisted of all of the children born in Denmark from 1993 through
2004 (689 196 children). Outcome data consisted of both inpatient and outpatient diagnoses
reported to the Danish National Psychiatric Registry. Information on ADs in parents and
Cited by 17Related articlesAll 6 versions

BR Møller, FV Kristiansen, P Thorsen… – Acta obstetricia et …, 1995 – informaworld.com
Actu O hm Gwerol Scund 1995, 74: 216-219 Printed in Denmark – ull righls reserved Acta
Obstetricia et Gynecologica Scandinavica ISSN 0001-6349 BIRGER R. MDLLER, FRANK
v. KRISTIANSEN, POUL THORSEN, LARS FROST AND S0REN c. MOGENSEN
Cited by 15Related articlesBL DirectAll 5 versions

…, DE Schendel, P Thorsen – Archives of Pediatrics and …, 2008 – Am Med Assoc
You are seeing this message because your Web browser does not support basic Web
standards. Find out more about why this message is appearing and what you can do to make
your experience on this site better. Add to CiteULike Add to Connotea Add to
Cited by 14Related articlesAll 4 versions

[PDF] from uniklinikum-jena.deK Skogstrand, CK Ekelund, P Thorsen… – Journal of …, 2008 – Elsevier
The interests in monitoring inflammation by immunoassay determination of blood inflammatory
markers call for information on the stability of these markers in relation to the handling of blood
samples. The increasing use of stored biobank samples for such ventures that may have
Cited by 14Related articlesAll 7 versions

R Menon, P Thorsen, I Vogel, B Jacobsson… – American journal of …, 2008 – Elsevier
Median TNF-α concentration was associated with preterm birth when whites and blacks were
analyzed together, with cases having higher values (191.5 pg/mL) than controls (68.9
pg/mL; P < .001). There were no significant associations with sTNFR1 or sTNFR2
Cited by 15Related articlesAll 10 versions

P Thorsen, I Vogel, J Olsen… – Journal of Maternal …, 2006 – informahealthcare.com
Results. At enrolment, 13.7% had BV. BV was not associated with an increased risk of spontaneous
preterm birth (crude OR 0.8 (0.5–1.5)). Nulliparity was found to affect birth weight to such a degree
that this variable was used for stratification. In nulliparous women BV was associated with
Cited by 13Related articlesBL DirectAll 5 versions

I Vogel, J Grove, P Thorsen… – … of Obstetrics & …, 2005 – Wiley Online Library
*Correspondence: Dr I. Vogel, North Atlantic Neuro-epidemiology Alliances (NANEA) at Department
of Epidemiology and Social Medicine, Aarhus University, Vennelyst Boulevard 6, 8000 Aarhus
C, Denmark. Objective To evaluate whether soluble CD163 (sCD163) and C-reactive
Cited by 13Related articlesAll 3 versions

R Menon, MC Camargo, P Thorsen… – American journal of …, 2008 – Elsevier
In this study, 321 amniotic fluids from cases (preterm birth 36 or fewer weeks’ gestation) and
controls (normal term delivery longer than 37 weeks’ gestation) were collected (147 cases [49
blacks and 98 whites] and 174 controls [85 blacks and 89 whites]) at the time of active
Cited by 13Related articlesAll 6 versions

…, C Pearson, K Ortiz, N Porta, P Thorsen… – Pediatrics, 2009 – Am Acad Pediatrics
RESULTS. The 27 biomarkers could be classified into 1 of 3 groups: (1) biomarkers increased
in preterm birth (interleukin [IL]-2, IL-4, IL-5, IL-8, IL-10, monocyte chemoattractant protein 1, macrophage
inflammatory protein [MIP]-1 , MIP-1β, soluble IL-6 receptor , tumor necrosis factor ,
Cited by 13Related articlesAll 5 versions

…, D Hougaard, J Olsen, P Thorsen – Acta obstetricia et …, 2007 – Wiley Online Library
Background. Few studies have investigated the relationship between inflammation and spontaneous
preterm delivery (sPTD) in women before preterm labour. The authors examine whether
mid-pregnancy plasma cytokine levels are associated with sPTD, and whether
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…, S Dalsgaard, PH Thomsen, P Thorsen – …, 2007 – journals.lww.com
Wolters Kluwer Health may email you for journal alerts and information, but is committed to maintaining
your privacy and will not share your personal information without your express consent. For more
information, please refer to our Privacy Policy. Skip Navigation Links Home > March
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…, LT Jensen, SA Ladefoged, P Thorsen… – Molecular …, 1998 – Wiley Online Library
Mycoplasma hominis contains a variable adherence-associated (vaa) gene. To classify variants
of the vaa genes, we examined 42 M. hominis isolates by PCR, DNA sequencing and
immunoblotting. This uncovered the existence of five gene categories. Comparison of the
Cited by 12Related articlesBL DirectAll 4 versions

DR Velez, S Fortunato, P Thorsen… – American journal of …, 2009 – Elsevier
The most significant associations were in the maternal interleukin (IL)-15 (rs10833, allele P =
2.91 × 10 −4 , genotype P = 2.00 × 10 −3 ) gene and the fetal IL-2 receptor B (IL-2RB)
(rs84460, allele P = 1.37 × 10 −4 , genotype P = 6.29 × 10 −4 ) gene. The best models for
Cited by 13Related articlesAll 7 versions

P Thorsen, BR Møller… – Acta obstetricia et …, 1991 – informahealthcare.com
Semen specimens from 21 men with urethral infection with Chlamydia truchomutis were tested
for the presence of the organism before and after cryopreservation for 3 weeks of storage at -
196°C. Five specimens were chlamydia-positive before preservation and four of them
Cited by 11Related articlesAll 5 versions

I Vogel, AR Goepfert, P Thorsen… – Journal of reproductive …, 2007 – Elsevier
This study aimed to analyze the associations between serum and cervicovaginal inflammatory
markers and recurrent spontaneous preterm birth in a cohort study of 62 pregnant women with
≥1 prior early spontaneous birth. Serum samples and cervicovaginal swabs from the
Cited by 11Related articlesAll 5 versions

[HTML] from nih.gov…, C Holzman, P Senagore, P Thorsen… – Journal of reproductive …, 2008 – Elsevier
Some spontaneous preterm deliveries (PTD) are caused by occult infections of the fetal membranes
(histologic chorioamnionitis [HCA]). High levels of infection-related markers, including some
cytokines, sampled from maternal circulation in mid-pregnancy have been linked to PTD,
Cited by 11Related articlesAll 6 versions

[PDF] from aace.com…, M Glavind‐Kristensen, P Thorsen… – … of Obstetrics & …, 2002 – Wiley Online Library
Setting Calculated sample size was reached over a two-year period, during which 9507 women
gave birth. Of these, 157 healthy women were eligible for the study as they were admitted with
symptoms of delivery before 34 weeks of gestation. Ninety-three women were included.
Cited by 11Related articlesAll 6 versions

K Mestan, Y Yu, P Thorsen, K Skogstrand… – 2009 – informahealthcare.com
Objective. In current, neonatal practice, clinical signs of intrauterine infection (IUI) are often
non-specific. From a large panel of immune biomarkers, we seek to identify cord blood markers
that are most strongly associated with the fetal inflammatory response (FIR), a specific
Cited by 11Related articlesAll 4 versions

…, HK Poulsen, B Teisner, P Thorsen… – European Journal of …, 1993 – Elsevier
Three low-dose oral contraceptives Trinordiol ® , Gynatrol ® , and Marvelon ® , containing ethinylestradiol
(EE) in combination with triphasic levonorgestrel (LNg), monophasic levonorgestrel, and monophasic
desogestrel (DSG), respectively, were given to 65 healthy women, n = 21–22 in each
Cited by 10Related articlesAll 7 versions

[HTML] from plos.orgDR Velez, SJ Fortunato, P Thorsen, SJ Lombardi… – PloS one, 2008 – dx.plos.org
Spontaneous preterm birth (<37 weeks gestation—PTB) occurs in ∼12% of pregnancies in the
United States, and is the largest contributor to neonatal morbidity and mortality. PTB is a complex
disease, potentially induced by several etiologic factors from multiple pathophysiologic
Cited by 10Related articlesCachedAll 6 versions

…, C Wilken‐Jensen, P Thorsen… – … of Obstetrics & …, 1994 – Wiley Online Library
A randomised controlled trial of prophylaxis of post-abortal infection: ceftriaxone versus
placebo. Carsten Ulrik Henriques Registrar 1 ,; Charlotte Wilken-Jensen Registrar 1 ,;
Poul Thorsen Registrar 1 ,; Birger R. Møller Associate Professor 2,*.
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P Thorsen, I Vogel, K Molsted… – Acta obstetricia et …, 2006 – Wiley Online Library
Background. No larger population-based study of bacterial vaginosis in pregnancy has previously
been available. The objective of this study was to examine risk factors for bacterial vaginosis
in pregnancy. Design. From a prospective population-based cohort of 3,596 eligible
Cited by 9Related articlesBL DirectAll 6 versions

…, A Madan, S Saha, D Schendel, P Thorsen… – Pediatric …, 2010 – journals.lww.com
Supported by The National Institutes of Health (General Clinical Research Center grants M01
RR30, M01 RR32, M01 RR39, M01 RR70, M01 RR80, M01 RR633, M01 RR750, M01
RR997, M01 RR6022, M01 RR7122, M01 RR8084, and M01 RR16587), the Eunice
Cited by 9Related articlesAll 5 versions

…, JL Thomsen, T Ovesen, P Thorsen – … –Head and Neck …, 2007 – oto.sagepub.com
Cited by 9Related articlesAll 8 versions

…, K Skogstrand, P Thorsen… – Obstetrics & …, 2009 – journals.lww.com
From the 1 Perinatal Center, Department of Obstetrics and Gynecology, Institute of Clinical
Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital/East, Göteborg, Sweden;
the 2 Imperial College, Institute of Reproductive and Developmental Biology, Queen
Cited by 9Related articlesAll 4 versions

R Menon, P Thorsen, I Vogel, B Jacobsson… – Placenta, 2007 – Elsevier
The objective of this study is to examine TNF-α and its soluble and membrane bound receptors
in fetal membranes derived from blacks and whites in response to in vitro infectious stimulus,
and the balance between TNF-α and the receptors. Fetal membranes collected from black
Cited by 10Related articlesAll 8 versions

…, K Skogstrand, P Thorsen… – Scandinavian …, 2007 – informahealthcare.com
IGF-I is primarily produced in the liver and mediates the anabolic effects of growth hormone
(GH). IGF-I and IGF-II are bound to six high-affinity IGF binding proteins (IGFBP-1 to
IGFBP-6) which act as carriers as well as modulators of IGF action [4]. In the circulation,
Cited by 9Related articlesBL DirectAll 7 versions

…, BH Bech, J Olsen, P Thorsen – Paediatric and …, 2008 – Wiley Online Library
In a previous study, we found that infants transferred to a neonatal ward after delivery had an
almost twofold increased risk of being diagnosed with infantile autism later in childhood in spite
of extensive controlling of obstetric risk factors. We therefore decided to investigate other
Cited by 8Related articlesAll 3 versions

[HTML] from biomedcentral.com…, C Wiuf, O Mors, M Didriksen, P Thorsen… – BMC …, 2009 – biomedcentral.com
Identification of disease susceptible genes requires access to DNA from numerous well-characterised
subjects. Archived residual dried blood spot samples from national newborn screening programs
may provide DNA from entire populations and medical registries the corresponding
Cited by 8Related articlesCachedAll 9 versions

…, R Menon, DR Velez, P Thorsen… – American journal of …, 2008 – Elsevier
In white patients, multilocus interactions in maternal DNA between single nucleotide polymorphisms
at −7227 (interleukin-6), 22,215 (interleuki-6 receptor) and −3448 (tumor necrosis
factor-alpha) was predictive of approximately 59.1% (P < .02; odds ratio, 2.3 [95% ...
Cited by 8 - Related articles - All 8 versions

[HTML] from rbej.com…, SM Williams, SJ Fortunato, P Thorsen – Reproductive Biology …, 2009 – rbej.com
This is an Open Access article distributed under the terms of the Creative Commons Attribution
License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use,
distribution, and reproduction in any medium, provided the original work is properly cited.
Cited by 8Related articlesCachedAll 10 versions

HO Atladóttir, P Thorsen, L Østergaard… – Journal of autism and …, 2010 – Springer
Abstract Exposure to prenatal infection has been sug- gested to cause deficiencies in fetal
neurodevelopment. In this study we included all children born in Denmark from 1980, through
2005. Diagnoses of autism spectrum disorders (ASDs) and maternal infection were
Cited by 9Related articlesAll 6 versions

[HTML] from oxfordjournals.org…, M Væth, E Ernst, L Nielsen, P Thorsen – Human …, 2005 – ESHRE
BACKGROUND: In a Danish population-based cohort study assessing the risk of cerebral palsy
in children born after IVF, we made some interesting observations regarding ‘vanishing
co-embryos’. METHODS and RESULTS: All live-born children born in Denmark from 1
Cited by 7Related articlesBL DirectAll 6 versions

[PDF] from clinchem.org…, B Norgaard-Pedersen, P Thorsen… – Clinical …, 2007 – Am Assoc Clin Chem
Programs to screen newborns for congenital disorders are based on analysis of dried blood
spot samples (DBSS), which have proven to be robust and convenient for collection,
transport, and storage. Because blood samples are collected with no selection, and
Cited by 7Related articlesBL DirectAll 4 versions

[HTML] from nih.gov…, DJ Dudley, DE Schendel, P Thorsen – American journal of …, 2008 – Elsevier
Presented at the 14th Annual Meeting of the Psychoneuroimmunology Research Society,
Arcachon, France, May 30 through June 2, 2007. 6 National Center on Birth Defects and Developmental
Disabilities, Centers for Disease Control and Prevention, Atlanta, GA.
Cited by 7Related articlesAll 7 versions

…, NP Bent, C Sværke, P Thorsen – Obstetrics & …, 2008 – journals.lww.com
From the 1 Department of Clinical Biochemistry, Statens Serum Institut, Copenhagen,
Denmark; 2 NANEA at Department of Epidemiology, Institute of Public Health, University of
Aarhus, Aarhus, Denmark; the 3 National Center on Birth Defects and Developmental
Cited by 7Related articlesAll 3 versions

[CITATION] Racial Disparity in Amniotic Fluid Tumor Necrosis Factor-α and soluble TNF Receptor Concentrations in Spontaneous Pretrem Birth: Evidence for Incresed …

R Menon, P Thorsen, I Vogel, B Jacobsson… – American Journal of …, 2008 – unknown
Cited by 7Related articles

[PDF] from au.dkI Vogel, P Thorsen, HH Hundborg… – European Journal of …, 2006 – Elsevier
In the women with a subsequent preterm delivery the relaxin level decreased by 0.9% per week
as compared to 1.9% per week (t-test, p = 0.004) in the women with term deliveries. From the
cohort the course of S-relaxin during pregnancy in both preterm and term deliveries were
Cited by 6Related articlesAll 7 versions

MV Hollegaard, J Grove, P Thorsen… – Genetic Testing and …, 2009 – liebertonline.com
Aims: The aim of this study was to investigate if dried blood spot (DBS) samples stored in the
Danish Neonatal Screening Biobank (DNSB) and the Danish National Birth Cohort (DNBC) repository
are useful for Illumina single- nucleotide polymorphism (SNP) genotyping. Genomic DNA (
Cited by 6Related articlesAll 2 versions

…, S Toft, J Grove, DE Schendel, P Thorsen – Journal of autism and …, 2010 – Springer
Marlene B. Lauritsen Æ Meta Jørgensen Æ Kreesten M. Madsen Æ Sanne Lemcke Æ
Susanne Toft Æ Jakob Grove Æ Diana E. Schendel Æ Poul Thorsen Published online:
1 September 2009 © Springer Science+Business Media, LLC 2009
Cited by 5Related articlesAll 5 versions

…, HJ Møller, S Cliver, P Thorsen… – American journal of …, 2006 – Elsevier
Of the 61 women, 26% had >1 previous spontaneous preterm delivery; 84% were black; 87%
were unmarried; 13% were smokers, and 39% were delivered before 37 weeks of gestation.
Neither relaxin (median, 368 ng/L; range, 83-1493 ng/L) nor soluble CD163 (2.4 mg/L;
Cited by 5Related articlesAll 6 versions

IDA VOGEL, H GRØNBAEK, P THORSEN… – In Vivo, 2004 – iv.iiarjournals.org
Abstract. Objective: To examine vaginal insulin-like growth factor binding protein 1 (IGFBP-1)
as a marker of preterm delivery, amniotic fluid leakage or vaginal infection. Materials and
Methods: The material consisted of a nested case-control study (67 with idiopathic
Cited by 5Related articlesBL DirectAll 2 versions

[PDF] from peerproject.euMV Hollegaard, P Thorsen… – …, 2009 – Wiley Online Library
Stored surplus of dried blood spot (DBS) samples from neonatal screening programs constitute
a vast potential for large genetic epidemiological studies. However, age of the samples and the
small amounts of DNA available may limit their usage. In this study we validate
Cited by 4Related articlesAll 7 versions

MV Hollegaard, J Grove, P Thorsen… – Acta obstetricia et …, 2008 – Wiley Online Library
Objective. To investigate the relation between 19 selected single nucleotide polymorphisms
in three cytokine genes, tumor necrosis factor alpha (TNFA), interleukin 1-beta (IL1B) and interleukin
6 (IL6) and preterm birth (<37 weeks’ gestation). Design. Case-control association study.
Cited by 4Related articlesAll 6 versions

…, J Lamoureux, K Skogstrand, P Thorsen – Cytokine, 2010 – Elsevier
Most previous studies of maternal cytokines and preterm birth have analyzed immunologic biomarkers
after the onset of labor or membrane rupture; fewer have examined the systemic (blood) immune
response prior to labor onset. We carried out a case–control study nested in a large (n =
Cited by 4Related articlesAll 6 versions

[CITATION] Risk factors for autism: perinatal factors, parental psychiatric history, and socioeconomic status

…, V Mogens, O Anne, A Esben, S Diana, T Poul… – Am J Epidemiol, 2005
Cited by 4Related articles

…, M Vestergaard, P Uldall, P Thorsen – … of Obstetrics & …, 2008 – Wiley Online Library
Objective To investigate the association of asphyxia-related conditions (reducing blood flow
or blood oxygen levels in the fetus) with spastic cerebral palsy (CP) considering different gestational
age groups and the timing of risk. Setting Danish Cerebral Palsy Register in eastern
Cited by 4Related articlesAll 7 versions

P Thorsen, BR Moller, M Arpi, A Bremmelgaard… – Lancet, 1994 – cat.inist.fr
Titre du document / Document title. PASTEURELLA AEROGENES ISOLATED FROM
STILLBIRTH AND MOTHER. Auteur(s) / Author(s). THORSEN P. ; MOLLER BR ; ARPI
M. ; BREMMELGAARD A. ; FREDERIKSEN W. ; Revue / Journal Title.
Cited by 5Related articlesBL DirectAll 4 versions

…, P Uldall, E Ernst, B Jacobsson, P Thorsen – Human …, 2010 – ESHRE
RESULTS There were 33 139 (5.6%) children born in Denmark from 1995 to 2003 as a result
of assisted conception and through to June 2009, 1146 (0.19%) children received a CP
diagnosis. Children born after assisted conception had an increased risk of a CP
Cited by 3Related articlesAll 8 versions

[CITATION] Die Hypnose im Dienste der Menschbeit

P Thorsen – 1960
Cited by 4Related articles

[CITATION] Eget sygesikringsbevis til børn. Nye muligheder for epidemiologisk forskning i den primære sundhedssektor

…, S Reusch, M Sørensen, H Thorsen – Ugeskrift for læger, 1999 – unknown
Cited by 1Related articlesBL Direct

P Thorsen, H Dybdahl, H Søgaard… – European Journal of …, 1991 – Elsevier
European Journal of Obstetrics & Gynecology and Reproductive Biology, 40 (1991) 67-11 0
1991 Elsevier Science Publishers BV 0028-2243/91/$03.50 EUROBS 01087 61 Ovarian tumors
caused by metastatic tumors of the appendix; two case reports Poul Thorsen, Helle
Cited by 2Related articlesAll 7 versions

[CITATION] Eta krestomatio

…, P Thorsen – 1944 – Esperanto-Forlaget SEFO
Library Search

[PDF] from ugeskriftet.dkSKP Sandager, I Vogel, P Thorsen… – UGESKR LÆGER, 2003 – ugeskriftet.dk
Litteratur 1. Jørgensen FS. Organisation af obstetrisk ultralyd i Danmark 1990. Ugeskr Læger
1992;154:2898-905. 2. Jørgensen FS. Ultralydundersøgelse af gravide kvinder i Danmark
1989-1990. Ugeskr Læger 1993;155:1627-32. 3. Jørgensen FS. Organisation af
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[CITATION] Bliv gammel uden at ældes

P Thorsen – 1954 – Capser Nielsens Forlag
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[CITATION] Presse, penge og politik 1839-48: Den sidste enevoldskonges forhold til konservative pressekredse–især i København

P Jensen – 1971 – Københavns Universitets Fond til …
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[PDF] from aau.dkG Thorsen, B Knudsen, P Panduro… – 2000 – vbn.aau.dk
13lhNGM-2000, Helsinki Наг lers aktivitet indflydelse pá risikoen for udt0rringsskader? Grete
Thorsen Aalborg Universitet, Aalborg, Danmark B0rge Knudsen Geoteknisk Institut, Ârhus, Danmark
Poul Panduro Vejdirektoratet, Skanderborg, Danmark Sten Thorsen Thorsen Geoteknik,
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[CITATION] Kulturkommission 2000 testamente: tillæg til Skoven 9/05

…, K Raulund-Rasmussen, J Skov, BJ Thorsen… – Skoven, 2005 – unknown

[CITATION] Journalisten refererer objektivt og sandt Journalisten afslører aldrig sine kilder Journalisten inviterer begge parter i konflikten Journalisten tager …

P Videbech
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[CITATION] Thorkil Kristensen: en ener i dansk politik

PN Andersen – 1994 – Odense universitetsforlag
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[PDF] from utdallas.edu…, D Hougaard, A Børglum, P Thorsen… – Journal of Neural …, 2009 – Springer
as a candidate gene for autism Henriette Nørmølle Buttenschøn Æ Marlene Briciet Lauritsen
Æ Agata El Daoud Æ Mads Hollegaard Æ Meta Jorgensen Æ Kristine Tvedegaard Æ David
Hougaard Æ Anders Børglum Æ Poul Thorsen Æ Ole Mors
Cited by 2Related articlesAll 5 versions

…, TB Henriksen, LT Goldsmith, P Thorsen… – American journal of …, 2009 – Elsevier
We conducted a case-control study within a cohort of 1080 singleton pregnant women. In all,
38 women (3.5%) delivered spontaneously preterm (< 37 completed weeks of gestation). Relaxin
was measured in serum in gestational weeks 12 and 19, cervical length only in week 19.
Cited by 2Related articlesAll 8 versions

[PDF] from hindawi.comI Vogel, P Thorsen, B Jeune… – … in Obstetrics and …, 2006 – downloads.hindawi.com
1 NANEA, Department of Epidemiology, Institute for Public Health, University of Aarhus, 8000
Aarhus C, Denmark 2 Department of Clinical Genetics, Aarhus University hospital, 8000 Aarhus
C, Denmark 3 Institute of Public Health, University of Southern Denmark, 5000 Odense C,
Cited by 2Related articlesView as HTMLAll 11 versions

AE Curry, P Thorsen, C Drews… – Acta obstetricia et …, 2009 – Wiley Online Library
Objective. To examine associations between first-trimester plasma cytokines and spontaneous
preterm delivery (sPTD). Design. A case-control study was nested within the Danish National
Birth Cohort, a cohort of women with 101,042 pregnancies from 1997 to 2002 who were
Cited by 2Related articlesAll 8 versions

[CITATION] Comparison of biochemical profiles of vaginal fluid in BV-positive pregnant US versus european women

S Cauci, P Thorsen… – American Journal of Obstetrics and …, 2003 – Elsevier
Cited by 2Related articles

…, C Sværke, E Ernst, P Thorsen – … of Epidemiology and …, 2010 – jech.bmj.com
Contributors DH, PT and JG were responsible for conception and design. DH, JG and CS conducted
the statistical analyses and the interpretation of data. DH wrote the first draft of the
manuscript. All authors provided critical input at all stages and critically reviewed and
Cited by 2Related articlesAll 2 versions

[CITATION] Time trends in the reported childhood diagnoses of neuropsychiatric disorders: a Danish cohort study

…, S Dalsgaard, PH Thomsen, P Thorsen – Archives of Pediatrics & …, 2007 – unknown
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[HTML] from nih.gov…, A Das, BJ Stoll, RD Higgins, P Thorsen… – Pediatric …, 2010 – ncbi.nlm.nih.gov
Matrix metalloproteinases (MMP) and chemokines appear to be induced by hyperoxia in preclinical
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FDA Halts HPV Vaccine Roll-Out – SaneVax News Release

SaneVax, Inc. Logo

SaneVax Asks the FDA: Gardasil® What is Wrong With This Picture?

Medical consumers worldwide applaud the recent FDA decision not to expand the use of Gardasil to women over the age of 26. Now they want to know when the FDA will admit the original approval may have been a mistake.

FOR IMMEDIATE RELEASE

PRLog (Press Release)Apr 12, 2011 – Last week, the FDA refused to approve Merck’s application for expanded use of Gardasil® in women over the age of 26. According to a recent article in MedPage Today,

“The decision was based on a trial in 3,253 women ages 27 to 45. Although the vaccine appeared to prevent persistent HPV infection, no significant benefit was found for more important outcomes such as high-grade neoplastic lesions or cervical cancer when all participants were included irrespective of baseline HPV status.”

The SaneVax team respectfully suggests that if this is the case for women between the ages of 27 and 45, it may also be true for young women between the ages of 9 and 26 for whom Gardasil® was originally approved as a potential cervical cancer preventive. It may also be true for the male population for whom Gardasil® recently received expanded approval by the FDA as a potential preventive for anal cancer.

The efficacy analysis submitted by Merck to obtain FDA approval for the use of Gardasil® in the male population in November 2010 contains the following pivotal results [note-AIN2/3 are high-grade neoplastic lesions, AIN3 is higher than AIN2 – both are potentially precancerous]:

Table 2 – Efficiency against HPV 6/11/16/18-related AIN in the MSM FAS Population:

AIN2 or worse     18/275 (Gar); 39/276 (placebo)     Efficiency= 54% (95%CI; 18, 75)

AIN3             10/275 (Gar); 19/276 (placebo)     Efficiency= 46.8% (95%CI; -20, 80)

Table 4 – Efficiency against any HPV type-related AIN in MSM FAS Population:

AIN2+ 44/275 (Gar); 59/276 (placebo) Efficiency= 24% (95%CI, -14, 50)

Please note the ‘efficiency’ ratings when the CI (confidence interval) is taken into consideration. The levels range from a potential low of minus (-) 20% to a potential high of 80%. One has to wonder what the FDA was thinking when they approved a ‘vaccine’ with such a broad range of ‘efficacy’ potential, particularly when there was an indication that it may actually increase the possibility of developing potentially AIN3 pre-cancerous lesions.

Since Gardasil® is not recommended to be used in conjunction with HPV genotype monitoring, the data for HPV 6, 11, 16, 18-related AIN means nothing to average medical consumers, or their physician. Without adequate genotyping no one knows which sexually active man or woman may benefit from the vaccine, or which HPV genotype is causing the lesions developing after vaccination.

Merck also included results on efficacy in regard to AIN1. AIN1 lesions are totally reversible, therefore, pose no threat to anyone. They can be caused by numerous “non-carcinogenic” HPV genotypes.

According to Dr. Garner, lead clinical monitor in the Gardasil® AIN trials, speaking to VRBPAC members at the FDA review hearing,

” …unlike cervical cancers, not all anal cancers are associated with HPV.  So HPV cannot be said to be, quote/unquote, necessary and sufficient for the development of anal cancer.”

During the same meeting, Dr. Vicki DeBold, the consumer representative member of the VRBPAC expressed many concerns, one of which was,

“One of the reasons that I’m not comfortable is due to some of the data that’s on slide 23 that the FDA presented where we see much higher levels of immunogenicity in the younger age groups, and I can’t help but to wonder if some of this reactivity that we’re seeing here might also have a relationship to some of the safety issues that have been raised not only by the last public speaker but the enormous number of reports that are coming into not only the National Vaccine Information Center but VAERS.

I am not reassured by the safety data that have been presented, partly because they’re using a reactive placebo, an aluminum-based placebo, rather than something that is nonreactive.  I think that it makes it very difficult, if not totally impossible, to understand what is truly going on.”

The SaneVax Team wants to know:  How can the results of studies conducted on MSM (males who have sex with males) of specific ages be used to determine potential outcomes when using Gardasil® in other men, or women for the possible prevention of anal cancer.

There are substantial hormonal differences between pre-pubescent males and young adult males, as there are substantial differences between males and females. A one-size-fits-all ‘vaccine’ just does not make sense unless studied for safety and efficacy in all target populations.

According to the National Cancer Institute, “Vaccines are medicines that boost the immune system’s natural ability to protect the body against ‘foreign invaders,’ mainly infectious agents that may cause disease.”

HPV (human papillomavirus) is a foreign invader. Cancer cells are not. Cancer cells are host human cells that have mutated to allow uncontrolled growth, hence the tumors. Scientists are trying to make patient’s cancer cells to be recognized as foreign invaders by the host immune system to create therapeutic vaccines to treat cancers with little success. A preventive vaccine against cancer is incomprehensible.

HPV vaccines were never designed to attack the cancer cells; they were designed to produce a greater immune response to ‘foreign invasion’ by human papillomavirus. The hope is that by eliminating the virus, cancer rates will be reduced. No one will know whether this will actually happen for at least 15 to 20 years. However, based on the post-vaccination reports, many Gardasil-vaccinated women have continued to develop cervical cancer and precancerous lesions.

The SaneVax Team wants to know: Why is Gardasil® approved by the FDA as a cervical cancer preventive when there is no clinical evidence that reducing some self-reversing lesions is indeed associated with reduction of cervical cancer rates?

The SaneVax Team wants to know: Have any of the ingredients in this vaccine, which is being promoted as protection against various types of cancer thought to be caused by HPV, been approved for use under the Food, Drug and Cosmetic Act, the Public Health Service Act, or the Virus-Serum-Toxin Act?

The SaneVax Team and medical consumers around the world, once again request the FDA rescind their approval of Gardasil® until studies are conducted with appropriate endpoints.

The SaneVax Team and medical consumers around the world demand scientific proof that Gardasil® is safe, effective and necessary.

[Note from SaneVax:  Three members of the VRBPAC officially retired the day before the hearing to decide whether they would recommend extended use of Gardasil® for men and boys. These three members were Dr. Jack Stapleton, VRBPAC chairman, Dr. Jose Romero and Dr. Pablo Sanchez. Drs. Romero and Sanchez attended the Gardasil portion of the meeting, but since they were retired, one can presume they did not vote on the ultimate outcome. That left only six members of what was originally a twelve member committee in attendance. To make up for the shortage of voting personnel, the FDA appointed nine ‘temporary voting members.’ One of these nine, Dr. Theodore Tsai, was an industry representative – the second industry representative in attendance. According to the FDA charter for VRBPAC, industry representatives are not allowed to vote. Even so, at least one of the industry reps in attendance was listed as a voting member. There is apparently no public record of who voted and who did not.]

Sources:
1. Visit http://sanevax.org/news-blog/2011/04/sanevax-asks-the-fd … for complete article with links to all sources.

# # #

SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.

— end —     Visit Press Room

Contact Email :

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Issued By : Norma Erickson, President of SaneVax Inc.
City/Town : Troy
State/Province : Montana
Country : United States
Categories : Health, Consumer
Tags : gardasil, fda, merck, hpv vaccine, human papillomavirus, efficacy, safety
Last Updated : Apr 11, 2011
Shortcut : http://prlog.org/11430865

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Anti-Vaccine-Safety Junk Science – Criticised in English Parliament

Here is another example of the junk science government officials and others cite to claim vaccines are safe for children.

In a debate in 2003 in the English House of Lords about ADHD and autism, the infamous 2002 Pichichero paper which claimed mercury in children’s vaccines is safe was specifically referred to and was criticised as wholly inadequate “science”.

The Lancet medical journal published Pichichero paper claimed:

INTERPRETATION: Administration of vaccines containing thiomersal does not seem to raise blood concentrations of mercury above safe values in infants. Ethylmercury seems to be eliminated from blood rapidly via the stools after parenteral administration of thiomersal in vaccines.

“Mercury  Concentrations and Metabolism in Infants Receiving Vaccines Containing Thimerosal: A Descriptive Study” Pichichero ME, Cernichiari E, Lopreiato J, Treanor J The Lancet, November 30, 2002, Vol. 360:1737-1741

The department [of Health] ought to be aware that Dr Pichichero, who, in any case, is an immunologist not a toxicologist, sampled the blood of only 33 children—too small a sample to catch a statistically significant number of children who would be allergic or hypersensitive. Furthermore, the issue is not whether undischarged mercury would be present in the blood but whether it would be retained in the brain. Dr Pichichero failed to check that. He also failed to carry out faecal tests, which is how most mercury would be discharged.

The full English House of Lords debate can be read online in Hansard, the official source of proceedings in the English Parliament: Attention Deficit Disorders HL Deb 05 February 2003 vol 644 cc299-322 299

New Study Shows Mercury in Vaccines Causes Brain Damage

A new paper published online in the Journal of Neurochemical Research concludes that:

  • low doses of Thimerosal in vaccines are associated with neurotoxic effects;
  • no studies have been carried out on the combination of Thimerosal with aluminium adjuvants in such Thimerosal containing vaccines;
  • animal studies show mercury accumulates in the brain in the metallic [inorganic] form [ie mercury as Hg];
  • that the doses in vaccines are sufficient potentially to affect brain neuro development;
  • the doses in vaccines given to infants have been shown to be toxic in in vitro experiments on cultured human brain cells and in animals;
  • the continued use of Thimerosal in vaccines is counter-intuitive.
This new paper follows on from a recent paper published last year which concluded that:
exposure to thimerosal during early postnatal life produces lasting alterations in the densities of brain opioid receptors along with other neuropathological changes, which may disturb brain development.

M Olczak et al Neonatal Administration of Thimerosal Causes Persistent Changes in Mu Opioid Receptors in the Rat Brain. Mieszko Olczak

Abstracts of both papers appear below.

And do vaccines cause autistic conditions?  If you read nothing else we strongly recommend you read this: PDF Download – Text of May 5th 2008 email from US HRSA to Sharyl Attkisson of CBS News].  In it the US Health Resources Services Administration [HRSA] state to CBS News reporter Sharyl Attkisson

We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.

Despite all the lies and deceit by health official worldwide, the question “do vaccines cause autism” was answered after the Hannah  Poling story broke in the USA in February 2008 [see CHS article here].  Hannah developed an autistic condition after 9 vaccines administered the same day.  Under the media spotlight numerous US health officials and agencies conceded on broadcast US nationwide TV news from CBS and CNN. Full details with links to the original sources can be found in this CHS article: Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines. [Blue Text added 10 April 2011]

______________________________

Here is the abstract of the newly published paper:

Integrating Experimental (In Vitro and In Vivo) Neurotoxicity Studies of Low-dose Thimerosal Relevant to Vaccines José G. Dórea Published online 25 February 2011 – Journal of  Neurochemical Research DOI: 10.1007/s11064-011-0427-0Online First™.

There is a need to interpret neurotoxic studies to help deal with uncertainties surrounding pregnant mothers, newborns and young children who must receive repeated doses of Thimerosal-containing vaccines (TCVs). This review integrates information derived from emerging experimental studies (in vitro and in vivo) of low-dose Thimerosal (sodium ethyl mercury thiosalicylate). Major databases (PubMed and Web-of-science) were searched for in vitro and in vivo experimental studies that addressed the effects of low-dose Thimerosal (or ethylmercury) on neural tissues and animal behaviour. Information extracted from studies indicates that: (a) activity of low doses of Thimerosal against isolated human and animal brain cells was found in all studies and is consistent with Hg neurotoxicity; (b) the neurotoxic effect of ethylmercury has not been studied with co-occurring adjuvant-Al in TCVs; (c) animal studies have shown that exposure to Thimerosal-Hg can lead to accumulation of inorganic Hg in brain, and that (d) doses relevant to TCV exposure possess the potential to affect human neuro-development. Thimerosal at concentrations relevant for infants’ exposure (in vaccines) is toxic to cultured human-brain cells and to laboratory animals. The persisting use of TCV (in developing countries) is counterintuitive to global efforts to lower Hg exposure and to ban Hg in medical products; its continued use in TCV requires evaluation of a sufficiently nontoxic level of ethylmercury compatible with repeated exposure (co-occurring with adjuvant-Al) during early life.

____________________________________

Abstract of M Olczak et al Neonatal Administration of Thimerosal Causes Persistent Changes in Mu Opioid Receptors in the Rat Brain

Abstract Thimerosal added to some pediatric vaccines is suspected in pathogenesis of several neurodevelopmental disorders. Our previous study showed that thimerosal administered to suckling rats causes persistent, endogenous opioid-mediated hypoalgesia. Here we examined, using immunohistochemical staining technique, the density of l-opioid receptors (MORs) in the brains of rats, which in the second postnatal week received four i.m. injections of thimerosal at doses 12, 240, 1,440 or 3,000 lg Hg/kg. The periaqueductal gray, caudate putamen and hippocampus were examined. Thimerosal administration caused dosedependent statistically significant increase in MOR densities in the periaqueductal gray and caudate putamen, but decrease in the dentate gyrus, where it was accompanied by the presence of degenerating neurons and loss of synaptic vesicle marker (synaptophysin). These data document that exposure to thimerosal during early postnatal life produces lasting alterations in the densities of brain opioid receptors along with other neuropathological changes, which may disturb brain development.


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