All Studies Claiming No MMR Vaccine-Autism Link Invalid – According to Merck’s Vaccine Director, former US CDC Director & the US HRSA

A recent article in the Whiteout Press appears to have reignited the debate about vaccines causing autism and has now been reported  by Fox News in Austin Texas.  But what both appear to overlook is the direct evidence from leading US health agencies and health officials which discredits all the prior evidence they have used and which is still being used on the internet and in the media to claim there is no autism-MMR vaccine link.  [Full quotes and links below].

Fox News in Austin Texas reported yesterday on the Whiteout Press article: Article stirs autism and vaccine debate Aug 15, 2013 By Noelle Newton KTBC Fox 7 Austin Texas USA.  And here is the Whiteout Press article:  “Courts Quietly Confirm MMR Vaccine Causes Autism” 27th July 2013.

Here is the problem for health officials now.  The US Heath Resources Services Agency and vaccine maker Merck’s vaccine division Director Julie Gerberding when heading up the US Centers for Disease Control as its Director both separately confirmed on and to national broadcast US news channels back in 2008 that any vaccine can cause an autistic condition [full quotes and sources below]. 

That confirmation immediately made completely invalid and useless all the “tobacco-science” statistical studies health officials had used to claim there was no connection between a child developing autism from the MMR vaccine.

Because researchers claimed to find no difference they assumed no link.  But they found no link because all those studies were intentionally carried out on the basis that only the MMR vaccine was a cause of autism and not all vaccines.

So now all those previous studies compared kids with autism who had MMR vaccine against kids with autism who had other vaccines and got autism from the other vaccines.  If you go shopping and compare all the candy in one store with all the candy all other stores all you will find is that its all candy.  Some might be Hersheys and some not.  But it is still candy.  Autistic conditions are like candy just in the sense there are all kinds and flavors but in a spectrum.  Of course that is where the similarity ends because the spectrum of autistic conditions is from the most debilitating to the least.  There is nothing sweet or attractive about that.

And if you want evidence of this then watch the British rate of childhood autism diagnoses increase with each change in the vaccine schedule.  This is a chart from a peer reviewed paper by US authors and researchers which only looked at the MMR vaccine and not the other vaccines. 

You can see the MMR vaccination rate is stable throughout [see nearly horizontal black line near top of the chart] but the autism risk jumps up [see red line on the chart].  Here at CHS we have added the notes showing when the changes to the British vaccine schedule took place.  With each change the risk of an autism diagnosis for children increased substantially:

CLICK GRAPH – OPENS LARGER ONE IN NEW WINDOW

Aut_Inc_vs_vax_prog

The graph above is adapted from a 2001British Medical Journal paper by Jick et al: Mumps, measles, and rubella vaccine and the incidence of autism recorded by general practitioners: a time trend analysis” BMJ 2001; 322 : 460 – 463 24 February.

The admissions by the US CDC Director Julie Gerberding and those by the US HRSA were not given voluntarily.  They only confirmed the true position when put under pressure by the media in 2008 when the Hannah Poling story broke about the US Court compensating a little girl who became autistic after getting NINE vaccines ALL ON THE SAME DAY.

But everyone overlooks that and the same old junk studies are being quoted all over the media and internet as evidence there is no link when they are completely useless as evidence for that proposition.

And then some studies looked for higher autism rates in the MMR vaccinated-autism kids. That is like looking to see whether under the wrapper of one brand like Hershey’s there is chocolate candy and under the wrappers of other brands like M&M’s it is chocolate candy or something of a different flavor or sweeter or less sweet.

The authors of the study into the British autism increase even admit the graph [see above] shows there must be environmental factors other than the MMR involved in the increases claiming [emphasis added]:-

“... the data provide evidence that no correlation exists between the prevalence of MMR vaccination and the rapid increase in the risk of autism over time. The explanation for the marked increase in risk of the diagnosis of autism in the past decade remains uncertain. ….. The increase ….. could be due to …… environmental factors not yet identified.

The data show when correlated with major changes in the UK childhood vaccination programme the most likely “environmental factors not yet identified” are the vaccines.  With each major change to the UK’s childhood vaccination programme cases of childhood autism increased substantially.

This is how the risk of a diagnosis increased [this is just childhood autism diagnoses – Aspergers is not included – note that 70% of UK ASDs are Aspergers]:

  • it first increased by 3 times with the introduction of the MMR vaccine in October 1988 [from between 1 to 4 in 10,000 it increased to 12 in 10,000];

As anyone can see from this, the studies needed to be done are comparing the total health of vaccinated kids with never vaccinated kids.   But the US CDC will never do them because never vaccinated kids are much healthier so showing the vaccine programmes pursued by the US CDC for decades do more harm than good.  The argument used to claim the studies cannot be done is junk – they claim it is unethical to prove a vaccine is safe to use or dangerous so we cannot do the studies.  This is on the basis it is unethical not to vaccinate a few kids to make sure millions upon millions of kids will be safe.  It cannot be unethical if done with consent and where the comparatively few kids who are not vaccinated can still be vaccinated after the studies are over. Surely, if “herd immunity” worked those few would still be protected by it?

And of course it is unethical to give any drug of unproven safety to any child.

Here is what the US HRSA told CBS news reporter Sharyl Attkisson back in 2008 about children compensated for injuries caused by a vaccine – any vaccine – not simply the MMR vaccine:

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.Text of May 5th 2008 email from US HRSA to Sharyl Attkisson of CBS News]

So according to the HRSA vaccines cause encephalopathies [general brain injuries] which result in autism and/or seizures in children.

Here is what US CDC Director Julie Gerberding said on national US broadcast TV back in 2008:

Now, we all know that vaccines can occasionally cause fevers in kids. So if a child was immunized, got a fever, had other complications from the vaccines. And if you’re predisposed with the mitochondrial disorder, it can certainly set off some damage. Some of the symptoms can be symptoms that have characteristics of autism.

HOUSE CALL WITH DR. SANJAY GUPTA – Unraveling the Mystery of Autism; Talking With the CDC Director; Stories of Children with Autism; Aging with Autism – Aired March 29, 2008 – 08:30   ET

You can even watch Gerberding saying it to Dr Sanjay Gupta of CNN here on YouTube.  If you watch the video [below on this page] you will then realise Dr Julie Gerberding is personally knowingly responsible for the biggest longest running programme of child abuse in the history of the planet – knowingly causing autism in hundreds of thousands of US children using vaccines [currently around 1 in 50 US kids depending on State]- and when she was in a position to stop it dead.  She then left the CDC and continued where she left off to join vaccine maker Merck as its vaccines division Director.  The CDC was officially castigated by the US Senate in an official report CDC Off Centeras an agency which “cannot demonstrate it is controlling disease“  but which was managing to spend US$11 billion in US tax dollars every year not doing what even its name says it is supposed to – Center for Disease Control.

********** – **********

FOR THOSE WHO WANT TO READ IT HERE IS OUR PREVIOUS ARTICLE REPORTING THE FULL ISSUE

Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines

Posted on June 30, 2010 by ChildHealthSafety

A New Scientist article 29 June 2010 by Jim Giles states:-

We still do not know what causes autism.

Desperate measures: The lure of an autism cure

That is not correct. Here we set out four ways autistic conditions are caused and confirmed by statements from the current President of pharmaceutical giant Merck’s Vaccines Division, by US Government agencies, by the US Federal Court and in formally published academic journal papers.

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.” [Text added 10 April 2011]

The first known cause of autism was rubella virus. So not only is New Scientist an unreliable source of information, this cause of autism has been known since the 1960s. And rubella virus is one of the three live viruses in the MMR vaccine.

… rubella (congenital rubella syndrome) is one of the few proven causes of autism.“  Walter A. Orenstein, M.D. US as Assistant Surgeon General, Director National Immunization Program in a letter to the UK’s Chief Medical Officer 15 February 2002.

rubella virus is one of the few known causes of autism.” US Center for Disease Control.
“FAQs (frequently asked questions) about MMR Vaccine & Autism”  [ED 8/Apr/12: This is the web archive of the CDC page – you will need to search in or scroll down the page to see the text.  As papers cited on the original page by the CDC as evidence for no link with the vaccine have been steadily discredited it seems the CDC has decided to remove the page and it seems someone has been deleting the archived versions of the page from the web archive too].

rubella can cause autismThe Pediatrician’s Role in the Diagnosis and Management of Autistic Spectrum Disorder in Children – PEDIATRICS Vol. 107 No. 5 May 2001

Journal references:

Chess, S. Autism in children with congenital rubella. J Autism Child Schizophr. 1, 33-47 (1971).

Chess S. Follow-up report on autism in congenital rubella. J Autism Child Schizophr. 1977;7:69 –81

Ziring PR. Congenital rubella: the teenage years. Pediatr Ann. 1997;6: 762–770

People who are pre-disposed to have a mitochondrial dysfunction can develop autistic conditions following vaccination.  The current President of Merck’s Vaccines Division, Julie Gerberding confirmed to CBS News when she was Director of the US Centres for Disease Control that:

….. if you’re predisposed with the mitochondrial disorder, it can certainly set off some damage. Some of the symptoms can be symptoms that have characteristics of autism.

HOUSE CALL WITH DR. SANJAY GUPTA – Unraveling the Mystery of Autism; Talking With the CDC Director; Stories of Children with Autism; Aging with Autism – Aired March 29, 2008 – 08:30   ET

Mitochondrial dysfunction is claimed to be “rare” but is not.  It can apply to a minimum of 20% of cases.

And this was said when Gerberding was then head of the US Centres for Disease Control – budget US$11 billion.  It followed from  award winning author and journalist David Kirby breaking the story of the Hannah Poling case, secretly settled by the US Government.  It was after this story broke that it started to be acknowledged that autism has an “environmental” cause and is not solely an “internal” condition [ie not determined solely by genetics]: AUTISM – US Court Decisions and Other Recent Developments – It’s Not Just MMR

[Gerberding went from the US agency charged with promoting vaccines [CDC] directly to become vaccine maker Merck’s Director of Vaccines Division: Dr. Julie Gerberding Named President of Merck Vaccines21 Dec 2009 – Merck & Co., Inc.

Autistic conditions can result from encephalopathy following vaccination.  The US Health Resources and Services Administration (HRSA) confirmed to CBS News that of 1322 cases of vaccine injury compensation settled out of court by the US Government in secret settlements:-

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.[PDF Download – Text of email from US HRSA to Sharyl Attkisson of CBS News]

CBS News Exclusive: Leading Dr.: Vaccines-Autism Worth Study Former Head Of NIH Says Government Too Quick To Dismiss Possible Link – WASHINGTON, May 12, 2008

Vaccine Case: An Exception Or A Precedent? – First Family To Have Autism-Related Case “Conceded” Is Just One Of Thousands – CBS News By Sharyl Attkisson WASHINGTON, March 6, 2008

Measles and mumps are two of the three live viruses in the MMR vaccine. Exposure to live measles or mumps viruses can cause encephalitis:-

measles and mumps can cause significant disability, including encephalitis

The Pediatrician’s Role in the Diagnosis and Management of Autistic Spectrum Disorder in Children – PEDIATRICS Vol. 107 No. 5 May 2001

So there is direct evidence that live measles, mumps or rubella viruses separately can cause encephalitis leading to autism.

More troubling is that this has been known for a long time.  So the risks of giving very young children a vaccine containing three live viruses all at once were known. These two World Health Organisation papers published nearly 40 years ago set out the hazards:

Virus-associated immunopathology : animal models and implications for human disease”:

1. Effects of viruses on the immune system, immune-complex diseases, and antibody-mediated immunologic injury Bulletin of The World Health Organisation. 1972; 47(2): 257-264.

2. Cell-mediated immunity, autoimmune diseases, genetics, and implications for clinical research Bulletin of the World Health Organisation. 1972; 47(2): 265-274.

Autistic conditions can result from acute disseminated encephalomyelitis (ADEM) following MMR vaccination as held by the US Federal Court in the case of Bailey Banks.  In his conclusion, US Federal Court Special Master Abell ruled that Petitioners had proven that the MMR had directly caused a brain inflammation illness called acute disseminated encephalomyelitis (ADEM) which, in turn, had caused the autism spectrum disorder PDD-NOS in the child:

The Court found that Bailey’s ADEM was both caused-in-fact and proximately caused by his vaccination. It is well-understood that the vaccination at issue can cause ADEM, and the Court found, based upon a full reading and hearing of the pertinent facts in this case, that it did actually cause the ADEM. Furthermore, Bailey’s ADEM was severe enough to cause lasting, residual damage, and retarded his developmental progress, which fits under the generalized heading of Pervasive Developmental Delay, or PDD [an autism spectrum disorder]. The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine, and that this chain of causation was… a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay.

[Banks v. HHS (Case 02-0738V, 2007 U.S. Claims LEXIS 254, July 20, 2007)].

And what does not cause autism?

Autism is not “caused” by “genes”

Dr Francis S. Collins, M.D., Ph.D. the 16th and current Director of the US$30.5 billion budget National Institutes of Health [nominated by President Obama: NIH News Release 17th August 2009 ] stated in evidence to US House of Representatives Committee May 2006 when Director of the US National Human Genome Research Institute:

Recent increases in chronic diseases like diabetes, childhood asthma, obesity or autism cannot be due to major shifts in the human gene pool as those changes take much more time to occur. They must be due to changes in the environment, including diet and physical activity, which may produce disease in genetically predisposed persons.

Francis S. Collins, M.D., Ph.D. evidence to US House of Representatives Committee May 2006

Collins controls the US $30.5 billion annual medical research budget and is a leading medical doctor and geneticist who led the Human Genome Project.

Autistic conditions affect 1 in 100 US children.  They affect 1 in 64 British children [1 in 40 are boys] according to a Cambridge University study.

ESTIMATING AUTISM SPECTRUM PREVALENCE IN THE POPULATION: A SCHOOL BASED STUDY FROM THE UK

Conclusions: The prevalence estimate of known cases of ASC, using different methods of ascertainment converges around 1%. The ratio of known to unknown cases means that for every three known cases there are another two unknown cases. This has implications for planning diagnostic, social and health services.”

American parents awarded £600000 in compensation after their son developed autism as a result of MMR vaccine

The UK’s Daily Mail newspaper has reported on a recent US Federal Court decision:

American parents awarded £600,000 in compensation after their son developed autism as a result of MMR vaccine

By David Gardner, Daily Mail [UK] 15 January 2013

  • Saeid and Parivash Mojabi claimed their son suffered a ‘severe brain injury’
  • The Californian couple said that son Ryan was diagnosed with Autism Spectrum Disorder

CHS has reported on this breaking news here:

US Court Awards Multi-Million Dollar Payouts To Two More US Children With Vaccine Caused Autism

The story has been covered in The Huffington Post here by David Kirby, the journalist who broke the Hannah Poling story in 2008:

Vaccine Court Awards Millions to Two Children With Autism David Kirby Huffington Post 14th January 2013.

MMR Vaccine Causes Autism – IV – Now Reported in English National Press

Now reported in the English national press. Read it here and pass it on. This is a major news story.

MMR: A mother’s victory. The vast majority of doctors say there is no link between the triple jab and autism, but could an Italian court case reignite this controversial debate?

By Sue Reid – Daily Mail PUBLISHED: 23:03, 15 June 2012 | UPDATED: 23:11, 15 June 2012

  • Landmark ruling in an Italian court has said Valentino Bocca’s autism was provoked by the MMR jab he had at aged nine months
  • His parents have already been awarded £140,000 and could be paid an additional £800,000 in their case against the Italian government
  • The case could set a precedent for many similar civil proceedings

At nine months old, Valentino Bocca was as bright as a button. In a favourite family photo, taken by his father, the baby boy wriggles in his mother’s arms and laughs for the camera.

Read on for more:

MMR: A mother’s victory. The vast majority of doctors say there is no link between the triple jab and autism, but could an Italian court case reignite this controversial debate?

Shocking New US Official Autism Figures – Kids With Autistic Conditions At Record High 1 in 88, 1 in 54 Boys

The new figures in the US Centers for Disease Control report, released on March 29 and published in last week’s Morbidity and Mortality Weekly Report (MMWR), states that more than 1 percent, or 1 in every 88 US children, is diagnosed with autism today, including 1 in 54 boys. This is a 78 percent increase in 6 years (2002-2008) and a 10-fold (1000 percent) increase in reported prevalence over the last 40 years. The report uses the same methodology that produced the CDC’s 2009 prevalence findings of 1 in 110 children with autism.

And despite a US$11.5 Bn annual budget the CDC still has no answers except that it has nothing to do with the vast number of vaccines they are responsible for pumping into US children every year

But if you want confirmation from US government officials that vaccines can cause autistic conditions you just have to read the quotes from them here made on US broadcast TV news back in 2008 when they were caught flatfooted with the breaking of the Hannah Poling story [Hannah got a secret settlement of US$20 for her autistic condition caused by 9 vaccines in one day – as conceded by Uncle Sam’s health officials and medical expert advisors]:

Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines

New Treatment For Autistic Children – Initial Results May Be Encouraging

CHS is republishing the following information because results of work by Dr Bradstreet with autistic children are more likely than not to be genuine.  As with all new suggested treatments, it is clearly appropriate to take a prudent approach and readers should similarly take a prudent approach to what is being suggested.  “Nagalese” it seems is an enzyme which can have an effect of suppressing the proper functioning of the human immune system.

A recent discovery by Dr Bradstreet in his autism clinic in America is that autistic children often have an elevated Nagalase level and this in turn his may indicate a viral cause behind the symptoms of autism.

Following on from this discovery in 2011, Dr Bradstreet looked to find a treatment that would reduce the Nagalase count and found GcMAF (Gc Macrophage Activating Factor). Results so far are that 85% of the children who received GcMAF responding positively.

We have now evaluated approximately 400 children with autism for the viral marker, Nagalase. From my perspective this is one of the most important developments in the clinical treatment of children on the spectrum that I have experienced in the last 15 years. The short story is nearly 80% of the children with autism evaluated have significantly elevated levels of Nagalase.” – Dr Bradstreet October 2011

Whilst parental anecdotes cannot take the place of a well implemented clinical trial, the very positive comments are cause for us to investigate this further. Amongst the many positive comments received and posted on Dr Bradstreet’s blog are:

After 24 weeks of the GCMAF, we are happy to report that she continues to have immense gains in all areas. She has shown an increased tolerance, socialization and speech with adults and same age peers, continued remarkable performance in Academics (she is at the first grade reading level (She’s in kindergarten), she knows the sight words, writes her name,etc……. We are so excited to see her blossom! ” – S.J. November 2011

and:

During the course of the GCMAF treatment we’ve seen improvements and this is a phenomenal. Her Language development went from repeating one word such as “iPad” over and over again, meaning she wanted to play with it, to “When I get home, I want to play with the iPad.”… Needless to say, we are feeling very blessed and we are so excited to see what more amazing things are in store towards her recovery in 2012! Thank you so much for all that you’ve done and continue to do! ” – M and R January 2012

However, there have been some reports of minimal side effects of flu-like symptons for a few hours. This is likely to be as a result of the immune system getting to work on undiagnosed viruses, as these are likely to have been the cause of the elevated Nagalase levels.

References:

http://www.DrBradstreet.org

http://www.Gc-MAF.de

http://www.GcMAF.eu

US National Public Radio – “Worries About Autism Link Still Hang Over Vaccines”

According to the latest NPR-Thomson Reuters Health Poll conducted for US National Public Radio 46% of Americans polled were concerned about a fear of side effects of vaccines and 47% of respondents had concerns about uncertainty about long-term health effects.  Autism remains a top worry, with 21 percent of respondents saying they believe autism is linked to vaccines. About 7 percent believe in a link between vaccines and diabetes.

Among households with children under 18, 30 percent were concerned about the safety or value of vaccines.

Read more here:

Worries About Autism Link Still Hang Over Vaccines – by Scott Hensley – US National Public Radio – September 29, 2011

Schoolgirls Are Given Toxic HPV Vaccine – Gardasil – Serious Adverse Reactions

Why are so many schoolgirls suffering serious health problems after they get Gardasil the HPV [human pappillomavirus vaccine] with some dying? It looks like international safety organisation SaneVax has found one of the reasons.  Contamination with an internationally known and recognised biohazard – toxic genetically modified recombinant DNA – it is recognised this can cause mutation and worse. 

For details read the report reposted below from Natural News Thursday, September 15, 2011 by Mike Adams, the Health Ranger Editor of NaturalNews.com

Why do the US Food and Drug Administration and the UK Medicines Healthcare and Products Regulatory Agency authorise these dangerous vaccines and then hide the adverse reactions which then occur?  When are their officials going to be sent to jail?  When are drug company Board Directors going to be sent to jail?  You cannot get the real news in the press or on TV.  You cannot trust them to do their job or tell you the facts.  But there are independent sources on the web which will tell you.

The following CHS reports also provide further background reading in addition to Mike Adams’ report in full below on the SaneVax laboratory test results of Gardasil revealing the presence of known biohazard recombinant DNA:

Gardasil Victims – In Memoriam – Healthy Young Women – Aged 15 to 21

Gardasil – HPV Vaccine – The Injured Continue To Pile Up

FDA Halts HPV Vaccine Roll-Out – SaneVax News Release

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

HPV Vaccine Questioned Internationally

_________________________________

[Source SaneVax/NaturalNews.com]

In seeking answers to why adolescent girls are suffering devastating health damage after being injected with HPV vaccines, SANE Vax, Inc decided to have vials of Gardasil tested in a laboratory. There, they found over a dozen Gardasil vaccine vials to be contaminated with rDNA of the Human Papillomavirus (HPV). The vials were purchased in the United States, Australia, New Zealand, Spain, Poland and France, indicating Gardasil contamination is a global phenomenon.

This means that adolescents who are injected with these vials are being contaminated with a biohazard — the rDNA of HPV. In conducting the tests, Dr. Sin Hang Lee found rDNA from both HPV-11 and HPV-18, which were described as “firmly attached to the aluminum adjuvant.”

That aluminum is also found in vaccines should be frightening all by itself, given that aluminum should never be injected into the human body (it’s toxic when ingested, and it specifically damages the nervous system). With the added discovery that the aluminum adjuvant also carries rDNA fragments of two different strains of Human Papillomavirus, this now reaches the level of a dangerous biohazard — something more like a biological weapon rather than anything resembling medicine.

As SANE Vax explains in its announcement, these tests were conducted after an adolescent girl experienced “acute onset Juvenile Rheumatoid Arthritis within 24 hours” of being injected with an HPV vaccine. (http://sanevax.org/sane-vax-inc-dis…)

rDNA found in Gardasil is genetically engineered

The rDNA that was found to be contaminating Gardasil is not “natural” rDNA from the HPV virus itself. Rather, it is a genetically engineered form of HPV genetic code that is added to the vaccines during their manufacture.

As Dr. Lee, the pathologist who ran the laboratory tests identifying the biohazard contamination of Gardasil said:

“Natural HPV DNA does not remain in the bloodstream for very long. However, the HPV DNA in Gardasil is not ‘natural’ DNA. It is a recombinant HPV DNA (rDNA) — genetically engineered — to be inserted into yeast cells for VLP (virus-like-particle) protein production. rDNA is known to behave differently from natural DNA. It may enter a human cell, especially in an inflammatory lesion caused by the effects of the aluminum adjuvant, via poorly understood mechanisms. Once a segment of recombinant DNA is inserted into a human cell, the consequences are hard to predict. It may be in the cell temporarily or stay there forever, with or without causing a mutation. Now the host cell contains human DNA as well as genetically engineered viral DNA.”

Innocent girls being injected with genetically engineered HPV rDNA

What all this means is that through Gardasil vaccines, innocent young girls are being injected with the recombinant DNA of HPV, and that this biohazardous substance persists in their blood. The implications of this are rather scary, as Dr. Lee explains:

“Once a segment of recombinant DNA is inserted into a human cell, the consequences are hard to predict. It may be in the cell temporarily or stay there forever, with or without causing a mutation. Now the host cell contains human DNA as well as genetically engineered viral DNA.”

The vaccine industry, of course, has a long and dark history of its vaccines being contaminated with cancer-causing viruses and other frightening contaminants.

SaneVax source documents:-

1.     SANE Vax Inc. Letter to FDA Requesting Investigation into Gardasil Contamination

2.    Policy on the use of Bio-hazardous Agents and Recombinant DNA in Research and Teaching Laboratories at the University of North Carolina at Greensboro

3.     Gardasil Patient Product Insert 

4.     EMEA Scientific Discussion on Gardasil    

5.     VAERS Data

Watch this astounding video of Merck scientist Dr. Hilleman openly admitting that polio vaccines were widely contaminated with SV40 viruses that cause cancer:

http://naturalnews.tv/v.asp?v=13EAA…

It’s called “Merck vaccine scientist admits presence of SV40 and AIDS in vaccines – Dr. Maurice Hilleman” and was partially narrated by Dr. Len Horowitz. You can view the full transcript of this extraordinary interview at:
http://www.naturalnews.com/033584_D…

If you thought vaccines were safe, think again. Get informed. Learn the truth, and please share this story so that others may also be informed.

Listen up, folks: Why do you think the vaccine industry pushed so hard for total financial immunity under the government’s vaccine injury compensation plan? Because they knew that if the truth ever got out about how many cases of cancer, autism and even death were truly caused by vaccines, they would be financially wiped out!

The Scandal of Vaccines and Drug Industry Profits.

No big article – just these thoughts:

But for vaccines, which can harm, 21st Century treatments would exist now saving millions of third world kids.  75%  still die – despite vaccines being claimed to be effective – which for the third world 75% clearly are not.

This is the kind of unnoticed damage the drug industry is doing to healthcare today.

Unvaccinated Kids Healthier Study – Apoplectic Dr David Gorski Excels Again

It is too priceless an opportunity to let it pass. The obsessive blogger Dr David Gorski [aka ORAC] has gone into apoplectic overdrive [again] over the CHS article here:  New Survey Shows Unvaccinated Children Vastly Healthier – Far Lower Rates of Chronic Conditions and Autism

It is not every day we can rip into the science free zone of Orac’s brain [aka pharma’s very own Homer Simpson of the blogosphere, Dr David Gorski – David Gorski’s Financial Pharma Ties: What He Didn’t Tell You].  But aside from the difficulty locating it, [his brain, if there is one] that is only because we don’t usually have the time – no other reason.

In Gorski’s latest rant Gorski’s apoplexy [standard issue for him] is in evidence. So not a reliable source to start with but it gets worse. Wot a nutter.  Apologies to our usual readers for the lower than usual standards.  These have been suspended for this post to write it in Gorskieese, Gorski’s style of scribble-drivel.

His near 2500 words we can encapsulate in a few quotes.

First the abusive rhetoric and derision which is the main basis for all his arguments [ie. bullying – so he obviously has a personal issue over self-esteem].

a study that’s just so mind-numbingly, brain-meltingly awful”

“the sheer intensity of its burning stupid”

“a starving cheetah ripping into its prey look downright restrained”

“anti-vaccine loons” “anti-vaxers”

“… they’ve been clamoring for what they like to call a “vaxed-unvaxed study.”

“Now they’re at it again”

“anti-vaccine propaganda”

“now this “study” will no doubt join the Generation Rescue “study” in the annals of crap vaccine/autism science, to circulate around Whale.to (where it belongs) and be dredged up as “evidence” periodically.”

Then we get the “scientific” criticisms [Ha] buried in Gorskidrivel:-

the whole survey was so ridiculously badly designed that you really couldn’t tell anything from it at all”

“an anonymous Internet survey that anyone can fill out? Let’s … have an actual control group, namely vaccinated children.”

“Generation Rescue did a crappy and arbitrary job of it”

“a poorly designed phone survey”

“entirely unvaccinated children.”

“Less than 10% said they preferred conventional medicine.”

“the parents who filled it out were a self-selected, biased sample, the vast majority of whom favor alternative medicine”

“99.69% of the respondents report being happy that they did not vaccinate their children”

So wee Davy Gorski, if you don’t like it, its about time we had a well funded independent objective and impartial study done. Stop complaining when independents take a crack at it. Its their taxes which are being spent wasted on the vast amount of useless medical research [genetics is a prime candidate along with cancer and psychiatry – the latter being the least successful branch of medicine in history].

And don’t fob the public off with the usual unscientic junk studies put out in drug industry funded medical journals to claim everything apart from Gorski’s brand of medicine is valid – people are voting with their feet – GorskiCare kills people and injures them in droves in the USA with adverse drug reactions and botched procedures

Then Gorski spews out in a rant the usual complete tosh to justify the nonsensical claim that:

…. such a study is neither feasible nor ethical”

But this is the real hoot. These children might really have asthma but because they don’t have any symptoms their parents don’t know. Ha ha ha ha ha ha …..:-

a lot of these children could have subclinical or mildly clinical disease that goes undiagnosed because they never take their children to a real doctor”

“One of the most common presentations of asthma is cough alone” …. “milder cases of asthma can be difficult to diagnose in children”.

“what the parents report probably doesn’t tell us much. Neither does the claim that far fewer of these children had allergies.”

What the Mighty Officials of GorskiCare did not tell you is that asthma and allergy have increased so dramatically in the 25 or so years since the late 1980s drive for vaccination that his profession in the UK were instructed just a handful of years ago to go out and look for as many cases as possible. The Mighty Officials then wanted to use the increased statistics to claim the science shows it was all greater awareness and better diagnosis. LOL.

And then Gorski reveals he has had an analytical skills total bypass from birth and his math education was wasted. He says:

Apparently, basic math isn’t a homeopath’s strong suit ….. if 20% of autistic children equals four, then there could only be 20 autistic children, but the survey suggests that there were twice that many in unvaccinated children.”

Really David? Let’s see what he bases this on and show that Gorski’s math is sadly a long way from his strong point [if he has one].

The numbers cited are entirely in keeping with the text:

  • there were 44 children reported as having an autistic condition
  • over 80% of parents reported the autistic conditions in children were mild and of the Asperger type.
  • only 4 were reported as having severe autism

What does that tell us?

  • Over 80% means 35 of the 44, leaving 9 or less cases.
  • 4 of the 9 were reported as having severe autism.
  • That leaves 5 cases where 1) either the parents did not say what kind of autistic condition their child had or 2)there were less than 5 cases of severe autism in those 5 or both.
  • Let’s say it was 5 cases and the parents did not say. At over 80% the probability is of those 5 cases 4 were mild, leaving 1 which might be the more severe autism.

So Gorski, 4 cases of severe autism or even 4 +1 is not 20% but that is still consistent with “over 80%” of parents reporting mild autistic conditions.  We hope that is not too hard for you to understand.

And here is another hoot:

a prevalence of 0.57%, even if this survey were accurate, would be within the range of estimated prevalences found in various studies.”

0.57% is 1 in 175. But wait a mo’. In the USA the figure is nearly twice that at 1 in 100. In the UK the figure is three times that at 1 in 64.

And in the UK 30% of autistic conditions are the more severe autism – in the US we understand the number is higher.

Yet for the unvaccinated this survey suggests the number [4 cases or less than 10%] is 300% lower or 1 in 2000 cases which is close to the pre vaccine era of 4 in 10,000. And the affected children had higher exposure to mercury or heavy metals.

And David, these figures reflect the kinds of differences seen in the Generation Rescue telephone survey you decry don’t they [see end for details]?

And this GorskiDrivel is a hoot too:-

autism prevalence is so obviously not appreciably different in the unvaccinated in this survey compared to reported prevalence numbers”

When Gorski in the same passage notes that:-

depending on the age range it ranges from 0.37% to a whopping 2.36%, ….. 3,075 were for children under two years old, … autism might very well have not been diagnosed … the reported prevalence was 0.37%, while in the 11-12 year range the prevalence was highest, at 2.36%.”

But at the same time ignores that in the 15-16 year age group the figure is 0.62%.

But that does not stop the science free zone between Gorski’s ears from concluding so stupidly it burns:

The prevalence of autism in unvaccinated children in this survey does closely match reported numbers for overall population prevalence in populations where the vast majority of children are vaccinated.”

This result is an unmitigated disaster for Bachmair and his groupies …

But hang on Gorski old boy, didn’t you just say a mere few million drivel points earlier hidden in abuse and rhetoric that:

the whole survey was so ridiculously badly designed that you really couldn’t tell anything from it at all”

We told you he is a nutter. That demonstrates it – the stupid it burns.

And what is Gorski and his band of amateur night pseudo-scientists going to do. Yep you guessed it they are going to sabotage this genuine effort to get data that everyone has been clamouring for for years.

How do we know? GorskiCare’s postscript to his blog:-

NOTE: I notice that the total number of children is increasing. It’s now up to 7,799 at this moment, suggesting that 30 people have filled it out since last night. Given that Child Health Safety lists it as 7,724 five days ago that suggests that the surveys still open and is automatically updating totals.”

Here are the results of the Generation Rescue Survey mentioned above:-

Cal-Oregon Vaccinated vs. Unvaccinated Survey

All vaccinated boys, compared to unvaccinated boys:

  • – Vaccinated boys were 155% more likely to have a neurological disorder (RR 2.55)
  • – Vaccinated boys were 224% more likely to have ADHD (RR 3.24)
  • – Vaccinated boys were 61% more likely to have autism (RR 1.61)

Older vaccinated boys, ages 11-17 (about half the boys surveyed), compared to older unvaccinated boys:

  • – Vaccinated boys were 158% more likely to have a neurological disorder (RR 2.58)
  • – Vaccinated boys were 317% more likely to have ADHD (RR 4.17)
  • – Vaccinated boys were 112% more likely to have autism (RR 2.12)

(Note: older children may be a more reliable indicator because many children are not diagnosed until they are 6-8 years old, and we captured data beginning at age 4.)

All vaccinated boys, removing one county with unusual results (Multnomah, OR), compared to unvaccinated boys:

  • – Vaccinated boys were 185% more likely to have a neurological disorder (RR 2.85)
  • – Vaccinated boys were 279% more likely to have ADHD (RR 3.79)
  • – Vaccinated boys were 146% more likely to have autism (RR 2.46)

All vaccinated boys and girls, compared to unvaccinated boys and girls:

  • – Vaccinated boys and girls were 120% more likely to have asthma (RR 2.20)
  • – No correlation established for juvenile diabetes

All vaccinated girls, compared to unvaccinated girls:

  • – No meaningful differences in prevalence were noted for NDs (which may be due to the smaller sample size of the study because girls represent about 20% of cases.)

Autism Figures – Existing Studies Show Shocking Real Increase Since 1988

In case you come up against the argument that the increase in autistic cases is only because the diagnostic criteria were broadened in the early 1990’s [in DSM IV] here is information published in the Journal of the Israeli Medical Association which you can use to show a benchmark was established for the position pre 1989 using the very same modern criteria claimed by some diehards to be solely responsible for  the increase: Time Trends In Autism IMAJ Nov 2010:12,711. 

The particularly shocking aspect is that the Paternal Age paper cited below shows that conditions like Asperger’s syndrome practically did not exist pre 1989 such that predominantly all the cases were of autism.  It has pretty much sprung from nowhere to be the front runner.

QUICK SUMMARY:

Baird UK – 1 in 86CHILDREN [figures for 2006 – children born two year period 1995-6]

Baron Cohen UK – 1 in 64CHILDREN when yet to be diagnosed are accounted for [figures for schoolchildren 2005]

Reichenberg, Israel – 1 in 1190CHILDREN with childhood autism and next to no Asperger cases [figures in 2005 – for 17 year old conscripts for Israeli military all born in 6 year period ending 1988].

Brugha UK – 1 in 100ADULTS [figures collected in 2007]

[The latter is not a particularly inspiring piece of work.  Brugha did not find a single adult with childhood autism, nor did he refer to Baird or Baron Cohen but baldly claimed for comparison a childhood figure of 1 in 100, and he changed the standard diagnostic criteria to catch adults who would not normally have a diagnosis.  Of the 14,000 potential participants there was a 50% drop out rate with 7000 responding to the original telephone survey.  The survey looked for adults with one of four mental illnesses.  The only autistic condition was Asperger syndrome but Brugha et al now claim to be able to give a global figure for all autistic conditions which is of course impossible.  Whilst having research ethics approval the study was not carried out according to accepted ethical standards.  Informed consent was not obtained.  Participants were misled as to the purpose of the survey.  They were not told they were being assessed to ascertain if they were mentally ill.  A financial inducement to take part of a shopping voucher was offered – aside from ethical issues that would tend to encourage those of lower incomes to participate and invalidate the study.  Mentally ill people are more likely to be of lower income if their ability to earn a living is impaired.]

_________________________

And of course one must not forget the information found in this CHS post Vaccination Causes Autism – Say US Government & Merck’s Director of Vaccines Posted on June 30, 2010. 

And especially not this information in 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.

Nor should the information in this CHS post be overlooked: Autism Increase Environmental Not Genetic – Says New Director of USA’s $30.5 Billion Health Research Budget

People who use the argument that there is no real increase in autism start out usually by using incorrect terminology.  They speak of “higher functioning autism” like Asperger syndrome.  It is a common mistake [or done deliberately].

“Autism” refers to what is known variously as “typical”, “Kanner”, “childhood” “classic” or “infantile” autism and that is the benchmark. Not the “higher functioning” kind others try to lump in with it like Asperger’s Syndrome. Autism makes up around 30% of UK autistic spectrum cases and Aspergers around 70%.

So if you stick to autism the paper Reichenberg et al “Advancing Paternal Age and Autism” Arch Gen Psychiatry. 2006;63:1026-1032 helpfully demonstrates this.  It shows real increases in autism by establishing a benchmark for comparing mid 1980’s autism prevalence with mid 1990’s. This was done using contemporary diagnostic criteria under DSM IV. So that helpfully eliminates the argument that modern criteria are wider and so the increase is not simply a matter of definition but real.

The Paternal Age study’s PDD prevalence is 8.4:10,000 in 132,000 Israeli citizens born during six years ending no later than 1988. The authors say most of the diagnoses are autism.  “PDD”or “Pervasive Developmental Disorder” under DSM IV is another term for Autistic Spectrum Disorder under the International Classification of Disease [ICD].

And we can compare that prevalence to papers like Baird 2006 [Baird G, Simonoff E, Pickles A, Chandler S, Loucas T, Meldrum D, Charman T. Prevalence of disorders of the autism spectrum in a population cohort of children in South Thames: the Special Needs and Autism Project (SNAP). Lancet. 2006:15;368:210-215.]

Baird 2006’s range of figures concern 56,946 UK children aged 9-10 years born in a two year period ending no later than 1996 and for autism provides two estimates:-

  • – 24.8:10,000 (17.6-32.0) for narrow definition autism
  • – 38.9:10,000 (95% CI 29.9-47.8) for autism

Baird 2006 provides estimates of a 116.1:10,000 (90.4-141.8) for the total PDD figure [autism, Aspergers etc] and 77.2:10,000 (52.1-102.3) excluding autism.

Baird 2006’s narrow definition figure is the most conservative. It meets autism criteria under DSM IV/ICD10, but also on both ADI and ADOS plus clinical judgement.

These two papers in combination assist to establish a conservative minimum 300% increase in 8 years 1988 to 1996 on Baird 2006’s narrow definition and 450% for autism. For all PDDs, these papers suggest a 1200% increase. Baird 2006 provides estimates of a 116.1:10,000 (90.4-141.8) total PDD figure and 77.2:10,000 (52.1-102.3) excluding autism against the Paternal Age paper’s figures.

Also the Reichenberg paper demonstrates how modern medical professionals go to peripheral issues thereby burying the bigger issue.  The authors focussed on just 3% of fathers in their study [diverting from the more interesting finding noted above] to claim on somewhat shaky data that fathers over 40 are more likely to father an autisitic child. The confidence interval was wide [95% confidence interval, 2.65-12.46]

The problem for them is that these numbers cannot account for the scale of the increase in children born after 1988 which is what papers like Baird 2006 deal with. And it also cannot account for the Cambridge University study that found a rate of 1:64 for all autistic spectrum cases [157 per 10 000] when yet to be undiagnosed cases were included.  This means 1 in 40 boys as 4 in 5 ASC cases are boys.  Baron-Cohen S et al Prevalence of autism-spectrum conditions: UK school-based population study. Br J Psychiatry. 2009 Jun;194(6):500-9.

UK Guardian Newspaper Caught Falsifying the Historical Record of Vaccine-Caused-Autism

In a first for journalism, the UK’s Guardian national daily newspaper has been caught falsifying their own newspaper’s public record in a bid to airbrush the facts about vaccine-caused-autism.  Whilst some other media outlets have adopted the approach of ignoring the evidence and writing and broadcasting one-sided reports, this time The Guardian newspaper has been caught changing it.  The Guardian removed the evidence – gone without a trace – from their online newspaper.

Like many other papers, The Guardian allows readers to post comments on articles published in their online version.  On Saturday 6 August 2011 the paper published a commentary by Tracy McVeigh “Research linking autism to internet use is criticised“.  This was about a public row over claims by Lady Susan Greenfield that there is a link between the increase in autism and the increase in the use of the internet.  Greenfield is a medical academic and researcher on brain physiology, particularly on Parkinson’s and Alzheimer’s diseases.

Inevitably this attracted debate between commenters about the causes of autistic conditions.

The surprising part is what The Guardian did in response to postings of clear evidence of an admitted link between vaccines and autistic conditions.  They obliterated the posts as if they had never been made on their newspaper’s site.  There is no trace of the posts to be found.  They are just gone, barring a trace for one of them only – the first to be removed.  There was no justification for this and none has so far been provided despite having been requested.  The posts met the “Community Standards” whereas in contrast offensive comments from anti-vaccine safety campaigners are not removed.

The importance of this of course is that it underlines the points that:-

  • news media are intentionally covering up the public disaster where 1 in 64 British children [1 in 40 being British boys] have an autistic condition and 1 in 100 US children do also;
  • when they should instead report such a terrible thing fairly and campaign to do something about stopping this happening;
  • the evidence presented is so strong that a UK national newspaper cannot answer it and airbrushes it from its online pages.

What happened was that in response to numerous comments claiming vaccines are not implicated in causing autistic conditions CHS intervened.  CHS posted publicly made quotes and links to evidence confirming numerous US government agencies and officials have confirmed vaccines do cause autistic conditions.  These include:

  • Merck’s current Director of Vaccines Julie Gerberding when she was Director of the US Centers for Disease Control;
  • the US Health Resources Services Administration;
  • the US Federal Court;
  • the US Secretary of State for Health and Human Services.

The evidence and posts appear below in full.  These include posts noting the financial ties between the Guardian newspaper and medical publishers with undeclared substantial conflicting financial and business interests in the pharmaceutical industry.

In all four posts were removed.  Three without trace and one was removed with the incorrect claim left in its place that “This comment was removed by a moderator because it didn’t abide by our community standards.

If you want to make a difference then do something and write to the Guardian “Readers’ Editor” Nigel Willmott (nigel.willmott@guardian.co.uk) and ask him to tell you what The Guardian and its Board have to say about this and what they think their journalists should do if they caught another newspaper or broadcaster rewriting and publishing an adulterated history or engaging in misconduct.

______________________________________

THE FIRST POST REMOVED WITHOUT TRACE

ChildHealthSafety

8 August 2011 7:46AM

Here is a public opportunity to see The Guardian’s censorship of facts and evidence in action. The following facts are publicly documented yet The Guardian’s Comment is Free [LOL] censors removed it in its entiretly to airbrush the unpalatable facts from their agenda journalism. There was and could be no contravention of any Guardian “Community Standards” [well not official ones that is – only the ones that say the Guardian only publishes facts which fit its political agenda journalism and removes all others.

Tracey McVeigh’s article on Lady Susan Greenfield’s public unscientific comments about the causes of autistic conditions has provoked comment about the causes of autistic conditions.

In response to various comments we posted quotes from numerous US government officials and agencies with links to original sources on what causes autistic conditions. The Guardian censors removed the posting. There is no conspiracy theory here – only documented fact – and The Guardian does this kind of thing repeatedly.

This posting was made 7 August 2011 11:14AM and you can check out above that it was removed.

Floost 7 August 2011 9:49AM

I think arec pretty much nailed it ….. given ageofautism’s dangerous views on vaccination, I think you got off lightly.

So how about the views of 1) Merck’s current Director of Vaccines Julie Gerberding when she was Director of the US Centers for Disease Control 2) the US Health Resources Services Administration 3) the US Federal Court? 4) the US Secretary of State for Health and Human Services?

All have confirmed autistic conditions can be caused by vaccines.

GERBERDING:

“.. if you’re predisposed with the mitochondrial disorder, it can certainly set off some damage. Some of the symptoms can be symptoms that have characteristics of autism.

CNN – HOUSE CALL WITH DR. SANJAY GUPTA Unraveling the Mystery of Autism; Talking With the CDC Director; Stories of Children with Autism; Aging with Autism Aired March 29, 2008 08:30 ET

US HRSA:

[when confirming of the 1322 cases of vaccine injury compensation settled out of court by the US Government in secret settlements]:-

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.

US HRSA to reporter Sharyl Attkisson of CBS News 5th May 2008

US FEDERAL COURT
[PDD is the US term under DSM IV for ASD – Autistic Spectrum Disorder]:

“…… Bailey’s ADEM was both caused-in-fact and proximately caused by his vaccination. …… Furthermore, Bailey’s ADEM was severe enough to cause lasting, residual damage, and retarded his developmental progress, which fits under the generalized heading of Pervasive Developmental Delay, or PDD. The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine, and that this chain of causation was a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay.

[Banks v. HHS (Case 02-0738V, 2007 U.S. Claims LEXIS 254, July 20, 2007).

US SECRETARY OF STATE FOR HEALTH AND HUMAN SERVICES:-

The Department for Health and Human Services conceded the Hannah Poling case – that Hannah’s autistic condition was caused by 9 vaccines [ie. not just the MMR] administered in one day. Last year the US Federal Court determined a settlement which reportedly amounts to US $ 20 million over Hannah Poling’s lifetime:

Court Awards Over $20 Million for Vaccine-Caused Autism PR Newswire (press release) – Sep 15, 2010

Family to Receive $1.5M+ in First-Ever Vaccine-Autism Court Award CBS News September 9, 2010

“Settlement reached in autism-vaccine case” September 10, 2010 By Carrie Teegardin The Atlanta Journal-Constitution.


THE SECOND POST REMOVED WITHOUT TRACE

ChildHealthSafety

8 August 2011 9:20AM

In our post above noting direct censorship of public facts by The Guardian perhaps we should have added “Follow the Money”.

GUARDIAN & BRITISH MEDICAL JOURNAL
Guardian partners with British Medical Journal Group for online first Tuesday 3 March 2009 00.00 GMT

“Derrick Malone, Guardian Product Manager said: “People naturally turn to the Internet when researching health issues and we were keen to provide our users with factual information they could trust to complement our extensive features on health issues. The pages were developed entirely in house by the GNM technology team in collaboration with BMJ Group.”

Rachel Armitage, Director, BMJ Evidence Centre said: “We’re pleased to partner with the Guardian and bring our knowledge to a wider audience. The information is based on our ‘Clinical Evidence’ product, which provides doctors with access to the very latest and most relevant medical knowledge and is used to make treatment decisions.”

BRITISH MEDICAL JOURNAL & DRUG INDUSTRY
The Editor in Chief of the British Medical Journal was forced to make an embarrassing correction regarding the BMJ’s own failures to disclose its conflicting financial interests in the drug industry.

Here is the correction forced ultimately by online criticism from New York charity The Alliance for Human Research Protection:-

“The BMJ should have declared competing interests in relation to this editorial by Fiona Godlee and colleagues (BMJ 2011;342:c7452, doi:10.1136/bmj.c7452). The BMJ Group receives advertising and sponsorship revenue from vaccine manufacturers, and specifically from Merck and GSK, which both manufacture MMR vaccines. For further information see the rapid response from Godlee (www.bmj.com/content/342/bmj.d1335.full/reply#bmj_el_251470). The same omission also affected two related Editor’s Choice articles (BMJ 2011;342:d22 and BMJ 2011;342:d378).

However, this also still fails to mention the most glaring conflict of all, which it all – BMJ’s business partnership with Merck through their information arm, Univadis (‘MSD signs partnership with BMJ group’).

THE THIRD POST REMOVED WITHOUT TRACE

ChildHealthSafety

9 August 2011 8:45AM

Artros @ 8 August 2011 9:32PM

Between the Internet, vaccines and dental amalgams, I think I’ve seen it all. Come on, man, vaccines? That’s like saying “influenza causes autism.”

Comments like this have been answered with quotes posted by us [with links to original publicly documented sources] but The Guardian removed them twice despite being in accordance with “Community Standards”. The second time there is no trace whatsoever of the original posting – The Guardian’s Comment is Free [LOL] removed it in its entiretly. This is an example of a national news media outlet using censorship to rewrite history and airbrushing facts from the record which directly contradict their strongly held personal beliefs.

The quotes were from 1) Merck’s current Director of Vaccines Julie Gerberding when she was Director of the US Centers for Disease Control 2) the US Health Resources Services Administration 3) the US Federal Court? 4) the US Secretary of State for Health and Human Services? All have confirmed autistic conditions can be caused by vaccines.

The second posting [8 August 2011 7:46AM] was removed with no trace of it ever having existed, whereas the position of the first posting can still be seen [7 August 2011 11:14AM].

We also added a posting [8 August 2011 9:20AM] with links to original sources showing the commercial and financial partnerships deals between The Guardian and The British Medical Journal and The British Medical Journal and the drug industry. That posting was removed without trace – no footprints, no traces, just gone.

So two of the three comments are gone and one has the following claiming without any truth that:

“This comment was removed by a moderator because it didn’t abide by our community standards.”

Frankly, normal sensible intelligent people may find such behaviour of The Guardian a little troubling.

If these comments were removed without trace, how much of what The Guardian publishes online is a moving target – being removed, deleted, altered and/or added to in order to write history according to what the Guardian wants it to be instead of what it is? Very Pravda.

And “Community Standards”? Please, no laughter at the back of class:-

10. The platform is ours, but the conversation belongs to everybody. We want this to be a welcoming space for intelligent discussion, and we expect participants to help us achieve this by notifying us of potential problems and helping each other to keep conversations inviting and appropriate. If you spot something problematic in community interaction areas, please report it. When we all take responsibility for maintaining an appropriate and constructive environment, the debate itself is improved and everyone benefits.

In short:

– If you act with maturity and consideration for other users, you should have no problems.

British journalism at its finest and no Rupert Murdoch to blame it on.

US GM food toxins found in the blood of 93% of unborn babies

Toxins from genetically modified crops are finding their way into over 9 in every ten babies new research reveals.  Read this UK news story for more:-

US GM food toxins found in the blood of 93% of unborn babies – UK’s Daily Mail national newspaper – By Sean Poulter 20th May 2011

Read the full paper here:-

Maternal and fetal exposure to pesticides associated to genetically modified foods in Eastern Townships of Quebec, Canada

A. Aris, S.Leblanc Journal of ReproductiveToxicology xxx (2011) xxx–xxx

Here is the abstract:-

Reprod Toxicol. 2011 Feb 18. [Epub ahead of print]

Maternal and fetal exposure to pesticides associated to genetically modified foods in Eastern Townships of Quebec, Canada.

Source

Department of Obstetrics and Gynecology, University of Sherbrooke Hospital Centre, Sherbrooke, Quebec, Canada; Clinical Research Centre of Sherbrooke University Hospital Centre, Sherbrooke, Quebec, Canada; Faculty of Medicine and Health Sciences, University of Sherbrooke, Sherbrooke, Quebec, Canada.

Abstract

Pesticides associated to genetically modified foods (PAGMF), are engineered to tolerate herbicides such as glyphosate (GLYP) and gluphosinate (GLUF) or insecticides such as the bacterial toxin bacillus thuringiensis (Bt). The aim of this study was to evaluate the correlation between maternal and fetal exposure, and to determine exposure levels of GLYP and its metabolite aminomethyl phosphoric acid (AMPA), GLUF and its metabolite 3-methylphosphinicopropionic acid (3-MPPA) and Cry1Ab protein (a Bt toxin) in Eastern Townships of Quebec, Canada. Blood of thirty pregnant women (PW) and thirty-nine nonpregnant women (NPW) were studied. Serum GLYP and GLUF were detected in NPW and not detected in PW. Serum 3-MPPA and CryAb1 toxin were detected in PW, their fetuses and NPW. This is the first study to reveal the presence of circulating PAGMF in women with and without pregnancy, paving the way for a new field in reproductive toxicology including nutrition and utero-placental toxicities.

Scientists and Drug Companies Scheme to Avoid FDA Scrutiny and Exploit US Vaccine Programme Immunity Against the Public Interest

From Age of Autism

Just eight days after the Supreme Court of the United States ruling granting vaccine manufacturers virtual immunity over prosecution ( Bruesewitz v. Wyeth) , scientists and company representatives met at a congress in Baltimore to “Understand the Changes in the National Vaccine Plan to Maximize Government Sponsored Funding and Avoid FDA Scrutiny”. The “workshop” which took place on 2 March 2011 was the first event in a Vaccine Business Congress held under the auspices of the Institute for International Research USA . Amongst the many participants at the congress were representatives of Merck, GlaxoSmithKline, Sanofi Pasteur, Roche, the Bill and Melinda Gates Foundation, the Wellcome Trust, and the National Cancer Institute (NIH) (IIRUSA Welcome , IIRUSA Agenda ).

Despite frequent bleating from industry apologists that vaccine manufacturers do not make money the pre publicity for the event showed the industry in rampant mood. The on-line brochure states:

“VACCINES are the continuing success story, earning over $27 billion in 2009 alone, despite difficult economic times for the pharmaceutical industry. By 2012, vaccines are expected to bring in more than $35 billion in revenue.”

The brochure demonstrates the utter negligence of the US Congress, administration and courts in leaving its citizenry subjected and exposed to an industry, forced to inject its products by mandate into their children, forced to pay for them through taxation and finally to do so without any sanction against manufacturers should damage occur. Is it any surprise then that instead of regarding the manufacture of safe and effective products as a solemn ethical duty, they just turn round and brazenly discuss how to milk the contemptible system to the uttermost? Please send this article to your Congressmen and women, and ask them what they intend to do about it.

With thanks to Hilary Butler and others.

John Stone is UK Editor for Age of Autism.

Fox News – US Pays $ Millions In Secret To Vaccine-Caused-Autism Injured Kids

See below video of a Fox News exclusive report yesterday announcing the publication today of a new peer reviewed study containing powerful evidence that not only do vaccines cause autistic conditions but the US government has been paying out multi-million dollar settlements to the few children and their families lucky enough to have been able to prove their cases.  But unlucky enough to have had their family life and child’s life destroyed by vaccines.  STOP PRESS @16:39 BST: The paper just published can be downloaded here:  Unanswered Questions from the Vaccine Injury Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain Injury, by Mary Holland, Louis Conte, Robert Krakow, and Lisa Colin

Fox reports that a Congressional Investigation is being called for.

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

The official rate for autism in the USA at 1 in 110 children [4 in 5 being a boy] vastly outstrips the hazards of infectious diseases, yet the US government and health officials worldwide continue to cover up this scandal whilst the US medical professions, American Medical Association and American Academy of Pediatrics continue to get rich from the dollars charged to parents without warning this could take their child’s life and health away forever by giving upwards of 50 vaccines to their children in infancy.  The safety of multiple vaccines has never been studied and adverse vaccine reactions are known to be highly under reported.

It is bizarrely illegal in the USA for US parents to sue drug companies for injury to their child caused by vaccines.  US Government’s health officials deny any causal link but US tax dollars are still paid out in secret multi-million dollar settlements to parents and their injured children.  Parents are told if they talk their child could lose the compensation. 

The first case to be made public was that of Hannah Poling.  Hannah’s case was broken in February 2008 when the details were leaked to and published by US award winning New York journalist and author David Kirby.  The story was one of the top ten US news stories of 2008 and received coast to coast news coverage.

The new peer reviewed study will be published today May 10 [US time] when the Summer Edition of the PACE Environmental Law Review, is published and put online from the Pace Law School with its world-renowned environmental law faculty.

For more information by David Kirby on The Huffington Post today:
High Rates of Autism Found in Federal Vaccine Injury Program: Study Says More Answers Needed

Winter Vaccinations Increase Autism Risk – New Study From California

A new statistical study [full abstract below] from the School of Medicine at the University of California, Davis shows a potential and small association in time in at best 6% of cases between between the month a child is conceived in California and the risk of developing autism.  This could indicate that winter vaccinations increase the risk of a child in California developing an autistic condition [explained below]. 

Winter conception (December through March) was associated with no more than a 6% increased risk compared with summer  (OR = 1.06, 95% CI = 1.02-1.10): [Month of Conception and Risk of Autism Zerbo, Ousseny; Iosif, Ana-Maria; Delwiche, Lora; Walker, Cheryl; Hertz-Picciotto, Irva Epidemiology., POST AUTHOR CORRECTIONS, 3 May 2011 doi:  10.1097/EDE.0b013e31821d0b53].

These results support an hypothesis that children conceived in winter months are at greater risk of developing autistic conditions when vaccinated during winter months. 

The study authors conclude:

Conclusions: Higher risks for autism among those conceived in winter months suggest the presence of environmental causes of autism that vary by season.”

Winter conceptions result predominantly in winter vaccinations

Children conceived in winter in the USA [December to March] will receive two doses of the Hepatitis B vaccine predominantly in winter in the period August to January ie. from birth and during the following two months. [Download .pdf of US vaccine schedule].

These children will also receive another 7 vaccines predominantly during the winter months. Some of these are repeated up to 3 times.  This is in the period aged two to six months [ie. seven vaccines: RV, DTaP, Hib, PCV, IPV].  This corresponds to the months of October through May for prior winter conceptions.

These children will also receive another series of vaccines predominantly during the winter in the period August through April aged 12 to 18 months: HepB DTaP Hib IPV Varicella MMR PCV Influenza HepA (2 doses).

Irresponsible Headline Grabber UC Davis Medics

As at least 94% of autistic childrens’ conditions clearly have nothing whatsoever to do with the month of conception the greedy publicity seeking widely announced publication of such a paper is grossly medically and ethically irresponsible.  Will parents now seek only to conceive children during May to August, being misled by the headlines in the media?  What might be the social implications – lower rates of conceptions, strains in marriages, increased divorce rates, burdens on health professionals concentrated on birth “booms” at particular times of year?   With such a small effect it is impossible to conclude anything from such a study.  The fact the authors had to look in the records of seven million children is not a strength but a weakness.  This is a result of increasing the size of the sample population until the calculation a such small difference becames “statistically” significant when in smaller populations it may not be.  Statistical significance is not a basis upon which to decide whether there is a real-world cause and effect relationship.  

These kinds of observational statistical studies should be treated with great caution. They are at best used only to consider hypotheses for later research. They do not prove cause but only associations. They can never prove there is no causal association even if they do not find a statistical association. With such a small effect as this study – no more than 6%, whilst the statistician might calculate the results are statistically significant, other errors not accounted for may mean such a small result is of no significance. It is notable the authors did not set out provisos like these to the world’s media when this study was being publicised.

The authors from a medical school [and therefore not necessarily trained scientists] did not appear to investigate a correlation to month of vaccination, nor between northern and southern California births [seasonal temperature differences can be significant], nor between regressive autistic conditions [appearing after birth from around the time of vaccination at 12-18 months] and autistic conditions apparent from birth.

Abstract:

Month of Conception and Risk of Autism Zerbo, Ousseny; Iosif, Ana-Maria; Delwiche, Lora; Walker, Cheryl; Hertz-Picciotto, Irva Epidemiology., POST AUTHOR CORRECTIONS, 3 May 2011 doi:  10.1097/EDE.0b013e31821d0b53].

Background: Studies of season of birth or season of conception can provide clues about etiology. We investigated whether certain months or seasons of conception are associated with increased risk of autism spectrum disorders, for which etiology is particularly obscure.

Methods: The study population comprises 6,604,975 children born from 1990 to 2002 in California. Autism cases (n = 19,238) were identified from 1990 through 2008 in databases of the California Department of Developmental Services, which coordinates services for people with developmental disorders. The outcome in this analysis was autism diagnosed before the child’s sixth birth date. The main independent variables were month of conception and season of conception (winter, spring, summer, and fall). Multivariate logistic regression models were used to estimate odds ratios (ORs) with their 95% confidence intervals (CIs) for autism by month of conception.

Results: Children conceived in December (OR = 1.09 [95% CI = 1.02-1.17]), January (1.08 [1.00-1.17]), February (1.12 [1.04-1.20]), or March (1.16 [1.08-1.24]) had higher risk of developing autism compared with those conceived in July. Conception in the winter season (December, January, and February) was associated with a 6% (OR = 1.06, 95% CI = 1.02-1.10) increased risk compared with summer.

Conclusions: Higher risks for autism among those conceived in winter months suggest the presence of environmental causes of autism that vary by season.

Vaccines Associated With High Infant Mortality Rates in Developed Nations

News Release For Immediate Release

Developed nations that require the most vaccines for babies tend to have the highest infant death rates

May 4, 2011 — A new study, published in Human and Experimental Toxicology, a prestigious journal indexed by the National Library of Medicine, found that developed nations with higher (worse) infant mortality rates tend to give their infants more vaccine doses. For example, the United States requires infants to receive 26 vaccines (the most in the world) yet more than 6 U.S. infants die per every 1000 live births. In contrast, Sweden and Japan administer 12 vaccines to infants, the least amount, and report less than 3 deaths per 1000 live births.

The current study by Miller and Goldman, “Infant Mortality Rates Regressed Against Number of Vaccine Doses Routinely Given: Is There a Biochemical or Synergistic Toxicity?” (and .pdf available online here), found “a high statistically significant correlation between increasing number of vaccine doses and increasing infant mortality rates.” This raises an important question: Would fewer vaccines administered to infants reduce the number of infant deaths? The authors concluded that “closer inspection of correlations between vaccine doses, biochemical or synergistic toxicity, and infant mortality rates, is essential. All nations — rich and poor, advanced and developing — have an obligation to determine whether their immunization schedules are achieving their desired goals.”

Other study findings:

  • The United States spends more per capita on healthcare than any other country yet 33 nations have better infant mortality rates.
  • Some infant deaths attributed to sudden infant death syndrome (SIDS) may be vaccine-related, perhaps due to over-vaccination.
  • Progress on reducing infant deaths should include monitoring immunization schedules and official causes of death (to determine if vaccine-related infant deaths are being reclassified).Infant mortality rates will remain high in developing nations that cannot provide clean water, proper nutrition, improved sanitation, and better access to health care.

______________________________________________________

Download the entire study here . (http://het.sagepub.com/content/early/2011/05/04/0960327111407644)
Hum Exp Toxicol published online 4 May 2011. DOI: 10.1177/0960327111407644

The study’s authors can be contacted as follows: Neil Z. Miller: neilzmiller@gmail.com and
Gary S. Goldman: pearblossominc@aol.com

______________________________________________________________________________

Funding Acknowledgment: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Open Access: The National Vaccine Information Center (NVIC) donated $2500 and Michael Belkin donated $500 (in memory of his daughter, Lyla) for open access to the journal article making it freely available to all researchers.

US Government & Scientists Agree: More Vaccine-Caused-Autism Research Necessary

By David Kirby April 26, 2011  – [reposted from award winning journalist & author David Kirby’s website – Animal Factory: Government and Many Scientists Agree: Vaccine-Autism Research Should Continue]

The vaccine-autism debate is far from over. If anything, it is just getting started.

As the following comments, funding decisions, research priorites and published papers suggest, the US government and many scientists will be researching and discussing this topic for years to come. Here are some reasons why:

I) FEDERAL HEALTH AGENCIES ENDORSE MORE RESEARCH

The federal government’s four leading health entitites dealing with vaccines and/or autism have all reached consensus: More vaccine safety research is required to fill gaps in knowledge, especially in the context of susceptible subpopulations, mitochondrial impairment, long-tern effects of vaccine-induced fever, seizures and brain injury, and other factors. Millions of dollars will be spent investigating these factors, and not because health officials somehow caved to parental pressure. Mercury in vaccines, for example, was designated as one of the CDC’s “high priority” vaccine safety issues, following an “extensive review of the literature, based on how strongly they seemed to be associated with ASD.

Centers for Disease Control and Prevention Office of Immunization Saftey

The CDC will study autism “as a possible clinical outcome of immunization” as part of its 5-year research plan. It will also study mitochondrial dysfunction and the risk for “post-vaccine neurological deterioration,” and will convene an expert panel on the feasibility of studying health outcomes, including autism, among vaccinated and unvaccinated children.

Centers for Disease Control and Prevention Study to Explore Early Development – NOTE – THIS WEBPAGE WAS RECENTLY ALTERED BY CDC TO REMOVE ALL REFERENCES TO VACCINES AND MERCURY – HERE IS THE ARCHIVED PAGE:

http://replay.web.archive.org/20080308214934/http://www.cdc.gov/ncbddd/dd/documents/SEEDfaqs.pdf

The CDC is currently looking at environmental, genetic and socioeconomic risk factors for ASD, including vaccines and mercury.

We chose to look at vaccines and other types of medical procedures that may have mercury exposure,” the CDC says. The agency “designated these factors as high priority” following “an extensive review of the literature, based on how strongly they seemed to be associated with ASD.”

Selected mercury exposures 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.”

Interagency Autism Coordinating Committee (IACC) – Includes CDC, HHS, NIH etc.

The nation’s leading autism research entity, the IACC, recently announced funding for studies of environmental factors for ASD, such as toxic exposures and

adverse events following immunization (such as fever and seizures), and mitochondrial impairment.”

It will also fund studies to determine if some subpopulations are

more susceptible to environmental exposures (e.g., immune challenges related to infections, vaccinations, or underlying autoimmune problems),”

and will continue to coordinate with the National Vaccine Advisory Committee on

public concerns regarding a possible vaccine/ASD link.”

The IACC has also concluded that existing population-based vaccine-autism studies are

limited in their ability to detect small susceptible subpopulations.”

National Institutes of Health Early Autism Risk Longitudinal Investigation

A network of NIH agencies and affiliated sites are following some 1,200 pregnant women who already have a child with autism to identify the earliest potential causes and

“possible environmental risk factors and their interplay with genetic susceptibility during the prenatal, neonatal and early postnatal periods.”

Researchers are reviewing each child’s medical records, including vaccination history. They are also asking about mercury exposures through flu shots during pregnancy, ambient air pollution, seafood consumption, dental amalgams, and thimerosal exposure through contact lens solutions and other OTC products.

US Dept of Health and Human Services National Vaccine Advisory Committee

The nation’s leading experts on vaccine safey recently endorsed the study of adverse events following immunization (e.g., fever and seizures) to see if they increase autism risk. The NVAC also supports an expert committee to consider examining outcomes in unvaccinated, vaccine delayed and vaccinated children, including autism. The Committee recommends more study of

“the possible occurrence of ASD in a small number of children subsequent to MMR vaccination” especially given “recent research around the incidence of mitochondrial dysfunction in children with an ASD phenotype.”

The NVAC also recommends studying adverse vaccine reactions in subsets of ASD children:

given “recent developments around mitochondrial dysfunction,” and because some children “may be at elevated risk of reduced neurological functioning, possibly including developing ASD, subsequent to vaccination.”

US Dept of Health and Human Services Vaccine Injury Compensation Program

The so-called Federal “Vaccine Court” has asked an Institute of Medicine committee to consider adverse events from the DTaP and MMR vaccines, including autism and autism spectrum disorders. The IOM committee will will consider vaccine-associated “secondary” autism or autistic features arising from chronic encephalopathy, mitochondrial disorders and/or other underlying disorders. The vaccine injury program has asked the committee to consider “primary autism” in light of

recent theories of neuro-inflammation and hyper-arousal/over-excitation of the immune system via multiple simultaneous antigenic stimulation” (several vaccines at once).

SCIENTISTS CALL FOR MORE STUDIES

Today, more scientists and research institutions are supporting further inquiry into the role of environmental toxins in the onset of autism spectrum disorder. While many doubt that vaccines are responsible for the dramatic increase in autism incidence, they point to knowledge gaps concerning susceptible subgroups that may have been missed in large population studies of MMR vaccine, thimerosal and ASD.

In general, vaccines are not the culprit, (but) there may be 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.”–David Amaral, PhD, Director of Research, University of California, Davis M.I.N.D. Institute. PBS, April 2011

One question [is] whether there is a subgroup in the population that, on a genetic basis, is more susceptible to some vaccine characteristic or component than most of the population, and may develop an ASD in response to something about vaccination. The trigger could be some adverse or cross-reacting response to a vaccine component or a mitochondrial disorder increasing the adverse response to vaccine-associated fever.”–Duane Alexander, MD, former Director of the National Institute of Child Health and Human Development (NICHD), current Senior Scientific Advisor to NIH’s Fogarty International Center. Interview, October 2009.

It remains scientifically plausible that the challenge to the immune system resulting from a vaccine (or other immunological challenges) could, in susceptible individuals, have adverse consequences for the developing brain. Evidence does not support the theory that vaccines are causing an autism epidemic. However, it is plausible that specific genetic or medical factors that are present in a small minority of individuals might lead to an adverse response to a vaccine and trigger the onset of autism symptoms.”–Geraldine Dawson, PhD, Chief Science Officer, Autism Speaks. July, 2009

It is important for autism researchers to study the children who have been most profoundly affected by their response to vaccines.” – Story Landis, PhD, Director of the National Institute of Neurodevelopmental Disorders and Stroke (NINDS), former member, IACC. Statement, October 2009

If a child was immunized, got a fever, had other complications from the vaccines. And if you’re predisposed with the mitochondrial disorder, it can certainly set off some damage. Some of the symptoms can be symptoms that have characteristics of autism… I think we have to have an open mind about this.” – Julie Gerberding, MD, former Director of the Centers for Disease Control and Prevention, current President of Merck Vaccines. CNN, March 2008

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 (vaccine-autism) 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.”– Martha Herbert, MD, PhD, Assistant Professor of Neurology at Harvard Medical School, Pediatric Neurologist at Massachusetts General Hospital. PBS, April 2011

We will continue to support authoritative research that addresses unanswered questions about whether certain subgroups of individuals with particular underlying medical or genetic conditions may be more vulnerable to adverse effects of vaccines. While large scale studies have not shown a link between vaccines and autism, there are lingering legitimate questions about the safety of vaccines that must be addressed.”
–Autism Speaks, Official Statement. February 2009

III) RECENT PAPERS AND FUTURE STUDY

Studies that refute an autism-vaccine association tend to get widespread coverage in the media, but studies suggesting that more research is needed tend to get overlooked. The following are just a few recently published papers, some from foreign journals. They are not presented here as evidence of an association between immunization and autism, but rather to demonstrate the types of investigations that researchers might pursue in the years to come.

Mitochondrial Impairment and Lead Found in Saudi Children with ASD – Vaccines May Trigger Metabolic Stress and Regression in Mild Impairment Cases

“Plasma fatty acids as diagnostic markers in autistic patients from Saudi Arabia”
Lipids in Health and Disease, 2011 Apr 21;10(1):62.

This small study found that “fatty acids are altered in the plasma of autistic patients,” and the differences were related to “oxidative stress, mitochondrial dysfunction and the high lead concentration previously reported in Saudi autistic patients.” Taken together with three related Saudi studies, the authors “confirmed the impairment of energy metabolism in Saudi autistic patients, which could be correlated to oxidative stress.” Vitamin E and glutathione were “remarkably lower” in ASD patients vs. controls. Saudi ASD children “are under oxidative stress due to GSH (glutathione) depletion,” the authors said. “This confirms that oxidative stress and defective mitochondrial energy production could represent the primary causative factor in the pathogenesis of autism.” And they added, “There may be an initial period of normal development and function before decompensation in association with metabolic stress or immune activation, such as fasting, illness or vaccination.”

Vaccine-Induced Fever Caused ASD Regression in Four Chidren with Mitochondrial Dysfunction

“Fever plus mitochondrial disease could be risk factors for autistic regression”
Journal of Child Neurology, 2010 Apr;25(4):429-34.

Researchers looked at 28 children with ASD and mitochondrial disease and found that 17 of them (60.7%) had gone through autistic regression, and 12 of the regressive cases happened following fever. Among the 12 children who regressed after fever, a third of them (4) had fever associated with vaccination, as was the case of Hannah Poling v. HHS.

Birth Dose of Hepatitis-B Vaccine Associated with Increased ASD Risk in Boys

“Hepatitis B vaccination of male neonates and autism diagnosis, NHIS 1997-2002″
Journal of Toxicology and Environmental Health 2010;73(24):1665-77.

This cross-sectional study used weighted probability samples from National Health Interview Survey 1997-2002. It findings “suggest that U.S. male neonates vaccinated with the hepatitis B vaccine prior to 1999 had a threefold higher risk for parental report of autism diagnosis compared to boys not vaccinated as neonates.”

Thimerosal may contribute to infant neurodevelopmental disorders, including autism.

“Lasting neuropathological changes in rat brain after intermittent neonatal administration of thimerosal”
Folia Neuropathologica 2010;48(4):258-69.

This study found that “numerous neuropathological changes were observed in young adult rats treated postnatally with thimerosal,” and that “These findings document neurotoxic effects of thimerosal, at doses equivalent to those used in infant vaccines or higher, in developing rat brain, suggesting likely involvement of this mercurial in neurodevelopmental disorders.” The authors concluded that thimerosal is “possibly contributing to pediatric neurodevelopmental disorders, including autism.”

Risk of Neurotoxicity from Thimerosal is Plausible, at Least for Susceptible Infants

“Making sense of epidemiological studies of young children exposed to thimerosal in vaccines”
Clinica Chimica Acta, International Journal of Clinical Chemisty, 2010 Nov 11;411(21-22):1580-6

Although this review did not look autism, it compared eight epidemiological studies conducted in the US, UK and Italy on “neurological issues and thimerosal-containing vaccines (TCV)” and found the data were “insufficient to establish non-toxicity for infants and young children.” The review identified “ambiguity” in some of the studies, likely caused by confounding variables. “The risk of neurotoxicity due to low doses of thimerosal is plausible at least for susceptible infants,” the author concluded. “There is a need to address these issues in less developed countries still using TCV in pregnant mothers, newborns, and young children. Developing countries should intensify campaigns that include breastfeeding among efforts to help prime the central nervous system to tolerate exposure to neurotoxic substances, especially thimerosal.”

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 Questions and Answers on the suspension of Hexavac –  EMEA/304888/2005
  • 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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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