Secret British MMR Vaccine Files Forced Open By Legal Action

Read here what will be discovered and more.

[Another World Exclusive Below Purple [ 22/Jan/2009]
[World Exclusive – 17 Jan red below – New revelations – 15 Jan  blue]
[Later Updates in Green including January 2010]

This is the story the UK media have steadfastly not been publishing and of the contrasting unprecedented new developments in the US politically and in the US Federal Court.

The UK’s Daily Mail newspaper reported [13/Jan/09] the British government was refusing the public release under the UK’s Freedom Of Information laws of confidential files on a proven dangerous MMR [measles, mumps and rubella] vaccine.  A recent legal case has forced the files open: [Confidential MMR vaccine files should be opened in the public interest, watchdog rules – The Daily Mail – Jenny Hope – 13th January 2009]

The British government has prevented its child citizens being compensated and treated. Money and politics override child health safety. 20 years on children continue to be injured. Starting in 1986 Canada, to 1988 Japan and the UK to the present this previously unpublished account is definitive carefully researched and accessible.

The problem is not just autism and not just the MMR vaccine [see USA developments and Federal Court decisions below]. What else are we not being told?

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

In the US Federal Court children have been compensated after findings they developed autism and other injuries. If you read nothing else we strongly recommend you read this: PDF Download – Text of email from US HRSA to Sharyl Attkisson of CBS News].  In it the US Health Resources Services Administration [HRSA] state to CBS News reporter Sharyl Attkission

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.

Contents

British Government’s Reckless Disregard for Child Health Safety

British Government & Establishment’s Efforts to Deny Compensation to MMR Vaccine Child Victims

AUTISM – US Court Decisions and Other Recent Developments – It’s Not Just MMR

Vaccine Risks Outweigh Risk of Disease

Vaccines, Autism and Your Child’s Allergies

In Whom Can You Trust?

What You Can Do – [click for action you can take]

To Contents

British Government’s Reckless Disregard for Child HealthSafety

The UK’s Department of Health and others appear to have been reckless as to the safety of British children over the manner in which Glaxo company, Smith Kline & French Laboratories Ltd’s Pluserix MMR vaccine was introduced and used on British Children in 1988

  • the problems with Pluserix MMR were known to the supplier, Glaxo company Smith Kline & French Laboratories Ltd from the experience of its introduction to Canada, in 1986, where Pluserix was marketed under the name “Trivirix”
  • Trivirix (Pluserix) was withdrawn from use in Canada in 1988 because it was dangerous, causing high levels of adverse reactions in children
  • the high levels of British adverse reactions to the vaccine were apparent and known about at British Ministerial level in 1990, as shown by ministerial correspondence
  • Pluserix/Trivirx are the identical vaccine manufactured in the identical Smith Kline factory in Belgium and with the exact same component parts and constituents
  • despite the Canadian position and contemporaneously with the final withdrawal of Pluserix/Trivirix in Canada the UK signed the contract to purchase Pluserix MMR from Glaxo company, Smith Kline & French Laboratories Limited in July 1988, even though it was known by then to be too dangerous for use on our children
  • SK&F was provided with a blanket indemnity in that contract by the NHS Procurement Directorate
  • the contract was signed up by the backdoor through the North East Thames Regional Health Authority as agent for the NHS Procurement Directorate rather than being a contract directly entered into with the NHS Procurement Directorate which negotiated the contract or the NHS Executive of the time
  • there was no Parliamentary scrutiny of this and it seems to have been effected in a manner Ministerially deniable
  • similar problems were experienced in Japan with the Japanese MMR vaccine which, in common with Pluserxi/Trivirix, contained the Urabe strain of mumps virus
  • the Japanese MMR was also withdrawn by 1992 on safety grounds having caused high levels of adverse reactions
  • the British government continued the licence for Pluserix MMR after 1992, which enabled it to be supplied overseas
  • even today, because it is cheaper than safer alternatives, organisations like UNICEF continue supplying urabe strain containing MMR vaccine to the more adverse reaction vulnerable and less well nourished third world children
  • since 1998, statistical papers claiming no evidence of an association between the MMR vaccine and autism have been published in a blaze of publicity, but when all the noise has died down, on subsequent careful examination, each one has been found to be flawed. These are the same kinds of statistical studies [epidemiology] used by the tobacco industry in the 1940’s and 50’s to claim smoking did not cause lung cancer
  • other than the Royal Free’s paper, no clinical studies of the MMR child litigants were undertaken or published
  • after being put under financial pressure by the British Government, in 2005 the Oxford based Cochrane Collaboration published a systematic review of all prior papers and its authors claimed to conclude the MMR vaccine was safe:-
    • it was shown the authors had violated the standards of evidence-based medicine [ref] and
    • their conclusions were not supported by the body of the review [ref]
    • and it later was discovered that the British Department of Health had increased the funding for Cochrane’s Oxford administration by £1 million per annum and extended the contracts of its British groups

To Contents

British Government & Establishment’s Efforts to Deny Compensation to MMR Vaccine Child Victims 

Legal Aid funded claims by children started as early as 1991 and well before Dr Andrew Wakefield warned the British public about the vaccine.  His efforts were met with the full force of the British establishment to discredit him and proceedings before the General Medical Council resumed only yesterday, which have been going on for three years.

The main false accusation levelled in February 2004 was that Wakefield made his disclosures in a medical paper published in The Lancet medical journal because he wanted to make money being an expert witness in Court.  But few people know the following [and there is naturally full documentation on this].

Crispin Davis, the Chief Executive of Reed-Elsevier, the owners of “The Lancet”, had a few months earlier in the July [2003] been brought onto the Board of Directors of MMR litigation Defendants’ parent company GlaxoSmithKline.

[Global publishing giant Reed-Elsevier owns 2,460 scientific journals, including the magazine New Scientist and earns substantial funds from the drug industry in advertising revenue.  Corruption in medical publishing is rife.  Elsevier was paid by drug  giant Merck to publish a fake medical journal with articles favourable to Merck’s drugs: [Merck published fake journal – Bob Grant – The Scientist – 30th April 2009].  Drug maker Wyeth flooded medical journals with some 40 ghostwritten articles penned by prominent physicians who sold their name for cash, in an all-out effort to offset the scientific evidence linking its female hormone replacement drug, Prempro, to breast cancer: [Judge orders Wyeth papers unsealed– Associated Press – July 25, 2009].  Reed-Elsevier’s former chairman, Jan Hommen, attended the secretive annual Bilderberg conference in 2007 and 2010.  Bilderberg was described to senior British politician Lord Ashdown as ‘fifty people who run the world and twenty hangers on’: The Ashdown Diaries – Volume One 1988-1997; Penguin – 2000 – ISBN 0 14 029775 8 – pp.42-44]  [Blue text added 29 May 2011]].

Brian Deer, a freelance journalist was commissioned by The Sunday Times two months later in September 2003 to write the stories attacking Wakefield.

This was about two weeks before the Legal Services Commission final decision was due on withdrawal of Legal Aid from the MMR children’s UK litigation and which did withdraw legal aid.

The person who commissioned Deer was Paul Nuki, Sunday Times’ sometime Head of Newsroom investigations and “Focus” editor.  Paul Nuki is son of Professor George Nuki. Professor George Nuki in 1987 sat on the Committee on Safety of Medicines when the CSM was considering Glaxo company Smith Kline & French Laboratories’ Pluserix MMR vaccine for safety approval.  The CSM approved Pluserix MMR but it caused very high levels of adverse reactions and was withdrawn by the manufacturers on very little notice in late 1992 leaving the Department of Health in an embarrassing position.

Large numbers of British children were injured and legal aid claims had already started from as early as 1991, five years before Wakefield became involved and contrary to The Sunday Times’claims that this was all a scam set up by Wakefield and solicitor Richard Barr.

Sitting on the CSM with Professor George Nuki was Professor Sir Roy Meadow and Professor Sir David Hull.  Professor Sir Roy Meadow is now notorious for his evidence falsely condemning mothers around the world for killing their children. This includes the Sally Clark case where vaccines are directly implicated in the cause of death, as revealed by Neville Hodgkinson in The Spectator, (What killed Sally Clark’s child? | The Spectator 16 May 2007 ) but which were specifically discounted by Professor Meadow in his evidence, despite sitting on the joint CSM/JCVI vaccine safety sub-committee with the UK Department of Health’s Head of Immunisation Professor David Salisbury and others to approve the MMR vaccine.

It was Professor Sir David Hull in 1998 who, as chairman of the Joint Committee on Vaccination and Immunisation, started the attacks on Wakefield’s work.  The Joint Committee on Vaccination and Immunisation advises the Department of Health on vaccination issues and the childhood vaccination programme.  As Chairman of the JCVI, Professor Sir David Hull could have taken action to deal with the issues over the MMR and protect British children.  Despite his attacks on Wakefield’s work, alleging unethical research on children for no clinical benefit, two years later in 2000, it was Professor Sir David Hull who rewrote the Royal College of Paediatrics and Child Health ethical guidelines to permit research on children where there was no clinical benefit (albeit in The Royal Free’s case all the investigations were clinically justified).

The Sunday Times’ freelancer was assisted in his efforts with free advice and assistance from the Association of British Pharmaceutical Industry funded and controlled company Medico Legal Investigations Limited.  Medico Legal Investigations Limited speciality was in getting medical doctors on charges before the General Medical Council. So we know that before a single word was published by The Sunday Times, it was already being planned with the involvement of interested parties that Wakefield and colleagues were to be taken before the GMC.

Another free of charge helper to Sunday Times’ journalist Deer was Glaxo Wellcome funded Fellow and active British Medical Association member, Dr Evan Harris MP.Harris has advised and assisted Deer up to the present, including attending the Wakefield GMC hearings with Deer.

The Sunday Times’ freelance journalist was also assisted by The Royal Free’s Strategic Health Authority which in early 2004 passed Deer confidential documents ‘in the spirit of openness’.  These included documents relating to the confidential medical treatment of the MMR child litigants. The SHA at first denied providing documents until it was pointed out the fact was disclosed by Dr Evan Harris MP, in Parliament on 15th March 2004.

In 2003 and later the freelance journalist was also being given illegally unofficial access [by a currently unconfirmed source] to confidential internal Royal Free documents.  Deer had also by 2003 been provided illegally [by another currently unconfirmed source] with copies of documents from the British MMR litigation including detailed medical notes and histories and expert reports [text added 24/Jan/2010].

On Saturday 21 February 2004, Lancet Editor Richard Horton pre-empted the Sunday Times’ stories. Horton was reported in The Times claiming he would not have published the MMR part of The Royal Free’s Lancet paper had Wakefield’s paid involvement in the MMR litigation been disclosed.  The Sunday Times had waited until Sunday 22 February 2004, 5 days before judgment in the MMR child litigants’ High Court challenge to the withdrawal of legal aid, to publish its stories attacking Wakefield.  Prime Minister Blair was reported in the press on the issue as was Health Secretary Reid.

As Dr Horton records in his book [“MMR Science and Fiction: Exploring the Vaccine Crisis,“], he was the next day exchanging notes over dinner and liqueurs with a member of the UK’s medical regulatory body, The General Medical Council on possible bases for GMC proceedings against Andrew Wakefield: [“The confusion”: Richard Horton – a remarkably frank passage‘ John Stone BMJ 2 November 2004].  Despite being consulted on the charges to be brought Horton was also later to be called as a witness for the GMC prosecution. [Added 25/1/2010]

After years out of government it was politically important to UK Prime Minister Tony Blair’s New Labour government to have become and to remain electable to  demonstrate it’s new credentials as friendly to UK business and commercial interests and “pro science”.  The British drug company and vaccine manufacturer GlaxoSmithKline was also significant economically achieving annual worldwide drug sales by 2005 of £18.5 billion.  Over one third of sales was for vaccines [£1.4 billion] and respiratory drugs [£5 billion] for treating asthma a chronic allergy condition which vaccines play a large part in causing [see further below on Vaccines, Autism and Your Child’s Allergies].  [Added 24/1/2010]

That MMR is solely a political and money issue was given away by journalist Jeremy Laurance’s The Independent’s story of 24th February 2004.  Laurance reported there was “delight” in Whitehall as “Ministers temper their triumphalism” and that “joy” was “unconfined at the discrediting of Andrew Wakefield“.  [“Ministers temper their triumphalism but delight spreads at Whitehall” The Independent – Jeremy Laurance, Health Editor Tuesday, 24 February 2004 ].

This was bizarre if the issue was just which measles vaccine might be given to children.  There was an acceptable, cheaper and more effective measles vaccine.   This was hardly stuff for Prime Minister Blair to involve himself in but even he jumped in with both feet.

However, in the light of the British government’s financial indemnity to Glaxo, the potential damage to billion pound sterling Glaxo’s financial interests from a scandal over the vaccine and the British government’s liability in negligence to large numbers of children, it starts to make sense.  This also puts into clearer perspective why the choice of which measles vaccine children received became a major political issue.  It had and has nothing to do with protecting your children from disease or child health safety. [blue text 15/Jan/09]

Legal aid was withdrawn on 27th February 2004 in a secret judgment by High Court Judge Nigel Davis.  The reasons remain unpublished today.  Evidence given in open court at a different hearing included the allegation from a parent that an official admitted to her that legal aid was withdrawn after government pressure.

It was discovered in 2007 that Judge Sir Nigel Davis is the brother of Lancet owner’s CEO and main Glaxo board member Sir Crispin Davis.  When challenged a statement was issued on Judge Davis’ behalf to The Telegraph newspaper’s legal correspondent Joshua Rosenberg and stated “The possibility of any conflict of interest arising from his brother’s position did not occur to him.

The outcome of an investigation by the Office for Judicial Complaints  found no impropriety and resulted in no action taken regarding the relationship between Judge Davis and his brother Crispin Davis’ GlaxoSmithKline board position.

On 15th March 2004 Dr Evan Harris launched an unprecedented and defamatory Parliamentary attack on Wakefield and his Royal Free colleagues and to which not one of Harris’ Liberal Democrat colleagues contributed.  This was based on material in documents Sunday Times’ freelancer Deer had obtained and passed to Harris. Harris used the opportunity to raise the allegations The Sunday Times chose not to publish after being dismissed by Lancet Editor Dr Richard Horton.  This occurred following a meeting at The Lancet’s offices on 18 February 2004 at which Harris was present with Brian Deer and attended by Andrew Wakefield, John Walker-Smith and Simon Murch.  Horton wrote of this in his book “The tension had been heightened…. by the shadowy presence of Evan Harris, a Liberal-Democrat Member of Parliament” and “Evan Harris, the MP who had mysteriously joined Brian Deer at the Lancet’s offices …” [Richard Horton,’MMR: Science and Fiction – Exploring the Vaccine Crisis’ Granta Books 2004, pps 3 & 7] [added 25/1/2010].

Harris later attended with Deer at the subsequent GMC hearings [added 27/Jan/2010].

Crispin Davis was awarded a knighthood June 2004.

Sunday Times’ freelance journalist Brian Deer confirmed numerous times on his website [later removed as reported in The Spectator online by journalist Melanie Phillips] that it was he who had made the submissions to the GMC which led to the present GMC proceedings against Wakefield. Wakefield’s lawyers had reported in November 2004 that Deer had made a statutory complaint to the GMC and freelancer Deer reported in the Sunday Times in December 2004 that the General Medical Council was investigating the complaints against Wakefield.  In 2004 The Sunday Times journalist wrote three letters of complaint to the GMC: 25 February, 12 March and 1 July 2004 [added 24/Jan/2010].

Professor Denis McDevitt was due in July 2007 to chair the unprecedented British General Medical Council hearing of the case of Doctors Wakefield, Murch and Professor Walker-Smith.  McDevitt and the GMC failed to declare McDevitt’s personal involvement in approving the dangerous Pluserix MMR vaccine in 1988.  He only stood down after Jamie Doward of the Observer, Martyn Halle, freelance journalist for the Sunday Express, Andy Wilks of the Mail on Sunday, Jenny Hope of the Daily Mail and Heather Mills of Private Eye challenged the GMC over the matter. [“MMR Conflict of Interest Zone” Private Eye – June 2007]

A British Medical Journal post suggests more troubling conflicts of interest of the current panel Chairman Dr Surendra Kumar. Kumar sits on two committees of the authority which licences the MMR vaccine (MHRA), the Independent Review Panel for Advertising and the Independent Review Panel for Borderline Products. Dr Kumar is also a shareholder in MMR defendants GlaxoSmithKline. “Re: Financial conflicts – shock horror” John Stone – British Medical Journal – 2 October 2008″ [Blue text 15/Jan/09]

Contrary to Lancet Editor Dr Richard Horton’s evidence to the GMC that he did not know of Wakefield’s paid involvement in the MMR litigation, Horton had detailed correspondence in 1997 disclosing that involvement  The correspondence was with Richard Barr, the solicitor who was working on the MMR litigation with Wakefield to help all those seriously injured British children.  This correspondence was considerably in advance of Horton’s February 1998 publication in The Lancet of the Royal Free’s paper containing the interpretation that MMR vaccine is associated with autism cases involving inflammatory bowel disease.

Notwithstanding this, the alleged non disclosure of the legal aid funding to Lancet Editor, Dr Richard Horton and the publication of the 1998 Royal Free paper was the nub of Deer’s The Sunday Times’ February 2004 attacks on Wakefield where it was claimed:-

The investigation has found that when [Wakefield] warned parents to avoid MMR, and published research claiming a link with autism, he did not  disclose he was being funded through solicitors seeking evidence to use against vaccine manufacturers.

Now we know from this that Horton’s claims do not stand up and with them, those of The Sunday Times fall as well.  But of course, not a word in the UK media.

Another key allegation in The Sunday Times’ journalist’s complaints to the GMC was that The Royal Free’s treatment of seriously ill autistic children with serious bowel disorder reported in the 1998 Lancet paper was simply research carried out without ethical approval.  But the journalist was referring to the wrong ethical approval granted in December 1996 reference 172-96 when the applicable ethical approval was granted in 1995 reference 162-95.  Ethics approval 162-95 was produced by Professor Walker-Smith’s defence team lawyers in the GMC. The production of this evidence contradicted numerous  of the GMC’s allegations of  professional misconduct against the doctors.  In the 90 pages of GMC charges there are 113 references to 172-96.[added 25/Jan/2010].

It seems had it not been for the complaints by The Sunday Times’ freelance journalist or the claims of Lancet Editor Dr Richard Horton, there may never have been any GMC case brought: [“Wakefield unlikely to be charged over MMR scare” – By Jeremy Laurance, Health Editor Sunday, 29 February 2004]. [added 25/Jan/2010].

Horton has not returned to the GMC Wakefield hearing this week [13/Jan/09] to clarify his evidence and face cross-examination.  It seems only his statement will be read out.

As for the Legal Aid money, for months in 1996 the Royal Free Medical School prevaricated  accepting it because “Clearly, this  could lead to a case against the Government for damages.” wrote Dean Zuckerman privately to the British Medical Association Secretary on 11th October 1996.

What no one knows and disclosed here publicly exclusively worldwide for the first time is that when The Sunday Times published its allegations against Wakefield in 2004 their journalist already had the documents showing Wakefield – a man accused of doing what he did for the money – was fed up with this and had arranged in May 1997 for all the legal aid monies to be sent back and that he had intended to raise the money himself for the injured children [see copy Freedom of Information memo below – added 17/Jan/09].

970520-tarhan-to-zuckerman-blatch-re-giving-the-money-back_11

It was the Royal Free which instead then reversed its position, decided to accept the money and arranged in July 1997 for it to be paid to special trustees.  Wakefield was never going to and never did receive a cent.

Wakefield’s Recent Summary of Sunday Times’ freelance journalist’s Complaints to GMC

Writing recently in the Autism File magazine [July 2009] Andrew Wakefield summarised the position regarding the allegations in The Sunday Times’ journalist’s complaints to the General Medical Council:-

Myths: The Lancet paper

  • was funded by the Legal Aid Board (LAB)

False – Not one penny of LAB money was spent on The Lancet paper. An LAB grant was provided for a separate viral detection study. This study, completed in 1999, does disclose the source of funding. The Lancet paper had been submitted for publication before the LAB grant was even available to be spent.

  • my involvement as a medical expert was kept ‘secret’

False – At least one year before publication, my senior co-authors, the Head of Department and the Dean of the Medical School7, and the CEO of the hospital were informed by me. This fact was also reported in the national press months prior to publication.

  • children were ‘sourced’ by lawyers to sue vaccine manufacturers

False – Children were referred, evaluated, and investigated on the basis of their clinical symptoms alone, following referral from the child’s physician.

  • children were litigants

False – At the time of their referral to the Royal Free – the time material to their inclusion in The Lancet paper – none of the children were litigants .

  • I had an undisclosed conflict of interest

False – The Lancet’s disclosure policy at that time was followed to the letter. Documentary evidence confirms that the editorial staff of The Lancet were fully aware that I was working as an expert on MMR litigation well in advance of the paper’s publication.

  • did not have Ethics Committee (EC) approval

False – The research element of the paper that required such an approval – detailed systematic analysis of children’s intestinal biopsies – was covered by the necessary EC approval.

  • I ‘fixed’ data and misreported clinical findings

False – There is absolutely no basis in fact for this claim and it has been exposed as false.

  • findings have not been independently replicated

False – The key findings of LNH and colitis in ASD children have been independently confirmed in 5 different countries.

  • has been retracted by most of the authors

False – 11 of 13 authors issued a retraction of an interpretation [that MMR vaccine causes autism]. This interpretation is not provided in the paper. While it remains a possibility, a possibility cannot be retracted.

  • the work is discredited

False – Those attemping to discredit the work have relied upon the myths above. The findings described in the paper are novel and important.

To Contents

AUTISM – US Court Decisions and Other Recent Developments – It’s Not Just MMR

[Blue added 15/Jan/09]

In February 2008, award winning best selling author David Kirby broke the story of the case of Hannah Poling and how the US Department of Health and Human Services secretly conceded [ie. there was no need for a hearing] in a US Federal Court case that Hannah’s symptoms of autism were caused by the nine vaccines [ie. not just MMR] which she received in one day [The Vaccine-Autism Court Document Every American Should Read – David Kirby – Huffington Post – February 26, 2008].

The official HHS position is that they conceded [whether frankly or spin] that vaccines caused Hannah’s autistic symptoms by exacerbating an underlying mitochondrial disorder. The case put the issue high up the US political agenda and continues to receive coast-to-coast media coverage in the USA [but almost total silence in the UK]. CNN lists the autism issue in its top ten US health stories of 2008:-

#2 – Autism  – “Debate over the causes of autism continued to rage after a court decided to compensate a family whose daughter developed the disorder after receiving childhood vaccinations” – Autism in CNN’s 2008 top ten US health stories

But Hannah’s case is not isolated and her “underlying” mitochondrial dysfunction appears not to be as rare as the US HHS would like us to think [Explaining Vaccines Autism & Mitochondrial Disorder].  And other cases have been made public [see below for details of another three involving MMRbut we do not know how many cases have been settled quietly, as Hannah’s case was before it became coast-to-coast news in the USA throughout 2008].

US Autism prevalence was put on the US presidential political agenda by all US presidential candidates in 2008:-

US President Barak Obama: “We’ve seen just a skyrocketing autism rate. Some people are suspicious that it’s connected to the vaccines. …. The science right now is inconclusive, but we have to research it.”  Obama Climbs On The Vaccine Bandwagon” – April 22, 2008 – David Kirby, Huffington Post]

You do not want to bring your children into the world where we go on with the number of children who are born with autism tripling every 20 years, and nobody knows why,Bill Clinton said.

In addition to the Hannah Poling case, the US Court also ruled last year in favour of a little boy Benjamin Zeller, deciding that as a result of the MMR vaccination received on 17 November 2004, Benjamin, suffered persistent, intractable seizures, encephalopathy, and developmental delay [US Court Rules In Favour Of Family In MMR Vaccine Case Ben Zeller J].

  • the judgement states the US Department of Health and Human Services had no alternative explanation beyond “Unconfirmed  speculation by a few treating doctors, as with Dr. Wiznitzer’s hypothesization
  • the standard of proof being applied in this US Court is identical to that in the English Court.
  • just like the English Court, these cases are decided by judge alone sitting without a jury [and that means better decisions on fact and evidence – no decisions from jury sympathy for the claimant]

In Banks v. HHS (Case 02-0738V, 2007 U.S. Claims LEXIS 254, July 20, 2007) MMR vaccine administered in March 2000 and the child was diagnosed with Pervasive Development Disorder [ie. Autistic Spectrum Disorder] secondary to acute disseminated encephalomyelitis (ADEM).  There have also been other reported cases.  Michelle Cedillo’s case was one of the first three test cases.  Michelle’s was a test case of whether Thiomersal and/or MMR vaccines were the cause of her autism and panapoly of other disorders. 

The three test cases were unsucessful with judgements given in early 2009.  Michelle Cedillo’s MMR case is under appeal.  Just as The Sunday Times Journalist Brian Deer published stories in the UK immediately before the English Court judgment by Judge Davis  [brother of Glaxo Director and Lancet CEO Crispin Davis]  Deer published again, visiting the USA the week of the US Court decision.  He had been also selectively passing documents about the UK litigation to the attorneys for the US defendant the Department of Health and Human Services. [Amended red 18/Jan/10].

The high and rising prevalence of autism brings into stark question the risk-vs-risk ratio of disease-vs-vaccines.  In a recent authoritative peer refereed study [January 7, 2009] researchers at the UC Davis M.I.N.D. Institute has found that the seven-to-eight-fold increase in the number of children born with autism in California  since 1990 cannot be explained by either changes in how the condition is diagnosed or counted — and the trend shows no sign of abating: [Press release “UC Davis M.I.N.D. Institute study shows California’s autism increase not due to better counting, diagnosis”  – full text of study found here – “The Rise in Autism and the Role of Age at Diagnosis” Epidemiology 20:1 January 2009].  This authoritative new US study shows:-

  • the substantial increase in autism is real and
  • must be caused by environmental factors and cannot be genetic
  • cannot be explained away as better diagnosis and greater awareness

New figures from the US show a doubling of autism in 5 years [ie. 2002-6 – see Table 1].  This represents US government tax dollars paid out.

TABLE 1 – USA SOCIAL SECURITY AUTISM FIGURES 2002-6

SSI RECIPIENTS
COUNTS FOR ADULTS AND CHILDREN
RECEIVING BENEFITS
FOR AUTISTIC & OTHER PERVASIVE DEVELOPMENT DISORDERS
AS OF DECEMBER IN 2002 – 2006
As Of December In Year Children 21 and under Adults 1/ All Recipients
2002 38,324 7,360 45,684
2003 44,076 9,282 53,358
2004 51,581 11,450 63,031
2005 59,479 13,647 73,126
2006 68,050 16,190 84,240
1/ INCLUDES PERSONS AGE 65 AND OVER WITH CLAIM TYPE = DISABILITY.

The US Inter-Agency Autism Coordinating Committee (IACC) has voted to recommend earmarking millions of dollars in research funds from the Combating Autism Act of 2006 to study the possible role of vaccines in the causation of autism – [“Top Federal Autism Panel Votes For Millions in Vaccine Research” – David Kirby – The Huffington Post – January 5, 2009].

Further recent news from the USA indicates US President Barak Obama is serious on the vaccines-to-autism  issue [“TV’s Gupta Chosen for US Surgeon General” – By Ceci Connolly and Howard Kurtz – Washington Post Staff Writers  – Wednesday, January 7, 2009].

This CNN interview by Dr Gupta openly discusses vaccines causing autism – if this was BBC Panorama everyone would be shocked – CNN’s Dr. Sanjay Gupta interviews Dr. Jon Poling.

And in another interview, Gupta interviews the Director of the US Centers for Diseases Control on the same issues: CDC Chief Admits that Vaccines Trigger Autism

And what is the British Department of Health doing about this?  It seems nothing whatsoever, even though at the Parliamentary and Scientific Committee 17th June 2008 MPs and Peers heard Cambridge autism expert Professor Simon Baron-Cohen concede to a questioner that more research into the vaccine/autism connection is needed and that a recent study indicates autism costs the UK £28 Billion pa.  The £28 billion figure includes hidden costs, like costs of people taken out of the economy, whether those affected or their carers.  [LSE “Economic Consequences of Autism in the UK” – Study by team led by Professor Martin Knapp [Executive Summary] [NB. The main defect in the research is the assumption there are 433,000 are adults (aged 18 and over) who have autistic spectrum disorders.  We have the research to show there are approximately 107,000 children but there is not such a number of adults, the 433,000 being a projection based on the numbers of children.]

Here are some of the politics and cronyism of Labour’s approach to burying the autism problem. Surprisingly, we do not have any official “body count” of autistic children and adults. All we have is the “first ever” prevalence study commissioned by the DoH in 2008 [announced by Ivan Lewis] but seemingly involving “Tony’s Cronies”.  “Department of Health announces adult autism strategy” – Thursday, 8-May-2008.

The study is to find all the adult autistics who should exist [to prove autism has always been this high] and is not due to report until this year. Minister Tessa Jowell’s first husband and New Labour stalwart, Roger Jowell’s old company, NatCen is involved.  NatCen (The National Centre for Social Research) is billed as a “not-for-profit” company and works almost exclusively for government and governmental organisations. : [“University of Leicester to lead audit of adults with autism” Eurekalert – 9-May-2008].

To prove autism has always been this high the authors must find approximately 400,000 adult autistics in the UK and their assumed approx 400,000 carers. But there cannot be that many.  Office for National Statistics figures show the total number of adults caring for a dependent adult or relative in September 2001 for any reason was 326,000: [Data source: “Census figures Table 1-7 “The economically inactive who look after the family or home“]

Measles Comparison

See here how the risk to children in Western economies from measles is now insignificant for the vast majority MEASLES MORTALITY UK & USA.

To Contents

Vaccines, Autism and Your Child’s Allergies

[New Exclusive Worldwide Revelations 22/Jan/2009]

In addition to the new MMR vaccine, in 1990 infants were also “hit” with the “accelerated” DTP vaccine schedule – receiving three DTP shots – one each at 2, 3 and 4 months.  Prior to this the intervals were 3, 5 and 9 to 12 months of age. The DTP vaccine contained a highly neurotoxic ingredient.  The ingredient was an organo-mercury excipient called “Thiomersal” [“Thimerosal” in the USA].   Thiomersal is toxic in parts per billion – in extremely small dilutions. The vaccine was The Wellcome Foundation’s Trivax AD DTP vaccine. The Wellcome Foundation is now GlaxoSmithKline.Thiomersal was first introduced by pharmaceutical company Merck in the 1930s and was not clinically trialled for safety in use in vaccines.

Research shows that children with autism appear to have deficient mechanisms for expelling toxins like mercury and it accumulates in the body.

Revealed here exclusively worldwide for the first time, information obtained under  the UK’s Freedom of Information law confirms the British MHRA [Medicines and Healthcare Products Regulatory Agency] has no data on how much Thiomersal was in Trivax AD DTP vaccine. Although the British DoH [Department of Health] claimed publicly to have known, that claim therefore appears incorrect.

Video: University of Calgary Faculty of Medicine – How Mercury Causes Brain Neuron Degeneration

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Your Child’s Allergies and Vaccines

Thiomersal is also known to induce allergy. Many children, in particular those with regressive autism, have serious problems with allergies.  Some have exceptionally high levels of IgE, [the allergic antibody immunoglobulin E].

Since the introduction of the accelerated DTP vaccination schedule in 1990 the prevalence of life-threatening food allergies in British children has also increased exponentially “Time trends in allergic disorders in the UK” R Gupta, A Sheikh, D P Strachan, H R Anderson, Thorax 2006;000:1–6.  Big rise in patients with deadly allergies – Jamie Doward, The Observer 16 Apr 2006.  Number of children treated for nut allergies soars Daniel Foggo, The Sunday Times April 2, 2006.

The date of the rise can be tracked back to 1990 using publicly available data. This increase has occurred in parallel with significant increases in other disorders like autism, asthma and childhood diabetes.

Thiomersal is a well recognised cause of allergies: [The European Agency for the Evaluation of Medicinal Products – Medicines Evaluation Unit – Safety Working Party Assessment of the Toxicity of Thiomersal in Relation to Its Use in Medicinal Product SCPMP/SWP/I898/1998 – 8 September 1998].

980908-emea-report-downloadable_1

980908-emea-report-downloadable_3

Thiomersal is not the only component of vaccines which causes allergy. Adjuvants are an ingredient in almost all vaccines and cause allergy. US biotech company BioSante’s CEO, Steve Simes said on the launch of their new adjuvant:-

The problem with most adjuvants is that they can cause allergies,” said Simes. “Ours might not be as potent as others, but it is safer.”

Last Update: 3:45 PM ET Apr 24, 2006

[Text added 24/Jan/2010]

And again revealed here exclusively worldwide for the first time is the recent British 2006-7 Parliamentary session House of Lords Science and Technology Committee Report “Allergy” [6th Report of Sesssion] makes no mention whatsoever ofany vaccine or of Thiomersal in vaccines or as being a cause of the exponential rise in childhood allergies which has occurred since 1990 in the UK [Amended 18/Jan/10].

The use of Thiomersal in other pharmaceuticals [eg. contact len cleaning fluid] has been strictly controlled in Europe: CPMP Position Paper on Thiomersal – Implementation of the Warning Statement Relating to Sensitisation. The European Agency for the Evaluation of Medicinal Products London, 21 October 1999 CPMP/2612/99]

Thiomersal contains 50% by weight of mercury.  There is no safe limit – only a “permitted daily/weekly tolerable” limit.  This is measured in parts per million per kilogramme of body weight.  Those limits apply when ingested in food]. This neurotoxic organo-mercury compound was injected directly into infants’ bodies at a time their bodies and nervous systems were developing the most rapidly at any time in their lives. The amount of thiomersal claimed to be in Trivax AD DTP vaccine was 50 millionths of a gramme injected directly into the body.

A 4 kilo weight 2 month old baby would have received in one injection 63 times higher than the permitted tolerable daily intake in food set by the US Environmental protection Agency and the UK’s Committee on Toxicity.

To protect infants the PTWI set by the UK Committee on Toxicity for intake of mercury compounds in food for women who are pregnant, or who may become pregnant within the following year, or for breast-feeding mothers is one tenth of a millionth of gramme per kilogramme of body weight per day – for a 9 stone woman [57 kg] that is 5.7 millionths of a gram per day.

Calculation of an infant’s daily and overall body burden of toxic mercury must also include the burden from environmental pollution.  [Sources include mercury in the air from power station emissions and in fish as a result of oceanic pollution by anti-fouling applied to ships’ hulls.  Mercury is liquid at room temperature and evaporates forming a toxic vapour in the air].

Also revealed here worldwide for the first time under Freedom of Information is that the British Government also had no data on Thiomersal content of many other vaccines around that time and some had more than claimed by the British government was in DTP.  Examples are Duncan Flockhart’s DTP vaccine – 130 millionths of a gramme  thiomersal per millilitre and Lister Institute Pertussis vaccine – 120 mcg/ml Thiomersal.  Accordingly, this brings into question how much was in Trivax AD DTP vaccine.

The British Government also hid this lack of knowledge from Parliament.  A further revelation made here exclusively worldwide for the first time is that British Health Minister Hazel Blears MP misled the English Parliament in 2001 when she said in a Parliamentary answer thatAll childhood vaccines licensed since 1986 which have ever contained thiomersal as an excipient are listed in the table” [to the answer]. [House of Commons Hansard Written Answers for 3 Jul 2001 (pt 19)]. The table contained no such details and listed only those vaccines granted a licence in the UK since 1993.

Julie Kirkbride MP had asked for the “vaccines …. licensed since 1986 which contain thiomersal.

If you are asked have you been licensed to drive your car since 2006, you will answer “yes” even if you have held a licence since 1980.  Blears’ answer was in fact the answer to the question of the “vaccines granted a licence since 1986 which contain Thiomersal”.

But, it seems mercury is not the only problem [See above – US Court Decisions and Other Recent Developments – It’s Not Just MMR].

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In Whom Can You Trust – [Added 24/Jan/09]

The British Government

The British Government claims Thiomersal was phased out of its childhood vaccines in October 2004 [but vaccine stocks may have taken longer to run down and how safe is what has replaced it?].

A previously confidential 1991 internal Merck memorandum published by the USA’s  Los Angeles Times shows the UK authorities had then known about the problem and were privately expressing concern to the vaccine manufacturer about the presence of mercury in vaccines.  This was along with Sweden, Japan and Switzerland: [‘91 Memo Warned of Mercury in Shots – By Myron Levin – LA Times – February 08, 2005].

So why did they take 13 years to do something about it and why did they and do they continue to tell the British public there is and was no problem when they knew there was and is?  And as vaccines also alter the functioning of the immune system, the removal of Thiomersal may well not be the only factor affecting the increases in autism, asthma, allergies and childhood diabetes.  [see above – US Court Decisions and Other Recent Developments].

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The US Centers For Disease Control and Drug Companies

On 7-8 June 2000, a confidential private meeting without public scrutiny took place between vaccine manufacturers’ representatives, 51 US scientists, and a representative of the World Health Organization.  This was to discuss a study by US Centers for Disease Control expert Dr Thomas Verstraeten of increasing doses of Thimerosal and neurodevelopmental disorders in children.  Verstraeten used US Vaccine Safety Datalink (VSD) data, an official US governmental data bank on the children from US health maintenance organizations (HMOs).

Verstraeten’s study showed a dose-response relationship between Thimerosal in vaccines and neurodevelopmental disorders in children that held up to rigorous statistical analyses.  This means Verstraeten’s study showed a causal association between the amount of Thimerosal in vaccines a child received and the extent to which the child developed the symptoms of impaired brain development .  These ranged from tics, speech impairment to symptoms of and full autism. The discussions can be read in the transcript of the Simpsonwood Conference obtained by US organisaton SafeMinds under Freedom of Information.

Three years later Dr Thomas Verstraeten, MD, MSc  [now working for GlaxoSmithKline Biologicals, Belgium] published a different paper in the journal Pediatrics: [“Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases“.  Verstraeten T, Davis RL, DeStefano F, et al.  Pediatrics.2003; 112 :1039 –1048].   The new paper included another set of data from a third HMO, reorganised the criteria for inclusion of children and restructured the patient groupings, and  a less than statistically significant link was demonstrated. It was heavily criticised by campaigners and concerned experts. Verstraeten published a vigorous letter in his defence in which he rejected any suggestion of impropriety: [“Thimerosal, the Centers for Disease Control and Prevention, and GlaxoSmithKline“]: PEDIATRICS Vol. 113 No. 4 April 2004, pp. 932.

What can be said about this?  When Verstraeten was a public official working for the US CDC there was a serious problem.  When Verstraeten was working for GlaxoSmithKline there was no problem.

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Independent Medical Professional Organisations

The US Institutes of Medicine published a report in 2001 on whether MMR caused autism [Immunization Safety Review – Measles-Mumps-Rubella Vaccine and Autism].

The IOM committee held closed meetings to discuss the report’s content and before considering the evidence.  A transcript of a meeting on 12th January 2001 was disclosed in Court proceedings [US District Court of Texas, Eastern District; Case #5:03-CV-141].

Here are some quotes from the transcript:-

  • [the Centers for Disease Control] “wants us to declare, well, these things are pretty safe on a population basis.” [p33]
  • We said this before you got here, and I think we said this yesterday, the point of no return, the line we will not cross in public policy is to pull the vaccine, change the schedule. We could say it is time to revisit this, but we would never recommend that level.   Even recommending research is recommendations for policy.  We wouldn’t say compensate, we wouldn’t say pull the vaccine, we wouldn’t say stop the program.” [p74]
  • we are not ever going to come down that it is a true side effect,” [p97]
  • Chances are, when all is said and done, we are still going to be in this category. It is just a general feeling that we probably still are not going to be able to make a statement,” [p123]

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What You Can Do

If you found this information helpful there are two things you can do about it.

Please share this page with others

  • email the links to this page to others
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    • on your website
    • on your blog
    • in comments on relevant websites and blogs
  • email them to health journalists and journalists from your local newspapers, TV and radio stations – [phone them for details of email addresses or look them up on the internet]

Here is a link for you to copy and paste :-

Secret British MMR Vaccine Files Forced Open By Legal Action

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UK Residents – Write To Your Politicians – Do It Now!

Write to your Member of Parliament with the link to this page. If you do not write to your MP, and do not keep on writing them, then don’t complain when politicians  do nothing.  Write to your Member of Parliament with the link to this page. It is their job to represent you.

Ask your MP to ask the UK’s Secretary of State to explain why the British Government allows officials of the UK’s Department of Health to cause the human rights of children to be violated.

To email your MP, all you need to know is your MP’s name.  MP’s email addresses are in the form:-

surname.initial@parliament.uk.

To find out who your MP is click on this link:-

http://www.writetothem.com/

_____________________________________________

Notes on terminology:-

In the US the official diagnostic definition of what we call “Autism Spectrum Disorders” or ASD are  instead called “Pervasive Development Disorders” or PDD for short.  That is under the “Diagnostic and Statistical Manual of Mental Disorders (4th edn)” or “DSM IV” for short.

“Autistic Spectrum Disorder” is the term applied internationally under the “ICD” or “International Classification of Disease”

Many refer to ASD and PDD as “autism” but “autism” is a subset of the spectrum and is often referred to also as “childhood autism”, “typical autism” and “Kanner autism”.  [The common behaviours like hand flapping, loss of eye contact and suchlike in young children are unmistakable, whereas other spectrum disorders like mild Aspergers Syndrome can be more difficult to diagnose.]

Copyright ChildHealthSafety 2009 – The authors hereby assert their moral rights.  All rights reserved.

LATEST NEWS – Lawsuit To Overturn US Compulsory Vaccination Laws [California]

Californians should know very soon if the Californian courts will issue an immediate urgent temporary Court restraining order against the new backdoor compulsory vaccination law [statute SB 277].  The evidence and procedure documents have been filed.  Some new Plaintiffs have been added.  Previously reported on CHS:

If the restraining order is granted it is just a temporary measure until the full case can be heard.  Winning or losing this application does not mean the final case is won or lost. It is just to keep things as they are until the full case is heard and a final decision made.

The filing of this amended case is reported on the Bolen Report in more detail:

SB 277 – First Amended Complaint For Declaratory, Injunctive And Other Relief… – Keeping Our Healthy Children in School… – By Consumer Advocate Tim Bolen

The new Court application can be found here:

FIRST AMENDED COMPLAINT FOR DECLARATORY, INJUNCTIVE AND OTHER RELIEF  

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA
ANA WHITLOW, Individually and as Parent and Next Friend of B.A.W. and D.M. F.-W., minor children; ERIK NICOLAISEN, Individually, and as Parent and Next Friend of A.W.N., a minor child; DENE SCHULTZE-ALVA, D.C., Individually, and as Parent and Next
Case No. 3:16-cv-01715-DMS-BGS

Judge Denies Temporary Restraining Order In Lawsuit To Overturn US Compulsory Vaccination Laws [California] – Hearing Not Taken Place With Defendants Present

As reported on CHS a lawsuit was filed in California on July 1 challenging the validity of California’s Senate Bill [SB] 277:  Massive Lawsuit Just Filed To Overturn US Compulsory Vaccination Laws [California]

SB 277 is in effect a law to introduce compulsory vaccination indirectly.

The lawsuit included an application for an immediate but temporary order without the Defendants and their Attorney’s being notified and present at a hearing and to restrain implementation of SB 277 until there is a hearing.

Under US law this can be done with evidence of immediate and irreparable injury, loss, or damage and of efforts to notify the Defendant and why the order should be granted without the Defendants being present and heard in Court.

San Diego Federal Judge Dana M. Sabraw has denied the application for the immediate restraining order without notice writing in her decision:

there are no allegations that any child is currently enrolled in a school and has been expelled or would face immediate expulsion if SB 277 is enforced”

However, that is clearly the nature and effect of SB277.  A judge can and in fact must take judicial notice of the law and can take judicial notice of the fact that California has children who are of school age and who do attend school.  The feared harm seems an inevitable consequence of the law for those who have not satisfied its requirements. 

On the other hand, to grant such an immediate temporary order without a hearing is a draconian step, so one might have some sympathy with the Judge not wanting to be appealed if an order were granted without there being evidence of specific individuals and their circumstances in support.

Not all applications for temporary restraining orders are made or heard without the Defendants or their Attorney’s being present.  More often they are made following a hearing.  In those rarer cases where there is extreme urgency and immediate risk of irreparable harm an application for an immediate order can be made and succeed without the Defendants being present or even knowing of the application.

However, in such cases, a hearing is normally held very soon after for the Defendants to be present and heard to decide if the order is to continue or not until there has been a full trial of the case. 

Similarly, a temporary order can still be made at a hearing with the Defendants notified and with their Attorneys present.

According to the Bolen Report, the Plaintiffs Attorneys will be pursuing the application for the temporary restraining order which obviously means filing the relevant evidence and confirmation of certifications required by law: Fed Judge Denies SB 277 TRO – Wants More Info…

That is likely to be at a hearing with all parties and their Attorneys present.

Here is the text of the Court’s decision:

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF CALIFORNIA

ANA WHITLOW, et al.,

Plaintiffs,

v.

STATE OF CALIFORNIA, DEPARTMENT OF EDUCATION, et al.,

Defendant.

Case No. 16-cv-1715 DMS (BGS)

ORDER DENYING PLAINTIFFS’ EX PARTE MOTION FOR A TEMPORARY RESTRAINING ORDER

This matter comes before the Court on Plaintiffs’ ex parte motion for a temporary restraining order (“TRO”) to prevent Defendants from proceeding with a foreclosure sale of Plaintiffs’ property.

Federal Rule of Civil Procedure 65(b)(1) allows for issuance of a TRO: without written or oral notice to the adverse party or its attorney only if:

(A) specific facts in an affidavit or a verified complaint clearly show that immediate and irreparable injury, loss, or damage will result to the movant before the adverse party can be heard in opposition; and

(B) the movant’s attorney certifies in writing any efforts made to give notice and the reasons why it should not be required.

Fed. R. Civ. P. 65(b)(1). Plaintiffs here have not served a copy of their motion on Defendants and have not claimed that they made any efforts to do so.

I. BACKGROUND

Plaintiffs are minors and corporations challenging the validity of California’s Senate Bill (“SB”) 277, which closes previously available personal belief exemptions (“PBEs”) to the general requirements that students seeking to enroll in California schools must be vaccinated. According to Plaintiffs, SB 277 violates their constitutional guarantee of the free exercise of religion under the First Amendment, in addition to other fundamental rights, without a compelling government interest. Additionally, they claim that even if the government shows a compelling interest, SB 277 is not narrowly tailored or the least restrictive means of achieving that interest.

Plaintiffs seek injunctive and declaratory relief from SB 277 to prohibit the enforcement of SB 277.

II. DISCUSSION

The purpose of a temporary restraining order is to preserve the status quo before a preliminary injunction hearing may be held; its provisional remedial nature is designed merely to prevent irreparable loss of rights prior to judgment. See Granny Goose Foods, Inc. v. Brotherhood of Teamsters & Auto Truck Drivers, 415 U.S. 423, 439 (1974) (noting a temporary restraining order is restricted to its “underlying purpose of preserving the status quo and preventing irreparable harm just so long as is necessary to hold a hearing, and no longer”). Injunctive relief is “an extraordinary remedy that may only be awarded upon a clear showing that the plaintiff is entitled to such relief.” Winter v. Natural Res. Def. Council, Inc., 555 U.S. 7, 22 (2008). The standard for issuing a temporary restraining order is identical to the standard for issuing a preliminary injunction. Lockheed Missile & Space Co., Inc. v. Hughes Aircraft Co., 887 F. Supp. 1320, 1323 (N.D. Cal. 1995). A party seeking injunctive relief under Federal Rule of Civil Procedure 65 must show “‘that

he is likely to succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in his favor, and that an injunction is in the public interest.’” Am. Trucking Ass’ns v. City of Los Angeles, 559 F.3d 1046, 1052 (9th Cir. 2009) (quoting Winter, 555 U.S. at 20).

Here, the Court need not reach the merits of Plaintiffs’ request, as it is facially and procedurally defective. In support of their motion, Plaintiffs state that “special education students in year-round IEP Programs face immediate expulsion.” Upon reviewing the motion, complaint, and attached affidavits, there are no allegations that any child is currently enrolled in a school and has been expelled or would face immediate expulsion if SB 277 is enforced. TROs are intended as a remedial measure to prevent harm before an adverse party can respond to a request for preliminary injunction. Here, there appears to be no harm to any plaintiff until the fall semester.

Additionally, Plaintiffs have failed to certify any efforts to serve the TRO or a preliminary injunction on Defendants. Without evidence of either frustrated attempts to notify Defendants or reasons why such notice should not be required, Plaintiffs have failed to comply with the plain language of Rule 65(b)(1). In addition, in the absence of an immediate and irreparable injury, Plaintiffs are not entitled to a temporary restraining order.

III. CONCLUSION

For these reasons, Plaintiffs’ ex parte motion for a temporary restraining order is denied.

IT IS SO ORDERED.

Dated: July 5, 2016

_____________________________

The Honorable Dana M. Sabraw

United States District Judge

How Crooked is The UK’s Drug Safety Regulator, The MHRA – The Story of Patient Reporting of Adverse Drug Reactions

This is the story of how the UK’s Medicines and Healthcare Products Regulatory Agency [MHRA] blocked the Ministerial mandated introduction of direct reporting of adverse drug reactions by patients.

Does this sound at all crooked to you?

Some History

A few years before the following events occurred a 1996 study in Holland showed that direct patient telephone reporting of adverse drug reactions [ADRs] can give up to 15 months earlier warning of problems than reliance on substantially under reported ADRs from medical professionals and coroners: Toine et al, 1996 Can adverse drug reactions be detected earlier? A comparison of reports by patients and professionals BMJ 1996;313:530.

The UK continues to have a system of adverse drug reaction monitoring which is claimed by some to be excellent but which is known to be inadequate. Dr Bill Inman, a retired Professor of Pharmacoepidemiology, University of Southampton, UK, pioneered the system of spontaneous reporting of adverse drug reactions (‘yellow card’) and of prescription event monitoring.  The Yellow Card scheme was a response to the 1960s Thalidomide drug scandal which left many children born with serious deformities including no arms or legs. 

The Yellow Card system could long ago have been improved but was not.  For example Dr Inman considered that there are no national systems in place which might prevent another tragedy like thalidomide: for which a database of pregnant women’s drug histories is critical. The lack of medium-term and long-term (25 years) follow-up for cancer treatments was another concern and he thought the World Health Organistion should be more active in that: “Profile of Bill Inman – Yellow Cards and Green Forms WHO Uppsala Reports 27 October 2004http://www.who-umc.org

What Was Meant to Happen in the UK

UK pilot trials for direct patient reporting were announced on 18 November 2002 by what is now the MHRA:

Lord Hunt [a Health Minister] …. announced his intention to introduce a scheme to allow patients to report adverse reactions through NHS Direct and NHS Direct Online in the New Year.”

Professor Alasdair Breckenridge, Chairman of the Committee on Safety of Medicines, said in relation to the extension of the Yellow Card scheme to nursing and other staff:

Doctors up and down the country know the Yellow Card goes hand in hand with improving what we know about drugs and how they are used. And now a new generation of reporters to the scheme – nurses, midwives and health visitors, including nurse prescribers, in the frontline of patient care – will be able to play a full part in making sure that we keep learning and that patients benefit from experience.’

Six months later on 8th May 2003, another MHRA press release stated:

Health Minister David Lammy has announced the first phase of patient reporting of suspected Adverse Drug Reactions (ADRs) via NHS Direct.

The NHS Direct call centre in Beckenham, covering South East London, has become the first centre in the country to introduce patient reporting of ADRs.

Subject to experience at the first call centre, the intention is to roll out the new service to all 22 NHS Direct call centres throughout England.”

Minister David Lammy was quoted:

Today marks an important step in putting patients in England at the heart of systems for promoting and protecting public healthcare by enabling them for the first time to report suspected ADRs.

Rather than having to go to a GP, patients can quickly access advice and report reactions that can help to improve our knowledge of the safe use of medicines.’

Professor Alasdair Breckenridge who was by then the chairman of the MHRA, was also quoted in the press release as saying:

The Yellow Card Scheme has been the cornerstone of monitoring drug safety for nearly 40 years.

We now plan to roll out across England a new service offered by NHS Direct.

This will enable patients to contribute directly to the Yellow Card scheme by reporting their own ADRs. We will be carefully monitoring the results of this pilot.”

[Professor Alasdair Breckenridge was previously the Chairman of the Committee on Safety of Medicines.  The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).]

What Really Happened

The MHRA under Professor Breckenridge’s Chairmanship wrested control of direct patient reporting of adverse drug reactions from the NHS and well and truly buried it.

The pilot trial was for the whole of SE London using what was then the NHS Direct call centre in Beckenham, Kent.  There were only 39 responses for the whole of South-East London in an entire year.

Dr Metters, the Chairman of the ‘independent’ review of the trial was reported in the British Medical Journal saying:

We can only speculate why participation has been so poor”

The truth was it was extensively unpublicised. The MHRA, in the person of Miss Carrie Scott Pharmacovigilance Co-ordinator Room 15-259 in a letter of 11th June 2004 ref: OG 04/43 to Social Audit admitted hardly anything had been spent promoting this scheme. In the letter she wrote:-

The MHRA has not incurred any significant costs due to this initiative. Advertising regarding the Scheme was limited to local press coverage. Due to the small number of reports received no costs were incurred in terms of staff resource.”

This was to cover the whole of South East London, an area with a population of several million people, and yet no significant costs were incurred.  Not even the local Beckenham GP surgeries or pharmacies appear to have had heard of it until some local GPs read an abridged news item in the paper version of the BMJ published Saturday 8th May 2004.  There were no posters in doctor’s surgeries or pharmacies; no patient ‘How To Report’ leaflets; nothing.

The MHRA published FAQ, items 16-19 and particularly item 17 stated:-

the number of reports [39] suggests the Scheme is not universally popular and anecdotal feedback suggests patients would prefer to report direct to the MHRA.”

There were only 39 reports because hardly anyone knew about the scheme.

The UK satirical and political commentary magazine Private Eye reported in an article titled “DRUG SAFETY Yellow fever” 29th May 2004:

But Metters and others should not have been surprised by this. Hardly anybody in the area had heard of the scheme – not even doctors or pharmacists. As one resident said: “My own local GP surgery did not know about it until they read about it in last week’s BMJ.” And as a pharmacist put it: “What scheme? Never heard of it.”

The current next-to-useless drug safety system whereby doctors fill in a yellow card if they suspect a drug or vaccine has caused an adverse reaction, certainly needs improving: it picks up only a tiny fraction of bad reactions.

While NHS Direct would have been an ideal body to collate reports of adverse incidents Metters and colleagues have seized on Beckenham’s “poor response” and suggested that reporting might be improved if patients have direct access to the new Medicines and Healthcare Products Regulatory Agency (MHPA). Unfortunately this would mean that information, and control of that information, would go straight to the body which, with its advisory arm, the Committee on the Safety of Medicine, has been criticised for its secrecy, conflicts of interest and past failings.

Key figures on both bodies have consultancy research, financial or employment links with the big drug companies. For example, the MRHA’s top man is Professor Sir Alasdair Breckenridge, who used to advise GlaxoSmithKline, the manufacturer of the antidepressant Seroxat. It was the failure of the drug regulators to warn doctors earlier about potential problems associated with Seroxat that led to the recent resignation in protest of Richard Brook, the lay member on the CSM.

The scandal prompted Charles Medawar of consumer group Social Audit and author of Medicines Out Of Control to suggest that it was Sir Alasdair who should have resigned. But he didn’t. 

The MHRA also announced:

The MHRA intends to get direct patient reporting up and running as soon as possible.”

But it was already up and running, at NHS Direct. All they needed to do was tell people about it like notifying the GPs and pharmacies and produce the leaflets and publicise it.

As Social Audit noted, there was still after the MHRA intervened with their own system no provision for direct patient reporting via the electronic yellow card scheme. The Scheme invites reports from by doctors, dentists, pharmacists, coroners, radiographers, optometrists and nurses, and expressly confirms no provision has been made for direct patient reporting.

It is not sound to put the MHRA in charge of the information which can show it has been failing in its duties to protect the public.  But that is what happened and the MHRA played its part in making that happen.

There is now a system for patients to report Yellow Card adverse drug reactions online but who knows about it?

European Medicines Agency Condemned Over Dangerous HPV Vaccines – By Respected International Medical Scientific Organisation

The following account is of extraordinary developments in the battle against corruption in drug safety, so settle yourself down and prepare for some surprises and for confirmation that what you already know or suspect is still at least as bad but more likely far worse than ever.

Corruption in governments and their agencies is so widespread in the 21st Century that it is regrettably the case that organisations like the European Medicines Agency [EMA] can sometimes truly, fairly and justifiably support an opinion they can be described as “crooked“.  This example seems to point in that direction. 

Observed to Expected analyses were a significant part of the EMAs clearing of the HPV vaccine.  A previous example showed the EMA for 16 years continued to accept a calculation of the Observed to Expected ratio of deaths of infants reported compared to those expected which was a factor of three times out and when fully corrected for all other factors showed a significant excess of deaths in the vaccinated group: Vaccines Proven To Cause Sudden Death in Children – 67 Deaths Only Explicable As Caused By Vaccines – Drug Safety Regulators Had The Information for Over 2 Years And Let Children Die.  The documents containing this information were leaked and had been kept confidential for over 16 years of annual reporting by the manufacturer.  The EMA keeps key information confidential which prevents public scrutiny and challenge.

At best that demonstrates a very high level of incompetence.  Essentially, they cannot be trusted, crooked or not.

Read on to answer this for yourself and see for yourself the evidence of how dangerous HPV vaccines are for you and your children.

Sadly this is conspiracy fact – not theory. The UK’s recent backlash vote to exit the corrupt undemocratic and institutionally economically and politically flawed European Union will fix none of that.

Some of the “Bad Guys

It is an open secret at the world renowned UK’s Great Ormond Street Children’s Hospital [GOSH] that the HPV vaccines are not safe.  Large numbers of British schoolgirls are routinely referred there for a variety of serious and less than usually-to-expected medical conditions following vaccination with HPV vaccines.  So it is hardly surprising when mothers discover routinely other mothers of girls with the same and similar serious medical conditions following HPV vaccination.

So have we seen public reports from GOSH reporting this phenomenon? No.  Why not?  What is wrong with these people?  Aren’t their patients meant to be able to trust their physicians?  Aren’t the physicians meant to tell them the truth so that they and their siblings and schoolfriends can avoid the harm?

The efforts of the UK’s Medicines and Healthcare Products Regulatory Agency [MHRA] to hide the adverse effects of HPV vaccines, were reported by CHS here:

UK Drug Safety Agency Falsified Vaccine Safety Data For 6 Million

The Danish Health and Medicines Authorities’ [DHMA] 17 April 2015 report on the EMA’s assessment of the HPV vaccine concluded that the benefits of the HPV vaccines outweigh the risks.  This was despite very high levels of under reporting of adverse events.  It was also despite the finding [as at 30 September 2014] of a total of 33 cases of Postural Orthostatic Tachycardia Syndrome (POTS) as a possible adverse reaction to Gardasil having been reported from 2006 to 2014. 

With the full extent of the problem not being reported DHMA claimed “it has not been possible to document a relationship between the vaccine and POTS“.  This is just one serious adverse reaction to HPV vaccines suffered by schoolgirls and women which go un and under reported worldwide.

The European Medicines Agency oddly had held an online video press briefing two weeks before their report was published.  This meant there was no opportunity for independent experts to review their claims in advance so that pertinent questions could be asked.  And that is just what they appear to be – claims.  Also troubling is the absence of hard detail and figures in the EMA’s report.  It is close to a narrative, telling a story of what they claim to have done and expecting everyone to believe them with no hard facts or data to make a judgment.  It is pretty much “we are the experts with all the information and what we say is what it is and we don’t care to prove it“.  One seemingly bizarre aspect was the claim to have carried out numerous analyses taking into account from 1% to 100% under reporting, aside from suggesting they have no idea how high the level of under reporting is.

The briefing can be viewed here.  It is worth watching, especially to see the people behind the report and for the press questions starting at 7 minutes and 45 seconds into the video:

How Modern Government, Its Institutions and Agencies Have Become Ever More Corrupt – but surprisingly – this time – the US Central Intelligence Agency are with the “Good Guys”!

Seemingly corrupt practices at the EMA are all part of a far too familiar story of a wider pattern of corruption in modern governments. 

Before considering the criticisms of the EMA, it is worth considering how far and how blatant this has come.  It puts it in perspective.  State agents too commonly now do whatever they want.

This pattern is set at the highest levels.  The now commonly reviled former UK Prime Minister Tony Blair demonstrated universally in the most public fashion how corrupt governments and their agencies have become in the 21st Century when he helped start a disastrous war in Iraq with false evidence of the Western territories being under threat within 40 minutes of launch of non-existent Iraqi weapons of mass destruction.

In the UK the long delayed Chilcot Inquiry report into the war is due to be published this week – conveniently further delayed until after last year’s UK general election to elect the UK government and Parliament: Iraq War report ‘delayed until after UK election’ BBC News 21 January 2015.

Blair’s false claims were repeated to the UN and world and believed. This enabled some of former US President George W Bush’s supporters to become even richer from US tax dollars on the back of the lives and bodies of US GI’s, British servicemen and women, and an estimated hundred thousand [or more] moslem’s by supplying military ordnance and other support to this illegal war. Obviously, a small minority rather than the majority of Americans who supported Bush benefited.  It is hardly likely the vast majority did.

In parallel to Blair, President George W Bush’s administration was busy fabricating evidence to the same ends.  That is a true life story told in the remarkable film “Fair Game” with excellent performances from actors Naomi Watts and Sean Penn as covert CIA operative Valerie Plame Wilson and her former US Ambassador husband Joe: Fair Game – review – by Philip French Saturday 12 March 2011 UK’s The Observer.

Remarkably, in “Fair Game” the CIA, Plame Wilson and her husband bucked the trend to be portrayed as the “good guys” working to prove the Blair and Bush claims were not true.

On the back of this endemic corruption in governments, social media is overrun by some trolls and bullies who bully, abuse and harass pretty much anyone and everyone who endeavours to expose the modern day corruption in science and medicine.  These are led and/or exhorted by loners like Dr David Gorski on his blog and the activities engaged in worldwide by some of those led and/or exhorted by the activities of non practising psychiatrist Dr Ben Goldacre: Dr Ben Goldacre, Online Abuse, Bullying and the Suicide of a Gentle British Doctor.

People like that distract effort and attention of ordinary people onto the internet and away from demanding answers and accountability of government, government agencies and politicians.  This dilutes public pressure and demands for public scrutiny of the drug industry by elected representatives and government officials.  At the same time it helps make the modern world the nasty place we all now have to live in and for Moms and Dads to raise their kids.

Some of the “Good Guys

Japan, Cochrane’s Nordic Centre and Louise Brinth MD PhD

Japan suspended the recommendation for Gardasil and Cervarix HPV vaccines for women because of large numbers of unexplained serious adverse reactions.

Louise Brinth, MD PhD of the Syncope Unit at Bispebjerg and Frederiksberg Hospital in Copenhagen, having published a number of papers on adverse reactions to HPV vaccines, wrote a December 15th 2015 response to the EMA’s Assessment Report on HPV vaccines of November 26th 2015 supported by the EMA’s plain language news release claiming the:

evidence does not support that HPV vaccines cause CRPS or POTS”

CRPS or “complex regional pain syndrome” is another of the many serious adverse events associated with HPV vaccines which go substantially under reported.

Essentially, Brinth criticises the EMA and sets out good evidence to support the view that HPV vaccines cause serious adverse reactions in children and adults.  Brinth however appears misguided and in error herself in the evidence upon which she relies, not that the HPV vaccines are a cause, but in underplaying the extent of their role in causing serious adverse events.  She with other internationally reputed and respected medical professionals make up for this later as you will see.

Brinth believes, as she wrote, that:

Vaccines are, within medical science, considered a global and groundbreaking health success. Through vaccination programs coordinated and implemented throughout the globe, diseases such as smallpox have been eradicated. Moreover, other infectious diseases have been reduced significantly with impressive impact on both mortality and morbidity worldwide.”

This shows that Brinth is a supporter of the sadly-for-children erroneous mainstream medical view on the safety and efficacy of vaccines, despite being misguided and lacking an appreciation of the falsity of that widespread canard – such as obtained from analysis of well-documented facts from over 200 years of official statistics.

Additionally, it is a certainty that Denmark under reports adverse events to HPV vaccines more so than they might be expected to.  Even Brinth’s report reveals a fundamental misunderstanding of when adverse events should be reported when she writes:

Denmark is a small country. Many patients who suspect that they suffer from side effects to a vaccine tell us that they have felt that their suspicion has been ridiculed or dismissed when presented to medical professionals. We have not reported all the patients who suspected to suffer from side effects as AER. However, if we had a suspicion that their symptoms could be related to the vaccine – and we could not dismiss this suspicion by finding other explanations for their symptoms etc – we reported it. We are obliged to do this by Danish law.”

Failing to report all suspected adverse events regardless of circumstances results in there being insufficient statistical data to judge whether there is a statistically significant signal against the background “noise” of events which are not adverse events. 

So even Brinth and her colleagues are part of the problem she complains about in her response to the EMA but again as you will see she makes up for this with the assistance of the Cochrane Nordic Centre and other respected mainstream vaccine experts.   But it does suggest that under reporting may be higher than might be expected.

This also however illustrates how defective the EMA’s analyses of adverse events to HPV vaccines are.  That is of course entirely usual for the EMA.  It appears an organisation less interested in protecting public health and more interested in making sure that potentially harmful and harmful-in-fact drugs are authorised and remain authorised to the financial profit of the drug industry.  Where do some senior EMA officials look to to get their next job when they retire from the EMA?  Surely not the drug industry perhaps?

So now enter onto the scene as part of the “good guys” the internationally respected Cochrane Nordic Centre and others with an extraordinary refreshing and excoriating 19 page complaint to and critique of the crooked EMA.  This is signed by:

  • Peter C Gøtzsche, DrMedSci, MSc, Director of the Nordic Cochrane Centre, Rigshospitalet, Professor, University of Copenhagen and co-signatories,
  • Karsten Juhl Jørgensen, Deputy Director of the Nordic Cochrane Centre, Rigshospitalet,
  • Tom Jefferson, Honorary Research Fellow, Centre for Evidence Based Medicine, Oxford OX2 6GG, United Kingdom
  • Margrete Auken, MEP (The Greens/European Free Alliance)
  • Louise Brinth, PhD, MD, Danish Syncope Unit, Frederiksberg

We suggest you read the whole document.  The following lengthy extract is from pages 12 to 17:

Are the vaccines safe?

According to the firms they are safe. Initially, the vaccine was compared with a placebo group being vaccinated with physiological serum, whereby the number of adverse reactions was much higher and much more serious than in the control group. After comparing 320 patients in the saline placebo group a quick move was made to an aluminium-containing placebo, in order to be able to only evaluate the effects of the active substance. However, this distorted the comparison, because no one voluntarily wants to be vaccinated with toxic aluminium, as this is not really necessary, when inoculation with a harmless saline solution can be done. The differences between Gardasil and the saline placebo group were, however, already noticeable15. Here we can refer to the Vioxx scandal, where the adverse reactions in fact were known, but concealed by the firm. Here also the difference between the vaccine and the saline placebo is concealed in all publications, as the table below clearly shows. For serious adverse reactions one suddenly takes the saline and aluminium group together, perhaps to cover up the major differences between these two groups.”

These two experts question seriously the prevailing assumption, apparently also at the EMA, that the vaccine is so important for public health that it is justified not to communicate to the public 1) that there are uncertainties related to vaccine safety, 2) that drug companies cannot be trusted; and 3) that it is wrong to lump together results obtained with a genuine placebo with those obtained with a potentially neurotoxic placebo. We agree with the two experts when they suggest that this lumping may represent a cover up and we also find that the EMA should have informed the public about this unacceptable lumping of a true placebo with an active placebo instead of keeping it secret. This is totally unacceptable and contrary to good scientific practice to such a degree that we consider it outright scientific misconduct committed by the EMA.

Conflicts of interest

According to laws of public administration in several European countries, people should never be in a position where they are being asked to evaluate themselves. For example, Danish law states (our translation):

“Anyone who works in the public administration is disqualified in relation to a particular case if he or she has a special personal or financial interest in the outcome … The person who is disqualified in relation to a case does not make decisions, participate in decision making or otherwise assist in the consideration of the case.”

1. The EMA asked the MAHs to provide “a cumulative review of available data from clinical trials, post-marketing and literature in order to evaluate the cases of CRPS and POTS with their product” … an analysis of the observed number of post-marketing cases of CRPS and POTS in association with their HPV vaccine in comparison to those expected in the target population, stratified by region, if available … a critical appraisal of the strength of evidence for a causal association with HPV vaccine for CRPS and POTS” (4, p5).

“The responses submitted by the different companies were assessed by the PRAC’s Rapporteur

(attachment 1) and Co-Rapporteurs (attachments 2 and 3) for this procedure. Before adopting a recommendation, the PRAC decided to convene the Scientific advisory group (SAG) on Vaccines and additional experts on vaccine safety, neurology and cardiology to provide an independent advice and responses to the questions below” (4, p5).

It is clear from its confidential document that the EMA relied heavily on the companies to come up with honest answers to highly complicated questions, and that the work of the EMA’s various assigned experts was not to control what the companies had done, but merely to discuss it (4). We find that this procedure provides poor protection of public health, particularly considering that there are so many egregious examples that companies have cheated by omitting major harms – including deaths – in their reports to the authorities (6, 10). We find it unacceptable that the EMA did not check the veracity of the MAHs’ work.

2. At a hearing about HPV vaccine safety in the Danish Parliament on 17 December 2015, which was video recorded (11), Enerica Alteri from the EMA told the audience that the EMA’s Scientific Advisory Group consisted of members who were independent. However, she also said that they had declared their conflicts of interest (her remarks on this point were not translated by the simultaneous translation). As stated above, we know from the confidential internal EMA report (4) that the members of the Scientific Advisory Group (SAG) are bound by a life-long secrecy clause that prevents them from discussing their disagreements in public. The EMA keeps it secret who they are and what conflicts of interest they have. We have been informed, however, by one of the persons who participated in meetings at the EMA, that some of the SAG members have financial conflicts of interest in relation to companies that sell an HPV vaccine, which means that they are not independent. Enerica Alteri told the audience that the HPV vaccine can prevent most, if not all, deaths from cervical cancer. She walked out immediately after her presentation with no excuse and did not take questions or participate in the panel discussion. This was perceived by some as being blatantly arrogant and counterproductive in terms of building trust in the vaccine and in the EMA.

We find it totally unprofessional and misleading to the extreme to suggest that the HPV vaccine can prevent all deaths from cervical cancer. Such a claim would not have been tolerated by the EMA if it had come from one of the manufacturers. The different vaccines don’t protect against infection from all HPV strains, only from 70%, 80% and 90% of the strains, respectively, and the vaccines are not 100% effective against the targeted strains (2).

We also find it inappropriate to use experts with financial ties to the manufacturers, as it is always possible to find experts without such conflicts.

………

4. We are aware that some of the top officials at the EMA have failed to declare their conflicts of interest in relation to the work they do at the EMA, although they have a legal obligation to do so. For example, the EMA’s director, Guido Rasi, declared on 20 July 2015 that he had no conflicts of interest (14). On a form called “EMA Public Declaration of Interests,” he replied “none” to all four questions, also to question 4, which is: “Other interests or facts whether or not related to the pharmaceutical industry4 which you consider should be made known to the Agency and the public, including matter relating to members of your household5.”

However a Guido Rasi, which we assume is the same person, holds a number of patents, some of which were filed or approved in 2012 or 2013, and where the applicant was a drug company (Applicant: SciClone Pharmaceuticals, Inc.; Inventors: Guido Rasi, Enrico Garaci, Francesco Bistoni, Luigina Romani, Paolo Di Francesco) (15). As they go back less than five years, we believe he should have declared them, according to the EMA’s regulations concerning the handling of declared interests of its employees (16).

Final remarks

We find that the EMA’s requirement of life-long confidentiality is absurd. All available material about suspected harms of a public health intervention directed towards healthy children should be accessible to anyone. The EMA’s internal report (4) and all other documents related to this case should therefore be made publicly available, without redactions. We did not find any commercially confidential information anywhere in the documents we reviewed.

The American College of Physicians found that 89 cases of premature ovarian failure reported for HPV vaccines (86 for Gardasil and 3 for Cervarix) versus no reports for other vaccines were sufficiently alarming to motivate an alert in January 2016 making physicians and the public aware of a possible link (17). The confidential EMA report mentions in one sentence that the vaccine is under increased surveillance for this possible harm, but the reason is not given: “Adverse events related to potential immune-mediated disease (piMD) following vaccination with Cervarix, as well as primary ovarian failure are currently under close safety surveillance and in depth discussed in PBRER” (4, p175, or 63/77 in the subdocument). In response to an “Expert Submission to EMA relating to absence of ovarian safety research 17-10-2015” (7, p.110), the “Assessor’s comment” is: “This document contains an argumentation that the “ovary safety research” undertaken with the HPV vaccines is insufficient. Ovarian safety is beyond the scope of this referral, and will therefore not be commented in detail. Nevertheless, in October 2013, the PRAC finalised a review of Premature ovarian failure for Gardasii/Silgard. The PRAC concluded that the available evidence did not support a causal association.” There is nothing about this important potential harm in the EMA’s official report (2) although it is widely suspected that the possible severe toxicity of the vaccine is autoimmune-mediated.

The EMA might also have considered that when doctors first alerted the scientific community to the possibility that Pandemrix, one of the pandemic influenza vaccines used in 2009-2010, could be related to the occurrence of narcolepsy in people with a specific tissue type, the reaction was to ridicule these doctors. It has now been firmly established that Pandemrix can cause narcolepsy, a very serious condition, up to several years after vaccination of children and adolescents, and that this disease is immune-mediated. However, there was nothing about this, neither in the EMA’s official report (2), nor in the confidential report (4).

The bottom line for the EMA seems to have been that the vaccine should be protected from criticism at all costs because it is believed to save lives by protecting against development of cervical cancer. One sign of this is that the text in the official report is nearly identical to the assessments of the rapporteur and the companies. However, this paternalistic attitude comes at a great cost. The EMA accepted uncritically substandard research performed by the MAHs and produced a superficial, substandard official report (2) that was clearly flawed and unrepresentative, considering the serious concerns raised in internal discussions, which were sealed by life-long confidentiality agreements. Unprofessional and defamatory criticism, such as the one the EMA raised against the Danish researchers, is not unknown to scientists but it is a serious threat to scientific progress and public health. Those who raise concerns should be complemented for their courage, even if their suspicions are later shown to be wrong. Indeed, it is a requirement by DMHA that Danish doctors raise concerns they might have. Unfounded criticism of whistleblowers from those at the top of the power pyramid are potentially highly damaging as it may prevent important concerns from being raised. Unfounded dismissal of signals from ADR reports as reported by the UMC also seriously undermines this central mechanism to monitor adverse drug reactions. These serious failures on behalf of the EMA could create a problem orders of magnitude greater than declining participation rates in HPV screening programmes. Should the concerns over possible harms of the HPV vaccine be confirmed, the trust in the EMA and in vaccines in general may be damaged beyond repair. In fact, we know that the EMA’s handling of the HPV controversy – pretending that we have sufficient knowledge when we haven’t – has already become a PR disaster. In Funen, the uptake of the vaccine decreased from 74% to 31% in just one year (18).

The EMA’s procedures for evaluating the safety of medical interventions – where the companies are by and large their own judges – need to be fundamentally reworked and all procedures and information should be made transparent to the public. Our societies should no longer accept that assessments of drug safety are left to companies with huge financial interests and to a drug agency that receives 80% of its funding from the drug industry.

The secrecy imposed by the EMA is not in the public interest. Drug regulators tend to have a narrow vision, either because of their remit or because they have become too close to the drug industry by their daily work, which often involves contacts with the industry, and by employment of people with long careers in the industry. As an example, the EMA’s director, Guido Rasi, has brought in a number of people from the drug company Sigma Tau that include Stefano Marino, his head of legal affairs. Rasi has worked with this company for many years and apparently owns several patents together with the company (15).

Public health is about the promotion of health and prevention of disease and disability through the organised efforts of society. This entails protection from harms and involves progression of knowledge in open collaboration. As far as we can see, the actions of the EMA in this case indicates that the agency is more concerned about protecting its own previous decisions and the vaccine than about protecting the citizens and giving them the option of choosing for themselves whether or not they would like to get vaccinated against HPV. Some people will prefer to avoid the vaccine, even if the risk of serious harm is very small, and some will prefer screening instead. It is not within the powers of regulatory authorities to deny citizens’ right to make informed choices about their own health by withholding important information. The citizens need honest information about the vaccine and the uncertainties related to it; not a paternalistic statement that all is fine based on a flawed EMA report (2).

Merck’s Ad Campaign Blames Vax-Safety Parents For Childrens’ Cancers

FiercePharma reports Merck holds parents accountable in new Gardasil ad campaign by Beth Snyder Bulik Jun 28, 2016.

With repeated claims about how effective the vaccine is, Snyder Bulik’s report makes no mention of the fraudulent efforts of the UK’s Medicines and Healthcare Products Regulatory Agency [MHRA] to hide the adverse effects of HPV vaccines, as reported by CHS here:

UK Drug Safety Agency Falsified Vaccine Safety Data For 6 Million

And it is of course impossible to know for about 20 to 30 years what effect if any these vaccines might have had – when those receiving them now will be at an age when cervical cancers do strike adults – particularly those over 40 years of age.

Nor does Snyder Bulik mention that the world of drug safety is now so crooked it seems well nigh impossible and a fool’s errand to try to find somewhere that is not crooked – if there is anywhere.

No mention for example is made in the FiercePharma report of the formal complaint filed by the internationally reputed Cochrane Centre.  Cochrane assesses the reliablity of allegedly scientific medical evidence.  In short, the naturally also crooked [what else?] European Medicines Agency, just like the US Federal Drug Administration does routinely, has been erasing from recognition the wide scale and very serious adverse effects of HPV vaccines on children and adults.  Not much of a surprise there.

The Cochrane Centre in Norway’s 19 page formal complaint can be found here:

Complaint to the European Medicines Agency (EMA) over maladministration at the EMA 26 May 2016 Nordic Cochrane Centre Trusted evidence. Informed decisions. Better health. Rigshospitalet,  2100 Copenhagen Ø, Denmark.

And that crooked company Merck has been caught numerous times engaging in outright fraud on a very large scale so it cannot be trusted on anything:

Merck Vaccine Fraud – 2nd US Court Case Over MMR Vaccine

More Fraud By Drug Giant Merck – US$650 Million

Albeit of course GSK is no stranger to fraud either:

GSK Fined US$3 BILLION – largest health fraud settlement in U.S. history

Anyone wanting to know more about the lack of safety of HPV vaccines is welcome to browse the CHS archives:

Useless FluMist ‘Flu Vaccine Dumped by US CDC – “poor/low effectiveness”

FiercePharma reports CDC shuns AZ’s FluMist, all but nixing U.S. sales this season writing:

In issuing its recommendation, the CDC’s Advisory Committee on Immunization Practices weighed “data showing poor or relatively lower effectiveness” from three previous flu seasons. In late May, the body received data showing that FluMist was just 3% effective in children aged 2 to 17 during the 2015-2016 flu season, compared with an estimated 63% effectiveness for flu shots. ACIP said “no protective benefit could be measured” from the nasal vaccine.

Flu vaccines are particularly useless vaccines especially for children who are at no major risk from this overhyped disease.  Children are given the vaccine supposedly to stop very old people catching ‘flu from them.  Of course with the widespread under reporting of adverse reactions and inadequacy of testing the extent of adverse effects on children is substantially undocumented – Hip Hooray for drug safety regulation – a fraudulent misnomer. 

Here are some previous CHS reports showing how useless ‘flu vaccines are for everyone:

Flu Vaccines

Australia Bans Flu Vaccine – Child In Coma – Many Hospitalised

Children Get Narcolepsy From Flu Vaccine – Confirmed in British Medical Journal

US Drug Company Released Deadly Virus In EU In Vaccine

New Flu Risk From Vaccine – “a very effective way to spread flu” – New Nasal Spray Vaccine

Piers Morgan Very Sick Days After USA TV Flu Shot Stunt Backfires – Piers Told “Don’t Ever Take A Flu Shot Again”

Children Risk Untested Flu Vaccines In Hyped Pandemic

“Children to Die” – Latest Flu Scaremongering

UK Fakes Flu Death Numbers

World Pandemic Health News Round-Up

Swine ‘Flu Jokes

“Don’t give children flu jab” says chief medical officer

US Docs “Children to Die” In Flu Non-Pandemic

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

New Study – Flu Vaccine Doesn’t Work

CBS News Investigation – Forced Swine Flu Vaccination Under Obama’s “National Emergency” Based on Wildly Exaggerated Statistics

Australian Government Dumps On Sick Kids Injured by ‘Flu Vaccine

Flu Vaccine Caused 3587 US Miscarriages & Stillbirths

Flu Vaccine Cripples Healthy US Cheerleader for Life

EU And Canada Flu Vaccine Ban – Not Reported By Press

Now UK Recalls Another Novartis Flu Vaccine – Agrippal – Recall Follows EU and Canadian Bans of Agriflu and Fluad Flu Vaccines

EU Flu Vaccine Bans Still Unreported – Medics Sick After Vaccine Refuse More

Most UK Medics Refusing Flu Vaccines – UK’s New Chief Medical Officer Resorts To Bullying

New York Times – Flu Vaccine Does Not Work – Yet More Research Says

 

Massive Lawsuit Just Filed To Overturn US Compulsory Vaccination Laws [California]

California’s Governor Brown signed into law the most stringent vaccine mandate in the United States  – SB 277 – on June 30, 2015.

The new law came into effect yesterday July 1, 2016.

On the same day a substantial lawsuit against 10 Defendants was filed electronically against this draconian unconstitutional and unnecessary US law by attorney Carl Lewis in the San Diego Federal Court on behalf of 10 Plaintiffs: six American Moms and Dads and four non profits.

Defendants include the State of California Department of Health, Department of Education, three Schools Districts, and one County Public Health Department (Santa Barbara), and their employees, some named individually, and others in a group.  [Further details appear below.]

US Health Fascism At Its Finest

As the California Coalition for Vaccine Choice explain, families that do not comply with Governor Brown’s one-size-fits-all vaccine mandate, will lose their State Constitutional right for a free and appropriate education in public and private K-12 schools. The use of licensed daycare facilities, in-home daycare, public or private preschools and even after school care programs are also included in SB 277.

School aged children, not up-to-date on every mandated vaccine, will be required to home school without options for classroom learning.

SB 277 eliminates a parent’s right to exempt their children from one, some, or all vaccines, a risk-laden medical procedure including death. 

In 2016, California parents will be forced to give their children more than 40 doses of 10 federally recommended vaccines. 

This open-ended vaccine mandate allows the State of California to add any additional vaccines they deem necessary at anytime. The only exemption available is a medical exemption that doctors deny to 99.99 percent of children under federal guidelines.  

Why is this important?  The drug industry has bought such a powerful level of influence in government, the media and health professionals that the serious adverse effects of vaccines have been and continue to be buried.  When children die or are seriously injured by vaccines it is commonplace these cases are not investigated properly or at all.  Medical professionals don’t report. Coroners commonly don’t investigate properly or the experts who testify don’t tell it as it is or both.

Vaccines have been promoted as necessary to control disease, safe and effective when none of these propositions stand up to proper scientific scrutiny.   But that holds no sway.  The drug industry promoted hype with its wide base of support in the medical professions and government has been so successful convincing the majority that those who turn to the facts are dismissed, personally attacked and subjected to widespread abuse and disparagement. 

It is not just the US and not just Dr Gorski.  Read here about the gentle British doctor who killed himself after years of abuse from some members of Dr Ben Goldacre’s BadScience forum: 

Dr Ben Goldacre, Online Abuse, Bullying and the Suicide of a Gentle British Doctor Posted July 1, 2016. 

As Europe’s seeming leading front man for this kind of online bullying, abuse and harassment, the now not-so-young Goldacre seems to have been set up some years ago with the image of irresponsibility, youthfulness and impetuosity specifically to appeal to the UK’s high school and university students.  On one view, it looks as if the now ageing Goldacre was a covert poster-boy for the UK drug industry; a never practising psychiatrist with a “BadScience” column in a UK national newspaper.

SB277 is also an example of how far US health fascism has come.  The US is behaving towards every US child, Mom and Dad and other citizen as it has to every Moslem and every Moslem country that hates the US.  Americans are seeing just a tiny little bit of why the US is so widely hated around the world. 

Get used to it.  For you all its vaccines today, with more just around the corner.  This is why the US Constitution’s right to bear arms is regrettably so important despite all the deaths which occur through gun crime.  It is sadly the option of last resort when government declares war on its own people. But this war is a war fought by buying up the media, by buying influence and perverting and corrupting government, politicians and institutions meant to protect not harm the citizen – like the US Centers for Disease Control.

The Lawsuit

Details have just emerged from Tim Bolen on the Bolen Report:

The Lawsuit Against SB 277 Has Been Filed…

It is called a “Complaint For Declaratory and Injunctive Relief – Temporary Restraining Order Sought.”

(1)  The Plaintiffs are asking the Court, in this case, to temporarily stop the enforcement of SB 277 until the issues brought to the Court, in the Motion, are finally decided, and then,

(2) on the findings, issue a Permanent Injunction against SB 277.

The background to the case is:

(1)  Effective July 1, 2016, SB 277 will bar children from attending any public and private school unless proof is provided that the child has received multiple doses of vaccines for ten enumerated childhood diseases.

(2)  SB 277 abolished the Personal Belief Exemption (“PBE”) to California’s school vaccination requirements and arguably eliminated an existing exemption from vaccination based on religious beliefs.

(3)  Forty-seven states currently allow either a religious or a conscientious/personal belief exemption from school vaccination mandates.

(4)  The California Supreme Court has long recognized that a child’s right to an education is a fundamental right guaranteed by the California Constitution. Laws that impact the fundamental right to education, and which are not narrowly tailored to serve a compelling state interest, are unconstitutional. As the court held in Serrano v. Priest 18 Cal 3d 584 at 606 (1971) “We indulge in no hyperbole to assert that society has a compelling interest in affording children an opportunity to attend school.”

(5)  The State has broad responsibility to ensure basic educational equality and to provide a statewide public education system open on equal terms to all.

(6)  Since 1961, California has allowed a philosophical exemption to vaccination based on one’s personal beliefs.

(7)  Since 1961, the number of vaccines and vaccine doses required for school attendance have dramatically increased.

(8)  Notwithstanding the increase in required vaccines and vaccine doses, PBE rates have always remained below four percent.

(9)  For decades, full vaccination coverage in California has remained well above 95% for each required vaccine.

(10)  Public health experts agree that 95% vaccination coverage meets or exceeds the levels of vaccination theorized to achieve herd immunity for infectious diseases for which vaccines are available.

(11)  California’s PBE rate has not exceeded four percent of the entire population of school children.

(12)  At the time SB 277 was enacted, according to the California Department of Public Health (“CDPH”), over 97% of California’s school-aged children were fully vaccinated for each of the vaccines required by SB 277.

(13)  Moreover, the overwhelming majority of the children with PBEs are selectively vaccinated. They received some, but not all of the required vaccine doses.

(14) Only one year before SB 277 was enacted, the Immunization Branch of the CDPH stated that “[v]accination coverage in California is at or near all-time high levels.”

(15)  At the time SB 277 was enacted, California had seen a 19 percent reduction in PBEs when AB 2109 (Pan, 2012) went into effect.

(16)  Notwithstanding declining PBE rates and historically high vaccination rates, SB 277 was enacted to permanently bar children who do not receive every dose of every mandated vaccine from all public and private schools.

(17)  Plaintiffs have thus been denied their fundamental right to an education guaranteed by the California Constitution.

Outcomes Sought From The Court

(1)  Declare unconstitutional and set aside SB 277 and its regulatory scheme;

(2)  Grant temporary, preliminary, and permanent injunctive relief prohibiting the enforcement of the unconstitutional ban on personal belief and religious objections and the restriction of medical choice exemptions;

(3)  Grant temporary, preliminary, and permanent injunctive relief immediately prohibiting the denial of school admission to the children of the individual Plaintiffs and all others similarly situated.

(4)  Award to Plaintiffs reasonable attorney’s fees, expert witness fees, and costs incurred in connection with this action; and

(5)  Grant such other and further relief as the Court deems just and proper.

Legal Grounds For The Action

(a) Infringement on Rights protected by the California Constitution,

(b) Infringement on Rights protected by the US Constitution,

(c) Violation of Federal Family Educational Rights and Privacy Act (FERPA),

(d) Violation of California Confidentiality of Medical Information Act, and

(e) Violation of California Information Practices Act, and Violation of California Health and Safety Code 120440.

For further details read the Bolen Report:

The Lawsuit Against SB 277 Has Been Filed…