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BLOG: February 2010

 The MMR vaccine war: Wakefield vs ?

The 1998 study - Code violation proceedings  - Wakefield vs. ?

The rant against Dr. Andrew Wakefield, started in 2004 with Brian Deer's media feeds, escalated to a full-blown campaign, not only very unusual in the circles of high-level medical professionals, but seemingly vastly outgrowing factual significance of his 1998 study. Whether the MMR vaccine - and even vaccines in general - do cause serious adverse health effects, or not, seems to have become solely dependant on whether or not Wakefield was honest in making and presenting this small study.

  As irrational as this shift of logic is, it did put a lot on stake. Or, should we say it the other way around: a lot has been put onto this mass perception, much more imaginary than factual. Hence there is much to gain by officially declaring Wakefield guilty, or even only by tarnishing his reputation.

What is it, exactly, that Deer accuses Wakefield of?

These are the main points, taken from the "Summary of Brian Deer's investigation into a threat to children's health" on his website:

allegations of serious adverse effects caused by MMR (measles, mumps, rubella) vaccine were triggered by Wakefield's 1998 study

it caused "unprecedented collapse in public confidence in the shot", causing U.K. vaccination rates to fall below safety level, resulting in reappearance of measles outbreaks

Wakefield further eroded public confidence, both in the U.K. and worldwide, by publicly stating that he considers a single (one at the time) vaccine safer

Wakefield's study did not have scientific goal and basis; instead, it was part of commercially motivated endeavor to produce evidence needed to win huge litigation case against vaccine makers

as witness expert in the litigation case, Wakefield was paid a total of ₤435,643 over the course of eight years, plus an initial grant of ₤55,000 awarded to him in 1996; the latter he used to fund the 1998 study, without declaring conflict of interest to Lancet prior to publication

a year preceding study publication, Wakefield applied for a patent on a vaccine that would compete with the MMR shot

most children participants were included in the study based on their parents being in litigation proceedings for vaccine damage compensation

Wakefield manipulated and rigged study data to create "the impression of a link" between MMR, bowel disease and onset of autism; study data doesn't match children's local hospital records

Wakefield subjected children to a battery of invasive procedures without obtaining the approval of the hospital's Ethics Committee

 Among these allegations, only four could possibly matter:

1 -  concealing conflict of interest,
2 -  study selection bias,
3 -  fixing/manipulating study data, and
4 - not having proper Ethics Committee approval.

The rest are indiscriminate accusations that may create impression of a "murky business" in causal readers (probably the majority), but indicate bad journalism to those who know some basic facts.

For instance, Wakefield's 1998 study cannot be reasonably implied as a trigger for allegations of serious adverse effects caused by MMR vaccine, considering that the study

does not claim that the causal link exists.

Wakefield's preference for single vaccines, expressed at a press conference, is a legitimate, educated opinion of a trained physician.

Accusing him of causing collapse in U.K. vaccination rates doesn't match the facts. The government data clearly show that the decline in vaccination rates started in 1995, three years before the study. The most significant decline was between 2000 and 2004. At the peak of U.K. MMR scare, in 2002, Wakefield was mentioned only in about one in four press articles. In any event, he cannot be held responsible for subjective perceptions, use or misrepresentations of the study data.

Wakefield's role of a paid expert witness for litigation seeking compensation for vaccine damages, or his patent application for a novel vaccine, does not constitute evidence of wrongdoing on his part.

So let's concentrate on these four possible code violations.

1 - Has he failed to disclose conflict of interest?

Not according to the data available. The Lancet paper was submitted before the ₤55,000 grant was even available (according to Wakefield, it was spent on another, 1999 study). As for his participation in litigation, it was reported in the national press 15 months before publication (A shot in the dark, The Independent 27 1997); Wakefield produced correspondence from February and March 1997 in which he notifies Prof. Walker-Smith (senior study co-author), Prof. A.J. Zuckerman (the head of department and the dean of the medical school) and the CEO of the hospital of his litigation activity.

On top of that, Lancet's 1998 rules were practically allowing the authors to decide for themselves what constitutes conflict of interests, and needs to be disclosed. The current strict standard begun developing in 2001. Wakefield cannot be responsible for breaking a standard that did not even exist at the time.

2 - Was there a bias in the selection of study participants that purposefully distorted study results?

According to the statement of Prof. Walker-Smith, children were referred, evaluated, and investigated on the basis of their clinical symptoms alone, following referral from the child’s physician.

3 - Did Wakefield tailor study results to fabricate even only possible link between MMR vaccine, gastrointestinal symptoms and autism?

When Wakefield complained to Press Complaints Commission about this allegation, The Sunday Times failed to present evidence to the Commission. Data discrepancies between prior routine clinical reports by various examiners and a single expert pathologist whose findings were used for the study can be expected, and do not per se constitute the evidence of manipulation.

GMC's ruling which is heavily - and likely unjustly, as will be explained in a moment - hitting Wakefield, does not mention data manipulation. This is another indication that there was none.

4 - Finally, did Wakefield subject children to invasive procedures unapproved by hospital's Ethics Committee?  

Not according to the Complaint to GMC filed on January 27. 2010 (Moody J., Complaint to GMC vs Horton R., Zuckerman A., Pegg M.,and Salisbury D.), only a day before GMC's ruling against Wakefield (which makes it all but certain that it wasn't considered in the ruling). It claims that the Ethics Committee has approved of collecting tissue samples as early as September 1995, in its approval letters, as Project 162-95 (placed in evidence by Dr. Walker-Smith, and submitted with the complaint).

The complaint alleges that Drs. Horton (Lancet editor), Salisbury, Zuckerman, Pegg, and Rutter, as prosecution witnesses at the GMC hearing, gave false testimonies, which denied Wakefield and the other two defendants, Walker-Smith and Murch, fair trial.

According to it, Dr. Horton, who testified that he didn't know for Wakefield's litigation involvement, and that Wakefield broke disclosure rules by not supplying it with the study, must have known for it (documentary evidence supplied includes a published letter from the reader raising the possibility of bias due to Wakefield's litigation involvement). Dr. Horton also applied inappropriate disclosure standard, which came into effect in 2001.

The complaint alleges that then Dean Zuckerman falsely denied his knowledge that Wakefield will, at a press conference accompanying publication, if asked, recommend single measles, mumps and rubella vaccines as a safety precautionary measure until the safety of triple MMR vaccine is examined (Zuckerman's letter to Wakefield instructing him to recommend the  monovalent vaccines at the post-publication press conference is submitted).

It also alleges that Dr. Pegg falsely testified that research biopsies in the study did not have the ethics committee approval, as noted above.

And it alleges that Dr. Salisbury mislead the public (and the GMC) by stating that MMR vaccine has an "exemplary record of safety" (two of the three MMR brands have been withdrawn for safety reasons, U.S. "vaccine court" is compensating vaccine autism claims since 1991, etc.).

Dr. Rutter, according to the complaint, gave false expert testimony voicing his opinion that Dr. Wakefield had the duty to disclose his litigation involvement to the Lancet. By the same standard, Dr. Rutter broke the ethics code by failing to disclose his own conflict of interests in this case, as a paid expert witness for vaccine industry - as well as for the U.S. government that acts as a defendant in the vaccine court (i.e. U.S. Court of Federal Claims) - in at least three major litigation projects.

Could Dr. Rutter be less than objective in this case? Judged on his comment on Wakefield's study cited in Brian Deer's Sunday Times article:

“Publication of a study claiming a casual relationship between measles, mumps and rubella (MMR) vaccine and autism spectrum disorders (ASD) sparked a heated debate...” (MMR doctor Andrew Wakefield fixed data on autism, February 8, 2009), yes, he could.

Coincidently, the spokesperson for the American Academy of Pediatrics and the Immunization Action Coalition, Dr. Ari Brown, expressed the same utter disregard of the fact that the study does not claim any causal relationships: “This flawed study concluded that the rise in autism was related to giving the combination vaccine of measles-mumps-rubella (MMR).”

Seems as if vaccine safety advocates are trying to create an icon of anti-vaccine movement (an inappropriate term, since most of the "anti-vaccine" movement is only concerned with making sure that they are safe), and

deliver to it decisive blow by tearing that symbol down.

Is Brian Deer's campaign to discredit Dr. Wakefield part of this strategy? No one can answer positively "yes", or "no", but it certainly appears to be a part of coordinated actions on the global level. His first Sunday Times article in 2004 appeared

just before a crucial English Court decision

throwing out UK children’s legal aid funding for vaccine-caused injuries (reportedly, only latter it was discovered that the Judge was the brother of a director of MMR vaccine manufacturer GlaxoSmithKline).

It was Deer himself who

initiated GMC proceedings against Wakefield in 2007,

acting as a complainant. He repeatedly denied that, but release of documents under the Freedom of Information Act produced incriminating correspondence.

According to his own website, Deer was directly contacted by, and assisted the U.S. Department of Justice, which acted as a defendant in the Cedillo proceeding, one of the three test cases for over 5,000 family petitions seeking compensation for vaccine-caused injury, in having Cedillo family denied by court's ruling on February 12 2009.

One presiding judge used Deer's allegations to undermine credibility of Cedillo's claim, stating that autistic enterocolitis theory, and Dr. Wakefield himself "have been strongly criticized as

constituting defective or fraudulent science".

That was a year before GMC had even ruled in their Wakefield proceedings.

Again, Deer's Sunday Times article, accusing Dr. Wakefield of altering study data (MMR doctor Andrew Wakefield fixed data on autism, February 8.) appeared with perfect timing,

just days before the court handed down the decision.


Oh, should we mention that James Murdoch, the Sunday Times owner, was appointed to the GlaxoSmithKline Board of Directors, effective May 20. 2009? It's a small world...

Does "autistic enterocolitis theory" really constitute "defective science", as one of the presiding U.S. Court of Federal Claims judges stated? Not really. There was long string of studies after 1998 - in fact, one of them year before (Walker-Smith et al, Ileo-caecal lymphoid nodular hyperplasia, ileo-colitis with regressive behavioural disorder and food intolerance: a case study, 1997) -

firmly establishing the link
between gastrointestinal disturbances and autism.

It is less clear when and how MMR, or other vaccines, become a causative factor. There is a number of studies that haven't found evidence of vaccine-autism link. But considering enormous influence of commercial interests in the research arena, that is not surprising.

A 2004 meta review of 120 MMR vaccine related studies, financed by the European Union, found that their data suggests link with autism "unlikely". But it also concluded that

"the design and reporting of safety outcomes
 in MMR vaccine studies ... are largely inadequate".

A 31 study review by Cochrane library came to similar conclusions.

In other words, we don't have evidence we can rely upon.

But that may be beginning to change. June last year, the U.S.  National Vaccine Advisory Committee approved a wide list of vaccine safety research recommendations. More specifically, studying vaccinated vs. unvaccinated groups of children for a number of outcomes, including autoimmune diseases, central nervous system demyelinating disorders, encephalitis, encephalopathy, complications from post-vaccine fever, and neurodevelopmental disorders,

including autism spectrum disorder.

It recommends to study effects of multiple, simultaneous and alternate vaccination schedules, as well as cumulative exposure to vaccine components.

It also recommends studying at-risk subpopulations, such as premature and low birth weight infants, those with immunodeficiency, autoimmune disorders, and children with inherited metabolic errors.

Much of these recommendations is what studies so far haven't been researching (one has to wonder what was it that they did research), and much of what "anti-vaccine" - or, rather, vaccine safety groups were advocating for years.

What these recommendations clearly communicate is:

we don't know nearly enough about vaccine safety

it is possible that vaccination carries risk for vulnerable sub-populations, and

we need better studies to establish the facts

So, the littl' 1998 study by Wakefield, Walker-Smith, Murch and colleagues may have been not that much off, and "scientifically defective", afterall. In fact, it probably did crack open new horizons, no matter how inconvenient to some, and earned becoming a symbol of the vaccine safety movement.

That also made it a target for some major "special interests".

Looking at the overall picture, seems as these interests did deliver some low blows in the undeclared "public relations" war - nothing unexpected, or new. But, this time, they may not be realizing what they are up against. They are on the collision course with the growing army of concerned, loving moms and dads, increasingly better informed, and less naive. They better watch out.



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