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BLOG: February 2010

 Who's afraid of a littl' 1998 study?

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

Wakefield's autism study, implying causative link between "environmental triggers", including vaccination, and "developmental regression", mainly autism, has been fully retracted by Lancet at the beginning of this month, after partial retraction (conclusion section) in 2004. The first question that comes to mind is: "Why did it take so long"? The second: "What was the reason?". -

 We are talking about quite small study, published in the Lancet in February 1998: Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children, Wakefield A.J. and 12 co-authors from Royal Free Hospital and School of Medicine, London.

It presented results of medical evaluation of a small group of children (12, 11 boys, 3-10y range, mean age 6y) who had normal development up to a point, when something caused it to stop. It was followed by loss of acquired skills, including communication, social and behavioral skills.

Another thing that the children had in common were chronic symptoms of gastrointestinal dysfunction, including diarrhea, bloating, food intolerance and abdominal pain.

Onset of symptoms was associated by the parents, or child's physician, with receiving MMR (measles/mumps/rubella) vaccine in eight of the children, with measles infection one, and otitis media (ear infection) in another.

(Some time following the study, according to Dr. Wakefield, parents of the child that previously associated its symptoms with otitis media, came forward saying that the symptoms become apparent to them after it received MMR vaccine, but they decided not to mention that after repeated negative reception of this observation by doctors they came to for help.)

After a thorough medical investigation, 9 of the children were diagnosed with autism, one with disintegrative psychosis and two with possible post-viral or vaccinal encephalitis. None had detectable pathological abnormalities of the nervous system. All 12 children received MMR vaccine, and 10 of them had reactions associated with it, ranging from rush, fever, and convulsion, to gaze avoidance, repetitive movements, self injury (e.g. head banging), and recurrent "viral pneumonia".

In one of two children w/o direct reactions associated with the vaccine, loss of speech development and deterioration in language skills were noted one month after vaccination; in the other, self-injurious behavior started two months after vaccination.

 All of the children have been diagnosed with chronic colitis (inflammatory bowel disease), and nine of them with reactive ileal and/or colonic lymphoid hyperplasia (swelling of the lymph glands in the intestinal lining).

This is the study conclusion (termed "interpretation" in the original text):

ABSTRACT: "We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers.", and

BODY: "We have identified a chronic enterocolitis in children that may be related to neuropsychiatric dysfunction. In most cases, onset of symptoms was after measles, mumps, and rubella immunisation. Further investigations are needed to examine this syndrome and its possible relation to this vaccine.".

This is a very brief history of what followed:

1998  study received moderate press coverage (122 articles)

2002  MMR vaccine safety subject re-emerges, scoring a total of 1,257 published articles; however, only about quarter of them mention Wakefield

2003  decline in U.K. MMR immunization rates that started in 1995 at 92% reaches its low point (79%)

2004, February 22nd  a story from freelance journalist Brian Deer appears in The Sunday Times, accusing Wakefield of undisclosed conflict of interest (working as a paid expert witness for litigation seeking compensation from vaccine manufacturers, with most of the children in the study being part of the litigation)

2004, March  10 of 13 study's co-authors issued a retraction of the interpretation that MMR is a possible trigger for syndrome described in the study

2004, November  in a BBC television documentary "MMR: What They Didn't Tell You", Deer alleges that, prior to the study, Wakefield applied for a patent on a vaccine that would rival MMR vaccine

2006  another Deer's story in The Sunday Times claims that Wakefield has been paid over ₤400,000 since 1996, for his expert work for the litigation against vaccine manufacturers

2007  at Deer's initiative (who acts as formal complainant), British General Medical Council (GMC), which is responsible for licensing doctors and supervising medical ethics in the UK, begins official investigation of Deer's allegations of professional misconduct against Dr. Wakefield, along with two other senior study co-authors, Professor John Walker-Smith and Professor Simon Murch (all three still standing by the study's original interpretation)

2009, February 8th  yet another Sunday Times story alleges that Wakefield had manipulated and misrepresented data to fabricate the link between MMR vaccine and autism

2010, January 28th  after 197 days, GMC panel of three doctors and two lay members rules that Wakefield acted "dishonestly" (for not disclosing conflict of interest), "irresponsibly" (for "conducting study without the approval of ethical committee"), and with "callous disregard" for safety of the children involved in his study (for performing "unnecessary invasive procedures")

2010, February 2nd  In response to GMC ruling The Lancet fully retracts Wakefield's 1998 study from published records

Now, this all seems to be too much of a commotion for a littl' study that did not claim any definite finding, and merely presented results of its investigation. And, by all professional standards, it has been properly designed and executed. Are we missing something? There were more than a few studies that could claim less than that, that had undisclosed conflict of interest, even those that were evident snow jobs, and

literally nothing has happened to their authors.

It is important to document this assertion, because it implies that the true reason behind indicting the three authors of this 1998 study for professional and ethical misconduct is not the possibility of misconduct, but something else.

What else? Following article gives some examples of the environment in which medical research and publishing are taking place these days.