MMR SCARE
DOCTOR FACES LIST OF CHARGES
The
Sunday Times (London) September 11 2005
Brian
Deer
THE doctor who
sparked a worldwide scare over the MMR vaccine faces
a six-week hearing before the General Medical Council
(GMC) over allegations of serious professional
misconduct, including dishonesty and intending to
mislead.
A list of
preliminary charges served on Dr Andrew Wakefield
alleges that his research, which purported to find a
possible link between MMR and autism, led to 11
different counts of misconduct.
It is claimed
in the papers that he acted unethically, in a manner
likely to bring the medical profession into disrepute
and against the best interests of autistic child
patients.
The GMCs
lawyers are halfway through a two-year inquiry into
events surrounding the publication in February 1998
of a paper in The Lancet, the medical journal,
written by Wakefield and 12 other doctors from the
Royal Free hospital in London.
The paper
triggered what was to become a worldwide alarm among
parents over the safety of the combined measles,
mumps and rubella vaccine. This was followed by
falling immunisation levels and sporadic outbreaks of
infectious diseases.
MMR
vaccination in Britain had been running at 92% but
after publication of the Lancet article fell to 78.9%
in the first half of 2003. The most recent figures
show a rise to 81.7%, although the figure for London,
the area with the worst take-up, is only 70.5%.
Following a
Sunday Times investigation last year, the authors of
the Lancet paper, except Wakefield, retracted the
claim of a possible link with autism. The journal
said it regretted publishing the paper.
The GMCs
inquiry, expected to conclude at a public hearing
next June, is understood to be investigating
Wakefields work with lawyers who were trying to
sue MMR manufacturers while he was apparently acting
as an independent researcher.
In the
original Lancet paper, the only evidence against MMR
were statements by the parents of eight children who
linked the vaccine with autism. The GMC is now trying
to establish how many of them were lawyers
clients.
At the heart
of the GMCs allegations is the conduct of
research carried out at the Royal Free following the
award of a £55,000 contract from lawyers in August
1996 to perform tests on 10 children for the Legal
Aid Board. Wakefield claimed last year the £55,000
contract was for a quite separate study.
This is called into question by confidential Royal
Free documents, including letters from Wakefield
himself.
These
documents indicate that the lawyers money was
initially rejected by the Royal Frees medical
school, but that Wakefield then arranged for the
hospitals management to accept it and to pay it
back to his research interests. The hospital has
denied any wrongdoing.
The GMC is
also understood to have put it to Wakefield that he
did not have approval from the hospitals ethics
committee either for including data on specific
children in The Lancet or for soliciting other
doctors to perform potentially hazardous tests, such
as lumbar punctures.
These
tests were, however, determined and routinely carried
out on the children who formed part of the study
without consideration of the individual history,
diagnosis, symptoms and clinical needs of the
children, and without an adequate evaluation of the
necessity of the tests, the GMC papers allege.
The purpose of
the research is alleged to have been to advance a
theory of Wakefields that live measles virus in
MMR damages the gut, allowing large molecules derived
from food to enter the bloodstream and then damage
the brain.
Other
allegations levelled at the 49-year-old former gut
surgeon include that he called for a boycott of MMR
without clear evidence that the vaccine could cause
harm; that he knew children were recruited to his
research through anti-vaccine pressure groups; that
he retained and used human tissues without consent;
and that he failed to answer questions from the
governments chief medical officer.
Sources
indicate that in recent months additional complaints
have been levelled at Wakefield by senior doctors and
scientists, questioning much of his research since
the early 1990s. These are understood to include
claims that MMR and related vaccines may be
responsible for the inflammatory bowel disorder
Crohns disease, and other research papers, in
The Lancet and elsewhere, making claims about autism.
Since leaving
the Royal Free by mutual agreement in
2001, Wakefield has worked mainly in America, where
he continues to campaign against MMR. He has also
started a business in Austin, Texas, to carry out
research on autistic children.
Wakefield,
through his lawyers, declined to comment this weekend
on the GMCs allegations, but it is understood
he denies any misconduct and insists he has acted
properly.
Earlier this
year he said through lawyers that the Lancet paper
was a report of findings of tests which had
been performed solely on the basis of clinical
need and therefore did not require ethical
approval. He denied any conflict of interest over the
legal funding.
A statement on
the website of his Texan company said this weekend:
Despite continued misrepresentations in the
media on his work, he and his collaborators continue
to focus on evidence-based medicine and the clinical
histories of the children that are affected.
The GMC
declined to comment on the documents but said
preparation of the case was continuing.
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