| Claims | A link between the measles, mumps and rubella vaccination and regressive autistic spectrum disorder |
|---|---|
| Year proposed | 1998 |
| Original proponents | Andrew Wakefield |
The Lancet MMR autism fraud centred on the publication in 1998 of a research paper titled Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children in The Lancet. The paper, authored by Andrew Wakefield, claimed to link the MMR vaccine to colitis and autism spectrum disorders. Events surrounding the research study and the publication of its findings led to Wakefield being struck off the medical register. The paper was retracted in 2010.
Characterised as "perhaps the most damaging medical hoax of the 20th Century", it led to a sharp drop in vaccination rates in the UK and Ireland. Promotion of the claimed link, which continues in anti-vaccination propaganda despite being refuted, led to an increase in the incidence of measles and mumps, resulting in deaths and serious permanent injuries. Following the initial claims in 1998, multiple large epidemiological studies were undertaken. Reviews of the evidence by the Centers for Disease Control and Prevention, the American Academy of Pediatrics, the Institute of Medicine of the US National Academy of Sciences, the UK National Health Service, and the Cochrane Library all found no link between the MMR vaccine and autism. Physicians, medical journals, and editors have described Wakefield's actions as fraudulent and tied them to epidemics and deaths.
An investigation by journalist Brian Deer found that Wakefield had multiple undeclared conflicts of interest, had manipulated evidence, and had broken other ethical codes. The Lancet paper was partially retracted in 2004 and fully retracted in 2010, when Lancet's editor-in-chief Richard Horton described it as "utterly false" and said that the journal had been deceived. Wakefield was found guilty by the General Medical Council of serious professional misconduct in May 2010 and was struck off the Medical Register, meaning he could no longer practise as a doctor in the UK. In 2011, Deer provided further information on Wakefield's improper research practices to the British Medical Journal, which in a signed editorial described the original paper as fraudulent. The scientific consensus is that there is no link between the MMR vaccine and autism and that the vaccine's benefits greatly outweigh its risks.
1998 The Lancet paper
In February 1998, a group led by Andrew Wakefield published a fraudulent paper in the respected British medical journal The Lancet, supported by a press conference at the Royal Free Hospital in London.
This paper reported on twelve children with developmental disorders
referred to the Royal Free Hospital. The parents or physicians of eight
of these children were said to have linked the start of behavioral
symptoms to MMR vaccination. The paper described a collection of bowel
symptoms, endoscopy findings and biopsy findings that were said to be evidence of a possible novel syndrome that Wakefield would later call autistic enterocolitis,
and recommended further study into the possible link between the
condition and the MMR vaccine. The paper suggested that the connection
between autism and the gastrointestinal pathologies was real, but said it did not prove an association between the MMR vaccine and autism.
At the press conference before the paper's publication, later criticized as "science by press conference",
Wakefield said that he thought it prudent to use single vaccines
instead of the MMR triple vaccine until this could be ruled out as an
environmental trigger; parents of eight of the twelve children studied
were said to have blamed the MMR vaccine, saying that symptoms of autism
had set in within days of vaccination at approximately 14 months.
Wakefield said, "I can't support the continued use of these three
vaccines given in combination until this issue has been resolved."
In a video news release issued by the hospital to broadcasters in
advance of the press conference, he called for MMR to be "suspended in
favour of the single vaccines". In a BBC interview Wakefield's mentor Roy Pounder,
who was not a coauthor, "admitted the study was controversial". He
added: "In hindsight it may be a better solution to give the
vaccinations separately,... When the vaccinations were given
individually there was no problem." These suggestions were not supported by Wakefield's coauthors nor by any scientific evidence.
The initial press coverage of the story was limited. The Guardian and the Independent reported it on their front pages, while the Daily Mail only gave the story a minor mention in the middle of the paper, and the Sun did not cover it.
Public controversy
The
controversy began to gain momentum in 2001 and 2002, after Wakefield
published papers suggesting that the immunisation programme was not
safe. These were a review paper with no new evidence, published in a
minor journal, and two papers on laboratory work that he said showed
that measles virus had been found in tissue samples taken from children
who had autism and bowel problems. There was wide media coverage
including distressing anecdotal evidence from parents, and political
coverage attacking the health service and government peaked with unmet
demands that Prime minister Tony Blair
reveal whether his infant son, Leo, had been given the vaccine. It was
the biggest science story of 2002, with 1257 articles mostly written by
non-expert commentators. In the period January to September 2002, 32% of
the stories written about MMR mentioned Leo Blair, as opposed to only
25% that mentioned Wakefield. Less than a third of the stories mentioned
the overwhelming evidence that MMR is safe.
The paper, press conference and video sparked a major health scare in
the United Kingdom. As a result of the scare, full confidence in MMR
fell from 59% to 41% after publication of the Wakefield research. In
2001, 26% of family doctors felt the government had failed to prove
there was no link between MMR and autism and bowel disease. In his book Bad Science, Ben Goldacre
describes the MMR vaccine scare as one of the "three all-time classic
bogus science stories" by the British newspapers (the other two are the
Arpad Pusztai affair about genetically modified crops, and Chris Malyszewicz and the MRSA hoax).
Confidence in the MMR vaccine increased as it became clearer that
Wakefield's claims were unsupported by scientific evidence. A 2003
survey of 366 family doctors in the UK reported that 77% of them would
advise giving the MMR vaccine to a child with a close family history of
autism, and that 3% of them thought that autism could sometimes be
caused by the MMR vaccine.
A similar survey in 2004 found that these percentages changed to 82%
and at most 2%, respectively, and that confidence in MMR had been
increasing over the previous two years.
A factor in the controversy is that only the combined vaccine is available through the UK National Health Service. As of 2010 there are no single vaccines for measles, mumps and rubella licensed for use in the UK. Prime minister Tony Blair gave support to the programme, arguing that the vaccine was safe enough for his own son, Leo, but refusing on privacy grounds to state whether Leo had received the vaccine; in contrast, the subsequent Prime Minister, Gordon Brown, explicitly confirmed that his son has been immunised. Cherie Blair confirmed that Leo had been given the MMR vaccination when promoting her autobiography.
Administration of the combined vaccine instead of separate
vaccines decreases the risk of children catching the disease while
waiting for full immunisation coverage.
The combined vaccine's two injections results in less pain and distress
to the child than the six injections required by separate vaccines, and
the extra clinic visits required by separate vaccinations increases the
likelihood of some being delayed or missed altogether; vaccination uptake significantly increased in the UK when MMR was introduced in 1988. Health professionals have heavily criticized media coverage of the controversy for triggering a decline in vaccination rates. There is no scientific basis for preferring separate vaccines, or for using any particular interval between separate vaccines.
John Walker-Smith,
a coauthor of Wakefield's report and a supporter of the MMR vaccine,
wrote in 2002 that epidemiology has shown that MMR is safe in most
children, but observed that epidemiology is a blunt tool and studies can
miss at-risk groups that have a real link between MMR and autism.
However, if a rare subtype of autism were reliably identified by
clinical or pathological characteristics, epidemiological research could
address the question whether MMR causes that autism subtype. There is no scientific evidence that MMR causes damage to the infant immune system, and there is much evidence to the contrary.
In 2001, Berelowitz, one of the co-authors of the paper, said "I
am certainly not aware of any convincing evidence for the hypothesis of a
link between MMR and autism". The Canadian Paediatric Society, the Centers for Disease Control and Prevention, the Institute of Medicine of the National Academy of Sciences, and the UK National Health Service
have all concluded that there is no evidence of a link between the MMR
vaccine and autism, and a 2011 journal article described the
vaccine–autism connection as "the most damaging medical hoax of the last
100 years".
Developing scandal
Conflict of interest
In February 2004, after a four-month investigation, reporter Brian Deer wrote in The Sunday Times of London that, prior to submitting his paper to The Lancet, Wakefield had received £55,000 from Legal Aid Board
solicitors seeking evidence to use against vaccine manufacturers, that
several of the parents quoted as saying that MMR had damaged their
children were also litigants, and that Wakefield did not inform
colleagues or medical authorities of the conflict of interest. When the
editors of The Lancet learned about this, they said that based on
Deer's evidence, Wakefield's paper should have never been published
because its findings were "entirely flawed". Although Wakefield maintained that the legal aid funding was for a separate, unpublished study (a position later rejected by a panel of the UK General Medical Council), the editors of The Lancet judged that the funding source should have been disclosed to them. Richard Horton,
the editor-in-chief, wrote, "It seems obvious now that had we
appreciated the full context in which the work reported in the 1998 Lancet paper by Wakefield and colleagues was done, publication would not have taken place in the way that it did." Several of Wakefield's co-researchers also strongly criticized the lack of disclosure.
Deer continued his reporting in a Channel 4 Dispatches television documentary, MMR: What They Didn't Tell You,
broadcast on 18 November 2004. This documentary alleged that Wakefield
had applied for patents on a vaccine that was a rival of the MMR
vaccine, and that he knew of test results from his own laboratory at the
Royal Free Hospital that contradicted his own claims. Wakefield's patent application was also noted in Paul Offit's 2008 book, Autism's False Prophets.
In January 2005, Wakefield sued Channel 4, 20/20 Productions, and
the investigative reporter Brian Deer, who presented the Dispatches
programme. However, after two years of litigation, and the revelation of
more than £400,000 in undisclosed payments by lawyers to Wakefield, he
discontinued his action and paid all the defendants' costs.
In 2006, Deer reported in The Sunday Times that Wakefield
had been paid £435,643, plus expenses, by British trial lawyers
attempting to prove that the vaccine was dangerous, with the undisclosed
payments beginning two years before the Lancet paper's publication. This funding came from the UK legal aid fund, a fund intended to provide legal services to the poor.
Retraction of an interpretation
The Lancet
and many other medical journals require papers to include the authors'
conclusions about their research, known as the "interpretation". The
summary of the 1998 Lancet paper ended as follows:
Interpretation 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.
In March 2004, immediately following the news of the conflict of
interest allegations, ten of Wakefield's 12 coauthors retracted this
interpretation,
while insisting that the possibility of a distinctive gastrointestinal
condition in children with autism merited further investigation. However, a separate study of children with gastrointestinal disturbances found no difference between those with autism spectrum disorders and those without, with respect to the presence of measles virus RNA
in the bowel; it also found that gastrointestinal symptoms and the
onset of autism were unrelated in time to the administration of MMR
vaccine.
Manipulation of data
On 8 February 2009, Brian Deer reported in The Sunday Times
that Wakefield had "fixed" results and "manipulated" patient data in
his 1998 paper, creating the appearance of a link with autism. Wakefield denied these allegations, and even filed a complaint with the Press Complaints Commission (PCC) over this article on 13 March 2009. The complaint was expanded by a 20 March 2009 addendum by Wakefield's publicist. In July 2009, the PCC stated that it was staying any investigation regarding the Times article, pending the conclusion of the GMC investigation.
In the event, Wakefield did not pursue his complaint, which Deer
published with a statement that he and The Sunday Times rejected it as
"false and disingenuous in all material respects", and that the action
had been suspended by the PCC in February 2010.
General Medical Council investigation
The General Medical Council (GMC), which is responsible for licensing doctors and supervising medical ethics in the UK, investigated the affair.
The GMC brought the case itself, not citing any specific complaints,
claiming that an investigation was in the public interest. The
then-secretary of state for health, John Reid, called for a GMC investigation, which Wakefield himself welcomed. During a debate in the House of Commons, on 15 Mar 2004, Dr. Evan Harris,
a Liberal Democrat MP, called for a judicial inquiry into the ethical
aspects of the case, even suggesting it might be conducted by the CPS. In June 2006 the GMC confirmed that they would hold a disciplinary hearing of Wakefield.
The GMC's Fitness to Practise Panel first met on 16 July 2007 to consider the cases of Dr. Wakefield, Professor John Angus Walker-Smith, and Professor Simon Harry Murch.
All faced charges of serious professional misconduct. The GMC examined,
among other ethical points, whether Wakefield and his colleagues
obtained the required approvals for the tests they performed on the
children; the data-manipulation charges reported in the Times, which surfaced after the case was prepared, were not at question in the hearings.
The GMC stressed that it would not be assessing the validity of
competing scientific theories on MMR and autism. The General Medical
Council alleged that the trio acted unethically and dishonestly in
preparing the research into the MMR vaccine. They denied the
allegations. The case proceeded in front of a GMC Fitness to Practise panel of three medical and two lay members.
On 28 January 2010, the GMC panel delivered its decision on the
facts of the case: Wakefield was found to have acted "dishonestly and
irresponsibly" and to have acted with "callous disregard" for the
children involved in his study, conducting unnecessary and invasive
tests. The panel found that the trial was improperly conducted without the approval of an independent ethics committee, and that Wakefield had multiple undeclared conflicts of interest.
Full retraction and fraud allegations
In response to the GMC investigation and findings, the editors of The Lancet announced on 2 February 2010 that they "fully retract this paper from the published record".
The Hansard text for 16 March 2010 reported Lord McColl
asking the Government whether it had plans to recover legal aid money
paid to the experts in connection with the measles, mumps and
rubella/measles and rubella vaccine litigation. Lord Bach, Ministry of
Justice dismissed this possibility.
In an April 2010 report in The BMJ, Deer expanded on the laboratory aspects of his findings recounting how normal clinical histopathology results generated by the Royal Free Hospital were later changed in the medical school to abnormal results, published in The Lancet. Deer wrote an article in The BMJ casting doubt on the "autistic enterocolitis" that Wakefield claimed to have discovered.
In the same edition, Deirdre Kelly, President of the European Society
of Pediatric Gastroenterology and Nutrition and the Editor of the Journal of Pediatric Gastroenterology and Nutrition expressed some concern about The BMJ publishing this article while the GMC proceedings were underway.
On 24 May 2010, the GMC panel found Wakefield guilty of serious
professional misconduct on four counts of dishonesty and 12 involving
the abuse of developmentally challenged children, and ordered that he be
struck off the medical register.
John Walker-Smith was also found guilty of serious professional
misconduct and struck off the medical register, but that decision was
reversed on appeal to the High Court in 2012, because the GMC panel had
failed to decide whether Walker-Smith actually thought he was doing
research in the guise of clinical investigation and treatment. The High
Court criticised "a number of" wrong conclusions by the disciplinary
panel and its "inadequate and superficial reasoning". Simon Murch was found not guilty.
On 5 January 2011, The BMJ published the first of a series
of articles by Brian Deer, detailing how Wakefield and his colleagues
had faked some of the data behind the 1998 Lancet article. By looking at
the records and interviewing the parents, Deer found that for all 12
children in the Wakefield study, diagnoses had been tweaked or dates
changed to fit the article's conclusion. Continuing BMJ series on 11 January 2011, Deer said that based upon documents he obtained under freedom of information legislation,
Wakefield—in partnership with the father of one of the boys in the
study—had planned to launch a venture on the back of an MMR vaccination
scare that would profit from new medical tests and "litigation driven
testing". The Washington Post
reported that Deer said that Wakefield predicted he "could make more
than $43 million a year from diagnostic kits" for the new condition, autistic enterocolitis. WebMD reported on Deer's BMJ
report, saying that the $43 million predicted yearly profits would come
from marketing kits for "diagnosing patients with autism" and "the
initial market for the diagnostic will be litigation-driven testing of
patients with AE [autistic enterocolitis, an unproven condition
concocted by Wakefield] from both the UK and the USA". According to WebMD, the BMJ
article also claimed that the venture would succeed in marketing
products and developing a replacement vaccine if "public confidence in
the MMR vaccine was damaged".
