Wakefield's Article Linking MMR Vaccine and Autism Was
Fraudulent

Clear evidence of falsification of data should now close
the door on this damaging vaccine scare

Editorial

Fiona Godlee, editor in chief, Jane Smith, deputy
editor, Harvey Marcovitch, associate editor
BMJ 2011; 342:c7452 doi: 10.1136/bmj.c7452 
(Published 5 January 2011)
Cite this as: BMJ 2011; 342:c7452

"Science is at once the most questioning and ...
sceptical of activities and also the most trusting,"
said Arnold Relman, former editor of the New England
Journal of Medicine, in 1989. "It is intensely sceptical
about the possibility of error, but totally trusting
about the possibility of fraud."1 Never has this been
truer than of the 1998 Lancet paper that implied a link
between the measles, mumps, and rubella (MMR) vaccine
and a "new syndrome" of autism and bowel disease.

Authored by Andrew Wakefield and 12 others, the paper's
scientific limitations were clear when it appeared in
1998.2 3 As the ensuing vaccine scare took off, critics
quickly pointed out that the paper was a small case
series with no controls, linked three common conditions,
and relied on parental recall and beliefs.4 Over the
following decade, epidemiological studies consistently
found no evidence of a link between the MMR vaccine and
autism.5 6 7 8 By the time the paper was finally
retracted 12 years later,9 after forensic dissection at
the General Medical Council's (GMC) longest ever fitness
to practise hearing,10 few people could deny that it was
fatally flawed both scientifically and ethically. But it
has taken the diligent scepticism of one man, standing
outside medicine and science, to show that the paper was
in fact an elaborate fraud.

In a series of articles starting this week, and seven
years after first looking into the MMR scare, journalist
Brian Deer now shows the extent of Wakefield's fraud and
how it was perpetrated (doi:10.1136/bmj.c5347). Drawing
on interviews, documents, and data made public at the
GMC hearings, Deer shows how Wakefield altered numerous
facts about the patients' medical histories in order to
support his claim to have identified a new syndrome; how
his institution, the Royal Free Hospital and Medical
School in London, supported him as he sought to exploit
the ensuing MMR scare for financial gain; and how key
players failed to investigate thoroughly in the public
interest when Deer first raised his concerns.11

Deer published his first investigation into Wakefield's
paper in 2004.12 This uncovered the possibility of
research fraud, unethical treatment of children, and
Wakefield's conflict of interest through his involvement
with a lawsuit against manufacturers of the MMR vaccine.
Building on these findings, the GMC launched its own
proceedings that focused on whether the research was
ethical. But while the disciplinary panel was examining
the children's medical records in public, Deer compared
them with what was published in the Lancet. His focus
was now on whether the research was true.

The Office of Research Integrity in the United States
defines fraud as fabrication, falsification, or
plagiarism.13 Deer unearthed clear evidence of
falsification. He found that not one of the 12 cases
reported in the 1998 Lancet paper was free of
misrepresentation or undisclosed alteration, and that in
no single case could the medical records be fully
reconciled with the descriptions, diagnoses, or
histories published in the journal.

Who perpetrated this fraud? There is no doubt that it
was Wakefield. Is it possible that he was wrong, but not
dishonest: that he was so incompetent that he was unable
to fairly describe the project, or to report even one of
the 12 children's cases accurately? No. A great deal of
thought and effort must have gone into drafting the
paper to achieve the results he wanted: the
discrepancies all led in one direction; misreporting was
gross. Moreover, although the scale of the GMC's 217 day
hearing precluded additional charges focused directly on
the fraud, the panel found him guilty of dishonesty
concerning the study's admissions criteria, its funding
by the Legal Aid Board, and his statements about it
afterwards.14

Furthermore, Wakefield has been given ample opportunity
either to replicate the paper's findings, or to say he
was mistaken. He has declined to do either. He refused
to join 10 of his coauthors in retracting the paper's
interpretation in 2004,15 and has repeatedly denied
doing anything wrong at all. Instead, although now
disgraced and stripped of his clinical and academic
credentials, he continues to push his views.16

Meanwhile the damage to public health continues, fuelled
by unbalanced media reporting and an ineffective
response from government, researchers, journals, and the
medical profession.17 18 Although vaccination rates in
the United Kingdom have recovered slightly from their
80% low in 2003-4,19 they are still below the 95% level
recommended by the World Health Organization to ensure
herd immunity. In 2008, for the first time in 14 years,
measles was declared endemic in England and Wales.20
Hundreds of thousands of children in the UK are
currently unprotected as a result of the scare, and the
battle to restore parents' trust in the vaccine is
ongoing.

Any effect of the scare on the incidence of mumps
remains in question. In epidemics in the UK, the US, and
the Netherlands, peak prevalence was in 18-24 year olds,
of whom 70-88% had been immunised with at least one dose
of the MMR vaccine.21 22 Any consequence of a fall in
uptake after 1998 may not become apparent until the
cohorts of children affected reach adolescence. One clue
comes from an outbreak in a school in Essen, Germany,
attended by children whose parents were opposed to
vaccinations. Of the 71 children infected with mumps, 68
had not been immunised.23

But perhaps as important as the scare's effect on
infectious disease is the energy, emotion, and money
that have been diverted away from efforts to understand
the real causes of autism and how to help children and
families who live with it.24

There are hard lessons for many in this highly damaging
saga. Firstly, for the coauthors. The GMC panel was
clear that it was Wakefield alone who wrote the final
version of the paper. His coauthors seem to have been
unaware of what he was doing under the cover of their
names and reputations. As the GMC panel heard, they did
not even know which child was which in the paper's
patient anonymised text and tables. However, this does
not absolve them. Although only two (John Walker-Smith
and Simon Murch) were charged by the GMC, and only one,
the paper's senior author Walker-Smith, was found guilty
of misconduct, they all failed in their duties as
authors. The satisfaction of adding to one's CV must
never detract from the responsibility to ensure that one
has been neither party to nor duped by a fraud. This
means that coauthors will have to check the source data
of studies more thoroughly than many do at present--or
alternatively describe in a contributor's statement
precisely which bits of the source data they take
responsibility for.

Secondly, research ethics committees should not only
scrutinise proposals but have systems to check that what
is done is what was permitted (with an audit trail for
any changes) and work to a governance procedure that can
impose sanctions where an eventual publication proves
this was not the case. Finally, there are lessons for
the Royal Free Hospital, the Lancet, and the wider
scientific community. These will be considered in
forthcoming articles.

What of Wakefield's other publications? In light of this
new information their veracity must be questioned. Past
experience tells us that research misconduct is rarely
isolated behaviour.25 Over the years, the BMJ and its
sister journals Gut and Archives of Disease in Childhood
have published a number of articles, including letters
and abstracts, by Wakefield and colleagues. We have
written to the vice provost of UCL, John Tooke, who now
has responsibility for Wakefield's former institution,
to ask for an investigation into all of his work to
decide whether any more papers should be retracted.

The Lancet paper has of course been retracted, but for
far narrower misconduct than is now apparent. The
retraction statement cites the GMC's findings that the
patients were not consecutively referred and the study
did not have ethical approval, leaving the door open for
those who want to continue to believe that the science,
flawed though it always was, still stands. We hope that
declaring the paper a fraud will close that door for
good.

Notes
Cite this as: BMJ 2011;342:c7452

Footnotes

Feature, doi:10.1136/bmj.c5347

References

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2 Wakefield AJ, Murch SH, Anthony A, Linnell, Casson DM,
Malik M, et al. Ileal lymphoid nodular hyperplasia, non-
specific colitis, and pervasive developmental disorder
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3 Chen RT, DeStefano F. Vaccine adverse events: causal
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4 Payne C, Mason B. Autism, inflammatory bowel disease,
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10 Transcripts of hearings of fitness to practise panel
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11 Deer B. Secrets of the MMR scare: how the case
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[FREE Full text]

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www.timesonline.co.uk/tol/life_and_style/health/article1027636.ece.

13 Office of Research Integrity. Definition of research
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14 GMC. Andrew Wakefield: determination of serious
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