The fraud squad
BMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d4017 (Published 28 June 2011) Cite this as: BMJ 2011;342:d4017
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I remain confused by Frank Wells, although I am grateful for his
reply. He now says he has no competing interests when previously he made a
disclosure, although it wasn't clear what it was. Was he, then, disclosing
some relationship with MLI which wasn't financial in the first place?
Competing interests: No competing interests
It is regrettable that accusations of fraud against Andrew Wakefield
continue to fly in this journal. I would just make three simple points
about it.
a) The findings of the 'Lancet paper' were extremely limited, and
certainly did not claim to have shown that MMR caused autism or bowel
disease [1].
b) None of Wakefield's 12 co-authors have ever repudiated the data in
the study.
c) The editor herself stated under pressure from Age of Autism
readers in February: "The case we presented against Andrew Wakefield that
the 1998 Lancet paper was intended to mislead is not critically reliant on
GP records." [2]
I suggest anyone repeating a claim of fraud against Wakefield needs
to minimally negotiate these three points first.
[1] Wakefield et al 'Ileal-lymphoid-nodular hyerplasia, non-specific
colitis, and pervasive developement disorder in children',
Lancet. 1998 Feb 28;351(9103):637-41.
[2] Fiona Godlee, 'BMJ response to emails from readers of Age of
Autism', http://www.bmj.com/content/342/bmj.c7452.full/reply#bmj_el_249550
Competing interests: Autistic son
Clare Dyer's "Calling time on research's Wild West" with its mug
shots of wrong doers and highlighted warnings about decades of science
fraud "poisoning the evidence base" competes well in catching the eye for
that light Sunday morning read. The justifiable indignation expressed by
it and the following piece by Chalmers and Haines may have distracted them
from a number of important points.
If we take the most notorious case, Dyers statement that "vaccination
levels in the UK have still not recovered and measles cases are on the
rise around the world" is misleading in that it implies that the Wakefield
saga caused a collapse in vaccination that has resulted in an increase in
measles which is still on-going. In fact, measles has continued to decline
in the UK following the outbreak that occurred in 1994, four years before
the Wakefield paper was published, and uptake of the MMR vaccine has been
maintained well since that outbreak (Hershel J, Wilcox Hagberg K. Measles
in the United Kingdom 1990-2008 and the effectiveness of measles vaccines
(Vaccine 2010, 28; 4588-4592).
As for "poisoning the evidence base on which doctors rely in choosing
treatments for their patients", the implication here is that clinicians
and scientists are easily misled by fraudulent publications. But the
evidence on vaccination refutes this and the scepticism expressed in the
editorial published alongside the Wakefield paper in the Lancet could not
have been clearer (Chen RT, DeStefano F. Vaccine adverse events: causal or
coincidental? 1998 Lancet, 351; 611 - 12). Both attest to a robust ability
to withstand misleading, erroneous or dishonest publications.
The most damaging aspects of the Wakefield saga were the time wasting
it caused, the huge expense in managing it and perhaps most importantly
the fillip of support it gave the public and media campaign (Begg N,
Ramsay M, White J, Bozoky Z. Media dents confidence in MMR vaccine BMJ
1998, 316;: 561) against the MMR vaccine, which preceded it, continues
today and is nicely illustrated in the placard behind Andrew Wakefield on
p.25 of Dyer's piece.
A striking and unusual feature of the Wakefield case, which attracted
little attention from Dyer, Chalmers & Haines and other commentators
was the major role played by media campaigns which ran pro and anti
Wakefield and the MMR vaccine. In the modern era that favours stakeholder
interests, democracy of opinion and the right to be right, it seems to me
that these campaigns enjoy a degree of influence which adds to the
difficulty in dealing with them objectively and rationally. This was/is
particularly so in the cases at Stoke on Trent, where campaigners were
actively involved and is also well illustrated by the ongoing stalemate
over chronic fatigue syndrome/ME (Hawkes N. The dangers of research into
CFS/ME. BMJ 2011, 342; 1392 - 4; Groves T, Heading for a therapeutic
stalemate. BMJ 2011, 342; 1396).
Chalmers and Haines lament the slow progress in resolving cases and
see the future in a robust independent forensic service to investigate
fraud. While a service to provide advice on detecting fraud such as
plagiarism, image manipulation and statistical misconduct and to keep
abreast of new technical tricks to deceive would be useful, the idea that
an independent "CSI" type service would improve matters seems unlikely for
several reasons; 1) complex cases need to be dealt with fairly and
accurately and this will always take time; experts still argue about
whether Mendel and Ptolemy cooked their books and we must not forget that
some scientists have suffered false allegations (Goodstein D. In defense
of Robert Andrews Millikan. Engineering and Science. 2000, 4; 31 - 38); 2)
for original and novel research, as distinct from standard or derivative
work, expertise may be limited and the issue of independence will then
have to rest on trust; 3) individual scientists (as distinct from those
who work for corporations, governments or the media) continue to enjoy a
high level of public trust (House of Lords Science and Technology
committee, Third report, available at:
http://www.publications.parliament.uk/pa/ld199900/ldselect/ldsctech/38/3...);
and 4) scientists have shown themselves robust in dealing with poor or bad
science in the past (Wood RW. The n-Rays. Nature 1904, 70; 530 - 531).
It is surprising that none of these authors addressed in any detail
prevention of fraud in science, now the main function of the ORI in the
US. The economic environment in which academia operates has changed
rapidly during the past two decades, with greater emphasis on commercial
exploitation and this was evident in the background to the Wakefield case.
We need to understand this better and develop ethical systems to manage
it. Punishments available to deter individuals who engage in fraud are
potent and particularly so for medics. In contrast, sanctions for
corporate or institutional misdeeds are inadequate. We need to educate
trainee scientists about fraud, about the damage it does, how serious it
is as well as the risks it carries. Dealing with fraud badly would differ
little from fraud itself.
Competing interests: No competing interests
In response to the query over my competing interests, I apologise for
the confusion. I have had no income from MedicoLegal Investigations since
2002 and therefore have no competing interests.
Competing interests: No competing interests
I am perplexed by Frank O Wells' disclosure of competing interests
[1]. Perhaps he could clarify whether he is saying that he has not had a
financial association with MLI for the last decade, or saying that he has.
If he is saying that he has I do not understand why he would mention that
he did not a long time ago.
I am also intrigued by the new allegation by Clare Dyer that Andrew
Wakefield lost his job at the Royal Free in 2001 because he refused to
repeat the Lancet paper [2]. It is difficult to see how a paper of this
kind, which appeared as a hypothesis generating small case series study
could be replicated in any meaningful sense, and it is surprising that
this was requested. I am aware that the GMC findings - which are currently
subject to legal challenge by Prof Walker-Smith - found that the paper was
based on a Legal Aid Board sponsored protocol while at the same time being
highly deficient in meeting its terms [3], but if by any chance this was
the case this was not at all obvious in 2001, at the time of the alleged
event.
[1] Frank O Wells, 'Research Integrity',4 July 2011
http://www.bmj.com/content/342/bmj.d4017.extract/reply#bmj_el_265399
[2] Clare Dyer, 'The Fraud Squad', BMJ 2011; 342:d4017 doi:
10.1136/bmj.d4017 (Published 28 June 2011)
[3] John Stone, 'The unexplained puzzle of the GMC verdict (and
reponses to Peter Flegg)', 10 February 2010
http://www.bmj.com/content/340/bmj.c644.full/reply#bmj_el_231147
Competing interests: Autistic son
Mr Wells says his personal ambition is to see a rapid response
forensic unit or units established and recognised in every country to deal
with research misconduct.
What we need more than that is a dedicated police investigation squad
to deal with fraud and corruption found in some parts of the
pharmaceutical industry and indeed to root it out whereever and whenever
it be found in the drug safety regulatory system.
The Police Service currently has no dedicated team with the
specialist skills and knowledge required to tackle what is certainly an
area in which much criminality can be found if you know where to look.
Competing interests: No competing interests
Clare Dyer's article, in the main, rightly laments the fact that
little official recognition is given to the need to tackle research
misconduct when it occurs. She also laments the uncertainty that still
hovers over the funding and continuation of UKRIO. However, whereas she
commends Peter Wilmshurst, whom I hold in the highest regard, for his
whistleblowing activities in this field, she gives but passing reference
to MedicoLegal Investigations (MLI), the body established in 1996 to
provide a rapid response forensic unit to investigate alleged cases of
research misconduct.
MLI is indeed a small company, but Dyer is wrong to imply that it
acts mainly for the drug industry as it has successfully investigated
cases submitted by academic departments and by NHS Trusts. The article
also misleads over the number of cases referred to MLI, the outcome of
many of which has been that there was no case to answer. Where MLI found
that there was a case to answer then a robust statement of the facts was
presented to the GMC or relevant professional regulatory body, and
virtually all such cases were found guilty of serious professional
misconduct and punished accordingly.
The case for skilled forensic capacity is well set out in the
Commentary by Iain Chalmers and Andy Hailes that follows Clare Dyer's
article (BMJ 2011;342:d3977), but, again, only passing reference is made
to MedicoLegal Investigations even though the company is exactly what is
called for in that commentary, as its track record demonstrates.
So I am frustrated by the lack of recognition that such a facility
already exists, even though it is small and unofficial. MLI has never
expected itself to be the exclusive operator in this field and yet the
opposite has occurred - it remains unique and is under-utilised. My
frustration is also enhanced by the failure of Dyer to acknowledge the
existence of the only textbook on this subject, Fraud and Misconduct in
Biomedical Research, for all four editions of which I have been the co-
editor, now with Professor Michael Farthing who is quoted in her article.
My personal ambition, stated clearly at the Second World Conference
on Research Integrity held in Singapore last year, is to see a rapid
response forensic unit or units established and recognised in every
country, but especially the UK, for investigating, without delay,
allegations of reseatch misconduct. Despite the dilution of this concept
by the simultaneous publication of these two articles, I hope that this
response to those articles might stimulate some action. If it is known
that such rapid investigation is bound to take place, then just possibly
the incidence of research misconduct will be minimised.
Competing interests: I co-founded MedicoLegal Investigations, referred to in Clare Dyer's article, but have had no financial association with the company for longer than the past decade.
The truth about the number of measles cases
Does Ms. Dyer truly believe that "measles cases are on the rise around the world" because Dr. Wakefield said during a 1998 press conference, that if he had a choice, he would give his own children monovalent measles, mumps and rubella vaccines, still a NHS parental option at the time?
Is Ms. Dyer aware that according to the Health Protection Agency, the number of reported measles cases in the UK kept dropping after 1998 and only exceeded the 1998 figures ten years later, when there were several measles outbreaks worldwide? (1)
Does she realize that in fact, there were strikingly fewer reported measles cases in England in the 10 years that followed Wakefield's 1998 paper (28,289 cases) than in the 10 years that preceded its publication (188,483 cases)? (1)
Does she know that there were 43,010 reported cases of measles in the UK from 1993 through 1997 compared to 13,981 reported cases from 1998 though 2002, an equal five year span? (1)
Is she aware that there were 14 (fourteen) reports to the US Vaccine Adverse Events Reporting System describing symptoms of autism appearing after MMR vaccinations before October 5, 1997 - when just about no one in the United States had ever heard of Andrew Wakefield? (2)
References
1. http://www.vaccinationnews.com/measles-united-kingdom-wakefield-factor
2.http://www.vaccinationnews.com/20110301ThereGoesThatArgumentYazbakFE
Competing interests: Grandfather of a young man with regressive autism