A Reflection on Fraud and Misconductin Biomedical ResearchFrank Wells

European Forum for Good Clinical Practice Ethics Working Party, Old Hadleigh, Ipswich, UK

Fraud and misconduct in biomedical research occurs all the

time, and although certainly not rife, it occurs sufficiently fre-

quently to raise real concerns, not least because it involves

patient exploitation. Also, if undetected, it could lead to licens-

ing decisions aboutmedicines being based on false or fabricated

data. So what is its prevalence? Well, as Thoreau famously said

(or was it Copernicus?), ‘‘we do not know what we do not

know’’ and can only estimate prevalence on what we do know.

My own experience as a fraudbuster for over 20 years puts it at

about 1% within all the clinical trials being conducted at any

one time. However, publication irregularities are much more

frequent, probably in the region of 5% of published research

reports, which most certainly gives cause for concern.

Pharmaceutical health workers will be aware that attitudes

towards research have always been ambivalent and have always

swung between extremes. Before scientific methodology was

able to be proved, research projects were considered to be sorcery

and quackery. Then came an uncritical acceptance or even re-

verence for science, particularly biomedical science or research.

Now there is a far more critical approach to research reports

and results, not least because of publicity given to horror stories

in the newspapers and on television. Nevertheless, the idea that

scientists might deliberately ‘cook the books’, fabricate data or

even exploit patients for personal gain or other reasons is

clearly cause for concern and this concern probably accounts

for such behaviour not being common. But human nature being

what it is, such behaviour will always be with us, though

hopefully to a diminishing extent.

I have to acknowledge that it is difficult to give an accurate

account of the history of medical research misconduct before

the last quarter of the 20th century, since little was written prior

to this time. In Europe, however, there were a few notorious

episodes before then that were well documented, including the

existence of ‘philosophicall robbery’ or plagiarism, described as

long ago as 1664 by Robert Boyle,[1] whose works were fre-

quently plagiarized and pirated. In the field of psychology, after

many years of controversy, it had been shown beyond a rea-

sonable doubt that Sir Cyril Burt committed fraud in his

comparison of monozygotic twins.[2] And in the history of

scientific fraud, remember 1913 and the discovery of a human

skull next to an ape’s jaw with a canine tooth worn down like a

human’s. The general community of British paleoanthropolo-

gists came to accept the idea that the fossil remains belonged to

a single creature that had a human cranium and an ape’s jaw.

But 40 years later, Piltdown ‘man’ was exposed as a forgery.

The skull was modern and the teeth on the ape’s jaw had been

filed down.

Returning to the beginning of the last quarter century, one of

the first reported European cases of research misconduct oc-

curred in 1975 with the clinical trial data falsification by a

general practitioner in HighWycombe, England. He forged the

signatures of seven other doctors participating in the same

multicentre drug trial, and submitted results showing that the

active drug was having a uniform and consistent effect, which

was significantly different from the test results submitted by

doctors situated in other centres. The pharmaceutical company

reported him to the General Medical Council (GMC) and, at

the end of the disciplinary hearing, his name was duly removed

from the Medical Register.[3]

Elsewhere in Europe, no other specific cases were published

for over a decade and, even in the UK, the next published case

was not until 1988 when a consultant psychiatrist in Durham

was found guilty of fabricating clinical trial results, including

inventing at least one non-existent patient, and was also erased

from the Medical Register.[4] This was my personal first of

26 cases in which I was responsible for referring doctors to the

GMC for serious professional research misconduct, all but one

of whom were found guilty and dealt with appropriately. How-

ever, across the North Sea, first in Denmark then in Norway,

Finland and Sweden, the biomedical fraternity were taking an

active part in setting up committees on scientific dishonesty,[5]

which are nowwell established. Essentially, having all inspired the

confidence of the stakeholders in various aspects of biomedical

research, these committees receive complaints of suspected

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ª 2009 Adis Data Information BV. All rights reserved.

research misconduct, which they then assess to determine

whether or not there is a prima facie case to answer. If there is,

then the employer of the person who has committed fraud or

misconduct is notified accordingly so that they can take ap-

propriate action.

During the past 6 years, there have been some positive

changes in the prevention, detection, investigation and prose-

cution of research misconduct in Europe, but not many. Chief

of these has been the establishment of national bodies in the

UK, Germany, the Netherlands and elsewhere to advise on

these aspects of research misconduct even though they have no

statutory powers. A UK Panel for Research Integrity in Health

and Biomedical Sciences, which includes the UK Research

Integrity Office (UKRIO), was announced in April 2006 ‘‘in

order to further integrity in research and promote good practice

in addressing misconduct in research.’’[6] It operates in-

dependently of government, sponsors, industry and universities

and, as in Denmark, takes no responsibility for prosecuting any

cases of research misconduct, leaving it to the employer or re-

search sponsor to take appropriate action.

Cases considered by the UK GMC Fitness to Practise Panel

during the past 6 years have been many and varied. I will, in

summary, cite five of them. Further details of these and all the

other cases considered and concluded by the GMC can be re-

ferenced on the GMC website.[7]

The first case was that of a junior doctor in training studying

for a MSc in palliative care at Kings College, London. As part

of his MSc coursework, he submitted a research study project

entitled ‘‘Short periods of hospice stay and anxiety in the be-

reaved: a cross sectional study at six months following be-

reavement.’’ This research project involved the collection of

data through questionnaires to be completed by the bereaved at

a hospice in Surrey, and in his dissertation he stated ‘‘Following

local ethical approval, it was agreed that [the hospice] would be

a suitable environment to introduce the questionnaire.’’ How-

ever, one of the staff at the hospice who happened also to be on

the local Research Ethics Committee (REC), and who read the

dissertation, knew that the REC had never received an appli-

cation with the above title. The REC administrator confirmed

this and it transpired that the investigator had not received any

ethical approval from anywhere for this study. Furthermore, it

also transpired that he had not even obtained approval for the

project to be conducted at the hospice. This was therefore re-

ferred to the King’s College Examinations Misconduct Com-

mittee, which found that the case against him had been proved

and in due course these matters were referred to the GMC. The

GMC’s Fitness to Practise Panel concluded that the above

statement in his research project was indeed misleading and

intended to mislead, was inappropriate and dishonest. It ruled

that his fitness to practise was impaired because of his mis-

conduct; but, noting his contrition and the support and refer-

ences he had received from his senior colleagues, the Panel

decided not to suspend his registration but imposed conditions

on his registration for a period of 12 months. These conditions

were largely related to the conduct of research and to the ap-

pointment of a mentor.

The second case involved a consultant ophthalmologist who,

although his involvement in a research project was flawed, was

also found guilty of bringing the profession into disrepute on a

number of different fronts. Concerning the research irregular-

ity, he conducted two separate but connected trials without the

approval of an REC or the consent of patients. The other in-

stances included failure to tell a patient about a lens problem

reported by the manufacturer, and confirming to a colleague

that there had been no problem with the lenses, when this was

not the case; failing to attend a clinic by purporting to be ill

when in fact he was not ill; and making exaggerated claims in a

brochure, which led the Advertising Standards Authority to

find the claims to be in breach of the Committee of Advertising

Practice Code. He was suspended for 1 year and then allowed

back on the Medical Register, but only with conditions re-

garding his surgical activities.

The third case involved an academic consultant endocrino-

logist, who, some years previously, had agreed to be the chief

investigator for a clinical trial to assess the safety and efficacy of

voglibose compared with placebo and glibenclamide (glybur-

ide). He had fallen short in the conduct of this study in a number

of different ways: he had failed to carry out adequate physical

examinations during the first visit of the patients recruited to

the trial; he did not conduct adequate examinations of joints as

specifically required by the protocol; he completed many of the

clinical report forms incorrectly, making up much of the data,

indicating that he had carried out examinations when he had

not; and he permitted seven patients to participate in the study

when he knew they should have been excluded.

The clinical trial monitor had become increasingly con-

cerned about a number of aspects of the conduct of the trial,

largely because the doctor was never there when he had ar-

ranged to be, but he had been fiercely defended by his research

nurse who was a very experienced outpatient sister, dedicated

to working with the doctor. Eventually, however, it was the

research nurse who blew the whistle; she had become deeply

concerned that she had been allowed to get out of her depth

in virtually running the study, never having been trained in

research methodology. She realized that she had been expected

to withdraw some patients’ original medication and place

270 Wells

ª 2009 Adis Data Information BV. All rights reserved. Pharm Med 2009; 23 (5-6)

them on placebo without the doctor’s involvement and that

she had had to obtain informed consent from patients parti-

cipating in the study because he had failed to do so. All this

had been toomuch and so shewent to the professor who headed

the department of endocrinology with all her concerns. These

were backed up by both the clinical trial monitor and the

quality assurance professional from the company who had

conducted a ‘for cause’ audit. The professor instituted a com-

mittee of enquiry and eventually the case was referred to the

GMC. The outcome of doing so was unexpected, as the doctor

then resigned from the department in which he had been work-

ing for some years and then left clinical practice completely.

The fourth case was that of another junior doctor who pla-

giarized two assignments while undertaking a medical science

course at Keele University. The first assignment contained

several passages that were copied directly from published pa-

pers, which he failed to attribute to their authors. The second

assignment was a more serious case, because he had on this

occasion plagiarized the work of another student. Further-

more, he denied this second act of plagiarism throughout a

university investigation and the university panel hearing that

followed, so that a fellow student had to appear before the

university panel; only at the very end of the hearing did he

admit that he had plagiarized the work. His defence was that

this was something that happened all the time. His registration

was suspended for a period of 9 months, during which he be-

came contrite.

The final case involved a doctor who, 1 year previously,

had had his name suspended from the Medical Register for

a period of 12 months. This was because he had included

the names of Professor A, Dr B and Dr C, or agreed to their

names being included in articles as co-authors, knowing that

they were not co-authors, on a total of 86 occasions between

1998 and 2003. Not surprisingly, when the 12 months was

up, the Fitness to Practise Panel expected to see the doctor

and to have received evidence of his trying to redeem himself

and to keep up to date while he was off the Medical Register.

However, in July 2007, despite being advised that he should

attend the hearing of the Panel or provide considerable evi-

dence of his attempts to have his name restored, he did not

attend and in effect told the Panel he did not know what they

were talking about. The Panel concluded that he had no insight

into the seriousness of his situation, had not engaged in a

meaningful way with the GMC and struck him off the Medical

Register.

These five cases demonstrate how seriously research mis-

conduct, including failing to seek REC approval, plagiarism,

fabrication of data and gift authorship, continues to be con-

sidered in the UK by the GMC. They exemplify what has

happened in the UK ever since the first documented case in

1975, although all of them took several years to reach the GMC

after the misdemeanours were first suspected. I hope that the

existence of UKRIO will both act as a further deterrent to the

committing of research misconduct and enable cases that still

occur to be dealt with much more expeditiously. Meanwhile,

elsewhere in Europe, other than the cases cited and the estab-

lishment of bodies dedicated to maintaining research integrity

or investigating scientific dishonesty, it is frankly difficult to

relate what has happened in this field, as so little has been

reported or documented. An exception was the case of the

previously respected Norwegian oral cancer researcher, Jon

Sudbø, who fabricated data for 900 patients in a study pub-

lished in October 2006 in The Lancet, which has now retracted

the article.[8] Nevertheless, it is highly likely that the incidence of

fraud and research misconduct elsewhere in Europe is no less

than it is in the Nordic countries and the UK.

Some of the topics in this article have already appeared in

the fourth edition of Fraud and Misconduct in Biomedical

Research, co-edited with me by Professor Michael Farthing,

Vice Chancellor of the University of Sussex. With his words,

I will conclude: ‘‘It has been argued that unlike financial fraud,

research fraud is a victimless crime. If you were a patient

harmed by a drug which came to market through a fraudulent

clinical trial you might see it differently. Similarly, funding

agencies particularly government funded bodies have respon-

sibilities to ensure that the funds that they disperse are used

appropriately and not for improper purposes such as fraudu-

lent research.’’[9]

Acknowledgements

The author has no conflicts of interest that are relevant to this editorial.

No sources of funding were used to assist in the preparation of this

editorial.

References1. HunterM.Robert Boyle reconsidered. Cambridge: CambridgeUniversity Press,

1994: 215-6

2. Tucker WH. Reconsidering Burt: beyond a reasonable doubt. J Hist Behav Sci

1997; 33 (2): 145-62

3. Anonymous. Erasures from register. BMJ 1975; 2: 392

4. Anonymous. GMC Professional Conduct Committee. BMJ 1988; 296: 306

5. Andersen D, Attrup L, AxelsenN, et al. Scientific dishonesty and good scientific

practice. Copenhagen: Danish Medical Research Council, 1992

6. UKRIO. The UK Research Integrity Office [online]. Available from URL:

http://www.ukrio.org/sites/ukrio2/uk_research_integrity_office__ukrio_/index.

cfm [Accessed 2009 Nov 27]

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7. GeneralMedical Council. Hearings and decisions [online]. Available fromURL:

http://www.gmc-uk.org/concerns/hearings_and_decisions.asp [Accessed 2009

Oct 22]

8. Horton R. Retraction. Non-steroidal anti-inflammatory drugs and the risk of

oral cancer: a nested case-controlled study. Lancet 2006; 367: 382

9. Rennie D, Gunsalus CK. Regulations on scientific misconduct: lessons from the

US experience. In: Wells F, Farthing M, editors. Fraud and misconduct in

biomedical research. 4th ed. London: Royal Society of Medicine Press, 2007:

277-87

Correspondence: Dr Frank Wells, European Forum for Good Clinical

Practice Ethics Working Party, Old Hadleigh, London Road, Capel St Mary,

Ipswich, IP9 2JJ, UK.

E-mail: frankwells36@aol.com

272 Wells

ª 2009 Adis Data Information BV. All rights reserved. Pharm Med 2009; 23 (5-6)