Written evidence submitted by Dr Peter Wilmshurst (RIN0091)
1. Academic institutions bear responsibility for the pressure to publish for career advancement that can result in research misconduct.
2. A record of prominent publication is likely to attract future funding, which institutions demand, and good publicity, which institutions desire.
3. Other pressures for misconduct come from the association of academic institution with industry, such as when investigators or their institutions hold patents or shares, or they receive payments from industry, so that there is financial pressure to publish research that will be profitable for the company and to suppress “negative” findings.
4. Some publications are simply organised criminal activities, which may be at the behest of sponsors, when prominent academics are paid large sums of money to publish false data by industry, or a sponsor may be one of the victims, when payments for conducting research are made to “investigators”, who simply fabricate data.
5. Medical journals have financial pressures to publish positive findings of research on drugs and medical devices, because their manufacturers buy reprints of the papers for distribution to doctors and they pay for advertisements linked to articles favourable to their product.
6. Academic institutions and journals depend on the public belief in the integrity of science, so they are unwilling to admit the seriousness and frequency of research misconduct.
7. To protect their reputations academic institutions conceal research misconduct, destroy evidence and silence whistleblowers.
8. Journals are reluctant to admit that they published flawed research, so they commonly refuse to publish failures to replicate.
9. Fear of a libel action contributes to the failure to expose research misconduct.
10. Investigation of research misconduct may be difficult because there may be international collaboration between investigators, many of who do not see the full data, and the resulting publications may be in journals that are published in countries where none of the investigators work.
11. The bodies that investigate research misconduct in the UK (such as the GMC and UKRIO) are hampered by a desire to play down the problem, by lack of proper forensic skills when investigating, by inconsistent interpretation of rules and by inadequate powers to compel the cooperation of academic institutions and journals.
12. My experience of UK tribunals that considered cases of misconduct are confined to cases involving doctors, but I believe that the GMC and MPTS are inconsistent and illogical in their findings, and too lenient in sanctioning even when doctors re-offend.
13. Because lenient sanctions are imposed, institutions believe that the misconduct is not very serious, and potential research fraudsters are not deterred.
14. I believe that the best way to address the problems of research misconduct would be by making serious forms of research misconduct criminal offences with meaningful sanctions and to have allegations investigated by a statutory independent body with legal powers (comparable to the Health and Safety Executive).
Conflicts of interest:
As described in my submission, I have investigated and reported cases of research misconduct. I have received no payments for doing so.
My background and experience of research misconduct:
1. I am a semi-retired consultant cardiologist at the Royal Stoke University Hospital. I continue to do publish research. I have also investigated and expose research misconduct for 35 years ago, since a pharmaceutical company offered me a bribe to falsify my research on a drug that had life-threatening side effects.[1,2] In 1996, Dr Richard Smith (then the editor of the BMJ) invited me to give a seminar on research fraud to 40 journal editors from the BMJ Publishing Group and the Lancet,[3] which caused the BMJ and Lancet to call for action on research misconduct.[4,5] My seminar was one of the drivers for formation of the Committee on Publication Ethics in 1997, and I have been a member since then. I was awarded the 2003 Health Watch Annual Award “for courage in challenging misconduct in medical research” and I was the first recipient of the BMJ Editor’s Award in 2012. I gave a lecture on “Research misconduct in the UK – current situation” at the January 2012 meeting that resulted in “The concordat to support research integrity”. I signed it, despite having some misgivings about the will of organisations to deal with the problem. I have also investigated research misconduct abroad. I chaired an investigation in a developing country at which four witnesses claimed that they received death threats. In another developing country, a senior doctor with an international reputation had set up a criminal organisation that fabricated “patient” data for the whole country for inclusion in an international multicentre study and by which the doctor and fellow fraudsters managed to con $5 million from the sponsoring charity. In the UK, doctors that I reported to the GMC have been sanctioned for research misconduct, including removal from the Medical Register. The most recent was Dr Andrew Dowson, whose appeal against suspension from the Medical Register for six findings of misconduct, including two findings of dishonesty, by the MPTS was rejected by the High Court in November 2015.[6,7] I have received many legal threats, including from UK universities and UK academics that hoped to prevent exposure of the frauds in their institutions.[8,9,10] I fought four defamation actions brought by NMT Medical, the US medical device corporation that sponsored the MIST Trial, when I exposed the misconduct in the trial.[11] The claims lasted almost four years and my legal costs were more than £300,000, until NMT went into liquidation. It was one of the stimuli for the Defamation Act 2013.[12]
2. My knowledge of research misconduct is confined to medical research. In my experience research misconduct is much more frequent and has far more serious consequences than is admitted by universities and journals.
3. Professor Don Poldermans was dismissed from Erasmus University in the Netherlands “because of violations of academic integrity” including use of “fictitious data” in research.[13] It is alleged that he falsified the data in the series of DECREASE Trials as described by Cole and Francis.[14] That series of trials were the justification for the guidelines of the European Society of Cardiology (ESC) on use of perioperative beta-blockers in high risk patients having non-cardiac surgery. Poldermans was a member of the ESC Committee for Practice Guidelines and Chair of the Task Force of the ESC. Poldermans was Associate Editor of the European Journal of Echocardiography and a member of the Editorial Boards of five other major cardiology journals. Despite these senior positions, the Erasmus Inquiry Committee on Academic Integrity found that Poldermans published fictitious patient data.
4. It has been estimated that use of beta-blockers in the clinical setting recommended in the ESC guidelines increased patient mortality by 27%.[15] Some estimates suggest that there may have been 800,000 excess patient deaths in Europe of which 10% (i.e. approximately 10,000 excess patient deaths per year for eight years) are believed to have been in the UK.[15] In the Polderman’s case, the ESC was slow to amend the guidelines, the journals that published the trials have been tardy at retracting the publications, and Erasmus University were slow to act until the scandal was widely publicised.[14]
5. There are many other examples where great harm has been done to patients and resources wasted by professors and other senior doctors who have been found to have committed research misconduct in the UK (see below) and abroad (A few of the many examples of which I am aware are: (i) Prof Strauer has been reported to the public prosecutor over stem cell research in patients with heart failure after a university investigation in Dusseldorf, Germany.[16] (ii) The University of Connecticut returned US Federal grants totalling $890,000 after they reported “145 instances of fabrication and falsification of data” by Dr Dipak Das, Director of the Cardiovascular Research Centre at the University of Connecticut Health Centre.[17] (iii) 88 fraudulent studies out of 102 studies published by Prof Boldt in Ludwigshafen, Germany have been retracted.[18] (iv) In 2015, the US Office of Research Integrity found that cancer researcher Dr Anil Potti at Duke University, USA falsified data in papers in numerous major journals including New England Journal of Medicine, Nature Medicine, Lancet Oncology, JAMA, which have been retracted: a whistleblower who raised concerns about Potti in 2008 was silenced by Duke University and questions have been raised whether Potti acted alone when the research had many co-authors, with “millions of taxpayer dollars misused and damage to hundreds of patients”.[19,20,21] (v) The US Office of Research Integrity found that Dr Sudbo in Norway “falsified and fabricated research” on cancer prevention and decided that 16 publications warranted retraction.[22] (vi) The US Office of Research Integrity found that Prof Eric Smart, Professor of pediatrics and physiology at the University of Kentucky “falsified and/or fabricated data that were included in 10 published papers (that they recommended be retracted), one submitted manuscript, seven grant applications and 3 progress reports over a period of ten years”.[23] (vii) A paper in the BMJ described that Prof Kurjak, the director of a World Health Organisation collaborative centre in medical ultrasound, plagiarism the research of others.[24] (viii) More than 80 papers and abstracts published by cardiologist Dr John Darsee when he worked at Emory University and Harvard were retracted because they were fraudulent, and the inquiry found that the head of department at Harvard, Professor Eugene Braunwald, had been told that Darsee was falsifying research by other workers in the laboratory and allowed him to continue doing research in the laboratory.[25,26,27] (ix) For 5 years before his misconduct was exposed, colleagues of Dr Slutsky, a cardiac radiologist in San Diego, knew that he was publishing fraudulent research.[2]). The large numbers of dishonest publications by these senior doctors have implications for patients with serious diseases, including cancers and heart disease. Many of the fraudsters gave gift authorship to other doctors and researchers.[2,20,24,27] There is evidence that in some cases those given gift authorship knew that the research on which they were named as authors had been fabricated and in some cases kept that secret for years.[28] In most cases the responses of the institutions and regulators have been slow to deal with the issues.[2]
6. Universities and journals are dependent on the public belief that the research they conduct and publish is ethical and accurate in order to generate income. They are as likely to admit the full magnitude of research misconduct as church leaders are to confess the extent of child abuse by priests.
7. In addition, the libel laws (particularly in the UK) protect the guilty and often prevent retraction of articles proven to be fraudulent.[29] The libel laws also dissuade editors from publishing factual articles about the problem of research misconduct.
8. I am a cardiologist and I have published many research articles that have implications for the safety and survival of patients, but no editor has ever asked me to provide proof that the research that I was reporting was performed or asked to see my data. In contrast, I have published a number of articles about misconduct in research and invariably I had to produce documents for editors and the journals’ lawyers to support my claims, so that they can try to head off defamation claims. It appears that the need to publish accurate research to protect patients has a lower priority with journals than the need to publish accurate comments about researchers to avoid libel claims.
9. Following my 1996 seminar at the BMJ, Dr Richard Horton invited me to write an article for the Lancet.[9] In it I wrote “I contend that those who should uphold the ethics of medicine and medical research tolerate and help to conceal dishonesty.” The article has the footnote “Documentary evidence corroborating Dr Wilmshurst’s article was made available to the Lancet.” The article described how senior academics and institutions had concealed misconduct for years to protect the reputations of their departments and institutions. One institution that I reported had concealed research fraud was King’s College London and as a result Prof Arthur Lucas, the College’s Principal, threatened me with litigation even though what I had reported was corroborated by documents seen by the Lancet before publication.
10. Soon after that publication, I reported two researchers at King’s College London (Dr A K Banerjee and Prof Tim Peters) to the GMC. Three years later, the GMC found both guilty of serious professional misconduct for research misconduct, including falsification of publications in the journal GUT. In 2002, I wrote in the BMJ about the 10 years of cover up of research misconduct by senior doctors and administrators at King’s College London and London University.[10] (I had supplied the BMJ and its lawyers with supporting documents as the footnote to that article shows.) King’s College threatened the BMJ and again threatened me with a libel action.[8] We had the strange situation that Sir Graeme Catto, in his capacity as Vice-Principal of King’s College London and Dean of its School of Medicine and Dentistry, threatened a libel action for reporting the findings of tribunals of Banerjee and Peters at the GMC when Catto was also President of the GMC. As I described in my article on institutional corruption in medicine in which I referenced the transcripts of those hearings and other documents that I supplied to the BMJ and the journal’s lawyers, it was clear that senior officials at King’s College had known of Banerjee’s research fraud for a decade, but by concealing and destroying evidence and by silencing whistleblowers they had delayed the hearings by the GMC and delayed retraction of fraudulent publications.[10]
11. It took a further 13 years to get London University to withdraw the Master of Surgery degree it awarded to Banerjee for the fraudulent research. One of its academic staff informed London University that the research was fraudulent before the University awarded the degree to Banerjee in 1991. Nevertheless the University awarded the degree. At his GMC in 2000, Banerjee admitted that the data in the Master of Surgery thesis were the same as in the fraudulent publications. London University was told at that time, but even then did not withdraw the degree. My repeated requests to the University to withdraw the fraudulent degree were ignored by London University over the next 13 years until the BMJ asked me to write a further article.[30,31,32] During the year of fact checking by the journal’s staff and its lawyers, London University were informed that the BMJ was publishing more about the Banerjee scandal, and withdrew his Master of Surgery degree 25 years after they had knowingly awarded the research degree for fraudulent research.[33] The Royal College of Surgeon had awarded Banerjee a prestigious Hunterian Professorship for the fraudulent research, which he presented in a lecture at the College, but 25 years later they have not withdrawn the honour.[30]
12. During the process of trying to get Banerjee’s Master of Surgery degree withdrawn, I asked the GMC to help because I thought that they would be concerned that Banerjee was continuing to use a medical qualification obtained by fraud. The GMC’s response was “Our education responsibilities for University Medical Schools are limited to the award of primary medical qualifications. As the Master of Surgery is not a primary medical qualification, it is a matter for the University to award it, and whether to withdraw it. Obviously while the award remains in place, no charge of claim to a false qualification can arise.” The GMC missed the point, which was that use of a research qualification obtained by fraud is evidence of lack of integrity.
13. At that time Banerjee’s history was that he had been suspended from the medical register for a year when I reported him first for misconduct. After the hearing, I informed the GMC that they had failed to consider all of his misconduct. The GMC said that they could take no action because he was not, at that time, on the Medical Register. I had to wait until he was back on the Medical Register in January 2002 and I reported him a second time. That resulted in his suspension under interim orders and him being struck off the Medical Register nine months later. The GMC allowed Banerjee back onto the Medical Register in 2008. Despite that history, Banerjee was awarded an MBE for services to patient safety in June 2014,[30] but that was forfeited two months later, following complaints from me and from the patients that Banerjee had harmed.
14. The GMC also found Banerjee’s co-author of the fraudulent research, Professor Tim Peters, guilty of serious professional misconduct, but Peters received only a severe reprimand.[10] I find it difficult to believe that Peters did not know the full implications of research fraud, because he was the Head of the Department of Clinical Biochemistry at King’s College London; Director of the NHS Pathology Services at King’s College Hospital; Sub-Dean for Higher Degrees & Postgraduates at King’s College School of Medicine and Dentistry; Associate Dean of the Thames Postgraduate Medical Education Department of the University of London; and the Editor of two medical journals.[30] The medical establishment and senior NHS management largely disregarded the GMC finding of serious professional misconduct. Peters returned to his posts at King’s College Hospital. Peters had an A+ Merit Award based on service including his research. It considerably enhanced his salary and pension. It was not withdrawn.
15. I know of several other cases where higher research degrees (Ph D degrees and MD degrees) are fraudulent. In two cases the degree supervisors told me. One supervising professor had reported concerns that the degree was dishonest to the head of the university school. He was told that he must conceal the dishonesty from external examiners or he would be sacked. Getting Banerjee’s Master of Surgery degree withdrawn took me so many years, even when the evidence of the fraud was clear,[33] that I know that I do not have time to get these other dishonest research qualifications withdrawn.
16. In addition, I have previously described how Professor Peter Collins was appointed despite his institution (the Royal Brompton Hospital) being aware that he had repeatedly claimed a research qualification that he had not been awarded in order to obtain advancement in his career and the GMC had taken no action when I notified them of his dishonesty.[34] Collins continues to perform research and is an organiser or undergraduate cardiology teaching at Imperial College and is responsible for postgraduate cardiology specialist registrar training for his Deanery. When I wrote about Collins and the failure of the medical establishment to deal with his dishonesty in the BMJ,[34] the journal was threatened with legal action. The threats evaporated when the BMJ’s lawyers responding by stating what evidence I had provided.
17. When dealing with clear cases of research misconduct the General Medical Council is inconsistent and illogical. The GMC has attempted to refuse to investigate cases of research misconduct on the grounds that the publication is not fraudulent if it has not been retracted (e.g. Dr Andrew Dowson – see below). Journals usually refuse to retract a false publication until an official body has investigated and found that the article was falsified. Thus the Lancet refused to retract the paper by Andrew Wakefield and colleagues until the GMC ruled that there was research misconduct. In the Wakefield case and in the case of A K Banerjee, if the GMC had refused to investigate until the journal had retracted the publications, those doctors would not have appeared before the GMC and those publications might not be retracted.
18. Most medical journals require that authors sign a declaration that they have seen the full data and take responsibility for it. In cases when corporations send a doctor (usually an opinion leader) a paper and ask him to submit it to a journal as his own work in return for a payment to the doctor (a practice known as “gift authorship” in medicine, but in other walks of life known as fraud), it is customary to make a false declaration and say that one has seen the data when one has not. The GMC consistently finds that making such false declarations are “negligent” but “not dishonest”. An example is Professor Richard Eastell.[35] In this country, making a false declaration is a criminal offence, but apparently the GMC believes that it is not misconduct when it relates to research publications.
19. Dr Andrew Dowson’s first appeared before a GMC Fitness to Practise Panel in 2006.[36] He had been chief investigator in a multicentre trial of botox injections for migraine prophylaxis. The Panel found and told Dowson “your fitness to practise is impaired by reason of your misconduct, in particular your unprofessional and unacceptable actions in recording vital signs data on the case report forms of several patients in the study in which you were engaged, and then signing their case report forms as accurate, when they were not.” In March 2004 the research ethics committee reported Dowson to the GMC and told him that he was not fit to be a trial chief investigator. In July 2004 Dowson agreed to be chief investigator in another industry sponsored migraine trial – the MIST trial. In 2006 the GMC tribunal determined that Dowson was guilty of misconduct in the botox migraine trial, but it determined that when he signed a declaration that what he wrote on the clinical record forms was a true record, when he claimed to have seen patients when he had not seen them and when he fabricating clinical findings he had not been dishonest.[36] (My view of dishonesty is different.) The tribunal’s sanction was trivial because it only placed conditions on Dowson’s registration.
20. His second tribunal in 2014 found that Dowson began to commit misconduct in the MIST trial within days of being appointed as chief investigator.[7] The tribunal transcripts show that Dowson admitted that during the almost 4 years of the MIST trial, he was paid approximately £2000 each week by the sponsor, NMT Medical, and he did not disclose that conflict of interest in the published paper.[37] Dowson did not disclose his share dealings in the sponsoring company, which earned him thousands of pounds. The GMC determined that on 13 April 2005 Dowson bought 3,400 shares in NMT and sold them at a considerable profit on 30 June 2005.[7] Dowson purchased the shares 8 days after a MIST Trial steering committee meeting at which the committee learned that the preliminary findings in the trial were very encouraging and we agreed that I would present and release those data at a major cardiological conference in Paris (EuroPCR) on 24 May 2005. The price of NMT shares increased because of the announcement of the encouraging findings and I believe that Dowson profited by insider knowledge. Later, the first published version of the MIST paper was corrected after publication when I pointed out that the paper contained false information and that life-threatening complications from the treatment had been omitted.[37] Disclosure of the true findings would have adverse financial effects for NMT. Dowson, the first author of the paper, was found guilty of dishonesty by the Fitness to Practise Panel, but the GMC refused to consider the main allegation that he had acted with other investigators and the sponsoring company to misrepresent the trial data. The GMC decided that they would not consider allegations involving decisions that were made by more than one person. Nevertheless some other investigators received advice about future conduct and the tribunal commented that a person employed by the sponsoring company had misled the research ethics committee that approved the MIST trial.[7] The tribunal suspended Dowson from the Medical Register for only four months. Many people are surprised by the leniency of the sanction considering that it was Dowson’s second adverse finding for research misconduct.
21. During his suspension, Dowson continued to sit as a member of the Medical Advisory Board of the medical charity Migraine Action. I wonder how much misconduct one must commit in migraine research before the migraine charity will decide one is not fit to be on its Medical Advisory Board. I asked the GMC whether it was permissible for Dowson to be a member of a Medical Advisory Board when he was suspended from the Medical Register. The GMC said that one does not need to be on the Medical Register to hold such a position.
22. When Dowson finished his period of suspension, a Fitness to Practise Panel had to consider his return to the Medical Register. The Panel found in March 2016 that Dowson’s fitness to practise remained impaired, but because he had completed his sanction, he was allowed to return to the Medical Register. Dowson returned to the post of Director of Headache Services at King’s College Hospital, which had been kept open for him as during his period of suspension.
23. The GMC appears to regard some other forms of research misconduct as trivial. I asked the GMC to investigate various forms of misconduct by authors of a paper in the Lancet from the Institute of Naval Medicine.[38] The GMC found that there were no ethics committee approval for the research, no ARSAC certificate for the radioactive isotope injected into patients and no consent forms. The GMC was content to give some authors the trivial sanction of “advice about future conduct”. One was a professor of medicine who implausibly claimed that he did not know that he needed approval from an ethics committee in order to inject a radioactive substance into civilian casualties. The GMC accepted the explanation from a consultant radiologist that he did not realise that an ARSAC certificate was needed for the isotope. (I believe that both excuses are comparable to a commercial pilot claiming that he did not know that he needed a pilots licence.) The GMC accepted that some “authors” were not responsible because they had allowed themselves to be named as authors even though they had no involvement with the research. The GMC ignored the fact that allowing oneself to be named as an author without satisfying the criteria for authorship is a form of research misconduct. The GMC said that they could not consider the actions of the two most senior doctors because the GMC had allowed them to remove their names from the Medical Register as a result of an administrative error. Attempts to replicate the claims in the paper have failed, but crucially the GMC said that they could not investigate allegations that the study results were fabricated because the Royal Navy would not let the GMC see the data.
24. The fact that the medical establishment does not regard research misconduct as a major misdemeanour is illustrated by the case of Dr Patrick Parfrey. In August 1981 his co-authors retracted two papers that he had published in the Lancet because they found that some of the patients did not exist.[39] He moved to Canada in 1982. He became professor of medicine in University of Newfoundland and Associate Dean for Clinical Research for the Eastern Provinces of Canada. Parfey was awarded the Order of Canada, the second highest level in the Canadian Honours system. Dr Ranjit Chandra worked in the same institution in Newfoundland as Parfey and also had the Order of Canada. He was stripped of the honour in 2016 after the BMJ retracted a paper by Chandra and he lost a libel suit against CBC over a three-part documentary that examined allegations of fraud by Chandra.[40,41]
25. It may seem strange, but some developing countries take a stronger line on research misconduct that the UK and other developed countries. I chaired a research fraud investigation in a developing country that is considered far more corrupt that the UK when dealing with financial misconduct. They provided better and more rapid support, including computer support, for forensic analysis of the data than I have witnessed in developed countries. The biggest obstacle to the investigation came from two professors with international reputations working in a world famous US medical school that wanted the investigation dropped. They had collaborated with the alleged fraudster over many years and were clearly concerned that a finding of misconduct would have implications for the credibility of their past research.
26. Based on my experience, I believe that self regulation of integrity in research has largely failed. The issue is so important and prevalent that the best way to address the problem of research misconduct would be by making serious forms of research misconduct criminal offences with meaningful sanctions and to have allegations investigated by a statutory independent body with legal powers (comparable to the Health and Safety Executive).
March 2017
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