21 June 2014

Medical research fraud and vetting

What happens when the watchdogs are asleep or complicit in serious misbehaviour? What does it take to live-down past stigma?

The UK Independent tartly reports that consultant surgeon Anjan Kumar Banerjee, who was appointed an MBE in last week's Queen's Birthday Honours for services to patient safety, is "a serial fraudster who has harmed patients and was struck off the medical register in 2002 for gross professional misconduct".
It appears the Cabinet Office Honours Committee, which selects candidates for the awards, was unaware of Dr Banerjee's background. In 2000 he was involved in one of the most notorious cases of research misconduct in recent medical history. He was found guilty of falsifying a scientific paper which had been published in 1990 but was covered up for a decade.
He was awarded a degree by the University of London and made a professor by the Royal College of Surgeons based on the fraudulent research. He was later suspended from the medical register and his co-author, Professor Tim Peters, was also found guilty of serious professional misconduct for his part in the cover up.
Two years later Dr Banerjee was again found guilty of serious professional misconduct for financial dishonesty and was struck off the medical register. He had misled patients about the length of NHS waiting lists to induce them to go private and had sought payment for treatments not performed. Concerns were also expressed about his clinical skills.
He was restored to the register in 2007. Under General Medical Council rules, doctors who are struck off may apply for re-instatement after five years. He now uses the name Swapu Banerjee and specialises in drug safety and clinical risk management as head of development consulting at Pope Woodhead, as well as operating part time at Bedford hospital.
Peter Wilmshurst, a cardiologist at the University Hospital of North Staffordshire and a campaigner on medical research fraud, said: "Mr Banerjee did awful things and only eight years after getting back on to the medical register he is rewarded with an MBE".
"If you have got a record of misconduct going back to the late 1980s, you would have to do something very remarkable in the next eight years to deserve an award. But I have not heard of him doing anything."
A spokesman for the Cabinet Office said: "We are currently looking into the MBE awarded to Dr Banerjee. Like any other nomination, it will have been considered on merit based on the information provided to the relevant independent committee, in this case the Health Committee."
A spokesman for Bedford Hospital said: "All necessary employment checks were carried out by the trust when he was appointed."
'Consultant suspended for research fraud' by Annabel Ferriman in (2000) 321(7274) BMJ 1429 adds some context, stating -
A consultant surgeon in England was found guilty of serious professional misconduct last week for publishing fraudulent research results.
Mr Anjan Kumar Banerjee, aged 41, of the Royal Halifax Infirmary, was suspended for a year by the General Medical Council for publishing an article in Gut in December 1990 that contained information which "was deliberately falsified".
"The outcome was that a wholly misleading article went into circulation", said Mr Rodney Yates, chairman of the professional conduct committee.
In addition to publishing a fraudulent article in Gut — a charge which the surgeon had denied — Mr Banerjee admitted that in 1990 he submitted an abstract to the British Society of Gastroenterology, the contents of which had been falsified. He claimed the results were based on urine samples from "12 healthy adults" whereas the samples were in fact of his own urine.
Mr Yates said: "Medical research is central to the advance of medical practice and must always be conducted with scrupulous honesty and integrity. It is highly irresponsible, and potentially dangerous for patients, for a doctor to falsify research."
"The committee consider that these events illustrate seriously irresponsible and dishonest behaviour on your part."
Mr Banerjee, who is at present suspended from his job in Halifax for reasons unconnected to the case, was a junior doctor at King's College Hospital, London, at the time that the offences took place.
He was reported to the GMC by consultant cardiologist Dr Peter Wilmshurst of the Royal Shrewsbury Hospital, who has campaigned over many years on issues of research fraud.
Dr Wilmshurst said this week: "Although it has taken three years for the GMC to investigate and find Mr Banerjee guilty, the real problem is the six to seven years that it took for the case to get to the GMC, despite the fact that it was well known at King's. The delay was due to the pressure brought to bear on the whistleblowers to keep silent".
The investigation by the GMC was made particularly difficult because the authorities at King's had selectively shredded the laboratory books that had been in existence when Mr Banerjee was carrying out his research, something which was admitted at the hearing.
We need to consider whether the medical school and the University of London behaved properly in this matter. It is clear that senior doctors and administrators were aware of the problems in the early ‘90s but took inadequate action to draw them to the attention of the proper authorities.
London University gave Mr Banerjee a Master of Surgery degree, when there are documents existing which show that they were told that the research in his thesis was fraudulent.”
In 2002 the BBC reported
A consultant surgeon who persuaded patients to opt for private treatment so he could make more money has been struck off for serious professional misconduct.
A General Medical Council (GMC) hearing in Manchester was told Dr Anjan Kumar Banerjee lied to patients about NHS waiting times for surgery.
He told them it would be quicker to go private - and then made money by providing the treatment himself.
Elizabeth Walker, chairman of the GMC committee which heard the case, said: "Your actions were motivated by financial gain and your evidence to the committee demonstrated that you continue to have little or no insight into the seriousness of your actions."
Dr Banerjee had twice as many paying patients as other consultant general surgeons, the GMC was told.
The surgeon, who worked for Calderdale and Huddersfield NHS Trust as well as the Bupa Hospital in Elland, West Yorkshire, pocketed money for carrying out operations on patients he had advised to go private between January 1997 and March 2000.
Timothy Brennan, counsel for the GMC, said: "This consultant was motivated by a zeal to charge for certain procedures in order to line his own pockets."
Dr Banerjee also claimed rates of payments for procedures which were different to the rate for the operations actually carried out.
"One such payment was misleading, dishonest and undertaken for financial gain," added Mr Brennan.
The sobering 'Institutional Corruption In Medicine' by Peter Wilmshurst in (2002) 325(7374) BMJ 1232 comments that
A decade elapsed between Anjan Kumar Banerjee admitting to senior doctors at King's College Hospital that he had falsified scientific research and the finding by the Professional Conduct Committee of the General Medical Council on 30 November 2000 that Banerjee was guilty of serious professional conduct because of that dishonesty. Professor Timothy John Peters, Banerjee's research supervisor from 1988 to 1991, was also found guilty of serious professional misconduct at a separate hearing on 28 February 2001. The GMC found that, after he became aware that Banerjee had falsified research, Peters had failed to prevent Banerjee falsifying further research, failed to retract publications that contained falsified research and which named both of them as authors, failed to bring Banerjee's misconduct to the attention of the GMC, and supplied a misleading final report on Banerjee's work to the Medical Research Council, which had funded the work.
This much is well reported, but the greater scandal is less well known. This was not just a case of one doctor covering up for another, but of corruption at a senior level in academic institutions that have special roles in the appointment of non-elected members to the GMC. The failure to deal with Banerjee's fraudulent research at an early stage in his career allowed him to gain a consultant post despite concerns about both his honesty and his clinical competence. By November 2000, when the GMC suspended Banerjee from the Medical Register for one year because he had falsified his research, he had been suspended from his consultant post for eight months because of concerns about financial probity and clinical competence. At his second hearing before the Professional Conduct Committee in September 2002, Banerjee was erased from the Medical Register because of serious professional misconduct resulting from his financial dishonesty and inadequate clinical care.
Wilmshurst offers a cogent and detailed analysis,  commenting
In 1988, soon after he started his research with Peters, doubts were expressed about Banerjee's honesty. Banerjee wrote two draft papers on the effects of non-steroidal anti-inflammatory drugs on the bowel of rats. He included four other workers from the hospital on the drafts. In addition to Peters, they were Dr (now Professor) Ingvar Bjarnason, Dr Paul Smethurst, and Dr (now Professor) Ashley Price. These workers expressed concerns to Peters. Bjarnason and Smethurst stated that they had no involvement with the studies and that they were unable to find evidence that Banerjee had done the large amount of animal work described in the papers in his spare time. Indeed, they could find no evidence that Banerjee had access to some of the equipment described in the draft papers or had been trained to use it Price stated that the few histology specimens shown to him did not justify the radical claims made. The three refused to have their names associated with the research. Shortly afterwards, Peters took up a professorship at King's College Hospital. Many of the staff who had worked with him at Northwick Park also moved to King's. Banerjee took up a MRC training fellowship, with Peters as his supervisor, in March 1989. His research on the effects of non-steroidal anti inflammatory drugs on the bowel was also awarded research grants by two charities and a pharmaceutical company. Bjarnason followed later. Before Bjarnason arrived, other researchers at King's (Dr Roy Sherwood, Dr Kishore Raja, and Dr Robert Simpson) and a collaborator at St Thomas's Hospital (Dr Ian Menzies) reported concerns to Peters that Banerjee had falsified research in human studies. Sherwood noted that the amount of radioactive isotope Banerjee had claimed to have used was considerably more than that ordered for the whole department. ....
Meanwhile, the two draft papers on non-steroidal anti-inflammatory drug enteropathy, from which three coauthors had asked that their names be removed,) were combined into one paper and submitted to Gut as a full paper, with Banerjee and Peters as the only authors. Ten years later, in November 2000, the GMC found that the research in this paper was also falsified. In 1990 other work by Banerjee came under suspicion, and King's College Hospital started an inquiry into Banerjee's research. At the end of that inquiry in July 1991, Professor Harold Baum (head of the School of Life, Basic Medical, and Health Sciences) wrote a confidential letter to Peters with a copy to Mr H T Musselwhite (secretary to the Medical School) stating: "Having carefully examined the documentary evidence which you sent me, I am totally satisfied that much of the research data reported by Dr Banerjee since 1988 is at best unreliable, and in many cases spurious."
That documentary evidence, including Banerjee's laboratory books, was never seen again. It absence impeded the GMC's investigation of Banerjee. King's College did not inform the Medical Research Council or other grant awarding organisations that the research that Banerjee had claimed to have performed with their grants was apparently falsified, and none of those grants was repaid. Peters was criticised by the GMC for failing to document the concerns about Banerjee in his final report to the MRC. Meanwhile, Banerjee had submitted a thesis to the University of London for a master of surgery degree based on the research published in Gut. We now know that this research was falsified. Because he was unable to get an assurance from the authorities at King's College that they would notify the University of London that Banerjee's thesis (for which he was awarded a master of surgery degree) was based on suspect research, Bjarnason notified the university directly. On 7 August 1991 Bjarnason wrote to the Senate and Academic Council Secretariat of the University of London. He reiterated concerns that he had previously expressed to the university that the research in Banerjee's thesis was falsified and that six coworkers had expressed similar concerns. However, he stated that he has been advised to drop the matter by Professor Peters or his career would suffer and accordingly he was retracting his allegations under duress. The university acknowledged receipt of the letter.Many people might consider a retraction made by a person who claims to be under duress is not a genuine retraction.
The university seems to have taken no further action, until prompted by me on 5 December 2000 to look again at Banerjee's thesis after his GMC hearing. The academic registrar of the university wrote to me on 21 December to ask whether I could provide them with copies of the university's documents, since they could not find their own copies. I did so. Despite repeated requests from me, the university has still not informed me whether it will withdraw the degree awarded as a result of fraud. ....
Banerjee left King's College and moved through other training posts to be appointed as a consultant surgeon in Halifax. New concerns quickly arose, and eight months before his hearing by the GMC Banerjee was suspended by his hospital because of allegations entirely unrelated to the research fraud at King's. The Royal College of Surgeons was asked to investigate Banerjee's clinical competence, and an independent authority was asked to investigate his honesty. While this was happening, Banerjee was nominated for fellowship of two of the three royal colleges of physicians in the United Kingdom. One nomination was successful. The other failed. This was not because of any official check, but because I chanced to see Banerjee's name on the nomination list and informed the college that his appearance before the GMC was imminent There seems to be a communication problem if two medical royal colleges were considering honouring a surgeon by awarding him a fellowship without being aware that he was facing a hearing before the GMC and was under investigation by the Royal College of Surgeons, his employer, and other bodies.
Banerjee resigned from his hospital after the GMC suspended him from the Medical Register for one year. During his suspension, I asked the GMC to speedily investigate the outstanding allegations about Banerjee. His suspension ended in January 2002, and he was suspended by the Interim Orders Committee on 21 January 2002. On 9 September, Banerjee was found guilty of serious professional misconduct for the second time. The main findings related to financial dishonesty over a sustained period of time. He misled patients about the length of NHS waiting lists to induce patients to opt for private treatment and sought payments for treatments not performed. Concerns were also expressed about clinical skills.
Wilmshurst concludes
Banerjee's erasure from the Medical Register may remove the incentive in the eyes of some to investigate the outstanding issues. I, for one, would like to know how concerns about his honesty and clinical skills during a decade were not reflected in reports and employment references.
Academic institutions and the GMC Medical schools, universities, royal colleges, and specialist societies have key roles in setting the standards for medical practice in this country and for the award of qualifications. King's College, the University of London, and the Royal College of Surgeons are among the bodies that directly appoint non-elected members to the GMC. In this case some senior doctors and managers in these institutions concealed serious professional misconduct by doctors for a decade. Some allowed Banerjee to gain a qualification and an honour dishonestly. By so doing, they devalue the qualification others received from their institutions. It was not just that some turned a blind eye to the deceit, but some made whistleblowers feel threatened and others destroyed evidence. Would a judge shown to be involved in concealing crimes and perverting the course of justice be allowed to continue on the bench? Should King's College, the University of London, and the Royal College of Surgeons be allowed to continue to appoint non-elected GMC members?
The case of Banerjee and Peters is not an isolated one. I am aware of other cases under investigation by the GMC in which academic institutions, which appoint members to the GMC, refused to cooperate with the GMC's investigations into research fraud and other forms of misconduct by doctors employed in their institutions. It is difficult to believe that the decision not to cooperate with the GMC is made at a junior level. It seems likely that in some cases appointed members of the GMC are involved in the decision of their institution not to cooperate with the GMC's inquiries. At a time when there is restructuring at the GMC, the role of academic institutions in appointment of GMC members needs to be considered.