When I was younger there was a very active National Institute for Medical Research at Mill Hill – now renamed the Francis Crick institute.. It seems the ability to check that research is valid and reliable and can be reproduced has been lost. Therefore we are at risk of expensive new treatments, led by Big Pharma which diminish the resources available for non pharmaceutical treatments. With apologies to the BMJ, I reproduce these articles in full. There is “something rotten in the state of British medicine”, but it extends beyond research, and into politics, philosophy and ideology. Covert rationing will be seen as a scandal.
Medicine has its fair share of scandals. This week The BMJ reports on three. First, cardiologists John Dean and Neil Sulke highlight what they see as the scandal of the short life of pacemaker batteries (doi:10.1136/bmj.i228). Over half of patients with pacemakers will need new batteries, they say, and many need several replacements. But there are no incentives to develop longer life devices. Increasing longevity would reduce profits for manufacturers, implanting physicians, and their institutions, they say. Meanwhile, patients risk infection and other complications of replacement, and money is wasted replacing batteries before they’ve expired.
The second scandal is a more deep seated one: medicine’s failure to act when members flout basic codes of probity and competence. In the extraordinary saga, doggedly pursued by Peter Wilmshurst for nearly 20 years, surgeon Anjan Kumar Banerjee was briefly awarded an MBE despite having been struck off for serious professional and research misconduct (doi:10.1136/bmj.h6952). He still retains fellowships from three royal colleges and a masters degree that was based on fraudulent data.
Uncovering a bizarre catalogue of failures, Wilmshurst finds rot in almost every pillar of the medical establishment: the universities, the GMC, the royal colleges, the medical honours system—all opaque to scrutiny and resistant to accountability. “When errors occur, the establishment would usually rather close ranks and silence whistleblowers than correct the error,” says Wilmshurst. We need, he says, to get rid of the existing “club culture” in British medicine and create instead a culture that values integrity and transparency.
In his linked editorial (doi:10.1136/bmj.i293), the former BMJ editor Richard Smith has understandably given up hope of change from within the profession. “Something is rotten in the state of British medicine and has been for a long time,” he says. What we need is “a statutory body with powers that can oversee research institutions, including universities.”
Our third scandal reflects an equally longstanding malaise, this time in drug development. Deborah Cohen has been on the trail of the evidence behind the new direct oral anticoagulants for three years. Her first report found hidden evidence of a therapeutic range for dabigatran, undermining claims that patients taking these new drugs don’t need regular blood checks (doi:10.1136/bmj.g4670). Further digging by Cohen has uncovered use of a faulty monitoring device in the only pivotal trial of rivaroxaban, casting serious doubt on findings that underpin use of what is now the world’s best selling new oral anticoagulant (doi:10.1136/bmj.i575). Efforts to allow independent analysis of the data have so far failed.
To paraphrase Smith’s conclusion, things will go wrong in medicine. The real scandal is in failing to act properly when they do.
Anjan Kumar Banerjee, a surgeon, spent the years 2002 to 2008 erased from the medical register for serious professional misconduct related to research fraud, financial misconduct, and substandard care, yet in 2014 he was awarded an MBE “for services to patient safety.”1 This embarrassing mistake was quickly rectified, and the MBE forfeited. But he remains a fellow of three medical colleges. Each either awarded him or reinstated a fellowship after his erasure, and the University of London has not withdrawn his MS degree, which has been known for 15 years to be based on fraudulent data. The long sorry story of Banerjee that cardiologist Peter Wilmshurst tells in the linked analysis article,1 and has told in part before,2 raises serious questions about the integrity of medical and scientific institutions.
Wilmshurst’s story comes a few weeks after an article in the Times Higher Education about a report to government that says: “Senior figures in UK science have warned that despite decades of awareness of the cultural problems driving misconduct in science, little progress has been made … The draft … concludes that some research institutes, university administrators, funders, journals and science leaders have been covering up malpractice.”3 It’s splendidly ironic that this report is an unpublished “secret dossier.”
But what the report says is not news. The United States had several high profile cases of research misconduct in the 1970s and ’80s, and in 1989 the government established the body that became later the Office of Research Integrity.4 It covers only medical research that is government funded, but it has real powers. Anxieties about research misconduct in Britain began to be raised in the ’90s, with Stephen Lock, the editor of The BMJ, taking a lead.5 It seems fair to say, however, that Britain has never taken the problem seriously.
Despite a high level consensus statement on research misconduct organised by The BMJ and the Committee on Publication Ethics,6 the UK Research Integrity Office (where I was a trustee) is poorly resourced and has no powers,7 and the Concordat to Support Research Integrity is largely a bureaucratic exercise that critics would say is designed to give the appearance of taking action but without the necessary commitment of resources to make a difference.8 The “secret dossier” may be a prelude to government action because, as the Chinese have recognised, an economy built on science has to have robust ways of ensuring the integrity of that science.9
Britain has failed to mount an adequate response for two main reasons. Firstly, many scientific leaders still do not acknowledge the seriousness of the problem, fooling themselves that research misconduct is rare, science is self correcting, and misconduct is a victimless crime. Secondly, universities jealously guard their independence: even though they depend heavily on government funding they don’t want government bodies having powers to investigate possible misconduct of their researchers.
But universities clearly have a major conflict of interest when one of their researchers is accused of misconduct, particularly if he or she is eminent. It is tempting to try to bury the whole thing, perhaps encouraging the miscreant to retire early or move on rather than be investigated. Until recently, and probably even now, universities and other institutions could be confident that they would get away with burying the case.
Wilmshurst has many other disturbing stories in addition to the Banerjee one; these, as he writes, can often not be told publicly because of the expense and difficulty of getting them through lawyers.1The BMJ recently published an account of the case of R K Chandra, who was investigated by his Canadian university in the 1990s and found to have produced fraudulent research.10 11 The university took no action, and all that it has done so far is agree that a paper retracted 10 years ago was fraudulent.12The BMJ and other journals belonging to the Committee on Publication Ethics have over the years asked many other research institutions to investigate worries, and often nothing has happened.13
We have no way of knowing how many cases are successfully covered up, but when talking to meetings on research misconduct, including one of European medical school deans, I ask how many people know of a case of research misconduct. Usually a half to a third of people put up their hands. I then ask whether the case was fully investigated, and if appropriate the perpetrator punished and the record corrected: hardly any hands remain raised.
Burying bad news and other forms of cover up are not, of course, unique to universities. In Britain high profile inquiries into the Bloody Sunday shootings in Northern Ireland and the crushing of football fans in the Hillsborough disaster have covered up malfeasance by authorities. Subsequent prolonged, and highly expensive inquiries eventually disclosed the cover ups. And cover up of sexual abuse of children was normal in the church and other institutions.
So what should be done? Cultural change seems to be the answer to almost everything these days, but we do need to move to a world where universities recognise the rightness of investigating allegations of misconduct and commit to punishing those found guilty and to publishing the results of their investigations, correcting the research record, and retracting fraudulent research. There is no shame that misconduct occurs in your institution, but there is disgrace in failing to deal with it properly. Training in ethical conduct is needed for all researchers, but it’s hard to escape the need for a statutory body with powers that can oversee research institutions, including universities.
And what about royal colleges dispensing their fellowships? The colleges play an important role in specialist training, but this process is overseen by the General Medical Council, a statutory body. Wilmshurst raises serious questions about the GMC in The BMJ and elsewhere,14 but it is a creature of parliament and can have its decisions overturned by the courts and by the Professional Standards Authority for Health and Social Care. But when it comes to dispensing fellowships, the colleges operate like private clubs. A fellowship explicitly endorses a doctor’s competence and probity so it’s shameful that the colleges do not retract Banerjee’s fellowships, and their failure to do so raises questions about their competence and integrity.
Something is rotten in the state of British medicine and has been for a long time. Statutory regulation is needed.
Pull quote: There is no shame that misconduct occurs in your institution, but there is disgrace in failing to deal with it properly