Jun 2 2004
Doctors, patients and the general public depend on results of scientific research to provide information about the safety and effectiveness of medical treatments. Following the controversy surrounding the Andrew Wakefield study on the link between MMR vaccines and autism, the public is now considering the reliability of medical research in Britain today. Dr Neville Goodman of Southmead Hospital in Bristol investigates the issue in the June issue of the Journal of the Royal Society of Medicine.
The problem of monitoring research fraud has been discussed publicly for the last twenty years but little has been done to provide possible solutions. COPE (the Committee for Publication Ethics) was formed by a group of editors, and ‘research governance’ was set up, but ‘official mechanisms for preventing and detecting research fraud are not evident in the UK,’ Dr Goodman states. Research governance puts the responsibility on the institution, and few are trained or equipped to handle cases of suspicion. Fraud investigators, he writes, are not needed in every research establishment as his hospital has only had ‘one fraud investigation in 20 years.’ Dr Goodman argues that the regulating body needs to be centralised.
Although some whistleblowers try to actively cause trouble, they are key in the process of identifying and investigating causes of misconduct, the article claims. ‘External random checking has too many flaws’ and the ‘English libel laws are at fault’ rather than journal editors. Dr Goodman’s preferred solution is that ‘institutions have to act and have to retract’ when research fraud is suspected. This process, however, starts with the whistleblower; this was very clearly demonstrated in the case of David Franklin and Pfizer, as reported in a recent issue of the British Medical Journal.
If an independent council was formed to respond to research misconduct, Dr Goodman points out that most fraud occurs in studies carried out by large pharmaceutical companies. Research also varies greatly from one institution to another, and it would be difficult for a regulating body to acquire enough knowledge to police all types of specialties. Despite these discrepancies, he supports a unified way of dealing with all cases. There are significant challenges in finding a solution but, particularly with medical research where ‘fraud more demonstrably harms people,’ the UK needs to bring its standards up to those in the United States. ‘Maybe research is just capitalism in microcosm,’ he concedes, ‘but if research is not honest then it is nothing.’ We don’t know the prevalence of research fraud, and we can’t ‘go out looking with suspicion.’ The cardiologist Peter Wilmshurst, who has experienced many accounts of research malpractice, feels that institutions can no longer be trusted. ‘If we can’t trust our hospitals and universities’, Dr Goodman says, ‘then who can we trust?’