Crackdown on clinical cheats

THE results of one in every hundred clinical medical studies may be faked, it is estimated. This means that 30 studies, which could influence the drugs and medical treatments of tomorrow, may be in the process of fabrication at any one time.

Peter Jay, a former detective chief inspector, has spent seven years on the trail of scientific fraud in clinical research. He and business partner Frank Wells run a commercial agency investigating suspected misconduct chiefly on behalf of pharmaceutical companies.

They have exposed some high-profile cases, but by being independent of government or statutory responsibility, they are legally vulnerable and without the full authority a statutory body may provide. Mr Jay would welcome change, and he is not the only one.

Clinical medical research has been punctuated by a number of big frauds. There was Malcolm Pearce, the St George's Hospital obstetrician who faked a study in which he claimed a woman suffering from an ectopic pregnancy had the foetus surgically transferred to the womb and successfully gave birth. But the patient never existed.

Such cases have rocked the community, said Richard Smith, editor of the British Medical Journal.

He and other editors of medical journals formed the Committee on Publication Ethics last year.

This month they called for a national watchdog, with "very big and sharp teeth", to investigate and unearth fraud. But COPE is not the only group looking at fraud. The General Medical Council this year established a group under George Alberti, president of the Royal College of Physicians, to devise a method of dealing with clinicians suspected of research misconduct.

It will devise a series of steps hospitals, general practices or universities can take when scientific fraud is suspected.

The group's remit is wider than that of COPE, covering clinical research ethics beyond publication. It will detail good research practice and define fraud and misconduct, which could cover anything from failing to obtain proper patient or ethics committee consent to removing data or completely fabricating results.

The Association of Medical Research Charities last year produced guidance stating that institutions must take responsibility for investigating allegations of fraud and have procedures in place to deal with it. A year on, it is surveying universities to find out which have such procedures. It was suggested that universities without procedures would be blacklisted, but it now appears the survey will feed into the GMC's study and await its outcome.

The National Academies' policy advisory group, which represents the Royal Society, the British Academy, the Royal Academy of Engineering and the Academy of Medical Royal Colleges, is also investigating scientific misconduct and fraud in medical research.

With such efforts suddenly devoted to addressing misconduct, it is easy to think this is a new or increasing problem. Not so, says the BMJ's Dr Smith who suggests cheating and fraud in academic and clinical research is a little like child abuse. "It's always gone on. But people were inclined to deny it. We are trying to get some idea of scale. I don't think we know whether it's getting worse."

He said: "There is no area of life devoid of fraud or misconduct, so why would there be no misconduct in medicine? I think it probably goes on in all academic subjects. Undoubtedly one of the problems particularly in medicine is that there are people who are wholly untrained as researchers doing research. Many doctors, who are not primarily academics, need to get published to get consultant roles. In these cases they may stumble."

* Richard Nicholson, page 17