Patients put at risk by medical research fraud

UNETHICAL medical research and fraudulent research results are going undetected, exposing patients to risk and undermining the credibility of scientific institutions, a group of medical editors said yesterday.

In the past year, 27 cases of research misconduct had been detected by the Committee on Publication Ethics, set up a year ago to study the problem. Dr Richard Smith, editor of the British Medical Journal, which has been forced to retract a paper this week because of fraud, said this was the tip of the iceberg.

A national agency with the power to send in hit-squads to investigate doctors and laboratories where fraud is suspected may be the only way to deal with the problem, the editors said.

"There are about 10 members of the committee and 20,000 medical journals published worldwide. We do not know the extent of the problem," Dr Smith added.

Dr Richard Nicholson, editor of the Bulletin of Medical Ethics, said: "We have a problem and people are loath to admit it exists. Over the last 20 years people in positions of authority ought to have been taking fraud seriously. Other countries have taken fraud seriously and acknowledged it exists and have set up research precautions."

One case involved a family doctor who experimented on patients at high risk of heart disease by giving them an untested cocktail of drugs without telling them what was going on.

The unnamed GP gave the cocktail to 77 of his patients who had high cholesterol to see if it would reduce their levels as effectively as the mainstream cholesterol-lowering drugs, known as statins. He then sent his findings to the BMJ.

Dr Smith said: "It was a crackpot therapy and scientifically completely meaningless. All drugs have side effects and if there was no benefit to the patients then that is potentially harmful."

He said he had sent details of the doctor to the General Medical Council but discovered that he had been struck off the medical register for another reason.

Past frauds have also led to doctors being struck off by the General Medical Council. Malcolm Pearce, an obstetrician at St George's Hospital in London, was erased from the register in 1995 for faking a study in which he claimed that a woman suffering from an ectopic pregnancy (in which the fertilised egg implants outside the womb, usually in a Fallopian tube) had the foetus surgically transferred into the womb, followed by a successful birth. Had it been true it would have been a breakthrough procedure. But the patient never existed.

Other examples cited yesterday included cases of plagiarism, manipulation of data and duplicate publication in more than one journal in order to give a finding greater credibility, especially where it involved a new drug. Dr Michael Farthing, chairman of the committee and editor of the journal Gut, said the problem was pervasive. "An example of massive plagiarism was discovered only because we happened to send the paper to a reviewer whose work had been plagiarised. We could have sent it to any one of 200 people and it might never have been noticed."