Pubdate: Sun, 24 Aug 1997 Source: Daily Telegraph Contact: Scandal of drugtrial fraud by doctors By Chris Boffey TWENTY cases of alleged fraud by doctors involved in clinical trials of drugs are being investigated by pharmaceutical companies and the General Medical Council. Doctors are accused of accepting money to conduct the tests and then falsifying the results. In some cases, it is claimed, patient consent forms have been forged. The unprecedented number of cases have come to light following the scandal of Dr John Anderton, a senior renal consultant and former registrar at the Royal College of Physicians in Edinburgh, who was struck off last month for conducting a sham study over 15 months of the antiangina drug amlodipine. Trials by doctors with their patients' consent are vital in discovering whether new drugs work and if they have any sideeffects. Fraud has major dangers. A bad drug might be allowed onto the market or development of a good drug stopped. Patients who agree to test the drugs could be in danger if their surgery records falsely say they are taking medication. The fraud by Dr Anderton was uncovered by Dr Frank Wells, a former GP, and Peter Jay, a retired detective chief inspector with the Metropolitan Police, who are partners in the investigation company Medicolegal Investigations. Dr Anderton was found guilty of forging patient consent forms, faking results and persuading his assistant to lie to drug trial auditors. Dr Wells and Mr Jay were hired by the pharmaceutical company Pfizer to compile evidence. They are working for a number of drug companies on 20 other cases where there is evidence of fabrication. Drug companies believe that one per cent of trials are fraudulent. "With some 3,000 clinical studies going on at any one time that means around 30 cases could be fraud," said Dr Wells. One recent case has involved fraud in trials on animals. "The research findings would be used in good faith by the pharmaceutical industry to take forward its work and use humans for the first time. If the animal studies have been fabricated this could cause immense harm," said Dr Wells. Pfizer called the investigators in after suspicions about Dr Anderton's results. Abandoning his studies and repeating the trials properly cost £250,000. Dr Wells spent six years at the British Medical Association as an undersecretary and 10 years as medical affairs director at the Association of the British Pharmaceutical Industry. Mr Jay, who was responsible for the arrest of Britain's biggest serial killer Dennis Nilsen, retired from the Met to become an investigating officer with the solicitors for the General Medical Council. Drug companies are usually alerted to possible fraud by clinical trial monitors. Mr Jay said: "Sometimes, it is because the data sent in by a doctor is totally out of line with everybody else, or there are anomalies in handwriting. Diary cards that patients have to fill in that come back in pristine condition, or tubes of medication that may have been used by the patients that have all been squeezed in exactly the same way. All these arouse suspicions." Dr Wells and Mr Jay have interviewed more than 300 patients during their investigations. Mr Jay added: "Many are devastated that they have been exploited by their own, trusted doctors. They cannot believe their signatures on the consent forms have been forged." Investigation of clinical fraud will take about four months, with a further year for the case to be dealt with by the GMC. This is quicker than taking criminal action against the doctor for obtaining money by deception. "The sad fact is that in virtually all cases, and certainly in Dr Anderton's, the doctors spend more time and work covering their tracks than they would do if if they were properly conducting the trials," said Mr Jay. © Copyright Telegraph Group Limited 1997