Source: Daily Telegraph
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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.

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