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BMJ 2003;326:304 ( 8 February )

News

GP suspended for enrolling patients in drug trials without consent

Owen Dyer, London

A Hertfordshire GP who included his patients in drug trials without their knowledge was last week suspended by the General Medical Council.

Dr Robert Macindoe Adams, 58, admitted enrolling 12 patients in seven drug trials for pharmaceutical companies including AstraZeneca and SmithKline Beecham without providing an opportunity for informed consent.

The trials involved drugs for depression and hypertension. In two cases Dr Adams was found to have overstated the patients' symptoms to meet the strict criteria for antidepressant trials. He was also found to have changed patients' treatment and prescribed placebo to conform to study protocols.

Dr Adams, who is reportedly in poor health, did not attend the hearing but was legally represented. His counsel, Charles Foster, said his client was his own harshest critic and had "excoriated himself" over his actions. Most of the charges were uncontested.

Ten of the patients entered into the drug trials were found to have been given insufficient information to provide informed consent. In particular, Dr Adams neglected to give them patient information leaflets relating to the studies. He failed to mention a trial at all to two patients.

One of these patients, referred to by the GMC's professional conduct committee as Mrs K, became suspicious when Dr Adams changed her treatment after enrolling her in a trial of the calcium channel blocker lercanidipine.

Mrs K expressed her concerns about her change of treatment in a letter, in which she also complained about frequent blood tests. Mr Edward Henry, counsel for the GMC, said she "thought there could be no reason for giving blood repeatedly with her arm turning black and blue." At one point she asked Dr Adams: "Are you selling my blood?" Taking of samples that are not necessary to the patient's wellbeing could be construed as assault, said Mr Henry.

Although Dr Adams wrote in reply to Mrs K's letter, he failed to mention that she was being prescribed lercanidipine as part of a clinical trial. He accepted the GMC's charge that this letter was misleading.

Professor Peter Richards, chairman of the panel hearing the case, said: "Patients were exposed to risks of treatment and to periods of placebo treatment without their knowledge. Patients must be able to have confidence that any treatment is both necessary and in their best interests. Pharmaceutical companies must be able to rely on doctors' strict compliance with drug protocols. Trust is a cornerstone of good medical practice. This trust was abused."

Mr Foster told the committee that his client was no longer practising and had no plans to resume clinical work. Unless he appeals against the decision, Dr Adams will be suspended for 12 months. His case will be reviewed before the end of that suspension period.

© 2003 BMJ Publishing Group Ltd


 

PDF of this article Email this article to a friend Respond to this article PubMed citation Related articles in PubMed Download to Citation Manager Search Medline for articles by: Dyer, O. Alert me when: New articles cite this article

Collections under which this article appears: Professional conduct and regulation Research and publication ethics

© 2003 BMJ Publishing Group Ltd

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