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BMJ 2001;323:825 ( 13 October )

News

World Medical Association clarifies rules on placebo controlled trials

Annabel Ferriman, BMJ

Clarification on the ethical use of placebo controlled trials was published last week by the World Medical Association following its four day council meeting in France.

The clarification follows criticism from researchers that when the association revised the Declaration of Helsinki last year, its guidance on clinical trials was impractical for researchers in many parts of the world.

The new ethical standards laid down under the revised declaration stated that the testing of drugs should be done against the best current treatment and not against placebo (BMJ 2000;321:913). The revision had particular implications for research in developing countries, where the testing of new drugs against the best current treatment would have massively increased the cost of research.

Professor James Whitworth of the Medical Research Council on AIDS in Uganda, voicing the reaction of many researchers, told the British Association's Festival of Science in Glasgow in the summer that the revised guidance was not always practical (8 September, p 531). He said that it might prevent some ethical and necessary research from going ahead.

"It seems a strange sort of logic to stop doing trials in Africa that are trying to help improve the health of poor people so that people in rich countries can have peace of mind," he told the festival.

Now the World Medical Association has looked again at its guidance. The association agreed that the use of placebo in research trials might be ethically acceptable in certain circumstances. These were:

Where for compelling and scientifically sound methodological reasons its use was necessary to determine the efficacy or safety of a prophylactic, diagnostic, or therapeutic method; or

Where a prophylactic, diagnostic, or therapeutic method was being investigated for a minor condition and the patients who received placebo would not be subject to any additional risk of serious or irreversible harm.

Commenting on the clarification, Professor Janet Darbyshire, director of the Medical Research Council's clinical trials unit in London, said: "It is still not very clear, but at least it does clarify that using a trial with a no treatment group, who are taking a placebo, is no longer completely unacceptable."


 

(Credit: SCOTSMAN, EDINBURGH)

Professor Sir James Black, who developed the first beta  blocker, propranolol, and the first H2 antagonist, cimetidine, was honoured last week with the unveiling of a portrait in the Scottish National Portrait Gallery in Edinburgh. The portrait of Professor Black, who was joint winner of the Nobel prize in physiology or medicine in 1988, was painted by Glasgow based artist George Devlin (pictured left). Professor Black is now emeritus professor of analytical pharmacology at King's College, London.



© BMJ 2001

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