Medical journals issue drug trials warning

By Victoria Griffith in Boston and David Firn in London - Sep 10 2001 00:00:00

Thirteen leading medical journals will on Monday warn that the promise of big financial rewards is corrupting human clinical trials.

The warning will be issued simultaneously in editorials by the New England Journal of Medicine, the Journal of the American Medical Association, The Lancet, and other publications in Norway, the Netherlands, Australia, New Zealand, Canada, Denmark and the US.

The editors will criticise pharmaceuticals companies for their use of private, non-academic research groups - called "contract research organisations" (CROs). CROs are fast gaining in popularity because - according to the editorials - they are cheaper and less independent than academic institutions.

In the US last year, 60 per cent of the industry's research grants went to CROs.

The editorials will assert that CROs fail to provide sufficient oversight of clinical trials. "The results of the finished trial," the editors warn, "may be buried rather than published if they are unfavourable to the sponsor's product."

Critics fear the substantial financial rewards compromise scientists' objectivity and place patients at risk.

The warning comes as the pharmaceuticals industry struggles to recover from criticism over the prices it charges developing countries for life-saving medicines and a string of high-profile recalls involving problems with treatments for obesity, irritable bowel syndrome and diabetes.

American Home Products has recently taken more than $12bn in charges to cover side-effects caused by a diet drug.

US patients last week filed a claim that GlaxoSmithKline, the Anglo-American drugs group, deliberately hid the side-effects of Paxil, its multi-billion dollar antidepressant from regulators.

Bayer of Germany is facing possible class action after its $1bn-a-year cholesterol treatment Baycol was linked to more than 50 deaths. And Pfizer, the world's largest pharmaceuticals company has been hit by charges that its clinical trials violated human rights in Africa.

The American Medical Association this year exhorted universities and hospitals to require researchers to disclose fully any financial interest they might have in products undergoing clinical trials.

The 13 publications will promise to raise their own standards for the publication of research. From now on, all authors and participants in the review process will have to reveal any possible conflicts of interest.

© Copyright The Financial Times Limited 2001.