Who to trust?

the integrity of clinical trials -- essential for the development of new drugs -- is increasingly under threat from commercial influence, alleges the World Health Organisation (who). According to who, recent reviews have documented how industry sponsors can influence clinical trials to produce desired results. "The reliability of clinical trials is being undermined by conflicts of interest on the part of researchers, inappropriate involvement of commercial sponsors in running the trials and prejudice in publishing the results," says Jonathan Quick, director of essential drugs and medicines policy at who (www.who.int, January 6, 2002).

Examples of conflicts of interest cited in the who report include financial links between researchers and manufacturers of cardiovascular drugs. Moreover, independently funded studies of cancer drugs have been shown to be seven times more likely to reach unfavourable conclusions on drug cost-effectiveness than studies sponsored by the pharmaceutical industry. Biasness in publicising positive results and under-reporting negative ones were also said to be threats to the clinical evidence base. A series of high-profile cases have shown how investigators who publish results contrary to the wishes of a sponsor face intimidation -- efforts to discredit them professionally and threats of legal action to recover the value of lost sales. "If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken," says Quick.

He has raised the idea of drawing up a 'declaration on the rights and obligations of clinical investigators and on how to manage the entire clinical trials evidence base', on the lines of the Helsinki Declaration adopted in 1964 by the World Medical Association. Such a declaration could bind sponsors and researchers to rules ensuring intellectual independence of investigators.