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WHO calls for closer monitoring of commercial interests

Rohit Sharma, Mumbai

Commercial interests are posing such an increasing threat to the integrity of clinical trials necessary for developing new drugs that new regulations are needed to safeguard them from corruption, according to Dr Jonathan Quick, director of essential drugs and medical policy at the World Health Organization.

In an editorial in the current Bulletin of the World Health Organization, Dr Quick says "researchers who publish or communicate results unfriendly to the sponsors have faced intimidation, attempts to discredit them professionally, and legal threats to recover `lost sales.'"

"If clinical trials become a commercial venture, 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," said Dr Quick.

Dr Quick suggested drawing up a declaration on the rights and obligations of clinical investigators and on how to manage the entire clinical trials evidence base, along the lines of the Helsinki Declaration adopted in 1964 by the World Medical Association to protect human subjects in medical research.

This could supplement the proposal from the editors of 13 medical journals in September 2001, he said. The proposal suggested that sponsors should guarantee the intellectual independence of investigators, trial details should be entered in a registry available to third parties, and legal action could be taken against investigators only where fraud was suspected.

Meanwhile the UK Association of University Teachers wants an independent commission set up to ensure that commercial companies cannot interfere with academics' research. It describes Nottingham University's decision to accept £3.8m ($5.3m; 6.3m) from British American Tobacco as "the worst decision of the year."