Study shows systematic bias in industry testing of drugs

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TORONTO, May 29, 2003 -- A new study shows that drug testing sponsored by the pharmaceutical industry is more likely to produce results favouring the sponsor’s product than testing funded by other sources.

"These findings indicate a systematic bias in drug testing and this is a serious problem as an increasing number of clinical trials at all stages in a product’s life cycle are funded by the pharmaceutical industry," said York University Prof. Joel Lexchin an emergency physician at University Health Network and the study’s lead author. The findings appear in the upcoming issue of the British Medical Journal (May 31).

The results are based on a detailed analysis of 30 research articles over a period of two decades and apply across a wide range of diseases, drugs and drug classes. Lexchin offers a number of possible explanations for the bias. He says trials funded by drug companies may choose comparison drugs that are likely to be inferior because of concern about the financial risk to companies of unfavourable test results. There could also be a publication bias says Lexchin, noting that industry-funded trials are less likely to be published than those with alternate sources of sponsorship. A second possible reason is the trend toward publication of findings in journal supplements, where the review process is less rigorous.

"In the past few years there have been a number of high profile cases where manufacturers have attempted to suppress publication unfavourable to their products," writes Lexchin. He praises the recent decision by major medical journals to establish more rigorous criteria for accepting industry-sponsored research as "a step in the right direction" but recommends that all clinical trials be registered in advance to ensure researchers have access to unpublished results.

"Clinical research sponsored by the pharmaceutical industry plays a role in determining the way medicine is practiced," writes Lexchin, a professor in the School of Health Policy and Management at York. He notes that the industry now spends more on medical research than the National Institutes of Health in the United States, and most drug pharmaco-economic studies are either performed in-house by the drug companies or by external consultants paid for by the company.

The School of Health Policy and Management in the Atkinson Faculty of Liberal and Professional Studies at York University employs an interdisciplinary approach to health systems education, focusing on the social determinants of health, such as, age, race, and access to health care, and the effectiveness of health care delivery systems. The School promotes learning from a human wellness perspective, with a goal to improving the health of individuals and communities alike.

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For further information, please contact:

Prof. Joel Lexchin Ken Turriff
School of Health Policy and Management Media Relations
Atkinson Faculty of Liberal and Professional Studies York University
York University 416-736-2100, ext. 22086
416-736-2100, ext. 22119 kturriff@yorku.ca
jlexchin@yorku.ca

YU/054/03