US Guidelines To Curb Bias In P/E Studies

The growth of managed care means that the use of pharmacoeconomics is now "simply exploding," according to Alan Hillman, head of the US Task Force on Guidelines for Economic Analysis of Health Care Technology, whose proposals for voluntary standards for the avoidance of bias were published in the Annals of Internal Medicine on July 1.

He told ICBI's InterPharma Europe 95 conference in Paris this month that the opportunity for bias in industry-sponsored economic analysis exists because of unstandardization, multiple assumptions, and lack of peer review and of sufficient knowledgeable peer reviewers. Good companies and good researchers with good products stand to gain (or lose) most from the adoption of a code of conduct for industry-sponsored economic analyses, he added. While the Food and Drug Administration does not regulate cost-effectiveness studies, there is a very real fear that the agency will step in unless academia and industry regulate themselves voluntarily. If you ignore the regulators, they will come, said Dr Hillman, who is associate professor of medicine and health care management at the University of Pennsylvania's School of Medicine and the Wharton School of Business.

"We Are All Guilty" He noted the current perceived problems of bias in industry-sponsored studies; a recent study revealed that 94% of managed care buyers do not believe the conclusions of such studies. Moreover, the New England Journal of Medicine has adopted a policy of not publishing cost-effectiveness analyses in which the authors have a "financial conflict of interest, including direct salary support from the sponsor, an equity interest in the company, an ongoing consultancy or membership of the scientific board."