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March 15, 2000

Sources of Bias in the Economic Analysis of New Drugs

Author Affiliations

Phil B.FontanarosaMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Fishbein FellowIndividualAuthor

JAMA. 2000;283(11):1423-1424. doi:10.1001/jama.283.11.1421

To the Editor: Mr Friedberg and colleagues1 have analyzed a sample of published pharmacoeconomic studies and found that "pharmaceutical company-sponsored studies were less likely than nonprofit sponsored studies to report unfavorable qualitative conclusions." It is important to notice that they identified a publication bias, not a study bias. In fact they fail to find biases in individual studies, meaning that the peer review process work reasonably well and that individual published studies are generally reliable. However, it is also important to encourage publication of negative results. We recently published a study with negative results2 despite reservations from the referees. We felt that they would have been more enthusiastic about positive results. Clinicians may also fear that reporting negative cost-effectiveness results will reinforce nonmedical limitations to their autonomy to prescribe.

It is obviously difficult to compel companies to support and publish studies showing that their products are not cost-effective. Because pharmacoeconomic studies are not the only factor in medical decision making, lack of positive data is not necessarily an indication that the drug has no value. The solution probably lies in a more systematic use of pharmacoeconomic data for treatment guidelines or for decisions about reimbursement and pricing, in both private and public health care settings. This would not guarantee that industry-sponsored negative results will be reported more frequently, but would allow more appropriate interpretation of unreported results.

Friedberg  MSaffran  BStinson  TJNelson  WBennett  CL Evaluation of conflict of interest in economic analysis of new drugs used in oncology.  JAMA. 1999;282:1453-1457.Google Scholar
Woronoff-Lemsi  MCArveux  PLimat  SMorel  PLe Pen  CCahn  JY Erythropoietin and preoperative autologous blood donation in the prevention of hepatitis C infection: necessity or luxury?  Transfusion. 1999;39:933-937.Google Scholar