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DRUG COST-EFFECTIVENESS STUDY RESULTS UNFAVORABLE TO INDUSTRY SPONSOR

Executive Summary

DRUG COST-EFFECTIVENESS STUDY RESULTS UNFAVORABLE TO INDUSTRY SPONSOR should be permitted to be published under a written agreement between the company and academic researcher, seven University of Pennsylvania researchers recommend in the May 9 New England Journal of Medicine. The editorial suggests that company funding be provided in the form of a research grant rather than a contract, and that the written agreement should "stipulate that the researcher may publish findings regardless of their nature and retains sufficient access to proprietary data to allow publication even if funding is withdrawn." The authors, Allan Hillman, MD, and six colleagues at the Wharton School's Davis Institute of Health Economics, suggest standards for "Avoiding Bias in the Conduct and Reporting of Cost- Effectiveness Research Sponsored by Pharmaceutical Companies." Hillman, director of the institute's Health Policy Center, has conducted a number of cost effectiveness studies of treatments for NSAID-associated gastric ulcers and also gastroesophageal reflux disease. Joining Hillman are Davis Institute Director J. Sanford Schwartz, MD; John Eisenberg, MD; Mark Pauly, PhD; Bernard Bloom, PhD; Henry Glick, MA; and Bruce Kinosian, MD. All seven authors have adopted the article's recommended standards to govern their own relationships with industry. The Davis Institute is in the process of developing the standards as official institute policy. While the methods and ethical issues surrounding industry- sponsored clinical research and industry-supported continuing medical education have received wide review (see related story, T&G-1), the authors remark that "economic analysis of pharmaceuticals has escaped attention." Economic studies, they note, "generally use data and analytic methods of varying degrees of precision and power that are usually unstandardized, . . . involve subjective opinion and interpretation about what the results demonstrate, . . . may make selective use of proprietary data gathered after marketing has begun rather than disclosing all data by FDA requirement; and are funded and overseen most commonly by marketing departments, rather than medical or scientific divisions." The authors propose that the selection of drug alternatives for economic analysis "should be based on their clinical relevance, not on potential favorability of the results. At a minimum, comparisons required by the FDA for controlled clinical trials should be included." Hillman, et al. also recommend that investigators be allowed to expand a study to include additional types of costs or comparison drugs as data permit and disclose any constraints against this imposed by the study sponsor. Researchers also "should not act as consultants on projects related to the study medication during the active period of the grant" and should be required by research journals to disclose financial relationships with pharmaceutical firms. Overall, the editorial recommends that studies be designed to avoid a "'good enough for marketing' mentality." The authors report that they have conducted 33 economic analyses for 15 pharmaceutical firms since 1978. The industry/academic partnership "is often exemplary, generating important and valid new information. Sometimes however, we have encountered difficulties that threatened to bias the conduct and results of analysis." These pressures include selection of economic measures most likely to produce favorable results and funding research in stages so that a company can cut its losses if results appear to be negative. One type of bias "is actually fostered" by FDA requirements that firms may promote only approved indications based on controlled clinical trial results, the authors comment. "Often, these trials do not reflect the ways doctors actually practice, because patient selection and monitoring in the trials are driven by protocols. When data (from studies undertaken after marketing has begun, for example) exist to indicate the effectiveness of a pharmaceutical in actual clinical experience, it may be desirable to assess the economics of the drug as it actually is used, not the effect of the FDA-approved uses alone." A separate NEJM article, entitled "Biotechnology -- the Enormous Cost of Success," asserts that "those who invest in the development, manufacture, and distribution of these products are entitled to fair and reasonable profit. But the public also deserves that these drugs, the products of long-standing public investment, be made widely available at fair and reasonable prices." EPO's clinical benefits "could not have been achieved" without the "contributions of a generation of biomedical researchers at the [National Institutes of Health] and in NIH-supported laboratories," Doolittle said. "Indeed, scenarios similar to that described for erythropoietin can be imagined for a number of other recombinant products, including Factor VIII, plasminogen activators, and interleukins, all of which are the direct descendants of NIH support and initiative."
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