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Post-marketing studies of new insulins: sales or science?
COMMENT: In this analysis published in the BMJ last month the author looks at post marketing observational studies from three insulin producing pharmaceutical companies Eli Lilly, Novo Nordisk and Sanofi-Aventis. Of the three Novo Nordisk has embarked on more that twice the number of studies than Eli Lilly and nearly ten times the number by Sanofi-Aventis (28, 13 and 3). He expresses a high degree of skepticism as to the scientific basis for these studies and suggests that their main purpose is to increase the use of the agents under study by the investigating physicians who are compensated based upon the number of patients recruited. In his concluding paragraphs he states:
“Since marketing can be guaranteed to expand in any direction that is not expressly forbidden, this type of study will continue unless tighter regulation is introduced. This should provide a much clearer definition of what constitutes a legitimate non-interventional study. One proposed definition is “a study where the medicinal product(s) is (are) prescribed independent to [sic] inclusion of the patient in the study and as part of a therapeutic strategy, including diagnostic and monitoring procedures, which is not decided in advance by a study protocol. ”Further criteria should include a scientifically valuable question, prospective design, a comparator group wherever possible, a representative population, and adequate (but not excessive) power to answer the research question. Eli Lilly has proposed similar criteria for observational studies. Last but not least, a company’s activities should be judged by the regulatory and legal standards of the country from which it originates, rather than those in which its research is undertaken.”
He then concludes:
“It seems reasonable to ask whether a company would invest in such large scale activities without a good commercial rationale. Participating physicians, particularly those with no previous research experience, may participate in good faith, unaware that one aim of the study is to influence their prescribing habits. Their judgment is nonetheless open to question, particularly when their own participation is remunerated and their patients are exposed to extra cost for little benefit. Patients may volunteer on altruistic grounds or with inflated expectations of personal benefit. The patient or healthcare system pays for a more expensive agent instead of one that is cheaper and equally effective, and the public is offered misleading claims of comparative merit based on studies of limited scientific value.”