Regulation of Clinical Research Sponsored by Pharmaceutical Companies: A Proposal

D rug development is indispensable to deal effectively with disease [1]. However, two dilemmas emerge from clinical research devoted to this goal. First, new drugs are the source of a huge economy ruled not by the standards of the medical profession, but by the rules of business and the market [2]. Second, although the testing and the medical community's " blessing " of a new drug lie entirely in the hands of medical institutions, medical journals, and regulatory agencies [3], once the drug is approved the ruthless mechanisms of industry propaganda and commerce take over [4,5]. The gains in health obtained by the advent of a new drug should always be considered according to the crucial concept of its cost–benefi t balance, and the benefi ts often fall far below the costs (either monetary or otherwise). Of course, patients and drug companies might have different feelings about the costs and benefi ts of a new drug: patients have high expectations that the drug will help them to recover their health, whereas companies rely mostly on statistical arguments to back up the superiority of their new drug over existing ones [2,3]. The marriage between pharmaceutical companies and academic medicine at times becomes a love–hate relationship [4]. Nonetheless, it is an indissoluble link that has brought countless benefi ts to society [1], that is bound to continue, and that must surely be supported. But the medical profession, not the pharmaceutical companies, must fi nd a way to base the relationship upon the academic and ethical aims that guide the practice of medicine and the public interest. Over the last few years, one scandal after another has shown how drug company marketing can distort prescribing patterns. The root of the problem seems to be simple: medical research sponsored by drug companies is a mixture of, on the one hand, impeccable scientifi c talent devoted to the well-being of society, and, on the other, marketing expectations on the side of the company sponsoring the research. Both actors are effective professionals, but their aims could not be more distant. In some instances sponsors control the trial design, interpretation of results, writing up of study results, and publication strategies. A number of proposals have been put forward to reduce the infl uence of the pharmaceutical industry upon medical practice. These include the creation of an independent institution to oversee clinical testing of prescription drugs [5], strict …