Shackling Innovation

The Regulation of Industry-Supported Clinical Trials

by Sigrid  Fry-Revere, Alison Mathey and David Malmstrom

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Over the past three decades, collaborative arrangements between academic biomedical researchers and private industry have grown dramatically, resulting in medical innovations that have benefited society greatly. However, a growing chorus of criticism directed at private companies that sponsor and conduct biomedical research casts doubt on the very ethos of science. Academics and anti-business activists have waged a campaign against industry-sponsored clinical trials that denies the fundamentally commercial nature of such research and hinders medical progress. These critics point to a small number of unfortunate and tragic cases in which financial conflicts of interest may have played a role in research-related injuries and deaths in order to unjustifiably condemn the profit motive in biomedical research as a whole.

The debate over conflicts of interest, once confined to the pages of medical journals, has jumped aboard a runaway train. In response to public outcry, the Obama administration and the 111th Congress have promised stronger federal regulation and a far more aggressive role for federal and state governments in the nation’s biomedical economy. Industry critics, however, are pushing for even stricter regulations, including the abolishment of industry-sponsored clinical trials altogether.

Prohibition or even greater regulation of industry sponsorship makes no sense. Given the paucity of evidence linking financial conflicts of interest to research-related mishaps, these new regulations elevate isolated incidents to the norm, and confuse correlation with causation. The way to prevent dangerous or ineffective drugs from reaching the market is not to eliminate financial incentives, but quite the opposite — to make well-conducted successful research so rewarding, both financially and otherwise, and errors in research so costly, that the only logical choice for researchers is to do their absolute best to produce accurate results. If the profit motive is removed, so is the most immediate benefit of doing good work and the long-term cost of doing poor work. The net result of policies that restrict industry-sponsored clinical trials will be a slowing of medical advances and a delay in the development and marketing of new medical technologies that have the potential to save thousands of lives. Suggestions for restricting financial incentives are being made without any clear evidence, let alone proof, that doing so will prevent the tragic incidents that fuel today’s movement to restrict industry-sponsored clinical trials.

After a careful analysis of both the facts and the arguments for and against restricting industry-sponsored clinical trials, we suggest that regulators should be moving in a totally different direction. Educating people about drug development, clinical trials, risks and benefits, and figuring out ways to increase compliance with medical instructions is likely to go much further toward reducing adverse reactions to medications than trying to eliminate conflicts of interest.