Shackling Innovation the Regulation of Industry-Supported Clinical Trials

Introduction

Collaborative arrangements between biomedical academic researchers and private industry have grown dramatically over the past three decades, resulting in medical innovations that have benefited society as a whole. However, a chorus of growing criticism directed at private companies that sponsor and conduct biomedical research casts doubt on the very ethos
of science. Some academics and anti-business activists have waged a campaign against industry-sponsored clinical trials. That criticism denies the fundamentally commercial nature of such research, and therefore 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. In response to claims that unchecked industry research has led—and will continue to lead—to disastrous outcomes, the Obama administration and the 111th Congress have promised stronger federal regulation and a far more aggressive role for the federal and state governments in the nation's biomedical economy.

Contrary to the anti-industry zealots' claims, financial incentives lead to innovation and progress. In those instances in which industry- sponsored trials have gone awry, money played no more a part than
did other potential motivations, such as professional ambition or a fear of failure. Therefore, there is no reason to believe that mistakes or malfeasance are more likely in industry-sponsored, or other for-profit, research than in the public or nonprofit sector.

A conflict of interest is a clash of competing interests in which
a socially sanctioned goal could potentially be compromised by a
more personal goal. Conflicts of interest exist in every form of human interaction. Therefore, the question should be not whether conflicts exist, but whether relevant individuals will succumb to the temptation to satisfy more immediate personal desires at the expense of long-term personal benefit and long-term social goals.

The most effective way to manage conflicts of interests is to create a social order in which personal interests and social interests coincide— that is, a social order where striving to achieve one's personal goals (at least one's long-term goals), also benefits society. To encourage long- term investment in serving social goals, two conditions must be present: 1) a potential for long-term personal gain, and 2) a certainty of negative

The question should
be not whether conflicts exist, but whether relevant individuals will succumb to the temptation to satisfy more immediate personal desires at the expense of long-term personal benefit and long-term social goals.

Fry-Revere, Mathey, and Malmstrom: Shackling Innovation

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Not all research mistakes are intentional, and financial gain is not the only factor that could motivate

an unwise choice. Ambition, fear of failure, a need for
job security, or glory seeking all can just as easily contribute

to shortsighted errors in judgment.

consequences for those who choose short-term personal interests that violate social norms over long-term ones that coincide with societal goals.