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American Society for Experimental Neurotherapeutics Abstracts
February 2002

Setting Standards to Avoid Conflict of Interest in Clinical Trials

Arch Neurol. 2002;59(2):324. doi:

The financial connections between academic clinical researchers and their institutions, on the one hand, and private companies with interests in the outcome of clinical research, on the other, are more extensive than ever before. Increasingly, academic medical centers and private industry see themselves as partners in a common endeavor.

This trend gives rise to a number of serious concerns. When researchers and their institutions have financial interests in companies whose products they are evaluating, it undermines public confidence in their objectivity and commitment to the welfare of human subjects. The case of Jesse Gelsinger was a powerful wake-up call in that regard. There is also good evidence that researchers with such ties are more likely to publish work favorable to the companies, suggesting widespread bias. In addition, the type of research undertaken at the outset may be skewed toward clinical trials that serve the marketing interests of industry, at the expense of more important research into the causes and pathophysiology of disease.

Financial conflicts of interest are not an inherent part of the research enterprise. They are largely optional, despite current rhetoric to the contrary, and nearly all of them could be eliminated. Instead, the academic community seems bent on accommodating or "managing" them. Even the most stringent of current academic guidelines permit researchers to maintain certain financial ties to industry and provide for exceptions to prohibitions.

Instead of wasting time and energy worrying about how to manage conflicts, we should be working to eliminate them whenever possible. Just as judges may not have financial interests in cases they are hearing, so clinical researchers should not have interests in products they are evaluating, other than grant support administered at arm's length. Academic medical centers, for their part, should have no equity in the drug and device industry, so they are not compromised in overseeing their faculties.

The mission of investor-owned companies is quite different from the mission of academic medical centers. The primary purpose of the former is to increase the value of their shareholders' stock, which they do by securing patents and marketing their products. Their purpose is not to educate, nor even to carry out research, except secondarily or as a means to their primary end. There is no doubt that academic/industrial collaborations can lead to important advances, but their missions should not be blurred by financial ties.