WaPo on Industry Influence of Clinical Trials

By Christopher Robertson

The Washington Post has an extensive story about the drug and device industry’s influence on the outcomes of clinical trials, which are published in leading medical journals and which then shape the prescribing decisions of physicians everywhere.  Below the fold, I share some of my own thinking on this issue, and link to some of my relevant publications.  

In an experiment published in the New England Journal of Medicine this year, we found that physicians also worry that drugmakers are biasing the scientific trials they support.  We found that disclosures of industry funding cause physicians to discount their reliance on journal articles, reducing the likelihood of prescribing the studied drug.  I hope that more journals will add meaningful summary disclosures to the abstracts themselves, rather than merely putting them in a box at the end of the articles, which many clinicians will not see.  The readers of their journals have shown that they will rely on that information, if provided in an intelligible and convenient format.  To physicians, this information about conflicts of interest is as important as the abstract’s description of the methodological rigor of the study.

Nonetheless, even if we improve the disclosure regime, in another article presenting my lab experiments, I have argued  that disclosures are only half the solution.  The disclosures say “don’t rely too much on this article, because it may be biased.”  But the disclosures fail to tell physicians how much reliance may nonetheless be appropriate.  Physicians need affirmative information — an alternative unbiased source of scientific expertise.  Of course, a huge influx of funding to the National Institutes of Health could provide that affirmative science, but public money is scarce.

I have argued for a solution that I call the “Money Blind,” where industry may continue to fund the bulk of biomedical science, but do so in a way that avoids biasing influence.  Our NEJM  article suggests that companies may have a rational interest in doing this themselves to improve the credibility of the research they fund, at least when they have bona fide safe and effective drugs, whose merits will be clear in a neutral study.  Even if the companies fail to rise to the occasion, I argue that the federal government has several policy levers available to cause such a change, without violating the First Amendment.

This entry was posted in Christopher Robertson, Conflicts of Interest, Empirical, FDA, First Amendment, Publications by crobertson. Bookmark the permalink.

About crobertson

Christopher Robertson is a professor at the James E. Rogers College of Law, University of Arizona, and affiliated faculty with the Petrie Flom Center for Health Care Policy, Bioethics and Biotechnology at Harvard. Robertson also leads the Regulatory Science program, a partnership with the Arizona Health Sciences Center and the Critical Path Institute. Professor Robertson's research focuses on how the law can improve decisions by individuals and institutions -- attending to informational limits, conflicting interests, and cognitive biases, especially in the domain of healthcare. Blending legal, philosophical, and empirical methods, Robertson's work has been published in the New England Journal of Medicine, New York University Law Review, Cornell Law Review, Emory Law Journal, and the Journal of Empirical Legal Studies. He has received research support from the Robert Wood Johnson Foundation, and runs the Law and Behavior Research Lab at the University of Arizona. Robertson graduated magna cum laude from Harvard Law School, where he also served as a Petrie Flom fellow and lecturer. He earned a doctorate in Philosophy at Washington University in St. Louis, where he also taught bioethics. For 2013-2014, he was a visiting professor at Harvard Law School, and will visit at NYU School of Law in 2016-2017. Robertson's legal practice has focused on complex litigation involving medical and scientific disputes.