Legal Matters: Clinical Trial Data and Sports Concussion

Some of the UW residents may recall that we are part of the Insulin Resistance Intervention after Ischemic Stroke (IRIS) trial, a randomized study of pioglitazone vs. placebo for non-diabetic patients who have insulin resistance. (We’re not recruiting anymore, but are still following our participants). During the trial, it came to light from other studies that there may be a very small increase in bladder cancer risk resulting from pioglitazone exposure. The IRIS Data Safety and Monitoring Board (DSMB) is, of course, aware of this and continues to recommend that the trial proceed based on their periodic review of the data, to which everyone else involved remains blinded.

In a very interesting development, a woman suing the manufacturers for product liability subpoenaed Yale University, the trial’s coordinating center, for the unblinded data. Her lawyers believed that her case might have been bolstered if the IRIS data, combined with the already published data in an ersatz meta-analysis, were to show an increased risk of bladder cancer. Yale filed an objection to the request in a Connecticut Superior Court, and the judge ruled in their favor, reasoning that the harms to which the disclosure would subject the IRIS trial participants outweighed the benefit to the plaintiff.

Today, JAMA Internal Medicine published a report about this saga, with an excellent review of the issues at stake. In particular, they review the potential harms of disclosure, such as the risk of breach of confidentiality of the trial participants, the public interest in having access to the unblinded data, and some related court cases.

Another neuro-legal-ethical paper that just came out is this one on sports concussion. It was primarily authored by AAN Ethics, Law, and Humanities Committee member Dr. Matthew Kirschen, a pediatric neurocritical care doc at Penn. Concussion / traumatic brain injury is an area where residency training tends to be rather thin. Indeed, a colleague of mine completed a highly regarded neurocritical care fellowship and found that she had to learn TBI on the fly when she arrived at her first job (in a vacation destination city where lots of people bonked their heads surfing, etc.) This paper addresses the legal context and, at greater length, the ethical issues confronting the neurologist who cares for patients who incur sports-related concussions. This would be a good read at the beginning of a peds rotation.

About Justin A. Sattin

I'm a vascular neurologist and residency program director. I created this blog in order to share some thoughts with my resident and other colleagues, and to foster my own learning as well.
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