Louisiana Tests Unapproved Anti-Addiction Implant on Inmates. Now, there have been a number of references to the fact that these devices haven’t had FDA review. However, that lack of review only highlights the more basic problem: the problem of informed consent.
I actually learned in detail about research ethics in healthcare before I learned about clinical ethics - the difference between ethics in research and ethics in actual treatment. Our concept of Informed Consent is actually rooted in professional and political reaction to abusive research, and only then applied to abusive care. Reflecting such research horrors as the Tuskegee Syphilis Experiment and the atrocities that came to light in the Nuremberg trials, we developed the standard that human subjects participating in research have the right to informed consent: to decide freely whether to participate, based on thorough information about risks, benefits, and procedures.
In that light, then, we developed the concept of “protected classes,” subjects to have special protection because they could not participate in informed consent. While the categories defining protection could be complicated, they largely fell into two broad categories: those who needed protection because they couldn’t or wouldn’t be informed (think children, or adults of limited capacity); or those who needed protection because their capacity to consent wasn’t free.
Among those “protected classes” are prisoners.They are not free in their daily life, and their freedom to consent it assumed to be limited until proven otherwise. That isn’t about the capacity to understand. It’s because being in prison limits freedom of action, and makes one potentially subject to coercion or to inducement that wouldn’t have the same power outside the walls.
The story as reported in The Advocate provides a more thorough discussion of the situation. For example, it lays out how this happened - apparent largesse from the decide manufacturer (who will, perhaps, benefit greatly) - and how the prisoners involved might benefit. The device provides a steady dose of a medication proven effective for some in curbing opioid addiction. However, it also highlights the issues of prisoners and informed consent. In that light, it only highlights the concerns that the device hasn’t had FDA review: part of informed consent has to do with knowing the risks, and FDA review is usually how most of us learn about risks.
It doesn’t explain, though, other aspects of research. For example, in most situations there is a review committee, commonly referred to as an Institutional Review Board or IRB, that reviews risks and benefits on behalf of the institution or company overseeing the research. While the company in this may have one, there’s no reference to it. The company, too, is funding this internally, so we don’t know about conflicts of interest, etc.
All in all, this is a questionable and concerning event. I’m not opposed to these few prisoners benefitting. However, if this becomes a more common practice for bypassing the FDA, it becomes a practice that should concern us all.
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