I hope the Royal College of Psychiatry are ready to suck on my chocolate salty balls.
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Less than a week after igniting a minor firestorm of debate regarding its overhaul (or lack thereof) of 510(k) regulations, FDA is tackling another longtime lightning rod (pun guiltily intended) of controversy: electroshock therapy.
The agency is considering whether it should downgrade devices used in electroshock therapy (also known as electroconvulsive therapy, or ECT) from Class III (high risk) to a lower class, like Class II (medium risk), according to a story inThe New York Times. An advisory panel will review the devices this week, and the agency could make a decision about them later this year.
When the three classes of medical devices were established in 1976, ECT devices (along with about 20 other devices) were grandfathered in, meaning that they did not have to go through the strict premarket approval process that new Class III devices were supposed to go through. In 2009, the Government Accountability Office recommended that such "grandfathered-in" devices either be subject to the same tough testing as all other Class III devices or be given a lower risk designation (which would, in turn, make them easier to make and market). You should read the article for the details, but suffice it to say that supporters of ECT are angling for the latter while opponents of ECT are arguing for the former.
What I find especially fascinating about this story in particular is highlighted by the following line in the article:
“By regulating the devices, the F.D.A. is indirectly regulating the procedure.”
As the Times article documents, ECT occupies a funny place in our culture. Popularly thought of as barbaric or crude, the treatment as modernly performed seems to have redeemed itself in the eyes of many psychiatrists and physicians, with 100,000 Americans getting ECT every year. In the other corner, however, are patient advocacy groups and some patients who cite concerns about ECT's dangers and effectiveness.
And thus, by a quirk of regulatory history, enter FDA as the surprise arbiter of this debate about a fundamental element of our society’s approach toward psychiatry and treating depression.
I realize that, in a general way, many of FDA’s regulatory decisions are similarly influential. But the specific factors of this case—the therapy is, as far as I can tell, entirely dependant on a specific type of device, and there are only two manufacturers in the United States that make such devices—put the agency in a unique position to significantly impact a whole field of medicine. Deciding whether and how to approve a type of orthopedic device, say, is one thing, but shaping the course of psychiatric history would seem to be quite another. FDA can rule that a specific type of knee implant is high risk without causing a cultural shift in how knee surgeries are performed.
FDA's role in this controversy was dictated by existing laws and policies, and therefore is not up for debate from a practical standpoint. The agency is going to make the decision, regardless of whether one thinks it should or not. But the story does open the door to an interesting philosophical discussion about the agency’s role in society, what it should do and how it should do it.
As a member of the unwashed masses whose mind flashes (again, pun shamefully, sorrowfully intended) to images of Nurse Ratched at the mention of electroshock therapy, it would seem to me that ECT should be regulated very carefully. Even if the therapy does have benefits, it would be worth it to make sure that ECT devices are safe. One of FDA’s missions is supposed to be making sure devices are safe, and if its decision regarding the safety of a type of device happens to affect a whole field of medicine, then so be it. I don't mean to dismiss an entire treatment option out of hand, but I would think that the agency being slightly removed from the psychiatric community would put FDA in a better position to make a decision about the devices' safety.
But I’d like to hear from anyone in the device manufacturing community, especially those who have a stake in manufacturing these devices. How should FDA take advantage of its ability to shape the field of psychiatry? Should it trust groups like the American Psychiatric Association, or should it require stricter testing? On a broader level, do you think that FDA should even be a part of this discussion?
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