From Vince Boehm’s email list:
I’m in shock. Really in shock. I never thought I’d see this.
It may come as a shock to some of you; but, Shock machines have never been approved by the FDA for safety or efficacy. These were “grandfathered” into the system when the FDA assumed jurisdiction over these items in 1976.
All machines manufactured after this date were routinely approved, as were things like female condoms, on a statement by the manufacturer that these were “Substantially equivalent” to the earlier devices.
This week the Agency told the makers of 25 different types of medical devices marketed before 1976, to submit safety and effectiveness data within 120 days. Electroconvulsive therapy devices are included. <see blog below WSJ article>
The ECT makers must submit proof of safety and efficacy to theFDA by August, 7, 2009. If the data submitted is not up to par, the FDA intends require manufacturers to undergo the more-rigorous premarket approval process for their existing devices, as well as new ones.
For some mysterious reason, Congress ordered the FDA to do this in 1990…..but it NEVER HAPPENED!
Medical Devices Face New Scrutiny From FDA
Bottom line here is that ECT has no proven efficacy in the literature available to us. Let’s hope something happens now to help protect the thousands of people subjected to this torture.