Electroshock machines were "grandfathered" into the system when the FDA assumed jurisdiction over medical devices in 1976.
In 1990, Congress ordered the FDA to have shock machines tested. Both ECT manufacturers and the closely knit shock advocates–most of who have significant financial interests in ECT–vehemently opposed safety tests. The agency went along with the vested stakeholders and failed to comply with the congressional order.
Electroshock–unlike other medical devices–is most often forced on non-consenting patients such as, Ray Sandford of Minneapolis. Ray, who is 54, has been subjected to 40 shock treatments against his will by court order!! Though Sandford is not charged with any crime , he has received over 40 such rounds of shocks on an outpatient basis so far–even after his original mental problems have long since subsided and he has repeatedly asked for the shocks to stop. Is it civilized to force a human being to undergo brain damaging electroshock as punishment ? What, if any crime has Ray Sanford committed?
The Wall Street Journal reports that the Government Accountability Office criticized FDA’s delay in January. So, this week the FDA ordered 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.
The ECT makers must submit proof of safety and efficacy to the FDA 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.
A just published book "Doctors of Deception: What They Don’t Want You to Know About Shock Treatment," by Linda Andre (published by Rutgers University Press, 2009) couldn’t be more timely! This is an insightful, extensively documented history of electroshock, that examines the controversial "treatment" in a social, legal, financial, medical and moral context. This book sheds light, among other things, on the maneuvers used by organized psychiatry and the makers of Shock machines to delay safety trials for 33 years. If Shock were "safe and effective" as its adherents claim–some even proclaim electroshock to be as safe and effective as penicillin–why, then has the profession avoided conducting scientifically valid, safety trials?
posted by Vera Hassner Sharav
THE WALL STREET JOUNRAL
APRIL 8, 2009
Medical Devices Face New Scrutiny From FDA
By KEITH J. WINSTEINThe Food and Drug Administration asked several medical-device makers to justify their products’ safety and effectiveness, as part of a move to require tougher evidence standards before products can be sold.
The request covers automatic external heart defibrillators from Medtronic Inc., Royal Philips Electronics NV and Zoll Medical Corp.; dialysis catheters from Covidien Ltd.; hip joints from Zimmer Holdings Inc.; spinal screws from Medtronic and Johnson & Johnson; a heart pump from Abiomed Inc.; and several other categories of products.
The move presents the possibility that the companies will have to pay for expensive clinical trials for products already on the market, unless they can persuade the agency to reclassify them as less risky.
The agency’s request comes in response to a 1990 order from Congress that directed the FDA to gather rigorous evidence before a manufacturer can sell medical devices considered to be in the most risky category, known as Class 3.
But despite several attempts during the 1990s, the FDA hasn’t finished implementing the law. In the past five years, it allowed hundreds of new Class 3 devices to be sold based on a less rigorous showing — called a 510(k), after a section of federal law — that they are "substantially equivalent" to combinations of other products marketed before 1976. Such evidence often is collected in a laboratory, not with a clinical trial in patients.
The Government Accountability Office criticized the delay in January. The agency said it will issue regulations Thursday asking makers of high-risk medical devices who had been allowed under the easier process to submit evidence to the agency backing their products’ safety and effectiveness.
The FDA will then either reclassify the devices into a less-risky category in which the 510(k) process is routinely allowed, it said, or require manufacturers to undergo the more-rigorous premarket approval process for their existing devices, as well as new ones.
Mary Long, an agency spokeswoman, said it could take several years for the agency to finish the process. Manufacturers would be granted a grace period to submit enough evidence backing their devices under the more-rigorous standard. "It is a priority, but it will really depend on the kind and amount of information we get on each type," she said.
Write to Keith J. Winstein at keith.winstein@wsj.com
Copyright 2008 Dow Jones & Company, Inc
See: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/04/fda-to-complete-unfinished-business-of-device-classification-call-for-pmas.html
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