Fwd: Doctors of Deception Electroshock machines to Undergo safety & efficacy tests

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ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountabilityhttp://www.ahrp.org  and http://ahrp.blogspot.comFYI It may come as a shock to some of you; but, Electroshock machines have neverbeen tested for safety or efficacy. They were "grandfathered" into the system when the FDA assumed jurisdictionover medical devices in 1976. In 1990, Congress ordered the FDA to have shock machines tested.  Both ECTmanufacturers and the closely knit shock advocates--most of who havesignificant financial interests in ECT--vehemently opposed safety tests. Theagency went along with the vested stakeholders and failed to comply with thecongressional order.Electroshock--unlike other medical devices--is most often forced onnon-consenting patients such as, Ray Sandford of Minneapolis http://www.mindfreedom.org/ray-sandford-minnesota.  Ray, who is 54, has beensubjected to 40 shock treatments against his will by court order!!  ThoughSandford is not charged with any crime, he has received over 40 such roundsof shocks on an outpatient basis so far--even after his original mentalproblems have long since subsided and he has repeatedly asked for the shocksto stop.http://twincities.indymedia.org/2009/mar/their-own-words-ect-survivor-advocates-speak-out-against-continued-forced-electroshocks Is it civilized toforce 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 Officecriticized FDA's delay in January. So, this week the FDA ordered the makersof 25 different types of medical devices marketed before 1976, to submitsafety and effectiveness data within 120 days.  Electroconvulsive therapydevices are included. The ECT makers must submit proof of safety and efficacy to the FDA byAugust, 7, 2009.  If the data submitted is not up to par, the FDA intendsrequire manufacturers to undergo the more-rigorous pre-market approvalprocess for their existing devices, as well as new ones.  A just published book "Doctors of Deception: What They Don't Want You toKnow About Shock Treatment," by Linda Andre (published by Rutgers UniversityPress, 2009) couldn't be more timely!  This is an insightful, extensivelydocumented history of electroshock, that examines the controversial"treatment" in a social, legal, financial, medical and moral context.  Thisbook sheds light, among other things, on the maneuvers used by organizedpsychiatry and the makers of Shock machines to delay safety trials for 33years. If Shock were "safe and effective" as its adherents claim--some evenproclaim electroshock to be as safe and effective as penicillin--why, thenhas the profession avoided conducting scientifically valid, safety trials? http://rutgerspress.rutgers.edu/acatalog/Doctors_of_Deception.htmlContact: Vera Hassner Sharavveracare212-595-8974---------http://online.wsj.com/article/SB123920937438601763.htmlTHE WALL STREET JOUNRALAPRIL 8, 2009Medical Devices Face New Scrutiny From FDABy KEITH J. WINSTEIN  The Food and Drug Administration asked several medical-device makersto justify their products' safety and effectiveness, as part of a move torequire tougher evidence standards before products can be sold. The request covers automatic external heart defibrillators fromMedtronic Inc., Royal Philips Electronics NV and Zoll Medical Corp.;dialysis catheters from Covidien  Ltd.; hip joints from Zimmer HoldingsInc.; spinal screws from Medtronic and Johnson & Johnson; a heart pump fromAbiomed Inc.; and several other categories of products. The move presents the possibility that the companies will have topay for expensive clinical trials for products already on the market, unlessthey can persuade the agency to reclassify them as less risky. The agency's request comes in response to a 1990 order from Congressthat directed the FDA to gather rigorous evidence before a manufacturer cansell medical devices considered to be in the most risky category, known asClass 3. But despite several attempts during the 1990s, the FDA hasn'tfinished implementing the law. In the past five years, it allowed hundredsof new Class 3 devices to be sold based on a less rigorous showing -- calleda 510(k), after a section of federal law -- that they are "substantiallyequivalent" to combinations of other products marketed before 1976. Suchevidence often is collected in a laboratory, not with a clinical trial inpatients. The Government Accountability Office criticized the delay inJanuary. The agency said it will issue regulations Thursday asking makers ofhigh-risk medical devices who had been allowed under the easier process tosubmit evidence to the agency backing their products' safety andeffectiveness. The FDA will then either reclassify the devices into a less-riskycategory in which the 510(k) process is routinely allowed, it said, orrequire manufacturers to undergo the more-rigorous premarket approvalprocess for their existing devices, as well as new ones. Mary Long, an agency spokeswoman, said it could take several yearsfor the agency to finish the process. Manufacturers would be granted a graceperiod to submit enough evidence backing their devices under themore-rigorous standard. "It is a priority, but it will really depend on thekind and amount of information we get on each type," she said. Write to Keith J. Winstein at keith.winstein  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 FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. 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