Navigation Links
New Book Highlights Human Cost of FDA's Failure to Investigate Medical Devices
Date:5/28/2009

NEW YORK, May 28 /PRNewswire-USNewswire/ -- A new history of shock treatment (electroconvulsive therapy, or ECT) - "Doctors of Deception: What They Don't Want You to Know About Shock Treatment" (Rutgers University Press) - reveals the human costs of the Food and Drug Administration's failure to investigate the devices that administer this controversial treatment for mental illnesses. The book is timely due to the FDA's recent decision to call on the manufacturers of the ECT device - and all high-risk Class III medical devices that were "grandfathered" in without the scientific testing that would be required today - to prove that it is safe and effective.

"The FDA has allowed shock machines to be used for 33 years without any evidence of their safety," said Linda Andre, the book's author and director of the Committee for Truth in Psychiatry, a national organization of former shock patients. Manufacturers of Class III devices may have to pay for costly clinical trials for devices that are already on the market, unless they can convince the FDA to change their classification to less risky, the Wall Street Journal reports. "If the manufacturers cannot provide such evidence, the agency is supposed to take the devices off the market," Andre said.

The FDA has known since 1979 that ECT poses serious risks, including brain damage and permanent memory loss. Andre's book chronicles the decades-long battle between former patients harmed by shock treatment and organized psychiatry over whether the shock machine should be investigated for safety, and includes first-person accounts from patients who were, Andre says, "guinea pigs for an untested device."

These patients formed their own organization to petition the FDA for brain-scan studies and for a consent form informing potential ECT patients of the known risks of ECT, and offered their own brains for study. They were joined by thousands of concerned citizens in a simple plea: If shock treatment is as safe as the American Psychiatric Association claims, why not investigate it?

In the past, bending to pressure from the APA, the FDA refused to conduct its own studies or require the manufacturers to prove safety. The agency said it would, instead, simply declare the device safe by reclassifying it as low risk (Class II).

"That is still the likeliest outcome," warns Andre.

Contact: Linda Andre, Committee for Truth in Psychiatry, 917-642-4625; ctip@rcn.com


'/>"/>
SOURCE Committee for Truth in Psychiatry
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Stanford study highlights cost-effective method of lowering heart disease risks
2. REACH Registry Highlights That Patients With Peripheral Arterial Disease (PAD) Suffer High Rates of Heart Attack, Stroke, Hospitalization, and Death
3. Other highlights in the September 11 JNCI
4. NEWSWEEK International Editions: Highlights and Exclusives, Oct. 1, 2007 Issue
5. Georgia Pecans Fit!: New Campaign Highlights Health Benefits, Recipes, Web Site
6. Highlights from the October 2007 Journal of the American Dietetic Association
7. Stereotaxis Highlights New Data on Acute Success in AFib Treatments With Niobe Magnetic Navigation System
8. NEWSWEEK International Editions: Highlights and Exclusives, OCT. 15, 2007 Issue
9. Study Highlights Impact of Chronic Conditions on Working America
10. Report highlights inadequate pandemic planning as a threat to EU security
11. World Bank Group Report on Malaria in Africa Highlights Progress Towards Goal of Significantly Reducing Malaria Deaths
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... 13, 2017 , ... While it’s often important to take certain medications during ... Austin, Texas, has identified a solution. , She developed a prototype for MOTION LIGHT-UP ... such, it eliminates the need to turn on a light when taking medication during ...
(Date:10/13/2017)... ... 13, 2017 , ... Lori R. Somekh, founder of the Law Office ... of elder law and special needs planning attorneys. “Membership in ElderCounsel helps our office ... forum to network with elder law attorneys nationwide,” said Somekh. , ElderCounsel ...
(Date:10/13/2017)... Milford, NJ (PRWEB) , ... October 13, 2017 , ... ... weekend at scenic Alexandria Park in Milford, NJ. This free event, sponsored by ... and physical activity. The fun run is geared towards children of all ages; ...
(Date:10/13/2017)... ... 13, 2017 , ... “America On The Brink”: the Christian history of the ... is the creation of published author, William Nowers. Captain Nowers and his wife, ... he spent thirty years in the Navy. Following his career as a naval ...
(Date:10/12/2017)... ... 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ), one of the ... new design of the shoulder pad. The shoulder pad provides optimal support and ... pain while using cold therapy. By utilizing ice and water that is circulated from ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... 25, 2017   Montrium , an industry ... today—from the IQPC Trial Master Files & Inspection ... that EastHORN Clinical Services has selected eTMF ... TMF management. EastHORN, a leading European contract research ... increase transparency to enable greater collaboration with sponsors, ...
(Date:9/19/2017)... Sept. 19, 2017 HistoSonics, Inc., a venture-backed medical device company developing a non-invasive, ... tissues, announced three leadership team developments today:   ... ... ... Veteran medical device executive Josh Stopek , PhD, ...
(Date:9/12/2017)... NEW YORK , Sept. 12, 2017   EcoVadis , ... supply chains, has published the first annual edition of its Global CSR ... than 20,400 companies evaluated by EcoVadis, based on Scorecard Ratings that analyzed ... ... & Performance Index ...
Breaking Medicine Technology: