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:6/25/2016)... ... 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his ... David Geffen School of Medicine at UCLA. He trained in Internal Medicine at Scripps ... in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary ... Work award to iHire in recognition of their exemplary accomplishments in worksite health promotion. ... Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... A ... procedures that most people are unfamiliar with. The article goes on to state that ... but also many of these less common operations such as calf and cheek reduction. ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is ... associated with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension ... that it will receive two significant new grants to support its work to ... its 25th anniversary by recognizing patients, medical professionals and scientists for their work ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... N.C. , June 24, 2016  Consumers ... decisions and regulators/payers have placed more emphasis on ... environment, patient support programs in the pharmaceutical industry ... patients, medications. Consequently, pharmaceutical companies are focusing on ... they are providing products and services that improve ...
(Date:6/24/2016)... Calif. , June 24, 2016  Global ... a biopharmaceutical company developing novel therapeutics for the ... needs, today announced the closing of its previously ... common stock, at the public offering price of ... the offering were offered by GBT. GBT estimates ...
(Date:6/24/2016)... June 24, 2016 ... announced the addition of the " Global Markets ... This report focuses ... an updated review, including its applications in various applications. ... market, which includes three main industries: pharmaceutical and biotechnology, ...
Breaking Medicine Technology: