New Book Highlights Human Cost of FDA's Failure to Investigate Medical Devices

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.

Source: lifesciencesworld.com