The Human Face of the FDA’s Failure to Investigate Risky Medical Devices

On April 8^th, the Food and Drug Administration announced its intention to finally require manufacturers of medical devices marketed prior to 1976 to submit evidence of the devices’ safety and efficacy. These devices had been “grandfathered” in and despite the FDA’s assessment that they posed serious risks to health, they were never required to undergo any clinical safety trials (as have devices sold in the past 33 years). One of these risky devices is the electroconvulsive therapy (ECT, or shock treatment) device.

Major media such as the New York Times and the Wall Street Journal quickly picked up on this story. Bloggers in particular zeroed in on the ECT device, with the general theme of incredulity: How could it that such a drastic procedure—applying electricity to the human brain to generate a dozen or more grand mal seizures—had been allowed to be used on a generation of patients (that’s over 3 million people even by the most conservative estimates) without ever having been tested to see if it were safe?

Indeed, this is the case; and it’s not news to readers of Linda Andre’s new book, Doctors of Deception: What They Don’t Want You to Know About Shock Treatment, published just a month before the FDA’s belated admission that it had essentially abdicated its responsibility to protect patients from harmful treatments.

The book is a history of shock treatment, with the emphasis on the history of the treatment since the 1970s. The author argues that this was a critical time for the shock industry, in part because the FDA’s assumption of the regulation of medical devices in 1976 and its classification of the ECT device in the high-risk Class III category in 1979 meant that—according to the law—the devices were to be subject to a safety investigation. No one knew at the time, nor could anyone have dreamed, that that day would not come for thirty years. The industry, Andre says, knew their treatment could not survive such scrutiny, so they adopted a public relations solution to what was essentially a scientific problem: They would make repeated claims for safety over the years, while lobbying the FDA to prevent any safety investigation from taking place.

At the same time former patients permanently damaged by shock treatment, as well as concerned citizens and scientists, lobbied the agency to conduct such an investigation. They lost, but not for lack of trying: They offered up their own brains for CAT-scans. They proposed animal brain scan studies. They submitted three formal citizen petitions to the agency, which the FDA essentially ignored…but in the process built up a public docket on the ECT device which takes a week to read (the author did so). They enlisted politicians and public health advocates as allies. They kept steady pressure on the FDA in every way they could think of for decades—but in the end the agency bent to the stronger pressure of the wealthy and powerful American Psychiatric Association.

It’s a dramatic David and Goliath story unparalleled in the history of medicine; and just last week, David was finally proven right.

It’s too late for a generation of patients who experienced permanent extensive amnesia and permanent cognitive disability, with the attendant loss of sense of self and of life chances. The author lets these former patients speak for themselves:

“I often feel as though a very vital part of my life ‘died’ as a result of these treatments.” “I do not think I will ever again be as intelligent a person as I was before.”

“ECT changed my life forever—and not for the better.”

“My personal belief is that an investigation is in order to prove that ECT is indeed beneficial and not brain damaging. How can I feel differently when that so-called therapy has wrecked a major portion of my life?”

“Doctors of Deception” makes clear that, at least in the case of the ECT device, the FDA’s failure to protect patients was not simply a matter of neglect or oversight; the agency had ample knowledge of the risks of the device and actively ignored repeated calls and opportunities to either conduct its own safety investigation or require the device manufacturers to do so.

The author reminds us that the FDA actually did call on shock machine manufacturers once before, in 1995, to prove their devices safe, but when the manufacturers simply ignored the call, the FDA did nothing. If history is any indication, the FDA is very likely to simply reclassify the ECT device to a low-risk category without any safety information or investigation at all rather than incur the wrath of the American Psychiatric Association.

At the very end of this cautionary tale, Andre writes: “Now that we know this history, now that what mostly hadn’t been written is written down in one place, maybe—just maybe—we can keep from repeating it. One thing is for certain: there will continue to be opportunities for the history of electroshock to take another turn.” Whether this will happen at the Food and Drug Administration or not, we will soon find out.

Links:

http://online.wsj.com/article/SB123920937438601763.html

“Medical Devices Face New Scrutiny from FDA” Wall Street Journal, April 8

http://www.fda.gov/bbs/topics/NEWS/2009/NEW01990.html

“FDA to Review Medical Devices Marketed Prior to 1976” April 8

http://psychcentral.com/blog/archives/2009/04/15/with-fda-change-ect-may-go-the-way-of-the-dinosaur/

“With FDA Change, ECT Machines May Go the Way of the Dinosaur” April 15