Jan Eastgate presented to the U.S. Food and Drug Administration Neurological Devices Panel examining the reclassification of electroconvulsive therapy (ECT) devices on January 27, 2011. These are her remarks as published in the public record of the meeting.
Good morning. I’m the President of the Citizens Commission on Human Rights. It’s a psychiatric watchdog group, and for 42 years, we’ve worked with consumers who fought for their inherent right to be informed about the harmful effects of ECT, and yet today the FDA is essentially asking you to ignore them.
The Exec Summary provided the public only two days ago a policy the FDA needs to change, and the questions being asked of you make a mockery of what Congress and the GAO intended when it told the FDA to do its job regarding Class III devices.
In fact, it appears from reading the Summary, the FDA has already made a decision to reclassify, and this hearing is just lip service to the public. They are leaving it up to you to be the fall guys to take the responsibility for the harm such a decision will cause. You are being asked to figure out how to mitigate the damage ECT causes by recommending controls to monitor or reduce the risks, and then while more than 70 percent of respondents oppose reclassification because of the damaging effects of ECT, you’re to consider how to expand it.
The FDA relies largely on randomized controlled trials despite earlier criticisms of its reliance on these for establishing safety of Avandia. They ignored other evidence of serious heart risk associated with the drug. Seriously with 60,000 Americans suffering heart attacks from this drug, would you be sitting here today considering how to expand Avandia’s use by mitigating its risks?
MECTA and Somatics seems to have had the opportunity to prove safety and efficacy but failed to do so despite a potential $30 million made in sales.
In the recent New York Times article about today’s hearing, Dr. Matthew Rudorfer of NIMH had the audacity to call these companies mere “mom and pop” operations. Therefore, they shouldn’t be expected to conduct expensive clinical trials. This comes from the same man that opposed the FDA placing a black box warning on SSRI antidepressants.
Essentially NIMH expects the profits of the shock makers to take precedence over the safety of patients.
The APA parrots this in its submission. This is an industry that has benefited more than $28 billion over the past 3 decades from ECT. Yet never, it seems, has it demanded that MECTA and Somatics conduct the necessary studies.
The APA claims it is no more dangerous than minor surgery under general anesthesia and, for some patients, maybe less dangerous than treatment with medication. This includes antidepressants that the APA also opposed carrying a black box warning. Arguably, a premarket approval was ignored because evidence already exists to show the device does not meet required standards, opening the door to massive lawsuits against the manufacturers as we have seen against pharmaceutical companies that covered up the risks of psychoactive drugs and Avandia. This and conflicts of interest are likely reasons for preventing ECT device safety studies.
MECTA’s submission to the FDA cites 18 studies by Harold Sackeim, 13 by Dr. Richard Weiner, and 8 by Dr. Andrew Krystal, all of whom have conflicts of interest with MECTA. Dr. Sarah Lisanby, who sat on this Advisory Panel in October and now we’ve heard is being FDA paid to appear here today, has done MECTA studies as well. I’d be interested to know why she didn’t demand MECTA conduct safety studies. Dr. Lawrence Park apparently co-wrote the Executive Summary. In his APA conflicts disclosure, he says that he has affiliations with Abbott Labs, which makes Quelicin chloride which is a muscle relaxant used in ECT. This Summary is so egregious that full transparency is needed, and the FDA must provide a disclosure of all conflicts of interest for each of the studies and the rating scales it relied upon.
Whether you mask ECT with anesthetic and muscle relaxants or add controls to try and mitigate the risk, the bottom line is that thousands of patients report that ECT causes harm. The electroshock destroys lives. The FDA has received 151 MAUDE reports for ECT since 1996, roughly 10 a year.
It took public and Senate Finance Committee pressure to obtain legislative changes forcing the FDA to educate consumers of their right to report adverse drug reactions. Government officials cited a survey that said 86 percent of consumers were completely unaware of their right to report.
MS. WOOD: Thirty seconds remain.
MS. EASTGATE: CCHR Italy recently interviewed the daughter of Dr. Hugo Cerletti. She is emphatic her father recognized the damage electroshock caused and researched alternatives. She said he was appalled to find ECT was primarily being used to enrich the pockets of those administering it. The Panel should take heed of Cerletti and the first victim that said, “Not another one. It’s deadly.” The ECT device must never —