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.