FDA Colludes with APA to Keep Dangerous ECT Device on the Market

Excerpted from CCHR’s submission to the FDA opposing its 2015 proposal to reclassify the ECT device as a Class II low risk device. CCHR’s submission was submitted in March 2016.

It is clear that the Food and Drug Administration (FDA) and American Psychiatric Association (APA) members know that the ECT device manufacturers are not going to conduct research while at the same time, don’t want the device taken off the market. FDA was and is only looking for “mitigating” circumstances to keep the shock device on the market without clinical trials supporting the devices’ safety—and is doing this, despite the ongoing risk to patients.

In 1982, APA filed a petition to the FDA for reclassification of the ECT device to Class II. The National Institute of Mental Health (NIMH) supported the petition.[1] APA cited studies done as far back as 1940; in the bibliography they referenced only a handful of studies conducted since 1979. The APA and the device manufacturers failed to conduct any safety tests to prove their claims.[2] This incestuous relationship continues today.

Ms. Malvina Eydelman, Director of the Division of Ophthalmic, Neurological and ENT Devices, said at the Advisory panel 2011 hearings into ECT devices that “in order to try to delineate potential mitigating factors, whether it goes into Class II or Class III, we need to figure out what is the safety profile of a particular device.” (p. 280, 28 January 2011). However, FDA has known since its inception that a Pre-Market Approval (PMA) (which requires clinical trials proving safety and efficacy) was needed and should have worked out the necessary safety profile long before 2011—or in the five years since.

  • Eydelman further stated: “What we’re trying to say, is there sufficient information about all ECT devices such that we can write special controls that will be able to control each ECT device that’s going to come on the market from now on? As opposed to PMA, its assurance of safety and effectiveness of each device on its own.” (p. 427, 28 January 2011 Hearing)
  • Wayne Goodman, a consultant to Medtronic, Inc. (Deep Brain Stimulator trainer)[3] and 2011 Panel member asked: “So let’s assume we leave ECT Class III for unipolar depression, PMAs are called for and those require, based on your question to me, a large-scale study, say, involving 150 patients…. And assuming that that led to a design of a trial that required 150 patients per group and a sham design, it is conceivable, then, that no manufacturer would be able to afford that and at some point after the period of, say, 30 months expired, existing ECT devices could be taken off the market?” Emphasis added. (pp. 429-430 January 2011 Hearing)
  • Panel Member Dr. Christopher Ross: “I think, based on the existing knowledge, it would be hard to design a trial in which you would give sham ECT.” (Emphasis added.) ( 431-432 January 2011 Hearing)
  • Eydelman: “I’m just throwing this out—for the current manufacturers, we do want their assessment, but we’ll believe that perhaps going back and trying to see if we can find historical information with that particular device, that that would—for us to consider that for assessment of safety and efficacy.” (Emphasis added) (p. 432 January 2011 Hearing) “See if we can find?” This is astonishing given the fact that the FDA has known for 40 years that the manufacturers needed to provide clinical data in support of a PMA, that the FDA’s 2010 Executive Summary had conducted research and not established such safety and efficacy, while the ECT device makers admit they don’t do research. The FDA knew this in 1982 and did nothing.
  • Panel Member Dr. William McDonald: “If we have a 33-month waiting period for people to conduct the clinical trial is nothing. There’s no way you’re going to get a clinical trial with an ECT group.” (Emphasis added. 433.) Dr. McDonald was a member of the APA ECT Task Force in 2010. He has received research support from and been a consultant for Neuronetics (brain stimulation device manufacturer).[4]
  • Sarah Lisanby, a consultant to the Neurological Devices Panel of the Medical Devices Advisory Committee and Chair of the APA ECT Task Force in 2010, testified in 2011 on behalf of the APA that if ECT were to disappear, “it’s not the economy that would suffer. The two companies that make ECT devices are small and not publicly traded. “[Emphasis added; p. 35, 27 Jan 2011 Hearing][5] Later quoted in media, she said it was unlikely ECT manufacturers could “finance the studies required to get it approved….”[6] Yet, Dr. Lisanby knows of the potential damage, stating previously in the media that “in terms of persistent retrograde memory loss, that has been, according to the evidence, found to be most marked for the events that occurred close in time to the treatment.”[7] Dr. Lisanby is on the Editorial Board of the Journal of ECT, along with Harold Sackeim and Max Fink and Dr. Richard Abrams, co-owner of SOMATICS, Inc.[8] In March 2015, Dr. Lisanby was chosen to be the director for NIMH’s Division of Translational Research. [9]
  • Charles Kellner, who appeared before the January 27, 2011 hearing, was a member of the APA ECT Task Forces. In July 2011, he wrote in Psychiatric Times: “The crux of the matter is that premarket approval [for ECT] usually requires controlled clinical trials be carried out prospectively; such trials cost many millions of dollars and, in the case of drugs, are typically supported by the pharmaceutical industry. For ECT devices, there may not be a funding source for such trials. FDA officials suggested that the existing scientific evidence base for the efficacy and safety of ECT might be sufficient for a determination of device classification. Such an option is referred to as a ‘paper’ premarket approval. That means no new trials would be required.[10]

While in 2011, the FDA said that special controls may not mitigate the risks of ECT, in the December 31, 2015 Proposal on ECT it said that based on new information (the Executive Summary on ECT, the 2011 Hearings etc., APA Task Force/Guidelines, etc.): “FDA believes that this new information is sufficient to demonstrate that the proposed special controls can effectively mitigate the risks to health identified” and that these “special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness for ECT devices intended for treating severe MDE [Major depressive episode] associated with MDD [Major Depressive Disorder] and BPD [Bipolar Disorder] in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.” [Emphasis added.]

“Believes” implies a supposition or assumption of truth, not a proven fact.  And in the case of the FDA and APA’s submissions regarding the safety and efficacy of ECT, they are empty of facts.

References:

[1] “Electroconvulsive Therapy: An Exchange: William H. Nelson and Marilyn Rice, reply by Israel Rosenfield,” The New York Review of Books, 30 May 1985, http://www.nybooks.com/articles/archives/1985/may/30/electroconvulsive-therapy-an-exchange/?pagination=false.

[2] Op. Cit., Linda Andre, pp.148-149.

[3] http://neurosciencecme.com/library/MM027-day3-1030-goodman-winstead.pdf

[4] American Psychiatric Association, 163rd Annual Meeting, New Orleans, LA, May 22-26, 2010, Program Book, p. 40; American Psychiatric Association, 162nd Annual Meeting, San Francisco, Shaping Our Future: Science and Service, May 16-21, 2009, Program Book, p. xxxii; American Psychiatric Association, 162nd Annual Meeting, San Francisco, Shaping Our Future: Science and Service, May 16-21, 2009, Program Book, p. xxxii.

[5] http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevicesAdvisoryCommittee/neurologicalDevicesPanel/UCM247594.pdf.%20Accessed%20December%203, 1/27/11, PP. 32-35.

[6] Jim Amos, “Future of ECT as Life-Saving Treatment at Risk?” The Practical Psychosomaticist, 10 Mar. 2011, http://jajsamos.wordpress.com/2011/03/10/future-of-ect-as-life-saving-treatment-at-risk/; “Study: Electromagnets Can Relieve Depression,” CBS News, 5 May, 2010, http://www.cbsnews.com/2100-500368_162-6462525.html.

[7] http://psychcentral.com/lib/informed-consent-for-ect/.

[8]  Journal of ECT Editorial Board, http://journals.lww.com/ectjournal/pages/editorialboard.aspx.

[9] http://www.nimh.nih.gov/news/science-news/2015/lisanby-chosen-to-lead-nimh-division-of-translational-research.shtml.

[10] Charles Kellner, MD, “The FDA Advisory Panel on the Reclassification of ECT Devices,” Psychiatric Times, 5 July 2012, http://www.psychiatrictimes.com/electroconvulsive-therapy/content/article/10168/1897020.

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