January 8, 2010
Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Room 1061 Rockville, MD 20852
Re: Docket #FDA 2009-N-0392
Dear Friends:
I am an attorney in solo practice located in Northern Vermont. I do a significant amount of volunteer prison advocacy work. Because so many prison inmates have significant mental impairment, that work puts me in touch with those advocating in that field.
My colleagues have asked me to write a short comment with regards to the FDNs consideration of current classification of ect machines, including the possible] reclassification of ECT machines from Class Ill to Class Il. From what I have read in the literature, I don’t see how informed consent to ETC is possible when there is so much contention in this area.. ECT practitioners have been fighting the need for FDA pre-market approval since 1982. They seem to be saying that ECT is so safe that it need not be independently studied. The skeptic in me cries “run for your life” when I witness this attitude from those who have a financial and career interest.
I would rather put my trust in the survivor community, which claims that ECT causes both retrograde and anterograde amnesia and cognitive deficits. This view is supported by the following studies, cited in Wikipedia:
Lisanby SH, Maddox JH, Prudic J, Devanand DP, Sackeim HA (June 2000). “The effects of electroconvulsive therapy on memory of autobiographical and public events”. Arch. Gen. Psychiatry 57 (6): 581—90.
Benbow, SM (2004) “Adverse effects ofECT”. In AIF Scott (ed.) The ECT Handbook, second edition. London: The Royal College of Psychiatrists, pp. 170—174.
Feliu M, et al. (June 2008). “Neuropsychological effects and attitudes in patients following electroconvulsive therapy.”. Neuropsychiatric Disease and Treament 4 (3): 613—17.
This study showed that patients often believe their memory had improved, when tests show that in fact there is a significant decline.
Coleman EA, Sackeim HA, et al. (March 1996). “Subjective Memory Complaints Prior to and Following Electroconvulsive Therapy.”. Biological Psychiatry. 39 (5): 346—56.
In July, 2007, a second study was published concluding that ECT routinely leads to chronic, substantial cognitive deficits, and the findings were not limited to any particular forms of ETC. The study, led by psychiatrist Glenda MacQueen and colleagues, found that patients treated with ECT for bipolar disorder show marked deficits across multiple cognitive domains. According to the researchers, “Subjects who had received remote ECT had further impairment on a variety of learning and memory tests when compared with patients with no past ECT. This degree of impairment could not be accounted for by illness state at the time of assessment or by differential past illness burden between patient groups.” MacQueen G., et al. (2007). “The long-term impact of treatment with electroconvulsive therapy on discrete memory systems in patients with bipolar disorder”. Journal of Psychiatry and Neuroscience 32 (4): 241—249.
Dr. Harold A. Sackeim is an American psychologist and proponent of electroconvulsive therapy, (ECT). He has been chief of the department of biological psychiatry at New York State Psychiatric Institute and professor of clinical psychology at Columbia University. From Columbia he received his Bachelorts degree in 1972; in 1974, he received his Master’s degree from Oxford University.
Sackeim is co-author of more than 200 publications relating to electroconvulsive therapy (ECT) and has researched it extensively, finding that excessive shock current correlates with risk of memory loss. [4]
In 2007 Sackeim and his colleagues published (in the journal ‘Neuropsychopharmacology’) the results of a study which followed 250 ECT patients in New York City hospitals. The study found that the most commonly used type of ECT, bilateral, does cause permanent memory loss, as patients have long complained, and results in mental impairment, especially in women and elderly patients. ‘The Cognitive Effects of Electroconvulsive Therapy in Community Settings’, Sackeim, et al, ‘Neuropsychopharmacology’, 2007
Despite over fifty years of clinical use, Sackeim states that prior to 2001, “the field itself never really had an opportunity to have a discussion about patients who have complaints about long-term memory loss. ” A Youtube video clip of his deposition, taken in 2004, Sackeim reveals that at a California ECT conference with 200 practitioners present, when polled as to whether they think ECT can lead to chronic cognitive deficits, two-thirds raised their hands. Sackeim says this was “almost a watershed moment for the field”, and was the “first time publicly that the field itself said “no” to the position that it can’t happen.” http ://www.youtube.com/watch?v=hvwVRn91 bAU&feature=related
As an attorney, my primary concern is whether patients can truly be informed so that they may give informed consent. With so many patients referring to themselves as “survivors” and claiming loss of memory and cognitive function, a claim which is at least marginally supported by the literature, there appears to be a definite need to conduct a full assessment of the dangers.
I would think that the practitioners would want a full study to protect themselves from law suits – unless of course that study showed that there are significant dangers.
It is my understanding that under 5513 of the Federal Food, Drug, and Cosmetic Act (Act), codified at 21 USC 5360c:
1. In order for reclassification of Electroshock Machines as a Class I device to be legal, there must be sufficient scientific information establishing that general controls are sufficient to provide reasonable assurance of their safety and effectiveness; 2. In order for reclassification of Electroshock Machines to a Class Il device to be legal there must be sufficient scientific information establishing that special controls would provide reasonable assurance of their safety and effectiveness;
3. Absent meeting the criteria for reclassification as a Class I or Class Il device,
Electroshock Machines must go through the Pre-Market Approval process; and 4. In evaluating the safety and effectiveness of Electroshock Machines, the FDA must weigh any probable benefit to health from the use of Electroshock Machines against any probable risk of injury or illness from such use.
5. In order to meet the exception under Section 360c. (a)(3)(b), the Secretary must be able to determine that there is pre-existing scientific evidence that the device is both effective and safe. As shown above, the scientific community is mixed on both issues. Consequently, the Secretary cannot certify this exemption.
Thank you for your consideration of this submission.
Barry Kade
View comment on Regulations.gov
