January 6, 2010
Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket #FDA 2009-N-0392
To Whom It May Concern:
We are attorneys with a public agency concerned with mental health issues in New York State, and in that context write this letter in opposition to the above-docketed proposal to reclassify from Class Ill to Class Il devices used to administer electro-convulsive therapy (“ECT”, also commonly referred to as electro-shock or shock treatment).
The views expressed herein are solely those of the undersigned authors and do not necessarily express the position of our agency, or the Appellate Division of the New York State Supreme Court, under whose aegis our agency operates.
Realities of Involuntary ECT Call for Heightened Scrutiny
As attorneys we provide free legal services to persons receiving inpatient and outpatient psychiatric treatment.
Through years of such advocacy we are thoroughly familiar with a modality of administering electro-shock treatment of which the general public is largely unaware, to wit, forced ECT over patients’ expressed objections.
The practice of court ordered, involuntary shock treatment has been prevalent in New York State for upwards of two decades and shows no signs of abating.
Psychiatric treatments such as ECT are the only medical treatments that are routinely forced on unwilling subjects.
Furthermore, patients who are the recipients of such involuntary procedures are deemed to lack the mental capacity to weigh the risks and benefits involved.
Once an individual’s basic right to decide whether or not to undergo a proposed medical procedure is taken away, the need for external safeguards, such as FDA regulation, is heightened.
It has been our consistent experience that hospital patients for whom ECT is recommended are rarely informed of the full panoply of risks and adverse effects associated with the treatment.
Doctors trying to persuade patients to consent to shock treatment commonly downplay the severity and incidence of common risks, such as memory loss; the low but nevertheless real risk of mortality often is not even mentioned.
Patients are almost never given any information about the ECT machines by which the treatment is delivered.
Over the past decade, state psychiatric hospitals have increasingly disregarded generally accepted standards, and even their own formal standards in regard to duration of courses of electroshock treatment and total numbers of treatments.
Several patients from three or four different state psychiatric centers have received hundreds of involuntary shock treatments on a so-called “maintenance” basis, often with upwards of 100 treatments in a single course of ECT, for which there is no support either in the literature or in institutional standards.
The administration of hundreds of maintenance ECT’s over years or indefinitely is clearly an extreme clinical approach, but one predicated on the assumed safety of the practice and of the ECT device used to deliver the required electric shock.
Richard Abrams, a leading proponent of and authority on electro-shock describes maintenance ECT as “an outpatient procedure” (whereas forcible ECT in New York is administered on inpatients).
Abrams, Electroconvulsive Therapy, Third Ed. (1997) at 190. He states:
maintenance ECT, like psychoanalysis, should not be interminably prolonged. Such a practice is unwarranted and if performed with bilateral placements may produce severe, continuous, cognitive deficits . In my view, a second opinion should be sought before continuing maintenance ECT for more than 1 year or 12 treatments, whichever comes first.
ß. at 191. Abrams refers to a report of “the appalling (but apparently ultimately reversible) cognitive consequences in a 57-year-old woman who had received a ‘maintenance’ ECT every Saturday morning for more than 2 years.” W. at 272.
It is not uncommon for hospitals to treat patients as competent individuals so long as they consent to shock treatment, but to deem them incompetent to make treatment decisions the moment they choose to withdraw such consent.
Moreover, long-term, forced maintenance electro-shock is often justified largely or partly by its contribution to behavior control with little or no expectation of recovery from the targeted mental illness.
The Necessity of Further Research on Efficacy of ECT
Because shock machine manufacturers have never been required to undergo the FDA’s PreMarket Approval process required for new medical devices, they have never conducted clinical trials to assess the safety and efficacy of the machines.
The risks and hazards of treatment with ECT machines are real, and even studies by shock advocates have gradually come to recognize both its risks and therapeutic limitations.
As to the limits of industry touted benefits of electro-shock, a 2000 study by Harold A. Sackeim, a leading proponent of ECT, and others, found that, among somewhat more than half the depressed subjects who attained a remission of symptoms from shock treatment, relapse rates were varied but overall quite high. Sackeim et al., “Continuation Pharmacotherapy in the Prevention of Relapse Following Electroconvulsive Therapy, A Randomized Controlled Trial”, 285 JAMA 1299 (March 14, 2000) (the article reports that 54.8% of the patients in the study who were treated with ECT were “remitters”, W. at 1302).
Remitted patients given follow-up treatment with placebo relapsed at a rate of 84.0%, those subsequently treated with the drug nortriptyline had a 60.0% relapse rate, and the most favorable result, for those treated with a nortriptyline-lithium combination, was still a high 39.1% rate of relapse. Id. at 1304.
Another review summarized: “Relapse of severe depression after successful treatment with electroconvulsive therapy (ECT) continues to be a major problem.” Bourgon, L.N., and Kellner, C.H., “Relapse of Depression After ECT: A Review”, 16 Journal of ECT 19 (2000).
Those authors concluded that “[n]ew approaches to sustaining the benefits of ECT . . . are urgently needed to reduce the rate of relapse Id. at 29.
If New York’s use of virtually never-ending “maintenance” shock treatment is intended to address this relapse problem, it finds no support in the professional literature, and indeed carries the risk of producing “severe, continuous, cognitive deficits”. See, Abrams, supra.
Risks of ECT Are Substantial and Inadequately Studied
Seven decades of electro-shock usage have provided substantial evidence of serious and severe risks.
The most common, long-recognized adverse effect of the treatment is memory impairment.
There is no question that shock treatment causes loss of memory. See e.g., the most recent Task Force Report of the American Psychiatric Association, The Practice of Electroconvulsive Therapy: Recommendations for Treatment. Training. and Privileging, Second Edition (2001) (hereinafter “APA 2001 Report”) at 70 (“ECT selectively results in anterograde and retrograde amnesia”); Sachs, G. S., and Gelenberg, A. J., “Adverse Effects of Electroconvulsive Therapy”, 7 Rev. of Psychiatry at 498, 501 (“The data suggest . . . a permanent loss of at least some memories formed during a period several months before and after treatment”); Weisberg, L.A., Elliott, D., and Mielke, D, “Intracerebral Hemorrhage Following Electroconvulsive Therapy”, 41 Neurology 1849 (1991) (“The well-described effects of ECT are acute confusion and memory impairrnent”); Aden v. Younger, 57 Cal. App. 3d 662, 672 (Ct. of Appeal, Cal. 1976) (Although the “extent of memory loss and the risk of permanent memory loss are not fully known or agreed upon, the fact of memory loss is not questioned”).
No thorough survey of the research literature could ignore the 1950 studies of Dr. Irving Janis of Yale University. e.g., Douglas G. Cameron, “ECT: Sham Statistics, the Myth of Convulsive Therapy, and the Case for Consumer Misinformation”, 1 5 Journal ofMind and Behavior 177, 178 (1994) (cited hereinafter as “Cameron”).
The Janis studies “showed extensive, permanent loss of important personal memories and life history following routine ECT.” Breggin, “Electroshock: Scientific, Ethical, and Political Issues”, I l Int. J. of Risk & Safety in Med. (1998) 5-40, at 53.2.
That type of prospective study has rarely been repeated.
Such a study was done by Larry R. Squire and his colleagues. Cameron at 178, f.n. 2; Squire and Slater, P.C., “Electroconvulsive Therapy and Complaints of Memory Dysfunction: A Prospective Three-year Follow-up Study”, 142 Brit. J. of Psychiatry 1 (1983). Squire and Slater summarize: “At three years after treatment approximately one-half ofthe persons who had received bilateral ECT reported poor memory.” Id.
More recently, a 2007 study by Dr. Sackeim and others, concludes that “some forms of ECT have persistent long-term effects on cognitive performance”, even cautioning that “the findings do not indicate that the treatments with more benign outcomes are free of long-term effects.” Sackeim, et al, The Cognitive Effects of Electroconvulsive Therapy in Community Settings, 32 Neuropsychopharmacology 244, 252 (2007) (the study characterizes itself as “the first large-scale, prospective study of objective cognitive outcomes of patients treated with ECT”, id.).
The study notes that bilateral electroshock “results in broader and more severe short-term cognitive effects than RUL [right unilateral] ECT, particularly with respect to retrograde amnesia”, id., and concludes that “there appears to be little justification for the continued first-line use of BL [bilateral] ECT in the treatment of major depression.” Ld., at 253.
It is noteworthy that most of the forced shock treatment in New York is still administered bilaterally. This disconnect between prudent treatment recommendations and actual institutional practices cries out for more research, not less vigilance.
While memory loss is unquestionably the most serious regularly experienced downside of ECT, other serious risks exist, including the risk of death. Although proponents often argue that risk of death with ECT is about 0.01 percent of patients and comparable to the risks of general anesthesia alone, that claim has no real documentation.
The reference often given is to the 2001 APA Task Force Report which states without attribution to any other authority: “A reasonable current estimate is that the rate of ECT-related mortality is 1 per 10,000 patients or I per 80,000 treatments.” APA 2001 Report at 59.
However, the report begins that paragraph with the following important caveat: “Precise rates of mortality attributable to ECT are difficult to determine because of methodologic issues intrinsic to studies of medical mortality, such as uncertainty about cause of death, the time frame for linking death to ECT, and variability in reporting requirements.” Id.
The APA 2001 Report does not address information which is at serious odds with its claims. For example, there is no attempt to analyze information gathered from legally mandated ECT reporting in Texas. See Texas Health & Safety Code “578.007 and 578.008. In 1996, the Washington Post reported:
Three years ago, Texas became the only state to require doctors to report deaths of patients that occur within 14 days of shock treatment Officials at the Texas Department of Mental Health and Mental Retardation report that between June I , 1993, and September 1, 1996, they received reports of21 deaths among an estimated 2,000 patients.
Sandra G. Boodman, “Shock Therapy: It’s Back”, Washington Post, September 24, 1996, p. Z14. That figure diverges dramatically from the 1 in 10,000 rate endorsed by the American Psychiatric Association.
Although the APA 2001 Report contains 66 pages of references, APA 2001 Report at 247312, there is no mention of a 1996 report from England that concluded that “index ECT treatment predicted high mortality, readmission, relapse and recurrence risks.” O’Leary, D. A., and Lee, A. S. , “Seven Year Prognosis in Depression: Mortality and Readmission Risk in the Nottingham ECT Cohort”, 169 British J. of Psychiatry 423, 428 (1996). Of the 118 patients who received shock treatment and were followed over a 7-year period, thirty-one (32%) were dead at the end of the period, “double the expected number”. Id. at 424.
Furthermore, the reassurance often given by shock practitioners that careful monitoring of the procedure allows timely identification and treatment of cardiovascular emergencies that may arise implies an ability to predict and detect cardiac effects that is belied by experience.
A dramatic illustration of this uncertainty is provided by the case of a 57-year-old man who suffered cardiac rupture and died immediately following an ECT treatment. Ali, P.B., and Tidmarsh, M.D., “Cardiac Rupture During Electroconvulsive Therapy”, 52 Anaesthesia 884 (1997).
The authors note that “the patient had no overt cardiac risk factors and base line investigations, including ECG, were normal. ” Id. at 885. Nevertheless:
Shortly following [shock] treatment, the patient’s face was noted to have become congested.
This observation coincided with that of an unrecordable blood pressure and an impalpable carotid pulse. . . . Electromechanical dissociation (EMD) was diagnosed and cardiac massage was immediately started, Despite efforts to resuscitate the patient, his ECG deteriorated to a broad complex agonal rhythm, followed by asystole.
Resuscitation was abandoned 30 [minutes] after the time of the initial diagnosis.Id. at 884. We do not argue that rupture of the heart is a common occurrence during electro-shock treatment.
The significance of that the disastrous outcome is that it could not have been predicted in advance and monitoring and rapid treatment were unable to prevent the death of that patient.
It is imperative that shock machine manufacturers provide this agency more definitive and detailed evidence pertaining to the cardiac safety of ECT devices.
Forced ECT Is a Major. Intrusive Medical Intervention Requiring Careful Study
When a major, intrusive procedure such as electro-shock treatment is forced upon objecting patients, the need for external oversight and regulation is more acute.
The administration of shock treatment entails the use of general anesthesia, and the electric current that is passed through the patient’s brain by the ECT machine causes a grand mal seizure.
Shock has long been recognized by the courts as “a highly intrusive and controversial form of treatment. ” Lojuk v. Quandt, 706 F .2d 1456, 1465 (7th Cir. Ill. 1983). see also, Matter of Gertrude K., 177 Misc.2d 25, 27 (Sup. ct., Richmond Cty. 1998) (characterizing ECT as a “psychiatrically intrusive treatment”); In re Schuoler, 723 P.2d 1103, 1107 (Sup. Ct., Wash. 1986) (“Electroconvulsive therapy is a highly intrusive medical procedure”); Price v. Sheppard, 239 N.W.2d 905, 912 (Sup. Ct., Minn. 1976) (characterizing ECT as “one of the most intrusive forms of treatment”); People in Interest of M.K.M., 765 P.2d 1075, 1076 (Ct. App., Colo. 1988) (“ECT is generally considered to be more intrusive than drug therapy”); Aden v. Younger, 57 Cal. App.3d 662, 672 (Ct. ofAppeal, Cal. 1976) (noting ECT’s “intrusive and possibly hazardous character”); New York City Health & Hospitals Corp. v. Stein, 70 Misc.2d 944, 945 (Sup. Ct., N.Y. Cty. 1972) (noting that ECT “is the subject of great controversy within the psychiatric profession, both as to its efficacy, and as to its dangers”).
The risks must not be belittled, and if it is to continue to be imposed upon unwilling subjects there must be further research into both its undeniable hazards and its presumed benefits to aid state and federal watchdogs such as FDA to assess the safety and efficacy of the machine through which the treatment is delivered.
Much court ordered treatment in New York is for “maintenance” ECT, which for some patients is continued indefinitely through hundreds of shock administrations.
The “absence of controlled studies of the efficacy or safety of long-term maintenance ECT” has been noted by the American Psychiatric Association. APA 2001 Report at 212.
Even as to the presumed benefits, the evidence is inadequate. See. e.g., NIH, Consensus Development Program: Electroconvulsive Therapy (1985)(“ECT has not been useful in chronically ill schizophrenic patients.
Although ECT is frequently advocated for treatment of patients with . . . schizoaffective disorders. . . there are no adequate controlled studies to document its usefulness for [this] disorder”) (emphasis added).
Many New York patients are being given involuntary ECT as treatment for schizoaffective disorders.
Conclusion
ECT devices must be kept in Class Ill and manufacturers should be mandated to comply with the pre-market approval procedure, including the conducting of adequate clinical trials to assess the safety and efficacy of the machines.
The literature and research cited herein, including significant studies by proponents of electro-shock treatment, and the continued and expanding use of forced ECT in New York, including long-term “maintenance” shock, make imperative the need for the greatest protection to the public because “insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of [the devices’] safety and effectiveness or that application of special controls would provide such assurance”, and moreover, there is substantial evidence that “the device presents a potential unreasonable risk of illness or injury.” See, 21 USCS 360c(1)(C)(i)(I) and (ii)(ll).
The petition for reclassification should be denied.
Respectfully yours,
Dennis B. Feld, Esq., and Kim L. Darrow, Esq.
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