FDA HEARING on reclassification of electroconvulsive therapy devices‏

  This hearing will be held at the Hilton Washington DC North/Gaithersburg, Ballroom, 620 Perry Pkwy., Gaithersburg, MD. on January 27 - 28, 2011  from 8 a.m. to 6 p.m.  Oral presentations from the public will be scheduled at approximately 10 a.m. on the 27th, immediately following the FDA’s presentation      Time is short.  If you plan to testify at this hearing, please contact the FDA's contact person for this hearing without delay. James M. Engles, M.S., M.B.A. Designated Federal Officer United States Food and Drug Administration Center for Devices and Radiological Health (CDRH) Medical Devices Advisory Committee Staff 10903 New Hampshire Avenue, Building 66, Room 1566 Silver Spring, MD 20993-0002 Phone: (301) 796-7543 Fax: (301) 847-8122


    If you cannot go, you can submit a written statement. As you know, ECT never went through the approval process now required for new devices by the FDA.  These devices were "grandfathered" into the system when the agency got jurisdiction in 1976.  Over the years, the shock industry has avoided any scrutiny of  their product for safety or efficacy.  All this changed in 2008 when the FDA sent letters to all manufacturers of devices in this category demanding clinical studies in this regard.  The industry responded by seeking a reclassification of their products to a lower category that does not require proof of efficacy on safety. This hearing is being held to determine the reclassification (from its highest Class III) to the lesser Class II (wheelchairs, etc) that do not require this regulatory procedure. Public safety and public responsibility demand that these devices get a full review by its regulatory agency. Vince http://www.fda.gov/AdvisoryCommittees/Calendar/ucm234979.htm

January 27-28, 2011, Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

Food and Drug Administration [Docket No. FDA-2010-N-0585] Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice.             This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.                      Name of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee.             General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.             Date and Time: The meeting will be held on January 27 and 28, 2011, from 8 a.m. to 6 p.m.               FDA is opening a docket for public comment on this meeting. The docket number is FDA-2010-N-0585. The docket will open for public comment on November 26, 2010. The docket will close on January 25, 2011. Interested persons may submit electronic or written comments regarding this meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit a single copy of electronic comments or a paper copy of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this meeting notice. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620 Perry Pkwy., Gaithersburg, MD.                Contact Person: James Engles, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20993, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512513. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.               Agenda: On January 27 and 28, 2011, the committee will discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy.               FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.                        Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before January 14, 2011. Oral presentations from the public will be scheduled at approximately 10 a.m., immediately following the FDA’s presentation, on January 27, 2011. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 6, 2011. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 7, 2011.   Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, at 301-796-5966 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).     Dated:   November 18, 2010.    Sign: Thinh Nguyen,         Acting Associate Commissioner for Special         Medical Programs.      ©2010 The Institute of Mind and Behavior, Inc. The Journal of Mind and Behavior Summer 2010, Volume 31, Number 3 Pages 265–270 ISSN 0271–0137 Doctors of Deception: What They Don’t Want You to Know about Shock Treatment. Linda Andre. New Brunswick, New Jersey: Rutgers University Press, 2009, 359 pages, $26.95 hardcover. Reviewed by David Cohen, Florida International University For a still undetermined number of people, entering the circle of psychiatric care begins a tragic process of disablement. Troubled or confused when they first contact officially accredited helpers for what are usually self-limiting and situational difficulties, their ensuing experiences with drugs or electroshock (electroconvulsive therapy, ECT) has a good chance of leaving them with diffuse stress syndromes and impaired cognition, sometimes for years. When this occurs, their injury is likely to be compounded because it is squarely denied or glossed over by those who have inflicted it and by nearly everyone else who should know better. Lacking a clear vocabulary to articulate their worsened predicament, and floundering in a previous or new subordinated social status, they watch helplessly as their discourse is dismissed as “mental illness.” A person thus diminished may be viewed as not believable, and if she persists in calling attention to her predicament, may be stigmatized as ungrateful or irresponsible. The dark side of the 60-year-old “biological revolution” in psychiatry is that when biological treatments “work,” treatments are praised, but when treatments harm, the responsibility is placed squarely upon their recipients or the intractability of their “disorders.” Nonetheless, to regain their integrity, to bear witness, or to fight injustice, some of these injured souls turn to advocacy and writing. Author and activist Linda Andre has written a marvelously lucid and ably documented book (over 500 references) that not only recounts her experiences and that of many others with electroshock, but mounts a systematic assault on the biomedical industrial complex and the willful distortions that many of its actors and servants — physicians, researchers, government regulators, journalists — engage in to maintain biomedical dominance and accrue benefits to themselves. In chapter after devastating chapter, Doctors of Deception describes, probes, analyzes, exposes, and deconstructs the entire electroshock industry. Andre focuses a steady gaze on the American Psychiatric Association’s (APA) successive reports on electroshock that have whitewashed the procedure. She details the Food and Drug Administration’s (FDA) tortuous evasions of its responsibility to evaluate objectively the risk of harm from shock devices by not requesting manufacturers to provide evidence of safety (unlike what it requires of manufacturers of any other medical device). She excoriates the small coterie of National Institute of Mental Health funded researchers whose careers are intertwined with shock machine manufacturers and the published sophism and casuistry that establish them as scientific experts on shock. She highlights the absence in the entire literature of a single well-controlled study testing the specific hypothesis that electroshock causes brain damage in humans, and she reviews study after study showing that shock impairs memory and other cognitive abilities. She portrays the confusion sowed by befuddled or manipulative journalists who announce, year after year for decades, that the “new” shock treatment is better and safer than the “old” and who cannot bring themselves to present injured shock survivors as anything but deluded or stubborn naysayers. Despite her elaborate portrayal of such a Kafkaesque system, one that has incarcerated and wounded her, Andre keeps an even, tranquil tone throughout the book, and at times compliments an obscurantist researcher for an occasional honest or forthright statement. The opening quote in Doctors of Deception is from iconic shock survivor and activist Marilyn Rice: “I don’t mean to say that these policies were ever written down or even necessarily known to the persons and organizations who have been actors in the drama, but they are detectable in the sweep of events and the rationalizations of the actors.” This quote expresses aptly the insight that complex systems can incarnate functions and finalities that escape the intentions of the actors themselves, but Andre does not spare the individual actors — far from it. She names names, exposes deeds, and attributes motives. That is perhaps why in the book’s dedication and in the acknowledgements, she describes it as a “dark” and a “sad” book. Andre appears simultaneously as revolted and resigned, angry and wise. Upon reading Doctors of Deception, even readers familiar with ECT’s history and literature — and familiar with the starkly opposite stances that characterize comments from both people who have received ECT and those who have studied or administered it — will discover that its author has many excellent reasons to take whatever stance she wishes. The book’s first chapter, “The Trouble with Time,” opens with Andre’s description of memory “loss” following the series of shocks she underwent as a 25-year-old woman after being forced into a psychiatric hospital where she was illegally detained (without formal commitment). The depressingly familiar story of her ignorance about coercive psychiatry compounds the tragedy. She states:The shock treatment erased five years of my life: four before, one after . . . . A period of time is wiped out as if it never happened . . . . Your life is essentially unlived. You never wrote that article, made that friend, took that trip, read that book, gave birth to that child. You didn’t just lose your suitcase; you can’t say where you got it, what it looks like, what you packed in it, what trips you’ve taken. You don’t know that you ever had it. (pp.3–4) The losses compound over time: Because I no longer knew who I was, I couldn’t build new relationships. Because I lost my knowledge and skills, I could no longer work. Because I couldn’t work, I became financially and socially marginal. Without work, friends, or identity, I lost my place in the world . . . . And so on, in a slow social death that can last a lifetime . . . . No one sees, no one knows; no one believes, unless they’ve had shock too. (p. 11) In two chapters, Andre discusses the eugenic conceptions that, she argues, set the stage for the acceptance of shock in America. She concludes that, “Without eugenic attitudes, no matter how it was brilliantly marketed, shock would have died off; countervailing forces would have been able to successfully unmask the marketing schemes” (p. 43). In “A Little Brain Pathology,” Andre reviews the numerous animal and human studies on the effects of electroshock that appeared in the 1940s and 1950s (ECT was invented in 1938), citing unambiguous excerpt after excerpt from investigators who typically concluded that significant brain damage was documented. She reminds readers that, “There was no sense in which the doctors at the time who admitted ECT was brain damaging felt they were saying anything unacceptable to the profession or the public” (p. 50). Nonetheless, a number of these psychiatrists did warn their profession and some, including Manfred Sakel, the inventor of convulsive treatment, asked pointedly whether ECT should continue to be applied. Andre cites extensively from Yale psychologist Irving Janis’ study in 1950 of amnesia following shock. According to Andre, the excerpts published by Janis “illustrate in a way no one else ever has how different ECT memory loss is from normal forgetting and how it has no parallel in ordinary human experience” (p. 60). She writes: “No one [since] the study was published has criticized Janis’s methodology. When his work is not ignored or dismissed, there are calls for its replication. These calls have been made for over fifty years, but to date no scientists have heeded them” (p. 63). The explanation is provided in the subsequent chapters, where Andre details how, despite increasing calls in the 1970s for studies that should use the latest techniques to establish the nature of organic and other defects that occur with ECT, the ECT industry strategy “was to grab ironfisted control over both the data and the terms of the debate, using tried and true public relations tactics, and to stay its course . . .” (p. 65). During the years that followed, a series of shock lawsuits established legal concerns over the intrusiveness of shock and its risks, and staked out a patient’s “right to refuse” it — if that patient was deemed “competent.” The shock industry woke up quickly. Andre argues that the key to shocking as freely as . . . before rights protection was in the legal definition of competency [which] includes the patient’s ability to understand the risks and adverse effects of the treatment. Organized psychiatry could define those risks as it pleased. If the APA said shock was harmless and could convince judges that it was, then any patient who disagreed with this assessment lacked an understanding of the risks of treatment . . . . (p. 83) Though the shock industry couldn’t make ECT safe, Andre argues that it didn’t need to. It needed rather to shape “what people, including the rank-and-file doctors and judges who would assess competency believed about shock, not what was actually true about it.” The problem was transformed by the ECT industry into a “public relations problem and not a medical, scientific, or moral problem” (p. 84). Within ten years, Andre demonstrates compellingly, the ECT industry had achieved a platform (with help of the APA’s power, numbers, money, and credibility, and an official, quasi-governmental report), control of the media (the ability to prevent, suppress or defuse negative portrayals of ECT through aggressive public relations campaigns), and control of the scientific journals (by controlling access to funding and publications). The parallels with the psychotropic drug industry, many of which have been revealed over the past few years, are obvious. Citing analysts’ views that a few well-respected opinion leaders with backing from the pharmaceutical industry were able to so thoroughly shape the views of thousands of practitioners about ineffective and harmful drugs, Andre notes that the comparatively smaller (“only” five-billion dollars) and incestuous shock industry was much more successful in this regard. How the media has jumped on the ECT public relations bandwagon is discussed and illustrated in a chapter entitled “The Lie That Won’t Die.” The lie is the fictional statement, never documented because no figures exist, that leads and frames nearly every mainstream story on shock that Andre has collected since the 1980s, that electroshock is making a comeback. The “near-identical comeback articles [have] titles like, ‘A New Image for Shock Therapy,’ ‘Taking the Shock out of Electroshock,’ and ‘Shock Therapy Loses Some of Its Shock Value.’ In a world in which media coverage feeds off itself, it now seems unthinkable that there could be any other way for covering shock in the mainstream media” (p. 214). In wrenching narratives of her meetings and interviews with the paragons of journalism at 20/20, 60 Minutes, the Phil Donahue Show, The Atlantic Monthly, and other media outlets, Andre describes what she calls “hit-and-run journalism”: . . . a total stranger asks you the most personal questions about yourself, requires you to answer every question he poses fully and truthfully (otherwise you will be suspected of hiding something), expects you to trust implicitly that he will not make any errors of fact or context when he publishes your name for thousands of people to see . . . . At the same time he will not tell you anything about his background, his motives, his opinions, whom else he has interviewed, or how he’s decided to frame the story . . . . This type of journalist makes himself inaccessible once the story is finished. He’s driven off and takes no responsibility for the damage he’s done to individuals or to the general level of public understanding of an issue. Why would he? He never intends to speak to the subject again . . . . Meanwhile, those who live with the issue every day, year after year, are left standing at the scene of the accident in disbelief, telling each other lamely, “If we hadn’t talked with them, it would have been even worse,” knowing that’s not true . . . . (pp. 222–223) Andre also shows that publicly trusted authorities, like the National Institute of Mental Health and the Surgeon General, have taken positions on ECT during the public relations era. In telling of her personal attempts to shape three major reports about ECT at federal or state levels, Andre reminds readers that “. . . whenever a government entity takes on ECT . . . these are hotly contested political statements, and the process by which they are developed is a political power struggle. Different constituencies fight for input, and the playing field is not level” (p. 231). We are shown over and over again that shock “survivors have always been excluded from a voice in research or policy, while industry spokesmen . . . made research and policy.” Though she finds this inequality to be true for all struggles for social change, “No two groups seem more unequal than psychiatrists and former ECT patients” (p. 233). The exclusion and dismissal of the negative views of shock recipients by actors representing professions, government, and industry, and the disparity between these actors’ power over resources is again illustrated by Andre’s foray into the workings of the FDA. This chapter, among others, is about the broader issue of citizens’ involvement in the process of science and health policy, and the struggle by patients and experts to castigate or elevate data as either “anecdotes” or “evidence.” In the case of the mostlyfemale ECT survivors trying to get their accounts into an FDA report of personal experiences with ECT, versus the mostly-male psychiatrists and shock-doctors trying to get their accounts in, the outcome again and again is depressingly familiar. Andre accepts fully that shock “works” in the short-term: A series of many electrically induced, closely spaced grand mal seizures, with the accompanying acute organic brain syndromes and the cumulative amnesia, is guaranteed to temporarily change mood and behavior . . . . It is a biological certainty that it is impossible to be depressed, or focus much on anything, while body and brain are struggling to recover from a grand mal seizure. (p. 96) She feels this is ECT’s biggest selling point, as patients come to ECT “experiencing extreme distress and/or are extremely distressing to others” (p. 96). But her review of the studies (or lack thereof ) leads her to state that “Rather than scientific evidence, the claim that ECT works is made by assertion and anecdote. There is no doubt that some patients are glad to have the short-term relief they obtain from ECT and . . . [d]esperate relatives are grateful for short-term respite . . . . But there is no evidence that ECT has any long-term benefit” (pp. 97–98). I find this to be an eminently reasonable summary of the accumulated evidence. This evidence, and how it has been skewed by the “moral choices” made by the industry, frame a later chapter of the book that asks, “Should ECT Be Banned?” Her reasoning here is cautious and inclusive, strengthened by evidence from so-called “informed consent forms” for ECT and by her recognition that some recipients claim benefits (as some recipients of any and all treatments have always claimed benefits). Nevertheless, Andre concludes as follows: Even knowing [all of the deceptions and the evidence on damage], some people would choose to have ECT, as some people choose to smoke. But people aren’t allowed to know. This is the strongest argument that ECT is immoral, and it makes a ban not only deeply consistent with the American values of freedom, choice, and autonomy, but the only way — at this point in history and given the choices the industry has made — to protect those values. (p. 286) Doctors of Deception is a compelling and comprehensive analysis and indictment of the modern psychiatric industrial complex. It is compelling because the motives, rationalizations, or lies of the actors in the system are presented in their own words. It is persuasive because the workings of the system to shape the very nature of public and scientific debate are taken apart, labeled one by one, and the relationships between the parts of this vast engine of deception are delineated. It is comprehensive because Andre frames each of her chapters within wider political and cultural issues surrounding the management of troubled people in society. Finally, it is unusual, because it weaves the author’s account of her struggle for survival and advocacy. Yet, even though the weight of the evidence paints a bleak picture and argues against an evolution of the system toward openness and practical changes making it easier for ordinary people and professionals to have access to less biased information about ECT, Andre notes in her concluding chapters and epilogue that some positive change does occur, like what has been occurring in the financially conflicted drug industry. These changes seem to illustrate the unpredictable dynamics of any vast social system. Andre believes that “a hundred unpredictable variables” will decide whether the great ECT deceptions will unravel. Still, she believes that for fundamental change to occur, “What’s needed, as always, are just a few individuals who care enough to put what’s right before everything else, who are willing to make personal sacrifices of time and resources, and who won’t give up” (p. 305