A Battle in Gaithersburg
A Battle in Gaithersburg:
January 27-28, 2011 FDA Hearings on Reclassification of Electroshock Machines
I want to share a few thoughts on last week’s hearings in Gaithersburg on the classification of electroshock machines. These comments are dedicated to Vince Boehm, psychiatric survivor and extraordinary activist who has been a key leader in taking on the FDA over the years on issues related to our cause. He has been actively involved in 8 or 9 hearings over the years on drug-related concerns, all of which have resulted in some type of win for us. Vince was a key instigator on this particular challenge and also hosted electroshock survivor activist Loretta Wilson and myself. As I tried to sleep Wednesday night on the floor of the Charlotte, North Carolina airport, stranded due to weather conditions in Washington D.C., Vince and Loretta spent the night in a D.C. airport where they were stranded after braving treacherous roads and scores of wrecked or stranded cars to get there with the intention of picking me up… what an adventurous ordeal!
Although my Texas compadres—CCHR activist Lee Spiller and psychiatric survivors Dianna Loper Posthauer and Evelyn Scogin—were unable to even get to Gaithersburg because of numerous flight cancellations, I fortunately managed to get the last seat on a plane Thursday morning and make it to the hearing—a little late, but soon enough to testify and participate the rest of that day and Friday.
Set and Setting
The stated mission was for this select panel to make recommendations to the FDA about whether to keep the electroshock machines in class III as high risk devices or reclassify them in class II as having demonstrated sufficient safety and effectiveness to be considered relatively benign and clearly of greater benefit than risk. It was a very high stakes meeting as a win for the industry would mean that electroshock was home free with an official stamp of approval. Remaining class III would ostensibly mean that the electroshock machine industry was required to go through a formal pre-market approval process (PMA) to demonstrate to the FDA’s satisfaction sufficient safety and effectiveness. According to the law, failure to do so would mean taking the machines off the market.
I characterize this overall set and setting as “Groundhog Day Déjà Vu All Over Again.” Electroshock has been around in this country for seven decades. And as electroshock survivor and researcher Linda Andre lays out in detail in her remarkable book, Doctors of Deception: What They Don’t Want You to Know About Shock Treatment,” this FDA-electroshock drama has been ongoing for 35 years, when the Medical Devices Amendment of 1976 put the FDA in a regulatory position over the electroshock machines. Andre details the stark repeated failure of the FDA to enforce the law and hold the industry accountable. Following in the wake of Andre’s powerful expose, I told the panel that the existence of this very hearing was clear evidence of the victory of the shock industry’s public relations campaign over science.
In any event, it has gotten so bad that not only has the FDA repeatedly let the industry off the hook regarding the legal demand that they submit PMA research to justify the use of electroshock, but now the FDA has chosen to actually do their work for them and search the literature and survey the field for evidence on electroshock safety and efficacy. The results of that effort were brought forward to the Gaithersburg hearing, and the panel was to make recommendations based on that data.
I got there a bit late Thursday morning, and missed a few of the testimonies of our allies. Those I did hear were both inspiring and compelling. Sitting through hours of psychiatric experts on the panel—five psychiatrists, all of whom either use or refer people for electroshock, one psychopharmacologist and one industry representative—extolling the virtues and necessity of electroshock was intensely troubling, however. That the psychiatric industry folks dominated the conversation from the panel was an Orwellian nightmare, and very troubling, frustrating and discouraging for me. I felt like this was a setup and that it did not look good for the visiting team (us).
Electroshock’s Orwellian Universe
In regards to Orwell and the perversion of reality, here is a little of what I saw:
1) There was a consistent rejection and disrespect of survivor testimony that was negative about shock. The psychiatrist who was also a shock survivor and praised its virtues was asked questions and encouraged to amplify his points. The testimony of our clear and courageous survivors was repeatedly dismissed as anecdotal. Of course, the anecdotes of the shock doctors and other psychiatrists were framed as valuable clinical expertise.
2) Relevant data on electroshock danger (e.g., brain damage) or efficacy (e.g., sham studies) were consistently rejected as referring to the older way of shock, as opposed of course to the “newer, safer ECT.” It was befuddling to see them do this with the survivor testimony as well, even when it was from people who were shocked within the last 10 years.
3) Another key strategy for discounting challenge has been used over the years by psychiatry in response to our struggle to gain acknowledgment of the iatrogenic effects of various drugs—as in, suicide is not an effect of SSRIs but due to the underlying depression. They repeatedly used the same argument regarding electroshock. It is just an astoundingly effective mode of denial to interpret all treatment failure as progression of the disease. For these staunch psychiatric proponents of electroshock, there is absolutely no way to demonstrate the failure of electroshock. Any data showing failure, or “relapse” is immediately seen as the ongoing, chronic intractable nature of serious mental illness. Whereas it is clear to me that repeated, ongoing electroshock is one of the clearest indicators of utter failure and abject destruction, these industry people see maintenance ECT as a valuable, necessary method in their medical effort to treat very sick people. It is an utter nightmare to listen to these highly respected doctors rebut a challenge about the lack of long-term positive outcomes with electroshock, by explaining that it is unrealistic to look for long-term results with these very sick people. As panel psychiatrist Scott Kim said, they think they are working desperately hard on behalf of their patients to somehow at least temporarily interrupt the “trajectory of the illness.”
4) Coercion, the proverbial elephant in the room, was a hot potato as the courageous patient representative on the panel, Michelle Carras, raised the issue more than once. The psychiatrists reacted quickly in defense of coercion and jumping quickly away from that touchy subject. Dr. Kim clearly said “No” to real consent as he strongly defended the importance of surrogate consent for these poor sick patients. My own one regret about my testimony is that, while I told the panel about out Texas ban on electroshock for children, I somehow forgot to tell them that forced electroshock is also banned in Texas.
The Result
As I said above, from the perspective of this particular participant observer, it did not look good. At one point, as I sat out in the hall, one ally after another came out looking dazed or murderous as the case may be. It was extremely troubling to listen to the hearing. I felt like administering emergency CPR to each of these troubled souls.
Finally, on Friday afternoon it came to a vote. I was expecting the worst, but as each of the panel members expressed their recommendation on whether to reclassify the odious machines for the purpose of treating depression, we began hearing from members who had said very little during the hearing. Three or four of the first responders voted to keep the machines class III, and when Dr. Mary Gordon, an opthalmologist, gave an eloquent statement about the failure to demonstrate safety and long-term effectiveness, and especially about the clear evidence and deep concern about long-term memory loss, I felt for the first time like we would win. And we did, by a vote of 10 to 8.
The panel conversation had been dominated by the psychiatrists, and I had failed to realize that we would convince every one of the non-industry people of the panel that these machines were dangerous and did not merit reclassification. All five psychiatrists, the pharmacologist, and the device industry representative voted for Class II. The eighth vote was the anesthesiologist, which makes sense when you consider that anesthesiology is a huge part of the shock industry. Remember that 2 or 3 times a week, an anesthesiologist has a gig for every shock patient. (Dr. Gordon also wondered aloud about the dangers of frequent, repeated use of anesthesia and muscle relaxers, and whether adequate research had been done on that subject.) In any event, I am convinced that absolutely no evidence, and no stories of human destruction, could reach these people and put a dent in the massive denial that perpetuates their practice and defense of brain-damaging electroshock.
The astounding thing is that these true believers, despite decades of PR and hours of intense effort in this hearing, failed to sway even one of the non-industry people to their side. All ten voted to keep the machines class III. Neurologist David Good pointed to a huge disconnect between the reports of the psychiatric clinicians on the panel and the actual research, and challenged their profession to meet the same standard as other medical specialties. In defense of his profession, shock doctor William McDonald assured us all about his work that “it really is the practice of medicine.”
There were votes on five more diagnostic categories after depression, and for the next four—schizophrenia, bipolar manic, schizoaffective, and schizophreniform—we got an even greater majority on our side. It is disturbing that the panel vote shifted just enough on the last item, so-called catatonia, to result in a slim majority recommendation of class II for this diagnosis. I was dumbstruck when our panel heroine, patient representative Carras, flipped her vote, succumbing to the psychiatrists’ rhetoric about the necessity for extreme measures with this “terrible, life-threatening illness.” I can only imagine that she just could not quite hold up in the last moment to the intense pressure of repeatedly standing up to the judgment of the powerful industry people on the panel. How else can one explain this vote from a woman who had so diligently and bravely defended the interests of the people during this hearing? How could the one person who had challenged forced electroshock during this hearing fail to see that electroshock of anyone who is truly “catatonic” (mute and unresponsive) has to by definition be forced? So this is a complication for us now.
With sadness, frustration, and a shake of my head, I acknowledge here that they did get by on the question of efficacy. It seemed that most of the panelists accepted that electroshock was effective, at least in the short-term for depression, and seemed to some extent buy into the psychiatrists’ notion that short-term impact was all that could be expected. I really only heard one panelist, biostatistician Jonas Ellenberg, as totally clear that electroshock failed to meet standards of both safety and efficacy—he actually brought up the sham studies in his final statement. That most of them accepted the industry PR on efficacy is extremely troubling, and shows we still have a huge challenge ahead.
Nevertheless, of the 10 non-industry people on the panel, we got a 100% positive result. That is a remarkable accomplishment. The committee chair, neurologist Thomas Brott, seemed to me to be very sympathetic and supportive of the industry position. However, he also appeared to have some integrity. He said more than once that the committee was under pressure to do this right, largely due to public outcry. He was also quoted the next morning in the Washington Post (David Brown, 1-29-11) about the stunning failure over the last 70 years to do the research to address the question of electroshock and brain damage: “Panel Chairman Thomas G. Brott, a neurologist at the Mayo Clinic's campus in Jacksonville, Fla., said he was amazed that essentially no research had been done on ECT's effects using functional MRI imaging, repeated brain wave (EEG) studies, or autopsy examinations of patients.” This is a huge point as most of the non-industry panel who voted our way, even though acknowledging negative cognitive effects and memory loss as a key risk, at the same time managed to deny evidence of brain damage. I think part of this was the spell woven by psychiatric storytelling, arguing that electroshock causes changes in the brain, but that this is not evidence of damage; in fact, it might be very good. The concept of neurogenesis, or the development of neurons, is being touted as a likely positive result of electroshock. Again, we have a hard row to hoe.
In the end, Brott’s deciding vote was to keep the machines class III, although he made a point to say that he was confident that the industry could meet the PMA demand and convince the FDA to reclassify. It is impossible to know the hidden machinations of government and industry, and we certainly know better than to think we can rely on the FDA, in spite of some good people who work there, to protect the people. Still, I am fairly certain that the industry fully expected to win this hearing, and that we threw a very upsetting wrench into their PR machine. Let’s enjoy this victory and keep on with our powerful truth-telling and resistance!
I want everyone to know that the public testimony, including all the written submission, made a huge difference. Several of the panel members referred to it, and said they could not ignore the reality of frequent harm caused by this procedure. The introduction of testimony from the aforementioned patient representative Carras, in spite of bullying from Brott, on her review of hundreds of electroshock survivor stories from an internet website, amplified this point. This led to a rebuke of the committee on the issue of scorning “anecdotes” by psychologist Jane Paulsen, who gave them a brief lesson in the scientific value of qualitative research, letting them know that the evidence of harm clearly met the relevant research standard of “saturation.” Carras also pushed forward the notion, in the face of considerable resistance, that psychological trauma should be added as a key negative effect. It was actually somewhat enjoyable to watch the panel debate that one, as the psychiatrist members pushed for wording that for a small minority of people it could cause some distress...but the issue kept coming uncomfortably back, due to your powerful voices.
A Final Tribute and Final Word
My work is challenging psychiatric oppression. One source of my education on oppression theory is the Re-evaluation Counseling Community. From them I learned the term “targeted for destruction” to refer to specific groups (like young black men mass incarcerated in our so-called war on drugs) selected as targets of systematic oppression. The so-called mentally ill are another, and electroshock is the destructive mechanism of next resort after the drugs. I am in awe that, in the face of such terrifying experience as electroshock, the voices of the courageous and powerful electroshock survivors are the heart and soul of our cause. You are an ongoing inspiration and an awesome force for the good. You made the difference in Gaithersburg!
David Brown’s aforementioned article the next morning in the Washington Post featured a powerful quote from Evelyn Scogin, one of our heroic electroshock survivor activists: “I lost not only my memories of the time I was subjected to this torture but I was robbed of almost all memories from about 2003, two years before treatment, to 2008, three years after treatment stopped." Brown also told the bottom line: “An expert panel advising the Food and Drug Administration decided Friday that electroconvulsive therapy (ECT) machines should undergo the same rigorous testing as new medical devices coming onto the market - a decision that could drastically affect the future of psychiatry's most controversial treatment.”
John Breeding, PhD
Coalition for the Abolition of Electroshock in Texas
February 4, 2011