GAITHERSBURG, Md. -- The FDA should continue to regulate electroconvulsive therapy (ECT) machines as high-risk devices for treating depression and most other conditions for which ECT is typically used, members of the agency's Neurological Devices Advisory Committee agreed.
No formal vote was taken, but a majority of members supported keeping ECT devices for most indications as Class III -- the highest-risk category -- in the FDA's regulatory structure for medical devices, an FDA spokeswoman said.
There was one exception, she said. Panel members were divided on whether ECT devices could be reclassified into the moderate-risk Class II for treating catatonia or whether they should stay in Class III for that indication.
ECT devices are already considered Class III, but the FDA has never developed standards for approving new machines with the premarket approval (PMA) process that is supposed to be used for high-risk products. Instead, the agency has cleared new models under the 510(k) process that merely requires manufacturers to demonstrate that the products are "substantially equivalent" to devices already on the market.
In 2009, the Government Accountability Office (GAO) recommended that the 510(k) process not be available for Class III devices. Such devices, the GAO said, should either be reclassified into the less-risky Class II category or else their manufacturers should have to go through the PMA process, which typically requires clinical safety and efficacy testing.
Consequently, the FDA was seeking guidance from its neurological devices advisory panel on whether ECT equipment deserved a lower-risk classification. Earlier in the week, the agency posed a similar question to its cardiology devices committee regarding automated external defibrillators. (Answer: no.)
ECT has been shown to be highly effective for treating acute, severe unipolar and bipolar depression and is also approved for schizophrenia, bipolar mania, schizoaffective and schizophreniform disorders, and catatonia.
On the other hand, the treatment has been controversial almost since it was first introduced in the 1930s. Patients complained of persistent adverse effects such as memory loss and cognitive dysfunction. Although protocols have changed dramatically since then, and adverse event rates in systematic analyses have plummeted, the complaints have not gone away completely.
Advocacy groups opposed to ECT urged the FDA not to reclassify the devices out of Class III. A briefing document prepared by FDA staff included a long list of known risks associated with ECT, ranging from skin burns and oral fractures to stroke and death.
The agency is not required to follow the advice of its advisory committees, but it usually does.
One middle-ground option available to the FDA is to reclassify the devices as Class II, but require so-called special controls, such as restrictions on which physicians may apply ECT, or more detailed instructions on how the devices should be used.
TESTIMONY BEFORE THE NEUROLOGICAL DEVICES PANEL OF THE MEDICAL
DEVICES ADVISORY COMMITTEE
DOROTHY WASHBURN DUNDAS
I have been waiting 50 years to give this testimony before those of you who have the power to make a humane difference. When I was 19 years old, I became sad and lonely and tried to kill myself. I swallowed one-half bottle of Aspirin. My parents took me to the Massachusetts General Hospital, and thus began my three-year hellish odyssey as a prisoner in the horrors of the mental health system.
I was transferred to Baldpate Hospital, diagnosed with schizophrenia and given 50 shock “treatments” against my will - 40 insulin comas and 10 superimposed electroshocks. Very early on the dark winter mornings of 1961, three other teenaged girls and I were awakened, dressed in johnnys, and told to lie flat on our beds which were lined up right next to each other. We were then injected with insulin, and on ten of
those mornings a dark-suited man would walk through the door. He carried all his equipment in a small black suitcase in one hand, this man of death and destruction. He set up his machine behind our heads, one by one. We were curled up beneath our sheets, as though seeking womb-like protection, when they peeled the sheets off of us, forcing us onto our backs, bare and open and vulnerable. I was second in the line-up.
Before being turned, I would often peek out from a small, secret opening in my sheet to see what they were doing to Susan, the first to receive the treatment. I would make myself watch as if it might prepare me in some way. And when she would shake violently all over, I could no longer watch. I would shiver beneath my sheet in fear. And then they would come to me. I can still feel the sticky, cold jelly they put on my temples. My arms and legs were held down. Just before he pushed the shock button, he would ask, “Is everybody ready?” Of course, he was not speaking to me - petrified and stone silent. Each time, I expected I would die. I would wake up with a violent headache and nausea. My mind was blurred. And I permanently lost eight months of my memory for events preceding the shock treatments. I also lost my self-esteem. I had been crushed as flat as a pancake. But I was very, very lucky. On one of those cold, winter mornings exactly fifty years ago my friend Susan never woke up after the shock. She had just turned seventeen. When she died, she became a part of me.
The ECT was a violent and damaging assault on my brain and my very soul. It made me emotionally worse, not better. I became catatonic and desperately in fear for my life.
EFFECTS OF ECT:
-----To this day, I have great trouble staying focused in a conversation, keeping my train of thought.
-----I forever lost the ability to do math in my head. Before that time, I had done very well in school.
-----When I was given an IQ test a few months after the ECT and asked the population of the USA, I answered 1,000. When he asked me to guess again, I answered 2,000. I remember having no idea where to find the answer in my head.
-----For me, in addition to losing my train of thought, the most troubling residual effect, by far, has been the memories of those traumatic mornings, the violent and abusive assaults on my brain.
For far too long there has been a collusion between the FDA, the APA, the AMA, and the companies which manufacture the shock machine. This is big business, and a lot of money is being made by many at the shameful expense of those who have been harmed over the years. To me, informed consent is meaningless. Those of us who have already experienced the ECT are the only truly informed. Right now, this is a human rights issue. And this is a torture issue.
In the end, after three years of hell, it was a kind young doctor, who spoke to me in a gentle voice, who gave me hope. He took me off all medication, expressed horror when hearing of my experience with ECT, and recognized that whatever my original problems had been, they were dwarfed by the magnitude of the subsequent ECT trauma. I am the person I am today because of his compassion and caring 47 years
ago. Quite simply, he believed in me.
I urge you to BAN the use of this dangerous and barbaric machine, and by doing so finally to show the courage and understanding to support the many more humane and holistic approaches to healing emotional pain.
Dorothy Washburn Dundas
15 Moreland Avenue
Newton, MA 02459
Read the entire Mindfreedom report Here
Now, for the unquestionable Pick of the Coverage Litter the Huffington Post has Dr Peter Breggin:
Monday, January 31, 2011
Tuesday, January 25, 2011
FDA To Review Safety Of Electroshock Devices
The classification of Electroshock machines will be the focus of an FDA advisory committee hearing this Thursday and Frida, Jan. 26 & 27.
As noted by The New York Times (below) the hearing has reignited a contentious 50 year + debate about ECT's safety and efficacy.
Once again, the powerful psychiatric lobby will join Electroshock device manufacturers in their effort to reclassify ECT machines from Class III, to Class II (benign risk)--in order to thwart a requirement for tests to determine whether ECT devices are safe for human application.
The catalyst for this hearing is a Government Accountability Office recommendation in 2009 that high risk medical devices--such as electroshock machines, pacemaker electrodes, implanted blood access devices that had not undergone a stringent approval process-- should undergo proper safety tests, or--if deemed appropriate--should be reclassified as medium or low risk.
The ECT literature is almost entirely corrupted by conflicts of interest--those who claim that ECT is "safe and effective" are the authors of self-serving, biased reports.ECT proponents have indisputable financial stakes that collide with patients' best interest.
“ This study provides the first evidence in a large, prospective sample that the adverse cognitive effects can persist for an extended period, and that they characterize routine treatment with ECT in community settings.”
“It’s all trial and error — it’s all experimental," said Vera Hassner Sharav, president of the Alliance for Human Research Protection, an advocacy group in New York. "All the years it’s been controversial and there have not been clinical trials. Why not?”
ECT practitioners operate in an unregulated, Devil-May-Care culture--psychiatry has the dubious distinction of disregarding the harm its "treatments" cause patients.
Proponents of ECT proponents--i.e., device manufacturers, practitioners and organized psychiatry--dismissively deride patient testimonies, as if their first-hand experience isn't valid. But in reallity, the most compelling testimony in opposition to ECT is the testimony of the eye witnesses--the patients whose memory and cognitive function has been damaged.
"only very minimal evidence for improvement during the treatment period and no evidence for improvement afterward....no evidence that ECT prevents suicide."
"strong evidence" for "persistent and, for some, permanent brain dysfunction." They concluded that"the cost-benefit analysis for ECT is so poor that its use cannot be scientifically justified."
They further stated, "The continued use of ECT therefore represents a failure to introduce the ideals of evidence-based medicine into psychiatry."For the FDA to consider reclassifying ECT devices to Class II--the FDA would have to assert that ECT's safety can be assured by specified safeguards which would include the mandatory maintenance of records on the devices, labeling, performance standards or practice guidelines for use, and post-market surveillance such as patient registries.
by Vera Hassner Sharav
January 23, 2011
F.D.A. Is Studying the Risk of Electroshock Devices
By DUFF WILSON
Federal regulators are weighing whether to downgrade the risk classification of electroshock devices, reinforcing what many psychiatrists consider a deepening acceptance of electroshock in modern therapy.
The procedure has had a resurgence in recent years. And an estimated 100,000 Americans — two-thirds of them women — undergo the treatment for major depression and other illnesses each year. Patients, anesthetized, receive a jolt of electricity from electrodes for several seconds, inducing a brain seizure andconvulsions of up to a minute.
The American Psychiatric Association and other leading specialists are recommending that the Food and Drug Administration downgrade the devices to a medium-risk category from high risk, a move that will be reviewed by an agency advisory panel in Gaithersburg, Md., this week.
To some extent, the review has renewed the debate over electroshock. In 1990, F.D.A. staff proposed declaring the devices safe for major depression, but never took final action amid an uproar by opponents.
If the F.D.A. downgrades the devices to a medium-risk category, the equipment could be promoted and sold without new testing. Such a downgrade would place the devices in the same risk category as syringes and surgical drills.
If the F.D.A. leaves the devices in the high-risk category, however, manufacturers may, depending on the agency, have to withdraw them from the market.
The F.D.A. could require safety and effectiveness tests that have not previously been done. By regulating the devices, the F.D.A. is indirectly regulating the procedure.
The agency could make a formal decision later this year. The F.D.A. usually, but not always, follows recommendations of its advisory panels.
Supporters, including mainstream psychiatrists, say the treatment is much safer than it once was and could pass a rigorous F.D.A. review. But they assert that the device manufacturers cannot afford those tests.
“These tend to be mom-and-pop operations,” said Dr. Matthew V. Rudorfer, a psychiatrist and top specialist at the National Institute of Mental Health. “So I think the dilemma might be that undergoing new expensive clinical trials might be too expensive.”
Opponents, including some groups of former patients, maintain that electroshock can cause memory loss and brain damage that outweigh its short-term benefits.
“It’s all trial and error — it’s all experimental,” said Vera Hassner Sharav, president of the Alliance for Human Research Protection, an advocacy group in New York. “All the years it’s been controversial and there have not been clinical trials. Why not?”
Only two manufacturers, Somatics L.L.C. of Lake Bluff, Ill., and the Mecta Corporation of Lake Oswego, Ore., make the devices in the United States. The F.D.A. has asked them to submit all safety and effectiveness information as part of an agency review to be released before the advisory committee meeting beginning on Thursday.
Dr. Richard Abrams, who founded Somatics in 1983 with Dr. Conrad M. Swartz, and has written a textbook on electroshock, wrote the F.D.A. to say that none of his patients in more than 10,000 sessions over three decades had reported prolonged memory loss.
Dr. Swartz, who, like Dr. Abrams, is a retired psychiatry professor, said in an e-mail that any cognitive side effects from Somatics’ latest device “are distinctly less than they had been.” But he said Somatics could not afford an in-depth safety study that the F.D.A. could require if it left the devices in the high-risk category. That could cost millions of dollars.
“There is not nearly enough money in this industry to begin to pay for clinical trials that would be substantially larger than those already in the medical scientific literature,” Dr. Swartz wrote.
Mecta would not comment. “We always get negative press,” said a woman who answered the telephone at the company’s headquarters and did not give her name. “Too bad, because it’s good equipment.”
Somatics and Mecta each have annual revenue exceeding $1 million, according to Dun & Bradstreet. Dr. Swartz, asked about the revenue figure, said Somatics, like Mecta, was a private company. Their Web sites do not list prices or sales figures.
More than 1,000 hospitals and outpatient clinics in the United States use the two companies’ devices, according to Dr. Charles H. Kellner, a leading researcher, professor and chief of geriatric psychiatry at Mount Sinai School of Medicine in New York.
“It’s a treatment for the most severe form of depression,” Dr. Kellner said. “It can really be life-saving.”
The F.D.A. review was recommended by the Government Accountability Office in 2009 as part of an examination of the regulatory status of electroshock and about 20 other less controversial medical devices, like pacemaker electrodes and implanted blood access devices for hemodialysis. They were grandfathered into F.D.A. regulations when the agency was given more authority over medical devices in 1976.
The G.A.O. said those devices should go through the stringent approval process for high-risk devices or be reclassified as medium or low risk. A medium-risk designation could include adding controls like performance standards and patient registries.
The treatment costs $1,000 to $2,500 a session, and typically involves three sessions a week for two to four weeks, Dr. Kellner said. The fee includes the services of a psychiatrist and anesthesiologist. The equipment itself costs about $15,000 and may last years.
Patients are given short-term full anesthesia, a powerful muscle relaxant to prevent pain and subdue convulsions, and a mouth guard. The electrical current causes a grand mal seizure with convulsions usually lasting less than a minute, doctors say. Five to 10 minutes later, the patient awakens and can usually go home within two hours.
A federally financed study in 2007 found long-term memory loss and other cognitive problems, especially for female patients, from the treatment at seven New York facilities. The study, of 347 patients, was the first such large-scale study of side effects, despite what its authors called “over 50 years of clinical use and ongoing controversy.” The study also said methods and voltage varied widely among practitioners.
Dr. Rudorfer, associate director of treatment research in a division of the National Institute of Mental Health, says modern electroconvulsive therapy, or E.C.T., as its supporters prefer to call it, is much better than earlier practices, like those portrayed in “One Flew Over the Cuckoo’s Nest.”
“As surprising as it might seem, it never went away,” Dr. Rudorfer said of the treatment. “The field has had ample opportunity to get rid of E.C.T. and it’s still with us because it seems to occupy a small but important niche in treatment.”
But Dr. Rudorfer and other scientists still do not know just how the treatment or brain seizures act to improve moods. “We’re still looking,” he said. “It’s been very difficult to tease out the ‘active ingredient’ from among the many changes in the brain that accompany having, and stopping, the therapeutic seizure activity.”
Patients appear to have mixed views, judging from comments to the F.D.A. and electroshock-related Web sites. Some say it saved their lives, some say they suffered too much memory loss, and some say both.
In addition to its use in cases of severe depression, the treatment is used in some cases where speed is essential, like psychosis or suicidal behavior, for catatonia and in elderly patients who take so many other drugs that they cannot safely add a powerful psychiatric drug.
Dr. James H. Scully Jr., medical director and chief executive of the American Psychiatric Association, wrote the F.D.A. recently to say the treatment was “extremely effective and safe.” It provides relief some 80 percent of the time, he wrote. Dr. Scully and the psychiatry association also say there is no evidence it causes brain damage.
A task force is updating the association’s 2001 recommendations on the treatment. Its report is at least a year away.
“People use it because it works,” said Dr. Laura J. Fochtmann, a member of the task force, professor and director of the Electroconvulsive Therapy Service at Stony Brook University Medical Center, Long Island.
“These disorders can be extremely life-threatening, and when it works, it can be dramatically effective,” she said.
Opponents of electroshock include some patient advocacy groups, but the opponents, clearly, are outnumbered among physicians.
Dr. Peter R. Breggin, author of more than a dozen books including one about electroshock and a consultant in personal injury cases involving drugs and the therapy, says he is the only American psychiatrist he knows who opposes the treatment.
“It’s a big money-maker,” he said. “I would say if anything it’s been on the increase because there’s a market that’s been exploited, that is the elderly depressed women on Medicare. The reason for that is they’re covered, and there’s no one to protect them. What commonly stops shock treatment is a family member saying ‘over my dead body.’ ”
Depressed older people, Dr. Breggin said, can be helped more by a pet or conversation.
Last year, two psychology professors, John Read of the University of Auckland, New Zealand, and Richard Bentall of Bangor University, Wales, criticized electroshock after reviewing studies comparing it with simulated treatment. Their findings were published in Epidemiologia e Psichiatria Sociale, a peer-reviewed European psychiatric journal. “The cost-benefit analysis is so poor that its use cannot be scientifically justified,” Dr. Read wrote in an e-mail.
John Breeding, a psychologist and member of the Coalition for Abolition of Electroshock in Texas, said that state had banned electroshock for youths under 16 and required second opinions for treating the elderly, giving it the strictest rules in the nation.
“It’s a very strong treatment for despair and hopelessness,” he said. “It’s a temporary blunting of your feelings, so you feel better for a while, then you feel worse, and now you’ve got the memory loss and brain damage.”
Epidemiologia e Psichiatria Sociale, 19, 4, 2010
The effectiveness of electroconvulsive therapy: literature reviewJOHN READ and RICHARD BENTALL
SUMMARY. Aim – To review the literature on the efficacy of electroconvulsive therapy [ECT], with a particular focus on
depression, its primary target group. Methods – PsycINFO, Medline, previous reviews and meta-analyses were searched in an
attempt to identify all studies comparing ECT with simulated-ECT [SECT]. Results – These placebo controlled studies show minimal
support for effectiveness with either depression or ‘schizophrenia’ during the course of treatment (i.e. only for some patients,
on some measures, sometimes perceived only by psychiatrists but not by other raters), and no evidence, for either diagnostic group,
of any benefits beyond the treatment period. There are no placebo-controlled studies evaluating the hypothesis that ECT prevents
suicide, and no robust evidence from other kinds of studies to support the hypothesis. Conclusions – Given the strong evidence
(summarised here) of persistent and, for some, permanent brain dysfunction, primarily evidenced in the form of retrograde and
anterograde amnesia, and the evidence of a slight but significant increased risk of death, the cost-benefit analysis for ECT is so
poor that its use cannot be scientifically justified.
Declaration of Interest: Neither author has any financial conflicts of interest in relation to this paper.