A divided FDA panel recommended that Electroshock machines should remain in Class III–FDA’s highest risk category for medical devices–and recommended that ECT machines undergo rigorous safety tests.
Below, an eyewitness report about the hearing in the Washington Post, and the comments by psychiatrist Dr. Peter Breggin, about the likely impact the panel recommendation will have.
Panel Chairman Thomas G. Brott, a neurologist at the Mayo Clinic, 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.
"I tried to look and saw very little. I concluded that the evidence is not there to decide either way," he said.
The absence of evidence, in the absence of a valid examination of the data, or failure to put the safety issue to scientific scrutiny, is NOT an indication of safety. By that logic,
However, his question–why has no research been done on ECT’s effects using MRI imaging, EEG brain waive studies, or autopsy examination of patients?– is worth probing. Especially, in light of the contentious battle about ECT’s safety between consumers who suffered the consequences, and ECT stakeholders.
The failure to conduct–or perhaps, more accurately, the failure to report–results from imaging studies and autopsy examinations, studies that would provide replicable, hard evidence of ECT effects on the Brain, demonstrates, we believe, that ECT promoters have evaded such studies for fear they would provide irrefutable documentation about ECT’s brain damaging effects.
Vera Hassner Sharav
Washington Post
FDA panel advises more testing of ‘shock-therapy’ devices
By David BrownFriday, January 28, 2011
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.
The majority of the 18-member committee said not enough is known about ECT, also known as "electroshock" or simply "shock" therapy, to allow the devices to be used without more research into its usefulness and hazards.
If the agency follows the panel’s advice, which it usually does, the two companies whose machines are used in the United States will have to provide evidence of the therapy’s safety and effectiveness either from existing research or new studies. If the FDA isn’t convinced, the devices could be removed from use.
The panel’s opinion is the latest chapter in ECT’s seven-decade history, during which the treatment has been lauded as a lifesaver, villified as a form of legally sanctioned torture, and has seen its popularity rise in recent years after a long decline.
ECT machines deliver an electrical current to the brain, inducing a generalized seizure in which the patient briefly loses consciousness. How that may be therapeutic or cause permanent memory loss – the side effect most frequently mentioned by patients – isn’t known.
About 100,000 Americans undergo ECT each year, usually getting about a dozen treatments over several weeks. Some then get "maintenance" ECT every few weeks, as the therapeutic effect, when it occurs, often doesn’t last. The treatment is most often used for depression and has also been prescribed to patients with schizophrenia, catatonia, and more recently, to some violent children with autism.
"It was the best possible outcome we could have gotten," said John Breeding, 58, a clinical psychologist from Austin who says the procedure should be banned. He testified before the panel at a two-day meeting in Gaithersburg.
For some patients, ECT epitomizes what they view as the coercion and lack of respect for the patient’s point of view that is unique to psychiatry. That’s also largely how it’s been depicted in popular culture, most famously in the book and film "One Flew Over the Cuckoo’s Nest," where it was a tool of punishment and social control of mental patients.
"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," testified Evelyn Scogin, a special-ed teacher who got ECT after a suicide attempt. Her statement was read by a friend because Thursday’s snowstorm stranded her in the Charlotte airport.
Other patients described ECT as a lifesaving, if mysterious, treatment worthy of wider use.
Among them was Kitty Dukakis, the 74-year-old wife of 1988 Democratic presidential nominee and former Massachusetts governor Michael Dukakis. She first got ECT at age 63, and continues to get it once a month.
"It is not an exaggeration to say that I don’t think I would be alive without ECT. It has been a miracle in my life," she said.
One proponent, a nurse from Baltimore, drove through the snow on her day off to read a grateful Christmas card from a patient, choking up as she did.
"I actually think it’s more controversial than abortion," Amy Lutz, a 40-year-old mother of five from Villanova, Pa., said of ECT, which her 12-year-old autistic and manic-depressive son gets regularly.
She brought with her two poster-size photographs of the boy, his face and hands bloodied from self-inflicted blows. She told the committee that ECT, tried after a half-dozen other therapies, stopped the violent behavior and increased her son’s achievement in school.
A 1976 law requiring safety and effectiveness of all new medical devices permitted ones in longstanding use, including ECT machines, to stay on the market. Later, however, Congress told the FDA that those grandfathered-in devices either had to undergo rigorous testing or be officially "reclassified" as already-proven to be safe and effective (although, in some cases with special warnings about their use).
In addition to patient testimony, the advisory panel heard FDA staffers describe their analysis of hundreds of ECT studies.
As a group, the studies tended to be poorly designed and with too few patients to allow the drawing of firm conclusions. Many failed to follow patients long enough to discover the duration of ill effects. Ones done decades ago studied techniques and electricity dosages different from current practice.
The FDA staff reported the existing research suggests that for depression, ECT is more effective than placebo or "sham" shocks and after a month more effective than antidepressants.
In terms of hazards, the FDA staff’s review found the treatment is associated with "impairment in orientation, memory and global cognitive function immediately after ECT and up to 6 months." Certain aspects of memory may return to baseline after six months. "Autobiographical memory" – recollection of events in one’s life – appears to be at greatest risk. High-dose electric current and current applied to both sides of the brain are associated with more thinking and memory problems.
Panel member Christopher A. Ross, a psychiatrist and neuroscientist at Johns Hopkins University, asked if the published studies identified any risk factors that predisposed patients to memory loss and thinking impairment.
"Evidence-based data for that issue just doesn’t exist," said Peter G. Como, a neuropsychologist at the FDA.
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.
"I tried to look and saw very little. I concluded that the evidence is not there to decide either way," he said.
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THE HUFINGTON POST
January 28, 2011 05:42 PM
FDA Panel Recommends Testing of ECT Machines
Friday afternoon, January 28, 2011: The FDA’s panel for electroconvulsive therapy (ECT) voted to place ECT machines in Category III for all but one indication. If the FDA accepts the panel’s recommendation, the agency will require testing for all uses except "catatonia" which was recommended for Category II, requiring less stringent testing.
A tiebreaker by the chair was needed to propose putting ECT machines into Category III for depression. Given acute trauma caused by the treatment and the evidence for long-term memory and cognitive problems, it reflects poorly on the panel that the vote was so close.
The use of ECT for catatonia was recommended for Category II, apparently on the grounds that nothing else works for that disorder. According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR, 2000), the qualifier "with catatonic features" can be applied to Major Depressive Disorder or Bipolar I and II. It is also a type of schizophrenia.
If the diagnosis of catatonia is given this loophole, we will see more and more people diagnosed with this disorder. It will be a potential medical disaster because most catatonic-like states are now caused by drug toxicity, including neuroleptic malignant syndrome from the antipsychotic drugs and serotonin syndrome from the serotonergic antidepressants. I have been a medical expert in malpractice cases in which clinicians have mistaken these toxic syndromes for psychiatric disorders, resulting in chronic disability or death from lack of proper treatment. I predict that thousands of patients who need treatment for psychiatric drug toxicity will instead end up on the shock table.
On top of that, as the panel apparently recognized, there are no credible studies of ECT for catatonic features or catatonic schizophrenia. It’s a very obscure disorder, but it will become a widespread disorder in order to justify shock treatment. It’s similar to what happened to children: massively increasing the diagnosis of bipolar disorder to justify giving them adult mood stabilizers and antipsychotic drugs.
It is scientifically unsound to act as though ECT causes serious safety risks with one disorder but not another. In all cases, the same traumatic doses of electricity are being given to the brain. The claim that there are no other effective treatments for catatonia, whether true or false, should never be used to justify a failure to test a device or drug for safety.
The reasonable and ethical approach for the FDA would require the agency to call for the phasing out of ECT over a period of months while developing protocols for testing ECT machines. It should begin with Phase I studies, like any other dangerous treatment, and first be tested on animals. All prior large-animal studies such as monkeys, cats and dogs have demonstrated brain damage in the form of small widespread hemorrhages and/or cell death. My earlier blog about these hearings provides citations to these studies. The animal studies can also be found in the bibliography on my website and in my book Brain-Disabling Treatments in Psychiatry, Second Edition (2008, pp. 237-241). If these studies are reconfirmed, then ECT should be stopped without further testing on humans.
Nothing would be lost by not giving ECT during the testing period. Many doctors never give ECT and never refer patients for ECT, and there’s no evidence that this deprives patients of a useful treatment. After all, there’s no substantial proof of efficacy and considerable proof of brain damage and long-term cognitive problems.
Unfortunately, the FDA is already waffling about whether or not it will in fact require the usual testing for Category III devices. In response to questions at the hearing, the agency staff said it was not certain whether a Category III designation for ECT would require the same rigorous testing routinely carried out for safety and efficacy. No one on the panel seemed to think the treatment should be phased out until safety and efficacy were proven.
Psychiatric reform moves ahead a step at a time, falters, and hopefully moves ahead again. The classification of ECT into Category III for most conditions, which at this point is only a recommendation, is a step forward and a somewhat positive sign to those of us who have called for this for decades. We hope the FDA will uphold its obligation to the public to thoroughly test such a dangerous device for safety and efficacy.
Peter R. Breggin, MD is a psychiatrist in private practice in Ithaca, New York, and the author of dozens of scientific articles and more than twenty books. His first medical book was about ECT: Electroshock: Its Brain-Disabling Effects (Springer Publishing Company, New York, 1979). His most recent medical book dealing with ECT is Brain-Disabling Treatments in Psychiatry: Drugs, Electroshock and the Psychopharmaceutical Complex (2008). Dr. Breggin’s professional website is www.breggin.com.