Posted by Phillipa on February 2, 2011, at 21:04:46
Seems a Chance that ECT could be discontinued as safe. Phillipa
From Medscape Medical News > Psychiatry
Does FDA Panel Recommendation Mean the Beginning of the End for ECT?
APA Fears For the Future of "Life-Saving' Treatment
Fran LowryAuthors and Disclosures
Information from Industry February 1, 2011 After a US Food and Drug Administration (FDA) panel's recommendation that electroconvulsive therapy (ECT) devices retain their high-risk class III classification, the American Psychiatric Association (APA) fears that the future of ECT for the treatment of severe, drug-resistant depression and other serious mental disorders is now in jeopardy.If the FDA decides to follow the advice of its Neurological Devices Committee, it means that the 2 companies that currently manufacture ECT machines would have 30 months to submit a premarket approval to show that the devices are safe and effective.
The continued availability of this life-saving treatment in the long-term lies in the hands of the FDA...We're pleased it wasn't taken off the market instantly but if new trials are going to be required, it's not clear who will fund them and whether they will in fact even be done.
ECT has been in use since before the FDA enacted new, more stringent laws for device approval, and psychiatrists fear that the logistics of conducting new trials will pose insurmountable problems for the manufacturers.They also doubt whether data from any new trial would be sufficient to convince a subsequent advisory panel of the efficacy and safety of the devices, long considered by the APA to be life-saving.
"It hasn't been yanked from the market right now," said Sarah H. Lisanby, MD, head of psychiatry, Duke University, Durham, North Carolina, and chair of the APA Task Force to Revise the Practice of Electroconvulsive Therapy.
"But the continued availability of this life-saving treatment in the long term lies in the hands of the FDA right now. We're pleased it wasn't taken off the market instantly, but if new trials are going to be required, it's not clear who will fund them and whether they will in fact even be done. This is the concern," she told Medscape Medical News.
Strong Evidence
In a statement released late last week, immediately after the FDA advisory panel's 2-day discussion about a possible reclassification of ECT devices, APA President Carol Bernstein, MD, declared that the association was optimistic that ECT would continue to be available as a treatment option for patients with debilitating illnesses.
"ECT is appropriate for a small percentage of patients, generally those with severe mental illnesses that have not responded to other treatments. When used properly, under the appropriate guidelines and by a well-trained psychiatrist, ECT is extremely safe and effective," said Dr. Bernstein.
Dr. Lisanby emphasized that strong evidence already exists for the safety and efficacy of ECT.
"There are long-term data that are published in the peer-reviewed medical literature on the safety and efficacy of ECT. For example, the Consortium for Research on ECT has published a series of studies sponsored by the National Institutes of Health.
"A recently published study with Charles Kellner as the first author found sustained benefit at 6 months after ECT in approximately half of people who had responded to the course of ECT. The studies show a remission rate of around 75% to 85%. Those people remain well at 6 months. That is long-term benefit," said Dr. Lisanby.
She added the FDA panel did not seem to be aware of the existence of this evidence. She also said that the panel appeared confused about the neuropathological effect of ECT.
Knowledge Gap Among Panel Members?
"The way that the literature on neurogenesis, which is the growth of new cells, was presented and reviewed seemed to lead to some confusion about whether this was a good or a bad thing," she noted.
The panel's advice to the FDA for the maintenance of ECT's class III high risk classification has many people worried.
"Antidepressant medications induce neurogenesis, and this is thought to be advantageous. ECT also does this and is the most robust inducer of neurogenesis known today, and yet when the data were considered by the panel they seemed to want more clarity about whether this was indicative of damage or whether this was a sign of therapeutic benefit."She believes it was difficult for many of the nonpsychiatrist panel members to comprehend all of the information that was presented at the hearing.
"Medical schools devote 2 or 4 weeks to their psychiatry rotation, so if that is all you've had then there is a learning curve to learn about psychiatric illnesses and treatment," she said.
"The same would be true for me if I were trying to master a different field. I'm concerned that the knowledge gap represents a challenge for the reevaluation of 7 decades worth of literature on this very important treatment."
High Stakes
The panel's advice to the FDA for the maintenance of ECT's class III high-risk classification has many people worried, Dr. Lisanby said.
No one is making a lot of money from ECT. It's about helping people through a crisis and being able to use the most effective means to do that. I don't know what we would do without ECT.
"I do think that it is a realistic concern that the FDA could restrict access to ECT, and this is distressing to many people. I specialize in the treatment of severe, resistant depression, and in my practice ECT is the last stop for patients who feel that they are at the end of their rope. Up until now I have had the wonderful privilege of being able to offer them ECT."There is a lot riding on the FDA's final decision, she added.
"A lot is at stake here. That is why I feel very passionately about it. It's not theoretical. No one is making a lot of money from ECT. It's about helping people through a crisis and being able to use the most effective means to do that. I don't know what we would do without ECT. I don't even want to go there."
poster:Phillipa
thread:978592
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