Measuring the risk of ECT machines

UPDATE ON STORY–link here
This week, the FDA is re-evaluating the risk classification for electroshock devices/ECT machines, which is currently classified as high-risk. American Psychiatric Association and other specialists wants to see the devices downgraded to a medium-risk category, which would mean that 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. While that may often be the case, the road to actually getting there is filled with mixed comments from both sides.

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.” (from NYTimes, FDA is Studying the Risk of Electroshock Devices)

While I don’t know if a syringe and a ECT machine have comparable risk factors, I can think of things like scalpels that could potentially cause huge physical harm. All I’m hoping for is that the FDA gives a ruling that would keep the option of electroconvulsive therapy open to all patients that are considering this treatment.

UPDATE (1.28.2011): FDA panel wants more testing

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