F.D.A. Is Studying the Risk of Electroshock Devices ECT

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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 and

convulsions 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. 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. 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. 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. 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. 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. 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, Read of the University of Auckland,

New Zealand, and 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.

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. "

http://www.nytimes.com/2011/01/24/business/24shock.html