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

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http://www.nytimes.com/2011/01/24/business/24shock.html?pagewanted=all

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

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.”