FDA revisits risks of electric shock treatment

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They used to call it “Edison’s medicine” or, with a touch of gallows humor, a “Georgia Power cocktail” — the practice of hooking mentally troubled patients up to an electrical current and jolting them until they went into convulsions.

Pioneered in the late 1930s, electroshock therapy, as it was more commonly known, was a scientifically crude practice that often left patients dazed and disoriented, sometimes with broken bones. For many it became a symbol of the callousness that often characterized the treatment of the mentally ill.

But that was then. Though its use waned as a result of reformers’ attacks and the development of powerful drugs that offered an alternative treatment, electric shock therapy never entirely disappeared. The controversy over its use resurfaced in January when an advisory panel of the Food and Drug Administration met to consider a proposal for changing the official risk classification of today’s electroshock devices.

Influential voices in the mental health establishment, including the American Psychiatric Assn. and the National Alliance on Mental Illness, urged the FDA to drop such devices into a medium-risk category, arguing that modern electroconvulsive therapy, or ECT, as it’s now known, has proved safe and effective over many years of use.

Although medical science still doesn’t understand exactly how it works, modern versions of the treatment offer the last, best hope of patients suffering from extreme depression and several other intractable psychiatric disorders, proponents say.

About 100,000 people, two-thirds of them women, are thought to receive such treatment annually.

“For a very small population of severely depressed people, there’s no other form of treatment like ECT,” said Roberto Estrada, chief of electroconvulsive therapy services at New York’s Lenox Hill Hospital. “It’s for patients who are beyond the reach of conventional psychotherapy and who don’t respond to drugs.”

Others remain sharply critical of the treatment, calling it dangerous, ineffective and often harmful.

“The classification should not be downgraded, and there should be a suspension of its use until it’s proven safe,” said Daniel Fisher, a Boston psychiatrist who argues that the jolts of current cause permanent brain damage. “To me, it’s unbelievable that they’re considering downgrading it. It would be putting it in the same classification as a wheelchair or a syringe.”

In January, after two days of hearings by the FDA advisory panel, 10 members favored keeping ECT equipment in the high-risk category, while eight favored ranking it a medium-risk device for treatment of depression. The panel also favored keeping the device’s high-risk rating for treatment of schizophrenia.

Most panel members agreed that ECT works to relieve acute depression in most patients, at least in the short run. But they were concerned about a lack of studies documenting safety and effectiveness over the long haul.

“The indications are all chronic conditions that are mostly lifelong, and for us not to have data in hand [for] a reasonable assurance of safety and efficacy long-term I think is a major failure,” said panelist Mae Gordon, a professor at the Washington University School of Medicine in St. Louis.

An advisory panel’s findings are not binding, though the FDA usually follows them.

At its core, ECT remains a mystery more than 70 years after its first use.

“We know that it does work, but we don’t know specifically how,” said William Narrow, an associate director of research at the American Psychiatric Assn.

It’s that combination of effectiveness, at least in extreme cases, and doctors’ inability to explain how it works that have kept both the treatment and the controversy alive.

In today’s version of ECT, an electrical current is applied to one side of the head, triggering a convulsion similar to a grand mal epileptic seizure that lasts for up to a minute. A typical course of ECT involves six to 12 sessions over three to five weeks.

Each session costs $1,000 to $2,000, and an ECT device, about the size of a bulky briefcase, runs about $15,000.

In contrast to the form of electroshock used half a century ago — the treatment that produced the stereotypical images of straining, violently convulsed patients — present-day ECT is given under general anesthesia and with muscle relaxants.

“Unless you were watching the EKG or the EEG, you wouldn’t know that the person’s actually gotten the shock,” said Larry Tye, a journalist who witnessed the ECT treatments of Kitty Dukakis, wife of former Massachusetts Gov. Michael S. Dukakis. Tye and Kitty Dukakis co-wrote a book about the benefits of electroshock therapy.

Modern ECT uses a far lower dose of electricity — enough to light a 25-watt bulb for one second — than the earlier procedures. To reduce chances of memory loss, it’s no longer administered to both sides of the brain.

One key point of contention between supporters and opponents is the scope and duration of memory loss. While the loss is temporary in most cases, doctors say, some patients report permanent memory deficits.

Tye said he found people who lost so much memory that they became stout opponents of ECT. Others regarded their loss as an acceptable tradeoff for feeling better.

Whatever the risk-benefit calculations of individual patients now, electroshock still carries historical baggage.

In early years, convulsing patients sometimes turned blue or broke teeth or bones.

And practitioners sought to apply it to a range of what they perceived as problematic conduct, leading to the spread of electroshock not just through mental hospitals but into prisons, where it was used as punishment as well as a way to modify behavior of troublesome inmates.

At the Georgia State Sanitarium, then the largest mental institution in the United States, inmates in the 1940s received the Georgia Power cocktail merely for being uncooperative.

The misuse also extended to psychiatrists groping for treatments for hard-to-reach patients.

“For years it was a voodoo treatment that was used for practically everything because it was all we had,” said Julia Frank, a professor of psychiatry at the George Washington University School of Medicine. She noted that anti-psychotic drugs didn’t begin to appear until the early 1950s, and antidepressants didn’t come along until later that decade.

ECT’s bad reputation was further tarnished in the 1975 film “One Flew Over the Cuckoo’s Nest,” the movie adaption of the Ken Kesey novel. The nonconformity of Randle McMurphy, the free-spirited mental patient played by Jack Nicholson, earned him electroshock sessions and eventually a lobotomy.

Only two small companies, Mecta Corp. of Lake Oswego, Ore., and Somatics of Lake Bluff, Ill., make the ECT devices. Officials at both companies declined to comment on the FDA review.

Some advocates of ECT worry that if the equipment stays in the high-risk category, manufacturers won’t be able to afford new testing.

But most panelists seemed confident that ECT would survive.

“We’re not going to be shutting down ECT. We’re not going to be taking a device off the market,” said Jane Paulsen, a psychology professor at the University of Iowa who recommended keeping the high-risk designation.