FDA May Zap Testing Requirement for Shock Therapy Devices

Electroshock therapy, a long-controversial practice that has grown more accepted in medical circles in recent years, may soon get a new jolt of momentum.

As The New York Times reports, the Food and Drug Administration is considering lowering the official risk classification for electroshock devices from high risk to medium risk. It would mean that at least some new electroshock devices could be approved without testing.

An FDA advisory panel is to consider the matter later this week. The proposed downgrade has the support of American Psychiatric Association.

While the therapy is subject to heated opinions, it has grown in popularity. An estimated 100,000 Americans receive electroshock therapy in more than 1,000 hospitals annually, typically for cases of major depression.

Opponents say, however, that the therapy can cause brain damage and memory loss.

“It’s all trial and error — it’s all experimental,” said Vera Hassner Sharav, president of the New York-based group Alliance for Human Research Protection. “All the years it’s been controversial and there have not been clinical trials. Why not?”

Electroshock supporters counter that the therapy can be invaluable, and the lack of research reflects insufficient funding to carry out the costly trials, rather than a plot to hide the dangers.

“It’s a treatment for the most severe form of depression,” said Dr. Charles H. Kellner, a researcher a Mt. Sinai School of Medicine. “It can really be life-saving.”

Electroshock therapy uses jolts of electricity to provoke brain seizures in anesthetized patients. In 1990, the FDA considered designating electroshock therapy as safe for the treatment of depression, but retreated amid a harsh outcry from opponents of the practice.

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2 comments to “FDA May Zap Testing Requirement for Shock Therapy Devices”

  1. carolyne Eisler

    I would like to know, if this like the old style treatments. And is in more
    humane then 30 years ago.? Thank you.
    Carol Eisler

  2. Norman

    Carolyne, I believe it’s worse than before because they sedate and relax your mind and muscles so no one can see the seizure, which looks better, but then they have increased the electricity way more than what they used to do. So it looks better when in fact it is actually more brain damaging then before. Remember that all of the rest of medicine tries to stop and control seizures because of brain damage while this treatment is specifically for causing seizures, even if you can’t see them anymore. It’s a closed skull head injury, which causes memory lose, lose of ability, like playing music, and for some permanent seizures, high blood pressure etc. It’s always been a nasty treatment and to not require the studies to prove it’s safety after all these years will be a betrayal to the people.

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