FDA Panel Recommends Testing of ECT Machines - more data

[Guest guest]

Dr. Breggin

reform psychiatrist

Posted: January 28, 2011

05:42 PM

FDA

Panel Recommends Testing of ECT Machines

Friday afternoon, January 28, 2011: The FDA's panel for

electroconvulsive therapy (ECT) voted to place ECT machines in

Category III for all but one indication. If the FDA accepts the

panel's recommendation, the agency will require testing for all

uses except "catatonia" which was recommended for Category II,

requiring less stringent testing.

A tiebreaker by the chair was needed to propose putting ECT

machines into Category III for depression. Given acute trauma caused by the treatment and the evidence for long-term memory and cognitive

problems, it reflects poorly on the panel that the vote was

so close.

The use of ECT for catatonia was recommended for Category II,

apparently on the grounds that nothing else works for that

disorder. According to the Diagnostic and Statistical Manual

of Mental Disorders (DSM-IV-TR, 2000), the

qualifier "with catatonic features" can be applied to Major

Depressive Disorder or Bipolar I and II. It is also a type of

schizophrenia.

If the diagnosis of catatonia is given this loophole, we will see

more and more people diagnosed with this disorder. It will be a

potential medical disaster because most catatonic-like states are

now caused by drug toxicity, including neuroleptic malignant

syndrome from the antipsychotic drugs and serotonin syndrome from

the serotonergic antidepressants. I have been a medical expert in

malpractice cases in which clinicians have mistaken these toxic

syndromes for psychiatric disorders, resulting in chronic

disability or death from lack of proper treatment. I predict that

thousands of patients who need treatment for psychiatric drug

toxicity will instead end up on the shock table.

On top of that, as the panel apparently recognized, there are no

credible studies of ECT for catatonic features or catatonic

schizophrenia. It's a very obscure disorder, but it will become a

widespread disorder in order to justify shock treatment. It's

similar to what happened to children: massively increasing the

diagnosis of bipolar disorder to justify giving them adult mood

stabilizers and antipsychotic drugs.

It is scientifically unsound to act as though ECT causes serious

safety risks with one disorder but not another. In all cases, the

same traumatic doses of electricity are being given to the brain.

The claim that there are no other effective treatments for

catatonia, whether true or false, should never be used to justify

a failure to test a device or drug for safety.

The reasonable and ethical approach for the FDA would require the

agency to call for the phasing out of ECT over a period of months

while developing protocols for testing ECT machines. It should

begin with Phase I studies, like any other dangerous treatment,

and first be tested on animals. All prior large-animal studies

such as monkeys, cats and dogs have demonstrated brain damage in

the form of small widespread hemorrhages and/or cell death. My earlier blog about these hearings provides

citations to these studies. The animal studies can also be found

in the bibliography on my website and in my

book Brain-Disabling Treatments in Psychiatry,

Second Edition (2008, pp. 237-241). If these studies

are reconfirmed, then ECT should be stopped without further

testing on humans.

Nothing would be lost by not giving ECT during the testing

period. Many doctors never give ECT and never refer patients for

ECT, and there's no evidence that this deprives patients of a

useful treatment. After all, there's no substantial proof of

efficacy and considerable proof of brain damage and long-term

cognitive problems.

Unfortunately, the FDA is already waffling about whether or not

it will in fact require the usual testing for Category III

devices. In response to questions at the hearing, the agency staff

said it was not certain whether a Category III designation for ECT

would require the same rigorous testing routinely carried out for

safety and efficacy. No one on the panel seemed to think the

treatment should be phased out until safety and efficacy were

proven.

Psychiatric reform moves ahead a step at a time, falters, and

hopefully moves ahead again. The classification of ECT into

Category III for most conditions, which at this point is only a

recommendation, is a step forward and a somewhat positive sign to

those of us who have called for this for decades. We hope the FDA

will uphold its obligation to the public to thoroughly test such a

dangerous device for safety and efficacy.

R. Breggin, MD is a psychiatrist in

private practice in Ithaca, New York, and the author of dozens of

scientific articles and more than twenty books. His first medical

book was about ECT: Electroshock: Its Brain-Disabling Effects

(Springer Publishing Company, New York, 1979). His most recent

medical book dealing with ECT is Brain-Disabling Treatments in Psychiatry:

Drugs, Electroshock and the Psychopharmaceutical Complex (2008). Dr. Breggin's professional

website is www.breggin.com.

You can meet and hear presentations by Dr. Breggin and some of

his closest colleagues at the annual Empathic

Therapy Conference to be held April 8-10, 2011 in Syracuse,

New York. Click here to learn more about the

conference and to register. Professionals and non-professionals

alike are welcome.