Write the FDA About ECT

From Linda Andre, Director of the Committee for Truth in Psychiatry, found on the JFA Blog, so sorry I found out so close to the deadline:

Dear Friends and Fellow Advocates,

Many of us in the disability rights movement, especially those of us living with psychiatric disabilities or labels, have good reason to be concerned about ECT (shock treatment): We've had it or know folks who have and we know that psychiatrists aren't honest about its permanent adverse effects. We also know that shock is frequently forced on people who say no to it.

Now there is something all of us can do about shock: we can tell the federal government to investigate it for safety.

The government has the power to do this through the Food and Drug Administration, which regulates the machines used to give shock. (For all intents and purposes, the machines and the treatment are the same thing.) Did you even know that the shock machine has, for over thirty years, been exempted from the scrutiny that all other medical devices must go through? That it has never undergone even one clinical safety trial, and that the manufacturers have never provided nor been asked to provide a single shred of evidence that their devices are safe? It's true. (I tell the whole story of the battle between doctors and patients over whether shock should be investigated or not in my new book "Doctors of Deception: What They Don't Want You to Know About Shock Treatment" from Rutgers University Press, http://doctorsofdeception.com)

In other words, a generation of shock patients have been experimented on without their consent. And they've submitted to a procedure without knowing its risks.

But those of us who've had it know that shock always causes permanent memory loss, brain damage and cognitive deficits. And this often results in permanent, preventable iatrogenic (doctor-caused) disability.

That's why organized shock survivors and our allies have been lobbying the FDA for a safety investigation of ECT for over 30 years, without success. The American Psychiatric Association opposes an investigation.

Now the FDA is being forced to take action; it can no longer delay a safety investigation of the ECT device (known as a PreMarket Approval Application in FDA language) but it will not risk running afoul of the APA. As a way out, it is looking at simply administratively reclassifying the shock machine from Class III (the high risk category for medical devices which have not been proven safe and must be investigated for safety) to Class II (the low risk category for devices such as X ray machines and mercury thermometers). If it did so, the ECT device would never, ever have to undergo any clinical trials. Reclassification would mean the FDA agrees to accept the APA's word that shock is safe, without scientific evidence.

As it ponders its next move, FDA has done one good thing: It has asked for input from the public.

It has opened an official public docket on ECT and by law must read and consider everything sent to it. But comments will only be accepted up until January 8, 2010.

It is important that all of us who are concerned about the rights of labeled and dislabeled people write. The comment can be about personal experiences of yourself or others or simply an appeal to science, logic, and the FDA's duty to protect patients. A good point to make is that if the FDA administratively declares shock safe without an investigation, patients will not have the information we need to make our own decisions about what happens to our brains and bodies. Another good point is that shock is often administered involuntarily, and since shock machines are the only Class III medical devices that can be used on a person against his or her will, the FDA has to be more cautious in regulating these devices, not less.

A short comment would be as follows:

I oppose the reclassification of the ECT device to Class II in the absence of adequate scientific evidence of its safety, and request that the FDA call for PreMarket Approval Applications for the device.

Comments can be sent either by mail or electronically, but in either case must include the docket number, which is FDA 2009-N-0392.

The address for written comments is:

Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 208252
Re: Docket #FDA 2009-N-0392

Submit electronic comments at: http://bit.ly/FDAECT

Please copy, forward and snowball this message! Every comment is counted and every one is important.

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My letter:

I'm writing in response to docket #FDA 2009-N-0392 As a mental health consumer I am horrified that the manufacturers of ECT devices have never been required to submit PreMarket Approval Applications. This makes me physically sick as this is one of the most invasive medical devices currently in use and patients are continually subjected to ECT against their will. EVERYONE has a constitutional right to have control over their own body and people should not be forced to waive this right just because they have a disability. EVERYONE should have the ability to be fully informed about all medical procedures that are preformed on them. This cannot happen without rigorous testing of the ECT device.

I oppose the reclassification of the ECT device to Class II in the absence of adequate scientific evidence of its safety, and request that the FDA call for PreMarket Approval Applications for the device.