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National Coalition for Mental Health Recovery | NCMHR

Electro Convulsive Therapy (ECT)

NYAPRS Urges FDA to Conduct Appropriate Evaluation of ECT Devices
Oppose FDA Declaration of Electroshock Safety
Template Letter to Send to the FDA
Letter from Dorothy W. Dundas, Shock Survivor

NYAPRS Urges FDA to Conduct Appropriate Evaluation of ECT Devices

July 7, 2010 - Following is a copy of a letter that the New York Association of Psychiatric Rehabilitation Services (NYAPRS) sent urging the federal Food and Drug Administration to conduct a comprehensive and appropriate level of review of the devices used to administer electroshock treatment. Our position on ECT is the same as with all treatments: we work hard to see that people with psychiatric disabilities get full access to all available treatments including ECT, in an environment of informed choice and, given the well documented potential side effects, an appropriate level of government oversight and inspection. We urge all of you who share these concerns to inform the FDA today, the last day they are seeking public comments, at http://bit.ly/FDAECT where you can say “The FDA should conduct an appropriate examination of the safety of ECT devices by calling for Pre-Market Approval Applications for the devices."

January 7, 2010

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Dear FDA,

I am writing you as executive director of the New York Association of Psychiatric Rehabilitation Services (NYAPRS) which represents a broad coalition of thousands of New Yorkers with psychiatric disabilities and over 125 community mental health recovery agencies that support them across our state.

Since 1981, NYAPRS has worked to improve services and social conditions for people with psychiatric disabilities by advancing their recovery, rehabilitation and rights through a range of grassroots advocacy, training and technical assistance and new service development activities.

Along the way, we have helped win passage of many landmark pieces of legislation and budget proposals, supported the development of numerous new service initiatives and helped support the empowerment, recovery and community integration of tens of thousands of New Yorkers.

The NYAPRS Board and Public Policy Committee has long viewed electroconvulsive treatment (ECT) as a controversial approach that, according to a range of reports, has both helped and harmed many of those who have used it.

NYAPRS has long believed that fully informed choice and appropriate government oversight is critical to ensuring that ECT use is properly treated.

As a long time advocate for informed choice and appropriate oversight over electroconvulsive therapy (ECT), NYAPRS strongly urges the Food and Drug Administration to maintain ECT devices as Class III and require the submission of a premarket approval application (PMA) and conduct a thorough review of the safety of the devices used to apply this treatment, consistent with the requirements of Class III categorization.

Moreover, we strongly question why such an examination has not been required of ECT devices in the past, given their classification and controversy.

We strongly urge you to conduct that investigation now and to reject efforts to avoid such a review by administratively reclassifying the device into Class II or Class I. Reclassification would mean the FDA would agree to accept the word of proponents that ECT is safe, without the required and appropriate scientific evidence.

While we know several individuals who have derived benefit from ECT, we also know many individuals who experienced severe memory loss, agitation, cognitive deterioration, long term brain damage and other injury, especially at the hands of equipment that was out of date and improperly inspected and maintained.

NYAPRS is particularly troubled about these reports since ECT is a treatment that is often involuntarily forced onto individuals, denying them the informed choice they have a right to have, especially regarding such a controversial and consequential treatment.

That is why NYAPRS successfully pressed state officials in 2003 to add regular inspection of ECT devices and treatment protocols to the duties of state mental health licensing and certification staff, a development that has revealed incidents of wrongful use of outdated ECT equipment and misuse.

We want to be clear: we are not advocating for the elimination of ECT but for appropriate inspection, oversight and informed consent for adults between the ages of 21 to 70, even if they are deemed incompetent by a court. Moreover, we don’t believe that that ECT should be given to children or the elderly under any circumstances as these populations are too vulnerable to usurpation by others.

We also urge the FDA to establish recommendations for treatment protocols in addition to evaluating the efficacy, safety and maintenance of the equipment both before their first use and on an ongoing basis.

As it is the FDA’s duty to assure full due diligence in its efforts to protect Americans who either consider or are required to accept ECT treatment, NYAPRS strongly urges you to conduct a comprehensive scientific investigation of the safety of the devices.

Please feel free to contact me at harveyr@nyaprs.org.

Thank you,

Harvey Rosenthal
Executive Director

cc: NYAPRS Board of Directors, Public Policy Committee members


Oppose FDA Declaration of Electroshock Safety

The FDA Wants to Declare Electroshock Machines
Safe Without a Safety Investigation.
TELL THEM NO!

The Food and Drug Administration is in charge of regulating medical devices just as it does drugs, including the machines used to give Electroshock. But it's not doing its job. It has allowed these machines to be used on millions of patients over the past generation without requiring any evidence whatsoever that shock treatment is safe or effective. This is so even though shock machines are Class III -- high risk -- devices, which by law are required to be subjected to thorough clinical trials as thoroughly as new drugs and devices just coming onto the market. But because of intense lobbying by the American Psychiatric Association -- which claims the devices are safe but opposes an investigation -- the FDA has disregarded its own law. (For the full story of how shock survivors and other advocates have fought for a scientific safety investigation of Electroshock for the past 25 years, see Linda Andre's new book, Doctors of Deception: What They Don't Want You to Know About Shock Treatment.)

In April 2009 -- 30 years after it first ruled the devices high-risk and named brain damage and memory loss as risks of the treatment -- the FDA belatedly announced it would call on the manufacturers of the devices to provide evidence of safety and efficacy. The deadline for submissions has passed, but the manufacturers have not conducted any clinical trials, claiming they cannot afford them. They simply point to the opinions of shock doctors (including those who have financial interests in companies making Electroshock machines) as evidence that shock is safe.

The FDA is now supposed to require Electroshock machines to undergo the rigorous Pre-Market Approval process (PMA) that is required of new devices, including clinical safety trials. The FDA could have called for this investigation any time in the past 30 years but has previously failed to do so. There is great risk the FDA will down-classify it to the low-risk Class II, without scientific evidence of its safety. As a Class II device, Electroshock machines would never be required to go through the Pre-Market Approval process. The amount of damage that electroshock has been allowed to inflict is an outrage.

The FDA has opened up a new docket for public comments on the ECT device. If we don’t write in, they will almost certainly reclassify. Do you think shock is safe? Have you evidence you want FDA to consider, including your personal experience? We now finally have a chance to at least register our opposition. It is important for as many people as possible to write in. Comments will be accepted through January 2010.

If you have personal knowledge or expertise about Electroshock, writing about that can be good. Or you can pull information from various sources. Linda Andre's book,  Doctors of Deception is a gold mine of information. Linda has compiled a two-page primer, "The FDA’s Regulation of ECT (Shock Treatment): A Beginner (or Refresher) Course." In addition, Leonard Roy Frank's Electroshock Quotationary is another good source of material, and there is also a new web page of historical materials from Leonard. Also, PsychRights has a large collection of materials at http://psychrights.org/Research/Digest/Electroshock/electroshock.htm from which comments can be drawn.

If you are not in a position to write something up, then please copy and send in the below coupon. You can also make electronic comments at www.regulations.gov  by entering “Notices” and then the docket number FDA-2009-N-0392.


Template Letter to Send to the FDA

<Sample text of letter to FDA>

To: Food and Drug Administration, Dockets Management Branch (HFA-305), 5630 Fishers Lane, Room 1061, Rockville, MD 20852

We are a support and advocacy organization for people who have psychiatric labels or disabilities, including those who have received or may receive electroconvulsive therapy (ECT). We are aware that the FDA has asked for public input on the safety and efficacy of the devices used to administer ECT. The devices are currently classified as Class III high risk devices. Class III devices are required by law to undergo the same rigorous safety testing as new devices just coming onto the market; their manufacturers must prove them safe and effective. Yet while other medical devices have had to undergo the rigorous safety investigation known as PreMarket Approval (PMA), the FDA has allowed shock machines to be used for over thirty years, not only without requiring clinical safety trials, but without any scientific evidence that the devices are either safe or effective. Nor have patients been informed that they were submitting to an untested procedure.

When it classified the ECT device in Class III, the FDA named brain damage and memory loss as risks of the treatment. Since then, dozens of volumes of evidence have accumulated in the FDA’s previous dockets on the device (#82P-02316 and #2003P-0555) documenting the risks of ECT, including firsthand accounts of permanent harm from former ECT patients.

The manufacturers of the devices, as well as the American Psychiatric Association and individual doctors who use shock, are lobbying to prevent the mandated scientific safety investigation from ever taking place. They are asking you to reclassify the device to the low risk Class II (ruling that it is as safe as an X ray machine). The manufacturers say they will not pay for clinical trials; the APA wants you to take their word that shock is safe. But if the devices really are as safe as they claim, an investigation will prove that.

If the ECT device is reclassified, the public and future patients will never be able to make an informed choice about ECT based on valid scientific evidence. We are strongly committed to informed consent and choice in the mental health system and that must include informed choice about whether to have ECT or not. That choice can only be informed if patients have full and complete knowledge about its short and long term consequences. FDA must place public and patient safety first, and that means not exempting the ECT device from the scrutiny required of other medical devices. We strongly oppose the reclassification of the ECT device. In the absence of adequate scientific evidence of the safety of shock machines, the only responsible course of action is to keep the device in Class III and call for PMAs from the manufacturers. That investigation will either show that ECT is safe or publicly reveal its lack of safety. Either way, patients have the right to know.

Sincerely,
 


To: Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Re: Electroconvulsive Therapy Device (882.5940), Docket #FDA-2009-N0392

The undersigned opposes the reclassification of the ECT device to Class II by the FDA in the absence of adequate scientific evidence of its safety, and asks the agency to call for Pre-Market Approval Applications for the device.

 Name:  
 Address:  
   
 Signature:  

http://www.gpo.gov/fdsys/pkg/FR-2009-09-10/html/E9-21807.htm

[Printable ECT Coupon]

Letter written by Dorothy W. Dundas, shock survivor

Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Re: Electroconvulsive Therapy Device (882.5940), Docket #FDA-2009-N0392

To Whom It May Concern:

I am writing to implore you not to reclassify the ECT device to Class II because there is no scientificfic evidence of its safety.

I speak from considerable, horrifying experience. I was given ECT against my will when I was an adolescent and have never forgotten the terrifying sessions. I have lost a certain amount of my memories preceding the shocks, they took away the essence of my true self, terrified me, and killed my teenaged roommate. I am no longer able to do math in my head the way I formerly was able to do. When given an IQ test a few weeks after the shocks, I stated the population of the USA as 1,000. When I was asked to guess again, my answer was 2,000. Sadly, I remember knowing my answers were incorrect, but I was unable to find the right number in my brain. Before the ECT, I had been a freshman at Smith College and certainly quite intellectually capable. In the end, the most horrifying fact is that the ECT sessions did nothing but harm to me and I remained in hospitals for three more terrible years.

These “treatments” are routinely given to people against their will around the world and in some of the most impoverished countries. Often it is used when no one has the time, desire, or patience to sit quietly with another in need. Kindness and patience from another person are what saved me in the end. This, in my opinion, is what is the most helpful. 

ECT should be banned around the world. It is abusive and barbaric. It has clearly been shown that there has for many years been a marriage of doctors, the APA and the builders of the ECT machines: the shock industry! It is all about money and it is high time for this business to STOP!

Sincerely,

Dorothy W. Dundas