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THERE IS STILL TIME LEFT! COMMENT BELOW. AN OPEN LETTER FROM THE OPAL PROJECT TO THE FOOD AND DRUG ADMINISTRATION
click here to download file
USE COMMENT BOX BELOW - your comments will be delivered to the FDA
The FDA Wants to Declare Shock (ECT) 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 shock treatment. 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 supposed to be investigated by 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
have fought for a scientific safety investigation of ECT for the past 25 years, see the new book Doctors of Deception:
What They Don’t Want You to Know About Shock Treatment by Linda Andre.)
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 the
device companies) as evidence that shock is safe.
The FDA is now supposed to require
the ECT device to undergo the rigorous PreMarket Approval process (PMA) that is required of new devices, including clinical
safety trials. But the FDA could have called for this investigation any time in the past 30 years and has steadfastly
refused to do so. It has never wavered from its intention (as stated in 1990) to declare the shock machine safe, and
downclassify it to the low-risk Class II, without scientific evidence of its safety. As a Class II device,
the shock machine would never have to go through the PMA process. After all, if a PMA showed shock to be unsafe, the
FDA would have to take shock machines off the market, and it knows that the American Psychiatric Association would never allow
that.
The FDA has opened up a new docket for public comments on the
device. If we don’t write in, they will almost certainly reclassify. Comments will be accepted up through January 8,
2010. Do you think shock is safe? Have you evidence you want FDA to consider, including your personal experience? Write
a letter to the address below or send in the coupon. You can also make electronic comments at www.regulations.gov by entering
“Notices” and then the docket number FDA-2009-N-0392.
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To: Food and Drug Administration, Dockets Management Branch (HFA-305), 5630 Fishers Lane, Room 1061, Rockville, MD 20852
Re: Docket #FDA-2009-N-0392
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 PreMarket Approval Applications
for the device.
Name: ___________________________________________________________________________________________
Address: ________________________________________________________________________________________
__________________________________________________________________________________________
Signature: _______________________________________________________________________________________
click here to download REPORT TORTURE POSTER
Welcome to The Opal Project! Recruitment for the first round of
this Institutional Review Board-approved research took place on the East Lawn of the State Capitol building in Albany, New
York, in July of 2006, at the 26th Annual Bastille Days Vigil and Demonstration with the Mental Patients Liberation Alliance, to stop the use of shock on children. I asked participants who were advocates and activists with psychiatric histories, who gave informed consent to be
involved with this study, to confront The Opal and offer ideas of what, if anything, they thought ought to be done with it.
The Opal, which was "dedicated to usefulness," is a ten volume Journal that was written and edited by the patients of the
Utica State Lunatic Asylum, circa 1851. The more than 3,000 pages of material in The Opal includes political commentary, humor, advice, and theory on
insanity in the form of articles, poetry, prose, cartoons, plays, and literature. The Opal was written by the patients who lived on one of the private wards in the Asylum, where there was little
reported violence, unlike the basement, for example, where Phebe B. Davis in her 1855 expose of the Utica State Lunatic Asylum reports crib patients were kept. The crib, known as the Utica Crib was invented at the Asylum. It was a wood slat adult-sized crib with a top that came down, locking a person inside of the
crate to be swung. The Utica State Lunatic Asylum,
opened in 1838, was the first state-operated asylum in New York State. As the premiere state-operated institution, there is
a wealth of information on its geography, design, construction, administration, implementation, and evaluation through many
different sources, but especially the Asylum's Manager Logs, which can be found at the Oneida County Historical Society. Though the Old Main building is no longer operational,
it still stands on the extended campus of the New York State Office of Mental Health's Mohawk Valley Psychiatric Center and was recently renovated, though there are sections that are going to be destroyed, so the building is endangered. Many
of the participants of this project live in Utica or are attached to Utica through the headquarters of the Mental Patients Liberation Alliance, which operates an advocacy office inside of Mohawk Valley Psychiatric Center's locked facility. Comparisons of treatment between the 19th and 21st centuries were much easier
to find than people expected. In the 21st century, those involved with The Opal Project see The Opal as evidence of
a 'lunatics liberation movement' from the 19th century that discussed the liberation movement from the 18th century.
There are several places on the web that you
can go to get more information about The Opal. The Library at the Disability Museum has 26 Opal entries available online for you to view.
You can see pictures of Old Main listed as one of its incarnations,
Utica State Hospital at the Historic Asylums of America website
Roger Luther has done incredible work at photographing some of New York's Asylums, including
Old Main. NYS Asylum has a wealth of images and information available.
Mary Rose Eannace published her groundbreaking dissertation
on the literature of The Opal and discussed many of the issues inmates faced including control and censorship. Eannace, M. (2001). Lunatic Literature: New York State’s The Opal (1851-1860). UMI. Furthering this work is Benjamin Reiss' Letters from Asylumia: The Opal
and the Cultural Work of the Lunatic Asylum, 1851-1860. American Literary History - Volume 16, Number 1, Spring 2004,
pp. 1-28. This site introduces "The Opal Project”
and asks, “Is there an Opal in your future?"
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