The FDA Wants to Declare Electroshock
Safe Without a Safety Investigation.
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 goldmine 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
which comments can be drawn.
If you are not in a position to write something up, then please copy and send in the
You can also make electronic comments at
www.regulations.gov by entering “Notices” and then the docket number
Law Project for
406 G Street, Suite 206
Anchorage, Alaska 99501
Phone: (907) 274-7686) Fax: (907) 274-9493
To: Food and Drug Administration
Dockets Management Branch (HFA-305)
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.