{"id":219,"date":"2009-09-23T15:17:14","date_gmt":"2009-09-23T21:17:14","guid":{"rendered":"http:\/\/cchrstl.org\/wordpress\/2009\/09\/23\/fda-wants-to-declare-electroshock-machines-safe\/"},"modified":"2024-07-14T05:43:12","modified_gmt":"2024-07-14T10:43:12","slug":"fda-wants-to-declare-electroshock-machines-safe","status":"publish","type":"post","link":"https:\/\/www.cchrstl.org\/wordpress\/2009\/09\/23\/fda-wants-to-declare-electroshock-machines-safe\/","title":{"rendered":"FDA Wants to Declare Electroshock Machines Safe"},"content":{"rendered":"

The FDA Wants to Declare Electroshock Machines Safe Without a Safety Investigation<\/strong><\/p>\n

TELL THEM NO!<\/strong><\/p>\n

The following newsletter from the Law Project for Psychiatric Rights solicits your attention and follow through. More information about shock treatment is available from the CCHR publication The Brutal Reality: Harmful Psychiatric ‘Treatments’ – report and recommendations on the destructive practices of electroshock and psychosurgery<\/em> — download it by clicking\u00c2\u00a0here<\/a>.<\/p>\n

If individuals wish to report an adverse event associated with the use of an ECT device, please use the MedWatch Online Voluntary Reporting Form available at https:\/\/www.accessdata.fda.gov\/scripts\/medwatch\/medwatch-online.htm<\/a>. The FDA will review information submitted through the MedWatch program prior to making any changes to the classification of ECT devices.<\/p>\n

\n
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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 is 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!<\/p>\n

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.<\/p>\n

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.<\/p>\n

(For the full story of how shock survivors have fought for a scientific safety investigation of Electroshock for the past 25 years, see Linda Andre’s terrific new book, Doctors of Deception: What They Don’t Want You to Know About Shock Treatment<\/a>.)<\/p>\n

In April 2009–20 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.<\/p>\n

The FDA is now supposed to require electroshock machines to undergo the rigorous PreMarket Approval process (PMA) that is required of new devices, including clinical safety trials.\u00c2\u00a0These machines, technically known as “devices,” are referred to as\u00c2\u00a0Electro Convulsive Therapy (ECT), but\u00c2\u00a0this is a euphemistic term for running electricity through people’s brains.<\/p>\n

The FDA\u00c2\u00a0could 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 ECT machines to the low-risk Class II, without scientific evidence of its safety.<\/p>\n

As a Class II device, electroshock machines would never have to go through the PMA process. The amount of damage that electroshock has been allowed to inflict is an outrage. We now finally have a chance to at least register our opposition because the FDA has opened up a new docket for public comment on electroshock machines<\/a>. It is important for as many people as possible to write in with their opposition. Comments will be accepted up through January 8,\u00c2\u00a02010.<\/p>\n

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<\/span> is a gold mine of information. Leonard Roy Frank issued the Electroshock Quotationary<\/a> in June 2006, which is a good source of material, and there is also a brand new web page of historical materials from Leonard at http:\/\/psychiatrized.org\/LeonardRoyFrank\/FromTheFilesOfLeonardRoyFrank.htm<\/a> Also, PsychRights has quite a large collection of materials at http:\/\/psychrights.org\/Research\/Digest\/Electroshock\/electroshock.htm<\/a> from which comments can be drawn.<\/p>\n

Read the instructions for docket #FDA-2009-N0392<\/a> and submit electronic comments and information to http:\/\/www.regulations.gov\/search\/Regs\/home.html#submitComment?R=0900006480a20202<\/a>.<\/p>\n

If you are not in a position to write something up, then please mail in the coupon below.<\/p>\n

\n
To: Food and Drug Administration<\/div>\n
Dockets Management Branch (HFA-305)<\/div>\n
5630 Fishers Lane, Room 1061<\/div>\n
Rockville, MD 20852<\/div>\n
Re: Electroconvulsive Therapy Device (882.5940),<\/div>\n
Docket #FDA-2009-N0392<\/div>\n
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.<\/div>\n
\n

Name: _________________________________________<\/p>\n<\/div>\n

Address: _______________________________________<\/div>\n
_______________________________________<\/div>\n
Signature: ______________________________________<\/div>\n
Date: __________________________________________<\/div>\n
\n

James B. (Jim) Gottstein, Esq.
\nPresident\/CEO
\nLaw Project for Psychiatric Rights
\n406 G Street, Suite 206
\nAnchorage, Alaska\u00c2\u00a099501
\nPhone: (907) 274-7686)\u00c2\u00a0 Fax: (907) 274-9493
\njim.gottstein[[at]]psychrights.org
\nhttp:\/\/psychrights.org\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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