Last week, the U.S. Food and Drug Administration (FDA) finally decided to start taking action to close a loophole that’s been around nearly as long as the agency itself. Last Wednesday it said that it would require safety and efficacy data from manufacturers of medical devices in 25 different categories. This data is equivalent to the types of data the FDA currently requires for medical devices and drugs — data that shows the device is both safe and effective in use for a prescribed disorder.
One of those 25 categories is electroconvulsive therapy (ECT) machines. Yes, you heard right. For decades, the most notorious of all psychiatric treatments available has never met any type of rigorous FDA approval for their use. How can this be?
In the case of electroconvulsive therapy machines, for example, there are eight companies that market the devices, none of which were ever required to undergo premarket approval.
Rather, they all were cleared under the so-called 510(k) process, which automatically okays the devices if it is "substantially equivalent" to an already approved product, called a predicate device.
Since no ECT machine went through the premarket approval process, there is no predicate device. Hence, manufacturers of ECT machines must seek approval for them as if they were new to the market.
The good news is that the FDA is finally fixing this loophole. The bad news (or more good news, depending upon how you look at it) is that the resulting need for rigorous data may mean that ECT machines may be a thing of the past. While ECT machines make a few companies some money, the kind of clinical trials the FDA may require may mean it is economically unadvisable to fund the studies.
Time will tell how the machines’ makers will react to this requirement, but I think this has been too long a time in coming. It’s necessary to make sure everyone who offers legitimate medical devices or drugs for things like depression are on the same level playing field. And it ensures that consumers are not subjected to unsafe devices, as the memory side effects of ECT treatment remain a hurdle to its more widespread use or adoption, even when modern ECT techniques are used.
Serious depression may occasionally need serious treatment like ECT. But such treatments must meet the same requirements the FDA places on all medical devices. Finally, ECT will be required to submit proof of showing they meet minimum levels of safety and efficacy.
Read the full article: FDA Near to Closing Books on Grandfathered Medical Devices
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4 Comments to
“With FDA Change, ECT May Go the Way of the Dinosaur”
Since I have personal knowledge of the effectiveness of ECT treatment, I am dismayed that another government bureaucracy is throwing obstacles in the way of people obtaining needed health care. I certainly hope that this doesn’t develop into an outright ban on ECT treatment.
The FDA has already had to backtrack on a ban announced March 31 on old morphine drugs. One of the drugs they banned is the only source of analgesia available for extremely deteriorated terminal cancer patients.
I don’t need an agency that is so ham-fisted and obtuse as to make the above mistake protecting ME from MY ignorance. I will make an informed choice, as I do with dietary supplements. Thank god whe didn’t let the FDA get their hooks into that category. I’d be buying my chamomile tea from the pharmacy at $10/cup.
Cordially,
YOGI
I personally had over 2 dozen ECT bilateral sessions. All they did was make me so mentally numb that my depression was *slightly* and by slightly I mean about 10% less severe…& that was only while getting shocks. It was a horrific experience that left me with permanent memory damage. The doctor who performed it refused to try a medication I had suggested, which ironically…ended up working after I finally quite the ECT.
Despite *all* these things, I would never ban the devices. I think anyone who currently recieves benefits from ECT should be allowed to continue their treatment. But I would hope medicine advances to the point, where these relatively barbaric machines are no longer needed. Its long past time.
Shock “works” via brain damage. This is an indisputable fact. Two of the effects of brain damage are temporary euphoria and apathy, a kind of giddiness that straw-clutching self-promoting medical businessmen have equated with the the yet undefined state of “mental health”. The long-term effects of course include the cognitive and memory deficits typical of brain damage, which these same businessmen are still systematically ignoring in their falsified consent forms.
Psychiatry still uses shock as a brainwashing device for the social control of women:
http://www.ncbi.nlm.nih.gov/pubmed/16567337
My mother was a victim of this orwellian abuse at the hands of a financially conflicted psychiatrist. After her death at their hands (brain hemorrhage is common) and the subsequent collapse of my family, I was also subjected to it at the age of 15.
Psychiatry has inflicted hidden atrocities on unsuspecting and neurologically muted victims for decades. They may miss the PR value of the high-tech facade surrounding shock, but I imagine they’ll adapt to new circumstances quickly, as their enduring conflicts of interest, pseudo-science and corruption will still provide a viable business model. They have made a virtue, a science and a business of child abuse.
There is no science in psychiatry only handwaving, conflicts of interest and occasional accidental success, with the rest (such as SSRI induced homicide: http://ssristories.com) being swept under the rug. With the recent scandals surrounding conflicted psychiatric opinion leaders
http://www.google.com/search?hl=en&client=firefox-a&rls=org.mozilla%3Aen-US%3Aunofficial&hs=Ppx&q=grassley+psychiatry&btnG=Search
it’s clear that the underlying institutional pathologies at the heart of psychiatric practice continue unabated.
Caveat emptor.
It is about time the FDA does an inspection on these ECT machines. The ECT machines are not safe. ECT is still around - it never left.
I consider these machines nothing short of being machines of producing “torture”.
I suffer from permanent memory loss and have difficulty learning anything new as a result of being forced to have ECT in 1973 in Ontario, Canada. On my 5th ECT my heart stopped and I had to be revived.
100,000 Americans get ECT yearly
14,000 approximately ECTs are given yearly in
Ontario Canada
Worldwide 1 to 2 million people get ECT yearly.
There have many reports and studies proving that ECT causes brain damage.
There is a worldwide movement to ban electroshock universally.
On Mother’s Day on May 10th, this year 2009, there will be ECT protests all over the world in Ottawa and Toronto, Ontario; Montreal, Quebec; and in Cork, Ireland.
The International Campaign to Ban Electroshock
(ICBE) deems ECT to be unethical, barbaric, torture, inhumane, and a crime against humanity.
The ICBE website URL is:
http://intcamp.wordpress.com
Other websites on ECT:
ect.org
breggin.com
capa.oise.utoronto.ca
mindfreedom.org/ray
mindfreedomireland.com
endofshock.com
psychrights.org
capacanada.wordpress.com
sueclarkstory.wordpress.com
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Last reviewed: By John M. Grohol, Psy.D. on 15 Apr 2009
