ECT Will Have to Prove Safety and Efficacy - Finally!
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ECT Will Have to Prove Safety and Efficacy - Finally!
With FDA Change, ECT May Go the Way of the Dinosaur
by John M. Grohol, Psy.D. on April 15th, 2009
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
Dr. John Grohol is the CEO and founder of Psych Central and has been writing about mental health and psychology issues online since 1992.
With FDA Change, ECT May Go the Way of the Dinosaur | World of Psychology
Shalom!
by John M. Grohol, Psy.D. on April 15th, 2009
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
Dr. John Grohol is the CEO and founder of Psych Central and has been writing about mental health and psychology issues online since 1992.
With FDA Change, ECT May Go the Way of the Dinosaur | World of Psychology
Shalom!
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From seeing quite a few people, firsthand, gain major benefit from this treatment I truly hope the FDA is able to streamline this so folks don't get denied treatment. I will never forget the Priest who went from barely moving from his depression to performing Holy Mass every morning after treatment. There was also the eighty year old woman who was unable to take medications due to age related side effects who went from being Baker Acted from her depression to eating hearty breakfasts and shopping with her daughter at least once a week after treatments.
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It's true there's been tremendous changes in the treatment over the years.
But, the stigma over ETC is there due to it's early stages where they literally ruined people's lives because they were experimenting with them. And there is still the issue of memories being forgotten today.
In the end, I don't think it's wrong for any medical treatment to have to show prove of it's safety and that the medical treatment works before it's given to people. We are well past the point of snake oil. And anedotal evidence isn't prove. The scientific method is the way to measure efficacy. Because people's lives are at stake. And yes, their memories make up a large part of our lives. Who are we, afterall, without our memories?
Shalom!
But, the stigma over ETC is there due to it's early stages where they literally ruined people's lives because they were experimenting with them. And there is still the issue of memories being forgotten today.
In the end, I don't think it's wrong for any medical treatment to have to show prove of it's safety and that the medical treatment works before it's given to people. We are well past the point of snake oil. And anedotal evidence isn't prove. The scientific method is the way to measure efficacy. Because people's lives are at stake. And yes, their memories make up a large part of our lives. Who are we, afterall, without our memories?
Shalom!
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