Psycho-Babble Medication Thread 978592

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ECT Could Be On The Way Out per FDA

Posted by Phillipa on February 2, 2011, at 21:04:46

Seems a Chance that ECT could be discontinued as safe. Phillipa

From Medscape Medical News > Psychiatry
Does FDA Panel Recommendation Mean the Beginning of the End for ECT?
APA Fears For the Future of "Life-Saving' Treatment
Fran Lowry

Authors and Disclosures


Information from Industry February 1, 2011 After a US Food and Drug Administration (FDA) panel's recommendation that electroconvulsive therapy (ECT) devices retain their high-risk class III classification, the American Psychiatric Association (APA) fears that the future of ECT for the treatment of severe, drug-resistant depression and other serious mental disorders is now in jeopardy.

If the FDA decides to follow the advice of its Neurological Devices Committee, it means that the 2 companies that currently manufacture ECT machines would have 30 months to submit a premarket approval to show that the devices are safe and effective.

The continued availability of this life-saving treatment in the long-term lies in the hands of the FDA...We're pleased it wasn't taken off the market instantly but if new trials are going to be required, it's not clear who will fund them and whether they will in fact even be done.
ECT has been in use since before the FDA enacted new, more stringent laws for device approval, and psychiatrists fear that the logistics of conducting new trials will pose insurmountable problems for the manufacturers.

They also doubt whether data from any new trial would be sufficient to convince a subsequent advisory panel of the efficacy and safety of the devices, long considered by the APA to be life-saving.

"It hasn't been yanked from the market right now," said Sarah H. Lisanby, MD, head of psychiatry, Duke University, Durham, North Carolina, and chair of the APA Task Force to Revise the Practice of Electroconvulsive Therapy.

"But the continued availability of this life-saving treatment in the long term lies in the hands of the FDA right now. We're pleased it wasn't taken off the market instantly, but if new trials are going to be required, it's not clear who will fund them and whether they will in fact even be done. This is the concern," she told Medscape Medical News.

Strong Evidence

In a statement released late last week, immediately after the FDA advisory panel's 2-day discussion about a possible reclassification of ECT devices, APA President Carol Bernstein, MD, declared that the association was optimistic that ECT would continue to be available as a treatment option for patients with debilitating illnesses.

"ECT is appropriate for a small percentage of patients, generally those with severe mental illnesses that have not responded to other treatments. When used properly, under the appropriate guidelines and by a well-trained psychiatrist, ECT is extremely safe and effective," said Dr. Bernstein.

Dr. Lisanby emphasized that strong evidence already exists for the safety and efficacy of ECT.

"There are long-term data that are published in the peer-reviewed medical literature on the safety and efficacy of ECT. For example, the Consortium for Research on ECT has published a series of studies sponsored by the National Institutes of Health.

"A recently published study with Charles Kellner as the first author found sustained benefit at 6 months after ECT in approximately half of people who had responded to the course of ECT. The studies show a remission rate of around 75% to 85%. Those people remain well at 6 months. That is long-term benefit," said Dr. Lisanby.

She added the FDA panel did not seem to be aware of the existence of this evidence. She also said that the panel appeared confused about the neuropathological effect of ECT.

Knowledge Gap Among Panel Members?

"The way that the literature on neurogenesis, which is the growth of new cells, was presented and reviewed seemed to lead to some confusion about whether this was a good or a bad thing," she noted.

The panel's advice to the FDA for the maintenance of ECT's class III high risk classification has many people worried.
"Antidepressant medications induce neurogenesis, and this is thought to be advantageous. ECT also does this and is the most robust inducer of neurogenesis known today, and yet when the data were considered by the panel they seemed to want more clarity about whether this was indicative of damage or whether this was a sign of therapeutic benefit."

She believes it was difficult for many of the nonpsychiatrist panel members to comprehend all of the information that was presented at the hearing.

"Medical schools devote 2 or 4 weeks to their psychiatry rotation, so if that is all you've had then there is a learning curve to learn about psychiatric illnesses and treatment," she said.

"The same would be true for me if I were trying to master a different field. I'm concerned that the knowledge gap represents a challenge for the reevaluation of 7 decades worth of literature on this very important treatment."

High Stakes

The panel's advice to the FDA for the maintenance of ECT's class III high-risk classification has many people worried, Dr. Lisanby said.

No one is making a lot of money from ECT. It's about helping people through a crisis and being able to use the most effective means to do that. I don't know what we would do without ECT.
"I do think that it is a realistic concern that the FDA could restrict access to ECT, and this is distressing to many people. I specialize in the treatment of severe, resistant depression, and in my practice ECT is the last stop for patients who feel that they are at the end of their rope. Up until now I have had the wonderful privilege of being able to offer them ECT."

There is a lot riding on the FDA's final decision, she added.

"A lot is at stake here. That is why I feel very passionately about it. It's not theoretical. No one is making a lot of money from ECT. It's about helping people through a crisis and being able to use the most effective means to do that. I don't know what we would do without ECT. I don't even want to go there."

 

Re: ECT Could Be On The Way Out per FDA Phillipa

Posted by Bob on February 3, 2011, at 0:55:47

In reply to ECT Could Be On The Way Out per FDA, posted by Phillipa on February 2, 2011, at 21:04:46

I seriously doubt ECT would be taken off the table. I don't think it's going anywhere. They may establish more rigorous guidelines for it's use however, and so they should.

 

Re: ECT Could Be On The Way Out per FDA

Posted by Christ_empowered on February 3, 2011, at 1:55:15

In reply to ECT Could Be On The Way Out per FDA, posted by Phillipa on February 2, 2011, at 21:04:46

Maybe this will lead to some honest, open debate about ECT and its effects on the brain, backed up by some solid data. South Carolina had the first successful ECT lawsuit a couple years ago (thanks in part to efforts Dr.Peter Breggin), so its apparent that even with ECT's mini-"comeback," people are (understandably) concerned about the potential ill-effects of zapping the brain.

I personally don't want to ever have ECT, but I would like for the FDA to at least regulate this industry and demand the kind of data they get from drug manufacturers before putting meds on the market. Then again--look at Avandia. Who's to say that the FDA review process will actually result in a safer ECT?

 

Re: ECT Could Be On The Way Out per FDA Christ_empowered

Posted by Phillipa on February 3, 2011, at 23:35:51

In reply to Re: ECT Could Be On The Way Out per FDA, posted by Christ_empowered on February 3, 2011, at 1:55:15

So true I remember a young girl that was a college student and was suicidal and got ECT. I asked the doc why as she was in group theraphy with me and so upset as had to drop out of college due to memory. He said only thing could do to stop a suicidal patient. Asked about memory as she was told not to worry and he said could take six months or more to come back. What kind of lawsuit was it? Phillipa

 

Re: ECT Could Be On The Way Out per FDA

Posted by Sailboat77 on February 4, 2011, at 16:39:22

In reply to Re: ECT Could Be On The Way Out per FDA Christ_empowered, posted by Phillipa on February 3, 2011, at 23:35:51

I had ECT myself 6 months ago and even though it didn't work, in fact it made me feel worse because of the side effects, I still think it should always remain an option. From what some people have said, it's a life saver and they depend on it in their constant battle with depression. I do agree though that testing for long-term repercussions is important.

Sometimes it's easy to dismiss certain medicines or treatments for depression because our own experience with them were unsuccessful or even negative. But what really matters in the end is if a treatment works for the individual. I think I just recently started to learn what this means.

 

Re: ECT Could Be On The Way Out per FDA Sailboat77

Posted by Bob on February 4, 2011, at 23:32:37

In reply to Re: ECT Could Be On The Way Out per FDA, posted by Sailboat77 on February 4, 2011, at 16:39:22

> I had ECT myself 6 months ago and even though it didn't work, in fact it made me feel worse because of the side effects, I still think it should always remain an option. From what some people have said, it's a life saver and they depend on it in their constant battle with depression. I do agree though that testing for long-term repercussions is important.
>
> Sometimes it's easy to dismiss certain medicines or treatments for depression because our own experience with them were unsuccessful or even negative. But what really matters in the end is if a treatment works for the individual. I think I just recently started to learn what this means.


I had very mixed results with ECT, as well as many other treatments. In fact, considering that I'm treatment resistant I'd had mostly negative results with all treatments. But I would never deny anyone else access to those treatments if they claimed it worked for them. I can see where that sentiment would come from however since a few treatments have played a part in bringing me to the brink of death, and when there one can get quite angry and think that no one else should try it.

 

Re: ECT Could Be On The Way Out per FDA

Posted by linkadge on February 5, 2011, at 11:06:54

In reply to Re: ECT Could Be On The Way Out per FDA, posted by Sailboat77 on February 4, 2011, at 16:39:22

Without any way of knowing when the treatment will work and when it won't, its difficult to give recomendations.

I don't think the treatment should be denied to anybody for whom it has worked previously.

However, recomending it to new patients should be based on a statistical cost / benefit ratio. It is arguable that previous analysis for ECT are somewhat flawed.

If a drug worked miraculously in 1 yet killed 99 out of 100, it would be hard to recomend (dispite the rave reviews from that 1).

Linkadge

 

Re: ECT Could Be On The Way Out per FDA

Posted by linkadge on February 5, 2011, at 11:18:20

In reply to Re: ECT Could Be On The Way Out per FDA Sailboat77, posted by Bob on February 4, 2011, at 23:32:37

I think it is "The Emperor's New Cloths" with some of these treatments.

Is ECT really as safe, reliable and effective as assumed? My personal thoughts are that the efficacy is bolstered in order to justify the treatment. How else would a procedure like ECT possibly continue to be available?

Some of the bias may be self fufilling. If patients think that ECT is really as effective as assumed, they may discount or downplay their own negative experiences with the procedure. Doing such will only distort a fair analysis.

Just like with the Emperor's New Cloths. Everybody assumes that everyone else is precieving correctly (i.e. seing the cloths), and only they cannot see the cloths, therefore nobody says anything. Or the multitude of studies on conformity out there. As long as enough people say that the short line is long, you can get a random person to say the same thing.

I think the efficacy of ECT is just misinformation that is hard to rectify. People have this image in their mind of the "big gun" ect. With a treatment like that, it has to work!!


Linkadge

 

Re: ECT Could Be On The Way Out per FDA linkadge

Posted by psychobot5000 on February 7, 2011, at 22:31:17

In reply to Re: ECT Could Be On The Way Out per FDA, posted by linkadge on February 5, 2011, at 11:18:20

I find the idea of ECT as somehow living in a bubble of presumed positives, immune to real examination, difficult to swallow; I don't know of many treatments more demonized in the popular mind, where it's associated by many with lobotomies and other midcentury abusive and failed treatments. Most people I've talked to (outside of a medical context) who've heard of ECT think its story is a horror tale of misuse, damaged brains and unwise, overreaching doctors. I've also read many stories on the web and even elsewhere, in which patients are very vocal in their dislike for it. In that context, it seems to me that perceptions of ECT among patients have not been unduly sanguine for a long time.

Respectfully,
Psychbot

> I think it is "The Emperor's New Cloths" with some of these treatments.
>
> Is ECT really as safe, reliable and effective as assumed? My personal thoughts are that the efficacy is bolstered in order to justify the treatment. How else would a procedure like ECT possibly continue to be available?
>
> Some of the bias may be self fufilling. If patients think that ECT is really as effective as assumed, they may discount or downplay their own negative experiences with the procedure. Doing such will only distort a fair analysis.
>
> Just like with the Emperor's New Cloths. Everybody assumes that everyone else is precieving correctly (i.e. seing the cloths), and only they cannot see the cloths, therefore nobody says anything. Or the multitude of studies on conformity out there. As long as enough people say that the short line is long, you can get a random person to say the same thing.
>
> I think the efficacy of ECT is just misinformation that is hard to rectify. People have this image in their mind of the "big gun" ect. With a treatment like that, it has to work!!
>
>
> Linkadge
>
>

 

Re: ECT Could Be On The Way Out per FDA

Posted by bleauberry on February 8, 2011, at 18:43:52

In reply to ECT Could Be On The Way Out per FDA, posted by Phillipa on February 2, 2011, at 21:04:46

This article is so full of falsehoods it is crazy.

Example. If someone stays well for 6 months that is considered longterm? Give me a break.

80% do well on ECT? No way. Someone really fudged the stats on that one.

No one is making any money? LOL! How about $22,000 for 12 shocks. That's what my insurance company had to pay for mine. Not to mention the $5000 copay I had to pay.

Sad, because people read stuff like this and assume that since it looks professional and formal and authoritative it must all be true.

 

Re: ECT Could Be On The Way Out per FDA bleauberry

Posted by Bob on February 8, 2011, at 18:46:49

In reply to Re: ECT Could Be On The Way Out per FDA, posted by bleauberry on February 8, 2011, at 18:43:52

> This article is so full of falsehoods it is crazy.
>
> Example. If someone stays well for 6 months that is considered longterm? Give me a break.
>
> 80% do well on ECT? No way. Someone really fudged the stats on that one.
>
> No one is making any money? LOL! How about $22,000 for 12 shocks. That's what my insurance company had to pay for mine. Not to mention the $5000 copay I had to pay.
>
> Sad, because people read stuff like this and assume that since it looks professional and formal and authoritative it must all be true.

They've been that ECT is 75 to 80% effective for a really long time.

 

Re: ECT Could Be On The Way Out per FDA

Posted by ed_uk2010 on February 11, 2011, at 16:01:10

In reply to ECT Could Be On The Way Out per FDA, posted by Phillipa on February 2, 2011, at 21:04:46

My opinion of ECT is that I would never agree to have it. I'm not convinced that electrocuting the brain is therapeutic.

 

Re: ECT Could Be On The Way Out per FDA

Posted by Bp_amanda on February 26, 2011, at 15:19:32

In reply to Re: ECT Could Be On The Way Out per FDA, posted by ed_uk2010 on February 11, 2011, at 16:01:10

I have had two rounds of ect. I can't remember exactly when or even the year for that matter. I'll just say 2 to 3 years ago. The first round was somewhere around twenty treatments and the second was only five. They stopped the second round because the seizures were lasting too long and they had to give me ativan to stop them.

I was told memory loss would be minimal. What a crock! I don't remember huge chucks of my life... Childhood is mostly gone as well as a good chunk of adult life. Since having ect I also have a lot of trouble forming new memories. I have to write everything down and follow written directions for things I have done hundreds of times before.

 

Re: ECT Could Be On The Way Out per FDA

Posted by Deahoidar on February 27, 2011, at 7:05:07

In reply to Re: ECT Could Be On The Way Out per FDA, posted by Bp_amanda on February 26, 2011, at 15:19:32

ECT can produce some benefits. But it can also produce significant, even severe, memory loss. Memory loss is kind of like severe pain, in that you can't really imagine it until you experience it.

My experience with ECT was marred by prolonged seizures and memory loss. A lot of memory loss. And loss or impairment of certain mental abilities.

I believe we don't know enough about how ECT works or what it really does to the brain. Extensive study is needed before it proceeds beyond the status of treatment of last resort.


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