Posts tagged ‘ECT’

FDA May Require Testing of Electroconvulsive “Therapy” Devices

You may remember a couple of posts I made last year at this time about the importance of speaking up when the FDA opened itself up to comments on the issue of reclassifying the as yet untested ECT (shock treatment) machines from a class III to a class II. The situation was simple — in all the years the machines have been in use, the industry has never had to prove that they are either safe or effective. For decades people have been having their frontal lobes assaulted by electricity in varying amounts from just plain dangerous to thoroughly destructive on machines with no standard of testing to ensure that they’re working as designed, much less designed to address any established clinical use at all. This is not only frightening but a terrible insult to the rights and safety of the approximately 100,000 people who face ECT each year in the US (by choice or force) and only serves those profiting from the shock industry. In essence, the hundreds of thousands of people who have undergone this so-called treatment are the experiment — the living test.

Well, the good news is that it seems that the FDA’s protection of the shock industry may be coming to an end…

Peter Breggin, MD for the Huffington Post:

Friday afternoon, January 28, 2011: The FDA’s panel for electroconvulsive therapy (ECT) voted to place ECT machines in Category III for all but one indication. If the FDA accepts the panel’s recommendation, the agency will require testing for all uses except “catatonia” which was recommended for Category II, requiring less stringent testing.

A tiebreaker by the chair was needed to propose putting ECT machines into Category III for depression. Given acute trauma caused by the treatment and the evidence for long-term memory and cognitive problems, it reflects poorly on the panel that the vote was so close.

Indeed. Despite the polarized response to the matter from proponents and opponents of giving ECT a pass, each side claiming history has proven their point, the fact of the matter is that the FDA is supposed to be ensuring our expectation of some level of safety. If an industry is unwilling or unable (or in this case both) to prove its product safe and effective given the established (and frankly, lax) channels, then that product has no business being passed off as a reasonable course of action in our nation’s hospitals. This shouldn’t have come off as a vote on ECT’s supposed merits but on its decades-long exemption from the system — and that shouldn’t be a close vote at all.

It’s a little early to cry victory as it remains to be seen whether the FDA will follow the panel’s recommendation, what result that will actually have and how much the overlapping psychiatric and shock industries will play off of the catatonia exemption.

If the diagnosis of catatonia is given this loophole, we will see more and more people diagnosed with this disorder…It’s similar to what happened to children: massively increasing the diagnosis of bipolar disorder to justify giving them adult mood stabilizers and antipsychotic drugs.

Unfortunately, the FDA is already waffling about whether or not it will in fact require the usual testing for Category III devices. In response to questions at the hearing, the agency staff said it was not certain whether a Category III designation for ECT would require the same rigorous testing routinely carried out for safety and efficacy. No one on the panel seemed to think the treatment should be phased out until safety and efficacy were proven.

Psychiatric reform moves ahead a step at a time, falters, and hopefully moves ahead again. The classification of ECT into Category III for most conditions, which at this point is only a recommendation, is a step forward and a somewhat positive sign to those of us who have called for this for decades. We hope the FDA will uphold its obligation to the public to thoroughly test such a dangerous device for safety and efficacy.

Since the psychiatric and shock industries have essentially shaken off the burden of responsibility for the safety of the consumer (certainly at the industry level the term is more fitting than patient) and the FDA is apparently questioning its convictions about the protection of the public, the burden rests on the people. As neither of those entities are wholeheartedly committed to moving forward of their own accord to ensure the safety and the efficacy of products on the market and ECT cannot prove itself under any honest scrutiny, the burden then falls on the people to pressure them toward forward momentum and to keep the scrutiny honest…but then, has there ever been a time when that wasn’t the case?

January 31, 2011 at 11:01 am 6 comments

Violence Prevention Medication?

This morning, I stumbled upon an opinion piece for the Buffalo News pushing for Kendra’s Law to be made permanent. Kendra’s Law is an attempt to prevent violent crime by essentially treating people diagnosed as mentally ill like some sort of pre-criminals. On paper it’s also supposed to be for the safety of the “patient” too but when it’s time to push for support, it’s almost always about protecting “us” from “them.” (As I’ve said before, fear sells when facts fail.) Advocates of Kendra’s Law and similar attempts to criminalize extreme states of mind use phrases like assisted outpatient treatment (AOT) instead of the more truthful involuntary or forced outpatient treatment.  These are the types of laws that allow for forced drugging, electroshock and hospital confinement — all based on the unfounded idea of biological mental illness but the idea is just the packaging. It’s essentially a way to keep people under control out of fear of what they might do. This thinking has no basis in fact regarding mental illness and certainly no place in the arena of human rights or a constitutional America. The article is a fine example of fearmongering but that’s the current state of media. Somehow factmongering never caught on.

As with most battles for thought and opinion, this one is very much centered on carefully crafted words and phrases — not unlike much of the current mental health industry. As with force being rephrased as assistance, drugs are renamed and recategorized, some officially and some in the minds and words of the public. (Neuroleptics have come to be called antipsychotics which are now being called antidepressants.) Sometimes words with no previous connection are paired and when spoken with some authority or when used to speak to people’s fear these words become inseparable, creating a false choice scenario. The latest I’ve seen, in the aforementioned article, is “violence prevention medication.” Of course, there is no such thing but it’s another step in grooming the vernacular.

Kendra’s Law—designed to keep people who really need it on their violence-prevention medication—was passed about 10 years ago. It’s up for renewal, again. Just make it permanent…

The law allows judges to order certain mentally ill people to remain on violence-prevention medication as a condition of release and, if that doesn’t work, to order involuntary committal to mental hospitals if shown to be a danger to themselves or others.

The author creates a connection between violence prevention and drugs. Simply by accepting the phrasing, you’d be accept the idea as truth. And if that’s the truth, you are either in favor of forced drugging or you don’t care if innocent children are slaughtered at the hands of madmen. Facts be damned, that’s your choice. Somehow, when I picture people being tackled to the ground, restrained by undue force, faces pressed against a cold hospital floor and forcibly injected with drugs — powerful mind and body altering drugs — it’s hard to see it as “violence prevention.” We are transferring violence at best and at worst and in truth, causing it.

March 17, 2010 at 7:42 pm

Two New Paintings

With my art show drawing very near (tomorrow night), I’ve been working especially hard at getting the ideas onto paper. I thought I’d post up two of the newest pieces — one I don’t have a name for and the other entitled, First, Do No Harm.

February 4, 2010 at 8:48 pm

The Deadline for Comments to the FDA on ECT is Tomorrow.

I can’t stress enough the importance of taking an active role in this instance. The FDA has been in a position to regulate ECT (shock treatment) for decades by way of clinical trials determining its safety and efficacy and has chosen not to. Proponents proclaim its safety and efficacy but oppose its testing. Why? If ECT is as safe and effective as those proponents claim, the device would fly through the testing without a hitch. If not, however, the FDA is our only safeguard from a procedure that many of its recipients have found ineffective at best and debilitating at worst.

Proponents of ECT claim it is fear mongering based on old and outdated methods that opponents use to bolster their argument but little has changed in ECT over the years, other than adding drugs into the mix. The same damaging and unpredictable shock is administered to the brain, intentionally causing a seizure. Ask anyone who has seizures and chances are they will not praise them for their safety and depression reducing qualities. Muscle relaxants are used to minimize muscle contractions and anesthesia is offered, making the procedure more appealing and easier to market but certainly not safer given the increased potential for toxic or allergic effects and harmful drug interactions.

Proponents of ECT claim it is an often life saving last resort that has proven its safety and efficacy through publice use. I’ll simply say two things to that. First,that the same was said about lobotomy and second, that using the public over time to determine the benefits of a procedure is using the public as guinea pigs in a poorly regulated experiment.

When ECT proponents weigh in on the topic, they often frame it in terms of taking ECT out of their arsenal. You know something is wrong when testing something to assure it is safe and useful to the public is tantamount to banning it. The move the FDA is considering is not to ban it but to test it. If those two things are one and the same in the eyes of the shock industry, then it’s no wonder they would rather have us take their word on it.

Please speak up. A brief comment, even a single sentence is all it takes. I’ve commented and it is incredibly easy. If you can post on your friends facebook wall or comment on their myspace photo, you can comment to the FDA.

Simply go to regulations.gov. Copy and paste this docket number into the search bar on the right: 2009-N-0392. A list of comments will come up. You can view the comments of others and add your own.

More info: Jon Breeding PhD on Electroshock

January 7, 2010 at 11:40 am 2 comments

New Year’s Revolution

I’ve never really gotten into the idea of New Year’s Day as a holiday. Sure, it’s as good a time as any to reflect on the recent past and look forward but so are days, weeks, months and seasons. For the overwhelming majority, all of these pass without even minor consideration. I’m not opposed. I just don’t get the idea or get into the idea the way a lot of people do. It seems a little arbitrary to pick a unit of measurement and mark it as an occasion. That said, I’m usually up past 12 on any given night and if I’m anywhere near a glass of scotch while somebody’s celebrating something — I’m happy to raise a glass.

It stands to reason that I don’t really make New Year’s resolutions. They, like most human conventions, are made to be broken and tend to mean little even when successful. Let’s face it — there are better ways to spend an entire year than trying to lose 10 vanity pounds and most resolutions are just a holiday approved way of saying, “…but this time I really mean it,”  about things people were already trying to do all along. Managing money better, fighting with the family less, finishing a forgotten project — what happens to make us drop the ball by the end of the month? We probably stop because it stops being important. I just don’t think the one year marker is the most tangible or realistic motivator toward moving forward. I think of more real and organic moments on which I might hang a marker and commit to change — the kind of subtler moments that pass without fanfare, the kind toward which there isn’t a countdown.

One such moment was on the morning of Christmas Eve last year. I got an email about Ray Sandford’s battle to stop his own forced electroshock (ECT). The day before, he lost at the hearing he had fought so hard for — a hearing which should have restored his rights. It didn’t. Ray had hoped the coming holiday would delay his forced shock for the week. It didn’t. His shock was to be carried out on schedule, December 24th. Knowing his memory and sense would be so rocked by the ECT that he wouldn’t be able to share the holiday with family, he had tacos with his aunt the night of the hearing to celebrate Christmas.

I read that email just before heading out to get some food to take to various family events. I had two or three houses to go to that day and somewhere in Minnesota, Ray was perhaps already being escorted from his home for an electrically induced seizure — knowing his Christmas festivities consisted of tacos and a hearing that turned out to be a charade. In one moment, while driving alone, I committed myself to doing whatever I could from that day forward to help bring Ray’s forced “treatments” to an end.

It took almost a year, but Ray won his fight. He and everyone who took action in support of him have  reason to celebrate. I was only one small voice in the crowd but as it turns out, it was public pressure that caused the psychiatrist who ordered the forced ECT to remove himself from the case. Ray got a new doctor opposed to forced shock and a new guardian. It worked because Ray spoke up and kept speaking up and because other people joined in — calling and emailing the appropriate agencies, informing the media, protesting, letting the local politicians know where they stand. It worked because people committed to action and stuck with it.

It doesn’t matter what number is attached to the year but maybe it does make sense to break time up into manageable chunks. Maybe we can take a little time and consider how much change we can achieve in the course of a year. Use a reasonable amount of time and consider real and achievable action. Look into current and proposed assisted (forced) outpatient treatment laws in your state. Find individual instances in which someone needs a voice or a number of voices behind them and offer yours. Look for an instance in which complacency on our part separates someone else from their basic human rights. These problems are not in short supply. Speak up, create something, destroy something, do something that matters this year, this month, this week, even today.

Submit a comment to the FDA (here or here) insisting that ECT be tested for safety and efficacy in the one week remaining. Sometimes there is a countdown.

December 31, 2009 at 7:52 pm

All I want for Christmas…

…is for you to comment to the FDA and ask that they do their job and test shock treatment (ECT) devices. It doesn’t matter how you feel about human rights, mental illness, recovery, psychiatry — any of it. All that matters is that the FDA has an obligation to test a medical device, especially one that is used involuntarily on our citizens, for safety and efficacy. It really is that simple. ECT is no gentle process. They are inducing grand mal siezures with electricity. Does that sound safe and effective to you? Please comment in the 16 days we have left.

From the Law Project for Psychiatric Rights:

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 supposed to be investigated by 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.

Click here for more.

You can make comments in writing to Food and Drug Administration, Dockets Management Branch (HFA-305), 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

You can also submit comments by going to www.regulations.gov and either type in electroconvulsive therapy as a keyword, or the number of the federal register notice: 2009-N-0392

The Federal Register Notice can be found on PsychRights’ website athttp://psychrights.org/Actions/FDA/090910FedRegisterFDAElectroshockReclassDkt.pdf

If you are not in a position to write something up, then please send in the below coupon:

————————————————————————-
To: Food and Drug Administration, Dockets Management Branch (HFA-305), 5630 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 PreMarket Approval Applications for the device.

Name:    _____________________________

Address: _____________________________

_____________________________

Signature:____ _________________________

Also, The Opal Project has made it incredibly easy by allowing you to comment directly on their page which will then forward your comment to the FDA. It takes moments. It’s as easy as typing your name, address, email and opinion.

Click here to comment via The Opal Project.

December 23, 2009 at 8:38 am

Memory is Sacred

This painting is not yet for sale as it will be part of an upcoming show. More soon.

The FDA could very well be on the way to approving electroconvulsive therapy (shock treatment) without the benefit of clinical trials to determine safety and efficacy. This is great for the psych and shock industries but a terrible step in the wrong direction for you and me. ECT is currently legal and administered to approximately 100,000 people in the US and 1 million globally. It is often happening with poorly informed consent and also by force. The ECT industry depends on its untested approval because it simply can’t pass the test. It has never proven to be predictable, safe or effective. Typically the only long term effects are the adverse effects, while the perceived “benefits” are temporary, requiring “maintenance treatments”.

Regardless of whether you stand aside me or in opposition to me in terms of the rights of people diagnosed as mentally ill, the FDA has a job to do and failure in this instance sets a precedent we can’t afford. If ECT gets reclassified it will be as a favor to a large and prosperous industry and  not in the interest of health of any kind. You don’t have to join a group, a team or a movement to be able to say you spoke up when it was necessary.

The FDA is open to comments on the issue but only for a limited time and, as it stands, proponents are speaking over opponents ten to one. I, for one, am tired of seeing victory go to the people who speak the loudest instead of those who are actually right. Here are two links that provide information on the matter. Both MindFreedom International and Jim Gottstein of PsychRights have laid out the facts and made it extremely easy to comment to the FDA.

December 4, 2009 at 9:24 am 1 comment

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