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

It’s Only Murder if You’re Sane

The Gothamist reports that:

On Wednesday, police found the body of a nude woman in Marcus Garvey Park in Harlem. Although initial reports suggested the woman may have been emotionally disturbed, last night police announced that they were treating Nina Rivera’s death as a homicide.

So, it’s one or the other is it? I don’t know whether this little blurb is a statement on the Gothamist’s “journalism” or the NYPD’s approach. Either way, there’s a severe problem of perception here.

December 6, 2010 at 11:20 am 4 comments

It’s Been Quiet Around Here

But I intend to be back at it. My life has been interrupted in a number of ways and my energy has had to be focused elsewhere. That’s ok, that’s life for most of us but I’ve found myself in a position to use some of my time differently. It may be a little sporadic at first while I feel things out but if there’s still anyone paying attention to this thing, you can expect new posts to become a regular occurrence.

I don’t mistake activism and blogging for being one and the same or even necessarily related though I have found that my posting here and my activism in the real world have dropped off simultaneously. I don’t think anyone being swindled by pharmaceutical companies, abused and neglected by the system or ostracized by their neighbors is waiting for my next post any more than abused children are waiting for a million people to post cartoons on their facebook profiles. There is a real world change to be brought about. That said, I see power in getting a message out and its ability to ignite people, myself included, to be a part of that change. Besides — if you look around long enough, you’ll see that some things just can’t go unsaid.

December 6, 2010 at 10:51 am

Hard Times in Toyland

No more pretend ECT for Barbie’s depression or antipsychotics for GI Joe’s PTSD — finally, the line of toys every budding psychiatrist has been waiting for — toys with specific mental illnesses already laid out from the German “asylum” that pumps them out.

These plush “patients” are the idea of Martin Kittsteiner from Hamburg, Germany. Each of the five toys from Paraplush has a specific psychiatric disorder presented in distinctly psychiatric terms on Paraplush’s online store — or as their website calls it, The Asylum: Psychiatric Clinic for Abused Cuddlytoys. Dub is a turtle suffering from depression, Dolly is a sheep suffering under the delusion that she’s a wolf and Kroko is battling paranoid psychosis and so on. Maybe the “asylum” can better relay the plight of these troubled toys. For example, Kroko, a crocodile:

The patient’s hypersensitive hallucinatory perception is a symptom of a paranoid psychosis. The signs are a mental block and a Gestaltzerfall (disintegration of structure) of the habitual field of experience. The consequence is a compensational reactivation of archaic reaction patterns.

The patient needs your help!

For the kid that just can’t help enough, they are available as a set — you know, for group therapy sessions.

The psychological dynamic of a group will challenge your analytic skills and leads to a complete new understanding of therapeutical treatment. Notice the relationships between different patients and discover the structure of a collective plush-subconscious.

Kittsteiner says of his creation,

“Children and grown ups like their vulnerability and find something in them that gives them a great sense of comfort in helping to heal them.”

Just like Cabbage Patch Kids come with adoption papers from Babyland General Hospital, these dolls are shipped out to your kids complete with medical histories and treatment plans. It is, after all, their new little owner’s job to  treat them — and really, who doesn’t like to revel in the vulnerability of the mentally ill?

It’s bizarre on so many levels and only becomes more so when you poke around on their website a little. There are illustrated posters detailing the theory of “plushtoy psychoanalysis” and treatment options and there’s even a game.

At least we can still count on Germany to offer up healthy approaches to mental hygiene.

September 11, 2010 at 5:08 pm 3 comments

What’s Beyond…Beyond Meds?

We shall see. Gianna Kali has announced that her popular and informative blog, Beyond Meds, has reached its end.

Thank you to all my readers for being part of this transformative journey with me. It’s time for me to move on and do other things.

This blog, depending on which ranking system you look at, is between number 1 and number 5 or so of non-pharma funded mental health blogs. I feel good about leaving and that the work has been a success. — Gianna Kali

It was one of the few blogs that I checked regularly and I know many people (myself included) have found it to be of use in so many ways — news, information, inspiration, encouragement or to know they weren’t the only ones experiencing an intensely harsh withdrawal from psych drugs, particularly benzos. It was a great blog and I’ll miss seeing new posts from Gianna. Past posts, however, will remain as a resource — and with such a wealth of information and personal experience, it’s one hell of a resource.

For something as simple as a self-supported means of relaying thoughts and information to have a direct and positive effect on people’s lives is remarkable — maybe the best we can hope for — and she’s done it many times over.

Gianna is ending Beyond Meds to move forward with her life beyond the keyboard and I’m glad she’s at a point in her recovery to even approach that next step. At some as yet undetermined time, we can expect another blog from her, focused on more positive things and free from the heavier issues that make up the broken mental health world. I can’t wait. It’s not one topic that makes her blog what it is, it’s her openness and perspective. I look forward to seeing what she approaches with these qualities next.

I wish her well, both in the “blogosphere” and beyond. I’m sure good things are to come as she determines her own future. If she clues us in, great. If not, I’ll assume she’s out living life — beyond meds and beyond the internet.

September 5, 2010 at 11:02 am 5 comments

Spit, Bristle and…Ad Space?

I’ve just discovered some ads right here on this weblog, selling some of the very things I’m railing against. I’m sorry if anyone has seen any of them and found them to be exploitive or offensive. I’ve found them to be both.

I have contacted WordPress about the ads and if necessary will pay for an upgrade to keep them off my page and out of your sight. Please disregard them until I get the issue resolved. I understand the supposed necessity of ads on a free service but we shouldn’t have to pay to keep from having a part in promoting what we are opposed to.

As I hope to resume regular updates this week and increase and rebuild readership, it will become increasingly important. For now I hope all ten or so of you have not been too put off by the ads!

August 29, 2010 at 3:45 pm 1 comment

It’s Just Like You’re One of Us (But With a Steel Strap and a GPS).

So this is what it’s come to? We’re willing to tag and track people based on a diagnosis? Oh that’s right, we’re not doing it to each other, only those sick ones we’ve so self assuredly separated out.

South London and Maudsley Hospital is trialling tracking of mental health patients. The tracker system involves fitting patients with a steel ankle strap linked to a GPS tracking system that can then monitor the location of the person.

As Gianna Kali of Beyond Meds wrote, “If you don’t automatically think ‘civil and human right violation’ there is something wrong with you.” I couldn’t agree more and would go so far as to say that you are part of the problem. There are two reasons these things happen — people in power are willing to disregard our rights and  the public is willing to allow it.

In response, a Department of Health spokesperson said;

‘This is a locally led initiative, not a national pilot.

“Patient rehabilitation into a community is an important part of recovery, but it relies on good risk assessment, trust between the patient and the service and patient responsibility. There can be no substitute for staff knowledge of patients to properly assess risk and to make the right decisions to ensure safety”.

Trust between the patient and the service? Is this what trust looks like — a steel strap with a tracking device? Maybe I’m reading this all wrong and they just mean the patient should trust the system. Personally, I have a problem trusting anyone with more power than regard for my interest. Similarly, rehabilitation only calls for patient responsibility. If it called for responsibility on the part of the system, we’d need a new one, rebuilt from the ground up.

What do you think this does for the idea of inclusion, by the way? I can’t imagine that a person wearing a device that advertises their private struggles and places them socially between a criminal and an animal to be studied is very well received in public situations. Perhaps we could forego the cost and complication of these devices and just go ahead with a ball and chain and scarlet letter…oh yeah, rights. We better keep it digital.

August 29, 2010 at 10:30 am

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