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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?

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January 31, 2011 at 11:01 am 6 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

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

I’m Still Here

Wow, has it really been a month and a half since my last post? Indeed, I have taken an unexpected, and frankly unwanted hiatus from much of my life outside of the things that keep my personal and interpersonal ship afloat. A lot has happened that has made me want to get on here and post but, as is so often the case when I’m burned out or burning out, I either have time, energy or neither but never both.  Hopefully things will get back to (ab)normal around here soon. I’ll start in the immediate future with an image post as I completed some prints last night. I’d like to see things get back on track soon as this little corner of the internet has become strangely important to me.

August 17, 2010 at 8:58 am 2 comments

New Page – A Gallery.

You wouldn’t think it would take so long for me to put one up, but I’ve now posted a gallery. Click the link or look up and click the box that says Gallery in the green bar up top.

It’s not necessarily current and not remotely complete but it’s something. I’ll still post my pieces on the main page when words seem necessary or the image timely but check the gallery once in a while too. If nothing else, it’s an organized way to see the pieces collectively.

I’ll be adding to it shortly as I’ve got some really exciting and very limited print projects in the works, thanks in no small part to the guidance and printing skills of artist and educator, Chad Andrews. I’ll let you know more about that soon.

June 27, 2010 at 2:40 pm

Should Transparency Take this Much Work?

Can a state’s Office of Protection and Advocacy do its job with only half of the information and the other half concealed to shield government agencies and state hospitals instead of  citizens?

From the Associated Press:

WASHINGTON — The Supreme Court says it will decide whether Virginia’s advocate for the mentally ill can force state officials to provide records relating to deaths and injuries at state mental health facilities.

I’m not sure why anyone would think there should be such a blind spot in an agency’s assessment of these facilities. Force implies resistance. Shouldn’t information like that be turned over upon request or even voluntarily recorded and addressed?

The justices agreed Monday to review a federal appeals court ruling dismissing the state advocate’s lawsuit against Virginia’s mental health commissioner and two other officials.

Backing the appeal, the Obama administration said the ruling by the 4th U.S. Circuit Court of Appeals in Richmond “threatens to undermine the enforcement of federal laws that Congress designed to protect especially vulnerable individuals from the abusive and neglectful practices that can result in injury and death.”

The Virginia advocate’s office, like those in the other 49 states, was created under two federal laws that give states federal money for monitoring the treatment of the mentally ill in state facilities. The first law grew out of public reports in the 1970s of crowded, filthy conditions and abusive treatment of mentally retarded children at the Willowbrook State School in New York.

The issue for the court is whether the Eleventh Amendment prohibits a state agency from going to federal court to sue officials of the same state. The state itself could not be sued in the same circumstances.

Argument will take place in the fall or winter.

The case is VOPA v. Reinhard, 09-529.

To read a brief summary of VOPA v. Reinhard II, click here (PDF).

Excerpt (emphasis mine):

The P&A system in Virginia is the Virginia Office for Protection and Advocacy (VOPA). In 2006, VOPA sought records relating to three incidents of deaths and injuries to residents of the Central Virginia Training Center (CVTC) and Central State Hospital (CSH) that occurred while these residents were in the custody of the Department of Mental Health, Mental Retardation, and Substance Abuse Services (DMHMRSAS) (now called the Department of Behavioral Health and Developmental Services).  When DMHMRSAS refused to provide the records, VOPA sought a declaration that this refusal violated federal law…

Additionally, the Fourth Circuit Court of Appeals is in conflict with a recent federal case decided by the U.S. Court of Appeals for the Seventh Circuit in Indiana, who noted that states cannot be allowed to shield their state hospitals and institutions from investigation and oversight — especially not the investigation and oversight created by Congress to fund some of the state’s most vulnerable citizens.

The Virginia decision has effectively rendered VOPA unable to fully exercise its federal authority to protect vulnerable citizens throughout the Commonwealth, even though Congress specifically created P&A systems for protection purposes.  Without access to the records from state-run facilities, VOPA has no way of completing an investigation—and without a complete investigation, VOPA has no way of protecting Virginians with disabilities from abuse and neglect.



June 22, 2010 at 11:33 am 1 comment

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