FDA ECT Meeting (I almost missed this) & January White House Disability Call

From MindFreedom International:

The US Food & Drug Administration holds a meeting about electroshock device

The US FDA announced that on January 27 and 28, 2011, a US Food & Drug Administration committee will "discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy."

what Forum

when Jan 27, 2011 08:00 AM to Jan 28, 2011 06:00 PM

where Gaithersburg, MD

contact name James Engles, FDA

contact phone 301-443-0572 code 3014512513

attendees All are welcome.

US Federal Committee To Have Meeting About Electroshock Devices

Location of FDA meeting:

Hilton Washington DC North/Gaithersburg, Ballroom, 620 Perry Pkwy, Gaithersburg, MD.

More info from FDA web site:

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm234979.htm

Background:

~~~~~

The FDA has appointed an advisory committee to assist it to determine if electroconvulsive therapy (also known as electroshock) devices will be moved from Class III to Class II, or as many have proposed, to require the manufacturers to submit a "Pre-Market Application" which they should have been required to do 35 years ago.

If the Committee agrees to downgrade the risk of ECT to Class II, it will be more readily available, and the manufacturers may never have be required to prove either that it is safe, nor that it is effective.

ECT survivors may briefly speak to the committee in this public meeting to provide their story or perspective on the harms caused to them by ECT.

Communication of long term harms is especially important, as the manufacturuers and ECT advocates are minimizing ECT long term ill effects - such as long term memory loss, as well as long term effect of reducing ability to learn and remember new information.

The FDA states that persons wishing to speak at this important meeting may contact James Engles at James.Engles@fda.hhs.gov. While a deadline of 14 January is listed to ask to speak, the sooner the better.

There will certainly be psychistrists and manufacturers representatives and others claiming ECT is a life saving treatment. The Committee needs to hear from people who know the true risks of electroshock.

From the Whitehouse:

In order to help keep you more informed, we are hosting monthly calls to update you on various disability issues as well as to introduce you to persons who work on disability issues in the federal government.

This call is off the record and not for press purposes.

We strongly urge and ask that you distribute this email broadly to your networks and list serves so that anyone who wants to participate can do so.

Our next call will be Monday, January 10 at 3:00 PM Eastern.

The conference call information is below.

Dial in: (800) 230-1093

Title: Disability Call (use instead of code)

Date of Call: 01/10/2011

Start Time: 3:00 PM Eastern

For live captioning, at time of call, log onto:

http://www.fedrcc.us//Enter.aspx?EventID=1679107&CustomerID=321

Again, please distribute widely.

How to Survive Therapy: Tips 9-16 Cheryl Style

9) If you're in the kind of therapeutic relationship where the therapist generally runs the show, decides what to talk about, and you just go along with it, BUT one week you have something you need to say that you're sure won't be on the agenda...

Call / text / email them, whatever their preferred method, enough in advance that you're SURE they saw it, and simply say "I have something specific I want to talk about this week." They'll be so curious about what it is, and so shocked at your unusual behavior that they'll ask you what it is first thing and you'll have plenty of time to talk.

10) Use students with CAUTION.

They're cheaper (or sometimes free) but the quality you get is iffy. The first student I saw was clueless. The second was GREAT! [Not to say that this hasn't happened to me with licensed professionals also] The other thing you have to consider is that you'll end up having to get a new therapist every year or every other year. Are you OK with explaining your history over and over?

11) If a therapist thinks that antagonizing you / pushing your buttons is good therapeutic motivation, chew that one over.

Maybe it is, but maybe they're reinforcing negative behaviors you'd like to curb.

12) If a therapist utters the words "people like you," or "those people," repeatedly, or even just once, FIND ANOTHER THERAPIST!

Back to the putting people in boxes thing, but HOW ABLEIST!!!! ICK! And PATRONIZING! I'm not a diagnosis, I'M A PERSON! G-d damn it! There is no person like me! Treat me! Help me! NOT my diagnosis! Can you tell I have baggage???

If your reading this blog chances are you have some grasp of the medical, social, charity models of disability. Way to medicalize! Not everyone knows disability theory of course, but some people just innately know NOT to medicalize people. FIND THEM!

13) Take your medication. Or don't. But then try yoga or something...

My point in this is not to be all, bow down to big pharma. The idea of being forcibly medicated sends chills down my spine. My point is that you need something to put you / keep you in balance, be it a mood stabilizer or an acupuncturist. Therapy works best in conjunction with things. Someone I know swears by his chiropractor, another by transcendental meditation, and another swims 10hrs / week. Do it with pills or without. Whatever floats your boat.

Feel like your treatment team is being too forceful, intentionally giving you a one sided picture of things, (especially of DANGEROUS things like ECT), or is even just the tinyist bit vague? Antagonize them. One pdoc suggested maybe I try a medication that, after searching the interwebs, I discovered has a possible side affect of muscle spasm with pain. I thought I was the crazy one. He's crazy for even considering this medication for someone with a diagnosis of spastic CP.

14) JOIN A PEER SUPPORT GROUP!

In addition to the yoga, time with furry creatures (a favorite of mine), or whatnot.

Who has the money to go to 6hrs of therapy a week? What therapist wants to see you everyday of the week? Unfortunately, they won't let you stay past an hr. Sometimes you need more then an hour in one sitting. Try searching for a DBSA affiliated group. My group is open 2.5hrs twice a week for unstructured time, followed by a 90min support group both days AND is open a 3rd day for a 2hr WRAP session. It'll get you through hopefully... My therapist might be more grateful then I am...

Don't be nervous to find out that there aren't any licensed professionals present at a peer run support group. "They're" not as crazy as you think, and can share more honest stories then a professional can. Plus, peers don't tend to medicalize.

15) If your therapist can't coordinate with your other treating professionals, DITCH THEM!

I'm not even talking about keeping in touch with my botox doc aka pain doc aka physiatrist (the technical term) because that is so complicated (Um, NOT! See #2). Let's start with the most basic and work up to that one. I once had a therapist and a pdoc who had never heard of each other, nor made any attempt to contact each other. Now if that isn't essential, I don't know what is...

16) Lastly, if you happen to find someone who is email savvy, is actually interested in what you have to say, DOESN'T medicalize or make you want to punch a wall, will willingly coordinate with other treating professionals, AND is open to your ideas for alternative treatments, HOLD ONTO THEM. They're a rare breed...

FUCK YOU APA

ECT ruins lives. Where/how do you submit comments? Can anyone figure that out? From baltimoresun.com

Psychiatrists Change Their Recommendation for Depression's Treatment

The American Psychiatric Assn., which labored to bring forth a revision of psychiatry’s “Bible” earlier this year, has just released a more modest opus likely to generate much discussion among mental health professionals.

With the release on Friday of its “Practice Guideline for Treatment of Patients with Major Depressive Disorder,” the nation’s leading psychiatric association makes a number of subtle adjustments to its past treatises on depression and its treatment. The new guideline is the first comprehensive update of the organization's guidelines for depression treatment since 2000.

For starters, the APA throws its considerable weight behind the rehabilitation of electro-convulsive therapy (a.k.a. “shock therapy”) as an effective recourse for those who fail to respond to antidepressant treatment. [emphasis mine]

The practice guideline ventures to say that for many patients with chronic or recurrent episodes of depression, “maintenance therapy”—including antidepressant medication and possibly ongoing psychotherapy—may need to continue “indefinitely.”

The guideline reveals a rift between the group drafting the document and the broader “Steering Committee” of psychiatrists on the value of psychodynamic therapy —an often-lengthy series of talk therapy sessions in which patient and therapist probe early-life experiences for the sources of negative thought patterns. While the authors of the guideline would have given psychodynamic therapy an extremely tepid endorsement as an effective depression treatment, the broader board of psychiatrists elected to recommend it “with moderate clinical confidence.” (Both recommended cognitive behavioral therapy without reservations.)

Finally, the association in its latest update bows to the “at least modest” value of physical activity — either aerobic or strength exercises -- in relieving symptoms of mood disturbance, and possibly in preventing depression.

The authors of the practice guideline also engaged in a level of self-disclosure that is new for many psychiatrists. The guideline opens with two pages detailing the extensive ties of those who drafted the document with the pharmaceutical industry. Of the work group’s seven members, all but one declared that he or she received research support, consulting payments, speaking fees or author’s honoraria from several firms developing, manufacturing or marketing psychiatric drugs.

The American Psychiatric Assn. sought to counter any appearance of undue pharmaceutical-industry influence by establishing an “Independent Review Panel,” whose five members were free of any direct financial ties to drug companies, and were charged with “identifying any possible bias.” That panel, the APA reports, “found no evidence of bias.”

--Melissa Healy/Los Angeles Times

Write the FDA About ECT

From Linda Andre, Director of the Committee for Truth in Psychiatry, found on the JFA Blog, so sorry I found out so close to the deadline:

Dear Friends and Fellow Advocates,

Many of us in the disability rights movement, especially those of us living with psychiatric disabilities or labels, have good reason to be concerned about ECT (shock treatment): We've had it or know folks who have and we know that psychiatrists aren't honest about its permanent adverse effects. We also know that shock is frequently forced on people who say no to it.

Now there is something all of us can do about shock: we can tell the federal government to investigate it for safety.

The government has the power to do this through the Food and Drug Administration, which regulates the machines used to give shock. (For all intents and purposes, the machines and the treatment are the same thing.) Did you even know that the shock machine has, for over thirty years, been exempted from the scrutiny that all other medical devices must go through? That it has never undergone even one clinical safety trial, and that the manufacturers have never provided nor been asked to provide a single shred of evidence that their devices are safe? It's true. (I tell the whole story of the battle between doctors and patients over whether shock should be investigated or not in my new book "Doctors of Deception: What They Don't Want You to Know About Shock Treatment" from Rutgers University Press, http://doctorsofdeception.com)

In other words, a generation of shock patients have been experimented on without their consent. And they've submitted to a procedure without knowing its risks.

But those of us who've had it know that shock always causes permanent memory loss, brain damage and cognitive deficits. And this often results in permanent, preventable iatrogenic (doctor-caused) disability.

That's why organized shock survivors and our allies have been lobbying the FDA for a safety investigation of ECT for over 30 years, without success. The American Psychiatric Association opposes an investigation.

Now the FDA is being forced to take action; it can no longer delay a safety investigation of the ECT device (known as a PreMarket Approval Application in FDA language) but it will not risk running afoul of the APA. As a way out, it is looking at simply administratively reclassifying the shock machine from Class III (the high risk category for medical devices which have not been proven safe and must be investigated for safety) to Class II (the low risk category for devices such as X ray machines and mercury thermometers). If it did so, the ECT device would never, ever have to undergo any clinical trials. Reclassification would mean the FDA agrees to accept the APA's word that shock is safe, without scientific evidence.

As it ponders its next move, FDA has done one good thing: It has asked for input from the public.

It has opened an official public docket on ECT and by law must read and consider everything sent to it. But comments will only be accepted up until January 8, 2010.

It is important that all of us who are concerned about the rights of labeled and dislabeled people write. The comment can be about personal experiences of yourself or others or simply an appeal to science, logic, and the FDA's duty to protect patients. A good point to make is that if the FDA administratively declares shock safe without an investigation, patients will not have the information we need to make our own decisions about what happens to our brains and bodies. Another good point is that shock is often administered involuntarily, and since shock machines are the only Class III medical devices that can be used on a person against his or her will, the FDA has to be more cautious in regulating these devices, not less.

A short comment would be as follows:

I oppose the reclassification of the ECT device to Class II in the absence of adequate scientific evidence of its safety, and request that the FDA call for PreMarket Approval Applications for the device.

Comments can be sent either by mail or electronically, but in either case must include the docket number, which is FDA 2009-N-0392.

The address for written comments is:

Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 208252
Re: Docket #FDA 2009-N-0392

Submit electronic comments at: http://bit.ly/FDAECT

Please copy, forward and snowball this message! Every comment is counted and every one is important.

----------------------------------------------------

My letter:

I'm writing in response to docket #FDA 2009-N-0392 As a mental health consumer I am horrified that the manufacturers of ECT devices have never been required to submit PreMarket Approval Applications. This makes me physically sick as this is one of the most invasive medical devices currently in use and patients are continually subjected to ECT against their will. EVERYONE has a constitutional right to have control over their own body and people should not be forced to waive this right just because they have a disability. EVERYONE should have the ability to be fully informed about all medical procedures that are preformed on them. This cannot happen without rigorous testing of the ECT device.

I oppose the reclassification of the ECT device to Class II in the absence of adequate scientific evidence of its safety, and request that the FDA call for PreMarket Approval Applications for the device.