FDA Plans to Deregulate Electroconvulsive Therapy

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FDA Plans to Deregulate Electroconvulsive Therapy

In a time when the FDA is criminalizing raw milk and classifying foods as

controllable drugs, they want to limit control of a device whose sole purpose is

to cause seizures and brain damage!

by Heidi son

11 December 2010

If you thought that electric shock treatment was a thing of the past...well,

it's come back under a new name, electroconvulsive therapy (ECT)—and the FDA

intends to make it even more common. January 27-28, they're holding a meeting of

the Neurological Devices Panel of the Medical Devices Advisory Committee. Though

they say it's for discussion on the issue of ECT, they've already signaled that

they support changing the class from III, the most restrictive, to II, which

could even exempt manufacturers from having to seek FDA approval to market them.

That's right, in a time when the FDA is criminalizing raw milk and classifying

foods as controllable drugs, they want to limit control of a device whose sole

purpose is to cause seizures and brain damage! In every sense, a seizure is an

indication of something wrong with the brain.

Electroconvulsive Treatment

Before discussing what the FDA is planning to do, let's review what

electroconvulsive treatment is.

Terminology

In an attempt to soften it, the term electroshock therapy was changed to

electroconvulsive therapy, and then shortened to ECT. The acronym won't be used

here again, because it hides the ugly truth. When enough electricity is applied

to someone's head, it causes a seizure, which is another term for a convulsion.

Thus, electroconvulsive therapy. Let's get away from the term therapy, because

that's not what it is. It's a treatment. So, though it takes a bit longer to

write out and say in your head or speak, the proper term is electroconvulsive

treatment, and it's no softer a term than the original.

Definition

Electroconvulsive treatment is the application of electrodes to a patient's

head, and the subsequent application of high charges of electricity through

them. The purpose is to cause a seizure. By some sort of magical thinking, the

doctors who do this claim that having an induced seizure will cure mental

illness, though all other seizures are treated as indicative of a serious

problem. So, what makes these seizures different? Apparently, it's the fact that

doctors are producing them.



In another example of the magical thinking that goes with electroconvulsive

treatment is the claim that it's perfectly safe for pregnant women. However,

when a pregnant woman receives an electric shock in any other manner, she's

advised to go straight to emergency treatment.

Is there any real difference between an accidental electric shock and

electroconvulsive treatment? In a word, no. The body and brain make no

distinction between sources of electric shock. The response is the same.

The Purported Modern Improvements

It must be admitted that watching someone undergo electroconvulsive treatment is

nowhere near as upsetting as it once was. The reason is simple: Doctors now drug

patients heavily to keep their bodies from reacting so violently. Thus, they

aren't seen to shake and jump and vibrate and go into spasms. There is one

benefit: Patients no longer get broken bones from the spasms, and that's

certainly good. Before the institution of drugging, it wasn't uncommon for

patients to suffer broken spines.

The fact that patients no longer suffer broken bones, though, doesn't mean that

the procedure is safe. The lack of safety is, in fact, tacitly noted by the

American Psychiatric Association (APA), which advocates for use of

electroconvulsive treatment. In their " Recommendations for Treatment, Training,

and Privileging " (1), they state:

Most practitioners using unilateral electrode placement routinely place both

electrodes over the right hemisphere, since it is usually nondominant with

respect to language even for the majority of left-handed individuals.

In other words, the risk to the brain is understood, and they certainly wouldn't

want to be caught doing obvious damage, like harming someone's ability to speak.

It should also be noted that the addition of anesthesia and muscle relaxing

drugs increases the risks to the patients, since they also have adverse effects.

The APA's instructions refer to " stimulus dosing " , which means simply the amount

of electricity to apply. Interesting, isn't it, that they don't say electrical

shock, but choose to use the evasive and vaguely medical-sounding term, stimulus

dosing?

The goal is to " produce an adequate ictal response " . Ictal response is

medicaleze for a seizure. They insist that, if " an adequate ictal response has

not occurred, restimulation should be carried out at a higher stimulus

intensity " . So, if the patient hasn't yet suffered a seizure, just increase the

juice until he does!

Pain

Nowadays, the enlightened doctors anesthetize patients before doing

electroconvulsive treatment. However, the trauma that caused the pain is still

experienced by the body, and doctors have yet to explain how that trauma can

possibly be helpful.

Memory Loss

A very large percentage of people, probably most, who undergo electroconvulsive

treatment suffer from memory loss, both short and long term. For some, it's

temporary—at least, that's what we're assured. The reality, though, may be

quite different. Many patients say that their lives have been ruined, that their

memory has never come back. Some complain that they cannot even track their

thoughts from moment to moment. Careers are lost. People often no longer know

just who they are. Lives are destroyed.

Worse, they express dismay that their doctors dismiss their complaints. It's no

wonder, though. Brain damage cannot be fixed. When neurons are destroyed, most

never manage to repair themselves. The term doctors use for this brain damage is

therapy.

Some People Get Better, Don't They?

There must be some benefit for patients, or doctors wouldn't do this—would

they? The answer is that it's been well documented that electroconvulsive

treatment causes brain damage. Here is what Dr. Breggin has to say on the

issue:

Patients given ECT are administered an electric current of sufficient intensity

and duration to produce an acute organic brain syndrome, characterized by the

classic symptoms of disorientation to time, place, and person; mental

deterioration in all intellectual spheres such as abstract reasoning, judgment,

and insight; emotional lability with extremes of apathy or euphoria; and overall

childlike helplessness.

Animal studies show diffuse brain damage following ECT: the most common findings

are petechial or pinpoint hemorrhages throughout the brain and surrounding blood

vessels, as well as areas of gliosis and neuronal degeneration, with patches of

cell death (ghost cells and neuronophagia). Occasionally larger hemorrhages and

edema of the brain are found. These findings are also seen on human autopsies

performed on ECT patients.(2)

Chillingly, Dr. Breggin wrote this about electroconvulsive treated patients who

believe they're unharmed:

Most damaged ECT patients minimize or deny their real losses. This is because

damage to either half of the brain, but especially the nondominant, tends to

induce a nosognosia—psychological denial associated with brain damage.

Advocates of ECT are well aware that shock patients suffer from anosognosia and

therefore cannot fully report the extent of their memorv losses and mental

dysfunction. Yet these same advocates claim that patients exaggerate their

post-ECT problems . Interviews with family and friends of patients often

disclose that they are painfully aware of the damage done to their loved ones.

Often. the psychiatrist is the only one who consistently and unquivocally denies

the patient's damaged state.(3)

The FDA

So, we have an inordinately dangerous procedure that always causes brain damage,

and any benefits seen are, apparently, illusory. So, the FDA should be

considering banning it. But they aren't. Instead, they're pushing towards

eliminating most control over it.

Dr. Breggin writes about a previous FDA attempt to ease restrictions on

electroconvulsive treatment. The amount of dishonesty on the part of the FDA is

stunning. Breggin notes that the FDA refused to consider documentation that

supports the banning, not just restriction, of the procedure. He notes that the

FDA referenced studies of poor quality to support easing of restrictions.

Breggin points out that, " In 1979, the FDA classified shock devices as

demonstrating 'an unreasonable risk of illness or injury. " Naturally, the APA

didn't like that, so they pressured the FDA, which capitulated, saying they'd

reclassify the procedure as safe. In spite of an outpouring of pleas from

hundreds of injured electroconvulsive treatment surivors, the APA got its way.

Breggin wrote:

The FDA' s final report reads remarkably like the APA's report. Although no

large animal studies have been done with shock devices since the 1950s, and

although those earlier studies consistently demonstrated brain damage, the FDA

defined ECT devices as safe for depressed patients. Curiously and without any

apparent logic, the FDA reclassified the treatment as safe only for depressed

patients. However, psychiatrists will not find it difficult to diagnose their

patients to fit the treatment.

The FDA committee that made the decision was not composed of people who looked

at the issue objectively. Breggin points out that the chair,

Weiner, was the official representative of electroconvulsive treatment at the

FDA hearings. Of the other six members, Max Fink and Harold Sackeim were noted

as " among the nation's most zealous defenders of the treatment " . No input from

patient organizations was asked for, and the opinions no professionals critical

of it were wanted, either. On the other hand, the FDA utilized manufacturers'

advertising handouts as useful information. Breggin goes on for several

paragraphs delineating how the expertise the FDA accept was severely imbalanced.

Upcoming Meeting

The FDA is now planning to take the next step, to loosen the rules controlling

electroconvulsive treatment, and they appear ready to acquiesce to what amount

to demands by the APA. Reviewing their announcement of the Advisory Committee

Meeting, it seems that transparency is not their goal.

The public is not to be provided with background material for the meeting until

two days before it takes place—and that's not a promise. The website states:

If FDA is unable to post the background material on its Web site prior to the

meeting, the background material will be made publicly available at the location

of the advisory committee meeting, and the background material will be posted on

FDA’s Web site after the meeting.

So, the FDA may provide background information on the meeting two days before it

takes place, and if they don't...well, then they don't. Too bad.

Inability to Comment

People interested in speaking at the meeting may request to do so on or before

the 14th of January. If too many people ask to present, then the FDA may select

who speaks by lottery. Then again, it may not, and may decide who they want to

speak. In any case, the lucky winners who get to speak will be notified on the

7th of January—a full week before the deadline for applying.

The FDA's website also says that public comment may be made, and they even

provide instruction in how to do it. They tell you to go to the website

http://www.regulations.gov, and use the Docket Number FDA-2010-N-0585 as the ID

to find the meeting announcement.

I tried to enter a comment. And tried and tried. There is no way to enter a

comment. The date it was supposed to be open for comments was 26 November 2010,

and it isn't supposed to close until 25 January 2011. I've sent a message asking

how to do it, and will keep you posted here when information comes in.

Update: On being unable to enter comments, I sent a message about the problem.

The response just arrived. You may now comment by clicking on this link. The

page that comes up is a copy of the information posted on the FDA's meeting

announcement page. Just click on the " Submit Comment " link near the top of the

page to tell them what you think of electroconvulsive treatment.

At the very least, the public's lack of ability to comment on the upcoming FDA

plans regarding electroconvulsive treatment helps to confirm suspicions about

their intent. Added together with their misleading information about how to

register to speak leaves the strong impression that they are not interested in

what the public has to say. Then, when you also factor in the, at best, short

term access to information about the topic of the meeting, coupled with no

promise to actually provide it even for that very brief time period, an obvious

pattern of keeping the public out is revealed.

The Future of Electroconvulsive Treatment

All indications are that the FDA intends to deregulate electroconvulsive

treatment, no matter what the evidence or what those who have experienced it

say. As Breggin noted:

[Electroconvulsive treatment is] by far the most remunerative treatment in

psychiatry. Shock holds a special place in the financial recovery of many

psychiatric units and individual practitioners

So, the bottom line wins. There's simply too much money to be made by

electrocuting people's brains to let the patients' bad results get in the way.

The FDA intends to assure the security of the money flow into the pockets of the

manufacturers of electroconvulsive treatment machines and the coffers of the

doctors who apply it—not to mention those of the APA.

For the amorally inclined, electroconvulsive treatment is a good gig. If the FDA

can make it happen—and they're pulling out all the stops to assure it—their

future looks good. If you're a person with depression, or diagnosed by a doctor

as having it...well, be very very careful.

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