Monday, July 15, 2019

FDA Plans to Deregulate Electroconvulsive Therapy

January 5, 2011 by  
Filed under CCHR Issues

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!

Gaia Health

by Heidi Stevenson

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. Peter 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. Peter Breggin points out that the chair, Richard 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 Peter 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.

You can also read the article here.

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