FDA ADVISORY PANEL RECOMMENDS KEEPING SHOCK MACHINES IN CLASS 3

More info coming, this is fantastic news everyone!!! Thank you to the good people here who worked on this, wrote letters to the FDA, testified, etc. There’s still more to go, the final FDA vote, but this is fantastic!

You all ROCK THE WORLD.

URGENT: FDA Wants to Declare Shock Treatment Safe Without a Safety Investigation! Public Docket is Now Open (Sept. 10, 2009-Jan. 8, 2010)For Your Comments—Tell Them No!

The Food and Drug Administration is in charge of regulating medical devices just as it does drugs, including the machines used to give shock treatment. But it’s not doing its job. It has allowed these machines to be used on millions of patients over the past generation without requiring any evidence whatsoever that shock treatment is safe or effective! This is so even though shock machines are Class III—high risk—devices, which by law are supposed to be investigated by clinical trials as thoroughly as new drugs and devices just coming onto the market. But because of intense lobbying by the American Psychiatric Association—which claims the devices are safe but opposes an investigation—the FDA has disregarded its own law. (For the full story of how shock survivors have fought for a scientific safety investigation of ECT for the past 25 years, see the new book Doctors of Deception: What They Don’t Want You to Know About Shock Treatment by Linda Andre.) Read the rest of this entry »

Linda Andre’s new book scheduled for 2008 publication

Linda Andre’s new book scheduled for 2008 publication

If you visit ect.org next year, expect that I’ll be promoting Linda Andre’s new book! And you’d better plan on buying.

Her book was purchased this week by a major publisher!

This book will shed light on an industry that has fed on a plague of self deception, of defensiveness, and of outright lies. Might as well put the shock industry on official notice: the chipping away at your ivory wall continues. This time, Ms. Linda Andre will be wielding a jackhammer.

I confess I’ve had a peek, and the writing is stunning. That’s not a surprise to me and won’t be to anyone who knows Linda’s skills. It may be a surprise to the “gang” (Sackeim, Ricky and friends), who won’t be able to conceive that she’s far more articulate than they are.

This book will illuminate the practices of an industry the way that my favorite book “And The Band Played On” by Randy Shilts did regarding the AIDs epidemic and the Reagan Administration’s failure to react. In a year’s time, Shilt’s book will have to accept its role as “second-favorite” book.

Please check back in a year, or head to your favorite bookstore to purchase Linda Andre’s upcoming book.

Congratulations, Linda!!!!!!!

Harold Sackeim Mecta deposition video clips

Here are a number of clips from the videotaped deposition of Harold Sackeim (2004). Sackeim was the expert witness for Mecta in a lawsuit in California.

You can read most of the deposition here, in PDF format.

I’m splitting the videos into two pages to reduce your load. If the page loads slowly, or the videos don’t load, try again in thirty minutes…it’s likely YouTube is down.

Richard Abrams is defensive, says Harold Sackeim

Harold Sackeim, king of ECT, discusses his complaints about Richard Abrams, president of Somatics, Inc., saying that Abrams is defensive because of the “fascist” groups, and goes too far with his defensiveness by ignoring the “problems” inherent with ECT. Meow!

[gv data="G9zm6Cqabc4"width="425" height="350"][/gv]


Harold Sackeim tells NY Assemblyman Rivera he “discarded” requests

After making a public offer to evaluate individuals with damage after ECT, Sackeim explains that he told the NY Assemblyman Peter Rivera (D-Bronx) he discarded the responses. They “spent the day” together. How cozy. Rivera is head of the New York Committee on Mental Health. Harold has more than one cozy relationship, and it’s paid off in a big way for him.

[gv data="FiQCYqjalSA"width="425" height="350"][/gv]

Killroy was here

An endorsement? No, but Harold admits he’s been here. Everyone, please, a warm welcome to the Lord of the Dance, Harold Sackeim.

[gv data="0dxpT4ArKjo"width="425" height="350"][/gv]

He’s said it, very clearly

Very emphatically: “I don’t dispute that there are some people who have very severe memory loss. I’ve been the one who’s been saying that very clearly.”

[gv data="QZacmKmDn-8"width="425" height="350"][/gv]
2 million people?

“Uh, what I do know is that probably about 2 million people are receive ECT each year…” When questioned by the attorney asking if he “knows” that, Harold backpedals and says he said “estimate.” A few years ago he told Extra it was a million. I guess that Cyberonics VNS device isn’t working out so well.

Perhaps saying “I do know” and then claiming he said “estimate” is being a tad picky. But consider that this seems to be a habit with him: reinventing himself, parading himself as the champion of the shock patient by criticizing “Dick” Abrams, and claiming he’s a purist scientist, even when he admits statistics were not genuine statistics as claimed, but merely a guesstimate. Since the long-held guess of how many Americans receive ECT annually is 100,000 to 200,000 (usually quoted as 100,000 in the media), where on earth did he get this 2 million figure for the world?

Oh, it’s an estimate. He made it up.

[gv data="12oScZatwKg"width="425" height="350"][/gv]
Follow the money…

Here’s something he can’t make up, because there’s a paper trail. He billed Mecta for $10,875 for pretrial consulting. And that was *before* the trial, or even this deposition, took place. No telling what the final bill will be! His rate is $500 an hour to help Mecta defend against a lawsuit. Notice how he refuses to say the amount, instead, referring to the “rate that’s there.” For whatever reason, Harold Sackeim cannot say the words “I charge $500 an hour.”

[gv data="ZubwVyFmU84"width="425" height="350"][/gv]
Part 2 of the video deposition

Harold Sackeim Mecta deposition video clips, page 2

The Awakening

This clip is an interesting explanation of why psychiatrists have apparently been unaware for 70 years that ECT can and does cause profound memory loss and cognitive damage. The reason? Because until a few years ago, the only persons who complained of severe memory loss also said it didn’t help them. It took finding some patients who experienced devastating memory loss who would also proclaim it “saved their life” before Harold Sackeim would listen.

Hey, I’m not the one who said it…Harold is. He’s the champion of the shock patient, at least in his own head. Maybe he needs to revisit the early years of Sackeimology, when his research revolved around self deception, the lies we tell ourselves.

Harold (call him doctor, damn you!) relates an interesting story, if true. He’s been known to make up statistics and a vignette or two. And he questioned whether or not the individuals on ect.org were really ECT patients. That’s called projection, Harold. Or deflection. You should have learned these terms when you studied Sackeimology.

The story takes place at an ECT donut course. (Shock docs and donuts are like cops and donuts.) One of the “very famous people” (that could really only be Abrams, Fink or Kellner, probably the Finkster) announced that profound memory loss just doesn’t happen. But our hero Harold asked the audience – all shock docs – if they’d encountered it. Two-thirds raised their hands. Oops. 70 years of denial down the drain.

It was almost a watershed moment, he says. The only thing missing was the heavens opening and the Angel Gabriel trumpeting the good news: Harold Sackeim is GOD, everyone. He’s your savior.

[gv data="hvwVRn91bAU"width="425" height="350"][/gv]

FDA and ECT devices

This is the well-known story of how the FDA has been lobbied by the industry to change ECT devices from Class III to Class II. What’s interesting (and keeps popping up in Harold’s testimony) is that apparently the psych rights movement is having an impact on things. Despite his admitting that he speaks with the FDA regularly, and that the industry has lobbied the FDA for the change, Harold says the FDA is afraid to make a move.

[gv data="5sI6B-vD2jA"width="425" height="350"][/gv]


“I DO consider it.”

When asked if he discounts the many personal accounts of memory loss post-ECT, he responds that he does consider it.

[gv data="M2mEFDnC-yg"width="425" height="350"][/gv]

Electrical parameters

Harold discusses the parameters of ECT, cognitive side effects and Mecta machines.

[gv data="ZPNHFq4Gks0"width="425" height="350"][/gv]

What they knew, when they knew

Is it necessary to inform patients of the risk of permanent, severe memory loss? Harold says it’s not in dispute…of course you tell them, and he always does. At least in the last three or four years…once they discovered it really happens. Before then, well, they kinda knew, but they just had no scientific evidence that it did, and the wrong kinds of people had been talking about it. So it’s not their fault because they didn’t know. They just didn’t know. Until a few years ago.

[gv data="mB4KqcbuvJQ"width="425" height="350"][/gv]

Sackeim: “I got the field to do that”

Harold says the APA Task Force Report now says that ECT can cause profound memory loss. ECT patients have only been saying that for…hmmm, nearly SEVENTY YEARS!

[gv data="-q1faZrHPPk"width="425" height="350"][/gv]

Senator Calls For Probe Of FDA Conduct

CBS News
July 30, 2006

In Connection With Its Actions As It Reviewed Safety of Vioxx

(CBS) Since Vioxx was pulled from the market in September, 2004 for increasing the risk of heart attacks and strokes, Merck has been slapped with more than 16,000 lawsuits.Now, as CBS News correspondent Sharyl Attkisson reports, documents turned over in some of those cases are providing new glimpses into the relationship between the FDA and Merck – a relationship that critics say was far too cozy.

Well before Vioxx was pulled from the market, an FDA senior scientist, Dr. David Graham had flagged its heart issues.

But, e-mails and handwritten notes reviewed by CBS News suggest FDA management which was supposed to be regulating Merck was giving the pharmaceutical company – and not the public – advance notice of those safety findings.

Dr. Graham butted heads with his FDA managers in trying to get the word out about Vioxx’s risks.

“The FDA officials didn’t want to allow me to present my work at a scientific conference, but at the same time they wanted to be sure that Merck had a copy of my scientific presentation,” Dr. Graham said. “So it’s good enough for Merck, but it’s not good enough for the American people?”

Sen. Chuck Grassley said the FDA and Merck went so far as to conspire together to undercut Dr. Graham’s findings.

Grassley says handwritten notes from a phone call between an FDA official and a Merck manager indicate that the FDA apparently proposed “an official rebuttal on Graham” and said they were looking for an “opportunity to get the message out on Graham” and “suggests we provide journalists a copy of our critique on Graham.”

“It was a conspiracy on the part of the company employee, the FDA employee, to just smother Dr. Graham or to ruin his reputation,” said Sen. Grassley.

Grassley has asked the inspector general to investigate the FDA’s conduct.

The FDA had no comment for this story, and Merck said it has the “right to express our views when we believe information others have presented is not fair and balanced.”

Merck goes on to say that on the topic of Vioxx, Dr. Graham differed with Merck and others at FDA, so they separately gave their scientific views.

Sen. Grassley is sending a fresh letter to the FDA accusing the agency of making the pharmaceutical industry the “FDA’s first client” when that client should be the American people.

WINNER: Gorham and Robin Nicol – How to get in the shock machine business

HOW TO GET INTO THE SHOCK MACHINE BUSINESS:

The true story of Gorham and Robin Nicol!

by Linda Andre

Note: The following may seem incredible, but it comes straight from the horses’ ass—er, mouth. It is based on the testimony of Gorham Nicol at the trial of his shock machine company Mecta in October 2005. All quotes are from the court transcript.

nicol.jpgWith all the media coverage on the “comeback of ECT” over the past thirty years, you’ve probably been wondering how you can get a little piece of the action. You may have thought about starting your very own shock machine company, but didn’t know how. Perhaps you thought you didn’t qualify to run a medical device company because you didn’t have any medical degrees or scientific background, or any training whatsoever that would qualify you to manufacture devices. Maybe you were afraid of those pesky FDA regulations, thinking the government would hold you responsible for proving your device safe, and then where would you be with no money or staff to conduct scientific safety studies? Maybe you were afraid you just didn’t know enough about shock or shock machines to be making them.

So here you are, reading this page instead of making millions on shock machines. Well, let the story of Gorham and Robin Nicol, husband-and-wife owners and sole directors of the Mecta shock machine company, be an inspiration to you. They didn’t have any experience or knowledge about shock, or any particular interest, or even any money of their own to invest, but did they let that hold them back? No way!

Robin’s only got a degree in English, and Gorham is an MBA. As Gorham tells the story, they didn’t really plan to buy a shock machine company. It just sort of happened. He walked into a building one day looking to buy another company that he’d heard was a good investment, and it just happened to be the same building that housed the Mecta Corporation. Mecta was having a kind of fire sale at the time, going out of business due to bankruptcy. Gorham didn’t even know what a shock machine was, but ever the alert businessman, he sniffed an opportunity. He asked his close friend, shock doctor Barry Maletzsky, if a shock machine company would be a good investment. (Barry Maletzsky achieved notoriety in the late 1970s by inventing “multiple-monitored ECT”, a technique in which more two are more seizures are induced at one time. The Mecta device was invented specifically for this purpose. Even the APA now says this technique is “not recommended”. Even Richard Abrams—see him in the Hall of Shame—doesn’t like it.) According to Gorham, Maletzky “told us what a fantastic piece of equipment this would be if it were made available on the market, and we went with that…He said that it was an outstanding, leading-edge product and that he thought it would be a good investment for us…My father-in-law put up the money and we bought it.”

That was all. The Nicols didn’t know anything about ECT and weren’t interested in learning. It was just another investment for them, just like their other company Easybar, which manufacturers drink-dispensing equipment for bars and restaurants. Shock machines, soda machines; electricity, beverages, what’s the difference? You just buy the company, pay people to make the things, and sit back and rake in the profits. They’d inherited engineers when they bought the company, so they didn’t need to know anything about the machines or how to build them (and his testimony makes clear, they still don’t.)

Someone, of course, has to tell the engineers what to do. Good thing the Nicols have friends who are psychiatrists! From its inception shock doctor Richard Weiner has been Mecta’s main man. He and Harold Sackeim (who has his own place in the Hall of Shame) design the machines, the engineers build them, and Robin sells them. Easy—why, you could do it too! Weiner and Sackeim both admit to a 20-year-+ relationship with Mecta, copping to getting tens of thousands from them. That’s what they say, but come on, it’s got to be much more; clearly the clueless drink-dispensing couple would be out of business in two seconds without the shock docs. As a former Mecta engineer says, “When Harold calls, they jump.”

Of course, it’s unethical to take money from a company when you’re simultaneously accepting millions of dollars in federal grant money to investigate that company’s product (as both Weiner and Sackeim have done these past 20 years), and illegal not to disclose the shock company dollars—but hey, who’s looking?

As far as the FDA law on medical devices which is such a source of concern to manufacturers of other medical devices, who go to great lengths to comply with it…well, Gorham and Robin don’t sweat that little detail, they just ignore it, and they’ve never gotten into trouble. Gorham doesn’t even know what Class III means. He only heard that the FDA categorizes medical devices in terms of risk when he was on the witness stand in 2005.

Gorham has his own standard on ECT’s safety. It’s more akin to religion than science. Without any scientific data or studies, he’s content to just rely on his feelings and beliefs. “I don’t believe that it’s possible that there’s brain damage. Not even possible.” “I don’t feel there are risks.” Now, there. Doesn’t that make us all feel better?

That seems to be the position of a corrupt, industry-friendly FDA as well. So far, they haven’t called on the company to submit a Premarket Approval Application (PMA) as required by law for all Class III medical devices. If they ever did, it’s clear that Gorham and Robin would be stumped. And in that scenario, federal law requires that a medical device be taken off the market. Asked if he had any employees who were capable of conducting scientific clinical studies (as required for a PMA), Gorham replied emphatically, “Absolutely not.” He doesn’t even know that his company has never submitted such an application! But are the shock machine entrepreneur couple concerned? Nah.

They’ll just rely on Weiner and Sackeim to take care of the FDA for them. After all, Weiner has worked tirelessly to uphold the interests of Mecta Corporation at the FDA since 1982, wearing his hat as the Chairman of the “APA Task Force on the FDA”, and never ever revealing his financial interest in the device to the agency. It’s a little-known fact that back in 1982, FDA was ready to call for PMAs on the ECT device. Richard Weiner forestalled that by filing a petition with the FDA to reclassify the device to Class II without a safety investigation; he then lobbied every single member of the APA to write to the FDA with the message Do not conduct a safety investigation of the ECT device; just take our word that it’s safe. Hell, we’re doctors. This went on for more than twenty years. And that put the fear of God (or the APA, same thing) into the FDA so that they backed down and never conducted their own safety investigation or required the device manufacturers to do so.

One would hope that Gorham’s bought Richie a nice gold watch for his long years of service to the company.

No wonder Mr. and Mrs. Nicol are not worried about—hey, they’re not even aware of—federal regulations requiring suspected injuries caused by their devices to be reported to the FDA. FDA, Schmef-DA. They’ve never made any such reports.

In 2001, a report was made that a woman died as a result of a stroke suffered during ECT with a Mecta machine. The FDA became aware of it and contacted Mecta, but nothing happened, not even a slap on the wrist. No wonder the Nicols are so blase about the FDA.

On the witness stand defending his company against charges that his machine erased 30 years of a man’s life and reduced his IQ to the level of mental retardation, Gorham made it clear about twenty-seven different ways that he will never, ever believe any reports of harm from ECT made by patients. Who are all those patients anyway? Do they buy shock machines? Well, if not, they’re no concern of his. Why should he care? His clients are the doctors, and as he said repeatedly, none of them have any complaints with his machines whatsoever. Mecta will ignore any report of serious memory loss unless “it comes from the doctor or a hospital”, not a patient. “If a doctor complained,” he said, “we would investigate to the nth degree. We just have never had a complaint.” Asked what he would deem a complaint serious enough to be concerned about, he conceded that a death would be serious in some circumstances, but only “if it came from the hospital or a doctor.” But then ECT has never killed a doctor, or erased one’s memory, or taken one point off his IQ.

There is one small downside to owning a shock machine company. Lawsuits. Mecta’s been sued seven times and has had to pay out a token amount of settlement money. As Gorham grumbles, “Finish one, start another, finish one, start another.” He prefers to see them as one continuous lawsuit. He even thinks they’re all secretly brought by the same people conspiring to put him out of business. Seven, ten, twelve, what’s the difference? All you do is hand them over to your lawyers and pay Rich Weiner twenty to thirty thousand per lawsuit as an “expert witness”, no need to bother your head about them. No one’s won such a suit and it hasn’t put a dent in the company’s profits. So really, despite that small annoyance, it’s still a great business to own.

In fact, business appears to be booming. Besides the USA, Mecta sells machines to Europe, to China, to Bangladesh, Indonesia, the Philippines, Taiwan, Vietnam, Albania, Egypt, India, Iran, Saudi Arabia, Turkey (a news article on the scandal of the use of ECT without anesthesia in Turkey featured a photo of a Mecta machine)….all over the world.

Sorry Mecta, but you might have some more competition soon. The secret’s out about how really, really easy it is to make money on shock machines! A rich daddy, a few friendly psychiatrists, and you’re in business.

Welcome Mr. and Mrs. Nicol! You may not be doctors, you may not have advanced degrees, but you are up there in the pantheon with the shock docs: You’re the 2006 inductees into the ECT.ORG Hall of Shame!

The top 33 reasons why Gorham Nicol of Mecta richly deserves the Hall of Shame award:

(Questions from lawyers and his responses at Mecta’s product liability trial)

1. Q: Your qualifications to own and operate a medical device company are what?

A: I have an MBA in business administration.

2. Q: Did you read any literature about ECT at the time that you purchased the company?

A: Dr. Maletzsky furnished us with some material…I didn’t go into a lengthy study of the pros and cons of ECT at that time.

3. Q: Had you come to some conclusions regarding the practice of ECT at the time you got the company?

A: Well, I felt it was safe.

Q: What was that conclusion based on?

A: Doctors were demanding it.

5. Q: Did you do any investigation into the harms caused by ECT?

A: I felt no need to do any investigating because I was once a year kind of immersed in it at the APA and I never heard a complaint.

6. Q: Have you ever looked at the FDA records of people that have filed complaints against ECT?

A: No. I talk to doctors that are practicing at the APA, and they haven’t brought any concerns to us as an manufacturer about the way our equipment is performing. So why would I do that?

7. Q: Did you read any of the books that were critical of ECT?

A: No. I believe I was aware of Friedman’s (sic) book. I haven’t seen it, but I heard that he wrote it.

8. Q: Did you make a search of any library indices?

A: I think we have been focusing more on improving equipment, adding features, that kind of thing. That is where my effort would go if I were going to take time to work on it.

9. Q: Why don’t you type in ECT on a computer and hit search and see what comes up?

A: Because I’m busy running another business.

10. Q: Do you have any knowledge concerning the physical effects on the body from ECT machines?

A: No.

11. Q: Have you heard that the purpose of an ECT machine is to cause a grand mal seizure?

A: I have heard that a number of times. Like, initially when I bought the company I was told that was what the machine did.

12. Q: None of Mecta’s ECT devices have ever undergone an FDA premarket approval process of scientific review to insure safety and efficacy, have they?

A: I’m not sure.

Note: The correct answer is No.

13. Q: The devices are marketed only on the basis that they are substantially equivalent to the shock devices that were being manufactured prior to 1976; correct?

A: I don’t believe that is correct.

The correct answer is: Yes, that is correct.

(At this point in his testimony, opposing counsel objects to Gorham’s lawyer giving him hand signals, apparently trying to communicate to his client that he had just given a wrong answer. To no avail; Gorham continues to give wrong answers.)

14. Q: Has Mecta conducted any risk assessments for its machines?

A: No.

15. Q: Does Mecta have any obligation to make reports to the FDA if there is an allegation against the company of damage due to their device?

A: I’m not sure.

The correct answer is: Yes.

16. Q: What, in your view, are the risks associated with your machine?

A: I don’t feel there are risks.

17. Q: Memory loss is not a risk of your machine; right?

A: Not of the machine.

18. Q: Didn’t Dr. Maletzky tell you there are a lot of risks to this machine?

A: No.

19. Q: If you were aware that only 26 percent of the APA psychiatrists who were surveyed disagreed with the statement that ECT causes at least slight or subtle brain damage, would you have conducted any risk assessment of your machine?

A: I would not have.

20. Q: As one of the board members and the vice president of the company, why didn’t you try to find out what kind of cognitive deficits this practice caused?

A: I had not heard of the cognitive deficits in the industry when I bought the company. The fact that doctors were excited about it, University of Oregon med school had put this machine together and the company had gone bankrupt was an opening for us to come in.
That’s why we bought it.

21. Q: Are you familiar with an adverse event reporting system by the FDA?

A: No.

22. Q: I want to know if you have ever done any safety studies on humans to see if it’s safe to use on human beings?

A: Those studies are done by the experts in the field, and we take the results of their expertise. Mecta is a machine manufacturer, and we make what we think is the best piece of equipment in the world, and we don’t do tests on humans in our plant.

23. Q: Have you never commissioned anyone to do any tests on humans to make sure your machine is safe to actually use on human beings?

A: No.

24. Q: Mecta doesn’t have any employees in the corporation with medical training, does it?

A: No.

25. Q: You don’t have any idea where the electricity goes in the brain that’s used in your machines, do you?

A: No.

26. Q: You don’t know whether the electricity destroys neurons, do you?

A: No.

27. Q: Do you know if the electricity in the machine causes any damages to brain cells?

A: No.

28. Q: In the past 25 years Mecta has never conducted any research of its own into the safety and efficacy of its ECT machines, has it?

A: That event needs to take place in the industry. We have used what the experts have found to be true.

29. Q: You haven’t done any survey of the purchasers of the machines either to find out if any patients have been harmed by the machine, have you?

A: No.

30. Q: Do you believe your machines are totally safe?

A: Yes.

31. Q: If any complaints are made against the machine, they can’t be legitimate?

A: If a doctor complained, we would investigate it to the nth degree. We have just never had a complaint in the 23 years.

32. Q: Is three anybody that is employed at the company that is capable of conducting scientific studies, clinical studies with human beings with respect to the effects of ECT?

A: Absolutely not.

33. Q: Severe loss of memory, would that be a serious enough complaint to deal with?

A: If it comes from the doctor or the hospital, yes. We don’t deal with it unless it’s from a doctor or hospital.

Max Fink letter to FDA

STATE UNIVERSITY OF NEW YORK AT STONY BROOK
SCHOOL OF MEDICINE – DEPARTMENT OF PSYCHIATRY
P.O. BOX 457
ST. JAMES, N. Y. 11780
PHONE: 516-444-2929

October 26, 1990

Dockets Management Branch (HFA-305)
Food and Drug Administration
5600 Fishers Lane, Room 4-62
Rockville, MD 20857

Ref: 21 CFR Part 882 Docket # 82P-0316

Gentlemen:

The FDA proposed reclassification of ECT (electroconvulsive therapy) devices to class II is commendable. The restriction in labelling for patients with “Major Depression with Melancholia” is inconsistent, however, with present practice, international experience since 1934, and numerous recent expert reviews, notable that of the Royal College of Psychiatrists of Great Britain in 1989 (1) and the American Psychiatric Association in 1990 (2). Nor is it consistent with the changing diagnostic schemes which are now beginning to view major mental illnesses as varying manifestations of a single endogenous disorder. In the proposed rule and in its in-house Task Force Review of the Literature on ECT. 1982 to 1988, dated June 10, 1988, the FDA failed to fully consider the scientific literature, failed to comprehend the meaning of the studies, and ignored well designed studies, some of which they cited and derogated.

I urge the FDA to recognize that ECT devices, when properly used to induce seizures, are effective for a range of disorders broader than that cited in the rule: ECT is effective for endogenous psychiatric illnesses in which psychosis can occur. In the present classification scheme (DSM-IIIR), these include (but are not limited to) the mood disorders of major depression, bipolar disorder (manic or depressed or mixed phases), with or without psychosis (296.xx); and schizophrenia, catatonic type (295.2x). Since it is highly likely that these labels will be changed in the next few years (DSM-IV is in preparation), a description of the populations suitable for ECT which define the labelling of these devices should be as broad as the prevailing evidence of efficacy and safety allow.

It is often difficult to separate these diagnoses, and many patients exhibit a variety of syndromes in the course of their lifelong illness. It is not unusual for patients to be depressed in one admission, psychotic and depressed in a second, and manic in a third. And these states may or may not be associated by melancholic signs and symptoms. Limiting the use of a treatment to the melancholic phase of an illness as if such a phase is unique is in error and will do a disservice to large numbers of patients.

Others have argued persuasively the merits of ECT in the treatment of a wide range of depressive disorders, notably psychotic depression (3); bipolar disorder with mania (4); and schizophrenia (5). Their arguments have been persuasive for the Task Force of the American Psychiatric Association (2) and the Royal College of Psychiatrists (1). It would be redundant for me to reiterate their persuasive arguments, when the agency staff can read those arguments directly.

I wish to comment on three issues in the recommended rule: the use of ECT in the syndrome of catatonia, in mania, and the recommendations for a sequence in treatment parameters.

Catatonia: When convulsive therapy was developed by Prof. Ladislas Meduna in Budapest in 1934, it was first used (and most successfully) in a patient with catatonia. When the first electrical inductions were made by Professors Ugo Cerletti and Luigi Bini in Rome in 1938, it was for a patient with catatonia. Catatonia is an uncommon psychiatric syndrome, but one which occurs in patients with psychosis (catatonic schizophrenia), in mania and depression (6), and secondary to medical disorders, such as lupus erythematosus and typhoid fever (7). Catatonia is also seen as a manifestations of a toxic reaction to antipsychotic drugs — the syndrome is known as neuroleptic malignant syndrome. Finally, catatonia has a form known as malignant catatonia, a disorder that is rapidly fatal. In each of these conditions, ECT has been found to be life-saving (8).

For example, in our hospital last year, we were called to treat a young woman with lupus erythematosus who developed a malignant form of catatonia. She was cachectic, was unable to stand or feed herself, and had lost 25% of her body weight. All medical treatments having failed, after five weeks she was treated successfully and rapidly with ECT, and was well in one year follow-up (9).

I recognize that the APA classification schemes, DSM-III and DSM-IIIR do not specifically recognize this syndrome except as a type of schizophrenia (295.2x). Nevertheless, ECT has been life-saving in this syndrome and it is essential that this application be made a feature of labelling (9).

Mania: The syndrome of mania appears in many guises, that of excitement and overactivity, psychosis, psychosis with melancholia, and delirium. It is often thought of as the obverse of depressive mood. In the history of convulsive therapy, manic conditions were identified as suitable for ECT at the same time that depressive states were identified. The development of lithium and its use with antipsychotic drugs replaced the use of ECT for a time — long enough to determine that therapy resistant and rapid cycling manic patients of may not respond to medication. In such cases, ECT is life-saving. In our recent experience, we have treated two patients in manic delirium who had been continually hospitalized for 2 and for 3 years. Further, a severely manic woman with sickle cell disease, in her second trimester of pregnancy, could not be treated with medication; ECT was highly successful (10).

Treatment Parameters: The FDA proposed rule states that “ECT use should progress from unilateral to bilateral electrode placement and from brief-pulse to sine wave stimulation and from subcritical to minimum amounts of energy needed to induce seizure activity.” This recommendation is wholly inconsistent with present practice and with the recommendations of national task forces (1, 2). By making such a recommendation, the FDA is engaging in the practice of medicine, a stipulation from which the agency is clearly enjoined.

The choice of electrode placement is determined by the type of syndrome, medical status, need for urgency in response, and individual psychology and employment. The 1990 APA report does not recommend unilateral placement as the initial choice for all cases; nor does it reserve bilateral placement as a secondary use. It stipulates that each case must be treated individually. In clinical practice, for patients who have concurrent medical illness where each anesthesia exposure must be considered, bilateral electrode placement is clearly preferred. In patients who are severely suicidal, or severely manic (especially where restraints are a consideration), bilateral placement is preferred. For severely catatonic patients, especially if mute and requiring tube-feeding, bilateral placement is preferred. The use of unilateral electrode placements, with their associated 15% response failure rate, is clearly dangerous to these patients (11).

Stimulation currents at subthreshold energy levels are associated with failed or inadequate seizures. Seizures which have been induced at marginal doses of energy are clearly less efficient than those with suprathreshold currents (12), especially when brief-pulse currents and unilateral electrode placements are used (13). Recent research led the two national reviews (1,2) to argue for moderately suprathreshold currents to induce seizures and to monitor seizure duration as an index of treatment efficacy. Comparisons of U.S. experience with fixed dose brief pulse currents with Scandinavian/German experience with variable dose, modified sinusoidal currents finds a greater number of treatment failures in the fixed dose methodology.

Since the definition of an adequate treatment is under active study, the prescription of a defined sequence of treatment parameters is clearly premature and prejudicial to medical practice.

I commend the FDA in seeking to clarify the status of ECT devices, and I urge the agency to simplify the classification and labelling requirements by assigning these devices to Class II. The labelling should be consistent with more than half a century of experience and research, and must include a wider range of endogenous psychiatric illnesses, including the affective illnesses of severe depression and mania, catatonic schizophrenia, and the special syndrome of primary and secondary catatonia.

But the agency should resist interfering in medical practice by seeking to define the technical details of electrode placement, energy level, and current type and dose, leaving these details to the continuing developments of the profession and departures from prevailing practice to case law.

I have been a licensed physician since 1945; certified in neurology in 1952, in psychiatry in 1954, and in psychoanalysis in 1953. I have been a practitioner of ECT since 1952; a researcher in ECT since 1954 with more than 200 publications in convulsive therapy; editor (with Seymour Kety and James McGaugh) of the volume Psychobiology of Convulsive Therapy (Winston/Wiley, New York, 1974); author of the textbook Convulsive Therapy: Theory and Practice (Raven Press, New York, 1979); and Editor-in-Chief of Convulsive Therapy, a quarterly scientific journal published by Raven Press, since its inception in 1985. I have been a Professor of Psychiatry at various medical schools since 1962.

Sincerely yours,

Max Fink, M.D. Professor of Psychiatry

Citations:

1. Royal College of Psychiatrists. The Practical Administration of Electroconvulsive Therapy (ECT). Gaskell, London, 30 pp., 1989.

2. American Psychiatric Association. The Practice of ECT: Recommendations for Treatment. Training and Privileging. American Psychiatric Press, Washington, D.C., 1990.

3. Avery, D. and Lubrano, A.: Depression treated with imipramine and ECT: the DeCarolis study reconsidered. Am. J. Psychiatry 136: 559-62, 1979.

Kantor, S.J. and Glassman, A.H.: Delusional depressions: natural history and response to treatment. Br. J. Psychiatry 131: 351-60, 1977.

Kroessler, D.: Relative efficacy rates for therapies of delusional depression. Convulsive Ther. 1:173-182,1985.

4. Milstein, V., Small, J.G., Klapper, M.H., Small, I.F., and Kellams, J.J.: Uni-versus bilateral ECT in the treatment of mania. Convulsive Ther. 3: 1-9, 1987.

Mukherjee, S., Sackeim, H.A., Lee, C., Prohovnik, I., and Warmflash, V.: ECT in treatment resistant mania. In; C. Shagass et al. (Eds.): Biological Psychiatry 1985. Elsevier, New York, 732-4, 1986.

Berman, E. and Wolpert, E.A.: Intractable manic-depressive psychosis with rapid cycling in an 18-year-old woman successfully treated with electroconvulsive therapy. J.N.M.D. 175: 236-239,1987.

Richard Abrams’ letter to FDA, asking for unlimited juice

Food and Drug Administration Action Is Required

Arch Gen Psychiatry 2000; 57:445-446
Richard Abrams, MD

SUBSTANTIAL research funds and energy have been expended over several decades in attempts to determine the benefits and risks of bilateral and right unilateral electroconvulsive therapy (ECT). Proponents of each method are divided into opposing camps; having been on both sides of the issue, I believe I can fairly state the arguments for each side as follows.

Those favoring bilateral ECT point to the controlled trials demonstrating its greater efficacy and discount its more pronounced adverse cognitive effects as being transient and not different from those of right unilateral ECT weeks or months after a course of treatment. The very infrequent occurrence of prolonged memory impairment after bilateral ECT is acknowledged, but it is held to be a small price to pay for the reduced patient morbidity and mortality thought to result from the use of bilateral ECT.

Those favoring right unilateral ECT point to the controlled trials showing therapeutic equivalence to bilateral ECT, and to the dramatically lower cognitive effects immediately after a course of treatment. The therapeutic advantage of bilateral ECT in some patients is acknowledged, but attributed to inadequate technique especially inadequate dosage with unilateral ECT. The occasional need to switch from unilateral to bilateral ECT during a course of ECT because of insufficient therapeutic response to right unilateral ECT is said to be a small price to pay for the pronounced cognitive advantages of unilateral ECT. These cognitive advantages are held to substantially dilute the negative image of ECT prevalent among the public, fellow professionals, lawmakers, and the media, thereby increasing patient acceptance of ECT.

The 2 articles published in this issue of ARCHIVES, when examined in light of previously reported data, should help resolve some of the issues that have separated the opposing camps and facilitate a rational conclusion of the controversy.

The article by Sackeim et al(1) compares right unilateral ECT given at 3 different dosage levels (1.5, 2.5, and 6 times seizure threshold) with the criterion standard of high-dose bilateral ECT given at 2.5 times threshold (mean dose, 277 millicoulombs [mC]). High-dose unilateral ECT (6 times threshold; mean dose, 441 mC) was indistinguishable in antidepressant efficacy from high-dose bilateral ECT at both post-ECT assessment intervals: 1 or 2 days and 1 week after the course of treatment (after which both groups were given the physician’s choice of treatment). The treatment response for the 2 groups was identical: 80% immediately after the ECT course, falling to 65% several days later.

At all post-ECT assessment intervals, there were greater deficits after bilateral than high-dose unilateral ECT in a variety of memory measures. Notably, 2 months after the treatment course, patients receiving bilateral ECT exhibited greater amnesia for past public and personal events than those receiving high-dose unilateral ECT.

The article by McCall et al (2) compared right unilateral ECT given with either titrated 2.25 times threshold dosing (mean dose, 136 mC) or fixed high dosing (403 mC). Patients receiving fixed high-dose unilateral ECT had a markedly superior therapeutic response at the 1- or 2-day post-ECT assessment: 67% (n=49) vs 39% (n=28) for the titrated moderate-dosage group.

Immediately after unilateral ECT, global cognitive disturbance was worse for those in the high-dosage group; they also recalled a somewhat smaller proportion of autobiographical memory items. Other memory measures, including verbal and figural anterograde tests, and patients’ self-ratings of subjective global memory, did not differentiate between the groups.

The antidepressant efficacy of right unilateral ECT in these 2 studies is comparable to that we reported earlier in a comparison of fixed high-dose (378 mC) bilateral and unilateral ECT.(3) In our study, the antidepressant response immediately after the sixth ECT dose was indistinguishable for the 2 methods: 79% for high-dose bilateral ECT vs 68% for high-dose unilateral ECT, employing the same response criterion used in the present studies. We performed no cognitive assessments.

The bilateral vs unilateral ECT controversy may be approaching resolution. Increasing the stimulus dose for unilateral ECT whether as a multiple of seizure threshold or as a fixed dose reliably increases its antidepressant effect to approximate that of bilateral ECT. Why do I hedge? Because the study by McCall and colleagues (2) excluded the most severely ill patients (preferentially assigning them to bilateral ECT at the outset), and because some depressed patients in the study by Sackeim et al (1) who failed high-dose right unilateral ECT responded well when switched to bilateral ECT.

Moreover, sample sizes were small (about 20 per group) in the comparisons of high-dose right unilateral and bilateral ECT the studies by Sackeim et al (1) and Abrams et al (3) suggesting the possibility of insufficient statistical power to demonstrate a real difference between the 2 methods.

Furthermore, optimal dosage levels and stimulus parameters for unilateral ECT remain to be established. Although some excellent results have been demonstrated with 6 times seizure threshold dosing for stimulus titration and 375 mC to 450 mC for fixed dosing, the point of maximal antidepressant response to increasing the dosage with right unilateral ECT has yet to be reached; higher doses may be even more effective. Similarly, the pulse widths employed have been at the higher end of the available range (1.0-1.5 milliseconds), and it is reasonable to predict that shorter pulse widths (eg, in the 0.25- to 0.5-millisecond range) might be more efficacious, either in themselves or via the longer stimulus trains they generally require. (4)

Dosage above the seizure threshold is an important determinant of the antidepressant efficacy of right unilateral ECT. An apparent relationship between absolute stimulus dose and treatment response (4) results from the facts that titrating the stimulus dose to a larger multiple of the seizure threshold yields both higher doses and a better treatment response, and that higher fixed dose produce a greater extent of dose above seizure threshold and thereby a better treatment response. Nevertheless, from a practical perspective, both the studies of McCall et al (2) and Abrams et al (3) show that increasing the absolute stimulus dose for unilateral ECT without consideration of the seizure threshold is a clinically effective strategy.

Finally, the choice of the seizure threshold as the variable on which to base ECT dosage is arbitrary; more useful measures may exist. (4) An individual physiological response, such as the degree of electroencephalographic postictal suppression (ie, a postictal suppression threshold), should provide a more rational guide to stimulus dosage because, unlike the seizure threshold, the degree of postictal suppression has been shown to be related to the antidepressant response.5-7 Other readily obtainable physiological measures (eg, heart rate) are also candidates for thresholds against which to titrate the stimulus dose. (8)

Even when administered at high dosages, unilateral ECT seems to retain important cognitive advantages over bilateral ECT. To date, unilateral ECT regardless of dosage has not been demonstrated to induce persistent amnesia, whereas studies have found detectable retrograde amnesia 2 to 6 months after bilateral ECT. However, because the 2.5 times seizure threshold dosing used in the study by Sackeim et al (1) is higher than required for the usual and expected antidepressant benefit from bilateral ECT, (9) it probably exaggerated the cognitive differences between the 2 methods.

It is time for the Food and Drug Administration to act. The aforementioned dosage considerations are moot for US psychiatrists and their patients in that present Food and Drug Administration regulations do not permit the sale in this country of ECT devices capable of administering, for example, 6 times seizure threshold dosing to all patients (high-dose ECT devices have been available outside the United States for many years). Unless more efficient forms of stimulation (eg, shorter pulse width, longer-duration stimuli) are proven effective at dosages within the range of presently available ECT devices, patients in the United States will be excluded from receiving the most efficacious forms of unilateral ECT. (4, 10)

Author/Article Information

Richard Abrams, MD
Department of Psychiatry and Behavioral Sciences
Chicago Medical School
3333 Green Bay Rd
North Chicago, IL 60064

Dr Abrams is director of Somatics Inc, Lake Bluff, Ill, the manufacturer of the Thymatron Electroconvulsive Therapy device.

I thank Max Fink, MD, and Conrad M. Swartz, PhD, MD, for providing helpful critiques of earlier drafts of this commentary.

REFERENCES

1. Sackeim HA, Prudic J, Devanand DP, Nobler MS, Lisanby SH, Peyser S, Fitzsimons L, Moody BJ, Clark J. A prospective, randomized, double-blind comparison of bilateral and right unilateral electroconvulsive therapy at different stimulus intensities. Arch Gen Psychiatry. 2000;57:425-434.

2. McCall WV, Reboussin DM, Weiner RD, Sackeim HA. Titrated moderately suprathreshold vs fixed high-dose right unilateral electroconvulsive therapy: acute antidepressant and cognitive effects. Arch Gen Psychiatry. 2000;57:438-444.

3. Abrams R, Swartz CM, Vedak C. Antidepressant effects of high-dose right unilateral electroconvulsive therapy. Arch Gen Psychiatry. 1991;48:746-748.

4. Abrams R. Electroconvulsive Therapy. 3rd ed. New York, NY: Oxford University Press; 1997.

5. Krystal AD, Weiner RD, Gassert D, McCall WV, Coffey CE, Sibert T, Holsinger T. The relative ability of three ictal EEG frequency bands to differentiate ECT seizures on the basis of electrode placement, stimulus intensity, and therapeutic response. Convuls Ther. 1996;12:13-24.

6. Nobler MS, Sackeim HA, Solomou M, Luber B, Devanand DP, Prudic J. EEG manifestations during ECT: effects of electrode placement and stimulus intensity. Biol Psychiatry. 1993;34:321-330. MEDLINE

7. Petrides G, Kellner C, Knapp R, Rummans T, O’Connor K, Hussain M, Fink M, Rush AJ, Rasmussen K, Beale M, Bernstein H, Biggs M, Mueller M, Zhao W. Can ictal EEG indices predict response to ECT? Presented as a poster at: the National Clinical Drug Evaluation Unit meeting; May 30-June 2, 2000; Boca Raton, Fla.

8. Swartz CM. Disconnection of EEG, motoric, and cardiac evidence of ECT seizure. Convuls Ther. 1996;12:25-30.

9. Sackeim HA, Prudic J, Devanand DP, Kiersky JE, Fitzsimons L, Moody BJ, McElhiney MC, Coleman EA, Settembrino JM. Effects of stimulus intensity and electrode placement on the efficacy and cognitive effects of electroconvulsive therapy. N Engl J Med. 1993;328:839-846.

10. Sackeim HA. Are ECT devices underpowered? Convuls Ther. 1991;7:233-236.

Express your concerns to the FDA with the FDA letter generator.

A dialogue with the FDA on electroshock

A DIALOGUE WITH THE FDA ON ELECTROSHOCK

The Center for Devices, Bethesda, Maryland, May 4, 1992

_____ Present, FDA: _____
Phillip White, Director of Office of Standards and Regulations
Midge Brier, Secretary to Mr. White
London Haflin(?), Office of Science and Technology
Gordon Johnson, MD, Head of Office of Health Affairs
Lynne Reamer, Assoc. Dir., Office of Device Evaluation
Elizabeth Jacobson, Deputy Director, Center for Devices and Radiological Health

_____ Present, Support Coalition International: _____
Sally Clay, PEOPLe, Ulster County, NY
Larry Plumlee, MD, National Capital Area Advocates, Washington, DC
Dennis Nester, Phoenix, Arizona
Linda Andre, Committee on Truth in Psychiatry, New York, NY
Louisa Jackson, PEOPLe, Dutchess County, NY
George Ebert, The Alliance, Syracuse, New York
Mary Ann Ebert The Alliance, Syracuse, New York

SALLY-First I should say that we represent a nationwide, even an international, network of people who are psychiatrically labeled. One of our main concerns is the issue of ECT. We want to talk about is what we know from our experience can happen with ECT, and why we believe it is a very dangerous procedure.

LARRY-A task force by the American Psychiatric Association published a report recently that made the claim that about one person in 200 who has had repeated shock therapy has longterm brain damage. People who have had these treatments have the impression that the frequency of longterm brain damage is much higher than 1 in 200, and when they asked the head of public affairs of the APA what was the scientific basis for this figure, no one could produce any reference. Yet those hospitals who use informed consent usually say that this risk of longterm memory loss is about 1 in 200. They cite the APA report. Yet the APA says that this report is not an official APA sanctioned document. “It was put together by a group of advocates and practitioners of ECT who are experts in this area, and it is their best opinion of what is the situation. But we, the APA, do not stand behind the information or endorse it. We merely published the task force report.”

FDA-Was a guy named Weiner the head of that task force report?

LARRY-Wasn’t it Max Fink? So basically we have a situation here where information is being cited by the medical community, but data is not provided to substantiate it. The anecdotal impressions of these people who received it, and networked among others who had it, is that the problems are much more frequent, and informed consent is not complete. People were very upset when they heard that the FDA had been petitioned by the American Psychiatric Association to reclassify this device from Class III to Class II. We have a situation where the advocates of electroshock therapy, people who make their living by it, have prepared a report by their trade association, the APA, and it disagrees with the anecdotal opinions of these people, and it seems as if some scientific resolution of this dispute is needed, rather than reliance on the authority of this task force of the American Psychiatric Association.

FDA-Thank you, Larry, that was very well said.

SALLY-That is basically our position, that if a proper scientific study were made, it would be found that the damage is far greater that (it seems) so far.

DENNIS-The only way I found out that I had memory loss was that I saw a magazine saying that Robert Kennedy was assassinated, and I was dumbfounded. This was two years after the shock …inaudible… Unless you have such a signpost you might not realize you have the memory loss….inaudible…

FDA-I think it’s well known that memory loss is common, and the question is, is it permanent or not?

SALLY-In my case, I completely lost two years of memory from the treatment that I had in 1969, and those two years included the years when my daughter was two and three years old, which are even more precious than they would normally be, because I lost custody of her. I forgot everything during that period, including a wonderful cross country trip that I know was wonderful from what people told me about it, but I can’t remember a thing about it. And I should say, also, that the shock treatment did not help me at all in removing the depression and despair that I felt, which is why I did consent to it.

FDA-It is my impression that most of the proponents, even the staunchest advocates of ECT, separate short term impairments versus longterm impairment.-short term cognitive dysfunction versus long term. Is that your general sense?

LARRY-Now that we have imaging techniques for the brain that are very sensitive, that are very non-invasive, it seems to me that a well-controlled, longterm follow-up study might lend information on this.

FDA-Maybe it would be helpful if we talked a little bit about what the responsibility of FDA is and how we go about getting data and information in which to make judgments, because I think it is not always clear to people how we do that. Unlike NIH or EPA or those agencies, we do not have money to do big studies. We are not a funding organization, so we do not have a grants program where we can go out and fund them.

LARRY-I remember that when Lithium was approved, there was an effort on the part of some psychiatrists to get Lithium through. It had no advocate in industry who was willing to make the safety and efficacy studies, and ultimately some pressures from Congress led the NIH to fund the studies independently of FDA, but in order to meet FDA requirements for safety and efficacy, and lithium was summarily approved by the FDA. So it might be in this situation also that a research agency could contract monies if the FDA were very clear that the APA and the advocates of the devices had not provided adequate basis for making regulatory judgment.

FDA-I think that that is always a possibility. We are dependent on the research that comes in from other sources, whether that be from NIH…inaudible…ECT was on the market before our law came to be, so it was a pre-amendment device. It was placed in Class III by our panel, and that means that we need data to show safety and effectiveness before we approve it. Since it was a pre-amendment device, through, it is allowed to stay on the market legally until we call for that data.

SALLY-Can I ask how this worked with the silicon devices, the breast implants? How did it reach the point where you determined that there was a danger?

FDA-Reports back in from the user, for one thing. That is another part of the system. When a device is on the market, it is incumbent upon the user or the physician or the manufacturer to report any malfunctions.

SALLY-Well, as I understand it, you have received hundreds of letters (regarding ECT). Linda can give you the figures. I know I sent a letter. Here is the letter that I sent in 1987, and this is just one of many hundreds of letters that were sent by users of ECT (gives letter to Philip White).

FDA (Mr. White)-We received a number of letters on the reclassification issue. Did you get a response from us?

SALLY-No, I don’t believe I did.

FDA (Mr. White)-…inaudible…I’ll make sure that it’s part of our record.

FDA-I think that, as with any technology, the problem with ECT has to do with the benefit/risk analysis–what is the benefit to the patient versus the risk. And that is always problematic, because, again, in the absence of clinical trials. And for an individual patient who has experienced some adverse effects, it doesn’t matter how good the benefit/risk equation was, for that patient it was a disaster. And I think right now I would say that ECT is on the slow track to reclassification, because we have not closed reclassification under the condition that there be a standard developed by the APA, which has not happened. I honestly don’t know where the development of that statement is, but we have no intention of proceeding forward until we get such a statement and are satisfied with it.

LINDA-The study that was cited…inaudible…on the risk of suicide showed that ECT had no effect on the suicide rate. There has never been any study that showed that ECT prevents suicide or has any effect on the suicide rate. And in fact I went through the Federal Register, and checked on many of the studies that were used in the so-called “literature review”…inaudible…, and many of the studies sometimes have nothing to do with the point they are supposed to be making. In many studies that have to do with memory loss and brain damage, and the longterm effects of ECT, were not at all included in this literature. We found the literature used to be very selective and (with a) very biased point of view based on reclassification. The manufacturers have admitted that they have never done studies on some of these devices for 20 years. How is it possible to take a selective review of old literature which does not even support the points that it is supposed to support, and then say that it justifies reclassification-especially when there are 32 volumes of letters in the dockets room regarding this device, more than half of ex-patients stating adverse and very tragic results-dozens of letters from congresspeople and letters from every 50 states, from Protection and Advocacy agencies. Don’t these carry any weight, especially when in the case of the reclassification of breast implants, there were very few letters from ex-patients with adverse effects? There were very many ex-patients with positive benefits from this device, and here we have the ECT device, with literally hundreds of letters, and each letter representing hundred more cases of adverse, longterm, tragic, brain-damage effects, and only a handful of letters supporting positive experiences. …inaudible…How can you justify this? How can you compare this with the breast implants device, where a very well-publicized investigation took place on the basis of much less evidence of adverse effects?

FDA-Well, it is not a question of justifying it. I think it is important for us to have a dialogue and to hear the things that you have to say. It is not that the letters are not important to us–they are very important to us. But it’s a very tough area, it really is. It is difficult when people say, “Look, we don’t have many modalities that are effective at all in treating some of these conditions, and this is one thing, we need it…inaudible… You get cogent arguments on the other side, too. None of that takes away from or negates the pain that people feel that have suffered adverse effects from this technology, and that is one of the reasons that we’re sitting here today is because we feel very much for you, and we want to see what we can do to come to the best resolution of this. I think even looking at the data, the data does not really give you … inaudible…but I would like to hear from some of our folks who have looked at this science. I don’t think the science presents a particular…inaudible…

LARRY-I come away from the data with very much the same impression. …inaudible…If this were a drug seeking approval… I gather you would say that the safety and efficacy data would be nowhere near what would be necessary for approval.

FDA-I am not familiar with the drug regulations and procedures…inaudible…I’m simply saying that I don’t find the data reported to be particularly…inaudible… It is really kind of an unknown, we hear polar positions…inaudible…

LINDA-It is interesting that just based on this literature, we find that the literature is very equivocal, even studies that talk about longterm effects…inaudible…So even with these studies that were left out of the APA’s very selective literature review, you still find that this literature is very equivocal.

FDA-I’d like to ask a question. Traditionally, as I understand it, ECT has been used for drug-resistant, or so-called pharmico-resistant, patients as a sort of last-chance therapy. Is that still the case?

LINDA-Not any more; that is not any longer the party line. That part of the APA which is on the APA task force to use electroshock…inaudible…

FDA-In the traditional view, in patients where drugs or pharmacological agents have no effect, and there is no ECT…inaudible…?

LINDA-Well, let’s point out that ECT …inaudible…In the studies that have been done on efficacy show that the beneficial effect of ECT, if any, lasts for a very short time, only for a week …inaudible… So four weeks at most, if anything, a tradeoff for an indeterminable permanent memory loss, of up to 40 years and permanent cognitive dysfunction.

LARRY-FDA does not permit the marketing of snake oil for those illnesses for which medicine does not have safe and effective treatments, so why would something, in which possibly 55 per cent of people receive longterm memory loss, be acceptable, simply because there is no other treatment available? It seems that one would want proof of safety and efficacy before allowing a device to be used which inherently so dangerous.

SALLY-I would also like to state my view, and the view of a lot of us here, that we are dealing with an industry here, the mental health industry, that, in fact and in itself, is responsible for creating more “mentally ill” people than for curing them. And I think if you look at those of us here who have achieved a degree of recovery and wholeness of mind, most of us would tell you that we have done it in spite of the mental health system, not because of it.

LINDA-Again I think we need to look at the longterm social cost of ECT-the four weeks of benefit, after which there is commonly what they call “relapse”…inaudible…But what about the longterm social cost of people who have had ECT and formerly were productive and working, and after ECT (such as myself and a great number of other people)…inaudible…. What does that cost our society to take somebody who was a productive person, who maybe experiences some temporary distress, and create a permanent disability?. …inaudible…Consider the cost of disability payments …inaudible…You know, most people who have ECT end up on SSI and disability.

FDA-I hear you. I think that statements like that, though, are a little incendiary, because before you can say that most people who have had it end up on Social Security roles, you need to know how many of them would have ended up there anyway. I mean, that’s kind of inflammatory.

SALLY-We would like to see all these things studied scientifically.

FDA-That gets to my next question, which is what would you, if you had three wishes, what would you like to see the agency do? What is it that you would like of us?

LINDA-First of all, we would like to see you do your job, which is to call for a safety investigation under Class III, …inaudible…and we would like you to make it a very high priority, given the controversy now going back twelve years, with much public interest on this issue. The 32 volumes of letters in the dockets would justify making it a very high priority.

LARRY-Well-controlled, double blind clinical trials.

FDA-How do we do double blind clinical trials? How is that possible?

FDA-Are you talking about the FDA doing the studies, or …inaudible…doing the studies?

FDA-We had a discussion before you came in, but I think…We don’t have the resources to fund clinical trials, so we are dependent either on the profession funding such a study or the manufacturers or another agency.

LINDA-We have a problem in that many people who have done such research as does exist are themselves paid by the shock machine companies…inaudible…and I think that raises an ethical question: Can this research be done fairly by persons who have a financial interest? That would be a big concern of ours, that whatever research be done be very carefully and ethically by people who have no financial interest in this treatment.

LARRY-Since the approved device can be used for things other than that for which it is approved, as is true of a drug, it seems to me we would want to have some input into the follow-up. Certainly no psychologists now have tests for memory, for learning ability, for mood. We would want to look at things such as employability.

LINDA-…inaudible…It does not have to be an expensive kind of test…inaudible…For organic brain injury, from my own experience and the experience of other people, after a year post ECT, recovery is as stable as it is ever going to be. So I would say wait at least one year afterwards to allow the person to recover as much as is possible, maybe three years…inaudible…

LARRY-I haven’t heard any mention yet of the impression that I have that of the amount of ECT being used, but my impression is that the amount of electroshock therapy being used by psychiatrists is greatly increased. It was something that had faded out in the 60′s, and now it is increasingly used. During this very time, the psychiatrists at APA are attending a course on learning these techniques. Then new people will be qualified to do it. So its importance from a regulatory priority is probably dependent on whether it is in frequent use, or whether it is very uncommonly used, it is important that someone address this question of how rapidly is the use increasing.

FDA-I’d like to make a couple of quick points. I think there are two separate issues here–it’s hard to keep them separate. One is that we have published a proposal to reclassify ECT devices from Class III to Class II for one specific indication-that is severe depression. I gather that you oppose that–but to the extent that there is a reference to it in literature, there is data-whether it is anecdotal or whether it is published in studies-that we may not know about or have not identified- please get that into the record, so it will be included. Mr. White just indicated that we have not closed that record. Anything along that line, if we could get it in writing and formally submitted, we can guarantee you it will be considered.

SALLY-I was concerned that you said that one of the reasons for approving the use for depression was that you were told by physicians. . .

FDA-Could I just correct that? We haven’t approved anything. What we did was, we proposed reclassifying from Class III to Class II. We have not finalized that yet, and, as I said, that’s really on a very slow track, because one of the conditions was that we wanted to see a standard for its use. And that has not materialized. So right now the status is Class III, and it has not changed.

SALLY-What concerns me about the thought process involved here is the weight given to the psychiatrists who claim that this is their only effective treatment, or something to that effect. I would hope that you people might keep in mind that we are the users here, and in my view and in most of our view, this industry is very questionable–the whole mental health system. And I think it is a little different from looking at treatments in other areas like diabetes, which these things are so often compared to, because it is not the same thing. And I hope you will keep that in mind and continue to listen to people who are the recipients of this treatment.

FDA-We will. But one point I made is the Class II proposal of reclassification. The other is that, I gather, as Ms. Andre indicated, that this group is opposed to the use of these devices for any purposes–that it really has no place in clinical medicine and clinical practice.

LINDA-There may be individuals who have. …inaudible… But the position of the organization of people who have had ECT is that there should be informed consent, and that people need to be told accurately of the risks, and then if they wish to have it they can have it.

LINDA-One thing we would like to see is the FDA…inaudible…In 1982 it said they were considering an informed consent statement. Because, as you may know, there is no standard informed consent statement. Any hospital can make up their own, each of the different manufacturers has its own version, the APA has another version, different doctors in the APA have their own version. We think there should be a standard for an informed consent statement…inaudible…

LARRY-Even if it is just your own staff saying, “Indeed the scientific evidence is very weak, that it is either ineffective or harmful.” This is an astounding thing, that such a device is permitted, yet stronger regulatory action has been taken in much less toxic…inaudible…

LARRY-You see, we’re not even dealing with a disease. Maybe we’re dealing with people who are sad about their lives and need to talk it over with someone and figure out that they need to make changes in their lives. And yet psychiatry is decreasingly interested in listening to people and increasingly interested in wanting the imprimatur of scientific medicine, by using devices and drugs to obviate this time-consuming process which actually peer counseling is beginning to replace. And perhaps a lot of people need to be in touch with their sadness to explore what are they sad about and how can they change their lives. And yet that opportunity is scarcely considered by many psychiatrists, particularly the advocates of these biological…inaudible…

SALLY-Psychiatrists base their judgments and their diagnoses on behavior, not on the basis of what is going on inside a person-what we feel like, or whether we are trying to make a spiritual transformation, or whether we are grieving for a lost husband or something like that. It is simply on the way we behave. And their judgment of success is very often-especially with ECT-whether we become compliant. And that it is true, because that is one of the first effects of ECT-apathy and compliance.

FDA-We control the device itself through our restrictions on the manufacturers that sell the devices. We don’t impact on those devices that are already out there, that have been sold legally in the past. I just want to make sure you understood that.

SALLY-But still, the findings of your agency do carry a lot of weight.

FDA-And I want you to know we really did hear you. I think it’s important that we can’t maybe control mental health care in this country, obviously, but we are responsible for this particular device, and we are responsible for getting the word out on what we know and don’t know about that device. You really came through loud and clear. And I guess I want you to know that we take that responsibility very seriously, we will do the very best we can to get out solid data on what is known and what is not known. People really do need to make an informed choice. I don’t know how to do that-that’s a different question. But at least we can get the information out there.

LARRY-We really appreciate this meeting. It is clear to me that the agency has brought forth people who have responsibilities in this area, and people who have useful information. It’s very nice of you.

***** Sharewrite 1994 Sally Clay * sallyclay@aol.com ***** Permission is granted for personal or electronic distribution of this document as long as it is unchanged in any way and this notice is included. For permission to reprint it for general publication, contact me at 310 Elm St., Northampton, MA 01060, or by email.

Proposal to reclassify shock machines

University of Health Sciences/The Chicago Medical School
Department of Psychiatry and Behavioral Sciences
3333 Green Bay Road
North Chicago, Illinois 60064-3095
Telephone 708.578.3331

October 10, 1990

Dockets Management Branch
FDA
Room 4-62
5600 Fishers Lane
Rockville MD 20857

Re: 21 CFR Part 882 (Docket No. 82P-0316): Neurological devices; proposed rule to reclassify the electroconvulsive therapy device intended for use in treating severe depression

Gentlemen:

I have the following comments concerning the above-referenced
proposed rule, which appeared in the Federal Register, vol. 55,
No. 172, pp. 36578-36590, Wednesday, September 5, 1990.

1. Limitation of intended use to severe depression, as defined by DSM-III-R criteria for major depressive episode with melancholia. (section IV, p. 36580)

a. Exclusion of non-melancholic major depressives.

The 5 references cited in support of this proposed limitation are mostly outdated–4 of them appeared between 1953 and 1965–especially in view of the several random-assignment, double-blind, sham ECT-controlled studies demonstrating the efficacy of ECT in depressed patients who do not meet DSM-III-R criteria for major depressive episode with melancholia, as follows.

Freeman, Basson and Crighton (1978) found genuine ECT (N=20) superior to sham ECT (N=20) in patients suffering from “depressive illness”, which the authors defined only as a persistent mood change exceeding customary sadness, accompanied by at least one of the symptoms of guilt, insomnia, retardation, or agitation. This definition is substantially less restrictive than that for DSM-III-R major depressive episode with melancholia, which requires a minimum of 10 depressive features: at least 5 for major depressive episode plus at least 5 more for melancholia.

West (1981) demonstrated the superiority of genuine (N=11) over sham (N=11) ECT in patients with “primary depressive illness” diagnosed according to the Feighner criteria, which are substantially less restrictive than those of DSM-III-R for major depressive episode with melancholia because they require only 5 depressive features for a “definite” or 4 for a “probable” diagnosis.

Brandon et al (1984) found an advantage for genuine (N=38) vs. sham (N=31) ECT in patients described only as having “major depression”, without any specification as to endogenicity, psychosis, melancholia, or number or type of symptoms required.

Gregory et al (1985) reported an advantage for genuine (N=40) vs. sham (N=20) ECT in patients who met ICD-9 criteria for major depressive disorder (296.2/3), which are very simply and broadly defined as “a widespread depressed mood of gloom and wretchedness with some degree of anxiety”, often with reduced activity or agitation and restlessness, and much less restrictive than DSM-III-R criteria for major depressive episode with melancholia.

Moreover, the FDA’s own summary of data in support of the proposed reclassification (section IV para. A, p. 36580) relies heavily on the 1976 study of Avery and Winokur (FDA reference #7) to support the claim that ECT exerts more potent antidepressant effects than tricyclic antidepressants. The Avery and Winokur (1976) study, however, employed only a Feighner “probable” diagnosis of depression–that is, at least four depressive symptoms–which is far less restrictive than DSM-III-R requirements for a major depressive episode with melancholia.

Thus, the proposed rule to limit the use of ECT devices in the treatment of major depression to patients who meet DSM-III-R criteria for major depressive episode with melancholia is unjustifiably restrictive, and should be broadened by dropping the “with melancholia” qualifier.

b. Exclusion of patients with schizophrenia.

The FDA’s position (p. 36582) that the evidence regarding the efficacy of ECT in schizophrenia is inconclusive because it is based on mainly anecdotal and uncontrolled studies omits consideration of two important double-blind, random assignment, sham-ECT controlled studies:

Bagadia et al (1983) found a course of 6 genuine ECTs plus placebo (N=20) to be therapeutically equal to a course of 6 sham ECTs plus 600 mg/day chlorpromazine (N=18) in a sample of 38 patients who met the stringent Research Diagnostic Criteria for schizophrenia. This study is notable for excluding patients with prominent affective symptoms.

Brandon et al (1985) found a course of 8 genuine ECTs (N=9) significantly more effective than 8 sham ECTs (N=8) in lowering Montgomery-Asherg Schizophrenia Scale scores in a sample of 17 patients diagnosed as schizophrenic according to the PSE-based CATEGO program.

Taken together with the Taylor and Fleminger (1980) sham-ECT controlled study cited by the FDA, these reports provide strong scientific evidence for the efficacy of ECT in schizophrenia.

c. Exclusion of patients with the diagnosis of mania.

In taking the position (p. 36585) that further scientific study is needed to demonstrate the effectiveness of ECT in mania, the FDA notes that it is already aware of the “well-designed prospective study” by J.G. Small et al (1988) . Perhaps because it is the only controlled study on the subject, the FDA apparently decided not to give it much weight; it is necessary, however, to place this study in a perspective that includes the fact that virtually every textbook on ECT, and every clinician experienced with using ECT, agrees that ECT is no less effective in mania than in melancholia. Moreover, the Small et al (1988) study must also be viewed in the context of a series of carefully-conducted retrospective chart review studies drawn from very large patient samples treated over many years (McCabe, 1976; McCabe and Norris, 1977; Thomas and Reddy, 1982; Black, Winokur, and Nasrallah, 1987), that provide compelling if not definitive evidence for a substantial anti-manic effect of ECT–in fact, no contradictory data exist. In this sense, the case was already considered proved by most experts, and lacked only the “formality” of confirmation by a controlled trial such as that of Small et al (1988)

It is further noteworthy that the recent chart review study of Black, Winokur, and Nasrallah (1987), which shows a much greater efficacy of ECT than lithium in the treatment of mania, was done at the same institution and with the same methodology as the study of Avery and Winokur (1976) that is so prominently cited by the FDA in support of the greater efficacy of ECT than antidepressant drugs. Moreover, Avery and Winokur (1976) reported that only 49% of depressives receiving ECT enjoyed “marked improvement”, whereas Black, Winokur and Nasrallah (1987) found that 78% of manics who received ECT achieved this degree of improvement.

These considerations all strongly suggest that FDA should include mania as a prime indication for ECT in the proposed labeling requirement.

2. The proposed labeling requirement that the use of ECT should progress from unilateral to bilateral placement, from pulse to sine wave energy, and from subcritical to minimum amount of energy needed to induce seizure activity.

The unfortunate result of this well-intended but antitherapeutic requirement is that all patients must intially receive brief pulse right -unilateral ECT administered with near-threshold dosing, ignoring the elegant study of Sackeim et al (1987) , which conclusively demonstrates that just-above-threshold brief pulse right unilateral ECT lacks significant therapeutic benefit in depression. The requirement also ignores the fact that the only one out of 6 genuine vs. sham ECT studies that failed to show an advantage for genuine ECT (Lambourn & Gill, 1978) employed low- dose (1OJ energy) brief pulse unilateral ECT as the “active” treatment.

Finally, my colleagues and I (Abrams, Swartz and Vedak, Arch. Gen. Psychiat., in press, copy enclosed) have recently demonstrated that high-dose (markedly suprathreshold) brief pulse right unilateral ECT is equal in therapeutic efficacy to bilateral ECT, in contrast to an earlier study at the same site (Abrams et al, 1983) that found conventional-dose unilateral ECT to be much less effective than bilateral ECT.

Sincerely yours,

Richard Abrams, M.D.
Professor of Psychiatry

Testimony of Anne Krauss to NY Assembly

Hello. My name is Anne Krauss. I’m presently employed as the Administrator for the National Association for Rights Protection and Advocacy, although I am here today as a private citizen, not as a representative for that organization. Up until March 21 this year, I worked for the New York State Office of Mental Health as Recipient Affairs Specialist for Long Island. On March 9, I received a call from John Tauriello, Deputy Commissioner and Counsel of the New York State Office of Mental Health (NYS OMH) and Robert Meyers, NYS OMH Deputy Director of the Division of Community Care Systems Management. They informed me that if I continued to actively advocate on behalf of Paul Thomas in his efforts to prevent Pilgrim Psychiatric Center from shocking him, OMH would view this as a conflict of interest with my employment. I explained that I was engaged in this activity on my own time and at my own expense. However, they insisted that, since Mr. Thomas is engaged in a legal battle with the organization for which I worked, that it would be unethical for me to advocate for Mr. Thomas while working for OMH. On March 21, I submitted my letter of resignation, which was accepted on March 22.

Up until December, 2000, electroshock had not been an issue to which I had devoted much attention. I would have been surprised to learn that less than four months later, electroshock would be the issue which would lead me to resign. When I learned in December that Pilgrim Psychiatric Center was seeking to treat a patient with electroshock against his family’s wishes, I began to seriously educate myself about this complicated issue. When I learned that Paul Thomas, whom I first met in 1998, had received over 50 shock treatments in less than two years despite his objections, I felt compelled to act.

I am a person who firmly believes that it is important to gain a scientific understanding of a problem before reaching any decisions about a course of action. I come from a family of scientists. Both my father and my brother were educated at the California Institute of Technology. I was a physics major at Harvard University when I married and dropped out to raise a family. My husband received a Ph.D. at Cal Tech in biochemistry after receiving a medical degree at Cornell College of Medicine. I eventually finished my undergraduate education at Empire State College, then entered a Ph.D. program in experimental psychology and cognitive neuroscience at Syracuse University. Once again, family obligations cut short my educational pursuits, but my devotion to scientific approaches remains unwavering.

Proponents of ECT claim that research overwhelmingly supports the hypothesis that electroshock is safe and effective. A cursory glance at the research literature would appear to support this claim. However, I would caution the members of this Assembly Committee to look very closely and critically at the scientific evidence which is currently available. In ten minutes, there is not time to adequately examine what research has been done, or, more importantly, what research has not been done. Even if this whole day were devoted to understanding the research picture, we could only scratch the surface. However, let me share some information which I hope will pique your curiosity, as it did mine, so that you will withhold judgment until you have time to thoroughly investigate the evidence.

Electroshock devices are classified by the Food and Drug Administration as Class III medical devices. Class III is the most stringent regulatory category for medical devices. Electroshock devices were placed in this category because of their potential to cause unreasonable risk of illness or injury. These devices can be marketed under current regulations only because they have been “grandfathered” in by virtue of being marketed prior to 1976, when the medical device classification and regulation system was put into place. The manufacturers of these devices have never submitted the evidence which the premarket approval process requires of all devices introduced after 1976. Premarket approval is a process of scientific and regulatory review to ensure the safety and effectiveness of class III devices. Keep this in mind if you hear that older reports of neuropathology resulting from electroconvulsive therapy in experimental animals and humans are “outdated”. Similar studies have not been conducted using contemporary shock techniques and devices. Such studies have not been required for marketing, since these new devices are accepted by the FDA to be “as safe and as effective or substantially equivalent” to the older devices. Until such studies are conducted, there is a lack of scientific evidence that these newer devices actually are safer, as claimed.

You may have noticed that I prefer the term “electroshock” rather than “ECT” or “electroconvulsive therapy”. The term ECT implies that the effectiveness of the treatment depends upon the production of a convulsion, or seizure. If this were indeed the case, the safest device would use the minimum dosage of electricity necessary to induce a convulsion. Such a device was developed, and, indeed, the memory changes, confusion, and agitation observed in people shocked with this device were not as large as observed in association with higher dose machines. However, use of low dose machines was abandoned, because psychiatrists found them considerably less effective. This suggests that the size of the electric shock, rather than simply the length of the convulsion, plays an important role in this treatment. It also suggests that negative side effects are inseparable from what psychiatrists perceive as the therapeutic effect. It is also interesting to note that even proponents of electroshock do not claim a therapeutic effect lasting longer than a few weeks, which coincidentally is the same length of time required for the most obvious of the memory disruptions to clear.

In considering the evidence, I also caution you to distinguish between solid research evidence and mainstream medical opinion. Remember that Moniz was awarded a Nobel prize for the lobotomy, which was considered a major medical breakthrough in its day. Remember also that tardive diskenesia was recognized by critical researchers and, yes, anecdotally by patients, for well over a decade before the medical establishment was willing to admit the true dimensions of this serious problem associated with pharmaceutical treatment of psychosis. Remember this before you hastily marginalize researchers and patients who are critical of electroshock.

During these past five months I have learned that, despite rhetoric which pays lip service to a concept of recovery from psychiatric disability based on self-help and empowerment, in practice OMH acts as though the only legitimate treatments are pharmaceuticals or electroshock. Twelve years ago I was hospitalized with what was diagnosed as a schizophreniform psychosis, and I had experienced considerable psychiatric disability even prior to my hospitalization. Symptoms of neuroleptic malignant syndrome, a life-threatening side-effect of medication, abruptly ended the pharmaceutical treatment I had been receiving. Since that time, a combination of psychotherapy and self-help through peer support have helped me to recover to a point that I no longer consider myself to have a psychiatric disability.

I realize that my story can be criticized as anecdotal, however, a careful review of the literature will reveal considerable evidence that, even for people experiencing extreme psychiatric states, effective alternatives exist other than drugs and shock. Dr. Bertram Karon conducted a study in which psychotherapeutic treatment of people diagnosed with schizophrenia was compared to pharmaceutical treatment. This study, which was funded by NIMH, provided evidence that the outcomes for the group treated with psychotherapy were superior to those of the drug treated group.

In his book, Recovery from Schizophrenia, Richard Warner compares conditions in non-industrialized countries to those in the West, in an effort to explain why, although the appearance of altered state is relatively constant across cultures, recovery rates seem to be much higher in the non-industrialized world. The factors he identifies which appear to promote recovery in non-western cultures are remarkably similar to those present in the self-help community which I found helpful in my recovery.

Both of the people I know for whom OMH is seeking court ordered shock have not been given adequate access to psychotherapy. Limitations on visitation have also seriously curtailed their access to peer support. One person is still not permitted to receive visitors other than immediate family members. The ward environment in which he must live would be stressful for anyone, and certainly has not been designed to effectively promote recovery in a person who is experiencing an altered state. Yet OMH claims that electroshock is the only available option for both of these individuals, because of dangerous effects each has experienced from drug treatment.

Recommendations:

At a minimum, a moratorium on forced electroshock treatment should be sought in New York State until FDA premarket approval requirements are met. No person should be involuntarily subjected to treatment with a Class III device for which the FDA has not yet received reasonable assurance of both safety and effectiveness. Acceptance by the medical community is not a substitute for rigorous testing.

Reporting requirements for basic information on each procedure administered in New York should be instituted, including patient age, location of treatment, status as voluntary or involuntary patient, and any death of a patient occurring within two weeks of the procedure. Similar reporting requirements in Texas indicate that a person receiving 60 treatments, the number Mr. Thomas has undergone in the past two years, faces a risk of death of approximately 2%. A retrospective study of electroshock in New York would also be illuminating.

Capacity determinations should be made by psychologists, not by psychiatrists, and certainly not by the same psychiatrists whom have determined that a particular treatment is the best or only treatment option. Under the present system, disagreement with the psychiatrist’s opinion is considered evidence of “lack of insight”, which in turn is viewed as a symptom of mental illness. Separating the issue of capacity to make a reasoned treatment decision, which is more of a psychological than a psychiatric question, from the question of agreement or disagreement with the proposed treatment, could effectively address this problem. Legislators could gain a better understanding of this issue if they read the transcript of Mr. Thomas’ hearing.

It is very difficult to devise a legislative approach to guaranteeing that patients will have access to alternatives to electroshock. Increased funding and continued support for psychotherapy and self-help, including research in these areas, is important. However, as long as mental health treatment is ultimately under the control of psychiatrists, it is likely that alternatives to somatic treatments will not be viewed as legitimate. Psychiatry tends to view all mental difficulties as resulting from physical abnormalities in the brain. At the risk of oversimplification to make a point, I’ll claim that in many cases this makes about as much sense as blaming the Intel Pentium processor for Microsoft’s buggy software. Perhaps psychiatry’s “hardware” bias could be offset through giving greater power to both psychologists, who by analogy are “software” experts, and to those of us who have experienced altered state, and know in the most intimate and direct way how somatic treatments and human relationships impact upon us.

Video and audio clips about electroconvulsive therapy

Audio

Tune in every Tuesday at 1 ET (12 Central, 10 am Pacific) for the Mind Freedom Weekly News Hour, hosted by David Oaks.
http://www.progressiveradionetwork.org/

Electroshock as violence against women:
Dr. Bonnie Burstow explores electroshock as a form of violence against women. She is a feminist therapist, an anti-psychiatry and anti-fascist activist. She is also the former co-chiar of the Ontario Coalition Against Electroshock and is the author of Radical Feminist Therapy: Working in the Context of Violence. Listen

Weekly Paul Henri Thomas updates:
WGBB radio has vowed that it will carry weekly updates until Paul Henri is no longer at risk of forced electroshock treatments. You may listen to the show live on the net on Monday nights at 7 pm Eastern time. I will try and record the shows for those who miss them:

  • Feb. 26, 2001: WGBB on Long Island, New York carried a GREAT program that featured Sherry Taub, a New York activist, and PAUL HENRI THOMAS! (He’s the man at Pilgrim being forcibly electroshocked currently) He’s difficult to understand at times due to his French accent and the effects of the THIRTEEN psychiatric drugs he’s on, but it’s a great interview. A MUST LISTEN! (30 minutes)
  • March 5, 2001: The second show featuring advocate Anne Kraus talking about the hearing and the latest news on Paul Henri. (29 minutes)
  • March 12, 2001: The third show featuring Sherry Taub and Laura Ziegler talking about the latest legal news concerning Paul Henri. (38 minutes)
  • April 2, 2001: Another show, featuring Linda Andre of CTIP and Anne Kraus. (11 minutes)

My interview on CKLN Radio in Toronto, where I discussed ECT, the Kathleen Garrett case, forced ECT and other issues in September, 2000. (25 minutes)

Feb. 26, 2001: KUCI in Irvine, California has a weekly show on Mondays called Mind…Your Own Business, where they discuss mental health issues. I was the guest for this show and talked about ECT, Paul Henri, forced ECT and more. (50 minutes)

Three excerpts from the recent series by Gary Null (www.garynull.com) on ECT and the use of force.

  • Gary interviews a number of ECT survivors, who speak about their experiences and talk about the issues surrounding ECT. Listen (45 minutes)
  • Gary speaks to psychiatrist Dan Fisher of the National Empowerment Center, who discusses issues, plus talks about why ECT isn’t an effective treatment. Dr. Fisher says 50 percent of psychiatrists are opposed to ECT. (The audio on this is a little fuzzy). Gary also discusses the current state of research and does an exhaustive lit review. Listen (22 minutes)
  • Gary interviews more ECT survivors and continues his series. Listen (57 minutes)

Dr. Max Fink on informed consent issues and protecting yourself against lawsuits (if you’re an ECT doc). (3 minutes)

Dr. Max Fink sums up how psychiatrists are given the power to play god: “The judgment is yours. Society says….YOU’RE the psychiatrist…” (1 minute)

Video

The issues

Channel 11 in St. Louis reports on HB134 which would require ECT reporting. (48 seconds)

[gv data="BbLcRXltJJk"width="425" height="350"][/gv]

An interesting clip from 60 Minutes II. (24 seconds) Oh boo hoo, CBS had the video removed.
[gv data="aZ3Boa8lUnY"width="425" height="350"][/gv]

Extra
The Extra news show explores the issues surrounding ECT. This segment interviews Liz McGillicuddy, who lost much of her memory from electroshock in 1994. (3:47 minutes)

[gv data="CYX19KuZCNI"width="425" height="350"][/gv]
It also includes interviews with Dr. John Friedberg, neurologist in California, who talks about the fact that the FDA has NEVER required safety testing of the machines, and they interview Harold Sackeim, PhD, shock proponent extraordinaire. In his interview, he *admits* that the famous 1 in 200 statistic is not based in science!
Here, Harold Sackeim admits the truth – the statistic is not based in science! (30 seconds)

[gv data="OShZ-iA8Ofs"width="425" height="350"][/gv]
Gordon Elliot Show

Diann’a Loper discusses how a bill she helped create has helped other ECT patients. This kind of reporting MUST be made mandatory across the USA. Lobby your legislators! (30 seconds)

[gv data="jvaoBPyE3vk"width="425" height="350"][/gv]
Diann’a Loper fell into a post-partum depression. Her psychiatrist pushed her into ECT, and she lost everything – her marriage, her new baby, and most of her life. Says Diann’a, “I wish they would have killed me.” (2:30 minutes)

[gv data="C0CW9Nd71N0"width="425" height="350"][/gv]
Hope Morgan received ECT when she began suffering from insomnia. Her doctor diagnosed depression. “My life was in a shambles,” says Hope, referring to the devastation following the ECT. (3:10 minutes)

[gv data="UthAbjInBCQ"width="425" height="350"][/gv]
Marcia Fink says ECT turned her life around. “I do things anyone else can do.” She says the only memory loss she suffered was three months’ worth. (1:47 minutes)

[gv data="HYcbMna3U-g"width="425" height="350"][/gv]
Hal Haralson says ECT in the state hospital 40 years ago turned his depression around. (43 seconds)

[gv data="NKmIQ5dglDA"width="425" height="350"][/gv]
A doctor from the audience speaks against ECT, and the role of insurance companies. (1:02 minutes)

[gv data="aa1u9ZEv_Z4"width="425" height="350"][/gv]
Dr. Charles Kellner blatantly lies about the current stimulus dosing used in today’s ECT! BUSTED! (1 minute)

[gv data="RDKaOi54qe4"width="425" height="350"][/gv]
More from Charles Kellner
When questioned about his financial ties to Mecta, one of the shock machine manufacturers, Dr. Charles Kellner attempts to change the subject. (32 seconds)

[gv data="Yk0-3_gjLVc"width="425" height="350"][/gv]
Here, Dr. Kellner says the tragic experiences of patients like Hope and Diann’a are “unfortunate” and goes on to say that most people will be cured by ECT. He fails to mention the now-admitted high relapse rate, or the need for continuation/maintenance ECT. (30 seconds)

[gv data="cZ7wjoJoMvE"width="425" height="350"][/gv]
Dr. Charles Kellner misleads the public about the effectiveness of ECT. (1 minute)

[gv data="S3kQSwudpnU"width="425" height="350"][/gv]
Dr. Charles Kellner makes up a story about how ect works. The truth is, nobody knows, and he’s CAUGHT ON TAPE fabricating a nice tale. (50 seconds)

[gv data="a7PHxCkAHak"width="425" height="350"][/gv]
Dr. Peter Breggin discusses the role of the FDA in the ECT controversy, and how they dropped the ball. (1 minute)

[gv data="6L6SVflAdyM"width="425" height="350"][/gv]
Dr. Breggin talks about the literature, and why some people become *more* depressed after ECT. (35 seconds)

[gv data="nUM8Ses1UB8"width="425" height="350"][/gv]
Dr. Breggin explains how the perception of ECT has changed, and how the longstanding theory that “brain damage was helpful” has been given a new spin. (50 seconds)

[gv data="myl7WZ4eTqc"width="425" height="350"][/gv]
Dr. Peter Breggin sums it all up: View the clip (10 seconds)

[gv data="WRjDXcZ4VOA"width="425" height="350"][/gv]

Scottish Documentary on Ewen Cameron, who worked with the CIA to brainwash and erase memory using electroshock. In three parts.
Part 1

[gv data="7aPPdKewAHc"width="425" height="350"][/gv]

Part 2
[gv data="82OdRogOfEA"width="425" height="350"][/gv]

Part 3
[gv data="n1Py20Zrm6s"width="425" height="350"][/gv]

News stories on Christian Hageseth and his legal woes

[gv data="DqAXOh_kqv8"width="425" height="350"][/gv]

[gv data="nN4DJYm5AKI"width="425" height="350"][/gv]

[gv data="aftPEFSHExQ"width="425" height="350"][/gv]

Video clips from the Mecta lawsuit, Harold Sackeim testimony

The Surgeon General’s New Clothes

The Surgeon General’s New Clothes:
How the press and the SG distort the truth about mental distress

(also available in Perspectives Mental Health Magazine, April-May, 2000):

By Richard Shulman, Ph.D.

Following the issue of the Surgeon General’s report on mental health (December, ’99), press headlines echoed Dr. David Satcher in declaring a new era of enlightened understanding. Headlines and media sound bites proclaimed science’s demonstration that emotional disorders and behavioral problems were truly legitimate physical illnesses, some would say brain disorders, rooted in genetics and biochemistry.

Imagine how surprised the writers of such headlines might be to discover these research summaries in the professional literature:

*

“Few lesions or physiologic abnormalities define the mental disorders, and for the most part their causes remain unknown.”
*

“[N]o single gene has been found to be responsible for any specific mental disorder…”
*

“[T]here is no definitive lesion, laboratory test, or abnormality in brain tissue that can identify …[mental] illness.”
*

“It is not always easy to establish a threshold for a mental disorder, particularly in light of how common symptoms of mental distress are and the lack of objective, physical symptoms.”

Surprise: these are QUOTES from within the Surgeon General’s report, just some of the many similar summaries of decades of research:

*

“The precise causes (etiology) of most mental disorders are not known.”
*

“DSM-IV [the diagnostic manual of the American Psychiatric Association] is descriptive in its listing of symptoms and does not take a position about underlying causation.”
*

“The thresholds of mental illness or disorder have, indeed been set by convention…”
*

“All too frequently a biological change in the brain (a lesion) is purported to be the ‘cause’ of a mental disorder…[but] The fact is that any simple association – or correlation – cannot and does not, by itself, mean causation.”
*

“[N]o single gene or even a combination of genes dictates whether someone will have … [a mental] illness or a particular behavioral trait.”
*

“Even with…schizophrenia, the median concordance rate among identical twins is 46 percent…meaning that in over half of the cases, the second twin does not manifest schizophrenia even though he or she has the same genes as the affected twin. This implies that environmental factors exert a significant role in the onset of schizophrenia.”
*

“Placebo (an inactive form of treatment)…is more effective than no treatment [for mental disorders]. Therefore, to capitalize on the placebo response, people are encouraged to seek treatment, even if the treatment is not … optimal…”

Why are headlines trumpeting that our emotional problems are best defined as medical illnesses, when physicians such as the SG can find no biological lesions or markers that define them? And why is the press simply parroting the SG’s summaries, when such headlines mislead the public, evidenced by details within the report?

Is it possible that this report, and the oft-repeated truisms that emotional problems are at root medical diseases, also reflect the influence of business interests, and not strictly academic science? Sound too paranoid? What’s next, would we suspect business interests of trying to influence government? Suspect the pharmaceutical industry of trying to influence the Food and Drug Administration and organized medicine? Could the press unwittingly be coopted by uncritically accepting the pronouncements of people in authoritative white lab coats?

We all know that emotional turmoil and human suffering exists — but is it disease? We’re so used to hearing that “mental illnesses” are “chemical imbalances” that we miss the point: Decades of research have failed to confirm this hypothesis. There are no “chemical imbalances” which validly and reliably define people’s troubles. That is why there are no lab tests or other assays of physical disease which confirm the “diagnosis” before you’re offered Prozac or your child is given Ritalin.

If your Aunt Doris is sad, demoralized or in a longstanding unhappy rut in her life, should we call her “dysthymic,” a psychiatric label with no demonstrable basis in biochemistry? If your 9 year old neighbor Andy’s parents inconsistently instill discipline in him, and he now misbehaves in school, do we affix the label “ADHD” [attention deficit hyperactivity disorder], a category for which there is no physical marker or disease entity? Yes, we can give Andy a medical-sounding label, and supply stimulant pills. We can give pills which have a sedative or stimulant effect on anyone; this does nothing to confirm the presence of a physical disease.

Misled by this medical paradigm, we frequently miss a key opportunity to understand the underlying personal reasons that someone is distressed.

A substantial literature now demonstrates that many psychiatric medications show only modest efficacy versus placebo, if studied scrupulously (and in research not funded or squelched by drug companies). [note: Some of this research has been published by Dr. Irving Kirsch right here at the University of Connecticut.] Interestingly, this perspective was briefly acknowledged, but minimized in the SG report.

The Wall Street Journal describes “an era of creeping commercialization in science,” citing an analysis of “210 influential journals, mostly in the bio-medical field” in which researchers publishing studies rarely disclose their financial ties to drug manufacturers. Such conflicts of interest have been covered in major medical journals and newspapers in the last year, even eliciting an apology from the New England Journal of Medicine recently, but this issue is not to be found in the SG report.

Surveys published in Psychiatric journals show that medical students are rejecting psychiatry as a specialty, often “citing a lack of scientific foundation,” with trends suggesting that psychiatry is viewed as “outside the mainstream of medical practice.” Psychiatric residents publish satires depicting their education as funded and shepherded by pharmaceutical companies, with little attention given to the subtleties of understanding the personal turmoils and hidden dilemmas of another human being. Loren Mosher, M.D., formerly a prominent researcher with the National Institute of Mental Health, published his resignation letter from the American Psychiatric Association in Psychology Today (Sept./Oct. ’99), documenting how the organization is “unduly influenced by pharmaceutical dollars;” over-relying on drugs, underemphasizing their shortcomings, side-effects, and toxicities, and virtually ignoring psychotherapy.

Even Consumer Reports and JAMA (Journal of the American Medical Association) reveal how drug companies conspire to influence prescribing Physicians and the consuming public.

But pharmaceutical company funds and influence aren’t mentioned by the Surgeon General, nor by uncritical publicists in the popular press. Nor does the report highlight that actual consumers of mental health services can be critical of groups comprised largely of family members of consumers, such as NAMI [National Alliance for the Mentally Ill]. The leadership of these latter “family” groups don’t advertise that they are covertly funded by pharmaceutical companies. Remember the group CHADD, a major proponent of stimulant medication for children, later revealed to be secretly subsidized by drug makers? NAMI advocates for biological treatment, even forced drugging, for what they repeatedly call “brain diseases.” The SG report portrays NAMI positively, minimizes the conflict over forced treatment with consumers themselves, and says nothing of NAMI’s multi-million dollar drug industry funding.

Are behavioral and emotional problems illnesses if decades of research have failed to find physical disease entities which cause them? The headlines surrounding the SG report blind us to this confounding miscategorization. Is this a summary of science, or is it marketing of psychiatric guild interests? Isn’t it in the financial and professional interest of psychiatrists (and drug companies) to insist that all of life’s confusion, unhappiness and conflict is their domain, over which they hold unique medical expertise? Especially when managed care will only pay for services deemed “medically necessary,” and clearly prefers to pay for pills over the expense of psychotherapy.

Without demonstrating any physical abnormalities, we can give disease labels that then grant a child the advantage of an extra hour and a half to take their SAT’s. Or we can fabricate disease labels which allow a criminal to murder, rape or embezzle, and then avoid legal consequences due to “psychiatric illness.” But isn’t this a subversion of logic and responsibility that the profession is purveying? Why is the press so uncritically accepting of this illogic, which spins medical illness labels out of no identifiable physical pathology, while benefiting particular “special interests?”

Here’s how two professors summarize this issue: “…American Psychiatry… has unsuccessfully attempted to medicalize too many human troubles…[A child's] school difficulties, your neighbor’s marital problems, your friend’s drinking habits, and your anxiety about an upcoming speech may cause great pain and be worthy of help from a psychotherapist, but that pain and that need for assistance require no psychiatric diagnosis to understand and no specific medical therapy to treat.”

The SG does endorse psychotherapy, but emphasizes primarily more simplistic forms of therapy that can be easily researched; those that are short-term, focused on limited problems, and that often have manuals. As H.L. Mencken said “For every complex problem there is an easy answer, and it is wrong.” Most people’s lives and problems are complex , and so is thoughtful therapy and the research which tries to document its helpfulness.

Why do we accept such oversimplified and medicalized truisms about life’s problems? Are we all blinded by the trappings of science? By misleading explanations repeated often? By appeals to political correctness? Do we prefer dreaming of “magic pills” rather than facing complex and upsetting human dilemmas that inevitably are part of life?

Why did the Surgeon General’s “sound bites” in the press misleadingly summarize the report in the first place? And why did the press repeat the SG headlines without 1) reading the report, and 2) thinking critically? There may be different answers to these questions, but none serves the advancement of the public’s knowledge.

Dr. Shulman, a Licensed Psychologist, is the Director of Volunteers in Psychotherapy, Inc. VIP provides psychotherapy in exchange for volunteer work clients donate to the charity of their choice: A nonprofit alternative to the loss of client privacy and control experienced under managed care. More information at (860) 233-5115 or on the web at www.CTVIP.org