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!!!!!!!

Electroconvulsive Therapy Causes Permanent Amnesia and Cognitive Deficits

ect.org note: This article is appearing in numerous publications and websites, so to avoid repeating the same information again and again, an ongoing list of publications will be posted below.

———–

Forbes
Electroconvulsive Therapy Causes Permanent Amnesia and Cognitive Deficits, Prominent Researcher Admits
12.21.06, 3:38 PM ET

NEW YORK, Dec. 21 /PRNewswire-USNewswire/ — In a stunning reversal, an article in the journal Neuropsychopharmacology in January 2007 by prominent researcher Harold Sackeim of Columbia University reveals that electroconvulsive therapy (ECT) causes permanent amnesia and permanent deficits in cognitive abilities, which affect individuals’ ability to function.

“[T]his study provides the first evidence in a large, prospective sample that adverse cognitive effects can persist for an extended period, and that they characterize routine treatment with ECT in community settings,” the study notes.

For the past 25 years, ECT patients were told by Sackeim, the nation’s top ECT researcher, that the controversial treatment doesn’t cause permanent amnesia and, in fact, improves memory and increases intelligence. Psychologist Sackeim also taught a generation of ECT practitioners that permanent amnesia from ECT is so rare that it could not be studied. He asserted that most people who said the treatment erased years of memory were mentally ill and thus not credible.

The National Institute of Mental Health (NIMH) estimates that more than 3 million people have received ECT over the past generation. “Those patients who reported permanent adverse effects on cognition have now had their experiences validated,” said Linda Andre, head of the Committee for Truth in Psychiatry, a national organization of ECT recipients.

Since the mid-1980s, Sackeim worked as a consultant to the ECT device manufacturer Mecta Corp. He never revealed his financial interest in ECT to NIMH, as required by federal law, and, until 2002, did not reveal it to New York officials as required by state law. Neuropsychopharmacology has endured negative publicity over its failure to disclose financial conflicts of journal authors, resulting in the editor’s resignation and a promise to disclose such conflicts in the future; yet there is no disclosure of Sackeim’s long-term relationship with Mecta, nor did Sackeim disclose his financial conflict when his NIMH grant was renewed to 2009 at approximately $500,000 per year.

The six-month study followed about 250 patients in New York City hospitals, an unusually large number; most ECT studies are based on 20 to 30 patients. Sackeim’s previously published studies were short term, making it impossible to assess long-term effects. “However, in other contexts over the years — court depositions, communications with mental health officials, and grant protocols — Sackeim has claimed to follow up patients for as long as five years. This raises serious questions as to how long he has actually known of the existence and prevalence of permanent amnesia and why it wasn’t revealed until now,” Andre said.

Besides finding that ECT routinely causes substantial and permanent amnesia, the study contradicts Sackeim’s oft-published statements that ECT increases intelligence and that patients who report permanent adverse effects are mentally ill.

“The study is a stunning self-repudiation of a 25-year career,” Andre said.

———————————————————-

Other publications that have picked up the story:

Dec 22 2006:

Forbes
Medical News Today
Brietbart
Dallas News
Kron.com
MedicalDevices.org
TXCN.com – Healthcare & Hospitals
WFAA
Philadelphia Weekly
Genetic Engineering News
Pharma-Lexicon

Cyberonics involved in med journal scandal

NEWS Journal editor quits in conflict scandal

Neuropsychopharmacology’s chief steps down after a paper
he co-authored omitted significant financial disclosures

By Stephen Pincock

[Published 28th August 2006 05:28 PM GMT]

The editor of a leading psychiatry journal announced last Friday (August 25) that he was stepping down after he published a paper about a treatment for depression without disclosing that eight of nine authors–including himself–had financial ties to the company that makes the device.

Charles B. Nemeroff, editor in chief of Neuropsychopharmacology, a publication of the American College of Neuropsychopharmacology (ACNP), will not serve another term as editor, the college told its members in an Email. The decision was made “in part, based on the recent adverse publicity to the journal and the ACNP,” the Email said.

That publicity arose after the journal’s July issue carried a positive review of a vagus nerve stimulation (VNS) device made by Cyberonics, Inc, of Houston, Texas. Nemeroff was the lead author for the paper, which described VNS as a “promising and well-tolerated intervention that is effective in a subset of patients with treatment-resistant depression.”

The article acknowledged funding from Cyberonics, and listed coauthor Stephen Brannan as an employee of Cyberonics. But it did not reveal that the eight other academic co-authors were all consultants for the firm.

The story, one of several recent conflict-of-interest cases, first made news in July, prompting the journal to print a correction

This isn’t the first time that Nemeroff has hit the headlines for undisclosed financial ties. In 2003, a review he coauthored in Nature Neuroscience neglected to mention significant financial interests in three therapies that were reviewed favorably (including owning the patent on one of the treatments), prompting the Nature Publishing Group to widen its disclosure policies. At the time, Nemeroff and his co-author Michael Owens said: “Going forward, we intend to provide all financial disclosure information, even if it is not requested by the journal editor.”

Clare Stanford, past president of the British Association for Psychopharmacology and an editor at several journals in the field, said Nemeroff was an influential researcher in his field who was unlikely to have been swayed by the Cyberonics money.

“I don’t believe for a minute that the fact the paper was funded by a company would have influenced his conclusions,” she told The Scientist. “It is unfortunate that he has had to stand down over this incident which is largely a reflection of the scientific community’s paranoia rather than any failing of his professional integrity.”

Not everyone shares her view, however. In a blog entry posted earlier this month on the Health Care Renewal blogspot, Bernard Carroll, scientific director of the Pacific Behavioral Research Foundation, called the incident a “slick, coordinated, public relations-disinformation campaign in which ACNP and its journal were exploited by paid consultants of the corporation.”

Nemeroff, chairman of psychiatry and behavioral sciences at the Emory University School of Medicine, told The Scientist in an Email that the financial disclosures of all authors were submitted to the journal, but due to an “oversight,” were not included in the print version. “There was absolutely no intent to withhold any information concerning financial disclosures.”

He added that he has served as the journal’s chief editor for five years, during which time the journal has “improved in all objective indices including manuscripts submitted, ISI rankings … I feel that we have accomplished our goals and I have opted not to accept the ACNP Council’s invitation to serve another three years.”

The group Alliance for Human Research Protection, meanwhile, has raised concerns that a professional writer paid by Cyberonics wrote the first draft of the paper. The writer was not listed as an author but was thanked in the acknowledgements.

Ronnie Wilkins, executive director of ACNP, told The Scientist that Nemeroff would serve out the rest of his current term as editor in chief, which ends in December. Earlier this year, he had been voted in for another term.

Meanwhile, the college wants to ensure the same thing doesn’t happen again, Wilkins said. “The council met on August 23 … and one of the things we asked the publication committee was to look at our policies and procedures to make sure that we have a checklist to avoid this kind of oversight happening again,” he said.

Stephen Pincock
spincock@the-scientist.com

Links within this article

Charles B. Nemeroff

http://www.psychiatry.emory.edu/NeuropsychopharmacologyLaboratory/Charles%20Nemeroff.htm

Neuropsychopharmacology

http://www.nature.com/npp/index.html

American College of Neuropsychopharmacology

http://www.acnp.org/default.aspx?Page=Home

C. Nemeroff, et al, “VNS Therapy in Treatment-Resistant Depression: Clinical Evidence and Putative Neurobiological Mechanisms,” Neuropsychopharmacology (2006) 31, 1345-1355.
PM_ID: 16880768

Cyberonics

http://www.cyberonics.com/

A. McCook, “Conflicts of interest at Federal agencies,” The Scientist, July 24, 2006.

http://www.the-scientist.com/news/display/24056/#24128

D. Armstrong, “Medical Reviews Face Criticism Over Lapses,” Wall Street Journal, July 19, 2006.

http://www.postgazette.com/pg/06200/706933-114.stm

B. Carey, “Correcting the errors of disclosure,” New York Times, July 25, 2006.

http://www.nytimes.com/2006/07/25/health/25news.html?ei=5070&en=794c681583ce7296&ex=1156910400&adxnnl=1&adxnnlx=1156760425-D1Sb+JF5FgICzW9qEslWjQ

“Corrigendum: VNS Therapy in Treatment-Resistant Depression: Clinical Evidence and Putative Neurobiological Mechanisms,” Neuropsychopharmacology advance online publication, 31 July 2006; doi: 10.1038/sj.npp.1301190

http://www.nature.com/npp/journal/vaop/ncurrent/full/1301190a.html

S. Pincock, “Full disclosure?” The Scientist, October 1, 2003.

http://www.the-scientist.com/article/display/21640/

Clare Stanford

http://www.ucl.ac.uk/Pharmacology/Research/scs.html

B. Carroll, “Money and Medical Journals,” Health Care Renewal, August 8, 2006.

http://hcrenewal.blogspot.com/2006/08/money-and-medical-journals.html

“ACNP journal editor quits amid exposure of conflicts of interest,” AHRP, August 27, 2006. http://www.ahrp.org/cms/content/view/327/55/stating the authors had submitted disclosures in accordance to journal policy, but that the information simply had not been included in the acknowledgement section of the published paper.

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!

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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.

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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.

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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.”

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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.

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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.”

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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.

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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.

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“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.

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Electrical parameters

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

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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.

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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!

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Recycling medical devices raises concerns

By LINDA A. JOHNSON, AP Business Writer
July 30, 2006

For eight months during his infancy, Sean Van Duyn gagged, retched and vomited daily. Now 6, the Winter Haven, Fla., boy still can’t eat or drink by mouth, instead being fed by a permanent tube in his belly.

Beset by multiple medical problems in his first months, the boy had to have a breathing tube inserted through a hole cut in his neck. The gagging began and continued until his mother, Susan, discovered the tube was misshaped at the end and had been poking the back of his throat the whole time. The tube was replaced, but by then Sean’s developing brain was programmed not to swallow; he still cannot.

The family alleged the injury occurred because the plastic breathing tube’s tip had been bent during “reprocessing” — cleaning and heat sterilization — done at an Orlando hospital even though the tube was labeled for single use only. They won a confidential settlement from the hospital.

The case has fueled the debate over the safety of reusing surgical blades, forceps and other medical devices. The practice was routine until a couple decades ago, when stronger plastics enabled manufacturers to start making devices designed for single use to cut costs and prevent infection spread in the era of AIDS.

Then hospitals, and eventually specialized companies, started “reprocessing” single-use devices, cutting device costs by about half — without patients’ knowledge.

Federal regulators say reprocessing is safe, but original device manufacturers say they can’t guarantee recycled products will work correctly — and that they are wrongly blamed for malfunctions and patient harm caused by reprocessing.

A federal law taking effect Tuesday, requiring reprocessors to put their company name on recycled devices as well as the packaging, could help determine who’s at fault when problems occur. For devices too small to mark, detachable stickers could be transferred to the patient’s chart.

“That’s like a ‘Sue Me!’ sticker,” and may not be used much, said Josephine Torrente, a lawyer and biomedical engineer who consults for device manufacturers.

Dan Vukelich, executive director of the Association of Medical Device Reprocessors, argues reprocessed products are totally safe because each item is inspected before being shipped.

The device makers and their trade group have been lobbying legislators in several states for bills that protect their interests — and patients. The battle has a big — and fast-growing — financial stake for both sides. Device makers saw combined revenues jump from $48 billion in 2001 to $71 billion last year; reprocessors went from a combined $20 million in 2000 to $87 million in 2004.

Johnson & Johnson subsidiary Ethicon Endo-Surgery is suing the biggest reprocessor, Ascent Healthcare Solutions, for trademark infringement over reprocessing its single-use devices.

“It is impossible to reuse them,” said Robert O’Holla, J&J’s head of regulatory affairs for medical devices, because they are not designed to be taken apart for cleaning. Yet J&J gets complaints from customers about problems with devices showing excessive wear or bleach on them — signs of reprocessing.

Ascent Healthcare’s regulatory chief, Don Selvey, said only about 2 percent of medical devices — a category that ranges from MRI machines to reading glasses — are now reprocessed. He said his company’s processes reduce chances of “viable organisms” surviving on devices to one in one million.

Reprocessed devices are soaked in sterilizing solutions, disassembled, blasted clean with a fine powder, reassembled and inspected, then packaged, sterilized and resealed. On average, they’re reused three to six times.

“It is as safe and effective as a new device if they meet our requirements,” said Larry Spears, compliance chief for medical devices at the Food and Drug Administration.

Since early 2004, when reports of problems with medical devices were first required to note if they had been reprocessed, the FDA has received 13 reports of patient deaths and 421 other trouble reports, including 130 involving serious patient harm, although some may be duplicate reports.

Reprocessors say they must meet stringent FDA standards after first proving they can safely clean and sterilize each type of device. But the manufacturers main trade group, the Advanced Medical Technology Association, notes about half of the reprocessors’ applications for reprocessing of individual devices were rejected by FDA, a sign of the difficulty of properly cleaning complex devices.

Rep. Tom Davis, a Virginia Republican who chairs the House Government Reform Committee, said Friday he plans a fall committee hearing to examine the issue.

“It is unclear to us at this time whether FDA is able to accurately track how often something goes wrong because a device meant to be used once was instead reused,” Davis wrote in a statement.

Congress also has asked its investigative arm, the Government Accountability Office, to update a June 2000 report which concluded more oversight is needed. GAO is unsure when it will begin investigating.

Ken Hanover, CEO of the seven-hospital Health Alliance of Greater Cincinnati, said his hospitals have used reprocessed devices for about eight years without a problem.

“There’s far more risk of medication errors in a hospital than of a problem arising with a reprocessed device,” he said, adding that his hospitals “probably” would honor patient requests to have only new devices used on them.

Children’s National Medical Center in Washington, on the other hand, doesn’t use reprocessed devices, said surgeon in chief Dr. Kurt Newman.

“We want to use the safest and most sterile equipment,” he said.

University of Pennsylvania bioethicist Arthur Caplan has “qualms” about the practice, particularly because patients don’t give informed consent — required when deviating from the standard of care raises safety or efficacy concerns.

“I just think people ought to know what’s going on,” Caplan said.

Susan Van Duyn, Sean’s mother, agreed.

“If anybody can learn from the tragedies with Sean, it’s worth telling” his story, she said.

Association of Medical Device Reprocessors – click on the link that says please help them fight state regs…one of their points of upset involves the proposal to have to give INFORMED CONSENT to patients.

Shock Machines – Letter to Editor from Don Weitz

March 31, 2004

Letters Editor
The Toronto Star
fax: 416-869-4322
Email: lettertoed@thestar.ca

Dear Editor:

As hi-risk or unsafe medical devices, I call readers’ attention to
electroshock (“ECT”) machines (“Medical devices called risky,” Mar.31).
Auditor-General Sheila Fraser probably did not specifically mention
electroshock machines in her recent audit report on Health Canada. However,
since 1978 the US government’s Food and Drug Administration (FDA) has
officially classified these hi-risk machines in “Class-III”, its lowest
approval category which indicates unsafe or high-risk. Nevertheless, Health
Canada hasn’t even  bothered classifying these machines, it hasn’t bothered
to evaluate or conduct independent tests of their medical safety. Instead,
it has  routinely relied on the self-serving, biased reports of the
manufacturers (US-based companies Somatics, Mecta). FDA also has refused to
conduct independent medical safety tests, it still relies on manufacturers’
unsubstantiated claims of safety and effectiveness.

In Canada, shock machines are used by hundreds of psychiatrists on
thousands of patients everyday as a so-called “safe, effective and
lifesaving” treatment for “depression”, “bipolar mood disorder” and
“schizophrenia”. Shock machines may be wired to satisfy electrical
engineering standards, but they’ve never been proved medically safe. These
machines deliver an average of 175-200 volts of electricity for 1-2 seconds
during each “treatment”, but they’re capable of delivering as much as 400
volts – at least 2 times the electical energy coming out of your home
electrical outlet! Nevertheless, they’re declared “safe”, “effective”,
even “lifesaving”. Shock machines always cause harm by inflicting brain
damage, permanent memory loss, other intellectual disabilities, and
sometimes death – all scientifically documented facts in the
medical-psychiatric literature for over fifty years.

I personally know of many psychiatric survivors in Canada and the US who
have been permanently traumatized and disabled by “lifesaving” electroshock
and its “safe and effective” engines of destruction. Today the main targets
of electroshock are women and elderly people, especially women over 60,
which means the administration of shock is also sexist and ageist, a form
of elder abuse.

Health Canada claims it’s protecting our health and safety from hi-risk
medical devices. Really? I say prove it – start inspecting these
memory-destroying, brain-disabling machines and publish the reports of your
inspections. These infernal machines should be banned, so should
electroshock.

Don Weitz

Mecta and Easybar: twins separated at birth?

As has been reported extensively on ect.org, the couple that has owned Mecta Corporation for years also owns Easybar Beverage Management Systems. Mecta makes shock machines, and Easybar makes machines that dispense beverages, primarily marketed to casinos.

Compare the two devices, the Easybar and a Mecta ECT device: (Easybar has the cocktail in front)

tower.jpgimages.jpeg

While they obviously aren’t the same machine (one gives electricity, the other gives booze), the similarity in design is striking. Perhaps that’s because, according to a former engineer with the company, the designers/engineers sometimes co-mingle and try to troubleshoot design flaws.

While searching the Internet, I came across some interesting websites, which are of great concern. It seems there’s a real market for “recycled” medical devices. In February of 2006, dotmed.com listed a Mecta SR1 device for sale. It’s now gone…WHO BOUGHT IT and where is it being used? This is very disturbing.

Listing of the used medical equipment sites I came across:

http://www.dotmed.com

http://www.hospequip4u.com (4u, that’s cute!)

http://www.pemed.com/

http://www.medmarketplace.com

There are more, but this gives you an idea of the market in medical device garage sales on the internet.

Update: A few days later, Associated Press carries a story on concerns over this very issue…recycled devices.

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.

Survey NEJM: conflict between researchers and industry sponsors

A National Survey of Provisions in Clinical-Trial Agreements between Medical Schools and Industry Sponsors
Kevin A. Schulman, M.D., Damon M. Seils, M.A., Justin W. Timbie, B.A., Jeremy Sugarman, M.D., M.P.H., Lauren A. Dame, J.D., M.P.H., Kevin P. Weinfurt, Ph.D., Daniel B. Mark, M.D., M.P.H., and Robert M. Califf, M.D.

ABSTRACT
Background Concerned about threats to the integrity of clinical trials in a research environment increasingly controlled by private interests, the International Committee of Medical Journal Editors (ICMJE) has issued revised guidelines for investigators’ participation in the study design, access to data, and control over publication. It is unclear whether research conducted at academic institutions adheres to these new standards.

Methods From November 2001 through January 2002, we interviewed officials at U.S. medical schools about provisions in their institutions’ agreements with industry sponsors of multicenter clinical trials. A subgroup of the respondents were also asked about coordinating-center agreements for such trials.

Results Of the 122 medical schools that are members of the Association of American Medical Colleges, 108 participated in the survey. The median number of site-level agreements executed per institution in the previous year was 103 (interquartile range, 50 to 210). Scores for compliance with a wide range of provisions — from ensuring that authors of reports on multicenter trials have access to all trial data (1 percent [interquartile range, 0 to 21]) to addressing the plan for data collection and monitoring (10 percent [interquartile range, 1 to 50]) — demonstrated limited adherence to the standards embodied in the new ICMJE guidelines. Scores for coordinating-center agreements were somewhat higher for most survey items.

Conclusions Academic institutions routinely engage in industry-sponsored research that fails to adhere to ICMJE guidelines regarding trial design, access to data, and publication rights. Our findings suggest that a reevaluation of the process of contracting for clinical research is urgently needed.

WINNER: Harold Sackeim: Lying for fun and profit

By Linda Andre

LYING FOR FUN AND PROFIT

sackeim.jpg In 1975, when he was a graduate student in psychology at the University of Pennsylvania, young Harold Sackeim wrote his masters thesis on self deception. And his PhD dissertation was titled “Self Deception: Motivational Determinants of the Non-Awareness of Cognition.”

So Harold became a doctor by self deception. He then seemed headed for a dead-end career in academic psychology, publishing on such decidedly unsexy topics as “Classroom seating and psychopathology.” He published a book chapter called “The Adaptive Value of Lying to Oneself” and an article titled “Self Deception: A concept in search of a phenomenon.”

Clearly Harold needed a product to pitch, a big-ticket tie-in; if he didn’t find one he would end up just another obscure academic researcher. Sometime around 1980, his concept met its phenomenon: Harold hitched his wagon to a shock machine. It was a perfect match. Harold’s star has done nothing but rise ever since.

Harold had received a grand total of about $5,000 in grant money up to 1981. That year he got half a million dollars, and the millions have been rolling in steadily ever since. By 1988, Harold was proclaiming himself a “world expert” on ECT, and not many in the world were inclined to contradict him.

The fact is that if Harold Sackeim didn’t exist the American Psychiatric Association would have had to invent him, in order to get out of what it perceived as a public relations problem with electroshock. Sackeim is a born PR man.

ECT PR battle- listen

No one else has had quite the stomach for ECT promotion that Harold has; other ECT advocates, not so skilled in self deception, tend to choke on the Big Lies he tells so glibly. Harold gives the impression of actually believing his own lies, and perhaps he really does.

Whenever the media does a story on ECT, Harold is there with a sound bite on the spot. Whenever an ECT survivor sues for memory loss, Harold is likely to be the “expert witness” testifying against her. He’s got his fingers in every dike where the truth about ECT might slip through.

A writer for a men’s magazine once called Harold Sackeim a “designer-suited scientist.” But only the first half of that description is accurate. Harold does wear the finest suits —though like the special souped-up shock machines he uses, they must be made to order, since he stands under five feet tall. But a scientist Harold Sackeim is not. All of his money and influence have gone, not into an objective scientific investigation of ECT, but into preventing such an investigation.

— Since 1981, Harold has been continuously funded by NIMH to study “Affective and Cognitive Consequences of ECT.” He’s received over five million dollars for this grant alone (he has several other million dollar grants from NIMH as well). That’s five million dollars that made sure that no one but Harold would have the official say as to exactly what ECT’s cognitive effects are. And it’s virtually certain now that no one else ever will. This grant, now entering its third decade, no longer has to compete with other proposals for funding; it’s renewed for ten years at a time, most recently in 2000.

What does Harold have to show for his twenty years of “research”? Well, he wrote last year that “we lack data” on the permanent adverse effects of ECT; in particular, he claims there is no research on the number of survivors who experience severe permanent amnesia.

— Rather than doing this research —- research he surely knows would be fatal to his published claims that ECT is safe, and to his position as the golden boy of the ECT industry — Harold’s chosen to simply make up some numbers. He wrote the APA’s informed consent form, which is used in one version or another in most hospitals in America. The form states that only “1 in 200″ ECT survivors report permanent memory loss. But that fake “statistic” is not based on anything. Harold was finally forced to admit (on national television) that this is simply a made-up number, and that there is no data to support it. Ever the PRman, he calls the figure “impressionistic.”

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Without blinking an eye, he’s now (as of mid-2001) begun touting a new “impressionistic” figure: 1 in 500.

— In a public hearing before the New York State Assembly in July 2001, Harold claimed he had “never” seen a case of anterograde memory loss after ECT. (Anterograde refers to loss of memory function; retrograde refers to loss of memories, or amnesia.) He invited “anyone in the country” who had experienced such loss to “come in for an evaluation.” Dozens of ECT survivors with anterograde memory loss contacted Harold. How many have been to Harold’s facility for an evaluation? Not one. Harold backpedaled on his invitation as fast as he could the instant it became clear that survivors would, indeed, take him up on it. Those who’ve phoned, emailed or faxed Harold report that he either never responded, or simply told them—-without meeting them or doing any testing or evaluation—-that something other than ECT was to blame for their deficits. Drugs, other psychiatric treatments—whatever he could think of—must have caused the disability or brain damage, not ECT, he said. Therefore there was no need for an evaluation to see if ECT had done it. In one memorable case of a woman whose brain damage and permanent cognitive disability had already been well documented (and attributed to ECT) by her doctors, a lesser PR man than Harold might have been at somewhat of a loss as to what to say to her. The woman had never had any drugs, treatment, or mental illness after having ECT. So what caused her deficits? Harold wasn’t stumped for an answer: why, it was the short period of mental illness she’d experienced nearly two decades earlier, for which she was given ECT, that damaged her brain! “You’re saying you believe mental illness causes brain damage?” asked the astounded woman. “We know it does,” came the answer, quick as a con man’s switch of the cards. He explained that he believes “depression itself, period” always causes brain damage even when successfully treated.

— But stop the presses! It’s not exactly correct to say Harold isn’t gathering data on the incidence of retrograde and anterograde memory loss, and brain damage, due to electroshock. A member of his research team recently admitted that he does, in fact, test his research subjects’ memory and cognitive abilities before and after ECT. And although many of his tests are too easy or irrelevant to be useful, he does use at least one of the tests that ECT survivors have found relevant to our deficits. The catch: he’s never published or disclosed any of the results of these tests, or even the fact that he administers them. Wonder why not? And since he’s using federal money to do the testing, how can he hide the results?

— Much of Harold’s grant money has gone, not into actual research, but into long “review” articles in which he selectively trashes everybody else’s research. He did this is a 1993 article in which he dismissed the existing brain damage research, and in a 2000 article in which he trashed the memory loss research. In both articles he simply left out or distorted those published articles which say that ECT causes brain damage and memory loss.

— For over a decade, Harold has expressed the opinion that research into whether ECT causes brain damage is “not of scientific interest”, “uninteresting”, and “unlikely to be funded.”

A real scientist doesn’t cut off entire areas of scientific investigation by fiat.

Sackeim is in a position not just to express this opinion, but also to enforce it, and that’s exactly what he’s done. By virtue of his role as a reviewer of every proposed ECT grant that comes into NIMH and other agencies that might fund ECT research, and by virtue of his position on the editorial boards of virtually all journals which publish ECT articles, Sackeim’s arguably done more than any man in America to prevent a scientific investigation of ECT’s effects on the brain from ever being funded or published.

Ironically, his lab at the New York State Psychiatric Institute is stocked with the latest brain imaging technology, technology that’s available in only a handful of institutions in this country. Harold’s got both the tools and the money to settle the question of whether ECT causes brain damage —- but you see, that’s what a scientist would do, and he’s a PR man.

— Harold does MRIs on his ECT patients routinely, but not to assess the effects of ECT! He uses the brain scans to help him learn how to design and use the giant magnet (or transcranial magnetic stimulation) machines from which is making a profit and stands to make a killing when and if they replace ECT machines! What a waste of costly MRI scans…paid for with our tax money. They could be used for science, to assess the effects of ECT on the brain, if someone would just read them for that purpose, instead of as a way to further Harold’s career as a brain damage profiteer. (If you guessed that Harold’s on the payroll of the magnet machine manufacturers such as Magstim, you’re correct! He “consults” for them, gets grants from them, and how could he resist owning stock in them?)

— He’s also a consultant to the shock machine company Mecta, and has been since the mid 1980s. He’s worked for shock machine company Somatics as well. He’s even received grant money from Mecta. Federal law requires NIMH grantees to disclose actual or potential financial conflicts of interest, and requires that the conflicts be managed or eliminated. Sackeim has never disclosed his financial ties to the shock machine companies.

He does, however, disclose that he was on the board of Cambridge Neuroscience, a company that made a drug that was supposed to alleviate ECT’s effects on memory. (It didn’t.) Harold’s position that ECT is safe and can’t cause memory loss doesn’t interfere with his eagerness to make a buck off that memory loss.

His biggest whopper, for which he is justly infamous, is this one:

ECT improves memory. This statement appears in the APA consent form and many other consent forms, such as the one recently adopted by the state of Vermont. When Harold first came out with this line in the early 90s, ECT survivors laughed, figuring it was some kind of sick joke.

But no one else is laughing.

As it turns out, even Harold’s own published articles don’t support that claim. He cites only to himself as “proof”, since there isn’t anyone else; he usually cites, for instance, Sackeim et al, “Subjective Memory Complaints Prior to and Following Electroconvulsive Therapy”, Biological Psychiatry 39: 346-356 and Sackeim et al, “Effects of depression and ECT on anterograde memory.” Biological Psychiatry 21: 921-930, 1986. What this research actually shows is that patients are poor judges of their memory functioning in the days and weeks shortly following ECT, and although when asked by their shock doctors they reported their memories to be good or better than ever, in fact their performance on objective tests of memory functioning was worse. In order words, Sackeim’s own research is consistent with the conclusion that patients are suffering from acute organic brain syndrome due to ECT.

Harold is so addicted to lying, he does it just for fun. A few years ago, while teaching one of his “How to do ECT” classes, he recounted an anecdote involving a well-known New York City human rights activist and a man who was Harold’s patient at the time. Harold claimed that the advocate had come to his hospital, demanded to see this patient, got into the hospital and then tried to talk the patient out of having ECT. The punch line of the story – which got a resounding laugh out of the aspiring shock docs – was that this patient then decided to go ahead with ECT.

It made a great story, flattering to Harold, derogatory to what he called “the anti-ECT movement.” Except for one thing: it never happened. The advocate never went near Sackeim’s institution, never spoke to his patient, never tried to contact him in any way. The “anti psychiatry” organization Harold claimed she represented did not exist. He just made up the name on the spot, for purposes of his story.

His audience was completely duped, to the extent that a discussion ensued on the topic of “What would you do if anti-psychiatry came to your door?”

Did Sackeim tell his students he made up the whole thing? No, he was having too much fun. Was he maybe psychotic when he told the story? Arguably. Or as a doctor of self-deception, did he actually believe it to be true?

SHAME on Harold Sackeim for worming himself into positions of public trust, then abusing the hell out of that trust, and for making a killing doing it.

SHAME for playing the “mental patients are irrational and dishonest” card, rather than honestly investigating and documenting our reports of permanent memory loss and brain damage. (See his many government-funded articles in which he argues that people who report amnesia and cognitive deficits after ECT are crazy – for example, “Subjective Memory Complaints: A Review of Patient Self-Assessment of Memory After Electroconvulsive Therapy,” Journal of ECT, June 2000.) SHAME for playing this card as an “expert witness” on the stand against persons with permanent memory loss and cognitive disability.

SHAME for playing the “violent mental patients” card with the media, as in his false claim that patients have made “death threats” on him.

SHAME for telling one of his research subjects who was brave enough to confront him after losing twenty years of memory that her memory loss “couldn’t” be caused by ECT, and “must have” been caused by a stroke she had without realizing it.

SHAME for telling each one of the hundreds of survivors who’ve been his subjects or who’ve contacted him, “Your losses could not possibly be due to ECT”, and then saying with a straight face and fingers crossed behind his back (in court, to policymakers, to politicians, to the media) that he has “never” seen a case of permanent ECT memory loss.

Whether for fun or profit, the net effect of Harold Sackeim’s lies has been to end all scientific investigation of ECT’s effects on memory and the brain, and to effectively discredit survivors who report memory loss and brain damage, and to prevent future patients from being informed of ECT’s permanent effects.

No one is more shameless than Harold Sackeim, and no one more richly deserves induction into the ect.org Hall of Shame.

Were you treated with electroshock at New York State Psychiatric Institute (NYSPI)? Treated poorly? Complaints ignored? Dropped from the study and read later that you were never included in the study participants? You aren’t alone, and we can help. Your privacy is guaranteed.
Email, fax or call: 212-NO-JOLTS

Were you an employee in the electroshock research department at New York State Psychiatric Institute (NYSPI)? You witnessed things that have weighed on your conscience ever since? Whistleblowers are encouraged to contact us. Your privacy is guaranteed.

WINNER: Max Fink, the grandfather of American ECT


fink.jpgGrandpa Max used to claim that ECT worked by causing brain damage. He argued for years that the therapeutic effect from ECT is produced by brain dysfunction and damage. He pointed out in his 1979 textbook that “patients become more compliant and acquiescent with treatment,” and he connected the improvement with “denial, disorientation,” and other signs of traumatic brain injury and an organic brain syndrome.

Fink was even more explicit in earlier studies. In 1956 he stated that the basis for improvement from ECT is “cranio-cerebral trauma.” In 1966, Fink cited his own research indicating that “there is a relation between clinical improvement and the production of brain damage or an altered state of brain function.” He does not, however, make such statements in public, in court, or in the 1990 APA Task Force Report.

Max has also been busy with other ventures. Born in 1923, he is currently professor (emeritus) of psychiatry at SUNY at Stony Brook. His CV is too long to list here, but here are a few interesting appointments:

Founding Editor, Convulsive Therapy
Consultant to the FDA
U.S. Army on the Feasibility of Using Incapacitating Agents Against Terrorists.
Captain, U.S. Army.

The Finkeroo owns a company called SciData, based in Atlanta, Georgia. Organized in 1967, the last year’s sales were listed at $170,000.

Fink helps out his buddy, Richard Abrams, with Somatics, Inc. He narrates Abrams’ videotapes for Somatics, Inc., which sell for $350 to health professionals, or $360 for patients and families. Or you can buy a “preview version” for $25.

Max has a habit of being a little less than honest at times.

For example, he is responsible for the famed 1 in 200 statistic, which the APA uses in its literature. This statistic, long criticized by ECT advocates and survivors, supposedly reflects the number of patients who suffer memory loss. Recently, Max admitted the number was *not* based on any scientific studies, as had been widely claimed, but rather, was an “impressionistic” number – meaning he made it up.

Here’s another example, in a post of his from the shock doc mailing list:

“2. The second question is how to achieve an effective treatment in the face of the limited output of brief-pulse devices. The usual approaches are to use bilateral placement; change anesthetic from methohexital to etomidate; determine the dosing of benzodiazepines and if these were used, block with the antagonist flumazenil; enhance seizure duration by either caffeine or theophylline; and when these fail, double stimulation. If the lack of adequate energy is a frequent issue in practice, the THYMATRON can be modified to the British version, or the MECTA can have the Sackeim modification added — for research purposes.” For research purposes, Max??? That’s his way of covering his butt. He’s telling other shock docs how to boost the juice way past the machinery’s capabilities….for “research” purposes. This post was in response to a query from another doctor with legitimate patient concerns.

Max also doesn’t take confidentiality very seriously. He’s often harassed a certain ECT survivor, shutting down question and answer periods when she arrived. But he’s gone beyond that, by shouting at her and telling the entire workshop medical information from her confidential medical records.

All in the name of science for Max Fink.

Here is an example of his condescension towards mental patients: during a session on ECT for doctors, a doctor is explaining a patient he has who is afraid she’ll die if the machine shuts down, and the need for backup batteries. Max finds this to be a chuckle.

Max Fink chuckles at patient’s fears

He also sees himself as a celeb of sorts, illustrating how “fans” approach him after seeing his old video.

I’m famous and mobbed by my fans

Reporters are frequently invited by Max Fink to witness patients being given the treatment. Psychiatrist Peter Breggin has urged him to allow them to see his patients *after* they have received a full course of shocks. Under pressure, Fink agreed, but with a catch. While he charges nothing for the media to watch a patient undergo the procedure, he decided to charge $25,000 for himself and $15,000 for the patient for a single interview with the patient awake after a course of ECT.

This old goat needs to be put out to pasture….

WINNER: Richard Abrams

Untitled-4.jpgRichard Abrams is the king of self promotion and conflict of interest. His grimy hands are dipped in every pot of electric gold he can find. Not only has he written *the* textbook on ECT (Electroconvulsive Therapy by Oxford Press, 1997), he co-owns Somatics, Inc., manufacturer of the ThymatronTM, the hottest new product in brain assault. And if that isn’t enough, Abrams’ company also manufactures the mouth guard to prevent dental injury during ECT.

When a doctor wrote in the medical journal Convulsive Therapy that doctors could save money by using sports mouth guards instead of more expensive ones, Abrams’ Somatics partner wrote a letter attacking the idea. He didn’t bother to mention that he and Abrams owned the company that manufactured the alternative (at $29 each!)

Some believe that Abrams suffers from multiple personality disorder because of his differing looks. (The above picture is from his blond permed period) I prefer to think that he simply has bad hair days. Thanks to my good friend Jean F. who has provided me with more laughter on this particular concept. Her monologues on Abrams’ varying hairdos are worth more than a year’s supply of Prozac!

Abrams’ text, considered the authoritative work on ECT, subtly promotes his ThymatronTM by pointing out the advantages of an audible system of monitoring induced seizures, over the old fashioned method of chart and pen. And of course the ThymatronTM has it!

thym.jpgHe sells all kinds of gadgets, courses and anything related to ECT: machines, mouth guards, books and videos. He’s the King of ECT! I’m looking forward to the infomercial and the Home ThymatronTM, soon to be seen on the Home Shopping Network.

Abrams will continue to promote ECT over any other method of treatment until the day he dies. In fact, he even says that no progress has been made in the pharmacological treatment of depression since the 1950s. He wrote the following statement in 1992, well after the successful introduction of Prozac and a host of other new antidepressants:

“…despite manufacturers’ claims, no significant progress in the pharmacological treatment of depression has occurred since the introduction of imipramine in 1958.”

Somatics, Inc. Links:
Isn’t it time to upgrade to a Thymatron? – Abrams goes on the offensive and compares his machine to Mecta’s.

Addendum: Here’s an interesting Letter to the Editor from Conrad Schwartz, Abrams’ business partner in Somatics. Conrad and Richard sieze any opportunity they can to diss the competition, Mecta:

Am J Psychiatry 158:973-974, June 2001

Letter to the Editor

ECT Failure Rate Among Specific Devices

CONRAD M. SWARTZ, PH.D., M.D.
Springfield, Ill.
To the Editor: In reporting that adequate ECT seizures were not obtained at the maximum electrical stimulus dose in 5% of ECT patients, Andrew D. Krystal, M.D., M.S., et al. (1) did not recognize that this result is limited to the MECTA Corporation ECT device they used. Instead, they suggested that their results apply to all devices: “Approximately one of six patients…required the maximum possible ECT stimulus intensity available on U.S. ECT devices” (p. 965). The result is limited to MECTA devices because the pulse width and frequency of the maximum stimulus they use are specific to MECTA devices, and their values are crucial to the reported study. These values are for a 2.0-msec pulse width and a 90-Hz frequency with a 2.0-sec duration and 0.8 A current. Compared to these values, the combination of a narrower pulse width, lower frequency, and longer duration should produce lower rates of failure for seizure induction (2, 3). The point that a 5% failure rate is needlessly high is indisputable. However, the failure rate should be substantially lower with more efficient electrical stimuli as well as with higher doses.

Dr. Krystal et al. repeatedly noted a “maximum stimulus intensity limitation of 576 millicoulombs (mC) imposed on U.S. ECT devices by the Food and Drug Administration (FDA)” (p. 963). The actual limitation is 100 J of energy at 220 {Omega} of impedance. For 0.8 A current, as used in MECTA devices, this limitation corresponds to 572 mC. The original source for a figure of 576 mC is MECTA’s commercial literature. I also wish to point out that nowhere in their published article do Dr. Krystal et al. note their relationship with MECTA Corporation.

Footnotes

The author is a member/manager of Somatics LLC, a maker of ECT instruments.

References

  1. Krystal AD, Dean MD, Weiner RD, Tramontozzi LA III, Connor KM, Lindahl VH, Massie RW: ECT stimulus intensity: are present ECT devices too limited? Am J Psychiatry 2000; 157:963–967[Abstract/Free Full Text]
  2. Swartz CM, Larson G: ECT stimulus duration and its efficacy. Ann Clin Psychiatry 1989; 1:147–152
  3. Swartz CM, Manly DT: Efficiency of the stimulus characteristics of ECT. Am J Psychiatry 2000; 157:1504–1506

ECT Machines





Note: This page was at http://members.aol.com/noshock/machines/machtest3.htm and the site has disappeared. Thanks to the wonders of the Wayback Machine, I was able to get a copy of this page. If the person who owns this sees this, and will contact me with a new URL, I would be happy to redirect people to the new address, if you have one. I just didn’t want to see this page gone from the net…..Juli




ECT Machines


The main aim of Electroconvulsive Therapy is to cause a massive convulsion in the brain (a massive epileptic fit).  This is achieved by giving the brain an electric shock using an ECT Machine.  ECT machines are, basically, transformers which modify Mains Current so that it is transmitted to the patient’s skull in timed pulses. 

Two of the most common fallacies regarding Electroconvulsive Therapy (and ECT machines) are that:

a small electric current is passed through the brain
the voltages used are no higher than 150 volts

Nothing could be further from the truth.  As can be seen from the table below, the smallest current is 0.75 amps. more than enough to kill if applied across the chest.  A voltage as high as 450 volts speaks for itself.

Machine Country Voltage
(V)
Current
(I)
Charge
(Q)
ECTRON Series
5A
UK 225
volts
0.75
Amps
700
mC
MECTA SR2 UK 240
volts
0.8
Amps
1200
mC
MECTA SR2 USA 240
volts
0.8
Amps
576
mC
MECTA SR2 EUROPE 240
volts
0.8
Amps
403.2
mC
THYMATRON DGx UK 450
volts
0.9
Amps
1008
mC
THYMATRON DGx USA 450
volts
0.9
Amps
504
mC
THYMATRON DGx EUROPE 450
volts
0.9
Amps
504
mC

The main parameters associated with Electroconvulsive Therapy and ECT Machines are Voltage, Current,Charge, Time, and Threshold Value.

Electrical Quantity (Charge)
The Electrical Quantity (or Charge) is defined as the amount of electricity passing through a given point in a given time.  The SI symbol for Electrical Quantity is “Q” and it is measured in Coulombs or milliCoulombs (thousandths of a Coulomb) and is usually abreviated to ‘mC’ as in the Table above.
For example, the UK version of the Somatics Thymatron (see above) will deliver a Charge of 1008 milliCoulombs in 5.3 seconds.  Looked at another way, 1008 milliCoulombs of Electricity will pass through a given point (the patient’s brain) in a given time (5.3 seconds).
Threshold Value
The Threshold Value is the Electrical Quantity (Charge) required to produce a convulsion in a particular patient.  Since we are all different, it takes different amounts of electricity to cause a convulsion in each of us (i.e. our Threshold Values are different).  The Threshold Value for one person could be as low as 25 millicoulombs whereas the Threshold Value for the next person could be more than 1000 millicoulombs (i.e. it can take more than 40 times as much electricity to cause a convulsion in one person as the next).
Current
Current is the rate of flow of electricity.  It is the amount of electricity – Electrical Quantity or Charge – which passes a given point in a second.  Since Electrical Quantity is measured in Coulombs (or milliCoulombs) the obvious measurement for Current is Coulombs/second or milliCoulombs/second.  However, Current has been given its own special unit; it is measured in “amps”.  One amp is equivalent to 1 Coulomb/second.  The SI symbol for Current is “I”.
Resistance
Resistance is that which opposes the flow of electricity.  Resistance tries to reduce the current.  The higher the resistance, the lower the current.  The SI symbol for Resistance is “R” and it is measured in ohms.
Voltage
Voltage can be defined as that which causes electricity to flow.  It is an electrical force.  Increasing the Voltage will cause the Quantity of Electricity to increase so that more electricity will be passing through a given point each second which means that the Current is increased (i.e. The higher the voltage, the higher the current).  The SI symbol for voltage is “V” and it is measured in volts.

Voltage, Current and Resistance are connected by the formula:

Voltage(V) = Current(I) x Resistance(R)


It can be seen from the formula that if the current is kept fixed, then increasing the resistance will cause the voltage to increase; decreasing the resistance will cause the voltage to decrease.

Electrical Quantity (Charge), Current and Time are connected by the
formula:

Charge(Q) = Current(I) x Time(t)

Time is the time in seconds during which the current is flowing. 
It can be seen from this formula that if the current is kept fixed, then the quantity of electricity is completely dependent on the time.  The longer the Shock, the more electricity flows through the brain.


EXAMPLE



The Thymatron, manufactured by Somatics Inc, is an extremely popular machine (with psychiatrists) and is one of the machines recommended by the Royal College of Psychiatrists in their 1995 ECT Handbook.

The UK version of the Thymatron has the following specifications:

Max Output Voltage (V) 450 volts
Output Current (I) 0.9 amps
Frequency 70 hertz
Pulse Width 1.5ms (0.0015 seconds)
Stimulus Duration 0.26-5.3 seconds
OutPut Charge 50.4-1008 mC
Stimulus Intensity (max) 191 mC/sec

Like most modern ECT machines, the Thymatron is a fixed-current machine which means that it will try and maintain the current (0.9 amps) going through the patient’s brain no matter the resistance.  If the patient’s head has a high resistance, the machine will increase the voltage in order to overcome the resistance and keep the current at 0.9 amps.  If the patient’s head has a low resistance the voltage will drop.  Remember that voltage, current and resistance are connected by a formula (see above).

The Thymatron is also a brief-pulse machine which means that it sends the electricity through the patient’s brain in a series of short pulses.  Each of these pulses lasts 1.5 milliseconds (thousandths of a second).
It can be seen from the table that the Thymatron has a frequency of 70 hertz which means that it goes through 70 cycles per second.  It is also a bi-phasic machine which means that it sends two pulses on every cycle, thus it sends 140 pulses of electricity through the patient’s brain every second.  Since the shock can last up to 5.3 seconds, the machine will send 742 pulses of electricity through the patient’s brain in this time.  This means that &#150 at maximum shock length &#150 a current of 0.9 amps would actually be flowing in the patient’s brain for 1113 milliseconds (i.e. 742 pulses x 1.5 milliseconds).   Current would be flowing for more than a second.

Earlier, it was mentioned that Electrical Quantity (Charge), Current and Time were connected by the formula below:
Charge(Q) = Current(I) x Time(t)
The
maximum Charge that the Thymatron can deliver is 1008
mC.  From the formula it can be seen that this is the current
multiplied by the time for which the current flows  The current
flowing through the brain of the patient is the Charge (1008
mC) divided by the Time (1113 milliseconds) during which the current is
flowing.  This works out at 0.9056 amps which, if rounded down to one
decimal place, works out at 0.9 amps. This is exactly as stated in the
specification.

The unit of energy in the SI system of units is the
“Joule”.   In an electrical system, the Energy(E) in Joules is
the product of the voltage(V), the current(I) and the time(t) for which the
current flows.

Energy
(E) =
Voltage (V)  x Current (I)  x Time (seconds)

Assuming maximum voltage (450 volts), the energy delivered to the patient’s
head by each pulse would be:

450 volts x 0.9 amps x 0.0015 seconds (1.5ms)
= 0.6075 Joules

Since the machine delivers 140 pulses per second then the
energy delivered to the patient’s head every second is:


Energy per second = 0.6075 Joules x 140 pulses = 85.05 Joules

Since Power (watts) is the rate of
transfer of energy (joules per second), 85.05 joules per second represents a
power output of 85.05 watts.  This machine can deliver enough power to keep a large lightbulb glowing brightly for more than 5 seconds.


Does This Sound Like a Small Amount of Electricity?


Doctor’s financial stake in shock therapy

USA Today Series
12-06-1995

Doctor’s financial stake in shock therapy

When medical students learn about shock therapy, they turn to the only textbook on the subject: Electroconvulsive Therapy, published by Oxford University Press.

Richard Abrams, a professor of psychiatry at the Chicago Medical School, writes that shock therapy is proven safe and effective for depression and other problems, even in children and the elderly.

He advises that shock should be considered as the first treatment given, not as the last resort.

He concludes with an attack on doctors who criticize shock treatment and attaches a form to have patients sign when they consent to shock therapy.

But Abrams doesn’t tell the medical students one thing: He owns Somatics Inc., one of the nation’s two shock machine manufacturers.

He didn’t tell his publisher, either.

“Wow,” says Joan Bossert, executive editor of Oxford University Press. “I did not know that.” She would have had him disclose that in the book’s preface, she says.

“I really wish he’d told us, but it doesn’t take away from his expertise,” she says.

Neither did Abrams disclose his financial interest in the academic journal Psychiatric Clinics in September 1994, when he wrote an upbeat article on shock titled, “The Treatment That Will Not Die.”

In some recent articles, Abrams disclosed that he’s a “director” of Somatics. But readers weren’t told that he is also president and owns the company with shock researcher Conrad Swartz, a University of South Carolina psychiatry professor.

Abrams says it’s ridiculous to think his ownership of a shock machine company may create a conflict of interest.

“Most advances in medical instruments and technology have come from practicing physicians putting (their) knowledge to work in building better equipment,” he says.

He says he thought Oxford University Press knew he owned Somatics. “The association is very well-known in the community,” he says.

In a 1991 deposition, Abrams said Somatics provided half his income.

Abrams and Swartz started Somatics Inc., in Lake Bluff, Ill., in 1985. Somatics makes about half the USA’s shock machines; MECTA Corp. of Lake Oswego, Ore., makes the rest.

Abrams wouldn’t reveal company revenues or profits, but the Somatics Thymatron shock machine is used in about 500 hospitals nationwide and costs approximately $10,000.

“It’s a very small industry,” Swartz says. “The sales of these machines don’t compare with the sales of any one drug.”

Swartz says Somatics’ profits are comparable to having an additional psychiatry practice. (The average psychiatrist made $131,300 in 1993.)

Swartz writes extensively on shock therapy, too, and also rarely discloses his Somatics ties.

For example, when a doctor wrote in Convulsive Therapy, a medical journal, that doctors could save money using sports mouth guards during shock treatment, Swartz wrote a letter attacking the idea. He did not disclose that Somatics sells specially designed mouth guards for $23 a dozen.

Abrams and Swartz should “absolutely, without a doubt, disclose their ownership in all their publications,” says Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania.

They also should disclose it to patients on informed consent forms before shock treatment, Caplan says.

“True informed consent is not what the doctor thinks you should know, it’s what a reasonable patient might want to know,” he says.

Swartz calls this absurd.

“It’s a nonissue. Every doctor who does ECT makes money, just as every doctor who prescribes drugs does,” he says. “Patients know . . . and don’t particularly care.”

Swartz says Somatics was founded because MECTA wasn’t listening to psychiatrists who do shock therapy.

“I’m now able to improve machines. Who else can best advance ECT? Someone like me, who knows what they’re doing,” says Swartz, who has a Ph.D. in engineering as well as a medical degree.

For his part, Abrams is the most quoted shock therapy researcher.

The American Psychiatric Association’s 1990 task force report on how to practice shock therapy cites him more than any other expert.

His 340-page textbook is often the sole source of information about shock therapy in general medical books and articles read by doctors and patients.

Abrams’ textbook never mentions Somatics by name.

But he describes new shock machine innovations found only on Somatics machines.

For example, his textbook reports that a charge “delivered over four to eight seconds will optimize the risk-benefit ratio for ECT and provide maximal clinical efficacy with minimal cognitive consequences.”

Only one machine gives a four to eight second charge: the Somatics Thymatron DGx.

And Abrams sells it.

By Dennis Cauchon, USA TODAY

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