Harold Sackeim reverses position in upcoming study « ect.org

Harold Sackeim reverses position in upcoming study « ect.org

Harold Sackeim reverses position in upcoming study

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by Linda Andre Director, CTIP

The Cognitive Effects of Electroconvulsive Therapy in Community Settings

NIMH-funded research study published in the January 2007 issue of Neuropsychopharmacology
Author and primary investigator: Harold Sackeim

Funding: NIMH grants

#35636, Affective and Cognitive Consequences of ECT, funded since 1981 for a total of approximately ten million dollars so far (grant has been renewed through 2009)

#59069, ECT Practices in Community Settings—Evaluating Outcomes, funded since 1999 for a total of approximately 3.5 million dollars so far

Summary: After 25 years and millions of dollars of federal funding to research the adverse cognitive effects of ECT—25 years in which not one single longterm followup study was ever published—self-proclaimed “world expert” on ECT Harold Sackeim has now reversed his position, admitting that ECT routinely causes permanent memory loss and deficits in cognitive abilities. His new study—the first to be published in which he followed patients as long as six months, and one of his only studies to use controls—validates a generation of patient reports of permanent iatrogenic disability, and disproves Sackeim’s previously published claims that these reports were simply symptoms of mental illness. Other findings: there is no evidence that ECT increases intelligence, as Sackeim has previously claimed; and women are much more likely than men to experience severe permanent amnesia.

Significance: Harold Sackeim has been called the Pope of ECT, and for good reason. He’s published more on ECT than anyone in the world, has received more money to research it than anyone in the world, and is the author of the American Psychiatric Association’s patient information statement and consent forms, which are used by most hospitals in America. Through his writing, teaching, testimony—and positions on peer review, editorial, and funding boards, including NIMH grant review panels—he has more influence on what the profession and the public believe about ECT than anyone in the world. What Harold says goes.

Conclusion: This study could have been done at any point in the past 25 years. If it had, a generation of patients could have been warned of the likelihood of permanent significant memory and cognitive deficits before, instead of finding out after, ECT. In fact, there is evidence—from Harold’s own statements—that over the years he has in fact conducted studies following up ECT patients for a long as five years…but never published the results. Why not? Why did it take 25 years and over ten million dollars to validate what patients have been saying all along? In other words: What did Harold know, when did he know it, and why wasn’t it revealed?

Quotable quote from the study: This study provides the first evidence in a large, prospective sample that the adverse cognitive effects can persist for an extended period, and that they characterize routine treatment with ECT in community settings.

For a detailed critique, see below. 

For the past 25 years, patients who received electroconvulsive therapy (ECT) have been told by the nation’s top ECT doctor that the controversial treatment doesn’t cause permanent amnesia or cognitive deficits and, in fact, improves memory and increases intelligence. Psychologist Harold Sackeim of Columbia University also taught a generation of ECT practitioners around the world that permanent amnesia is so rare it could never be studied. Sackeim was the popularizer if not originator of the position that former patients who said the treatment erased memory were simply mentally ill and thus not credible.

His newest and perhaps last ECT research study disproves his tenaciously held claims about the treatment’s harmlessness. It is, in effect a stunning self-repudiation of a 25-year research career…one in which he accepted federal research money with one hand and consulting fees from shock machine companies with the other.

See, for instance, the key finding:

This study provides the first evidence in a large, prospective sample that the adverse cognitive effects can persist for an extended period, and that they characterize routine treatment with ECT in community settings.

Similarly, from the abstract:

Despite ongoing controversy, there has never been a large scale, prospective study of the cognitive effects of electroconvulsive therapy

Sounds like the research team is congratulating itself for being “the first,” as if they’d made a discovery before anyone else, doesn’t it? You might think that…if you didn’t know that Sackeim has held the only available NIMH research grant to study ECT’s adverse effects, titled “Affective and Cognitive Consequences of ECT,” continuously since 1981…and if you didn’t know what Sackeim promised the federal government in his original application for grant funding:

“The major objective of the proposed research is to examine the effects of bilateral and right unilateral electroconvulsive therapy on affective and cognitive functioning. The consequences of the two treatment modes will be studied in regard to neuropsychological functions that have previously not been studied…Drug-free inpatients presenting major unipolar depressive disorder will be tested before, during and after treatment and a matched normal control group will be tested at comparably spaced times.”

Instead of doing this, however, he used his grant money largely to compare different types of ECT to each other, not to examine the effects of ECT; and only less than a handful of his 200+ published studies used normal controls, an absolute necessity to isolate the effects of ECT.

Why did it take 25 years to conduct one large, long-term controlled follow-up study? And in the absence on this research, why did Harold so confidently assure professionals, patients, legislators, and the public that ECT was safe?

A closer look at the study shows us that, in fact, Harold and his team are still not being honest with us, still not revealing all they know. They tried their damnedest not to find out what ECT really does…but failed. Here they reveal only the minimum information they had to concede after using every trick in the book to bias their research in favor of not finding negative effects of ECT.

What tricks did they use here?

1) The assumption that ECT does not cause permanent amnesia and cognitive deficits was built into the design of the study. How so? The study allowed subjects who’d had ECT before, as recently as two months prior, to be counted as the “before ECT” patients–meaning before this course of ECT. It assumed that any effects of ECT resolve within two months. 43% of the subjects had had prior ECT, so that at least half of the data involved comparing the effects of ECT to the effects of more ECT–not isolating the effects of ECT.

2) The outcome measures used to measure amnesia and cognitive function are irrelevant and inadequate to measure the known effects of ECT. Yet even deliberately using measures that would result in underestimating deficits, these deficits were still found to be profound and persistent!

For a critique of the tests used by Sackeim, see Robertson and Pryor’s article, Memory and cognitive effects of ECT: informing and assessing patients, in Advances in Psychiatric Treatment (2006), vol. 12, p. 228-238. For example, the Mini Mental Status exam used by Sackeim is a test that screens for dementia, the grossest and most glaring form of cognitive disability, and is useless for detecting the kinds of deficits caused by ECT.

Sackeim uses a memory test he invented himself, the Autobiographical Memory Inventory. This test is unpublished, not publicly available, not validated, and is not used except by ECT advocates. Robertson and Pryor note that the majority of questions are not relevant to the types of information forgotten by ECT survivors, nor can the test detect amnesia beyond a one-year period. A string of references in Sackeim’s new article attempt to provide support for the claim that the AMI “has shown strong reliability and validity as a measure of retrograde amnesia.” Not only do they not show this, but all the referenced articles were written by Sackeim himself!

3) Patient IQs were estimated pre-ECT using a method that underestimates intellectual ability especially with much higher than average IQs; no attempt was made to ascertain actual IQ. No one looked at these patients’ IQs post-shock to see what happened to them; why not?

Sackeim et al. conclude, based on inaccurate assumptions and no data from these or any other patients, that “Individuals with greater premorbid abilities can better compensate for the impact of ECT on cognitive functions” (references claiming to support this point have nothing to do with ECT but are articles about an unproven theory of “cognitive reserve”).

Even if the researchers didn’t choose to seek out survivors of ECT who once had very high IQs, or to respond to the many survivors of formerly superior IQs who have contacted them, there is a substantial record of accounts by persons who had extremely high or genius IQs who have spoken and written publicly of the devastating effects of having those IQs lowered by ECT (Jonathan Cott, Linda Andre, Anne Donahue, and Marilyn Rice are four such individuals.) None of these accounts suggests that people with “greater premorbid abilities” have an easier time after ECT; in fact, they strongly suggest the opposite.

In addition to these tricks, the researchers used one of the most reliable methods of biasing results: concealing data.

1) “A substantial number of secondary cognitive measures” are said to have been administered along with the named tests, yet the researchers nowhere reveal what they were and what the results were.

2) The names of the seven facilities in the New York City metropolitan area are not revealed. While this isn’t necessary for evaluating the results of the study, it means the facilities with the worst outcomes can’t be held publicly accountable, nor can the millions of city residents protect themselves from the worst offenders.

3) The results of the cognitive tests on the 24 control subjects are not revealed, nor is how they compared to the people who had ECT.

It’s a very big deal for the Sackeim team to use matched normal controls; in 25 years and hundreds of studies they have not done so. Normal controls are essential to ethical and valid research. This article states that “The comparison sample completed the same neuropsychological battery at time points corresponding to the assessment period in patients.” But you search in vain to find out how the controls did on the five named tests of memory and cognitive functioning and the unnamed “secondary measures”, and how they compared to the ECT patients immediately and six months after ECT. It’s not in the text, and it’s not in the tables. So why have the controls take the tests at all, if you’re not going to reveal the results?

Only one thing is revealed: The normal controls did much better than the bilateral ECT patients on the (flawed) measure of amnesia:

“The average decrement in AMI-SF scores in patients treated exclusively with BL ECT was 3.4 and 2.8 times the amount of forgetting seen in the healthy comparison groups at the post-ECT and 6-month time periods, respectively, suggesting that the deficits were substantial.”

4) Sackeim does not reveal—has never revealed in hundreds of published articles—his financial ties to the shock machine companies Mecta and Somatics. Yet in sworn testimony, Sackeim admits he has worked for Mecta for at least twenty years. He designs their shock machines for them. Not only is disclosure required by journals such as Neuropsychopharmacology (ironically, the subject of a recent scandal in which authors and even the journal’s editor did not reveal their ties to another company which has hired Sackeim, Cyberonics), it is also required by state law (because Sackeim is an employee of New York State) and federal law (because Sackeim accepts NIMH money). Sackeim flaunts these laws by not disclosing the money he makes from the shock machine manufacturers.

This article is a damning critique of work done over 25 years (and at the expense of millions of taxpayer dollars) by this very team of researchers.

If you know that Sackeim’s been funded for decades to do this research and chose not to do it, the following statements read very differently than the researchers intended. Instead of self-congratulation, they read as condemnation.

“Empirical information about ECT’s long-term effects derives mainly from small sample studies conducted in research settings, with follow-up intervals limited to two months or less…These studies could not adequately assess the severity and persistence of long-term deficits.”

The use of small samples and short-term follow-up characterizes all of Sackeim’s work until now, and was their choice, deliberately made so as not to know (officially) about “the severity and persistence of long-term deficits.” These researchers single-handedly had the wherewithal to address these belatedly-acknowledged flaws in their own research at any time since 1981.

“We conducted the first large-scale, prospective study of cognitive outcomes following ECT.”

Why the first study only after 25 years? What of the generation of patients—two and a half million people according to their own estimate—who have received shock in those years without knowing the long-term consequences?

“Severity of depressive symptoms showed little relationship with the cognitive measures. At the post-ECT time point, none of the 11 measures were related to concurrent HRSD scores. Findings were also negative for 8 of the 11 measures at the six-month follow-up.”

Translation: patients aren’t just imagining or lying about their cognitive and memory deficits because they’re crazy. Yet in many published articles written on the NIMH dime, and over and over in public testimony and in court, that is exactly what Sackeim and Prudic have claimed. And they have influenced countless others to believe it.

DAMNING FINDING #1: amnesia is substantial and permanent

“The average decrement in AMI-SF scores in patients treated exclusively with BL ECT was 3.4 and 2.8 times the amount of forgetting seen in the healthy comparison groups at the post-ECT and 6-month time periods, respectively, suggesting that the deficits were substantial.”

“At the six-month time point, there continued to be a significant relationship between the number of BL ECT treatments and the extent of retrograde amnesia.”

“Greater amnesia for autobiographical events was significantly correlated with the number of ECT treatments received 6 months earlier.” 

DAMNING FINDING #2: cognitive deficits are substantial and permanent

“Compared to baseline performance, at the postECT time point the total patient sample showed deficits in the mMMS, sensitivity of the CPT, delayed recall of the BSRT, delayed reproduction on the CFT…” (All are measures of memory and cognitive ability).

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

DAMNING FINDING #3: ECT permanently affects reaction time

“Although psychomotor function is of practical importance with respect to driving and other motor activities, the impact of ECT on this domain has rarely been examined…”

(Once again: Whose fault is that?)

“The fact that relative reaction time deficits were observed at the 6-month follow-up indicates a persistent change in the speed of information processing, motor initiation, or response levels…The findings here raise the concern that this form of stimulation has deleterious long-term effects of elemental aspects of motor performance or information processing.”

DAMNING FINDING #4: Bilateral ECT is no good

“For decades, BL ECT represented the gold standard with respect to ECT efficacy…A majority (of US ECT practitioners) administer mainly or exclusively BL ECT…
There appears to be little justification for the continued first-line use of BL ECT in the treatment of major depression.”

(More than 90% of the ECT given in the U.S., and at least as high a proportion in other countries, is bilateral.)

DAMNING FINDING #5 They lied when they wrote in the APA consent form that ECT improves your memory

What this team has said in numerous published articles—and what Sackeim wrote into the American Psychiatric Association guidelines on ECT, the “bible” used by all rank and file shock doctors—that ECT improves memory and intelligence, is not true.

“It is noteworthy that most cognitive parameters were substantially improved at 6-month follow-up relative to pre-ECT baseline, presumably because of the negative impact of the depressed state on baseline performance…It cannot be concluded, however, that the extent of improvement in any group returned to premorbid levels.”

DAMNING FINDING #6: A much greater percentage of women than men are damaged by ECT than men: 81% vs. 18%.

“There was a gender difference, with a greater preponderance of women (81.6%) compared to men (18.4%) in the persistent deficit group.” 

No doubt Sackeim and his handlers will try to “spin” this study as a scientific breakthrough, and hold him up as a reformer and patient advocate. Nothing could be farther from the truth.

Where is the apology to the generation of people who were lied to, who will never regain their memories and their cognitive abilities?

Full study