Lobbying for the status quo

The Food and Drug Administration has proposed easing restrictions on the use of ECT devices, despite the fact that these machines have never undergone the stringent safety testing required of other medical devices since 1976. (They were 'grandfathered' in when the FDA passed the Medical Device Act, with the expectation they would eventually undergo safety and efficacy studies.)

When the Medical Devices Act was introduced, the FDA classified shock machines as Class III, which means it demonstrates "an unreasonable risk of illness or injury." Class III is the most restrictive category for medical devices.

This would have undoubtedly meant that manufacturers would have to do extensive research. Not only would this tap into profit margins of MECTA and Somatics, Inc., the two largest ECT device makers, it would place the entire shock industry under intense scientific scrutiny. The shoddy research of the last several decades might not be up to FDA research standards.

Faced with regulations of a practice that had remained virtually regulation-free, the American Psychiatric Association campaigned to have that classification changed. The FDA acquiesced, and announced it would reclassify the machines as Class II. Thus, the FDA would not require any safety testing of any of the ECT machines currently on the market, or those to come. The ECT industry moguls would be free to reign as they always had, their cozy refuge shielding them from outside scientific scrutiny.

Shock survivors were outraged, and began to pressure the FDA to maintain the Class III rating.

This was followed by the APA's 1990 report that claims ECT is practically risk free, as well as public attempts to smear the reputations of honest shock survivors. These are the popular tactics of ECT practitioners, when confronted with the human faces of negative effects of ECT: dismiss them as cultists, a "handful" of disgruntled patients, or attempt to publicly smear them, as Max Fink did to activist Linda Andre. At an APA convention, he publicly began to berate her, using her (private) history against her. It's a common technique, to dismiss critics of ECT as simply "crazy." Yet that condescension shows just what kind of derision some so-called healers actually have towards those they profess to help.

In 1990, the FDA proposed a compromise that would classify the machines as Class II, but only for severe depression, not other disorders. This "compromise" would still allow ECT to be used with no regulation, and without any testing of the machines to prove safety and efficacy, as long as the patient was diagnosed with depression. Psychiatrists are well-known for their abilities to juggle diagnoses, but this ruling could open the door to more frequent malpractice lawsuits against the doctors when the patient did not meet the proper diagnostic standard.

Immediately after the announcement of the proposed change, the shock docs rushed in to lobby for the status quo. They did not want the FDA to restrict their use of ECT in other mental disorders, or to dictate any guidelines concerning the use of bilateral ECT or electricity parameters.

Letters to the FDA, obtained under the Freedom of Information Act, point out just how far these industry "gurus" will go to retain absolute control of their profession, called "God's gift to mankind" by Max Fink. In order to make the case to the FDA, they have contradicted their own published works.

Says Richard Abrams, in his textbook on ECT, "It should be no more than that of prescribing a medication for an indication not recognized by the FDA in its review of manufacturers' pharmaceutical package inserts."

And to illustrate the "need" to use ECT without restriction or accountability, he adds, "No data exist from controlled trials to support the use of ECT in disorders other than those described earlier; such usage belongs to the art rather than to the science of psychiatry."

When that art is carelessly applied, without responsibility for patients' lives, art becomes monstrosity.

Abrams, who stands to lose financially if forced to report to the FDA the ECT machines his company manufactures, writes in his letter to the FDA, concerning the use of ECT in schizophrenia:

"Brandon et al (1985) found a course of 8 genuine ECTs significantly more effective than 8 sham ECTs."

Yet in his book, Electroconvulsive Therapy (Oxford Press 1992), considered the bible of ECT practitioners, he is more honest about the effectiveness of ECT in treating schizophrenia. Citing the same case:

"...but at 12 and 28 week follow ups, this was no longer the case." (referring to a distinction between the sham and real ECT recipients)

He quotes the Taylor study in his book as showing "no difference (between sham and real ECT) at one month after treatment concluded."

However, in his letter to the FDA on the same study: "Taken together with the Taylor and Fleminger (1980) sham-ECT controlled study cited by the FDA, these reports provide strong scientific evidence for the efficacy of ECT in schizophrenia."

His book concludes "It is reasonable to conclude from these data that ECT is no better than sham ECT in the treatment of chronic schizophrenia and no better than neuroleptic agents in the treatment of nonchronic schizophrenia."

One should remember that his textbook is geared to the ECT practitioner, not the layperson. It is considered the industry standard.

But in trying to convince the FDA that ECT has been shown scientifically to be effective in the treatment of schizophrenia, he contradicts his own "bible."

Abrams conveniently quotes studies that use data from over 40 years ago when making the case for the use of ECT in mania, yet claims that the data showing brain damage is "outdated."

In today's climate of a "kinder and gentler" ECT, the focal point is that 'modern' ECT is safer, using less electricity, and because of unilateral techniques, the effects on memory and cognitive abilities are less severe.

Yet Abrams makes the case to the FDA that its proposed labeling requirement concerning unilateral treatment and energy parameters are "antitherapuetic."

The FDA's proposal includes labeling requirements that would indicate the use of unilateral, low dose ECT in the beginning, contradicting current practice of high dose bilateral.

Abrams draws on Harold Sackeim's study which shows that for ECT to be effective it needs to be suprathreshold (see footnote 1). This high amount of electricity needed to produce the desired effect directly negates the "kinder and gentler" public relations campaign.

And indeed Max Fink, considered the grandfather of American ECT emphasizes the disparity between the publicity materials and actual practice in clinical use. (Oddly, he does not publicly mention his former position as consultant to the FDA. It is found on his CV)

In his letter to the FDA, he states that not only does the APA not recommend unilateral placement as the initial choice, that in most cases "bilateral electrode placement is clearly preferred."

Further, he says that the FDA's proposed labeling for electricity parameters "are associated with failed or inadequate seizures." He goes on to say that current research calls for suprathreshold currents.

He concludes that the FDA "should resist interfering in medical practice by seeking to define the technical details..."

In other words, "hands off our ECT, FDA!"

What other medical specialty has a legacy of:

• virtually no regulation;
• a monopoly by a handful of "experts" who not only do much of the current research, but own the companies, or receive royalties from the manufacturers of the devices;
• an extensive history of shoddy research?

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