This is the text of my personal (NOT official) submission to the Food and Drug Administration on its proposal to reclassify ECT for some, but not all, uses as a Class II device. I argue that it should also reclassify ECT as Class II for the other uses. Note that anyone can submit comments on the FDA proposal by the March 28, 2016 (just before midnight, EDT) deadline. Here’s the link for commenting.
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I am a law professor at Stanford, as well as a professor, by courtesy, of genetics. I direct Stanford’s Program in Neuroscience and Society, am a founder and director of the International Neuroethics Society, a member of the National Academy of Medicine’s Neuroforum, a member of the NIH Multi-Council Working Group on the NIH BRAIN Initiative, and the co-chair of the Neuroethics Work Group of that Multi-Council Working Group. I regularly teach a course at Stanford on FDA Law with respect of health.
I also have a close older relative whose sanity, and, given the effects of delusions on the person’s eating, whose very life, was saved from depressive psychosis in 2015 by electroconvulsive therapy (“ECT”). Drug treatment did nothing to slow a terrifying downward spiral; in twelve days, after the fifth ECT treatment, my relative was almost back to normal. I am not submitting this comment in any of the above capacities – except as a grateful but still worried family member – and speak only for myself.
I applaud the Draft Guidance from Administration for its decision to reclassify ECT as a Class II device for adults in the acute phase of a major depressive disorder. That is clearly in keeping with the overwhelming scientific and medical evidence that this treatment is remarkably effective and relatively safe.
I strongly disagree with the decision to retain the Class III designation for the use of ECT for other illnesses, for children, and for maintenance treatment (as opposed to treatment in only the illness’s acute phase). In each of those areas, the scientific and medical evidence, though more limited than for treatment in the acute phase of an adult’s major depressive disorder, significantly supports the efficacy of ECT, particularly when compared with other treatments. ECT does have some risks but the risks are well known, based on decades of use; are not enormous; and for many cases are quite clearly worth taking in light of the seriousness of these disorders.
It is extremely important to give physicians the option of using this as an FDA-approved therapy in appropriate cases – when a juvenile’s disease is particularly serious, when there is reason to believe a person with a serious case of a non-depressive disorder can be helped by ECT, or when a patient shows recurrence after the end of the acute phase of treatment that maintenance treatments may help. If this were a “direct to consumer” device, I would not favor it becoming Class II, but it is not. It will be used under a physician’s direction, which, although not promising perfect results, does tend to limit its use to situations where a trained professional concludes the potential benefits outweigh the potential risks.
In some instances the difference between classification for some uses as Class II and for others as Class III would not matter because it could be used off label or could be the subject of a PMA application by a manufacturer. This is not such a case, for three reasons.
First, the continuing prejudice against ECT makes the fact of FDA approval of its use for other indications important. Such approval is not only consistent with the scientific and medical evidence but can be useful in convincing patients, their family members or guardians, and sometimes their physicians of the value of ECT.
Second, although FDA decisions have no legal effect on reimbursement decisions in the health care financing world, they have huge practical effect. If FDA approves ECT for only some indications, many payors will not cover treatment for other indications. These treatments are sufficiently expensive – in the four digits at least – that few patients in need will be able to afford them out of pocket. Although the Draft Guidance, on its face, only retains the status quo for ECT other than acute phase use in adults with major depressive disorders, a new FDA decision that the other uses still belonged in Class III could both lead payors that currently reimburse such uses to stop and other payors not to start. If Medicare, Medicaid, or private health plans were to refuse to pay for maintenance ECT in cases of geriatric depression or acute ECT for a catatonic adolescent, the odds are that ECT will not be provided . . . and the patient will continue to suffer. My own relative is benefiting from maintenance ECT, treatment that could become financially unavailable as a result of the current FDA proposal.
Third, one solution, of course, would be for manufacturers to file PMAs and do clinical trials necessary to win approval for a Class III device for the other indications. If ECT equipment constituted a large and profitable potential market for multi-billion dollar device firms, that might be plausible. But ECT equipment is a small market (the devices, as I understand it, rarely need replacing), comprising a few small firms. These firms could not spend millions of dollars on clinical trials to support a PMA even if that would open a much larger market. I think it highly unlikely in this particular market that PMAs will ever be filed to win approval for the indications left in Class III.
In an ideal world, it would be wonderful to have further research on the safety and efficacy of ECT for all indications, for all ages, and for maintenance as well as acute treatment. But no one knows better than the FDA that we do not live in such an ideal world – decisions often need to be taken based on imperfect information. Sometimes an adverse FDA decision can induce further and better evidence; sometimes, as here, it will lead to no new evidence but instead cause the effective denial of a well-established, if not perfectly proven, treatment to those in need.
It bears repeating just how terrible many of these disorders are and how limited are our other interventions. To watch a loved one become a frightening stranger, dangerous to self and others, is a terrible thing. I can only imagine how much worse the experience must be for the patient. ECT will sometimes – I expect usually – help, often when nothing else will. The continuing popular and, to some extent, professional prejudice against this treatment – a hangover from earlier, more primitive versions of the treatment as well as from the (great) novel and movie, One Flew Over the Cuckoo’s Nest, has terrible consequences for suffering people, and for those who love them.
As someone deeply involved in neuroscience, mental illness, and law – and as a very concerned relative of a patient receiving maintenance ECT – I implore the Center for Radiological Health and Devices and the Commissioner to broaden the reclassification of ECT to Class II to include, in appropriate cases as determined by the treating physician, juveniles, illnesses in addition to major depressive disorder, and maintenance treatment.
Henry T. Greely