Dr. Robert Roca presented to the U.S. Food and Drug Administration Neurological Devices Panel examining the reclassification of electroconvulsive therapy (ECT) devices on January 27, 2011. These are his remarks as published in the public record of the meeting.

Thank you for this opportunity to speak. I’m Dr. Robert Roca. I’ve no relationship to industry of any sort. I’m a board certified psychiatrist, board certified internist, and I’m in the active practice of geriatric psychiatry. I’m also the Medical Director at Sheppard Pratt Health System in Baltimore, and in that role, I have responsibility for the safety and quality of care for a very large mental healthcare system.

We perform thousands of ECTs yearly. So I’m acquainted with all the issues that have been raised today, primarily on persons who come in as outpatients, and I want to make three points today.

The first is that ECT works. It’s one of the most dramatically effective treatments in medicine. Others have presented the empirical data showing that ECT helps in a variety of conditions and is the single most effective treatment for severe depression, particularly when depression is accompanied by delusions. It’s unquestionably more reliable and effective than talk therapy for these kinds of depressions and more effective than medications.

But let me recount a few anecdotes. A woman I treated recently in her 80s, she was curled up in a ball, in a fetal position, in a local medical facility, requiring total nursing care and a feeding tube because she was not willing to eat. She could barely be persuaded to speak, but when she did speak, she expressed the conviction that there was no hope for her. Everything was over. She had once had a good response to ECT. So her family begged her medical team to transfer her to our hospital. They did that. They then begged us to do ECT, and the patient agreed although she didn’t expect any benefit from it. After about three treatments, she was out of bed. She was walking. She was wanting to eat. She was much clearer and more accessible than she had been when profoundly depressed. She went on to return to the assisted living facility from which she had originally been referred.

Another story, a retired machinist, who is in his 70s now, develops recurrent depression characterized by this terrible distress every morning accompanied by a strong wish to die. The only thing that’s kept him from suicide is a very devoted family and the experience that the distress gets substantially better later in the day. Medicines haven’t worked. Family support, which is abundant, has not helped, but his symptoms are eliminated dramatically and immediately by one or two ECTs, and he’s had this over the years on three or four occasions.

A 95-year-old woman, the mother of two doting sons who are both physicians, gets a weekly treatment as an outpatient because if she doesn’t have timely treatments at about this frequency, she becomes frantic, ruminative, and disorganized to the point of becoming disabled. She’s someone who could not tolerate medicines of any kind because they made her drowsy and prone to fall. ECT clearly renders her more functional and engaging. It does not, in her case, produce any clouding or impairment.

And then finally, an elderly cantor, who has a ruminative, disabling depression characterized by profound feelings of worthlessness and paralyzing anxiety, has been unresponsive to medication and psychotherapy over the years. ECT was found to be the only thing that helps him, and with the strong encouragement of his daughters, he has ECT about every two weeks. This allows him to remain integrally involved with his family and with his synagogue where he continues to be respected as a cantor.

I could go on with these kinds of stories, but suffice it to say that I’ve seen ECT help people again and again. I don’t personally have any doubt that it works.

Now, these stories also serve to make my second point, that ECT as it’s provided today is well tolerated by most people, even very elderly people. We know that the main acute risks are those associated with the anesthesia, not with the procedure itself or with the machine. There’s always an anesthesiologist present. There’s always a psychiatrist who has special training present. The patient is very closely monitored.

In the decades over which we’ve given tens of thousands of treatments, we’ve never had a complication as serious as a death. The main worry is the effect on memory, of course, and, in fact, this effect is highly variable. Some have very little or none. Others clearly have more, but this is always part of the consent discussion, and patients decide for themselves if relief of the depression is worth the risk of memory difficulty, which truthfully it is usually minor and temporary if it occurs.

The final point to emphasize is another truth that was apparent from my stories. ECT is sometimes the only thing that works. It’s the only thing that keeps people well in some cases, and it can be literally lifesaving. I’ve already mentioned several cases in which people who were experiencing agonizing symptoms and profound disability were literally brought back to life by ECT.

MS. WOOD: Thirty seconds remaining.

DR. ROCA: This is not rare or exceptional. It’s something that you have to witness to fully appreciate. I can’t say I can think of an instance in which I regret having ordered it, but I know of instances in which ECT was withheld and the patients went on to die. These are people who didn’t need to die. They had a treatable illness for which we have a very effective treatment and to which they were denied access. Some people say it’s —