Monday, January 24, 2011

The Children of ECT

On Thursday, January 27, the FDA will open hearings on the reclassification of electroconvulsive (ECT) machines from Class III to Class II medical devices. Coincidentally, that is also the day my entire family leaves for Disney World, the first time in over four years all seven of us will get on a plane. Our oldest son Jonah, now 12, suffers from autism and rapid-cycling bipolar disorder. Until March of 2010, he was plagued by frequent, unpredictable and violent rages that countless medication trials and an almost year-long hospitalization failed to stabilize. Not only couldn’t we take him on a plane, but it was becoming increasingly clear that it wasn’t safe to keep him at home: his almost daily attacks left me, his teachers and his aides bruised, scratched and bitten.

Why is this such an ironic coincidence? Because it was ECT that finally stopped Jonah’s aggression, that finally brought peace to our home, that allowed us to plan the paradigmatic American vacation so many families take for granted. And at the exact moment we push through the gates of the Magic Kingdom, rabid anti-ECT activists will pour into the ballroom at the Washington DC Hilton to convince the FDA to further restrict access to, or even completely ban, ECT.

Estimates suggest about 100,000 people receive ECT every year, typically adults suffering from treatment-refractory mood disorders. But there is a growing group of patients whose quality of life depends exclusively on their access to ECT – developmentally delayed kids and teens who, like Jonah, suffer from aggressive, self-injurious and/or catatonic behaviors. I met several of these families over the past year – including a 14-year-old autistic boy who was so self-injurious he detached his own retinas, as well as a 16-year-old – born with half a cerebellum due to an in-utero stroke – who vacillated between periods of uncontrollable rage and catatonic stupor, during which he would remain frozen, unable to eat, toilet or communicate, for up to eight days. ECT resolved the extreme behaviors of both these boys, as well as those in other cases reported in the psychiatric literature by doctors at the Kennedy Krieger Institute and the University of Michigan, among other places. And it did so without any of the cognitive impairments or personality changes trumpeted by the anti-ECT movement – data collected by Jonah’s school, for instance, shows that his acquisition rates for new material are as high as they’ve ever been, with no retention problems that might signify memory loss.

It’s hard to imagine that anyone would try to keep ECT out of the hands of a group that so desperately needs it, but that’s exactly what will be happening at the FDA hearings, which will help determine whether ECT machines will be reclassified as Class II medical devices. Currently, the machines are in Class III, the riskiest group, which requires manufacturers to file a pre-market approval application (PMA), including large-scale clinical trials. Because ECT predates the FDA's regulation of medical devices, however, the ECT manufacturers were grandfathered in without the studies. But now the FDA is at a crossroads: they must either reclassify the devices or force the manufacturers to submit a PMA – and the owners of these small companies, who aren’t scientists, have already stated that they can’t afford to do these clinical trials (let me add there are dozens of studies in the literature over the past sixty years or so that document the safety and efficacy of ECT, just not ones done by the makers of ECT machines).

I know that when people think of ECT, they don’t think of kids like mine who, without ECT, would be condemned to restraints, locked wards, blindness, even death. They think of Jack Nicholson thrashing on a table – even though by 1963, when Ken Kesey published One Flew Over The Cuckoo’s Nest, ECT was already being performed with muscle relaxants under general anesthesia. I’m sure it comes as a tremendous surprise to many that ECT is used with this population. But that’s why I’m telling Jonah’s story now, so you do think about him and his terribly afflicted peers, and so the FDA doesn’t forget them under the onslaught of accusations from anti-ECT groups that ECT is torture, a human rights violation. So perhaps the public may begin to develop the constellation of associations we, the parents of these children, have with ECT: lifesaver. Game-changer. And even, as melodramatic as it sounds, miracle.

(The FDA is receiving electronic comments on ECT in its public docket through January 25.)


Cheryl Swarthout said...

Amy - What an important issue. I know that you have searched far and wide for help for your son. I am happy for you that you have found a treatment that is working. Thank you for making us all aware of some of the issues involved. I will definitely leave a public comment with the FDA.
I would really like to encourage you to make NAMI (The National Alliance for Mental Illness) aware of your blog post. I would think that they are aware of this FDA hearing, but I am also thinking that they might like to further publicize your well-written explanation of the issue for non-professional readers. I will certainly make my local NAMI group aware of your post. Cheryl Swarthout (Sarah W.'s mom).

Heather said...

Hi I’m Heather! Please email me when you get a chance! I have a question about your blog. HeatherVonsj(at)gmail(dot)com

Cara said...

Thank you for bringing this subject to our attention!!! This is very important and should be passed along in the community! I wanted to chime in to support your stance although our story and diagnosis are different, I believe my opinion on the necessity of ECT is the same. My 16 year old daughter is currently in treatment. She suffers from Bipolar Disorder and is medication resistant - meaning anitdepressants did not help. She was suicidal for 3 years. The week before we began treatment she tried three times! But, now her depression is GONE. She is happy now! We can all breathe. She is in her 24 th interval since the beginning of March 2012. We are currently tapering to once every other week. It is very scary to sign to give permission to these treatments. No one WANTS to do this. We know it is our last resort for hope of a healthy lifestyle for our daughter. I get very upset when I hear people who are not living with disabilities tell those who are why they don't need treatments. My daughter would probably be dead without ECT.