Reflection on Depression

FDA advisory panel requires new testing of ECT machines

I finally had a chance to catch my breath at work and can get back to blogging! There's a lot to catch up on because a number of interesting mental health issues have been in the news. In particular, this article describes last week's meetings of an FDA advisory panel to review the classification of ECT (electroschock therapy) machines.  

When the FDA put the current medical device rating system into effect in the 1970s it rated ECT machines as Class III devices, meaning rigorous safety testing should have been required for market approval. However, ECT had been around for decades and so the FDA grandfathered in the machines to exempt them from costly new trials. Recently, the Government Accountability Office eliminated this grandfathering, forcing the FDA to either reclassify the devices--in effect lowering restrictions--or require new (and costly) safety tests.  After two days of meetings the advisory panel decided to maintain the Class III rating.  As a result, new safety trials are necessary to keep the machines on the market. 

Psychiatrists worry that there could be an incipient ECT "shortage" because the two companies that make the devices may be not be able to afford the necessary clinical trials. Most patients' rights groups, however, are pleased with the FDA's decision to require new testing.  These ECT "survivors" are concerned about memory loss, ECT's most severe side effect, and would like to see more data on the efficacy/safety profile of the treatment. 

This tension between short term need and long term understanding is difficult to resolve. My first thought was that the FDA should have reclassified the devices in order to keep ECT widely available because ECT is thought to be the most effective and fastest acting treatment for severe depression. Eliminating it as an option is like taking morphine and other powerful painkillers away from doctors, asking them to rely on over-the-counter painkillers instead. The FDA, however, is taking the long-term view that new testing will ultimately clarify the risk/benefit profile of the devices, allowing doctors to make more informed decisions in prescribing the treatment. 

The new trials will have to be financed by a deep pocket--probably the government since ECT machine manufactures may not be able afford the clinical trials themselves. Let's hope the trials happen and, in the long run, we have more information about a treatment that (historically at least) has been a critical item in psychiatrists' tool kits. 

Alternatives to medication and ECT

Although medication and ECT are the primary medical interventions for severe depression, a number of more experimental options are becoming available. In this column about treatment resistant depression a doctor advises a reader to look at transcranial magentic stimulation (TMS), vagus nerve stimulation, and deep brain stimulation (which is where doctors implant electrodes directly into the brain).

Although some of these treatments sound extreme (DBS requires brain surgery), they may actually be safer and more effective options than staying on medication for a lifetime. Moreover, TMS and DBS seem to have very few side-effects. No weight gain, mental fogginess, or drug interactions to worry about!

I asked my doctor about TMS recently but learned that it cost over $200 a session and isn't yet covered by insurance. That makes it over $4,000 for the standard 20-session treatment. One 20-course treatment is still cheaper than a lifetime of meds, but it's my understanding that patients must continue to undergo treatment periodically. At $4,000 a pop, that could add up quickly!

I also looked into DBS but it is still in clinical trials. However, approval should be realtively fast because it has been approved to treat movement disorders like Parkinson's for nearly 20 years (thus its safety record is well-established).

TED Talk: A Surgeon Beats Depression with Electroshock Therapy

TED's website has a fascinating collection of 20-minute speeches on "ideas worth spreading." The issues discussed range from technology and design to healthcare and the human condition. In this talk, Sherwin Nuland recounts his battle with severe depression, his close-call with lobotomy, and the electroshock therapy that saved his life. Ultimately able to return to his surgery practice and rebuild his life, his story is inspiring.

Sherwin Nuland on Electroshock Therapy