A Funny Thing Happened on the Way to the FDA
Neither snow nor sleet deters Struck by Living
Posted April 9, 2011
On January 27, 2011 I testified before the FDA about my experience with ECT. My testimony was published recently: (http://psychcentral.com/lib/2011/julie-hersh-on-ect/). As mentioned in an earlier PT blog (http://www.psychologytoday.com/blog/struck-living/201101/conflict-common-sense) this experience frustrated me. ECT is an optional procedure that can save lives. My concern is the way this procedure is being vetted is neither scientific nor optimal. My own experience reads a little like an I Love Lucy episode.
I happened to hear about the FDA hearing from several psychiatrists I've met since publication of my book, Struck by Living. Of the 40 people that testified, the only qualification for testimony was to apply. I wrote an email to the FDA personnel in charge of qualifying individuals for testimony and was told I would "likely" get a spot. Weeks before the hearing I wrote again, asking if I had been selected and when I should appear, how long should I speak, etc. I heard nothing. Being the stubborn sort I am, I bought my plane ticket and booked my hotel anyway. I figured worse case I could listen, gaining material for my blog.
On 1/26, reports of bad weather in the Washington, DC area caused American Airlines to cancel flights. I sprinted from a luncheon for Grant Halliburton Foundation (http://www.granthalliburton.org/) to catch an earlier flight. By the time I landed at Dulles Airport, six inches of snow piled on the ground. Snow fell horizontally pushed by strong winds. By the time I got off the plane and met the driver I'd hired (Doug from Capitol City Limo), I was informed that it would be 3 hours before I could get my luggage. Doug and I looked at each other and said let's get out of here. Sleeping on the floor at Dulles Airport does not fall within my Top Six things I do to stay mentally healthy (http://www.youtube.com/struckbyliving#p/a/u/1/5Qay6Skv7Go).
The snow left cars littered on the freeway, and it took us 45 minutes to get to the first exit. I was calling hotels - only to be told SOLD OUT. I encouraged Doug to forge on, that I'd cry in the lobby to get a room. My strategy worked, but when poor Doug entered to get his room, the inn was full. I offered Doug the other bed in my room, but he declined, feeling it was unprofessional. I mumbled Thank God. Doug saved me from sleeping at the floor at Dulles - I didn't want to be the one responsible for him freezing on the side of a highway.
I woke the next morning and took the hotel shuttle to Dulles to get my bag. I leisurely took my time, thinking there was no way the hearings would take place. The news said the government was shut down; schools were shut down. At about 8 am I got an email telling me the hearings were on, starting at 9 am. Gaithersburg is about 45 minutes from where I was staying - in good weather.
I called Doug, waking the poor man up. He had just reached home at about 4 am - taking over 14 hours to make the drive. I found another, closer driver, a Pakistani man who pontificated on the evils of India the entire ride. He told me Allah wanted me to reach the hearing. I'm a big believer in accepting anyone's help. I failed to mention that my last name is Hersh.
I reached the hearing at 10 am and was told I had missed my spot to testify. I explained that the FDA had never responded and did not let me know if I was testifying or when. And BTW in case they hadn't noticed there was a massive snowstorm that had shut down the city. "Oh don't you know," the moderator explained, "if the FDA does not contact you, that means you will testify." Huh? She let me know they'd stick me in at the end. That was fine with me, I had not prepared because I didn't think I would testify. Going last would allow me to listen to the others and form a strong statement. Two people testified, then the moderator pointed at me: You're up.
Needless to say this was one of those oh crap moments - when I have to remain cool and calm, but chaos reigns within. I got to the podium and could not tell when timing for the testimony started. From watching the two speakers before me I figured out I had 5 minutes, but floundered for the first 30 seconds because I couldn't tell when the timer started. When I finished, I realized I had 2 minutes more, so I continued to speak. That's why it seems like I end twice in my testimony.
The point of me telling you is this. If you had a positive experience with ECT, would you go to this much trouble to testify? No. Would most people pay for a plane ticket, hotel, and trudge through a massive snowstorm admit they had a mental illness serious enough to warrant ECT? No. This probably explains why all but three of those testifying were negative about ECT. The ones that had a bad experience (most of them from several decades ago) have an axe to grind. The ones with a positive experience are continuing their lives with no or little knowledge that this life-saving procedure is at risk for an untimely death. This is not the way to obtain a scientific sample.
For an organization who cares so much about clinical trials and placebo testing - the FDA has a very strange way of soliciting information. Has anyone ever done a citizen's petition to the FDA? What do we need to get this started? The silent majority needs to have a voice.
More information on Julie K. Hersh is available on her website: www.struckbyliving.com, YouTube channel: http://www.youtube.com/struckbyliving, or facebook page: http://www.facebook.com/#!/struckbyliving.