February 10, 2012

I heard that some petitions to reclassify a medical device would be discussed at the Neurological Devices Panel meeting scheduled for February 10, 2012.  The device to be discussed was the Cranial Electrotherapy Stimulator, or CES for short.

Although I had no real interest in CES devices, I wanted to observe how the Panel and CDRH would interact concerning petitions to reclassify.  I decided to attend the meeting, intending only to listen and observe.

This was my first Panel meeting in over 30 years.  I found that the meeting was highly structured, with times allotted (and strictly enforced) to speakers for each of the three companies; speakers who had pre-registered for the Open Public Hearing; and CDRH presenters.

I found the room layout rather interesting.  The Panel members and selected CDRH personnel were arranged around a U-shaped table at one end of a large meeting room, with signs forbidding anyone else from crossing a line several feet from the table.  There was an elaborate sound board on the left side of the room.

For the audience, there was theater seating with a fairly wide center aisle.  There were quite a few rows of seats, with ten chairs on each side of the center aisle.  The public microphone was located on a lectern (which most everyone incorrectly identified as a "podium") on the left side of the room, between the audience and the Panel.  On the left side, nine rows were reserved for company representatives, three rows for each company.  Behind those were rows for presenters during the Open Public Hearing.  On the right side, three rows (30 seats!) were reserved for CDRH people.  The general audience could sit anywhere else.  During this meeting and two other Panel meetings I attended later, I observed as many as 15 of the CDRH seats occupied.

At the back of the room, two commercial firms had video recording equipment.

Mid-afternoon, a CDRH biomedical engineer named Tim Marjenin spoke.  His presentation included a slide with an (abridged) definition of Class III.  This turned out to be an important event of the day for me.

As I reflected on the definition of Class III in slide number 70 and what I had learned during the meeting about CES devices, I felt increasingly confident there was a valid basis to question whether CES devices belonged in Class III.  I approached Tim Marjenin during the coffee break, but he was too busy to speak with me.

As the meeting was about to adjourn, I decided on a rash course of action.  I would move to a seat in the front row, closest to the public microphone.  I would try to inveigle permission from the Panel chair (Dr. Robert Hurst) for me to speak briefly.  I felt it was important to get a question into the record, because it might be many months before the Panel would meet again.

As the last authorized public speaker finished, I hustled up to the microphone.  When Dr. Hurst saw me, he said I had two seconds (the balance of the previous speaker's time). 

Acting on impulse, I offered him a choice:  let me speak or call the police to arrest me. 
Certainly this was an unconventional way to get his attention, but I was willing to take the risk.

After a bit of back-and-forth, Dr. Hurst gave me permission to speak.  Immediately, Lt. Aveena Russell, the Designated Federal Officer, intervened, saying "Sir, you may not address the Panel.  Please take your seat."

By this time, the man operating the sound recording system had turned off the public microphone.

If you want to watch the video to see what actually happened, click here.

I won't apologize for how unprepared I was for a public speech.  I acted on impulse, bolstered by a deep-seated conviction that everyone involved in the day's activities had ignored the possibility that CES devices had been misclassified, and that this oversight should be made part of the official record.

When the official transcript was released a few weeks after the meeting, the incident was "off the record."  The transcript addendum explained the omission as follows:

" [page 281] At this time, a member of the audience approached the podium and spoke without being recognized by the Chair. He had not elected to address the Panel during the Open Public Hearing portion of the meeting and was not a presenter for any of the petitioners. He was instructed to stop and return to his seat by the Panel Chair since this portion of the meeting was not open for public participation, except at the specific request of the Panel Chair. His comments were not recorded, nor captured in the transcript."

There is little correlation between the statement in the transcript addendum and what actually happened.  This is what I call an example of FDA's "creative writing" - a skill which may be valued too highly in the agency.

Taking the explanation point by point:

1.  I was recognized by the Chair.
2.  While it is true that I didn't speak during the Open Public Hearing, that was not a conscious decision at the time.  The slide which provoked my act of civil disobedience was shown after the Open Public Hearing was over.
3. I was never instructed by the Panel Chair to stop and return to my seat.  It was Lt. Russell who used her very authoritative voice and uniform in an attempt to control and intimidate me.

The pertinent regulations for such meetings state that the Panel Chair has sole discretion about who may speak, not that the Chair has to make a request for the person to speak.  In my opinion, Lt. Russell violated the regulation by overstepping her authority and infringing on my right of free speech.  If I had been aware the regulations at the time, I would have appealed her orders to the Chair.

As the video clearly shows, Dr. Hurst granted me permission to speak.  Moreover, he uttered the words "Thank you for your input, sir" when I finished!!

Advisory committee meetings are supposed to be open to the public, except during specified closed sessions.  It seems to me this example shows one way the agency censors the meeting transcripts.  If they don't want someone's words to be recorded (or amplified through the public address system), they simply cut off the public microphone.

Thank goodness that commercial video recording companies are not contractors to the FDA.

copyright 2013 - Leroy L. Hamilton