I sent in my self-nomination on Monday, August 22, a few days before I spoke at the Modified Risk
tobacco Products workshop and made my pitch for consumer representation on TPSAC.
I attached my CV (like a Resume, only it also lists your presentations and publications) and supplied all the requested information.
All of the other FDA Scientific Advisory Committees have a seat set aside for consumer representation. TPSAC does not. The law specified that in addition to the scientists, the committee include a "representative of the general public." The person currently serving in that role is
Patricia Nez Henderson, M.P.H., M.D.10
Expertise: Public Health, Epidemiology
Term: 02/16/10 - 1/31/14
Vice President
Black Hills Center for American Indian Health
I suggested in my cover message that Ms. Nez Henderson be identified as one of the 8 scientifically qualified members, in view of her expertise in public health and epidemiology and that the seat for "representative of the general public" be occupied by a representative of consumers. I pointed out some of the benefits of this action:
As a former smoker, I feel that I can provide TPSAC with valuable insights regarding why smokers have such difficulty quitting, share with them what worked for me and what has worked for others, and provide them with suggestions for consideration that have the potential to dramatically improve the rates of smoking cessation. Late in 2008, still struggling to become abstinent from smoking, I joined an online forum of electronic cigarette consumers. On March 27, 2009, I stopped smoking. Late in 2009, a group of several thousand forum members formed a non-profit organization called the Consumer Advocates for Smoke-free Alternatives Association. I was elected to the Board of Directors, and currently serve as Vice President. We have two-way communication going between the board and members. We hold online membership meetings twice a month. We make use of internet forums, Facebook, Twitter, and other social media tools to keep in touch with our membership. Our members would be most happy to provide input to TPSAC when the committee has questions regarding consumer perception of various issues.
I have made presentations at public hearings on Scientific Standards for Modified Risk Tobacco Products, Risks and Benefits of Long Term Use of NRTs, and on Dissolvable Tobacco Products. I have been working with smoking-cessation researchers at the University of Catania in Italy, providing a consumer viewpoint for their work. I am attaching my CV which includes my education, work history, contact information, presentations, selected publications, and references. Please let me know if there is any additional information you require.
To date, I have not even received an email, letter, or phone call stating "We received your application."
I fear that this situation is going to be handled in the same way that government tends to handle things when the public asks a question that they don't want to answer honestly (e.g., "Exactly how many nanograms of TSNAs did you detect in an e-cigarette cartridge?" I sent emails to various FDA personnel asking that question and all were ignored, with the exception of the one to the PR representative who replied asking what newspaper I worked for. The question, however, was never answered.)
They pretend they never heard from you. "Just ignore her and maybe she'll go away."
