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A Public Participation Forum for the FDA Advisory Committee (TPSAC)

Discussion in 'Campaigning discussions' started by Traver, Jan 24, 2011.

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  1. Traver

    Traver Ultra Member ECF Veteran

    Supporting member
    Oct 28, 2010
    WV
  2. Traver

    Traver Ultra Member ECF Veteran

    Supporting member
    Oct 28, 2010
    WV
    This is what caught my attention. I seems like not only something we should keep an eye on but gives us a chance to respond if something related to e cigs comes up.

    About Us « A Public Participation Forum for the FDA Advisory Committee (TPSAC)
    About Us

    This Forum is managed by the Center for Regulatory Effectiveness, a regulatory watchdog founded and managed by former regulatory officials of the White House Office of Management and Budget. CRE manages a number of websites dedicated to increasing the transparency of the federal regulatory process.

    The Forum is an Interactive Public Docket (IPD) which allows the public to communicate with the TPSAC on a 24/7 basis. The Forum receives two types of comments.

    If you wish to make a comment, including attaching a study, go to the Discussion Forum in the upper right corner of the home page and link on the relevant page and type your comment and include an attachment if you wish. Please note no registration is needed and anonymous comments are accepted.

    If you wish to comment on one of the studies which are currently posted on the website merely click on the term “comments” in the article of interest
     
  3. Traver

    Traver Ultra Member ECF Veteran

    Supporting member
    Oct 28, 2010
    WV
  4. Traver

    Traver Ultra Member ECF Veteran

    Supporting member
    Oct 28, 2010
    WV
    Here's a little tidbit that I found to be interesting on Dr. Michael Siegel site.

    Chantix can kill; but, how many smokers have to start NRT with Chantix to prevent one death from lung cancer due to smoking?


    Sort of a 'Number Needed to Treat'.


    It takes 100,000 Chantix NRT's to prevent ONE lung cancer death from smoking!!!!


    There are 2/10,000 never-smoker lung cancer deaths and 7/10,000 smoker lung cancer deaths; thus, there are 5/10,000 smokers' lung cancer deaths that might be said to be caused by smoking.


    That is 1/2,000.


    NRT is sucessful in about 2% of the program starts and that is 1 in 50.


    2,000 times 50 equals 100,000.


    It takes 100,000 Chantix NRT's to prevent ONE lung cancer death from smoking!!!!


    I do not know how much Chantix costs; but, I would guess that it costs way over 10 million dollars to prevent one lung cancer death!!!
     
  5. rothenbj

    rothenbj Vaping Master Verified Member ECF Veteran

    Supporting member
    Jul 23, 2009
    Green Lane, Pa
    I tries to find a long term (2 year) success rate for Chantix with little success. I believe PFE claims 44% vs 18% placebo after their 12 week, much controlled study. To me, that signifies an effective 26% quit rate. But that is only up to the end of the treatment in a highly controlled and supported program. Three studies showed a 22% quit rate at 52 weeks, with a Thorax study suggesting a 26% quit rate compared to 20% for the patch.

    If we are to believe at two years most NRT products are only 2% successful and Chantix is better, let's give them the benefit of doubt and be generous at 10% success. If I have the math and assumptions right, you are still talking 20,000 scripts at about $375 per cessation cycle $7.5m to avoid one lung cancer case.

    Now since it's launch in 2006, PFE has had about $3.2b in sales, translated to appx. 7.5m smokers treated of which around half are in the US. Since the smoking rates really haven't varied much from that 20-22% range since 2003 and the population keeps growing, I don't see all this money and the billions invested between TC, the FDA, THE GOVERNMENTS, or the ?non-profit?"health" associations and other NRT BP companies being very successful other that to generate a lot of health noise and profits for the various components.

    What we have here is a failure to communicate.
     
  6. Traver

    Traver Ultra Member ECF Veteran

    Supporting member
    Oct 28, 2010
    WV
    I keep seeing around 5 and six percent six month success rate for six months and 2 percent for a year. I never investigated how valid these figures are. Even using your more generous numbers it's still a monmental waste of money. Especially since we have more effective ways to control smoking tobacco.
     
  7. afrazier5

    afrazier5 Super Member Verified Member ECF Veteran

    Chantix is VERY expensive and so much so, that many insurance companies are no longer covering it or are covering it at their lowest coverage rates. I have Walgreens health for my prescription insurance (through my employer) and Walgreens only allow a single attempt at usage before they force you to go through a doctors smoking cessation program unless you are to pay full non-insurance cost. After this, you can make another attempt at it. I recall from my paperwork that the off-insurance cost was around $200-225/month but I paid I think about $50.
     
  8. Desert Willow

    Desert Willow Super Member Verified Member ECF Veteran

    Sep 11, 2010
    Bullhead City, AZ
    I feel that everything is worth doing, contact them all! I found their page re' e-cigs and added my 2 pennies. There was only 1 comment there, so I am sure they have room to hear from many of us.

    How Safe Are E-Cigarettes? « A Public Participation Forum for the FDA Advisory Committee (TPSAC)

    Brightest Blessings!
     
  9. Traver

    Traver Ultra Member ECF Veteran

    Supporting member
    Oct 28, 2010
    WV
    My comment:
    A far as safety goes I agree the with the FDA it doesn't know anything. Not exactly a convincing argument that lung cancer is a better option. After 16 or more studies showing no serious side affects It's a no brainer I chose to live and vape. After over 40 years of smoking it took about three puffs to quit cigarettes.

    According to the Wall Street Journal electronic cigarettes are are over a a hundred million dollar business in this country. A million or more Americans use or have at least tried them. Hundreds of thousands have given up tobacco. They are sold all over this country. No wonder the makers of smoking cessation products are panicking and for reasons not entirely clear to me the anti smoking non profits have joined the drug companies in this campaign. I thought they they were supposed to be saving lives. No one including the FDA has found anything in quantities that harm us. So they have adopted the same argument of if, maybe, could be and we don't know anything.

    In the real world.
    Deaths related to smoking 400,000 and up.
    Deaths from electronic cigarettes 0. That's right zero.
     
  10. MoonRose

    MoonRose Super Member Verified Member ECF Veteran

    Aug 3, 2010
    Indiana, USA
    Here's the comment that I left:



    I was 24 yrs. old when I first started smoking and I began smoking to relieve stress. I smoked a pack a day for the next 25 yrs, made multiple attempts to quit smoking during that time as well. In 2001 my mother died of cancer at the age of 59, that was her second battle with cancer only that time she lost the battle and she smoked until her last day. I still continued to smoke even after watching her lose the battle. I am also a nurse as well, and worked for 5 yrs. as a hospice nurse, so have seen the effects that smoking can have on someone thousands of times, and yet I continued to smoke.

    Then the end of February of last year I had a mild heart attack, I knew then that I absolutely had to stop smoking somehow. Over the years I’ve tried the gum (left blisters in my mouth), the patch (smoked while using those) and Wellbuterin (side effects left me unable to function). Absolutely refuse to even consider Chantix because of the severe side effects known to happen with that one.

    In July of this past year my husband and I happened to see a commercial about electronic cigarettes and decided to give them a try as he also wanted to stop smoking after over 35 yrs. On July 19th our electronic cigarettes arrived, that’s the last day I ever smoked a regular cigarette. 2 weeks later my husband had his last regular cigarette, we have not looked back since then.

    We both continue to use our electronic cigarettes daily and have no desire to return to smoking regular cigarettes. Our doctor is very supportive of our using electronic cigarettes as he is smart enough and progressive enough to realize that these are much healthier for us than smoking. During the past 6 months I have been able to stop using both of the blood pressure medications I had been on as well as the medication I was on for a rapid pulse rate.

    Perhaps if we hadn’t been lied to for the past 30 yrs. concerning the safer use of smokeless tobacco products we would have switched over to those and possibly my mother would still be alive as well if she had had a safer alternative to use for nicotine consumption that smoking. Electronic cigarettes offer my husband and I the ability to get the nicotine that we are dependent on and also satisfy the actual hand to mouth habit as well.

    Nicotine in the safer form of smokeless tobacco products and electronic cigarettes is no more addictive than caffeine is for those who simply cannot function without that cup of coffee every morning. Yes it is a stimulant and vaso-constrictor and there are some minor cardiac risks but they are hundreds of times safer to use than actually smoking a cigarette. It’s past time that the continued lies about smokeless tobacco products being just as dangerous as actually smoking be put to an end. How many more people must die to keep those lies alive?
     
  11. Traver

    Traver Ultra Member ECF Veteran

    Supporting member
    Oct 28, 2010
    WV
  12. markfm

    markfm Aussie Pup Wrangler Verified Member ECF Veteran

    Supporting member
    I asked over on Vocalcek's new thread on this topic (http://www.e-cigarette-forum.com/forum/comments-needed/160754-tell-your-story-tobacco-products-scientific-advisory-committee.html), I'll ask here too:

    Does anyone have any idea what thecre.com's actual connection is to TPSAC? I don't see any of the FDA TPSAC members claiming to rep CRE. Just who is backing CRE's involvement in this? The site makes it sound, on a quick read, like it's some conduit to get comments to TPSAC on the topic, but I don't see any relationship between thecre and TPSAC. This doesn't mean there's anything wrong with the site, but the connection is not obvious, what their stake is in this.
     
  13. my2heartboys

    my2heartboys Super Member ECF Veteran

    Oct 2, 2010
    Kansas, USA
    Folks we are talking about an agency that rushed the approval for Norplant through....WITHOUT knowing all of the nasty side effects that many experienced...I was just one of those many. Their latest bungle is the fact that they have indiscrimently pulled Darvocet off the market. Yes this is a medium level narcotic, problem is that for those of us who deal with chronic pain and cannot tolerate many of the other pain killers on the market, it is the one medication that works for us....again, I am one of those many who fall within chronic pain AND cannot tolerate any of the other pain medications.

    The FDA is full of nothing but idiots....I honestly doubt their ability to listen and understand as well as consider ecigs as a legitimate option of smoking cessassation.

    Anne
     
  14. Traver

    Traver Ultra Member ECF Veteran

    Supporting member
    Oct 28, 2010
    WV
  15. Desert Willow

    Desert Willow Super Member Verified Member ECF Veteran

    Sep 11, 2010
    Bullhead City, AZ
    Cool! I couldn't help myself from commenting on another article there.

    http://www.examiner.com/health-and-science-in-national/electronic-cigarettes-are-unsafe-and-pose-health-risks?cid=parsely#parsely

    (e-cigs are unsafe and pose public health risks)

    Brightest Blessings!
     
  16. Traver

    Traver Ultra Member ECF Veteran

    Supporting member
    Oct 28, 2010
    WV
  17. Brewlady

    Brewlady Super Member Verified Member ECF Veteran

    Supporting member
  18. Brewlady

    Brewlady Super Member Verified Member ECF Veteran

    Supporting member
  19. Traver

    Traver Ultra Member ECF Veteran

    Supporting member
    Oct 28, 2010
    WV
    Feel free to post these urls anywhere and everywhere.
    I am going to try and find an article every day and keep this thread going as long as people respond to it.
     
  20. Desert Willow

    Desert Willow Super Member Verified Member ECF Veteran

    Sep 11, 2010
    Bullhead City, AZ
    Thanks Traver! I found your original link and responded to it.

    Now I am a letter writing machine. I plan to write 3 letters daily, which is just about enough to really get my adrenaline up, along with my morning coffee. Should be a fine wake-up activity and hopefully fruitful.

    BECOME A CITIZEN OF OUR GOVERNMENT, NOT A VICTIM OF OUR GOVERNMENT!
    (My new daily mantra)

    Thanks so much again!

    Brightest Blessings!
     
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