Thad Marney - In light of the fact that evidence-based treatments for nicotine dependence have less than 50% long term success rates, why does Dr. Fiore not recommend non-therapeutic smoke-free alternatives to smokers who have been unable or unwilling to completely quit smoking even while suffering from a chronic disease that is caused or worsened by continued smoking?
Marc Steinberg - I can't speak for Dr. Fiore, but I would never recommend anything that wasn't evidence-based because by definition, if it wasn't evidence-based, I wouldn't have a reason to believe it would work.
There are many evidence-based options available, so if one didn't work, I would switch to another - or even use mutliple approaches at the same time.
Thad Marney - I understand the restrictions of your profession, but isn't that being a bit disingenuous unless you clarify what type of "evidence" is sufficient to make a recommendation? Surely you wouldn't wait for a specific diet and exercise plan to receive FDA Approval and decades of epidemiological research to prove the effectiveness before you would recommend it to a patient? Your suggestion to "use multiple approaches at the same time" is off-label usage and therefore NOT evidence-based.
Marc Steinberg - I suspect that you are advocating for e-cigs, and the evidence I would want to see for that would be at least one sufficiently powered double-blind randomized clinical trial published in a peer reviewed journal. Even with that, I would have safety concerns, but that's for a different post
I know this wasn't your main point, but off-label uses can be evidence-based. Combination medications have not been submitted to the FDA for a labeling change, but there is scientific support via randomized clinical trials for using multiple FDA approved smoking cessation medications at the same time.
Thad Marney - You are correct that a "Double-blind randomized clinical trial" is what would be needed for an e-cigarette to be approved by the FDA as a smoking cessation drug, device or combination, but are you suggesting that randomly chosen subjects would be given e-cigarettes with or without nicotine and some of them will stop smoking and some of them will not? Other than proving that people who receive a sufficient dose of nicotine have reduced desire to smoke, what do you think that will prove? Do you honestly suppose that e-cigarettes used as part of a formulated smoking cessation program could possibly be any LESS effective than the current assortment of "evidence based options" that have left tobacco usage virtually unchanged in the past few years?
When considering alternatives to what is supposedly the "#1 cause of preventable death" (smoking), why would you insist that products meet pharmaceutical requirements of premarket testing while combustible cigarettes dominate the recreational nicotine/tobacco products market before recommending them? Would you not recommend that someone try chewing gum or drinking tea if it helps them avoid smoking--even though that is not an "evidence based approach" or do you only have a problem with smoke-free alternatives that mimic the act of smoking and/or deliver nicotine?
What are your specific safety concerns? Preliminary FDA testing did not find any toxic or carcinogenic levels of any constituents of the e-cigarette cartridges, and none were even detected in the actual vapor. Propylene Glycol and glycerin vapor have a long history in germicidal air sanitizers and artificial fog machines--do you expect to find any negative effects of long term exposure to very small quantities (generally less than 1tsp/day)?
Marc Steinberg - When you feel the need to put the phrase evidence based options in quotes and say that tobacco use is "supposedly" the '#1 cause of preventable death' you're letting me know that you're not interested in an honest, scientifically based conversation.
Thad Marney - I put the phrases "Double-blind randomized clinical trial" and "evidence based options" in quotes because I was quoting the terms you used. I said that smoking is "supposedly 'the #1 cause of preventable death'" in quotes because I am not actually making this claim on my own authority and some have challenged the assertion because FDA approved interventions are less than 10% effective for long term smoking cessation. I did not know if you would agree that the CDC's estimate of over 400,000 annual American deaths are actually preventable by tobacco control status quo since the rates of tobacco use have not changed significantly since 2006.
I completely understand your reluctance to endorse a specific product without peer reviewed clinical trials, but I am not advocating specifically for e-cigarettes or any proprietary brand or product but for tobacco harm reduction generally by the substitution of smoke-free alternatives to combustible cigarettes--including, but not limited to therapeutic products or pharmaceuticals--rather than advocating for an abstinence-only approach as advocated by many corporate funded organizations and government agencies.
Marc Steinberg - I apologize for misunderstanding you then, +Thad Marney. Best wishes.
Thad Marney - By the way, establishing an evidence base for off-label usage really WAS my main point. Other than the long term epidemiology that novel products like e-cigarettes simply haven't existed long enough to support, the ONLY scientific evidence to prove the safety and effectiveness of e-cigarettes that hasn't already been done is the "sufficiently powered double-blind randomized clinical trial published in a peer reviewed journal" you mention that the FDA requires for premarket review of pharmaceutical products but is notably NOT required for non-therapeutic products or "off-label" uses. NRTs are only approved for use for 12 weeks--not because using them for more than 12 weeks is dangerous, but because the clinical trials required for FDA approval were only 12 weeks long.
I understand that you have a vested interest in endorsing the use of products that support the RWJF portfolio, but understanding that a certain percentage of population (seemingly around 20%) is either unable or unwilling to completely stop using recreational nicotine or tobacco products, should we not encourage these inveterate users to at least switch to smoke-free alternatives rather than continue to suffer and die from diseases that are caused or worsened by smoking? Among 46 million American smokers, 8.6 Million suffer from a chronic disease caused by smoking--should these people be limited to approaches that are proven to be less than 50% effective, or can "off label" long term NRT use or non-pharmaceutical substitutes be encouraged? Is it necessary for a smoking replacement product meet the exacting standards of pharmaceutical products before we can offer it to people who continue to smoke in spite of increasing costs on their health and finances?
Marc Steinberg - I guess I was too quick to apologize. While I love being accused of being motivated by supporting the RWJF portfolio, you could check my profile more carefully and see that I do not work for the RWJ Foundation. You'll have to check quickly though because I'm blocking you. I'm just not interested in the non-scientific viewpoint of CASAA.
Marc Steinberg - I can't speak for Dr. Fiore, but I would never recommend anything that wasn't evidence-based because by definition, if it wasn't evidence-based, I wouldn't have a reason to believe it would work.
There are many evidence-based options available, so if one didn't work, I would switch to another - or even use mutliple approaches at the same time.
Thad Marney - I understand the restrictions of your profession, but isn't that being a bit disingenuous unless you clarify what type of "evidence" is sufficient to make a recommendation? Surely you wouldn't wait for a specific diet and exercise plan to receive FDA Approval and decades of epidemiological research to prove the effectiveness before you would recommend it to a patient? Your suggestion to "use multiple approaches at the same time" is off-label usage and therefore NOT evidence-based.
Marc Steinberg - I suspect that you are advocating for e-cigs, and the evidence I would want to see for that would be at least one sufficiently powered double-blind randomized clinical trial published in a peer reviewed journal. Even with that, I would have safety concerns, but that's for a different post
I know this wasn't your main point, but off-label uses can be evidence-based. Combination medications have not been submitted to the FDA for a labeling change, but there is scientific support via randomized clinical trials for using multiple FDA approved smoking cessation medications at the same time.
Thad Marney - You are correct that a "Double-blind randomized clinical trial" is what would be needed for an e-cigarette to be approved by the FDA as a smoking cessation drug, device or combination, but are you suggesting that randomly chosen subjects would be given e-cigarettes with or without nicotine and some of them will stop smoking and some of them will not? Other than proving that people who receive a sufficient dose of nicotine have reduced desire to smoke, what do you think that will prove? Do you honestly suppose that e-cigarettes used as part of a formulated smoking cessation program could possibly be any LESS effective than the current assortment of "evidence based options" that have left tobacco usage virtually unchanged in the past few years?
When considering alternatives to what is supposedly the "#1 cause of preventable death" (smoking), why would you insist that products meet pharmaceutical requirements of premarket testing while combustible cigarettes dominate the recreational nicotine/tobacco products market before recommending them? Would you not recommend that someone try chewing gum or drinking tea if it helps them avoid smoking--even though that is not an "evidence based approach" or do you only have a problem with smoke-free alternatives that mimic the act of smoking and/or deliver nicotine?
What are your specific safety concerns? Preliminary FDA testing did not find any toxic or carcinogenic levels of any constituents of the e-cigarette cartridges, and none were even detected in the actual vapor. Propylene Glycol and glycerin vapor have a long history in germicidal air sanitizers and artificial fog machines--do you expect to find any negative effects of long term exposure to very small quantities (generally less than 1tsp/day)?
Marc Steinberg - When you feel the need to put the phrase evidence based options in quotes and say that tobacco use is "supposedly" the '#1 cause of preventable death' you're letting me know that you're not interested in an honest, scientifically based conversation.
Thad Marney - I put the phrases "Double-blind randomized clinical trial" and "evidence based options" in quotes because I was quoting the terms you used. I said that smoking is "supposedly 'the #1 cause of preventable death'" in quotes because I am not actually making this claim on my own authority and some have challenged the assertion because FDA approved interventions are less than 10% effective for long term smoking cessation. I did not know if you would agree that the CDC's estimate of over 400,000 annual American deaths are actually preventable by tobacco control status quo since the rates of tobacco use have not changed significantly since 2006.
I completely understand your reluctance to endorse a specific product without peer reviewed clinical trials, but I am not advocating specifically for e-cigarettes or any proprietary brand or product but for tobacco harm reduction generally by the substitution of smoke-free alternatives to combustible cigarettes--including, but not limited to therapeutic products or pharmaceuticals--rather than advocating for an abstinence-only approach as advocated by many corporate funded organizations and government agencies.
Marc Steinberg - I apologize for misunderstanding you then, +Thad Marney. Best wishes.
Thad Marney - By the way, establishing an evidence base for off-label usage really WAS my main point. Other than the long term epidemiology that novel products like e-cigarettes simply haven't existed long enough to support, the ONLY scientific evidence to prove the safety and effectiveness of e-cigarettes that hasn't already been done is the "sufficiently powered double-blind randomized clinical trial published in a peer reviewed journal" you mention that the FDA requires for premarket review of pharmaceutical products but is notably NOT required for non-therapeutic products or "off-label" uses. NRTs are only approved for use for 12 weeks--not because using them for more than 12 weeks is dangerous, but because the clinical trials required for FDA approval were only 12 weeks long.
I understand that you have a vested interest in endorsing the use of products that support the RWJF portfolio, but understanding that a certain percentage of population (seemingly around 20%) is either unable or unwilling to completely stop using recreational nicotine or tobacco products, should we not encourage these inveterate users to at least switch to smoke-free alternatives rather than continue to suffer and die from diseases that are caused or worsened by smoking? Among 46 million American smokers, 8.6 Million suffer from a chronic disease caused by smoking--should these people be limited to approaches that are proven to be less than 50% effective, or can "off label" long term NRT use or non-pharmaceutical substitutes be encouraged? Is it necessary for a smoking replacement product meet the exacting standards of pharmaceutical products before we can offer it to people who continue to smoke in spite of increasing costs on their health and finances?
Marc Steinberg - I guess I was too quick to apologize. While I love being accused of being motivated by supporting the RWJF portfolio, you could check my profile more carefully and see that I do not work for the RWJ Foundation. You'll have to check quickly though because I'm blocking you. I'm just not interested in the non-scientific viewpoint of CASAA.
