November 30, 2017

Stanton A. Glantz, PhD

Is FDA going to end up helping prolong the tobacco epidemic? It's beginning to look that way

Reuters has reported that “The U.S. Food and Drug Administration said on Wednesday it is considering measures to speed development of products that help people quit smoking, including easing requirements for approval of over-the-counter nicotine replacement therapies... The new measures could enable e-cigarette companies to get the devices approved as medical products, which could offer consumers greater reassurance that they perform as advertised and also open the possibility of being covered under health insurance.”
While developing better ways to help smokers quit is always a good thing, there is a good chance that this FDA initiative will end up helping the tobacco companies keep people smoking.
As Dorie Apollonio and I reported last October in our paper “Tobacco Industry Research on Nicotine Replacement Therapy: ‘If Anyone Is Going to Take Away Our Business It Should Be Us,’" the tobacco companies figured out back in the 1990s that, while NRT is very effective when used with proper medical management, few physicians ensure that their patients will use it correctly and OTC NTR was associated with less not more quitting. 
The industry’s conclusion was reconfirmed in 2014 by Robert West’s group, when they reported that in the real world “The use of NRT bought over the counter was associated with a lower odds of abstinence (odds ratio, 0.68; 95% CI, 0.49-0.94).” 
In other words, unsupervised NRT is doing essentially the same thing as e-cigarettes: depressing quitting smoking.  (Yes, I know that some people do successfully quit with e-cigs, but the overall population-level effect, even considering the new studies, remains that smokers who use e-cigarettes are less likely to stop smoking cigarettes.) 
West’s group also found, consistent with many other studies, that NRT done right worked: “Compared with smokers using none of the cessation aids, the adjusted odds of remaining abstinent up to the time of the 6-month follow-up survey were 2.58 (95% CI, 1.48-4.52) times higher in users of prescription medication in combination with specialist behavioral support and 1.55 (95% CI, 1.11-2.16) times higher in users of prescription medication with brief advice.”
So, the real thing the FDA needs to prioritize is developing rules to ensure that medical providers give proper support and supervision to people using NRT, not make it even easier to use e-cigarettes and other addictive nicotine products with pyrrhic hopes of quitting smoking.

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