May 6, 2015
Stanton A. Glantz, PhD
Comments on what Bonnie Herzog said Mitch Zeller said at the SFATA meeting
Several people have emailed me asking what I think about the summary of Mitch Zeller's comments at the SFATA conference published by Wells Fargo analyst Bonnie Herzog on May 5, 2015:
E-Cigarette/Nicotine Debate Needs to be Re-Focused on Opportunity to Reduce Net Population-Level Harm Caused by Smoking – We attended the Smoke-Free Alternatives Trade Association (SFATA) Conference outside of Chicago, “headlined” by Mitch Zeller, Director of the FDA's Center for Tobacco Products. Encouragingly, Director Zeller underscored the importance of “opening up the dialogue” across various stakeholders in the nicotine space, suggesting to us that he and the agency remain committed to using science and data to shape regulation while recognizing the nicotine continuum of risk which is consistent with his previous comments. Director Zeller even remarked that conference participants were “preaching to the choir” with regards to the need for the debate to change. Other takeaways from Director Zeller: (1) The societal debate around e-cigs needs to be re-focused on “issues that really matter” – namely what role e-cigs or other potentially less harmful, noncombustible nicotine delivery systems could play in net population-level harm reduction, potentially reversing the trend of 500K Americans dying annually from tobacco-related harm; (2) The issues driving the e-cig/nicotine debate center around youth access, flavors, and marketing, which are undoubtedly very important but have diverted attention from the bigger-picture issues as described in #1; (3) The FDA has “taken seriously” the comments, considerations and concerns of small manufacturers who don’t have the financial and human resources of Big Tobacco; and (4) The FDA is engaged with other FDA “centers” – particularly the Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) to explore the role of “therapeutic nicotine.” Bottom line - we remain cautiously optimistic that the FDA “gets it” with regards to a nicotine risk continuum that will ultimately be reflected in regulation. We remain bullish on vapor long-term, but near-term we’re more cautious given increased uncertainty. [her emphasis]
One always has to take Bonnie's reports with a grain of salt, since she is a strong industry supporter, but if this report is accurate it raises serious concerns about the direction the FDA is moving if it indeed views the exploding youth use of e-cigarettes as a "diversion from the bigger-picture issues" of e-cigarettes for population-level harm reduction.
I would hope that the FDA will not accept millions of kids getting addicted to nicotine as acceptable collateral damage to accomplish as-yet unproven harm reduction claims for e-cigarettes (and other similar products).
Equally important, the evidence to date consistently shows that e-cigarettes are not only dramatically expanding the number of kids being introduced to nicotine addiction, but also are having the effect of keeping smokers smoking conventional cigarettes.
Thus, based on current use patterns, e-cigarettes are a form of harm enhancement.
Comments
An FCTC 5.3 perspective on the meeting
Although the United States is not an FCTC treaty party, it might still be worth noting that the engagement here appears to contradict the global consensus with regards to interactions with the tobacco industry specified in FCTC Article 5.3 and the accompanying Guidelines, especially if the Director's appearance at the conference was not "strictly necessary" for effective regulation.
Quoting, the Guidelines recommend the following for addressing tobacco industry interference in public health policies:
<blockquote;
<em;<strong;(2) Establish measures to limit interactions with the tobacco industry and ensure the transparency of those interactions that occur. </strong;</em;
<strong;20. </strong;In setting and implementing public health policies with respect to tobacco control, any necessary interaction with the tobacco industry should be carried out by Parties in such a way as to avoid the creation of any perception of a real or potential partnership or cooperation resulting from or on account of such interaction. In the event the tobacco industry engages in any conduct that may create such a perception, Parties should act to prevent or correct this perception.
<strong;Recommendations </strong;
2.1 Parties should interact with the tobacco industry only when and to the extent strictly necessary to enable them to effectively regulate the tobacco industry and tobacco products.
2.2 Where interactions with the tobacco industry are necessary, Parties should ensure that such interactions are conducted transparently. Whenever possible, interactions should be conducted in public, for example through public hearings, public notice of interactions, disclosure of records of such interactions to the public.
</blockquote;
http://www.who.int/fctc/guidelines/article_5_3.pdf";http://www.who.int/f...
Mark Levin, University of Hawai'i
FDA follow ASH???
Visual examples of the “collateral damage” that you speak can be found here:
http://www.techtimes.com/articles/50313/20150503/what-lures-teens-into-u...
with confirmation that kids are, indeed, finding the myriad of flavours now available: very appealing and satisfying indeed. See the Yale study referred to here:
http://ntr.oxfordjournals.org/content/early/2014/12/02/ntr.ntu243.full?s... )
Your “collateral damage” comment is very similar to this one:
<STRONG;“At the moment, we have an uncontrolled experiment with e-cigarettes: millions of Canadians are trying products with unknown safety standards for a wide variety of reasons. There is an urgent need for even more evidence to guide policy in this fast-moving area.”</strong;
which was issued subsequent to this new Canadian data on ENDS use:
http://www.tobaccoreport.ca/2015/TobaccoUseinCanada_2015_EcigaretteSuppl...
ASH England’s recent “report” here http://www.ash.org.uk/media-room/news/ash-daily-news/:ash-daily-news-for... on new data from UCL regarding the efficacy of ENDS drew a question from a colleague: “are they trying to sell the f…. things?”
Looks to me like, if these reports from Herzog ARE correct, that maybe the FDA are also???
One of the key conclusions that Brose, West et al made (see the link from the ASH Daily News above) was that:
“We found no evidence that e-cigarette use while smoking increased subsequent smoking cessation.”
These are the devices that ASH England have previously “urged” http://www.ukctas.ac.uk/ukctas/news/news-items/article130414.aspx";http:... smokers to try: prior to the evidence of their efficacy being established. This is, surely, scientifically unforgivable.
Dave Bareham.
Net population harm reduction is unethical
Assuming Herzog correctly paraphrased Mitch Zeller's comments, I find the idea of "net population-level harm reduction" very disturbing, because it necessarily implies that while e-cigarettes may be beneficial to some people they will be detrimental to others and the goal is to have more of the former than the latter -- for a net benefit. As you point out, this is extremely problematic in the area of youth access to e-cigarettes, but it also comes into play in terms of where e-cigarette use is allowed. The proponents of e-cigs are fighting to allow their use essentially everywhere and are opposing all attempts to prohibit their use in smokefree environments. This is tantamount to a vast medical experiment in which the general population is deliberately exposed to dangerous chemicals in order to assist a subset of people to cure an addiction. (Of course, this is assuming that e-cigs do help smokers to quit -- if they don't, then exposing nonsmokers to e-cig vapors for no benefit at all is an even worse policy.)
Exposing some people to dangerous chemicals in order to cure other people's medical problems is contrary to any reasonable standard of medical ethics and I simply cannot understand why some doctors are pushing for unlimited use of e-cigs. I thought that involuntary exposure of persons to possible harm as part of a medical experiment ended some time ago, but evidently some people are willing to bring it back!
Pete Hanauer
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