According to a press release issued earlier this week: “In July of this year, the Food and Drug Administration released a study that condemned electronic cigarettes as an unsafe alternative for smokers, but not all physicians are convinced that the study was accurate or even completely transparent to the tax payers that fund them. “We urge FDA to make public the laboratory data behind the July 22 condemnation of electronic cigarettes, along with comparable data on pharmaceutical nicotine products and conventional cigarettes. Then, on the basis of these data, either fully justify or retract the July 22 condemnation of electronic cigarettes,” says Joel L. Nitzkin, Chair of the American Association of Public Health Physicians Tobacco Control Task Force in a letter to the FDA.”

“The letter specifically targets the new tobacco legislation that passed through Congress this summer which gives the FDA power to regulate tobacco products in the United States and notes that the success rate of current smokers who attempt to quit by using pharmaceutical aids is as low as 5%. Making smokers more aware of less harmful alternatives, snus and e-cigarettes included, could significantly reduce the amount of smokers who die due to tobacco-related illnesses.”

“The message the AAPHP is sending to the FDA is a clear one and that is that electronic cigarettes are not the wildly dangerous alternatives that they have been portrayed as in news publications and on television, but perhaps one of the best products available for current smokers to switch to. Only time will tell if the FDA will retract their July study in favor of a more complete one or if smokers will continue to be limited to only products offered by big tobacco or big pharma with no explanation.”

The Rest of the Story

I applaud the AAPHP for taking this strong and science-based stand, which contrasts with the ideology-driven positions that have been taken by a number of anti-smoking groups that have called for the removal of electronic cigarettes from the market, despite clear evidence of their utility in helping smokers quit and their relative safety compared to cigarettes. As I have mentioned previously, every one of these anti-smoking groups, it turns out, has received funding from pharmaceutical companies and thus have a conflict of interest — none have disclosed this conflict.

In contrast, the AAPHP position is based not on pure ideology, but on the science, which clearly indicates that electronic cigarettes are a far safer alternative to regular cigarettes and that they appear to be effective in helping highly resistant smokers to quit successfully.

The anti-smoking groups’ condemnation of electronic cigarettes is based largely on the FDA’s laboratory findings, which actually indicated that e-cigarettes are much safer than regular ones because they contain miniscule levels of carcinogens, while cigarettes contain very high levels of a large number of carcinogens. The level of tobacco-specific nitrosamines is reduced by a factor of up to 1400, indicating a substantial degree of relative safety compared to smoking.

Taking electronic cigarettes off the market is the worst single thing we could do to harm the public’s health. Hundreds of thousands of vapers would be forced to return to cigarette smoking and they would therefore suffer a deterioration in their health. How is that a good thing for the public’s health? So far, none of the anti-smoking groups have answered this question.

Another thing that none of the anti-smoking groups have done is to disclose their conflicts of interest with Big Pharma, a failure which I believe is unethical. Financial interests in pharmaceutical companies which rely upon smoking cessation drugs for substantial profits are quite relevant to policy regarding e-cigarettes because these products represent a huge threat to the financial well-being of these companies. E-cigarettes represent a huge potential threat to Big Pharma, because they appear to be much more effective than pharmaceutical smoking cessation products.

A final thing that none of the anti-smoking groups has done is to meet my challenge of naming even one specific hazard that e-cigarettes likely pose to vapers. While the damage that would be done to the health of huge numbers of vapers if e-cigs are taken off the market is definite, the health damage that is supposedly being done to vapers from using e-cigarettes is purely speculative and completely hypothetical.

The anti-smoking groups don’t appear to want to address the specific scientific issues, probably because they have little ground upon which to stand. Instead, they insist on diverting the issue to talk about anti-freeze, children shelling out $90 to buy e-cigarette kits, and dangerous carcinogens present in e-cigarette cartridges (without mentioning that the levels of these carcinogens are trace levels, and orders of magnitude lower than in cigarettes, confirming their relative safety).

When groups make national policy recommendations without a willingness to actually address the science, you know we’ve got a problem. Never is that more apparent than with the issue of electronic cigarettes.

The Rest of the Story by Michael Siegel.

It will last for one hour, don’t miss it!

ANR writes to alert its constituents as follows: “We want to alert the field that the “Electronic Cigarette Association” (ECA) is lobbying against the Marion County/Indianapolis smokefree bill. The fast growing electronic cigarette industry is trying to be sure that its products will circumvent smokefree workplace and public place laws. The Indianapolis bill would strengthen the city’s law to include bars and also add electronic cigarettes to the definition of smoking. Just to clarify, this isn’t saying that people can’t use these products, but rather – that electronic cigarettes should be treated like traditional cigarettes and should not be used indoors or in any way that may put others at risk. While the e-cigarette industry claims their products are “safe”, the health risks are still unknown — both to the smoker and those around them.”

To see Dr Michael Siegel’s opinion on this, visit his blog – The Rest of the Story.

These are just a few of the questions that will be addressed at the 2009 William J. Bicknell Lectureship in Public Health to be held at Boston University School of Public Health. The event will be held on Friday, Oct. 23, from 9 a.m. to noon, in the first-floor auditorium of 670 Albany Street, on the Boston University Medical Campus. A continental breakfast will be available from 8:30 a.m. The event is free and open to the public.

I want to extend a special invitation to Rest of the Story readers, especially those in the Boston area, to attend this event.

Link to original post with more details.

August 29, 2009
Lawrence Deyton, MD
Incoming Director
FDA Center for Tobacco Products

Re: Don’t Write Off Current Smokers

Dear Dr. Deyton:

For the past half century, the American Association of Public Health Physicians (AAPHP) has served as the national voice of physician directors of state and local health departments and other like-minded physicians. We have long been involved with tobacco control, with the singular goal of doing everything in our power to reduce tobacco related illness and death.

As you assume leadership of the new FDA Center for Tobacco Products, we urge you to consider the actions FDA can take, within the powers granted by this new legislation, to rapidly and substantially reduce tobacco related illness and death in current adult smokers.

Unfortunately, FDA has not gotten off to a good start. FDA condemnation of electronic cigarettes, in its July 22 press conference, and FDA insistence that electronic cigarettes should be regulated as a drug/device combination rather than as a tobacco product makes no sense from a public health perspective. It flies in the face of FDA laboratory findings on other products already approved by FDA. If one looks at electronic cigarettes as a sentinel for all tobacco products less hazardous than conventional cigarettes – the outlook for FDA action reducing tobacco-related illness and death among current adult smokers is dismal.

With this in mind, we respectfully request your consideration of the following actions:

1. We urge FDA to make public the laboratory data behind the July 22 condemnation of electronic cigarettes, along with comparable data on pharmaceutical nicotine products and conventional cigarettes. Then, on the basis of these data, either fully justify or retract the July 22 condemnation of electronic cigarettes.

2. We urge FDA to reclassify electronic cigarettes from a drug/device combination to a tobacco product.

This will enable FDA to immediately regulate manufacturing and impose marketing restrictions during this initial period of FDA Tobacco Center development. This reclassification will eliminate pressure on the several hundred thousand current American users of electronic cigarettes to switch back to the much more hazardous conventional cigarettes.

This year, about 400,000 American adult cigarette smokers will die of a tobacco-related illness. Their second hand smoke will kill about 48,000 non-smokers. About 700 more will die in residential fires. Despite progress on other measures of tobacco use, per CDC estimates, this death count continues to inch up from year to year.

In contrast, even though smokeless tobacco products represent about 20% of nicotine intake in the United States, the number of deaths per year from these products is too small for reliable estimates from the CDC. Our (AAPHP) best estimate is that smokeless tobacco products currently cause about 700 cancer deaths per year in the United States. This is less than 1% of the more than 110,000 deaths that would occur each year if smokeless products carried the same mortality as conventional cigarettes.

This last week, Boffetta and Straif published a paper alleging evidence of an increased risk of fatal heart disease and stroke among smokeless tobacco users. This is a study sure to be referenced by those seeking evidence of the harmfulness of smokeless tobacco products. Unfortunately, this study suffers from major technical and ethical flaws, including failure to note in the abstract that they found no increased risk of non-fatal heart attack or stroke. Even worse, of the many studies reviewed, only two showed evidence of even a slight increase in risk of death – and these were the ones selected for the conclusion and abstract. That having been said, their allegations of a 13% increase in risk of fatal heart attack and 40% increase in risk of fatal stroke pale in comparison with the 180% to 300% increases in risk for men and women 35-64 years of age posed by smoking conventional cigarettes.

Contrary to prevailing conventional wisdom, virtually all the heart and lung disease from conventional cigarettes, and an estimated 98% of the cancer mortality, are due to direct inhalation of fresh products of combustion deep into the lung. Our best estimate (based on the work of Pankow et al and others) is that only about 2% of the cancer mortality from cigarettes is from the named carcinogens commonly found in tobacco products. Smokeless tobacco products carry little or no risk of heart disease and no risk of lung disease. They do not kill innocent bystanders and they do not burn down houses. The risk of cancer of any kind from smokeless products ranges from a high of about 5% of the risk of cancer posed by conventional cigarettes to a low well under 1% of the risk of cancer posed by conventional cigarettes. While definitive studies have not been done, we have reason to believe that tobacco products, such as electronic cigarettes, consisting of nicotine extracted from tobacco with only trace amounts of other chemical substances, should carry even less risk.

Most of the discussion to date around the new FDA/Tobacco bill has focused on reducing initiation of nicotine use by children and teens. The only discussion of current smokers has been limited to encouraging use of pharmaceutical products to aid cessation. This has been touted as doubling quit rates – but without mentioning that this doubling is from about 3% to about 5% per year. In other words, this option fails 95% of smokers willing to try it, even under study conditions with optimal counseling.

It should be possible to save the lives of 4 million or more of the 8 million adult American smokers who will otherwise die of a cigarette-related illness over the next twenty years. This could be done by making smokers aware of selected smokeless tobacco products (including but not limited to snus and electronic cigarettes) that promise to reduce the risk of tobacco-related illness by 99% or better for smokers who are unwilling or unable to quit. Rather than discouraging nicotine cessation, however, such an approach, even with no medical intervention, would be expected to triple the rate at which current smokers eventually discontinue their nicotine use.

Those writing the new FDA legislation endorsed a harm reduction component to current tobacco control programming, but in a most peculiar way. The law encourages cigarette manufacturers to develop “reduced exposure“ products and market them with no scientific proof that such reductions in exposure will reduce risk. The law then requires presumably new “scientific evidence” for smokeless products, already known to be of substantially lower risk. This makes no sense. The law encourages a harm reduction component to current tobacco control programming that might reduce tobacco-related cancer mortality by one or two percent; while actively discouraging switching to lower risk tobacco products that promise to lower total tobacco-related illness and death by 99% or better.

The secret to success, as we see it, will be to add an effective harm reduction component to current tobacco control programming while using the tools made available by this new law to prevent this new harm reduction initiative from increasing the numbers of children and teens who initiate tobacco use.

Reconsidering the FDA stance on electronic cigarettes would be the most logical first step.

We look forward to working with FDA to use the powers granted by this new legislation to rapidly and substantially reduce tobacco-related illness and death, among both current and potential future tobacco users.

References:
The data on smoking attributable deaths on page 2 of this letter are from the Centers for Disease Control MMWR report of November 14, 2008 Smoking-Attributable Mortality, Years of Potential Life Lost, and Productivity Losses — United States, 2000–2004

The estimate that 20% of current nicotine consumption in the United States is from smokeless tobacco was generated by Mr. William Godshall, based on the formula utilized by Fagerstrom et al, when estimating 2002 nicotine consumption by type of tobacco product in multiple countries.

The discussion on risk of heart disease and stroke from smokeless tobacco products is from Paolo Boffetta and Kurt Straif : Use of smokeless tobacco and risk of myocardial infarction and stroke: systematic review with meta-analysis. Published August 18, 2009. BMJ 2009; 339: b3060 [Abstract] [Full text]

The data on relative risk of fatal heart attack and stroke from smoking, in men and women 35-64 years of age, are data from the American Cancer Society as quoted in “Changes in cigarette-related disease risks and their implication for prevention and control.” Smoking and Tobacco Control Monograph 8. Bethesda, MD: US Department of Health and Human Services, Public Health Service, National Institutes of Health, National Cancer Institute 1997;305-382. NIH Publication no. 97-1213.

The other references to the scientific literature that back-up the points made in this letter can be found on the Tobacco Issues page at the Tobaccolegfeb07 web site. There is an October 2008 “Resolution and White Paper on Tobacco Harm Reduction.” This paper, on pages 6 and 13, includes then-current CDC and AAPHP mortality projections. “The Myth of the Safe Cigarette,” is based on the paper by Pankow et al (Calculated Cancer Risks for Conventional and “Potentially Reduced Exposure Product” Cigarettes — Pankow et al. 16 (3): 584 — Cancer Epidemiology Biomarkers & Prevention ) and others. It makes the case that conventional cigarettes cannot be made measurably safer. The exchange of correspondence with Zhu et al, from a paper published earlier this year, deals with the difference in quit rates, comparing conventional cigarettes to smokeless tobacco products.

Yours,

Joel L. Nitzkin, MD, MPH, DPA
Chair, AAPHP Tobacco Control Task Force
jln@jln-md.com
504 899 7893

Kevin Sherin, MD, MPH, FACPM, FAAFP
President, American Association of Public Health Physicians
ksherin@yahoo.com

Conflict of Interest Disclaimer: Neither of us, nor the American Association of Public Health Physicians, has received or anticipates receipt of any financial support from any tobacco product manufacturer or vendor, or any pharmaceutical firm making nicotine replacement products.

The agency also reported that of 18 cartridges tested, one contained diethylene glycol, an ingredient in antifreeze. The FDA threatened to remove electronic cigarettes from the market and to take enforcement action — including potential criminal sanctions — against product distributors.

Backed by the finding that e-cigarettes contain carcinogens and diethylene glycol, a number of anti-smoking groups and several other states in addition to Connecticut have jumped on the bandwagon, considering or enacting legislation to remove these “harmful” devices from the market.

However, the FDA failed to mention in its press conference that the levels of tobacco-specific nitrosamines (the carcinogens) detected in electronic cigarettes were extremely low, below the level allowed in nicotine replacement products, such as nicotine patches, inhalers and gum. The agency is not threatening to take nicotine patches or gum off the market, although they too contain detectable levels of carcinogens.

The nicotine in electronic cigarettes and FDA-approved nicotine replacement products is derived from tobacco, which makes traces of some tobacco carcinogens essentially inevitable.

The level of the same tobacco-specific nitrosamines in conventional cigarettes is at least 300 to 1,400 times higher than what has been detected in electronic cigarette cartridges. In other words, you would have to smoke as many as 1,400 electronic cigarettes to be potentially exposed to the same amount of these carcinogens as smoking one conventional cigarette.

In fact, the FDA failed to perform the laboratory test of most importance: a comparison of the presence of, and concentrations of, toxins and carcinogens in electronic cigarettes and conventional ones. Scientific studies have demonstrated that conventional cigarettes contain 57 identified carcinogens, while electronic cigarettes have not been found to contain any carcinogens at higher than trace levels.

The bottom line is this: Conventional cigarettes have been thoroughly tested. They are known to contain at least 10,000 chemicals, including about 57 carcinogens. Electronic cigarettes deliver nicotine without these 10,000 chemicals and 57 carcinogens. It doesn’t take a rocket toxicologist to figure out that electronic cigarettes are a much, much safer alternative to conventional ones.

Unfortunately, what the FDA and the anti-smoking groups are essentially telling smokers is that they would rather have them continue to smoke the most toxic cigarettes — the conventional ones — rather than switch to a product that is likely orders of magnitude safer.

The question the FDA and the anti-smoking groups are asking is: “Are electronic cigarettes safe?” That is not the right question. The right question is: “Are electronic cigarettes much safer than conventional ones?” The FDA and anti-smoking groups are comparing electronic cigarettes to a solution of spring-fresh Maine mountain stream water. What they need to compare electronic cigarettes to is a Marlboro cigarette.

This doesn’t mean that there aren’t problems with e-cigarettes that need to be addressed. This doesn’t mean e-cigarette manufacturers shouldn’t be asked to make certain changes, such as instituting tighter quality control procedures and making sure the propylene glycol is devoid of diethylene glycol. This doesn’t mean that there shouldn’t be restrictions on the sale of these devices to minors.

But it does mean that it is lunacy to ban the product, especially given that the very same FDA is now approving deadly Marlboros, Winstons, Kools, Newports, Camels and others.

The FDA and anti-smoking groups are on the verge of losing sight of the actual objective of public health regulation: to improve the overall population’s health. The combination of FDA approval of conventional cigarettes and FDA banning of the much safer electronic ones would be ludicrous, would have detrimental population health effects and would send exactly the wrong message to the public.

The real threat to our children’s health is not electronic cigarettes. It’s the real ones.

•Dr. Michael Siegel is a professor in the Department of Community Health Sciences at the Boston University School of Public Health. He is a longtime advocate for tobacco control initiatives including smoke-free bar and restaurant policies.

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