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.

According to the policy statement: “The FDA should take electronic cigarettes off the market until it is satisfied that they are safe and effective.” Given that the average time it takes for drug companies to conduct clinical trials and demonstrate the safety and efficacy of their products is about 8 years, this would mean the removal of electronic cigarettes from the market for about 8 years.

The American Legacy Foundation expressed concern that “the FDA detected carcinogens, including nitrosamines. In other words, these analyses showed that the tested products contained detectable levels of known carcinogens and toxic chemicals.”

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At the same time, the FDA which has approved Chantix, seems focused on keeping electronic cigarettes, which have yet to be proven harmful, from the public.

A growing number of tobacco control experts and medical professionals are questioning the motives of the FDA. Dr. Michael Siegel, associate chairman and a professor in the Department of Community Health Sciences at the Boston University School of Public Health, wonders why the FDA is threatening to take electronic cigarettes off the market.

“If Chantix has been studied and has been found to have likely caused 98 deaths and an additional 188 attempted suicides and it is allowed to remain on the market because smoking cessation is such an important goal, then what is the point of removing e-cigarettes from the market while studying its potential adverse effects? Suppose e-cigarettes were to be found to have caused 100 deaths. Would that warrant taking it off the market, since it – like Chantix – is helping people to quit smoking?” Dr. Siegel asks in a statement released by the Center for Public Accountability in Tobacco Control.

According to the JAMA article: “Although varenicline’s label had already indicated potential psychiatric risks, the agency has continued to receive reports of attempted and completed suicide in varenicline-treated patients, including some who had no history of psychiatric problems. An FDA analysis, released earlier this year, of varenicline adverse event reports submitted to the agency between May 2006 and November 2007 documented 19 suicides and 18 reports of suicidal behaviors, including 15 suicide attempts… But at a press briefing in July, Rosebraugh said that based on crude counts the agency now has reports of 98 suicides and 188 suicide attempts.”

The JAMA article also notes that the FDA is requiring Pfizer, the makers of Chantix, to conduct clinical studies to determine the incidence and severity of the adverse effects of Chantix: “To better understand the incidence of these adverse events and which patients may be at greatest risk, the FDA is requiring the manufacturers of both drugs to conduct additional randomized controlled trials. Unlike previous studies, these trials will include individuals with preexisting mental health conditions, who make up a disproportionate number of smokers.”

Siegel notes that unlike Chantix – for which there were many immediate post-marketing reports of potential adverse effects — e-cigarettes have been on the market for more than three years and there have yet to be any severe adverse effects reported.

“In other words, we know that people are dying from taking Chantix but we’re going to allow it to remain on the market because it’s helping people to quit smoking. We know that there is no evidence that anyone is dying from using electronic cigarettes, but we’re going to take them off the market, even though they are helping people to quit smoking. That just doesn’t make any sense,” Dr. Siegel said.

Another thing that troubles Dr. Siegel is why anti-smoking groups are calling for the removal of e-cigarettes from the market, “when we are not aware of any documented severe adverse effects, yet they are not calling for the removal of Chantix from the market even though we know this drug is probably killing people.”

One answer, he believes, is the heavy financial influence of the pharmaceutical industry. “So far, every anti-smoking group which has called for the removal of e-cigarettes from the market has been found to be financially tied to Big Pharma. The Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, American Lung Association, and Action on Smoking and Health have all received funding of some sort from the pharmaceutical industry. None of these groups, however, disclosed their financial conflicts of interest when they called for a ban on electronic cigarettes.”

On September 2, Pfizer was fined $2.3 billion by Federal prosecutors for illegal drug promotion. Authorities called Pfizer a repeat offender, citing this was the fourth such settlement in the past ten years.

Dr. Siegel is concerned that the one constituency not being represented here is the public, which would want a reasonable alternative to products that are known to cause harm.

“I believe that not only are the actions of these groups inappropriate, unsupported by science, harmful to the public’s health, and heavily biased due to financial relationships, but these actions are also unethical because it is unscrupulous to advocate for a public policy like this without revealing such an important and relevant financial conflict of interest,” Dr. Siegel said.

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Dr. Michael Siegel is associate chairman and a professor in the Department of Community Health Sciences at Boston University. He is a physician who completed his residency in Preventive Medicine at the UC Berkeley School of Public Health and trained in epidemiology for two years at the Centers for Disease Control and Prevention in Atlanta before coming to Boston. With more than 20 years of experience in tobacco control, primarily as a researcher, Dr. Siegel’s primary interest is in the area of tobacco control, focusing on secondhand smoke health effects, exposure, and policies, cigarette advertising and marketing practices and their effects on youths, and evaluation of tobacco control policies and their impact on youth and adult smoking behavior. His primary teaching is in the areas of mass communication, marketing, and public health advocacy. He is co-author of a book, entitled “Marketing Public Health: Strategies to Promote Social Change” and has been active in promoting smoke-free bar and restaurant policies throughout the country. Dr. Siegel has served as an expert witness in several major tobacco litigation cases. His research and writing on tobacco issues can be read at http://tobaccoanalysis.blogspot.com/.