American Thoracic Society Lies to Public, Claiming that Smoking is No More Hazardous than Vaping

One of the following is blatantly lying to the American public by telling us that smoking is no more hazardous than vaping, which involves no use of tobacco and no combustion process and has been found to dramatically improve the health of smokers who switch to these products. Guess which one.

A. The tobacco industry; or
B. The American Thoracic Society.

If you guessed A, you are wrong. The correct answer is B. In a whopping ironic twist, it is the American Thoracic Society, and not Big Tobacco, that is lying to the public and downplaying the severe health consequences of smoking.

In a press release issued last Friday, the American Thoracic Society stated as follows:

"Frank Leone, MD, chair of the ATS Tobacco Action Committee, believes the misconception that e-cigarettes are safer than traditional cigarettes is driving the trend to increased use, which puts children and other first-time users at risk for significant health problems."

The Rest of the Story

It is absolutely not a "misconception" that smoking is more hazardous than vaping, it is undeniably true.

There is abundant scientific evidence that vaping, which has caused no documented chronic disease or death in any identified individual, is safer than smoking, which kills more than 400,000 people each year, causes chronic lung disease, cardiovascular disease, and cancer, and contains more than 10,000 chemicals, of which more than 60 are proven human carcinogens.

There is no debate in the tobacco control community about this point. Even Dr. Stan Glantz - a fierce opponent of vaping - acknowledges that smoking is more hazardous than vaping.

Ironically, while the American Thoracic Society is lying to the public, the tobacco companies are telling the truth. Each of the major tobacco companies has acknowledged that smoking its cigarettes is far more dangerous than vaping.

By informing the public that smoking is no more hazardous than using a product which contains no tobacco and merely creates an aerosol by heating propylene glycol, glycerin, nicotine, and flavorings, the American Thoracic Society is dangerously undermining the public's appreciation of the severe consequences of cigarette smoking.

The misinformation that the American Thoracic Society is disseminating is damaging to the public's health. First, it may discourage people from quitting smoking - people who otherwise would have greatly improved their health by quitting smoking completely with the help of e-cigarettes. Second, it may convince ex-smokers who have quit using electronic cigarettes that they are just as well off returning to smoking than remaining ex-smokers by virtue of those electronic cigarettes.

Like the American Thoracic Society, I believe that the FDA should regulate e-cigarettes, ban the sale of these products to minors, and restrict the marketing of e-cigarettes to youth. However, unlike the American Thoracic Society, I do not believe that it is acceptable to lie to the public in order to achieve these aims. I believe that telling the truth is sufficient. There are potential health hazards associated with vaping which, although they of a much lower magnitude than those associated with smoking, still warrant regulation of these products and measures to keep them out of the hands of minors.

The American Thoracic Society is not only lying about the hazards of smoking, but it is also hiding a financial conflict of interest that is relevant to its statement and should have been disclosed in the press release. Namely, the American Thoracic Society has received financial support from two pharmaceutical companies that manufacture smoking cessation drugs: GlaxoSmithKline and Pfizer.

In fact, the American Thoracic Society readily acknowledges that it partners with the pharmaceutical industry and that its corporate partners include GlaxoSmithKline and Pfizer, along with at least nine other drug companies. Both GlaxoSmithKline and Glaxo market smoking cessation drugs. Electronic cigarettes are a direct competitor of these drugs for the smoking cessation market. Thus, taking money from these companies is a significant financial interest that should have been disclosed in the press release.

The Pfizer Corporation disclosed that it gave the American Thoracic Society $25,000 in 2015, another $25,000 in 2014, another $50,000 in 2013, $215,000 in 2012, and $380,000 in 2011.

On an individual level, Dr. Leone has previously disclosed that he "has received commercial research grants or contracts from Pfizer, Merck, Ono, GlaxoSmithKline, and Ortho Biotech." But none of this is disclosed in the press release.

The failure to disclose this funding creates the appearance that the American Thoracic Society's statement is being influenced by its receipt of money from Big Pharma.

The rest of the story is that in 2016, it is the American Thoracic Society, and not Big Tobacco, that is deceiving the American public by lying about the relative health effects of smoking and vaping and thereby undermining the public's appreciation of the hazards of smoking. I could not possibly have predicted things would end up like this.

Despite Best Efforts of Anti-Smoking Groups, Electronic Cigarettes are Here to Stay

The Food and Drug Administration along with at least seven national anti-smoking groups made a valiant effort to remove electronic cigarettes from the market. In 2009, the FDA exerted what it purported was its jurisdiction over electronic cigarettes under the Food, Drug, and Cosmetic Act and effectively banned these products. At the same time, seven national anti-smoking groups promoted the removal of electronic cigarettes from the market. These seven groups, along with the amount of money they received from Pfizer and GlaxoSmithKline between 2009 and 2012, are as follows:

Pfizer

American Academy of Pediatrics: $720,800
American Cancer Society: $252,750
American Heart Association: $136,000
American Lung Association: $190,250
Campaign for Tobacco-Free Kids: $100,000
American Medical Association: $857,500
American Legacy Foundation: $300,000
Action on Smoking and Health: $200,000

GlaxoSmithKline

American Cancer Society: $602,010
American Lung Association: $143,461
Association for the Treatment of Tobacco Use and Dependence: $5,000
Campaign for Tobacco-Free Kids: $400,000
American Heart Association: $115,000
American Medical Association: $15,000
American Academy of Pediatrics: $65,075
American Legacy Foundation: $10,000

The Rest of the Story

Today, I am happy to opine that despite the best efforts of these anti-smoking organizations, electronic cigarettes are here to stay. The FDA failed in its efforts because the courts ruled that its jurisdiction over these products falls under the Tobacco Act, not the Food, Drug, and Cosmetic Act (in the absence of therapeutic or drug claims made by electronic cigarette companies). The anti-smoking organizations failed in their efforts because the state legislatures which considered bans on electronic cigarettes were swayed by an outpouring of protest from vapers who testified that they would most likely return to cigarette smoking if these devices were taken off the market.

Today, because of a number of subsequent developments in the electronic cigarette market, I can assert that these products are here to stay and that they will form the basis of a competitive and expanding market in the years to come.

Among the important developments (in addition to the D.C. District Court's decision on the FDA's regulatory authority) is the entrance of the major cigarette companies into the electronic cigarette market. I have already discussed the acquition of Blu cigs by Lorillard. Today, I report the efforts of Reynolds American to enter the electronic cigarette market.

According to an article in the Business Journal, Reynolds American has formed a subsidiary called the R.J. Reynolds Vapor Company which is test-marketing what it calls a "digital" cigarette, which is similar to but more advanced technologically than most electronic cigarettes on the market.

According to the article: "Reynolds American President and CEO Dan Delen said during Investors Day presentations Monday morning that the company is focusing over the long-term on emerging smoke-free products such as snus and its new electronic cigarette Vuse that offer larger margins and greater potential for growth. "Everything we're working on from an innovation standpoint has a higher margin than cigarettes," Delen said. "I think we're very well positioned in an evolving market." ... In the growing electronic cigarette category, which offers users a nicotine-infused vapor to inhale, Delen said RAI subsidiary R.J. Reynolds Vapor Co. is preparing to make a "big splash" after a limited launch of its Vuse product earlier this year. Delen said Vuse is more of a "digital cigarette" than merely an electronic one given its use of computer chips that Delen said help offer an experience closer to that of actually smoking. Delen said Vuse is also set apart by being produced domestically, while most electronic cigarettes are produced abroad. "We're not looking to make a little splash in the category," Delen said. "We're looking to make a big splash in the category." ... Delen said ... Reynolds American is focusing on markets centered around emerging products."

Philip Morris has also entered the "non-tobacco" cigarette market, after having purchased the patent to a new nicotine aerosol technology, although it is not clear how closely this new nicotine aerosol system resembles a cigarette rather than an inhaler.

British American Tobacco has also entered the electronic cigarette market. Its Nicoventures division is working on a nicotine inhaler to be launched within the next two years and it is supporting the development of what is apparently some type of non-tobacco, electronic cigarette. According to this same Financial Times article, Imperial Tobacco and Japan Tobacco are also preparing to enter the electronic cigarette market.

All of these tobacco companies realize something that the major anti-smoking groups fail to realize: It is no longer 1954 and the cigarette companies have not just issued their Frank Statement. Nor is it the 1960s, 1970s, 1980s, or 1990s. It is 2012, and the major cigarette companies have - unlike the major anti-smoking groups - begun to embrace the concept of harm reduction in the form of non-tobacco cigarette alternatives that deliver nicotine without the tar, toxins, and carcinogens and which therefore promote smoking cessation with an approach that may be more effective than traditional pharmacological methods.

A second major development is the increasingly effective voice of the vaping community. Vapers are letting their voices be heard, and after hearing the truth from vapers, policy makers are just not able to take the anti-smoking groups' advice and remove these products from the market. The electronic cigarette consumer advocacy and trade groups, internet forums, and vapers themselves have changed the dynamics of the playing field. The voices of the anti-smoking groups and pharmaceutical companies are not the only ones being heard. The true stories being shared by vapers who have successfully quit smoking or greatly reduced the amount they smoke thanks to electronic cigarettes, and who have experienced dramatic improvements in their health, are outweighing the financially conflicted and ideologically-driven voices of the anti-smoking movement. This is not to say that the battle is over, but I do believe that in the U.S. at least, the battle is now going to be over the nature of regulation, not the presence or absence of electronic cigarettes on the market.

An article published yesterday in the Financial reports that the electronic cigarette industry is currently a $2 billion global market. According to the article:

"after an initial fad period where the product was available exclusively on-line, e-cigs are now gaining acceptance as repeat usage products available through a variety of popular distribution channels, including convenience stores and supermarkets (for example, Tesco in the UK has signed a deal to stock E-Vapes) and the product is now no longer the preserve of specialists. ... Little wonder then that Tobacco and Pharma players have begun to sit up and take notice. In the world’s biggest e-cigarette market, the US, two leading tobacco players have entered the e-cig market by either buying an established e-cig brand (as in the case of Lorillard buying Blu for US$135mn in April 2012) or by launching their own e-cigarette brands on the market (eg Swisher’s eponymous e-cigarettes and e-cigars, also in 2012). Larger tobacco companies with more sizeable financial outlay have decided to develop their own alternative cigarette-mimicking nicotine delivery devices, such as global no.2 tobacco player, BAT, which in 2011 set up a company called Nicoventures to develop modified risk and nicotine delivery products. According to its product developer, Kind Consumer, its lead product will be a "pharmaceutically regulated substitute cigarette”. ... Globally, the NRT retail market is worth US$2.4bn (excluding prescription sales), and enjoying stable overall growth, but how long before it is eclipsed by the already US$2bn-strong e-cigarettes market?"

Euromonitor International recently projected that by the year 2050, the non-tobacco cigarette market (which is dominated by electronic cigarettes) will account for 4% of the entire tobacco market.

Sadly, if electronic cigarettes do take off as a more effective tool for getting smokers off their cigarettes and helping to save their lives, it will not be thanks to the efforts of the national anti-smoking groups. It will be despite their best efforts.

Anti-Smoking Groups that Oppose Electronic Cigarettes Received an Additional $1.4 Million from Big Pharma, Beyond the $2.8 Million Revealed Earlier; Groups Repeatedly Failed to Disclose this Conflict of Interest

Previously, I revealed that anti-smoking groups which opposed electronic cigarettes received payments from Pfizer to the tune of $2.8 million. Today, I expose further financial links between Big Pharma and these anti-smoking groups, this time from the pharmaceutical company GlaxoSmithKline, maker of the smoking cessation drugs Zyban, Wellbutrin, Commit, NiQuitin, CQ/Nicoderm, CQ/Nicabate, and Nicorette.

According to GlaxoSmithKline's disclosure of contributions for the years 2009, 2010, 2011 and for the first two quarters of 2012, eight anti-smoking groups which have all called for a ban on electronic cigarettes received nearly $1.4 million during the period 2009-2012 from GlaxoSmithKline alone.

The contributions by organization are as follows:

American Cancer Society: $602,010
American Lung Association: $143,461
Association for the Treatment of Tobacco Use and Dependence: $5,000
Campaign for Tobacco-Free Kids: $400,000
American Heart Association: $115,000
American Medical Association: $15,000
American Academy of Pediatrics: $65,075
American Legacy Foundation: $10,000

Total: $1.36 million

To the best of my knowledge, these contributions were not disclosed in the public statements made by these organizations in opposition to electronic cigarettes.

The Rest of the Story

In my view, it is unethical for these organizations to make public policy pronouncements about electronic cigarettes - calling for their removal from the market - without disclosing their significant conflict of interest with pharmaceutical companies that manufacture competing products. Yet these groups have repeatedly made such statements without revealing that they have received money from Big Pharma.

For example, in this policy statement calling for the removal of electronic cigarettes from the market, the American Heart Association, American Cancer Society, American Lung Association, and Campaign for Tobacco-Free Kids fail to disclose that all of these groups have received money from pharmaceutical companies that manufacture competing smoking cessation products. Nowhere in the policy statement does it reveal that all four of these organizations have been heavily funded by Big Pharma, as exposed above.

In its own fact sheet on electronic cigarettes, the American Legacy Foundation also supports a ban on these products, but fails to disclose its own financial connections with Big Pharma. The fact that Legacy has a substantial financial conflict of interest is hidden from the public in this document.

Similarly, the Association for the Treatment of Tobacco Use and Dependence wrote a letter to the FDA and issued a press release demanding that electronic cigarettes be taken off the market, but failed to disclose that this organization has received money from Big Pharma and that at least two members of its executive board had financial relationships with pharmaceutical companies that manufacture nicotine replacement products and stand to lose out in a major way if electronic cigarettes become popular

The American Medical Association also issued a press release calling for the removal of electronic cigarettes from the market, and guess what? The AMA also failed to disclose the tens of thousands of dollars it has received from Big Pharma. Thus, readers and the media have no way of knowing that the AMA has a severe conflict of interest in making its policy recommendation.

Not to be outdone, the American Academy of Pediatrics also issued a press release calling for the removal of electronic cigarettes from the market, and it too failed to disclose its significant financial conflict of interest with Big Pharma.

Thus, it is a clean sweep. Every one of these eight anti-smoking organizations that have called for the removal of electronic cigarettes from the market has received money from Big Pharma companies that make competing smoking cessation products, yet none of these organizations disclosed these conflicts in making their public statements.

Why are these organizations hiding this critical information from the public?

And incidentally, these are some of the very same organizations that have blasted tobacco industry-affiliated scientists or organizations for not revealing their financial ties to the industry when making policy statements of their own.

Had the FDA or other policy makers at the federal or state level heeded these groups' advice, it would have been a public health tragedy, as thousands upon thousands of ex-smokers would have essentially been forced to return to cigarette smoking. The gains that they experienced in their health would have been reversed, and the policy would undoubtedly have resulted in disease and death for many relapsing smokers.

The rest of the story is that every one of the nine major anti-smoking groups that has called for the removal of electronic cigarettes from the market (Action on Smoking and Health was discussed earlier) has a significant financial conflict of interest with Big Pharma companies that manufacture competing smoking cessation products, yet every one of these nine organizations hid these conflicts from the public. Not only were these recommendations inappropriate and detrimental to the public's health, but the issuing of the recommendations was unethical because of the failure to disclose these important conflicts of interest.

New Study Finds No Effect of Bupropion (Zyban) on Craving to Smoke; Will Anti-Smoking Groups Call for Zyban to Be Pulled Off Market?

A new study published in the current issue of the journal Nicotine and Tobacco Research finds that the drug bupropion (Zyban), which is approved by the FDA for the treatment of smoking cessation and whose use is widely promoted by anti-smoking groups, had no effect on suppressing the craving to smoke among smokers in a randomized, double-blind, placebo-controlled clinical trial (see: Madden GJ, Kalman D. Effects of bupropion on simulated demand for cigarettes and the subjective effects of smoking. Nicotine and Tobacco Research 2010; 12(4):416-42).

According to the paper: "The effects of bupropion on simulated demand for cigarettes were investigated in a placebo-controlled double-blind clinical trial. Participants reported the number of cigarettes they would purchase and consume in a single day at a range of prices. The effects of medication on the subjective effects of smoking were also explored. ... Demand for cigarettes was well described by an exponential demand equation. Bupropion did not significantly decrease the maximum number of cigarettes that participants said they would smoke in a single day nor did it significantly alter the relation between price per cigarette and demand. ... Medication group had no effect on any subjective effects of smoking."

The paper concludes: "Bupropion had no significant effects on demand for cigarettes."

The Rest of the Story

The results of this study stand in stark contrast to those of a recent study which found that electronic cigarettes significantly suppress the desire to smoke.

That study, published in the April issue of Tobacco Control, demonstrated that electronic cigarettes are effective in suppressing the desire to smoke, have similar efficacy to nicotine inhalers, and are more pleasant to use than the nicotine inhaler (see: Bullen C, McRobbie H, Thornley S, Glover M, Lin R, Laugesen M. Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tobacco Control 2010; 19:98-103).

While I am not arguing here that Zyban should be taken off the market or that it has no effect in treating smoking cessation, I am pointing out that there is credible scientific evidence that electronic cigarettes are more effective than Zyban in suppressing the desire to smoke. Anti-smoking groups continue to argue that electronic cigarettes must be taken off the market because there is no evidence that they are effective in treating smoking cessation. However, the evidence right before their eyes suggests that these products are more effective than those approved by the FDA to treat smoking cessation.

In other words, I do not truly believe that it is the scientific evidence that these anti-smoking groups are concerned about. They continue to claim that we have no idea what is in electronic cigarettes when in fact, the constituents of these products have been studied extensively. In fact, we know far more about the constituents of electronic cigarettes than we do about the constituents of regular cigarettes. The evidence is not what these groups are concerned about. What I believe they are concerned about is the idea that it could be beneficial to someone's health to go through the motions of what looks like smoking. I believe the battle is a purely ideological one, not a scientific one.

In addition, I think the battle is a financial one, as the groups calling for a ban on electronic cigarettes have received funding from pharmaceutical companies which stand to lose severely if electronic cigarettes are shown to be more effective than pharmacotherapy in facilitating smoking cessation.

Zyban is manufactured by GlaxoSmithKline, and in fact, several of the anti-smoking groups supporting a ban on electronic cigarettes have a financial interest in Glaxo by virtue of having received significant funding from this company. For example, the American Academy of Pediatrics, which called for a ban on electronic cigarettes, has received sponsorship support from GlaxoSmithKline for its annual conference at the "gold" level. Other groups which have called for a ban on electronic cigarettes - the American Lung Association, American Cancer Society, and Campaign for Tobacco-Free Kids - have also received financial support for their activities from Glaxo.

This story also explains why it is so inappropriate for the FDA Tobacco Products Scientific Advisory Panel to contain members who have financial conflicts of interest with Big Pharma. They cannot objectively review data on the effectiveness of electronic cigarettes and pharmacotherapy for smoking cessation, a key issue which the FDA will need to consider. The chair of the Committee - Dr. Jonathan Samet - has received grant support from GlaxoSmithKline. In addition, the organization that he directed - the Institute for Global Tobacco Control - is funded by GlaxoSmithKline and Pfizer. A second panel member - Dr. Neal Benowitz - has also consulted for GlaxoSmithKline. And worst of all, a GlaxoSmithKline consultant - Dr. Jack Henningfield of Pinney Associates - was appointed to the panel.

The rest of the story is that despite the claims of anti-smoking groups that nothing is known about the safety or effectiveness of electronic cigarettes, there is in fact evidence that these devices may actually be as effective or even more effective than approved pharmaceutical therapies for decreasing the desire to smoke, probably because they address the behavioral and not just pharmacologic aspects of the addiction. But anti-smoking groups, I am convinced, are not interested in the actual scientific evidence. Like the data on smoking bans and heart disease, these groups will simply ignore data that does not conform to their pre-conceived ideas.

Journal Commentary on Electronic Cigarettes is a Scientifically Unsupportable Hatchet Job and Fails to Disclose Author's Conflict of Interest

A commentary that appears in the current issue of the journal Pediatric Allergy, Immunology, and Pulmonology demonizes electronic cigarettes, claiming that they are not necessarily safer than cigarettes, that they are a gateway to nicotine addiction and smoking, and that they are not helpful in smoking cessation.

(See: Schraufnagel DE. Electronic cigarettes: vulnerability of youth. Pediatric Allergy, Immunology, and Pulmonology 2015; 28(1):2-6.)

The commentary argues that e-cigarettes are not necessarily safer than tobacco cigarettes:

"Electronic cigarettes are widely promoted as a safe alternative to smoking and even many health advocates and medical journals declare how much safer they are than combustible cigarettes. Their premise is that electronic cigarettes produce less tar than combustible cigarettes, and tar causes emphysema, bronchitis, and cancer. Therefore, electronic cigarette use is a harm reduction strategy compared with combustible cigarettes. There are several problems with this reasoning: (1) the comparator, tobacco, is the most deadly substance to which humans are commonly exposed; (2) it assumes that electronic cigarettes are well-manufactured regulated products; (3) it ignores nicotine and its harmful effects; (4) it assumes that the harms of electronic cigarettes are known; and (5) it does not account for population effects, including the potential harm to nonsmokers."
The commentary also argues that e-cigarettes are a gateway to nicotine addiction and smoking:

"Youthful experimentation and susceptibility to the brain-modifying effects of nicotine may be the start of a lifelong addiction. ... Initiating nicotine use and increasing dependence in the population may be linked with increased tobacco and other addictive substance abuse... ."

The commentary also argues that e-cigarettes are not helpful for smoking cessation:

"Although many smokers used electronic cigarettes to stop smoking, the record of electronic cigarettes for smoking cessation is poor. It was generally not different from a placebo. The studies also did not find a difference from medicinal nicotine patches, but the patches were often not used by the study participants. ... Recently quit smokers felt that electronic cigarettes were not associated with success." 

The Rest of the Story

Unfortunately, this commentary is a heavily biased, unscientific hatchet job. All three of its major points are completely unsupported by scientific evidence. Moreover, the commentary misinterprets much of the scientific literature and misrepresents the major findings. It also ignores the literature where convenient so as not to ruin what appear to be pre-determined conclusions.

First, the article challenges the premises that: (1) "electronic cigarettes produce less tar than combustible cigarettes, and tar causes emphysema, bronchitis, and cancer"; and that (2) electronic cigarettes are "much safer ... than combustible cigarettes." But both of these premises have been solidly established with abundant scientific evidence.

There is no question that electronic cigarettes produce less tar than combustible cigarettes. In fact, they produce no tar. By definition, tar is the residue formed by the combustion of tobacco in cigarettes. Since e-cigarettes involve no combustion and do not contain tobacco, no tar is produced. Moreover, it is quite true that the tar in tobacco smoke causes emphysema, bronchitis, and cancer. Even the tobacco industry readily admits as such.

There is also no question that e-cigarettes are much safer than tobacco cigarettes. How could smoking possibly be no more hazardous than occasional use of a non-tobacco containing, non-combustible product that eliminates exposure to more than 10,000 of the chemicals and more than 60 of the carcinogens in tobacco smoke? In addition, electronic cigarettes have tobacco-specific nitrosamine levels that are two to three orders of magnitude lower than real cigarettes, have been shown not to cause acute changes in spirometry-measured lung function (unlike real cigarettes), are not known to have caused any deaths in the U.S (compared to more than 400,000 per year for real cigarettes), and have been shown to reduce respiratory symptoms and improve lung function in asthmatic smokers who switch to them. It is also well-documented that there is dramatic clinical improvement in smokers who switch to electronic cigarettes.

Second, there is absolutely no evidence that e-cigarettes are a gateway to smoking, and there is not even any evidence that e-cigarette experimentation is leading to nicotine addiction among youth. The studies which have examined this question have found that nonsmoking youth who experiment with e-cigarettes almost uniformly use these products only occasionally, not on a regular basis as would be the case if they were addicted. Moreover, there is strong evidence that as the use of e-cigarettes rose dramatically among youth, the rate of decline in youth smoking has accelerated. If anything, the current evidence supports the conclusion that e-cigarettes are a gateway away from smoking and over to vaping. These products do not normalize smoking. On the contrary, they denormalize smoking by drawing people away from it. What they normalize is vaping, not smoking.

Third, there is clinical trial evidence that e-cigarettes are helpful for smoking cessation. In fact, they are at least as helpful as the nicotine patch, which is a well-accepted smoking cessation approach. The commentary acknowledges as much. However, it misinterprets this evidence and/or misrepresents it by arguing that it shows that e-cigarettes are not effective for cessation. But how could that be the case if these products are as effective as the nicotine patch?

The commentary tries to write off this finding by arguing that "the patches were often not used by the study participants." But that is exactly the point! You have to be quite biased to not count as a failure subjects who try to quit smoking using the patch but discontinue using it. And you would also have to dismiss all of the e-cigarette users who stop using those products, which would greatly increase the observed cessation rate among e-cigarette users.

Furthermore, while the commentary cites one study to support the contention that "smokers felt that electronic cigarettes were not associated with success," it ignores a number of studies in which smokers overwhelmingly indicated the helpfulness of e-cigarettes in smoking cessation. This is what we call "cherrypicking."

Finally, the commentary argues that e-cigarettes are ineffective because in the New Zealand clinical trial, nicotine-containing e-cigarettes performed no better than what the commentary calls "placebo." But what the commentary fails to mention is that in the trial, "placebo" was actually the use of e-cigarettes, only without nicotine in the e-liquid. What the finding demonstrates is that the delivery of nicotine is only part of the reason why e-cigarettes can help smokers quit. The e-cigarette, in and of itself, aids in cessation because it simulates the smoking behavior. E-cigarettes are potentially more effective than nicotine replacement therapy because they address not only the pharmacologic aspect of smoking addiction, but also the behavioral, physical, psychological, and social aspects of the addiction to smoking.

Despite these serious flaws in the article, what I find most problematic is that the commentary fails to disclose a significant conflict of interest of its author. The author of the article is a past president and vice-president of the American Thoracic Society, and during his tenure as president and vice-president, the Society received financial support from two pharmaceutical companies that manufacture smoking cessation drugs: GlaxoSmithKline and Pfizer.

In fact, the American Thoracic Society readily acknowledges that it partners with the pharmaceutical industry and that its corporate partners include GlaxoSmithKline and Pfizer, along with at least nine other drug companies. Both GlaxoSmithKliine and Glaxo market smoking cessation drugs. Electronic cigarettes are a direct competitor of these drugs for the smoking cessation market. Thus, being president of an organization that takes money from these companies is a significant financial interest that should have been disclosed in the article. But the article states that there are no conflicts of interest.

Imagine if I were president of the American Heart Health Association (AHHA), and during my tenure as president, the AHHA received financial support from several electronic cigarette companies. Suppose I went on to publish a commentary arguing that e-cigarettes are a great strategy for smoking cessation and harm reduction. It would certainly be expected that I disclose my being president of the AHHA and receiving e-cigarette industry funding as a conflict of interest. I can guarantee that anti-smoking advocates, including Stan Glantz, would try to vilify and discredit me for not revealing this financial conflict.

The American Thoracic Society continues to receive financial support from Pfizer, which is supporting its 2015 international conference in May. The commentary's author is still affiliated with the American Thoracic Society, as he is listed as being a member of the Board of Trustees of the American Thoracic Society Foundation, on which also sits the Vice President of MedCenter Sales for GlaxoSmithKline.

The rest of the story is that the commentary fails to disclose a significant financial conflict of interest of its author, which has the appearance of creating a bias in the reporting of the scientific evidence and in the formation of the opinions expressed in the article.

It is particularly unfortunate that this conflict of interest was hidden from the public and the media, because news articles are reporting that e-cigarettes are a "gateway to addiction" and that they are "not a safer option." These unsupported and false conclusions are misleading the public and causing public health damage by undermining years of progress in convincing the public of the severe hazards of cigarette smoking. And unfortunately, the media and the public are not being made aware of the financial conflict of interest of the commentary's author, which would at least allow the conclusions to be taken with a grain of salt.

North American Quitline Consortium Responds to My Criticism of Its Conference Sponsorship by Big Pharma by Lying About My Position and then Failing to Address the Argument

Yesterday, I published a commentary in which I criticized the North American Quitline Consortium for accepting as sponsors of its annual conference three pharmaceutical companies that have a vested financial interest in the advice given to smokers via these quitlines. I argued that the funding by Big Pharma destroys the scientific integrity of the conference by making it impossible for the conference to objectively address critical issues in smoking cessation practice, such as the debate between the reliance on pharmaceuticals versus cold turkey quitting and the safety profile of Chantix.

I concluded that "the acceptance of Big Pharma money to fund a quitline conference at which smoking cessation strategy is going to be discussed is not just a private matter. It represents a disservice to the public who we in tobacco control are supposed to serve. Thus, the rest of the story is that not only is the North American Quitline Consortium sacrificing its scientific integrity by accepting Big Pharma money, it is also betraying the clients who it is supposed to be serving."

The basis for my position is the following: "the 2012 NAQC annual conference is being sponsored by GlaxoSmithKline, Novartis, and Pfizer. GlaxoSmithKline markets Commit lozenges, Nicoderm CQ (the nicotine patch), Nicorette (nicotine gum), and a behavioral smoking cessation program called Committed Quitters. Novartis markets Nicotinell (nicotine patches and gum). Pfizer markets varenicline (Chantix). Thus, the conference is being sponsored by the very companies which stand to gain or lose most by the supposedly objective scientific discussions that are supposed to take place at the conference. There is simply no way that objective scientific discussions can take place when the conference is being sponsored by these very companies."

The Response - Part One

The North American Quitline Consortium responded to my commentary in two ways:

First, NAQC attacked me personally, trying to discredit me by lying about my position on smoking cessation medications. On its web site, NAQC wrote: "Earlier today, Dr. Michael Siegel posted a blog commentary suggesting that NAQC’s actions are destroying the scientific integrity of the global tobacco control movement. As many of you may know, Dr. Siegel is opposed to the use of medications in the treatment of tobacco dependence." (emphasis is mine)

The Rest of the Story

This statement is completely fallacious. I do not oppose the use of medications in the treatment of tobacco dependence and have never expressed such an opinion. I do believe that there has been an overemphasis on the role of medications compared to the role of cold-turkey quitting, but this is hardly the same as believing that medications should not be used in treating tobacco dependence. As a physician, I prescribed smoking cessation medications to many patients when I was working in the area of addiction medicine. Never have I opined that medications should not be used in the treatment of tobacco dependence.

The technique of responding to a criticism by lying about the individual critic's position is a common tactic used when groups find it difficult to argue the substance of an issue. The idea is to try to discredit the critic by misrepresenting their views to the public and to make the person appear to be a lunatic with outlandish views.

Here, by casting me as someone who opposes the use of medications in the treatment of tobacco dependence, NAQC has made me appear to its constituents and to the public as being a crazy radical who does not even believe that smoking cessation medications have any role in the treatment of nicotine addiction. 

There is no basis for such an attack since I have never suggested that smoking cessation medications should not be used. However, I can understand why the organization might level such an attack given its apparent reluctance to address the issue of its Big Pharma sponsorship head on. By diverting attention with its lie about me, the organization attempts to divert attention away from the issue at hand: namely, its decision to accept funding from companies whose products' efficacy and safety will be directly addressed at the conference.  

Incidentally, I wrote to NAQC asking the group to remove its inaccurate statement about my position. At this time, they have not yet removed the statement, but it has only been a few hours and I will certainly give them more time to respond and update my readers at that time.

The Response - Part Two

The response by NAQC was as follows:

"Thank you for the opportunity to respond to your commentary and to share NAQC’s position. I respectfully disagree with your opinion that "the acceptance of pharmaceutical industry sponsorship by a conference which aims to objectively discuss science and objectively consider policy strategies to promote smoking cessation destroys the scientific integrity of the global tobacco control movement.”

NAQC’s mission is to improve the quality of quitline services in North America and to make high quality cessation services more available to all tobacco users. We support cessation and encourage quitlines to adopt evidence-based practices. FDA-approved cessation medications are well-accepted evidence-based treatments for cessation. They are included as part of the U.S. Public Health Service’s Guideline on Tobacco Cessation Treatment. Currently, 75 percent of all U.S. quitlines provide medications along with counseling services. We hope to report 100 percent of quitlines are providing cessation medications to smokers in the near future. Providing medications as part of a quitline’s treatment protocol increases the likelihood that smokers will successfully quit.

NAQC Conference 2012 is supported by ClearWayMN, the American Cancer Society, the Canadian Cancer Society, the American Legacy Foundation, GlaxoSmithKline, Novartis and Pfizer. NAQC is grateful to all of the organizations that sponsor and support our programs, including those who support the upcoming conference. This is the first year pharmaceutical company contributions have helped support the NAQC conference and we are proud to have them on-board. We look forward to working with these partners in the pharmaceutical industry to advance NAQC’s mission and ensure that all tobacco users have access to evidence-based treatment services.

Thank you, again, for the opportunity to express NAQC’s opinion."

The Rest of the Story

This response, while quite courteous and much appreciated, does not actually address the specific arguments that I raised in my commentary. The response simply reiterates the fact that most quitlines provide smoking cessation medications. But I never took issue with the fact that quitlines provide smoking cessation medications. What I took issue with is the fact that the Consortium is accepting sponsorship for a scientific conference from companies whose products will be directly addressed at the meetings. This precludes any objective consideration of these important issues, as the companies have a vested financial interest in the outcome of the discussions. Subconsciously, the sponsorship of the conference by Big Pharma is going to have an effect on all aspects of the conference, including what topics are discussed, what papers are accepted for presentation, how results are presented, what conclusions are drawn, and what recommendations are made.

Even in this response, the issue is being diverted. The response is written as if my argument was that quitlines should not provide smoking cessation medications. I have never advanced such an argument, nor do I think that is a rational position. Of course quitlines should provide smoking cessation medications as part of their overall strategy. The issue is not whether quitlines should provide certain types of medications but whether an organization running what it hopes to be an objective scientific conference should accept sponsorship money from companies with a vested financial interest in the outcome of the discussions at the conference.

Let's suppose that a tobacco control conference was sponsored by a tobacco company. It is easy to see how that conference could not possibly offer an objective consideration of the issues, since the sponsoring tobacco company has a vested financial interest in the discussion and if the wrong things are said, the company could easily decide to withdraw its sponsorship. In fact, I imagine that most of the tobacco control groups in the nation would be protesting vigorously against acceptance of tobacco industry money for the conference.

But the issue is exactly the same with the sponsorship of this conference by Big Pharma, at least as far as the scientific objectivity of the conference is concerned. The financial conflict of interest created by the sponsorship precludes the possibility of objective consideration of scientific issues, just as the sponsorship of a tobacco control conference by Big Tobacco would preclude its scientific objectivity.

The rest of the story is that not only are tobacco control groups now solidly in the pocket of Big Pharma, but they appear unable to even engage in a discussion of the substantive scientific and ethical issues regarding the acceptance of conference sponsorships from companies with a vested financial interest in the proceedings.

Public Health Malpractice? Nursing Journal Article Recommends Scolding Smokers Who Quit Using E-Cigarettes

Cited Guidelines by AACR and ASCO Demand Conflict of Interest Disclosures, But Fail to Disclose their Own Conflicts

In a review article published online ahead of print Monday in the Journal of the American Association of Nurse Practitioners, a University of Pennsylvania Nursing School professor makes a number of clinical recommendations regarding communications that nurses should have with patients about tobacco and nicotine use. One of those recommendations is that practitioners should not commend smokers who have successfully quit smoking by switching completely to electronic cigarettes.

The author writes:

"Currently, it is neither advisable for practitioners to recommend e-cigarettes for smoking cessation, nor is it recommended to commend patients for making the switch to e-cigarette use over traditional cigarette smoking (Brandon et al., 2015)."

The article cited to support this recommendation is a joint policy statement issued by the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO). In this statement, these organizations emphasize that in any articles regarding e-cigarettes:

"Consistent with best practices, investigators should disclose potential conflicts of interest such as funding received from pharmaceutical, tobacco, and ENDS industry sources."

The Rest of the Story

Imagine that I, as a physician making recommendations about the treatment of high blood pressure, issued a recommendation to my fellow physicians that they not commend any patients who successfully get their blood pressure under control using an exercise routine and dietary restrictions. In lieu of commending these patients, what I am really suggesting is that physicians scold their patients for successfully lowering their blood pressure. Not only would this be a ridiculous recommendation, but it would at least border on public health malpractice, since scolding patients for lowering their blood pressure violates any medical standard of care and will likely cause damage by discouraging those patients from continuing to control their blood pressure through diet and exercise.

Unfortunately, the recommendation made by the nursing professor in this article is essentially the same thing. She is essentially telling nurses to scold patients who successfully quit smoking using electronic cigarettes. This is ridiculous, and may represent public health malpractice, since scolding patients for quitting smoking violates any nursing standard of care and will likely cause damage by discouraging those patients from continuing to avoid smoking by using vaping products instead.

The article also seems to criticize e-cigarette users for having the perception that vaping is safer than smoking. For example, the author writes:

"The majority of adult e-cigarette users studied in the nine research articles in this review perceived that e-cigarettes contain less toxins than traditional cigarettes. This could be because of the marketing strategies that label e-cigarettes as “healthy,” or the fact that they come in a variety of flavors."

Well, there's another possible reason for this perception: namely, that e-cigarettes do contain fewer toxins than traditional cigarettes.

The author implies that this is an incorrect or even dangerous perception, but this "perception" is absolutely true.

Can you imagine someone writing that: "Many people have the perception that exercise and dietary changes can precipitate weight loss." Would you not agree that such a statement implies that this perception is incorrect? It is not just a perception, it is the truth. The same is true about the "perception" that e-cigarettes contain fewer toxins than traditional cigarettes. It is not  "perception"; it is the truth.

It would be one thing if the author merely recommended that e-cigarettes not be used as first-line therapy. But to actually counsel health practitioners not to commend patients who quit smoking - regardless of how they quit - reveals much about the state of the current tobacco control movement.

It reveals that what is now most important is not saving the lives of smokers, but controlling them. The goal is apparently not to protect the health of smokers, but to make them comply with our ideology of no addiction to nicotine being allowed. It's not enough for smokers to quit; they have to quit the way we tell them to quit. And since we weren't the ones who came up with the great idea of vaping products, it is not acceptable for smokers to use that method to quit. It is either our way, or no way. If they don't quit using our methods, then we can't take credit for it. And apparently, credit is more important than health right now.

Now to the joint policy statement by the AACR and ASCO. The statement recommends that physicians not advise patients to use e-cigarettes to quit smoking. This is unwise and inappropriate advice. But what is even more disturbing is the fact that these organizations make such a big point about the need for disclosure of conflicts of interest. In itself, that's not disturbing. What makes it disturbing is the fact that in this very article, both of the organizations fail to disclose their own conflicts of interest with Big Pharma, which stands to gain significantly if the policy statement's recommendation is followed.

The AACR has received funding from a large number of pharmaceutical companies, including Bayer, Bristol-Myers Squibb, Merck, Jannsen, Lilly, Astra Zeneca, GlaxoSmithKline, and Pfizer.

Similarly, the ASCO has received funding from a large number of pharmaceutical companies, including Novartis, Astra Zeneca, GlaxoSmithKline, Onyx, Lilly, Sanofi, Bayer, and Pfizer.

I guess that the need for disclosure of conflicts of interest that AACR and ASCO emphasize only applies to other organizations, not to them.

Members of TPSAC Acknowledge There is No Science Base to Support Redution of Nicotine as Measure to Have Profound Effect on Tobacco-Related Disease

Three members of the FDA Tobacco Products Scientific Advisory Committee (TPSAC), in an article published in the current issue of Tobacco Control, acknowledge the lack of a scientific basis for mandating reduced nicotine levels as a means to achieve a profound reduction of tobacco-related morbidity and mortality (see: Hatsukami DK, Perkins KA, LeSage MG, Ashley DL, Henningfield JE, Benowitz NL, Backinger CL, Zeller M. Nicotine reduction revisited: science and future directions. Tobacco Control 2010;19:e1-e10).

The paper reviews the scientific basis for the idea of requiring reductions in nicotine levels in cigarettes. The FDA Tobacco Act allows the Agency to reduce, but not to eliminate nicotine in cigarettes. Anti-smoking groups, such as the Campaign for Tobacco-Free Kids and the American Cancer Society, have boasted that this is going to result in millions of lives being saved. The paper, however, reviews the actual research and demonstrates that there is presently little scientific evidence to support the contention that reducing nicotine levels will save any lives, much less millions of lives.

First of all, the article points out that there is no known threshold below which nicotine is not addictive and below which cigarettes would not be addictive:

"Although studies of the threshold for nicotine discrimination have been conducted, to date no systematic human study has examined the threshold dose for the development or maintenance of nicotine addiction nor directly examined the best approach for reducing levels of nicotine in cigarettes to maximise public health benefits."

Moreover, the article points out that existing evidence indicates that cigarettes with very low nicotine levels are still effective in reducing nicotine craving and still produce pharmacologic effects associated with nicotine. Apparently, the article concludes, even very low doses of nicotine are capable of binding to receptors and causing pharmacologic effects:

"Laboratory studies show that denicotinised cigarettes produce acute subjective effects similar to those of nicotine cigarettes. For example, denicotinised cigarettes have been shown to reduce craving and negative affect due to withdrawal during short-term abstinence periods from usual brand cigarettes. The acute withdrawal relieving effects are found not to be due to expectancies for nicotine or the simple motor aspects of smoking (eg, handling), highlighting the importance of smoke inhalation per se. Denicotinised cigarettes and standard nicotine cigarettes can produce similar self-reported liking and satisfaction in smokers although another study found results to the contrary, and can produce similar delays in the latency to smoke (ie, the time to smoke a cigarette) or reductions in the amount of subsequent smoking of nicotine cigarettes. Denicotinised cigarettes may also be as acutely reinforcing as nicotine cigarettes in dependent smokers, suggesting that denicotinised cigarettes may serve as an effective short-term substitute for nicotine-containing cigarettes when the latter are unavailable." ...

"The responses observed with denicotinised cigarettes may be because non-nicotine sensory aspects have acquired reinforcing effects, non-nicotine constituents other than nicotine are reinforcing, or that low levels of nicotine are sufficient to maintain smoking behaviour because these levels can produce effects of physiological significance, at least acutely. For example, recent brain imaging studies show that smoking a single very low nicotine cigarette results in significant (23%) occupancy of α4β2 nicotinic receptors, which are considered the primary receptor subtype mediating nicotine's reinforcing and other behavioural effects. Thus, the reinforcing and mood effects of very low nicotine cigarettes may be attributable, in part, to nicotine's pharmacological effects. Other evidence also suggests that very low level nicotine exposure may have important pharmacological effects. This includes in vitro studies showing that significant nicotinic receptor desensitisation, a potential contributor to nicotine addiction, can occur with nicotine doses below a threshold for activating receptors, which mediates nicotine's acute reinforcing effects. In summary, abrupt switching to denicotinised cigarettes does not appear to result in significant withdrawal symptoms and may maintain similar levels of smoking reward and reinforcement in the short term."

The article also points out that animal studies indicate that extremely low doses of nicotine in animals are still capable of producing nicotine dependence:

"While NSA in animals typically decreases at unit doses below 0.01 mg/kg, unit doses as low as 0.003 mg/kg have been shown to maintain NSA in rats above saline extinction levels when substituted for a higher training dose (eg, 0.03 mg/kg), though variability between subjects is apparent (see also De Noble and Mele and Donny et al). No animal studies have specifically characterised the reinforcement threshold dose of nicotine during acquisition of NSA in adolescents or in the context of progressively reducing the unit nicotine dose during maintenance of NSA in adults."

The paper also points out that it is unknown whether reducing nicotine levels would have any effect on decreasing youth smoking:

"The dose of nicotine that will lead to extinction of smoking may not be the dose that is associated with the onset of dependence symptoms or nicotine addiction. Studies conducted with adolescent smokers suggest that the potential threshold for onset of nicotine addiction is likely to be substantially lower than the five standard nicotine cigarettes per day suggested by earlier research. Several cross-sectional and longitudinal studies have shown that youth smoking on a less than daily basis nevertheless report onset of dependence symptoms. About half the youth smokers who reported 1 or more symptoms reflective of a loss of autonomy over smoking had smoked on average 2 cigarettes 1 day per week, and half of those who met WHO International Classification of Diseases, 10th edition (ICD-10)-defined dependence reported smoking cigarettes a month, or 1–2 cigarettes per day. That symptoms of dependence can develop with low rates of smoking is consistent with results from a small study of adults demonstrating about 50% occupancy of α4β2 nicotinic acetylcholine receptors (nAChRs) for 3 h after just 1–2 puffs on a 1.2–1.4 mg nicotine yield cigarette. Similarly, other prolonged brain effects (long-term potentiation of the excitatory transmission to the brain reward centres) have been observed after brief application of low concentrations of nicotine (0.5–1.0 μM). Human and animal studies have shown that the adolescent brain is more vulnerable and sensitive to nicotine's effects. For example, adult smokers who initiated smoking during adolescence exhibit greater cigarette consumption, lower likelihood of trying to quit and increased risk of relapse compared to those who started smoking later in life. Adolescent rats and mice might also be more sensitive than adults to the rewarding and reinforcing effects of nicotine, as indexed by greater conditioned place preference, faster acquisition of nicotine self-administration (NSA) and higher baseline NSA rates compared to adults (see also Shram et al). What remains unknown are the effects of low dose nicotine cigarettes in adolescents and whether there is a dose that reduces the probability of sustained cigarette use."

Importantly, the article points out that there could be adverse consequences of reducing nicotine levels in cigarettes:

"In the literature concerning human and animal trials, there is a scarcity of data on the effects of reduced nicotine doses on smoking or nicotine intake and on other responses. Even if a threshold reinforcing nicotine dose is identified and a non-addictive cigarette can be produced, it will be important to determine whether there are other adverse effects from the nicotine exposure that occurs in adolescents who nonetheless experiment with such cigarettes. The threshold for nicotine's reinforcing effects may be higher than the threshold for nicotine's other potentially adverse effects, including enhancing vulnerability to other drug use. ... Therefore, low level nicotine exposure in adolescents experimenting with cigarettes designed to prevent nicotine addiction could potentially produce risk of addiction to other drugs of abuse." ...

"Among potential concerns are: (1) a switch to other drugs of abuse, particularly among populations smoking for social reinforcement, self-identity, or self-medication purposes; (2) dual use of tobacco products, such as reduced nicotine cigarettes with oral tobacco or small cigars, which may lead to greater exposure to toxicants, especially if these other tobacco products continue to contain higher nicotine levels; (3) use of reduced nicotine cigarettes as starter products. Just as low freebase nicotine smokeless tobacco products served as starter products for higher nicotine and more toxic smokeless tobacco products, these reduced nicotine cigarettes may lead to the use of other tobacco products with higher levels of nicotine, unless these other products also contain low nicotine levels; (4) illicit cigarette marketing and smuggling including through the internet and through territories that do not require reduced nicotine content of cigarettes; (5) product tampering or manipulation (such as adding nicotine to the product); and (6) industry manipulations (eg, nicotine analogues, companion products to increase nicotinic effects)."

Ultimately, the article concludes that reducing nicotine levels would not necessarily result in an improvement in the public's health, and that surveillance would be necessary to determine the effects of such a policy:

"If nicotine reduction is enacted, then large-scale surveillance is needed in order to understand the population-level impact of such changes. Marketplace monitoring and assessing unintended consequences (smuggling, nicotine spiking, new product introductions, etc) will also involve broad surveys."

The Rest of the Story

Once again, the anti-smoking groups have been tricked by Philip Morris into supporting federal legislation that does more for Philip Morris than for the public's health. The Campaign for Tobacco-Free Kids, in negotiating the legislation with Philip Morris, agreed to the clause that prohibited the FDA from eliminating the nicotine in cigarettes, and only allowed the agency to reduce nicotine levels. As a result, the agency is powerless to mandate changes in cigarettes which would actually result in a dramatic reduction in their addictive potential. As is clear from the article, even with low levels of nicotine, cigarettes retain strong addictive potential as only a minute amount of nicotine is necessary to occupy enough nicotine receptors to produce a pharmacologic effect.

Even more troubling than the fact that the Campaign for Tobacco-Free Kids was duped by Philip Morris in the negotiations over the tobacco legislation is the fact that the Campaign is boasting about how this provision in the law is going to save millions of lives. The Campaign is apparently unaware of the science which demonstrates, quite convincingly, that even low levels of nicotine are capable of producing reinforcing pharmacologic effects.

But the most troubling aspect of the story is the conclusion of the paper: "Reduction of nicotine in tobacco products could potentially have profound impact on reducing tobacco-related morbidity and mortality. ... an organised and multidisciplinary effort should be established to set priorities and goals..., engage appropriate scientific, research and government communities/organizations, shape the direction of research, and ensure that efforts stay focused on the ultimate goal of understanding how nicotine reduction could impact the morbidity and mortality of tobacco use."

After a comprehensive review of the literature in which the authors convincingly demonstrate that the science base does not support the idea that reducing nicotine levels will substantially reduce the addictive potential of cigarettes and that such a policy could have severe negative public health consequences, they still conclude that reducing nicotine levels is a desired public health policy which should be vigorously pursued, and that millions of dollars of taxpayer money should be funneled into research to study a policy which quite likely might be doomed to failure from the get-go.

There is a strange disconnect between the scientific evidence presented in the review and the conclusions and recommendations of the article.

For example, while the authors state that: "switching to denicotinised cigarettes does not appear to result in significant withdrawal symptoms and may maintain similar levels of smoking reward and reinforcement," they nevertheless conclude that reduction of nicotine levels could have a profound impact on tobacco-related mortality. If the levels of smoking reward and reinforcement are not substantially reduced in very low-nicotine cigarettes, then how would such a reduction have a profound impact on tobacco-related mortality? The conclusion just doesn't follow from the scientific evidence.

In trying to understand why the science is so divorced from the recommended policies and the strategic agenda, I can only point to two possibilities.

First, as researchers in the area of nicotine science, the authors have a vested interest in promoting research funding into their area of expertise. This is a financial conflict of interest that appears to be influencing the conclusions and recommendations of the article.

Second, all three of the TPSAC authors and two additional authors of the paper have a vested financial interest in maintaining the paradigm that nicotine is the agent responsible for smoking addiction because they have financial ties to pharmaceutical companies which manufacture nicotine replacement or smoking cessation pharmaceutical products:

"DKH has received grant funding from Nabi Biopharmaceuticals to conduct nicotine vaccine clinical trials. JEH provides consulting support for GlaxoSmithKline Consumer Health through Pinney Associates on an exclusive basis on issues related to tobacco dependence treatment, has financial interest in a potential new oral nicotine replacement product and serves as an expert witness in litigation against tobacco companies. NLB serves as a consultant for Pfizer and as an expert witness in litigation against tobacco companies. MZ provides consulting support to GlaxoSmithKline Consumer Health through Pinney Associates on an exclusive basis on issues related to tobacco dependence treatment. KAP has served as a consultant to Cypress Bioscience."

That pretty much says it all. With this magnitude of conflict among the study authors, there is no way we could expect an objective set of recommendations and conclusions. And, by the way, this is exactly the reason why I have argued that scientists with financial conflicts of interest should not be making national policy recommendations.

The rest of the story is that there is a complete disconnect between the scientific base and the policy agenda in tobacco control today. Financial and political influences have wrested the policy agenda in tobacco control firmly away from the science base.