American Legacy Foundation Takes More Money from Pfizer; Still Fails to Disclose Conflict of Interest on Electronic Cigarette Recommendations Disseminated to the Public

The American Legacy Foundation took money from Pfizer as recently as last year; this money was used to support a national survey of more than 3000 American smokers about smoking cessation.

The 2011 funding is in addition to additional funding that Legacy received from Pfizer in 2009, and further confirms that Legacy has financial ties to the pharmaceutical industry, which stands to lose severely if electronic cigarettes continue to become more and more popular.

At the same time that it accepts funding from Pfizer, Legacy continues to fail to disclose this significant conflict of interest on its web page which disseminates to the public recommendations about electronic cigarettes. Specifically, the web page recommends that the FDA take electronic cigarettes off the market until they are proven to be safe and effective: "The FDA should take electronic cigarettes off the market until it is satisfied that they are safe and effective."

According to the web page, Legacy's recommendation is as follows: "While we remain open to promising products that can help smokers quit smoking, a consideration of all of the available evidence combined with important unanswered questions strongly supports our call on the FDA to prohibit the marketing and sale of e-cigarettes unless and until the FDA is satisfied that they are safe and effective."

Importantly, nowhere on the web page does Legacy disclose that it has received funding from a pharmaceutical company which manufactures a smoking cessation product, and thus that the Foundation has a conflict of interest by virtue of this pharmaceutical company funding. The public is therefore not able to take this conflict of interest into consideration when evaluating Legacy's presentation of the scientific evidence and formulation of its recommendation.

The Rest of the Story

It is interesting that the American Legacy Foundation chooses to continue pointing readers to this recommendation to ban electronic cigarettes, even though the District Court for the District of Columbia has ruled that the FDA does not have the authority to remove electronic cigarettes from the market in the absence of therapeutic claims by manufacturers because they must be regulated under the Tobacco Act rather than under the Food, Drug, and Cosmetic Act.

It is unfortunate that the American Legacy Foundation misrepresents the findings of a 2009 FDA laboratory study on electronic cigarettes, and fails to even mention numerous studies conducting since that time which point to the relative safety of electronic cigarettes over regular cigarettes. Legacy highlights the finding that electronic cigarettes were found to contain tobacco-specific nitrosamines, without notifying readers that the levels of these TSNA's were extremely low, that these levels are comparable to those in nicotine gum and patches, and that the TSNA's are present at trace levels simply because the nicotine is derived from tobacco.

All nicotine products derived from tobacco are going to have trace levels of tobacco-specific nitrosamines so this finding is essentially meaningless. It does not indicate that electronic cigarettes are carcinogenic. Instead, it demonstrates that electronic cigarettes pose a much lower level of carcinogenic risk that tobacco cigarettes, because the levels of TSNA's in these devices are orders of magnitude lower than in regular cigarettes.

Why is the American Legacy Foundation misrepresenting the health risks of electronic cigarettes to the public?

Well, one potential explanation - only apparent to those who might somehow discover the Foundation's financial ties to Big Pharma from sources other than the recommendations themselves - is that the financial conflict of interest is contributing to this bias in the reporting of the scientific evidence.

A second factor could be the reluctance to admit that a behavior which looks like smoking might actually be significantly safer than cigarette smoking and therefore might be something which a public health organization might actually recommend as a strategy for smoking cessation. Of course, this would take sales away from pharmaceutical companies, including Pfizer, and so it also plays into the bias caused by the conflict of interest.

The failure to disclose a significant conflict of interest is unfortunate because it deprives the public the information it needs to appropriately evaluate the validity of the Foundation's presentation of the scientific facts and recommendations about electronic cigarettes. In this case, a blatant misrepresentation of the scientific evidence occurs, but readers have no way of knowing that Legacy has a financial interest in promoting the sales of smoking cessation drugs over electronic cigarettes.

Another public communication from Legacy which has the appearance of a bias potentially resulting from a conflict of interest is the Foundation's 2008 press release praising Pfizer for "proactively and voluntarily giving more prominence to its consumer warning messages specific to their popular smoking medication, Chantix." Unfortunately, and quite inexplicably, the press release fails to mention just what the adverse side effects of Chantix might be that are the subject of these warning messages.

Ironically, the press release closes by emphasizing that: "smokers therefore need to be armed with all the available information to make the best, most informed choices about the smoking cessation medications available to them." But Legacy fails to provide the very information that smokers need most: that Chantix was associated with severe psychiatric side effects - including suicide.

In the press release, Legacy appears to be intentionally hiding from the public the fact that Chantix was associated with adverse side effects as severe as death. Given the funding from Pfizer, what else are we to think, other than that this biased reporting of the science is being influenced by this financial conflict of interest, which - incidentally - is not even disclosed in the press release.

According to the American Legacy Foundation, There's No Evidence that Smoking is More Harmful than Using Non-Tobacco Electronic Cigarettes

In 2013, even the tobacco companies have acknowledged for more than a decade that cigarette use is very hazardous to health and refrain from minimizing the risks of smoking by comparing it to clearly less hazardous activities such as using non-tobacco products.

Not so for one of the leading national anti-smoking organizations: the American Legacy Foundation.

In its apparent zeal to squelch the phenomenon of smokers using something that looks like a cigarette to potentially save their lives, the American Legacy Foundation is telling smokers, and the public, that there is no evidence that cigarette smoking is any more hazardous than vaping, which involves the use of a product that contains no tobacco.

Even the tobacco companies themselves would not dare make such a bald claim in 2013 - that cigarettes may be no more hazardous than the use of a non-tobacco product.

However, on its web site, Legacy states the following:

"Electronic cigarettes are designed to give you an experience that’s like smoking but without any smoke. Since they don’t burn tobacco, they’re marketed as less harmful than regular cigarettes. But so far, there’s no evidence to prove that claim. There’s also no evidence that electronic cigarettes help you quit smoking."

The Rest of the Story

There are actually two false statements in the American Legacy Foundation's "fact" sheet about electronic cigarettes.

First, Legacy is misleading the public by suggesting that there is no evidence that smoking is any more harmful than vaping. This is a dangerous and misleading statement. Legacy is implying that smoking is not all that hazardous, since if it is no worse than electronic cigarette use, it involves only exposure to minute levels of carcinogens (as has been documented to be the case with electronic cigarettes).

It doesn't take a rocket toxicologist to figure out that the current data on the levels of carcinogens in cigarettes versus electronic cigarettes does provide strong evidence that vaping is less hazardous than smoking, and specifically, that vaping is associated with a lower cancer and chronic lung disease risk than active smoking of cigarettes that combust tobacco.

In fact, I have estimated that the level of tobacco-specific nitrosamines in electronic cigarettes is about 1400 times lower than that in Marlboros. In light of these data, how can Legacy possibly argue that there is no evidence that smoking Marlboros is any more dangerous than using an electronic cigarette?

It is problematic enough to disseminate irresponsible advice to the public about such an important a health issue as quitting smoking. But to base that advice on blatant misrepresentations of the available scientific data to the public is even worse.

Why is Legacy ignoring the available data which clearly show that the levels of carcinogens in electronic cigarettes are orders of magnitude lower than in regular cigarettes?

Frankly, this isn't science anymore. It's becoming pure propaganda.

Unfortunately, there appears to be a very strong bias operating which does not allow anti-smoking groups - like Legacy - to objectively view the scientific evidence on electronic cigarettes. I believe that the very fact that these devices are similar to cigarettes blinds many anti-smoking groups to the actual scientific evidence that is readily available. It is apparently not the documented hazards of vaping which are troubling the anti-smoking movement, but the fact that it looks like smoking. How can anything which looks like smoking be a good thing, even if there is strong evidence that these products are bringing immense and immediate health benefits to thousands of users?

According to the American Legacy Foundation, smokers who have quit smoking successfully using electronic cigarettes may just as well return to their Marlboros than remaining ex-smokers with the use of electronic cigarettes because there is no evidence to prove that they have lowered their health risks by quitting smoking and using non-tobacco electronic cigarettes instead. Any physician who gave that medical advice would be doing a great disservice to his or her patients. What the American Legacy Foundation is doing, then, is committing public health malpractice on a massive scale.

Legacy makes a second false statement by asserting that there is "no" evidence that electronic cigarettes can help people quit smoking. There is actually subtantial evidence, coming both from the testimonials of thousands of electronic cigarette users who have reported successfully quitting using these products and from a clinical trial demonstrating that even among smokers with no desire to quit, electronic cigarettes helped more than half of them to achieve smoking cessation or smoking reduction.

In light of the existing evidence, how can one Legacy deceive the public by asserting that there is no evidence for the potential of electronic cigarettes in smoking cessation. To do so is to completely ignore the results of the clinical trial evidence, as well as to ignore the multitude of anecdotal evidence based on personal reports of ex-smokers.

Moreover, the advice from the American Legacy Foundation is irresponsible because it suggests that the many electronic cigarette users who have quit successfully using these devices should discontinue their use and take their chances with NRT or Chantix. But because a large proportion of these ex-smokers are vaping specifically because they tried NRT or Chantix and failed, this advice is tantamount to urging these ex-smokers to return to cigarette smoking. It is difficult to imagine more irresponsible medical advice.

In fact, many vapers have reported dramatic improvement in their health, such as increases in lung function and physical stamina. Discontinuing electronic cigarette use and returning to smoking is the last thing in the world these individuals should be encouraged to do. Returning to smoking will undoubtedly harm the health of these individuals and perhaps even ruin what would have been a great opportunity to keep them off cigarettes permanently.

Making Legacy's statement even more problematic is the fact that it fails to disclose anywhere on the web page that it has a financial conflict of interest in recommending NRT and Chantix while shunning electronic cigarettes by virtue of its having received funding from pharmaceutical companies that manufacture the former products.

As I revealed last week, the American Legacy Foundation has received substantial funding from Pfizer - the very company which manufactures Chantix, a smoking cessation drug which stands to lose severely if electronic cigarettes become more and more popular. Thus, the Foundation's receipt of funding from Pfizer is a conflict of interest that I believe should have been revealed in its statement providing medical advice to smokers, urging them to use a drug like Chantix rather than to try electronic cigarettes.

The rest of the story is that the American Legacy Foundation is doing something that even the tobacco companies would not dare: claiming that there is no evidence that cigarette smoking is more hazardous than using a non-tobacco, non-combustion product that has been shown to contain levels of carcinogens that are up to 1400 times lower than in cigarettes.

Of course I applaud Legacy's efforts to support smoking cessation among smokers and fully support the Foundation in those efforts. But it is also important to be truthful and to maintain a high level of scientific integrity. And it undermines the very purpose of the Foundation when it discourages literally millions of smokers from attempting to quit using a strategy that has been successful for thousands of (now) ex-smokers. We can certainly have differences of opinion about the appropriate role of electronic cigarettes in a national smoking cessation strategy, but if we can't even get past arguing that there's no evidence smoking is any more hazardous than vaping, then there's no possibility of having any kind of evidence-based discussion. We're left in the land of ideology and propaganda, not science.

American Legacy Foundation Sounds Alarm About Electronic Cigarette Use Among Young People, Calling for a Ban on Flavored E-Cigarettes, But Fails to Document a Single Youth Using These Products

In a press release issued this week, the American Legacy Foundation sounded the alarm about electronic cigarette use among young people, arguing that new data show that electronic cigarette companies are targeting youngsters with their flavored varieties. The press release concludes and recommends that the FDA ban flavored electronic cigarettes in order to protect young people.

According to the press release, entitled "FDA Should Extend Ban on Flavors to Other Products to Protect Young People" (Legacy includes electronic cigarettes among these "other products"):

"In 2009, the U.S. Family Smoking Prevention and Tobacco Control Act banned the sale of flavored cigarettes, except for menthol, largely because of their wide appeal to young people. A new study from Legacy researchers published in the American Journal of Preventive Medicine, reveals the effects of the tobacco industry’s continued efforts to sell other flavored tobacco products, such as cigars and smokeless tobacco. The study is the first to examine the prevalence of flavored tobacco products in a nationally representative sample following the 2009 ban on flavored cigarettes, and shows that flavored tobacco products remain popular among U.S. young adults aged 18-34." ...

"“While most candy-flavors – such as chocolate, vanilla and peach – were banned in 2009 from cigarettes, flavored tobacco products like cigars, hookah, snus and e-cigarettes persist in more than 45 flavors and are still legally on the market,” said Andrea Villanti, PhD, MPH, CHES, Research Investigator for Legacy. “These products can be just as appealing to young people as flavored cigarettes, offering a product appearing to be more like candy to those most at-risk of becoming lifelong tobacco users,” she added." ...

"The tobacco and e-cigarette industries deny that flavored tobacco products are aimed toward young, minority consumers; however, these study findings suggest that flavored tobacco product use was more likely in those who were younger, black, and used a menthol product. Meanwhile, it was less likely among those with lower education. “The tobacco industry is using the same marketing tactics on new products to lure new and young people to their products. We hope this research showing that it is working – and young people are using these products at high rates – will signal the FDA to extend the flavor ban beyond cigarettes, and to also include menthol flavored products in that ban” said Cheryl G. Healton, President and CEO of Legacy."

The Rest of the Story

I don't contest the American Legacy Foundation's conclusions or recommendations as they relate to flavored cigars or cigarillos. The use of such products by youth has been documented in other studies. However, I have to question the Foundation's conclusion that electronic cigarettes are being targeted towards youth and/or nonsmokers and its recommendation that flavored electronic cigarettes should be banned on the basis of the findings it reports in this study.

To be honest, when I first read the press release, based on Legacy's recommendation to ban flavored electronic cigarettes, I thought that the study found a high prevalence of flavored electronic cigarette use among youth. Then I went to the actual article and was shocked to find that the study did not find a single youth who reports using electronic cigarettes, flavored or otherwise. In fact, the study sample consisted only of adults. The subjects were young adults ages 18-34. Thus, the study fails to document a single minor using electronic cigarettes.

It is entirely possible that the young adults who are buying electronic cigarettes are using them in an effort to quit smoking. There is evidence that many young adult smokers want to quit but are not particularly enamored with the idea of using the nicotine patch or taking a drug like Chantix or Zyban. Thus, many young adult smokers have tried electronic cigarettes in an attempt to quit. The flavored versions indeed aid to the appeal of these products as a smoking cessation aid.

How the American Legacy Foundation can call for a ban on flavored electronic cigarettes based on these data - which merely show that some young adults are using these products - is beyond me. First show me at least one youth who is using flavored electronic cigarettes. Then we can begin a discussion about whether this is a substantial problem and whether it is appropriate to promulgate a ban on the product. But to justify such a regulation, you need to provide scientific evidence that this is a problem among youth.

Again, I don't contest Legacy's findings or conclusions regarding traditional smokeless tobacco products because there is evidence that a significant proportion of youth are using those products. But to lump electronic cigarettes in with these other "actual" tobacco products is not evidence-based. It is just another example of how Legacy has some sort of ideological opposition to electronic cigarettes.

The article fails to disclose any conflict of interest. However, I have previously documented that Legacy has received funding from pharmaceutical companies that produce competing products to electronic cigarettes. Thus, there is a conflict of interest and it should have been reported in this article.

The bias that is apparent in the article has the appearance of being related to this conflict of interest. This makes the failed disclosure doubly problematic.

There is no evidence that electronic cigarette companies want youth to use their products. In fact, this is the last thing in the world that they want. They know that if youth begin to use these products, the future of the entire electronic cigarette industry will be in jeopardy. There is bountiful evidence that adult vapers enjoy the various flavors that are available. Banning these flavors would reduce the appeal of electronic cigarettes to adult smokers who desire to quit and therefore would substantially harm the public's health.

I do not question the need to balance the benefits of enhancing smoking cessation among adult smokers with the costs of youth beginning to use this nicotine-containing product. But show me at least one youth using the product before you call for a ban. This recommendation makes a mockery out of the idea of science-based or evidence-based policy making in tobacco control.

American Legacy Foundation Policy Statement on Electronic Cigarettes Fails to Disclose Financial Conflict of Interest with Big Pharma

Friday, I reported that the American Legacy Foundation has issued a policy statement calling for the FDA to pull electronic cigarettes from the market. I criticized this policy because it is essentially saying that Legacy would rather that ex-smokers who have successfully quit smoking using e-cigarettes return to conventional cigarette smoking, rather than remain off tobacco cigarettes. I argued that this undermines Legacy's own goal of promoting smoking cessation. Why condemn hundreds of thousands of ex-smokers to have to return to cigarette smoking and suffer the serious known health consequences? So many of these ex-smokers have already experienced a dramatic improvement in their health. It seems criminal to sentence these vapers to a return to the morbidity they were experiencing on regular cigarettes.

Up until this post, I had determined that every national anti-smoking group supporting a ban on electronic cigarettes had a substantial financial interest in Big Pharma, and specifically, in companies that manufacture traditional nicotine replacement medications and other cessation pharmaceuticals, and which are therefore threatened financially by the marketing of electronic cigarettes as an alternative to cigarette smoking, and as an alternative way to quit smoking (as opposed to using NRT products or other smoking cessation pharmaceutical aids).

The Rest of the Story

Today (thanks to comments by my readers to the previous post), I report that the pattern of every national anti-smoking group which has called for a ban on e-cigarettes being funded by Big Pharma is still intact. Because the rest of the story is that, as it turns out, the American Legacy Foundation is indeed funded by Big Pharma.

According to Legacy's web site, the Foundation receives support from Pfizer. The manufacturer of the smoking cessation drugs Chantix and Nicotrol NS is listed as a Legacy contributor. In addition, Pfizer has provided sponsorship support to help Legacy conduct a survey of physician support for smoking cessation. Not surprisingly, that study concluded that physicians must be urged to recommend more smoking cessation drugs for their patients. Also not surprisingly, the stop smoking program that Legacy runs insists upon pharmaceutical use by every individual trying to quit - no place for cold turkey quitting according to the Pfizer-sponsored American Legacy Foundation.

Particularly troubling is the fact that the American Legacy Foundation fails to disclose its financial conflict of interest with Big Pharma in its policy statement on electronic cigarettes (or in its quit guide on the Become an Ex web site). If you are going to issue a policy on electronic cigarettes, lobbying the FDA to ban these devices, I think you have an obligation to disclose any financial conflicts of interest that might be perceived as having a potential influence on your policy position. Certainly, financial support from a company that stands to lose millions from the sale of e-cigarettes constitutes a relevant conflict of interest that should be disclosed.

So the record remains intact. Every national anti-smoking group which has called for a ban on electronic cigarettes has a financial conflict of interest with Big Pharma. Moreover, these conflicts of interest have not been disclosed in the policy statements issued by these organizations. Here, the American Legacy Foundation has issued a policy statement on e-cigarettes without disclosing that it receives funding from Pfizer, which stands to lose financially from the continued sale of these products, which are now directly competing with Pfizer products for the smoking cessation market.

This is a conflict of interest that should, and must, be disclosed. To hide such a conflict in statements regarding national policy is, in my view, unethical.

American Legacy Foundation Still Failing to Disclose Conflict of Interest in Commenting on Electronic Cigarettes

In a June 26 press release, the American Legacy Foundation downplayed the results of a new clinical trial showing that electronic cigarettes can surprisingly enhance smoking cessation among smokers with little motivation to quit.

According to the press release: "The researchers reported that e-cigarettes decreased some smokers’ cigarette consumption and that 8.7% quit smoking 40 weeks after the intervention ended. Unfortunately, they also found that smokers quit rates were not statistically different whether given e-cigarettes with or without nicotine –thereby causing a placebo effect. ... We cannot conclude from this study that e-cigarettes promote cessation. While the study showed that some smokers quit, it does not show that the product itself had any role in the behavior change. In fact, the results merely show that sucking on an empty cigarette holder (a placebo) would likely accomplish the same thing."

This press release misses the whole point. And in doing so, it ends up misleading the public.

There is no true "placebo" effect involved with electronic cigarettes because the mimicking of smoking with the use of a cigarette-like device is the main point of the product. We do not want research to control for this effect. We want research to measure this effect.

Unfortunately, the misinterpretation and misrepresentation of this scientific evidence by the American Legacy Foundation appears not to be simply a mistake, but it has the appearance of being a result of a financial conflict of interest that Legacy once again fails to disclose.

The Rest of the Story

The rest of the story is that the American Legacy Foundation has taken money from Big Pharma. In 2009-2011, it acknowledges having accepted donations from the following pharmaceutical companies, many of which manufacture smoking cessation products:

• GlaxoSmithKline
• Pfizer
• Novartis
• Schering-Plough  

The receipt of this money represents a conflict of interest that I believe must be disclosed in any statement in which Legacy is making recommendations for national policy regarding electronic cigarettes. However, I cannot find any financial disclosure in the press release which informs the public that Legacy has received significant funding from the pharmaceutical industry.

This funding is highly relevant because electronic cigarettes represent a major potential threat to pharmaceutical company profits. If electronic cigarettes prove to be effective and continue to increase in popularity, they could put a huge dent in pharmaceutical smoking cessation drug sales, causing billion dollar losses for the pharmaceutical companies. This could threaten Legacy's future funding. Thus, by accepting this funding, Legacy has a vested financial interest in the stability of these pharmaceutical companies, and therefore, in the continued high rates of sale of their smoking cessation drugs. Electronic cigarettes threaten those high rates of sale, especially because preliminary evidence suggests that they may actually be far more effective than traditional pharmaceutical approaches to smoking cessation.

I believe that the American Legacy Foundation should have disclosed its financial conflict of interest.

The rest of the story is that not only is Legacy misrepresenting the scientific evidence on electronic cigarettes, but this misrepresentation has the appearance of being influenced by the foundation's financial conflict of interest with Big Pharma.

American Legacy Foundation Gives Medical Advice to Smokers About Cessation Drugs, But Fails to Disclose Conflict of Interest with Makers of the Recommended Drugs

In a public statement of February 28, the American Legacy Foundation has this medical advice for smokers who are considering quitting using electronic cigarettes: Don't. Instead, use nicotine replacement therapy (NRT) or Chantix.

According to the statement: "Given the poor quality control of these products, consumers are taking unknown risks by using e-cigarettes, with few proven benefits. Until adequate research and regulation is in place, users should be wary of using e-cigarettes, and smokers who want to quit should pursue science-based effective cessation tools, such as nicotine replacement products, free counseling services available via telephone quit lines and Web-based cessation services, as well as non-nicotine pharmacotherapies."

One of these "non-nicotine pharmacotherapies" is of course Chantix, which has been associated with hundreds of deaths from suicide or other severe forms of violence. The number of lawsuits against Pfizer for deaths or severe injuries allegedly due to Chantix use exceeds 3,000.

Despite these severe adverse effects that have been associated with the use of Chantix, the American Legacy Foundation fails to give these effects so much as a mention in its statement.

While Legacy avoids making any mention of the known risks of Chantix, it does emphasize the unknown risks of electronic cigarettes, which the Foundation cannot articulate because so far, none have been clearly identified or documented.

While it is problematic that Legacy is presenting a biased picture of the health information regarding the known risks of various drugs used for smoking cessation by recommending Chantix - which has been associated with hundreds of deaths - while discouraging the use of electronic cigarettes - which have yet to be associated with a single death, that is not what this post is about.

The Rest of the Story

This post is about the ethical obligation of a body giving medical advice to the public about the use of various drugs to disclose any financial conflicts of interest related to funding received from makers of those drugs. It is because of the failure of the American Legacy Foundation to disclose its conflicts of interest with the very maker of the drug it is recommending for smokers over e-cigarettes (despite the vast difference in the currently known safety profiles of the two drugs) that I am writing.

The American Legacy Foundation has received substantial funding from Pfizer - the very company which manufactures Chantix, a smoking cessation drug which stands to lose severely if electronic cigarettes become more and more popular. Thus, the Foundation's receipt of funding from Pfizer is a conflict of interest that I believe should have been revealed in its statement providing medical advice to smokers, urging them to use a drug like Chantix rather than to try electronic cigarettes.

What is the evidence for a financial connection between Pfizer and the American Legacy Foundation? Although you apparently won't easily find any disclosure of this connection on the Legacy web site, Pfizer - unlike Legacy - is transparent, and readily reports its donations to the American Legacy Foundation on its web site:

• In the first quarter of 2011, Legacy received $150,000 from Pfizer for a "Quitting Smoking Public Opinion Initiative."


• In the third quarter of 2011, Legacy received $150,000 from Pfizer for a "Quitting Smoking Public Opinion Initiative."


• In the first quarter of 2009, Legacy received $260,500 from Pfizer for a "Smoking Cessation Awareness and Benefit Survey."


• In addition, Pfizer is listed as a contributor to the 2009 American Legacy Foundation Honors event.


• Pfizer is not the only pharmaceutical company from which Legacy has taken money. The Foundation also admits to receiving funding from GlaxoSmithKline, Novartis Consumer Health, and Schering-Plough between 2008 and 2010.

The rest of the story is that these substantial conflicts of interest were not revealed in the statement of medical advice to smokers, thus hiding from smokers the fact that this advice could potentially be affected by, influenced by, or biased due to the funding from multiple companies that manufacture smoking cessation drugs and stand to lose tremendously if electronic cigarettes become more popular. I think that smokers deserve to have this information and I therefore think these conflicts should have been disclosed.

Furthermore, I think that relevant financial conflicts of interest among Legacy senior staff members should also have been disclosed. Thus, the statement should have revealed that Dr. David Abrams - a Legacy senior staff member - has received grant funding from multiple pharmaceutical companies that have investigated or manufactured smoking cessation drugs, including Eli Lilly, Dupont Merck, Glaxo-Wellcome, SmithKline Beecham, Sano Corporation, Bristol-Myers Squibb, Knoll Pharmaceuticals, and Pfizer.

Lack of transparency in failing to disclose financial conflicts of interest has become a serious problem in tobacco control, but it is a particularly substantial problem when it involves a statement providing medical advice to smokers in which the financial relationships of the body making the statement and the drug companies making the recommended products are not disclosed.

American Legacy Foundation Called for Removal of E-Cigarettes from Market Without Disclosing its Financial Ties to Big Pharma

The American Legacy Foundation released a policy statement on electronic cigarettes, in which it called for the removal of these products from the market. The statement was entitled "The FDA Should Take Electronic Cigarettes Off The Market Until It Is Satisfied That They Are Safe and Effective."

According to the statement: "While we remain open to promising products that can help smokers quit smoking, a consideration of all of the available evidence combined with important unanswered questions strongly supports our call on the FDA to prohibit the marketing and sale of e-cigarettes unless and until the FDA is satisfied that they are safe and effective."

I have already explained why this is an inappropriate policy suggestion that would result in severe public health harm. There is little doubt that these products are helping literally thousands of people to remain smoke-free and that removing them from the market would result in thousands of ex-smokers returning to cigarette smoking because e-cigarettes are no longer available. I have also explained how this policy statement misrepresents the scientific evidence, as it suggests that electronic cigarettes present a carcinogenic risk, although the actual laboratory findings show that only trace levels of carcinogens are present in these products, comparable to the levels of carcinogens present in nicotine gum and nicotine patches -- products which the American Legacy Foundation has no concerns regarding safety. Moreover, the levels of carcinogens in electronic cigarettes are more than 1000 times lower than in Marlboros, meaning that these products can dramatically reduce a smoker's cancer risk.

This commentary, however, focuses on another issue: the question of the objectivity of the policy statement and whether or not Legacy appropriate revealed conflicts of interest that may be perceived as affecting Legacy's position and its reporting of the scientific evidence.

The Rest of the Story

The rest of the story is that the American Legacy Foundation has taken money from Big Pharma. In 2009-2011, it acknowledges having accepted donations from the following pharmaceutical companies, many of which manufacture smoking cessation products:

• GlaxoSmithKline
• Pfizer
• Novartis
• Schering-Plough  

The receipt of this money represents a conflict of interest that I believe must be disclosed in any statement in which Legacy is making recommendations for national policy regarding electronic cigarettes. However, I cannot find any financial disclosure in the policy statement which informs the public that Legacy receives significant funding from the pharmaceutical industry.

This funding is highly relevant because electronic cigarettes represent a major potential threat to pharmaceutical company profits. If electronic cigarettes prove to be effective and continue to increase in popularity, they could put a huge dent in pharmaceutical smoking cessation drug sales, causing billion dollar losses for the pharmaceutical companies. This could threaten Legacy's future funding. Thus, by accepting this funding, Legacy has a vested financial interest in the stability of these pharmaceutical companies, and therefore, in the continued high rates of sale of their smoking cessation drugs. Electronic cigarettes threaten those high rates of sale, especially because preliminary evidence suggests that they may actually be far more effective than traditional pharmaceutical approaches to smoking cessation.

I believe that the American Legacy Foundation should have disclosed its financial conflict of interest.

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.

More Conflicts of Interest Being Hid by Electronic Cigarette Opponents: Funding of their Organization by Big Pharma Not Disclosed

Two days ago, I pointed out a strong bias against electronic cigarettes in the response of Drs. Nathan Cobb and David Abrams to a commentary I co-authored with Drs. Ted Wagener and Belinda Borrelli in the September issue of Addiction. After pointing out the bias, I posed the question of whether there may be a potential explanation for this strong apparent bias against a potentially effective new smoking cessation product that might compete with the mainstays of current treatment: smoking cessation drugs and cessation quitlines and web sites.

Yesterday, I revealed that there is indeed a possible explanation: financial conflicts of interest of both authors with companies which produce products used in smoking cessation treatment (cessation web sites and cessation drugs).

Specifically, I revealed that:

• Dr. Cobb is a paid consultant to a company that makes its profits based on an internet smoking cessation site which heavily promotes smoking cessation drugs: "Dr Cobb is a consultant to Healthways Inc, the current owner of the QuitNet system." Thus, he is conflicted because to the extent that the use of electronic cigarettes presents a different pathway to cessation than the traditional one - the use of a smoking cessation internet site, medication, online support, etc. - e-cigarettes may represent a threat to the profits of Healthways. 


• Dr. Abrams has received grant funding from multiple pharmaceutical companies that have investigated or manufactured smoking cessation drugs, including Eli Lilly, Dupont Merck, Glaxo-Wellcome, SmithKline Beecham, Sano Corporation, Bristol-Myers Squibb, Knoll Pharmaceuticals, and Pfizer. Dr. Abrams also reports having served as a senior scientific advisor for Johnson & Johnson. It is difficult to find a pharmaceutical company involved in smoking cessation drugs that Dr. Abrams has not had an association with over the years. 

None of these conflicts were disclosed in the article, which reported that the authors had nothing to disclose.

The Rest of the Story

The conflicts of interest with Big Pharma go far deeper than I revealed yesterday. The conflicts I revealed yesterday relate to personal conflicts of the co-authors. But there is also an institutional conflict of interest.

Both authors are with the Schroeder Institute for Tobacco Research and Policy Studies at the American Legacy Foundation.

What these authors did not disclose in the article is that the American Legacy Foundation receives funding from Big Pharma - specifically, from Pfizer, which is the maker of Chantix, a smoking cessation drug which stands to lose severely if electronic cigarettes become more and more popular. Thus, the Foundation's receipt of funding from Pfizer is a conflict of interest that I believe should have been revealed in the article.

What is the evidence for a financial connection between Pfizer and the American Legacy Foundation? Although you won't easily find any disclosure of this connection on the Legacy web site, Pfizer is transparent in reporting its donations to the American Legacy Foundation:

• In the first quarter of 2011, Legacy received $150,000 from Pfizer for a "Quitting Smoking Public Opinion Initiative."


• In the third quarter of 2011, Legacy received $150,000 from Pfizer for a "Quitting Smoking Public Opinion Initiative."


• In the first quarter of 2009, Legacy received $260,500 from Pfizer for a "Smoking Cessation Awareness and Benefit Survey."


• In addition, Pfizer is listed as a contributor to the 2009 American Legacy Foundation Honors event.


• Pfizer is not the only pharmaceutical company from which Legacy has taken money. The Foundation also admits to receiving funding from GlaxoSmithKline, Novartis Consumer Health, and Schering-Plough between 2008 and 2010.

The rest of the story is that these substantial conflicts of interest were not revealed in the article, thus hiding from readers the fact that these authors work at an organization which receives substantial funding from multiple companies that manufacture smoking cessation drugs and stand to lose tremendously if electronic cigarettes become more popular. I think that readers deserve to have this information and I therefore think these conflicts, along with the personal conflicts of interest I revealed yesterday, should have been disclosed.

New Article Calls for Removal of Electronic Cigarettes from Market With No Data to Substantiate Benefits of their Removal and Without Disclosure of Conflict of Interest of Study Author

A new article published online ahead of print in the American Journal of Public Health reviews the results of an American Legacy Foundation survey related to awareness and use of electronic cigarettes.

The study reports the survey results as follows: "In the online survey, 40.2% (95% confidence interval [CI] = 37.3, 43.1) had heard of e-cigarettes, with awareness highest among current smokers. Utilization was higher among current smokers (11.4%; 95% CI = 9.3, 14.0) than in the total population (3.4%; 95% CI = 2.6, 4.2), with 2.0% (95% CI = 1.0, 3.8) of former smokers and 0.5% (95% CI = 0.16, 1.4) of never-smokers ever using e-cigarettes. In both surveys, non-Hispanic Whites, current smokers, young adults, and those with at least a high-school diploma were most likely to perceive e-cigarettes as less harmful than regular cigarettes."

Based on these findings, the article makes the following recommendation:

"Given the widespread availability, awareness, and use of ENDS by millions of consumers,
ENDS should not be marketed until adequately tested and regulated by the FDA."

In a press release accompanying the article, David Abrams, PhD, Executive Director of the Schroeder Institute at Legacy and senior author of the paper, encouraged smokers to use all kinds of pharmaceutical products other than electronic cigarettes, stating: "Until adequate research and regulation is in place, smokers should be wary of using e-cigarettes, and smokers who want to quit should, instead, pursue research-proven effective cessation tools, such as nicotine replacement products, telephone quit lines and Web-based cessation services, as well as non-nicotine pharmacotherapies like bupropion and varenicline."

The Rest of the Story

There are three major findings of this new paper:

1. Many smokers are now very aware of the existence of electronic cigarettes as an alternative to smoking tobacco cigarettes and a substantial proportion of smokers (11%) has used electronic cigarettes. Approximately 4.1% of current smokers are currently using electronic cigarettes, which translates into about 1.8 million smokers using the product.

2. Very few neversmokers appear to be using the product.

3. Smokers who use the product appear to have a greater interest in quitting smoking.

This study therefore confirms the findings of previous research which has found that electronic cigarettes are a growing phenomenon among smokers, that use is very low among nonsmokers, and that smokers are largely using the product as a safer alternative to smoking tobacco cigarettes and as a means to cut down on the amount they smoke or to attempt to quit altogether.

Based on the findings of the study, the paper concludes that ENDS should not be marketed until adequately tested and regulated by the FDA. Since these products have not been regulated by the FDA (and any regulations could not possibly be put in place before about 2 years), the paper is thus calling for the discontinuation of e-cigarette marketing, which is essentially a call for a ban on the sale of electronic cigarettes.

Strikingly, this conclusion has nothing to do with any data presented in the paper. In fact, if anything, the data actually presented in the paper point to the promise of electronic cigarettes as a harm reduction strategy in tobacco control. The popularity of the product speaks to its likely usefulness to smokers in keeping away from tobacco cigarettes. If the product were not useful, its popularity would not be growing as it is. The study also confirms previous findings that e-cigarettes are primarily being used by smokers as either a safer alternative to tobacco cigarettes or as a strategy for reducing or eliminating tobacco cigarettes.

All of these findings, taken together, suggest that electronic cigarettes have great promise as a harm reduction and smoking reduction/cessation strategy. Of course, FDA regulations are necessary and would help to ensure that these products are as safe as possible and that quality control standards and other safety measures are adhered to, as well as that youth cannot access these products.

However, there is nothing in the findings of the paper that speaks to the need to take the product off the market because of safety concerns or demonstrated hazards.

It may therefore strike some readers as curious that the paper draws this striking conclusion. The conclusion is striking, by the way, not only because it has nothing to do with the study findings, but because it runs afoul of the law. The District Court for D.C. has already ruled (and the FDA has accepted its decision) that the FDA cannot regulate electronic cigarettes as drug-delivery devices in the absence of therapeutic claims. Thus, this paper is calling on the FDA to do something (halt the marketing of electronic cigarettes) which it has no legal authority to do.

Equally striking is the recommendation of the paper's senior author that smokers trying to quit not use electronic cigarettes but try every drug under the sun (nicotine replacement therapy, buproprion, Chantix, etc.). This is an odd recommendation because these drug products have dismal success rates: less than 8% long-term.

Even odder is the implied recommendation that smokers who have successfully quit  using electronic cigarettes stop using their e-cigarettes and make an attempt to stay quit using NRT or drugs, something which is very unlikely to be successful. Most electronic cigarette users acknowledge that taking these products off the market would most likely lead to their returning to cigarette smoking, not to their maintaining themselves smoke-free using NRT or other drugs.

Despite the striking lack of connection between the study conclusion and its actual findings, and despite the strange recommendation - coming from public health practitioners - that ex-smokers who are successfully staying off cigarettes by virtue of e-cigarettes should discontinue their e-cigarette use and risk returning to smoking, a presumably hidden fact which is not disclosed in the article may help explain the study conclusion and recommendations.

Specifically, the senior author of the paper has a significant financial conflict of interest by virtue of his previous grant funding from a number of pharmaceutical companies. Dr. Abrams has received grant funding from multiple pharmaceutical companies that have investigated or manufactured smoking cessation drugs, including Eli Lilly, Dupont Merck, Glaxo-Wellcome, SmithKline Beecham, Sano Corporation, Bristol-Myers Squibb, Knoll Pharmaceuticals, and Pfizer. Dr. Abrams also reports having served as a senior scientific advisor for Johnson & Johnson. It is difficult to find a pharmaceutical company involved in smoking cessation drugs that Dr. Abrams has not had an association with over the years.

This is not to criticize him; the research has made important contributions. It is simply to make note of the financial conflicts of interest that are present with respect to his views on electronic cigarettes, a major threat to the profits of these very same pharmaceutical companies. I believe that these conflicts of interest should be readily disclosed in the paper.

The rest of the story is that:

1) the article draws a major conclusion which lacks supportive evidence and which has no relation to the findings actually reported in the paper;

2) the paper advances a piece of medical advice which is ill-chosen and could be harmful to many people; and

3) that both of these problems appear in the setting of substantial financial conflicts of interest which are not readily disclosed.

WebMD Article Highlights Debate Over Electronic Cigarettes

A WebMD article published yesterday highlights the debate over electronic cigarettes.

On one side of the debate are public health practitioners who argue that there is no evidence that these products are safer than regular cigarettes and that they may be leading to smoking among youth and former smokers.

The article highlights this side of the debate as follows: "This is an unproven device and we know very little about its long-term health effects,'' says researcher Jennifer Pearson, PhD, MPH. She is a investigator at Legacy, an antismoking group in Washington, D.C. "E-cigarettes are probably less harmful than combustible cigarettes, [but] we don't have data to say that and can't talk about long-term effect.' There are many unknowns and unanswered questions, she says. For example, have they encouraged former smokers to reignite their nicotine addiction? Are current smokers using them to quit or to circumvent smoke-free indoor air laws? And how are they affecting people who have never smoked. 'Are they acting as gateway products?"

Pearson and colleagues have called for the removal of electronic cigarettes from the market until the FDA regulates them.

On the other side of the debate are public health practitioners like myself who argue that if one actually takes the time to review the available evidence, one will readily see that there is strong evidence that electronic cigarettes are much safer than regular cigarettes, that youth are not taking up vaping in any significant numbers, and that the primary use of these products is among smokers who are trying to quit or cut down on the amount of the harmful cigarettes they are smoking. In fact, a clinical trial demonstrated that 54% of smokers who were not motivated to quit were able to cut down by at least half on their smoking with the help of electronic cigarettes.

According to the article: "Michael Siegel, MD, disagrees. He is the associate chairman of community health sciences at the Boston University School of Public Health. They do have an important role to play in getting people to quit smoking, he says. "Taking them off of the market would be a disaster because essentially all of these smokers would be forced to go back to cigarette smoking," he predicts. They feel like a cigarette, look like a cigarette, and you smoke it like a cigarette and see vapor when you exhale,'' he says. This is appealing to a smoker who is often as addicted to the nicotine as the actual act of smoking a cigarette. They are not attracting new smokers, he says. Very few never-smokers are using these products, so all the concerns that kids and nonsmokers are going to use them seem unfounded,' Siegel says."

"Gilbert Ross, MD, agrees. He is the executive director and medical director of the American Council on Science and Health, a New York City-based consumer education/public health organization. 'E-cigs contain only water vapor, safe [diluents] such as glycerin, and nicotine, in a cigarette-like delivery device, and [are] highly likely to be much less harmful than inhaling combusted tobacco smoke.'"

The Rest of the Story

The current evidence suggests that, far from causing former smokers to "re-ignite their nicotine addiction," electronic cigarettes are helping nicotine-addicted smokers to become former smokers, or at least to cut down substantially on the amount they smoke.

There is also abundant evidence vaping is far less hazardous than smoking. I fail to understand how in July 2012, public health practitioners who have thoroughly reviewed the existence evidence can tell the public that "we don't have evidence to say that" vaping is less hazardous than smoking.

Particularly problematic is the fact that the American Legacy Foundation investigators fail to disclose a significant conflict of interest, which is that Legacy has been a recipient of Pfizer money, and therefore has financial ties to the pharmaceutical industry, which stands to lose severely if electronic cigarettes continue to become more and more popular.

The American Legacy Foundation continues to argue that "the FDA should take electronic cigarettes off the market until it is satisfied that they are safe and effective." This would be a devastating blow to the public's health because it would force many ex-smokers who are currently staying smoke-free with the help of e-cigarettes to return to cigarette smoking. It would also take away a viable alternative to cigarettes for about 1.8 million people, undeniably resulting in an increase in cigarette consumption, and therefore, in disease and death.

I absolutely cannot understand such a recommendation, especially in July 2012 when we now have clinical trial evidence of the effectiveness of these products in helping even unmotivated smokers to cut down substantially on the amount that they smoke.

Pharmaceutical Consultant Appointed to Head FDA Center for Tobacco Products, Creating an Immediate and Inappropriate Conflict of Interest

According to an article in the Winston-Salem Journal, the current head of the FDA's Center for Tobacco Products - Dr. Lawrence Deyton - is stepping down and will be replaced by Mitch Zeller, who heads a firm that does consulting work for Big Pharma.

According to the article: "What could make Zeller’s appointment controversial is he currently serves as an executive with Pinney Associates, a pharmaceutical consulting firm that does work for GlaxoSmithKline, the top seller of nicotine-replacement therapy products." ...

"In October 2010, the consumer health care division of GlaxoSmithKline requested that the FDA take Reynolds’ dissolvable tobacco products out of test markets. GlaxoSmithKline sells nicotine-replacement therapy products Nicorette and NicoDerm. In August, U.S. District Court Judge Richard Leon denied the FDA’s attempt to have the manufacturers’ lawsuit dismissed."

The Rest of the Story

In my view, this is an inappropriate appointment because it creates an unacceptable conflict of interest, thus mixing corporate politics with science and federal regulatory policy. This is precisely the type of appointment that President Obama promised to avoid when he stated in his first inauguration speech that it was time to take politics out of science.

Washington D.C. has become a virtual revolving door between corporate lobbyists/consultants and politicians/policy makers. This revolving door was what President Obama stated he would close in order to reduce corporate influence in the capital.

Now, however, we have an extreme example of conflict of interest and corporate influence. A pharmaceutical consultant is taking over a center of the very agency which regulates pharmaceuticals!

The conflict of interest is particularly inappropriate because one of the very first orders of business of the Center for Tobacco Products under Zeller's leadership will be promulgating regulations for the products that will compete with pharmaceuticals for the smoking cessation market: namely, electronic cigarettes and some other alternative nicotine-delivery devices. These regulations will have a major impact on the profits of GlaxoSmithKline, the top seller of nicotine replacement drugs and what appears to be the primary (if only) pharmaceutical company for which Zeller did consulting work.

This is tantamount to inviting GlaxoSmithKline to come to Rockville and issue its own regulations to govern its competitors.

The fact that Zeller is stepping down from his position at Pinney Associates to take this position is irrelevant, as it doesn't negate the conflict of interest.

Zeller has acknowledged that he "provides consulting support to GlaxoSmithKline Consumer Health through Pinney Associates on an exclusive basis on issues related to tobacco dependence treatment."

How can the FDA possibly appoint an individual with this severe a conflict of interest to head the center of the agency that will regulate GlaxoSmithKline's competitors?

To be clear, I am not questioning Zeller's other qualifications for the position. He is - otherwise - an outstanding choice for the position because of his extensive experience and leadership in the tobacco control movement and his prior service for the FDA itself. Unfortunately, however, the conflict of interest is unacceptable.

An article in the Wall Street Journal highlighted this conflict of interest:

"Mr. Zeller, an attorney and former official in the FDA's Office of Tobacco Programs from 1993 to 2000, helped build the first nationwide program to reduce youth access to tobacco. He was an executive at the American Legacy Foundation, an anti-smoking organization, from 2000 to 2002 before joining consultants Pinney Associates, where he advised pharmaceutical companies such as GlaxoSmithKline on smoking cessation products." ...

"Michael Siegel, a professor at Boston University's School of Public Health, thinks Mr. Zeller will likely take "a much more hard-line approach" in his dealings with tobacco companies but voiced concern that the incoming official has been paid to advise pharmaceutical companies in recent years. Dr. Siegel said that represented a conflict of interest as the FDA mulls how to regulate e-cigarettes, which are viewed by many researchers to be far less harmful than combustible cigarettes and a potential rival to FDA-approved quitting aids such as nicotine patches. An FDA spokeswoman said the agency "assiduously" complies with ethics standards, including recusals if there is any potential conflict of interest."

The FDA response is ridiculous. If the head of a major center at the agency needs to recuse himself from the chief decisions to be made by the center, then he simply shouldn't be heading the center.

 

Hypocrisy and Inconsistency in Modern-Day Tobacco Control Policy are Exposed: Walgreens' Lawsuit Against San Francisco Tobacco Sales Law is Reinstated

A California state appeals court has overturned a trial court's ruling against Walgreens in its challenge of the constitutionality of a San Francisco city ordinance that bans the sale of tobacco products in pharmacies, but exempts grocery and "big box" stores that contain pharmacies. The trial court found no valid legal basis for the lawsuit, but the appellate court ruled that the ordinance violates the equal protection clauses of the state and federal constitutions. He therefore reinstated the lawsuit.

The court ruled that there is no rational basis for prohibiting tobacco sales at pharmacies like Walgreens and CVS that contain pharmacies, but not at grocery stores or box stores that also contain a pharmacy. In order to be consistent with the equal protection clause of the Constitution, there must be a rational basis for the unequal legislative treatment of retail outlets that are similarly situated with respect to the law in question.

The court ruled that: "There is no rational basis to believe the supposed implied message conveyed by selling tobacco products at a Walgreens that has a licensed pharmacy in the back of the store is different in any meaningful way from the implied message conveyed by selling such products at a supermarket or big box store that contains a licensed pharmacy. Accordingly, we reverse in part the judgment of the trial court sustaining the City's demurrer without leave to amend."

The case now returns to the trial court, having been reinstated on the grounds that Walgreens has a valid legal premise to challenge the ordinance's constitutionality.

The Rest of the Story

On March 15, in a post entitled "San Francisco Tobacco Sales Law Shows Irrationality of Modern Tobacco Control Movement's Approach," I wrote:

"Is there a rational basis for letting Safeway sell cigarettes but telling Walgreens that it can't?"

"That's the question that a California appellate court is trying to answer in considering the appeal of a lawsuit challenging the constitutionality of a San Francisco law that bans the sale of tobacco products in pharmacies. The law only bans the sale of tobacco in some pharmacies. Those that are part of "box stores" are not included. Thus, although many Safeway supermarkets contain pharmacies, the pharmacies within those stores are still allowed to sell cigarettes. However, a large Walgreens store which may sell may products in addition to pharmaceuticals may not sell tobacco products, even though it offers for sale many food and household items."

"To make matters worse (and seemingly, more arbitrary), it is not the case that tobacco products cannot be sold at all Walgreens stores. If a Walgreens contains a pharmacy, then it can sell tobacco products. But if a Walgreens is otherwise exactly the same but does not contain a pharmacy, it cannot sell tobacco products." ...

"If the sale of cigarettes sends a bad message, then why should one Walgreens be allowed to sell cigarettes but not another Walgreens which may be located right down the street? It is very unlikely that the consumer views one Walgreens as having a different mission from another Walgreens, so on what basis is it going to protect the consumer from getting a mixed message by outlawing the sale of cigarettes at one Walgreens but not the other?"

"Similarly, there is absolutely no public health rationale for banning the sale of cigarettes in a Walgreens that has a very small pharmacy, but not in a Safeway that may have an extremely large pharmacy. If it sends a mixed message for the Walgreens pharmacy to sell cigarettes at a location where drugs are also being sold, then why does it not also send a mixed message for the Safeway store to sell cigarettes at the same location of an even larger pharmacy?"

The appeals court has therefore agreed with my argument. It finds no rational basis to prohibit the sale of tobacco at Walgreens but not at Safeway. It rejected the city's justification for the distinction, which the court decided "does not justify treating stores such as Walgreens differently from general grocery stores and big box stores. "

I think there is a larger issue here, beyond merely the legality of the San Francisco ordinance. The larger issue is the hypocrisy and inconsistency in the modern-day tobacco control movement. This irrational law is representative of a larger problem that I have noticed in the tobacco control movement these days: the loss of rationality to its policy positions.

Remember, anti-smoking advocates in San Francisco are also pushing for an ordinance to limit the number of stores that can sell tobacco products in San Francisco to 385. Apparently, if 385 stores sell tobacco products in a city, it is perfectly acceptable, but if 386 stores sell tobacco products, then it is an affront to the public's health.

As another example, the Kansas legislature just declared secondhand smoke to be an extreme danger, so hazardous that it needs to be banned inside any workplace, including bars and restaurants. But the legislature apparently did not find secondhand smoke to be a hazard inside state-owned casinos, which it exempted from the law. Apparently, secondhand smoke has a special property whereby it spontaneously de-toxifies itself when it is present in a state-owned casino.

And perhaps the greatest act of irrationality is the major national anti-smoking groups' support for a ban on electronic cigarettes at the same time as they supported the federal government's explicit approval of the much more toxic analog cigarettes.

The question that arises is this: why is it that the public's health no longer seems to be the driving force behind the tobacco control movement? The movement is no longer standing up for any principle of public health protection. Instead, it is standing up merely for an ideology by which certain actions are allowable and certain actions are not, but the distinction between the two is completely arbitrary.

When tobacco companies tell the public that lower yield cigarettes may be safer, they are guilty of fraud. When the anti-smoking groups tell the public the exact same thing, they are "defeating the tobacco companies" and "saving countless lives."

When tobacco companies or paid consultants draw conclusions based on studies without a control group, they are undertaking "junk science." When anti-tobacco researchers do the same thing, they are contributing breakthrough findings that must immediately be disseminated through the media.

When a university takes money from the tobacco industry, it is to be scorned and not worthy of receiving funding from the American Legacy Foundation. But when Legacy wants to pursue tobacco industry funding to sustain its media campaign, the money suddenly becomes clean.

And of course, most recently, when tobacco industry consultants have a conflict of interest, they are to removed from an FDA scientific panel. But when pharmaceutical consultants also have a conflict of interest, they are fine. Apparently, conflicts of interest are defined not by whether there is a conflict, but by whether the cause is a good one or not.

If this story teaches us anything, the court's ruling should caution tobacco control advocates that they can no longer go along with this disregard for rationality in policy making. It is time for a return to the basic principles of public health protection. It is time to require of ourselves that we formulate rational, consistent, science- and evidence-based policies that adhere to principle, and not merely to ideology.

Globalink: A Forum for Global Groupthink in Tobacco Control

Today, I am going to put forward the argument that Globalink (the international tobacco control list-serve) would be better called GlobalGroupthink. It is a perfect example of the groupthink phenomenon which has gripped the tobacco control movement and which I believe threatens the integrity and scientific credibility of the movement.

When I first joined Globalink, I did so because I believed it would be a valuable way for me and other tobacco control researchers and advocates to share critical research findings, discuss scientific and policy issues, and obtain thoughtful feedback on ideas to advance the tobacco control field.

What I discovered is that Globalink serves precisely the opposite functions. It is a mechanism for preventing critical discussion of research, science, and policy issues in tobacco control. It serves to stifle thoughtful discussion of ideas, suppresses dissenting opinions, and plays out as a forum for malicious individual attacks against researchers, advocates, or citizens who dare to go against the mainstream opinions within the tobacco control movement.

I found this out in an interesting way. We were having a discussion on Globalink about employer policies to refuse to hire smokers. While many of the advocates spoke out in favor of such policies, a small number opposed them. It was suggested that we take an informal vote in order to get a sense of how opinion split on the issue. I thought this was a fair idea and would have helped us to get a sense of where tobacco control advocates’ positions split on the issue.

However, a number of advocates argued vehemently against taking a vote, arguing that if information were made public showing that a significant number of tobacco control advocates opposed these policies, it would give ammunition to “our opponents.” This point of view carried the day and the vote was quashed.

This move not only prevented a vote and ensured that we would never know the extent of opposition workplace smoker bans, but it also sent a message to everyone on the list-serve that support of such bans is the “official” dogma of the movement and that anyone who dares express disagreement to such policies is viewed as the “opposition.” Thus, this move made a clear statement that expressing disagreement with the idea of refusing to hire smokers was essentially heresy and that by doing so, the dissenter would be cast out of the movement and be viewed and treated as the opposition.

This is but one example, but it demonstrates how groupthink operates on Globalink. For all I know, it Is very possible that the majority of Globalink members actually opposed the refusal to hire smokers. However, because it was made clear that expressing such an opinion would be viewed as heresy, very few were willing to speak out. This, in turn, created the false perception that almost everyone on Globalink supported such measures. In effect, groupthink makes it possible for a group of people who almost all oppose a particular measure to come to the conclusion that they uniformly support such a measure.

I was soon to found out the extent to which groupthink dominates Globalink. I submitted a comment in which I suggested that the strength of scientific evidence supporting the conclusion that smoking bans lead to a dramatic, immediate reduction in heart attacks was not as strong as being asserted by many anti-smoking groups. Instead of responses that took issue with my interpretation of the scientific evidence, I was met with a defamatory personal attack: an accusation that I am a “traitor” who has gone to the other side and who now takes tobacco industry money.

In addition to personal attacks, there were also calls for me to be removed from Globalink for having the gall to express disagreement with one of the most entrenched pieces of dogma in the movement: that all research demonstrating adverse effects of secondhand smoke or positive effects of bans must be correct.

While most people are deterred by these personal attacks and defamatory accusations, I remained undeterred, somehow withstanding getting pummeled by my own colleagues. I continued to express my opinions, which from time to time, differed with those of the mainstream. Eventually, the inevitable happened. Globalink and its members had enough of my willingness to express disagreement, and I was expelled from the list-serve.

During my time on Globalink, I witnessed vicious personal attacks against any and all opponents of tobacco control policies, including private citizens who had no affiliation with tobacco companies. It was a forum for mud-slinging against anyone who dares to disagree with “our” point-of-view on the issues.

One of the characteristics of groupthink is that by insulating the group from criticism or differing opinions, the scientific rigor and integrity of the group gradually dissipates. Without being subject to challenge, scientific arguments and evidence begin to fail. No reputable scientist insulates herself from criticism or challenge. In fact, it is by subjecting ourselves to constant challenge that scientists are able to ensure the quality of their work and the accuracy of their conclusions. The very best scientists actually try to knock down their own arguments and do not draw conclusions until they are able to address every reasonable alternative hypothesis.

This process is not possible with groupthink. And this is why groupthink destroys the scientific integrity and credibility of social movements.

The Rest of the Story

Social psychologist Irving Janis coined the term groupthink and listed eight characteristics:

"1. Illusion of invulnerability – Creates excessive optimism that encourages taking extreme risks."

"2. Collective rationalization – Members discount warnings and do not reconsider their assumptions."

"3. Belief in inherent morality – Members believe in the rightness of their cause and therefore ignore the ethical or moral consequences of their decisions."

"4. Stereotyped views of out-groups – Negative views of “enemy” make effective responses to conflict seem unnecessary."

"5. Direct pressure on dissenters – Members are under pressure not to express arguments against any of the group’s views."

"6. Self-censorship – Doubts and deviations from the perceived group consensus are not expressed."

"7. Illusion of unanimity – The majority view and judgments are assumed to be unanimous."

"8. Self-appointed ‘mindguards’ – Members protect the group and the leader from information that is problematic or contradictory to the group’s cohesiveness, view, and/or decisions."

Each of these eight characteristics was present in Globalink (and is present more generally within the tobacco control movement). Below, I provide one example of each of these characteristics.

"1. Illusion of invulnerability – Creates excessive optimism that encourages taking extreme risks."

I witnessed an illusion of invulnerability regarding the scientific evidence related to secondhand smoke and the effectiveness of smoking bans. There can be no scientific study reporting adverse effects of secondhand smoke that is weak or wrong. There can be no scientific study reporting benefits of smoking bans that is weak or wrong. Thus, anti-smoking groups are willing to take great risks with respect to the claims they are willing to make about the effects of brief secondhand smoke exposure and about the immediate cardiovascular benefits of smoking bans. The normal carefulness that would temper extreme claims largely does not operate when it comes to this aspect of the tobacco control movement.

"2. Collective rationalization – Members discount warnings and do not reconsider their assumptions."

The perfect example of this is policy regarding electronic cigarettes compared to Chantix. Anti-smoking groups have been unwilling to reconsider their assumptions regarding the role of harm reduction in tobacco control, even though electronic cigarettes are not manufactured by tobacco companies, contain no tobacco, and involve no combustion. Anti-smoking groups have also discounted warnings regarding the life-threatening effects of Chantix and thus find themselves in the absurd situation of calling for a ban on electronic cigarettes, which have killed no one, while promoting the continued availability of Chantix, which has been associated with more than 200 suicides. Anti-smoking groups are not willing to reconsider their basic assumptions.

"3. Belief in inherent morality – Members believe in the rightness of their cause and therefore ignore the ethical or moral consequences of their decisions."

Anti-smoking groups too often justify unethical behavior, personal attacks on others, or receipt of funding from corporations with conflicting interests by arguing that the cause is a good one, so these pitfalls are justified. A perfect example of this was the American Legacy Foundation's argument that its taking tobacco money to fund anti-smoking ads was acceptable because the cause was a good one, but that nobody else could take tobacco money because by doing so they were contributing to the public relations work of the evil tobacco companies.

"4. Stereotyped views of out-groups – Negative views of “enemy” make effective responses to conflict seem unnecessary."

Anyone who opposes tobacco control dogma is viewed as the enemy and is personally attacked. Globalink is loaded with these personal attacks on opponents. The opponents are viewed in a stereotypic way and factual evidence is not needed to support attacks on these individuals.

"5. Direct pressure on dissenters – Members are under pressure not to express arguments against any of the group’s views."

My expulsion from Globalink, as well as the efforts to directly suppress opposing viewpoints are perfect illustrations of this fifth characteristic of groupthink.

"6. Self-censorship – Doubts and deviations from the perceived group consensus are not expressed."

I cannot tell you how many times I would receive phone calls after one of my posts to Globalink thanking me and telling me how much the individual agreed with me and was grateful that I had the courage to express my dissenting opinion. However, very few of these advocates were willing to share their opinions publicly. Self-censorship is rampant in the tobacco control movement.

"7. Illusion of unanimity – The majority view and judgments are assumed to be unanimous."

The effect of this self-censorship is an illusion of unanimity. Because dissent is discouraged or quelled and individuals do not feel free to disagree, an illusion of unanimity is created.

"8. Self-appointed ‘mindguards’ – Members protect the group and the leader from information that is problematic or contradictory to the group’s cohesiveness, view, and/or decisions."

The actions of the Globalink leadership to expel me when my opinions threatened the group by being contradictory to its views demonstrate this characteristic in action.

The rest of the story is that in many ways, Globalink is a textbook illustration of the phenomenon of groupthink in practice. All eight of the characteristics described by Janis are present and they work together to create a group that is largely insulated from outside opinion and where groupthink therefore flourishes.