Thursday, May 05, 2016

My Op-Ed in Wall Street Journal Points Out Folly of FDA E-Cigarette Deeming Regulations

My op-ed published today in the Wall Street Journal summarizes the reasons why the FDA deeming regulations make no sense from a public health perspective.

(Note: There was one error - where it says "For example, R.J. Reynolds now owns Vuse" it should instead say: "For example, Imperial Tobacco now owns Blu.")

FDA E-Cigarette Deeming Regulations are a Disaster for Public Health

Ninety minutes ago, the FDA released its long-awaited electronic cigarette deeming regulations. Sadly, the "deeming regulations" would better be called "The Cigarette Smoking Promotion Regulations of 2016." They regulate tobacco-free and smoke-free electronic cigarettes much more stringently than real tobacco cigarettes, which the agency knows kills more than 400,000 Americans each year. And by essentially decimating the vaping industry, stifling innovation, and forcing dishonest marketing, the regulations prevent these much safer products from competing with cigarettes - the deadliest consumer product on the market.

I will have much to say about the regulations in the coming days, but for now, I want to outline the three major provisions of the regulations and discuss their impact on public health.

1. Pre-Market Tobacco Applications

SUMMARY
As expected, the regulations require virtually every manufacturer of a vaping device and/or e-liquid to submit a burdensome and costly pre-market tobacco application (PMTA) for each of its devices and products. The FDA established a grandfather date of February 15, 2007, meaning that unless your product was already on the market in 2007, you must submit a PMTA. Although the FDA allows a pathway for products that are "substantially equivalent" (SE) to predicate products that were on the market in 2007, virtually none (if any) existing products are substantially equivalent to products on the market in 2007.

To demonstrate substantial equivalence, the FDA will require the manufacturer to show that the product is not only similar to the predicate product, but that any differences between the products raise no "questions of public health." Since virtually every aspect of the design of e-cigarettes and e-liquids affects its public health implications, unless a product was actually on the market in 2007, it will not be able to demonstrate substantial equivalence. This means that, as expected, the PMTA pathway will be the only available pathway for virtually every vaping product whose manufacturer wishes to stay on the market.

The effective date of the regulations will be approximately August 10, 2016. Manufacturers will have two years from that date to submit PMTA's for every product (meaning every vaping device and every e-liquid) they wish to stay on the market. If the manufacturer submits a PMTA within this two-year period, it will be allowed to stay on the market for one additional year unless the FDA makes a decision on its application prior to that additional 12 months. If the application is not approved, the product must be taken off the market.

In addition, no new vaping products or e-liquids will be allowed on the market from August 2016 forward unless the manufacturer submits and obtains approval of a PMTA.

What constitutes a vaping product or e-liquid? Every different vaping device is considered a separate product, and a PMTA must be submitted for each. Similarly, every different e-liquid is considered a separate product and a PMTA must be submitted for each. E-liquids with different nicotine strengths are different products. So are e-liquids with different flavors or any differences in ingredients. Thus, if you are a manufacturer that makes 20 different e-liquid flavors and each comes in three nicotine strengths, you will have to submit 60 different PMTA applications, each one demonstrating that the particular e-liquid in question, when used in a variety of different vaping devices, will be beneficial for the public's health.

To demonstrate that a product is beneficial for the public's health, the manufacturer will have to consider not only the risks and benefits to smokers, but the risks and benefits to nonsmokers (including youth) and former smokers. Manufacturers will have to demonstrate not only that the product is safer than cigarettes, but that it is effective for smoking cessation and its cessation benefits will not be outweighed by uptake of the product by nonsmokers, including youth.

IMPLICATIONS

The FDA has conservatively estimated the cost of a PMTA to be $330,000. While I think this is a gross underestimate, even if we accept this as accurate, a manufacturer of 20 e-liquid flavors with three nicotine strengths each is looking at a capital cost of $19.8 million. Quite clearly, this is a cost that only a very small number of manufacturers (the tobacco companies and the very largest of the independent manufacturers) can afford. This is why the e-cigarette industry will be devastated and thousands of companies will be forced out of business.

Although vape shops will not themselves have to submit PMTA's unless they mix their own liquids, the companies that produce the products sold in vape shops are almost uniformly small manufacturers that will be forced out of business. Thus, there is no way vape shops will be able to survive. The only products remaining on the market will be those produced by the largest companies, and those are typically sold in convenience stores and drug stores rather than vape shops. Thus, these regulations are going to specifically decimate the more than 16,000 vape shop businesses, creating a significant negative economic impact and putting tens of thousands of people to the unemployment line.

More importantly, the severe contraction of the market will limit the growth of the overall market. I don't see the possibility for the continued growth of this market under these circumstances and believe that the level of e-cigarette use will plateau within five years. Thus, the prediction that vaping products could produce a public health miracle - decreasing tobacco cigarette consumption by 50% in the next decade - has been extinguished by the FDA.

Moreover, the regulations will stifle innovation. They not only take away any incentive for innovation because of the burdensome new product application process, but they also make it literally impossible for all but the largest manufacturers to commit the resources necessary to develop and test the new products extensively enough to submit a successful new product application. The public health impact of this requirement is that it will greatly impede the development of even safer and much more effective vaping products that can help a greater proportion of smokers to quit in a way that minimizes any long-term health risks.

2. Modified Risk Claims

SUMMARY
As of the effective date of the regulations (approximately August 10, 2016), manufacturers will not be allowed to make modified risk claims. This means two things: (1) they will not be able to truthfully inform consumers that vaping is much safer than smoking; and (2) they will not be able to truthfully inform consumers that vaping does not produce smoke, that e-cigarettes do not contain tobacco, or that the levels of constituents in the e-cigarette aerosol are much lower than in tobacco smoke, or absent altogether. The FDA has specifically stated that companies cannot even describe their products as a "smoke-free" alternative to smoking.

While a company could apply to be allowed to make a modified risk claim, the regulations make it extremely unlikely that a successful application could be developed. To make a claim that e-cigarettes are safer than real cigarettes, one would most likely have to conduct or cite relevant human studies demonstrating long-term benefits of the product. This would be a time-consuming and cost-prohibitive process that could only be conducted by the very largest of the manufacturers.

To make a reduced exposure claims, such as that e-cigarettes contain lower levels of a particular carcinogen or that they are smoke-free, one would have to show that consumers will not interpret this to mean that the product is safer than cigarettes. I believe this is an impossible showing.

IMPLICATIONS
There are two major implications of the modified risk provisions of the regulations. First, it means that manufacturers will not be able to market their product based on the three most important benefits of the product: (1) that they can help people quit smoking; (2) that they are safer than cigarettes; and (3) that they contain no tobacco and produce no smoke. This severely hampers the ability of the companies to market their products and of course, this will reduce the potential demand for vaping products. This will also result in the protection of cigarette sales because it eliminates the most effective competitive market claims that could possibly be made to convince people to switch from tobacco cigarettes to tobacco-free vaping products.

Second, it will prevent companies from telling consumers the truth and will effectively force them to lie to the public. Remember that deception can occur not only from what a company says, but from what the company fails to say. By forcing companies not to tell consumers that the products are intended to help smokers get off cigarettes and to reduce the risks from smoking, the FDA is essentially forcing companies to deceive the public. For this reason, I believe this aspect of the regulations is unconstitutional as it violates the free speech rights of vaping manufacturers.

3. Listing of Potentially Harmful Aerosol Constituents

SUMMARY
Within three years of the effective date of the regulations, every company will have to submit - for every one of its products - a list of all of the potentially hazardous constituents present in the aerosol. This is itself very costly, as it requires contracting with a testing laboratory, the testing is expensive, and every single flavor or variation must be tested separately.

IMPLICATIONS
This aspect of the regulations - although burdensome - will not actually increase the burden of the regulations because in order to submit a successful PMTA, a company would have to present the results of chemical testing of the aerosol produced by every one of its products anyway. So this requirement is superfluous because you can't submit a PMTA without providing this information anyway.

The Rest of the Story

Without question, the FDA has done a huge favor for the continued strength of cigarette consumption in the United States. It has blocked what would otherwise been a wonderful opportunity to develop a strong competitor to tobacco cigarettes that could have eventually eroded the cigarette market by nearly 50%, resulting in what could have been literally a public health miracle in terms of the number of lives saves and diseases and suffering averted.

Instead, the FDA basically preserves the status quo, with more than 400,000 Americans dying each year from a cause that is very much preventable.

This is a huge disaster for public health.

What Can Be Done
The only way out of this disaster would be for Congress to enact legislation that prevents the FDA from requiring PMTA's for vaping products and forces the FDA instead to develop actual safety standards for these products. While the Cole amendment is a step in the right direction, it is still problematic because PMTA's would still be required for new products. We need to encourage innovation, not stifle it. That is the only way to develop safer and more effective products that will maximize the benefits while minimizing the risks associated with this much safer alternative to cigarette smoking.

Tuesday, May 03, 2016

Harvard Medical School Teams Up with Makers of Bacardi Rum, Smirnoff Vodka, Jim Beam Bourbon, and Jack Daniels Whiskey, Providing Great PR at Bargain Rates

Last July, Harvard Medical School and its Cambridge Health Alliance accepted $3.3 million from the Foundation for Advancing Alcohol Responsibility to create an endowed chair in behavioral sciences research at Harvard Medical School and the Cambridge Health Alliance. The Dean of the Harvard Medical School proudly announced the acceptance of this money and praised the Foundation for Advancing Alcohol Responsibility, while acknowledging a long-standing alliance between the two entities: "The Foundation for Advancing Alcohol Responsibility has long been a strong supporter of the research program at Cambridge Health Alliance, particularly in the Department of Psychiatry."

The Rest of the Story

This would be a wonderful story except for a couple of things. First, the Foundation for Advancing Alcohol Responsibility isn't some independent foundation that provides grants for a wide spectrum of alcohol research. Instead, it is an alcohol industry organization that is funded by several alcohol companies, including Bacardi (the maker of Bacardi rum), Diageo (the maker of Smirnoff vodka), Beam Suntory (the maker of Jim Beam bourbon), Brown-Forman (the maker of Jack Daniels), and Constellation Brands (maker of Svedka vodka and Corona Extra beer). Its primary purpose is, as I discussed yesterday with respect to Anheuser Busch InBev, to obscure the devastating health hazards associated with "responsible" drinking by suggesting that as long as you drink alcohol responsibly, there is no problem.

While the Foundation claims to provide "the facts," you won't find anything about the health effects of "responsible" drinking on the web site. I could not find the word "cancer" mentioned once, even after extensive searching. Obviously, the Foundation has something to hide. How can a medical school possibly team up with Big Alcohol like this in a way that provides tremendous public relations for the companies, and at the bargain price of only $3 million. If you're going to prostitute your integrity by playing a role in the alcohol companies' marketing strategy and provide the companies with the public relations opportunity to boast about how they are partnering with the prestigious Harvard University, then you ought to at least haggle for a lot more than 3 million.

Second, the Foundation isn't the only entity with something to hide. The medical school has not exactly been forthcoming about the fact that it is partnering with Big Alcohol and accepting huge amounts of money from these companies. For example, in a medical school news article about the donation, the school mentions that the funding is coming from the Foundation, but it hides from readers the fact that the Foundation is none other than a group of alcohol companies.

The biography of Dr. Shaffer (the first endowed chair under the Big Alcohol-funded program) provided by the Cambridge Medical Alliance omits any mention of the fact that Dr. Shaffer's financial support comes largely from the alcohol industry.

Potentially even more problematic is the fact that in a 2015 paper published in the Archives of Scientific Psychology on which Dr. Shaffer was a co-author, there is no disclosure informing readers that Dr. Shaffer has received research support from alcohol companies. Yet according to the alcohol companies, they provided research support for four years (presumably 2012 through 2015) to Dr. Shaffer and his colleagues in the Division of Addiction. The Foundation states: "Over the past four years, with multi-year support from the Foundation for Advancing Alcohol Responsibility, Dr. Shaffer and his colleagues at the Division of Addiction have begun work to develop and test a computerized clinical report generator tool, the Computerized Assessment and Referral System (CARS), for use in DUI intervention and treatment settings." If this is true, then it should have been disclosed in the 2015 paper and it certainly creates the appearance that the authors were trying to hide this financial relationship. If the Harvard Medical School is really so proud of accepting alcohol money, then why are they apparently afraid of disclosing that they are taking alcohol money?

After further investigation, I found that it does appear to be true, as the Cambridge Health Alliance Division on Addiction acknowledges research support from the Foundation for Advancing Alcohol Responsibility, stating: " In partnership with the Foundation for Advancing Alcohol Responsibility (FAAR), a nonprofit organization with a focus on preventing DUI, we have refined and expanded
CARS, and tested its usability within multiple Massachusetts DUI treatment settings." This is from a 2014 publication, so it certainly should have been disclosed in the 2015 paper. Tellingly, despite a detailed description of CARS, the Division of Addiction does not disclose that the funding is coming from alcohol companies. Deceptively, all it says is that FAAR is "a nonprofit organization with a focus on preventing DUI." This appears to be blatant and intentional deception to hide the Alliance's partnership with Big Alcohol.

The partnership between Harvard Medical School and Big Alcohol is itself problematic because it helps to advance the goals of the Foundation, whose overall program has been carefully crafted to avoid any focus on the many, substantial adverse health effects of alcohol use, including liver disease, esophageal cancer, oral cancer, breast cancer, liver cancer, gastric ulcers, heart disease, stroke, hypertension, pancreatitis, suppression of the immune system, and adverse effects on the brain, including depression. These effects can occur even in persons who do not engage in binge drinking, underage drinking, or drink-driving. In epidemiological studies, increased risk for most of these effects occurs at levels of drinking just 2 drinks per day (for women). On an individual level, some of these effects can occur at much lower levels of alcohol use.

By focusing only on the "harmful" use of alcohol through its promotion of "responsible" drinking, the Foundation diverts attention away from the substantial burden of disease caused by heavy drinking. The alcohol companies are not interested in telling you about the harmful effects related to the "responsible" drinking of their products. They love telling you about the hazards associated with "harmful" drinking because that implies that responsible drinking is perfectly safe. Adverse effects of alcohol only occur to those who abuse it is the message that the Foundation is paying $3 million to send.

In essence, the goal is to actually promote alcohol use by ignoring and obscuring the devastating effects that "responsible" drinking has on the population. That Harvard Medical School is partnering with the Foundation and enabling the alcohol companies to help achieve this goal, and apparently not readily disclosing the connection, is disgraceful.

Anheuser Busch "Smart Drinking" Initiative is a Complete Farce

Last December, Anheuser-Busch InBev (AB InBev) announced its commitment of more than $1 billion over ten years to promote "Smart Drinking," whose major purported purpose is to "reduce the harmful use of alcohol" by reducing "binge drinking, underage drinking and drink-driving." The company claims that this represents "Doing Right, While Doing Well." A major goal is to reduce the "harmful use of alcohol" by at least 10% in six cities within 10 years.

The Rest of the Story

The truth is that this initiative is essential a huge scam designed to promote alcohol use, to divert attention away from the alcohol industry's culpability in the damage caused by alcohol, and to also divert attention away from much more effective public health programs and policies to reduce alcohol-related morbidity and mortality.

Promoting Alcohol Use

This campaign was carefully crafted to avoid any focus on the many, substantial adverse health effects of alcohol use, including liver disease, esophageal cancer, oral cancer, breast cancer, liver cancer, gastric ulcers, heart disease, stroke, hypertension, pancreatitis, suppression of the immune system, and adverse effects on the brain, including depression. These effects can occur even in persons who do not engage in binge drinking, underage drinking, or drink-driving. In epidemiological studies, increased risk for most of these effects occurs at levels of drinking just 2 drinks per day (for women). On an individual level, some of these effects can occur at much lower levels of alcohol use.

By focusing only on the "harmful" use of alcohol, the campaign diverts attention away from the substantial burden of disease caused by heavy drinking. The alcohol companies, including AB InBev, are not interested in telling you about the harmful effects related to the "responsible" drinking of their products. They love telling you about the hazards associated with "harmful" drinking because that implies that responsible drinking is perfectly safe. Adverse effects of alcohol only occur to those who abuse it is the message that AB InBev is spending $1 billion to send around the globe.

In essence, the goal is to actually promote alcohol use by ignoring and obscuring the devastating effects that "responsible" drinking has on the population. In fact, AB InBev admits as such. They state: "We also know that it is not in the long-term interests of our company for consumers to misuse our beers. We would rather that consumers enjoy our products responsibly on a more frequent basis than misuse them on any occasion."

Indeed. The company's goal is to promote alcohol use, not to discourage it. They admit that they want people to drink more frequently. The only thing that needs to be avoided is irresponsible drinking, meaning don't binge drink and don't drink and then drive. But keep in mind that someone who consumes 2-3 drinks a day is, by definition, not binge drinking. And if they don't drink and drive, then they are a "responsible" drinker. Nevertheless, we know that such a person is at increased risk for cancer and many other diseases.

The rest of the story is that this is a brilliant, yet deceptive campaign to promote alcohol use under the guise of "doing well." The campaign is able to - at the same time - promote more frequent drinking while hiding behind a pretense of being a responsible corporate citizen.

Thus, the "Smart Choices" initiative must be viewed as a marketing program. In fact, it's a brilliant marketing program. But let's not confuse this marketing program with being a public health initiative.

Diverting Attention Away from the Alcohol Industry's Culpability

Corporate sponsorship of health-related initiatives is a well-recognized marketing tactic used by the tobacco and alcohol industries. The purpose of sponsorship - such as the "Smart Choices" initiative - is to improve the company's public image, divert attention away from the industry's role in promoting the consumption of its potentially hazardous products, and to develop brand capital, all of which help to increase sales and improve the bottom line.

The "Smart Choices" campaign is brilliant because it puts the focus on individual choices, rather than on the decisions that AB InBev has made, such as: (1) deciding to heavily promote alcohol to underage youth by advertising in media with high youth audiences; (2) deciding to promote heavy use of alcohol by portraying positive images of heavy alcohol use in its advertising and marketing; and (3) deciding to undermine public health efforts to reduce alcohol use by opposing advertising restrictions, excise taxes, and essentially any and all public policies that would reduce alcohol use.

Spending $1 billion on the "Smart Choices" initiative is a very smart choice for AB InBev, because as a marketing initiative, it will work wonders and help take the focus off of its culpability, which will protect it from detrimental (to its profits) public health policies throughout the world.

Diverting Attention from More Effective Public Health Programs that Would Reduce Alcohol Use

We know from a multitude of research that the most effective strategies for reducing alcohol-related morbidity and mortality are increasing alcohol taxes, restricting advertising that targets underage youth, and conducting aggressive alcohol counter-advertising campaigns that expose the marketing tactics being used by alcohol companies to recruit underage drinkers, promote heavy drinking, and hide from consumers the myriad of adverse health effects associated with heavy "responsible" drinking. Of course, the "Smart Choices" initiative avoids doing any of these. If AB InBev were sincerely interested in reducing the adverse consequences of alcohol use, it would take the $1 billion and give it to public health officials for use in an alcohol counter-advertising campaign. At best, the "social norms" campaign that AB InBev will run will have a marginal effect.

Moreover, the "social norms" that it advances will not be social norms related to the adverse health effects of alcohol. Instead, the campaign is intended to make drinking a norm (albeit not involving actual binge drinking or drinking and driving). The campaign does not, for example, encourage people with a family history of alcohol dependence to avoid alcohol. Everyone is instructed to drink, albeit to drink in a "responsible" manner (which is a manner that could very well increase your risk of disease and death).

A Brilliant, But Deceptive Farce

AB InBev's "Smart Drinking" initiative is a brilliant one. Its brilliance rivals the fraudulent campaigns that the tobacco industry used to run. And we know how sincere the tobacco companies were in their supposed desire to reduce tobacco consumption. Here, the initiative is also fraudulent because its underlying purpose is far different than what is being presented to the public. The only difference between the strategies of the tobacco and alcohol industries is that Big Tobacco didn't have the ability to promote "smart smoking" because there is no such thing. The alcohol industry has the advantage of producing a product that causes a large amount of damage from acute over-consumption. Thus, AB InBev can accomplish the dual purposes of promoting drinking and discouraging "harmful" drinking at the same time. Sadly, a large proportion of that "smart drinking" is going to result in disease and death.

Sunday, May 01, 2016

Research Forum Claiming that Moderate Drinking Improves Health is Deliberately Hiding Its Conflicts of Interest with Big Alcohol

An organization calling itself the "International Scientific Forum on Alcohol Research" (ISFAR) has published on its web site a scathing review of a recent meta-analysis which concluded that moderate alcohol consumption does not reduce mortality as previously thought. The review contains statements from 14 members of ISFAR, and every one of the 14 blasts the study, with the review concluding that the study "markedly distorts the accumulated scientific evidence on alcohol and CVD [cardiovascular disease]."

The International Scientific Forum on Alcohol Research claims to be committed to providing a "balanced" analysis regarding alcohol and health. A co-director of the Forum asserts that: "Serious scientists should focus on the content and quality of research and their findings without bias in the interest of furthering our knowledge of alcohol and its effects on the human body."

The 14 Forum members (scientists) who provided the reviews of the paper were:
  • Elizabeth Barrett-Connor, MD,
  • Giovanni de Gaetano, MD, PhD
  • R. Curtis Ellison, MD
  • Ramon Estruch, MD, PhD
  • Harvey Finkel, MD
  • Tedd Goldfinger, DO, FACC
  • Ulrich Keil, MD, PhD
  • Dominique Lanzmann-Petithory, MD, PhD
  • Fulvio Mattivi, MSc
  • Erik Skovenborg, MD
  • Creina Stockley, PhD, MSc
  • Pierre-Louis Teissedre, PhD
  • Fulvio Ursini, MD
  • Andrew L. Waterhouse, PhD
Dr. Ellison is a co-director of the Forum and director of the Institute on Lifestyle and Health at Boston University Medical Center, which is the scientific center for the Forum. He claims that: "Our chief goal is to make it possible for the Institute to serve as a balanced, scientifically sound, and unbiased source of information on alcohol and health, making up-to-date information readily available to all who are interested."

The Rest of the Story

While the Institute on Lifestyle & Health and the International Scientific Forum on Alcohol Research would like the public to think that they are "unbiased" and presenting "balanced" critiques, especially as they read this recent review on the health effects of moderate drinking, the truth is that the review is hiding from readers critical information which renders it highly biased and wholly unbalanced.

Most importantly, the review does not reveal to the public that far from being an "unbiased" source of information, the Institute on Lifestyle & Health and the International Scientific Forum on Alcohol Research are alcohol industry-funded entities. Nowhere on the web page where the review is published is this information revealed. That is quite an important piece of information to fail to disclose to readers of this review.

Moreover, it appears to be a deliberate attempt to hide this information from readers of the review, since the Institute and ISFAR do disclose this information on the home page for the Institute and Forum. Even that disclosure is in some respects hidden, because you have to click to another page to see it; the Institute does not reveal its alcohol industry funding on the home page itself, and anyone who does not click through will have no idea that Big Alcohol is funding this project.

But the deception does not end there.

It turns out that five of the Forum members who reviewed the article have conflicts of interest by virtue of either their having received research funding from the alcohol industry or serving on advisory boards of alcohol industry-funded organizations, yet none of these conflicts are disclosed.

One reviewer - Dr. Ramon Estruch - is on the board of or receives money from three different research foundations, each of which is funded by alcohol companies. According to a published article: "Dr. Estruch reports serving on the board of and receiving lecture fees from the Research Foundation on Wine and Nutrition (FIVIN); serving on the boards of the Beer and Health Foundation and the European Foundation for Alcohol Research (ERAB)."

Well, it turns out that the Research Foundation on Wine and Nutrition is funded by alcohol companies.

And the Beer and Health Foundation is funded by the Spanish beer industry.

And the European Foundation for Alcohol Research acknowledges that it: "is supported by The Brewers of Europe, the voice of the brewing industry in Europe, whose members are the national brewing trade associations, representing more than 90% of European beer production."

A second reviewer - Dr. Creina Stockley - is listed as being with the Australian Wine Research Institute, which is also an alcohol industry institute.

A third reviewer - Dr. Pierre-Louis Teissedre - elsewhere acknowledges that his research team has received financial and in-kind support from a wine manufacturer (the maker of Perrin et Fils).

A fourth reviewer - Dr. Andrew Waterhouse - has received research funding from E & J Gallo Winery.

A fifth reviewer - Dr. Erik Skovenborg - is listed as being on the Board of ERAB, which is funded by the alcohol industry.

Unfortunately, that's not the end of the deception either.

The other co-director of the Forum is Helena Conibear, the Executive Director of Alcohol-in-Moderation (AIM) in the UK. BeamSuntory (manufacturer of Jim Beam bourbon and several other alcohol brands) states that it provides financial support to AIM.

Also, six of the Forum reviewers are listed as Alcohol in Moderation (AIM) Council Members:
  • Curtis Ellison
  • Harvey Finkel
  • Giovanni de Gaetano
  • Tedd Goldfinger
  • Erik Skovenborg
  • Creina Stockley
While the Council Members are not paid, their association with a foundation that apparently receives "financial support" from alcohol companies represents a conflict of interest that should have been disclosed.

Because of its alcohol industry funding and the fact that at least four of its members have financial conflicts of interest with Big Alcohol, the so-called "balanced" and "unbiased" International Scientific Forum on Alcohol Research is neither balanced nor unbiased. Stating that ISFAR is unbiased is like claiming that research on global warming funded by ExxonMobil is unbiased or that research on the health effects of smoking funded by Philip Morris was unbiased.

But while bias is simply a natural and unavoidable consequence of the corporate funding of research, hiding these conflicts of interest from the public is neither natural nor unavoidable. It represents, in my view, a deliberate attempt to deceive the public by hiding critical information.

If the Forum were so committed to transparency and full disclosure, why wouldn't it disclose, on the review page itself, that the Forum is alcohol industry-funded and that four of the article reviewers have received alcohol industry funding and a fifth is on a Board of a foundation that is funded by the alcohol industry? The failure to disclose is in some ways more problematic than the acceptance of alcohol industry money because it represents deception.

The Institute on Lifestyle & Health's deception of the public is even more evident in the biographies it provides of its Forum members. These biographies actively hide from readers the alcohol funding of several of these Forum members.

For example, Dr. Estruth's biography states that he is a member of the Advisory Board for "ERAB." The reader is not told what ERAB stands for, but that's of little consequence. What is of consequence is that the biography hides from the public the fact that ERAB is "supported by The Brewers of Europe, the voice of the brewing industry in Europe, whose members are the national brewing trade associations, representing more than 90% of European beer production."

Dr. Stockley's biography states that she works for the Australian Wine Research Institute. But it hides the fact that this Institute is funded by the alcohol industry.

Dr. Teissedre's biography fails to disclose that his research group received alcohol industry funding.

Dr. Waterhouse's biography hides the fact that he has received alcohol industry research funding.

Dr. Skovenborg's biography fails to disclose that he is on the Board of ERAB, which is funded by the alcohol industry.

Believe it or not, the deception goes even further.

While ISFAR claims that it is presenting a "balanced" review of the meta-analysis study, guess how many of the 14 reviewers are scientists who had a vested personal interest in the issue because they had published research that reported positive effects of moderate alcohol consumption and presumably had a pre-existing belief that moderate alcohol use improves health?

The answer, absurdly, is all 14!

The following Forum reviewers have previously published articles reporting positive health effects of moderate alcohol use:
  • Elizabeth Barrett-Connor
  • Giovanni de Gaetano
  • Curtis Ellison
  • Ramon Estruch
  • Harvey Finkel
  • Tedd Goldfinger 
  • Ulrich Keil
  • Dominique Lanzmann-Petithory
  • Fulvio Mattivi
  • Erik Skovenborg
  • Creina Stockley
  • Pierre-Louis Teissedre
  • Fulvio Ursini
  • Andrew L. Waterhouse
Sample articles documenting all of the above authors are:
Paper 1
Paper 2
Paper 3
Paper 4
Paper 5
Paper 6
Paper 7
Paper 8
Paper 9
Paper 10
Paper 11

It is absolutely ludicrous to attempt to provide a "balanced" review of a scientific question by having that review conducted by 14 people, all of whom have published research drawing a conclusion in the same direction. If there was any serious intent in providing balance, you would think that perhaps they could have asked one, even just one, scientist who had not published on this issue to provide a review. Talk about stacking the deck!

The issue of ISFAR hiding its conflicts of interest is not restricted just to its web site. In an October 2014 Medscape article in which Dr. Ellison was interviewed about research on the health effects of moderate alcohol consumption, he discusses the work of the International Scientific Forum on Alcohol Research. He is asked specifically to describe what the Forum is. However, nowhere on the web page or in the interview does he disclose that the Forum receives funding from alcohol companies.

Moreover, in the disclosure that Dr. Ellison provides, he also hides the fact that his project is alcohol industry-funded. All he discloses is that he: "Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: International Scientific Forum on Alcohol Research." But the reader or listener has no way of knowing that ISFAR is an alcohol industry-funded project. This is yet another aspect of ISFAR's deception.

Before closing, let me make two points very clear. First, I am not arguing that any member of the Forum is intentionally biasing his or her interpretation of the scientific literature. Conflict of interest has nothing to do with intentional bias. It has everything to do with subconscious bias that is simply unavoidable when one is receiving corporate funding (or any type of funding for that matter). And further, there is nothing unnatural about this bias. We are programmed - our brains are wired - to engage in reciprocity. This is a well-demonstrated psychological phenomenon which has been documented to occur in situations even less obvious than the receipt of corporate funding for research. Nor is there anything inherently wrong with having a conflict of interest. Failing to disclose a significant conflict is a different story.

Second, I am not arguing that accepting corporate funding for research is inherently wrong. It is not that "black and white." In this case, however, since the declared purpose of the Forum and the Institute is to provide a balanced and unbiased summary of research literature, it is completely unacceptable and inappropriate to be funded by corporations that have a huge, vested interest in the result of those reviews. It sacrifices the scientific integrity of such an organization when many of its members have individual conflicts of interest with the corporations whose financial interests are at stake.

And it is ludicrous - almost hilarious in a dark sense - that such a "balanced" review would be obtained by stacking the deck and soliciting a review only from scientists who have previously expressed their disagreement with the views expressed in the reviewed article. That is about as strong a systematic bias as one could imagine, even if one were trying to explain the concept by giving an extreme example. 

The rest of the story is that far from being a "balanced" and "unbiased" forum for review of scientific research on alcohol and health, the Institute for Lifestyle & Medicine and the International Scientific Forum on Alcohol Research are heavily conflicted entities that have strong ties to the alcohol industry. These ties occur not only through the Institute receiving alcohol funding, but through several of the Forum members having received alcohol industry funding or serving on Boards of organizations that are alcohol industry-funded.

But what makes the actions of these organizations even more inappropriate and scientifically dishonest and deceptive is the fact that they are largely hiding these immense conflicts of interest from the public.

Thursday, April 28, 2016

Throwback Thursday: April 28th, 1986 (30 Years Ago): Anti-Tobacco Groups Blast Cigarette Companies for Not Supporting Development of a Safer Cigarette

April 28, 1986 (AP, New York): Today, a coalition of anti-smoking organizations, heath agencies, and researchers are attacking the nation's cigarette companies for failing to support the development of much safer cigarettes. Health officials complained that for many years, cigarette companies have had the technology to produce a much safer cigarette, but have failed to show any support for even the idea of manufacturing a safer product.

Also today, a class-action lawsuit was filed against Philip Morris, R.J. Reynolds, Lorillard, Brown & Williamson and Liggett, alleging that each of these companies could easily have produced a much safer cigarette that didn't contain tobacco and didn't involve combustion.

According to the lead attorney for the plaintiffs: "It is absolutely feasible for the cigarette companies to produce a product that looks exactly like a cigarette, but which contains no tobacco and doesn't rely on burning anything. Instead, such a product would merely heat a solution of vegetable glycerin in which nicotine was dissolved. The resulting aerosol would contain a few chemicals, but would be vastly safer than the tens of thousands of chemicals and more than 60 human carcinogens present in cigarette smoke."

A University of California, San Francisco professor who spoke at today's press conference stated: "This is a no-brainer. It doesn't take a rocket scientist to figure out that if you remove the tobacco and the combustion process, you're going to have a much safer product. We don't need to do 10 years of research to find that out."

Cigarette market leader Philip Morris lashed out at the anti-smoking groups, disputing their claims that a non-tobacco, non-combusted, cigarette-like product would offer any health benefits: "We have not seen to this point evidence that contradicts the idea that putting something in your mouth, a stick-like device, and inhaling is not risky."

A spokesperson for R.J. Reynolds noted that even if you reduce the toxic emissions by 99%, the product is still hazardous, emphasizing that with such a product, "the emissions are not merely harmless water vapor."

Lorillard actually produced and circulated a brochure entitled "Not Harmless Water Vapor" which notes that even if a safer product were to emit just a small number of chemicals, it still could be hazardous. Lead counsel for Lorillard said that he looked forward to defending his company in court, saying: "We are going to have a field day in the courtroom. We have incontrovertible evidence that the product health groups are asking us to make does not just emit harmless water vapor."

London-based British American Tobacco, the parent company of Brown and Williamson, told the Associated Press that anti-tobacco groups in the U.S. are unique in their "extreme enthusiasm" for a non-tobacco cigarette. "They're quite blind to some of the concerns that people in other countries are expressing."

The president of the American Lung Association told the AP that while some of the tobacco companies initially tested a non-nicotine, non-combusted device back in 1977, and it proved to be quite acceptable to smokers, the companies have since abandoned further development of the product.

Liggett's spokesman defended his company, arguing that these purportedly safer products "have only been around since about 1977 and that's a very, very short period by which to determine whether they are as safe as everybody hopes they will be." He argued that it will take years, even decades, before we understand the full spectrum of potential risks from these products.

Philip Morris added another concern - the possibility that even if these products turn out to be much safer than conventional cigarettes, they might still have a negative public health impact because they could lead kids to smoking the real thing. A Philip Morris public relations spokesman stated: "There's no question that they are a gateway to smoking tobacco cigarettes." He added that: "Many kids are starting out with these imitation products and then going on to smoke conventional cigarettes. These allegedly healthier products are condemning many kids to struggling with a lifelong addiction to nicotine."

When pressed to provide evidence to back up his claim, he said: "We know this because in test markets, there were many kids who used these alternative products and who also smoked. This proves that these alternative products are a gateway to smoking."

The Tobacco Institute, which represents all of the major cigarette companies, argued that the purported safer products that the anti-smoking groups are calling for would not benefit the public's health because they contain nicotine and "are as addictive as regular cigarettes."
The lead scientist in Philip Morris' research division told the AP that: "Many consumers believe that the non-tobacco, non-combusted products we tested are "safe" tobacco products or are "safer" than cigarettes. We have not made such a determination and conclusive research is not available."

The lead counsel for R.J. Reynolds explained that his company would be "delighted" to produce a safer substitute for cigarettes once the FDA determines that such a product is 'safe and effective.' But until then, allowing such a product to be marketed would be like "the wild, wild west."


Correction: Due to technical problems with our lithograph, the Associated Press regrets that it printed the wrong date in the above story. The date should be April 28, 2016, not April 28, 1986.

Correction: We have been notified of another inadvertent error in the above story. In every place where the name of a tobacco company is mentioned, it should be replaced with the name of an anti-tobacco group or health agency or organization. And in every place where an anti-tobacco organization or researcher is mentioned, it should be replaced with a Big Tobacco company or tobacco company researcher. We apologize for the mistake and are sorry for any confusion or misinterpretation that it caused.

Correction: The non-combusted, non-tobacco product in question was not merely test marketed. It has actually been on the market for 10 years, is being used by more than 3 million people, and has been studied in more than 50 peer-reviewed articles, many of which documented dramatic health improvement in smokers who switched to these alternative products.

Addendum: Returning our phone call too late for the print edition, Professor Michael Siegel from the Boston University School of Public Health did add the following comment:

"It seems to me that the anti-tobacco groups have provided the tobacco companies with a nearly impenetrable defense in future litigation. A huge component of the legal argument being made by plaintiff's attorneys is that the tobacco companies had the technology, and experimented with the technology to produce a much safer cigarette, but failed to do so. 

Now, the companies have been provided with a new line of defense. They can simply bombard the court with abundant statements from anti-smoking groups and health officials and agencies which argue that there is no way the companies could have brought such a product to market, because - as the anti-smoking groups themselves note - it would have taken 10 years or longer to understand the potential long-term risks of such a product. Even if all the tobacco were removed and a heating process was substituted for combustion so that there was no smoke, it still would not have been harmless water vapor. Moreover, even if such a product were safer, it still could have harmed the public health by serving as a gateway to a lifetime of addiction to smoking. 

Nicotine itself is harmful and causes brain damage in adolescents. And even with a truly safer product, it would not benefit the public's health because there is no question that it would be a gateway to smoking.

The bare truth is that putting something in your mouth, a stick-like device, and inhaling is going to be risky. Thus, there would have been no definite public health advantage to creating a presumably safer product and by failing to pursue a safer cigarette, the companies therefore did not violate any public health duty of care."


Documentation of "Tobacco Company" Quotes

"We have not seen to this point evidence that contradicts the idea that putting something in your mouth, a stick-like device, and inhaling is not risky."
Source: Australian Medical Association

"E-cigarette emissions are not merely harmless water vapor."
Source: University of California, San Francisco

"Not Harmless Water Vapor"
Source: Vermont Department of Health

"These products do not just emit harmless water vapor."
Source: Americans for Nonsmokers' Rights

"extreme enthusiasm ... They're quite blind to some of the concerns that people in other countries are expressing. They've only been around since about [2007] and that's a very, very short period by which to determine whether they are as safe as everybody hopes they will be."
Source: Professor Simon Chapman

"There's no question that they are a gateway to smoking [tobacco] cigarettes."
Source: Professor Stan Glantz

"They are just as addictive as regular cigarettes."
Source: California Department of Health Services

"Many kids are starting out with [e-cigarettes] and then going on to smoke conventional cigarettes. [E-cigarettes] are condemning many kids to struggling with a lifelong addiction to nicotine."
Source: Centers for Disease Control and Prevention

"Many consumers believe that [e-cigarettes] are "safe" tobacco products or are "safer" than cigarettes. FDA has not made such a determination and conclusive research is not available."
Source: Food and Drug Administration 

"Safe and effective"
Source: American Lung Association 

"Wild, wild west" 
Source: American Cancer Society 

Wednesday, April 27, 2016

Royal College of Physicians Report Recommends Widespread Promotion of Electronic Cigarettes for Smoking Cessation

Moments ago, the Royal College of Physicians released a new report that summarizes the scientific evidence on e-cigarettes and public health and concludes that these products should be widely promoted as a substitute for real tobacco cigarettes. The RCP also issued a summary statement regarding the report, which is entitled "Nicotine Without Smoke: Tobacco Harm Reduction."

The major conclusion of the report is that: "e-cigarettes are likely to be beneficial to UK public health. Smokers can therefore be reassured and encouraged to use them, and the public can be reassured that e-cigarettes are much safer than smoking."

This conclusion is based on a number of key findings:
  • "E-cigarettes are not a gateway to smoking – in the UK, use of e-cigarettes is limited almost entirely to those who are already using, or have used, tobacco.
  • E-cigarettes do not result in normalisation of smoking – there is no evidence that either nicotine replacement therapy (NRT) or e-cigarette use has resulted in renormalisation of smoking. None of these products has to date attracted significant use among adult never-smokers, or demonstrated evidence of significant gateway progression into smoking among young people.
  • E-cigarettes and quitting smoking - among smokers, e-cigarette use is likely to lead to quit attempts that would not otherwise have happened, and in a proportion of these to successful cessation. In this way, e-cigarettes can act as a gateway from smoking.
  • E-cigarettes and long-term harm - the possibility of some harm from long-term e-cigarette use cannot be dismissed due to inhalation of the ingredients other than nicotine, but is likely to be very small, and substantially smaller than that arising from tobacco smoking. With appropriate product standards to minimise exposure to the other ingredients, it should be possible to reduce risks of physical health still further."
The chair of the RCP's Tobacco Advisory Group - Professor John Britton - said:

"The growing use of electronic cigarettes as a substitute for tobacco smoking has been a topic of great controversy, with much speculation over their potential risks and benefits. This report lays to rest almost all of the concerns over these products, and concludes that, with sensible regulation, electronic cigarettes have the potential to make a major contribution towards preventing the premature death, disease and social inequalities in health that smoking currently causes in the UK. Smokers should be reassured that these products can help them quit all tobacco use forever." 

The ultimate recommendation of the report is that electronic cigarettes should be promoted "as widely as possible" as an alternative to smoking.

The Rest of the Story

This is an outstanding report with a meticulous and balanced review of the relevant scientific literature, an enlightened perspective on the evaluation of current data on smoking and its harms, the use of nicotine replacement therapy, and the potential role of e-cigarettes, and evidence-based recommendations that aim to protect the public's health rather than to promote any particular bias or ideology.

It is also a breath of fresh air that helps to clean out some of the stench we have been getting from the completely non-evidence-based rhetoric and propaganda we have been getting for the past six years from anti-nicotine organizations and researchers in the U.S. and from numerous health agencies and regulatory bodies, including the FDA and the CDC.

The report also presents an enlightened view on regulation of vaping products, as it astutely points out that regulations must maximize the potential benefits while minimizing the potential harms of these products, rather than banning a huge segment of the products on the market, as the FDA is poised to do, and to give cigarettes a huge boost by virtually eliminating competition from a much safer alternative.

The report acknowledges that there are some potential long-term risks associated with vaping, but that these are certainly much lower than the risks of continued smoking. It also dispels the absurd assertion, widespread in the U.S., that e-cigarettes are going to re-normalize smoking. Finally, it provides strong evidence against the claim that e-cigarettes are a gateway to youth smoking and argues that vaping is actually a gateway away from smoking.

The report confirms what real-live vapers have been telling us all along, but what we in the U.S. have completely ignored because we don't "approve" of people getting any enjoyment from nicotine or improving their health through the use of a product that looks and works like a cigarette. It vindicates the vapers who have been repeatedly attacked by anti-nicotine groups in the U.S. for the past six years and hopefully, it will reassure vapers that they are truly to be congratulated and celebrated for having taken an action that will greatly improve their health and their lives.

Tuesday, April 26, 2016

Simultaneously Published Studies Demonstrate Severe Bias in E-Cigarette Research

In a remarkable coincidence of the publishing of two nearly identical analyses of e-cigarette advertising at the same time, the equally remarkable bias in e-cigarette research has become apparent.

The studies, published by two completely different sets of researchers, both conducted an identical analysis using an identical data set. Both studies were cross-sectional examinations of the relationship between self-reported exposure to e-cigarette advertising and current use of e-cigarettes among youth surveyed in the 2014 National Youth Tobacco Survey conducted by the Centers for Disease Control and Prevention (CDC).

The first study was conducted by researchers from the University of Texas and was published in the Journal of Adolescent Health. The second study was conducted by researchers from CDC and was published in the journal Pediatrics.

In the survey, youth were asked how often they see ads or promotions for electronic cigarettes on the internet, in newspapers or magazines, in retail stores, and on television or in movies. The responses were "never," "rarely," "sometimes," "most of the time," and "always." Youth who reported seeing e-cigarette ads never or rarely were categorized as unexposed to e-cigarette advertising through a particular source.

The other variable - youth e-cigarette use - was measured through a question regarding the number of days a youth reported using e-cigarettes. Current use was defined as using e-cigarettes at least one day in the past month.

Both studies examined the association between self-reported exposure to e-cigarette marketing and current e-cigarette use using a logistic regression analysis, while controlling for gender, race/ethnicity, grade in school, and use of "other" tobacco products.

Both studies found a significant association between self-reported exposure to e-cigarette marketing and current e-cigarette use. And both concluded that e-cigarette marketing therefore appears to influence youth e-cigarette use:

Study #1: "This study highlights widespread environmental influences promoting e-cigarette use through a variety of platforms, and that these influences increase the odds that a young person might also be using e-cigarettes."

Study #2: "These findings suggest that comprehensive tobacco prevention and control strategies, including efforts to reduce youth exposure to advertising, are critical to prevent all forms of tobacco use among US youth, including e-cigarettes."

The Rest of the Story

There is a glaring limitation in both studies which render them unable to conclude, as they do, that e-cigarette marketing is likely influencing youth to use e-cigarettes. Because they are cross-sectional, it cannot be determined whether exposure to e-cigarette marketing is causing youth to use e-cigarettes or whether youth who use e-cigarettes are more likely to notice and recall exposure to e-cigarette marketing.

Given that e-cigarette advertising is not as ubiquitous as cigarette advertising used to be, this is a particular problem with these studies, and it is a more serious problem than in previous studies of the relationship between cigarette advertising and youth smoking. Many youth do not even know what e-cigarettes are, and one would expect that these kids would not pay attention to or recall exposure to e-cigarette advertising. In contrast, youth who are familiar with these products would be much more likely to notice and to recall exposure to such advertisements or promotions.

For this reason, it is not clear that these studies are even measuring e-cigarette marketing exposure. It may be that what they are really measuring is simply recall of e-cigarette marketing exposure, which may well have been equal in the "exposed" and "non-exposed" groups.

Nevertheless, both studies conclude that the e-cigarette marketing is influencing e-cigarette use rather than the other way around. The first study articulates this conclusion by stating that e-cigarette marketing "influences" youth e-cigarette use and "increases the odds" of e-cigarette use. The second study articulates this conclusion by stating that "reducing exposure" to e-cigarette advertising will "prevent" youth e-cigarette use.

Here is where the remarkable demonstration of bias is evident. Given that you cannot tell whether the e-cigarette advertising influenced youth e-cigarette use or whether youth who use e-cigarettes are more likely to notice e-cigarette marketing, you would expect that neither study would have concluded one or the other. Given these two plausible possibilities with no way to decide between them, one would not expect researchers to nevertheless choose one or the other. Remarkably, both studies articulate the conclusion that it is the marketing that is influencing the e-cigarette use.

What makes these conclusions even more remarkable is the fact that both studies acknowledge that because the studies are cross-sectional, they cannot conclude that there is a causal relationship between e-cigarette advertising and e-cigarette use:

Study #1: "the analyses were cross-sectional which prohibits causal inference."

Study #2: "data were cross-sectional, and thus, causal relationships between e-cigarette advertising and use cannot be made."

Well, if causal conclusions cannot be made, then why do both studies make causal conclusions?

I believe this is a demonstration of bias on the part of e-cigarette researchers. This has become apparent in a wide range of research on electronic cigarettes being carried out in the tobacco control movement.

That I am not the only one to perceive that the studies were drawing causal conclusions is revealed by examining the newspaper headlines associated with these studies:

Reuters: "Teens Most Drawn to E-Cigarettes by Online Ads"
NBC News: "E-Cigarette Ads Get Through to Teens"
Tech Times: "This is How Ads Lure Kids to Start Using E-Cigarettes"

Anti-tobacco groups also jumped on the bandwagon and disseminated the conclusion that e-cigarette ads are causing youth to take up vaping:

Campaign for Tobacco-Free Kids: "This study provides further evidence that the irresponsible marketing of e-cigarettes, coupled with a lack of government oversight, is putting our nation’s children at risk."
Truth Initiative: "New Research Affirms Need for FDA to Regulate Online E-Cigarette Ads"
 
Lest one think that the research teams were working together and reached a joint decision on the causal direction, the papers make it clear that this was not the case. Both studies claim to be the first to investigate the association between e-cigarette marketing exposure and e-cigarette use, indicating that neither set of researchers knew that the other set of researchers were simultaneously conducting the same analysis:

Study #1: "To our knowledge, this is the first study to investigate the association between exposure to e-cigarette marketing from several channels and use/susceptibility of e-cigarettes using a nationally representative sample."

Study #2: "However, to date, no study has assessed the association between exposure to different sources of e-cigarette advertising and current e-cigarette use among US youth."

It is also remarkable that despite the apparent inability to draw causal conclusions, both studies conclude nevertheless that reducing youth exposure to e-cigarette marketing will prevent youth use of e-cigarettes:

Study #1: "The increasing reach and intensity of e-cigarette marketing, along with the potential for these messages to recruit adolescent users, highlights the need for regulation of marketing strategies that are used by these companies to prevent and reduce adolescent initiation of these products."

Study #2: "Given that youth use of tobacco in any form is unsafe, comprehensive tobacco prevention and control strategies, including efforts to reduce youth exposure to advertising, are critical to prevent use of all tobacco products among youth."

The question that naturally arises is what is the point of this research? If the researchers were going to conclude that e-cigarette marketing influences e-cigarette use anyway, then why do the research? The apparent drawing of a priori conclusions essentially negates the purpose of conducting research in the first place. Both studies mention the need to conduct longitudinal research to determine the causal direction. But why is that research needed if the causal conclusions have already been drawn?

Ultimately, it is my belief that the underlying explanation for the severe bias we are observing in e-cigarette research is that we in the tobacco control movement are severely threatened by e-cigarettes. We are threatened because vaping throws off all of our pre-existing perspectives and challenges our ideology. We are threatened because we didn't think of this approach to smoking cessation and so vaping threatens the status of the tobacco control movement. We are threatened because we cannot possibly acknowledge that a behavior which looks like smoking could possibly be a solution to the problem of the low efficacy of existing smoking cessation products. We are threatened because we cannot stand the idea that people may gain enjoyment from the use of nicotine in a way that actually improves their health or at least does not harm it significantly. And we are threatened because it just may be that industry innovation and marketing of industry products may actually contribute to protecting the public's health.

It can't be so. Thus, we must manufacture all the research we can to show that these products, the companies which make them, and the marketing conducted by these companies are all dangerous, wicked, and antithetical to public health.

Monday, April 25, 2016

DNC Chair Mistakenly Claims that Cole Amendment Will Make it Harder to Regulate E-Cigarettes

Last week, during the mark-up of the FY17 Agriculture appropriations bill, Representative Debbie Wasserman Schultz (D-FL)--who is Chair of the Democratic National Committee--argued that passage of an amendment (the Cole amendment) that would prohibit the FDA from requiring pre-market applications for e-cigarettes that are currently on the market would "make it harder to regulate this product."

The proposed FDA deeming regulations would require every electronic cigarette product on the market to submit a pre-market application in order to remain on the market. Such an application, which would take an estimated 5000 hours to prepare and would cost more than $300,000 per product, is not only unduly burdensome but is virtually impossible for any small business to complete successfully. The effect of the regulations would be to decimate the e-cigarette industry, eliminating all but the largest of companies from remaining in the vaping business. This would have a chilling effect on the sales and growth of vaping products, and would protect a continuing stream of high cigarette sales.

The Cole amendment would remove this requirement for e-cigarettes currently on the market to submit a pre-market application, thus allowing current products to remain on the market and preventing the destruction of the vaping industry. It would also help maintain lower rates of smoking by ensuring that the hundreds of thousands of ex-smokers who quit using e-cigarettes will continue to have access to the products which helped them to quit. If the Cole amendment does not pass, then many former smokers will return to smoking as their favored products will be removed from the market and many smokers who would otherwise have quit smoking using vaping products will not do so because of the limited options that will be available.

The Rest of the Story

It is difficult to see how any Congressmember could oppose the Cole amendment on public health grounds. How could legislation that allows vaping products to challenge cigarette profits possibly represent a good thing for the public's health? Clearly, it is by allowing cigarettes to be challenged by the much safer electronic cigarettes that the public's health can best be protected. And, as explained above, in the absence of the Cole amendment, the FDA regulations will lead to higher rates of smoking. This is obviously not in the best interests of the public's health.

Not only do those opposing the Cole amendment fail to understand that they are actually protecting cigarette sales and harming the public's health, but they also are deceiving the public when they claim--like the DNC Chair--that the Cole amendment would make it harder for the FDA to regulate e-cigarettes.

This is complete nonsense. All the amendment would do is prevent the FDA from banning the overwhelming majority of vaping products currently on the market. It would have no impact on the FDA's ability to regulate these products. The FDA would still be free to regulate product safety. In fact, the FDA would be required to regulate product safety by setting safety standards, something that the FDA is not doing in its deeming regulations.

Although the Cole amendment represents a last-gasp attempt to prevent the FDA from creating a public health disaster by destroying the vaping industry, it still does not represent the ideal solution to the problem. After all, the Cole amendment would still allow the FDA to require pre-market applications for new products introduced after the effective date of the deeming regulations. This would stifle innovation in the vaping market, thus impairing the ability of new and potentially safer and more effective products to enter the market. In this way, the Cole amendment is simply the better of two evils.

The appropriate way to regulate vaping products is not to do so through pre-market applications, which do nothing to directly make these products safer, but by directly promulgating safety standards for vaping products. As the FDA has demonstrated a lack of interest in doing this, it may be far more beneficial to place e-cigarettes under the jurisdiction of another agency that is better prepared to regulate product safety. Alternatively, the Cole amendment could be revised so that it precludes the FDA from establishing any requirement for pre-market review of vaping products and instead, requires the agency to set product safety standards.

Wednesday, April 20, 2016

A Lie A Day: Campaign for Tobacco-Free Kids Wrongly Accuses Tobacco Companies of Marketing Gummy Bear E-Cigarettes

In what is rapidly becoming a tragic farce, anti-nicotine groups are now lying at a rate of at least one per day in a deliberate attempt to demonize electronic cigarettes.

Today's liar is the Campaign for Tobacco-Free Kids, which claimed in a press release that the tobacco companies are marketing gummy bear-flavored electronic cigarettes to youth. The Campaign asked: "Why in the world is Congress helping tobacco companies lure kids with gummy bear-flavored e-cigarettes?"

The Rest of the Story

The rest of the story is that, as I said yesterday, you simply cannot trust anything you hear from anti-nicotine groups these days about electronic cigarettes. They are incapable of simply telling the truth.

Here, the Campaign for Tobacco-Free Kids falsely claims that Big Tobacco is marketing gummy bear e-cigarettes to youth. But the truth is that the tobacco companies do not even produce gummy bear e-cigarettes. Those products are being marketed by independent vaping companies that are not associated with Big Tobacco.

In the U.S., here are the flavors being sold by the major tobacco companies:

Mark Ten: Classic, Menthol, Fusion, Winter Mint
Vuse: Tobacco, Menthol, Mint, Chai, Berry, Crema
Blu: Tobacco, Menthol, Cherry, Vanilla, Pina Colada, Peach Schnapps, Carolina Bold

You'll notice that Gummy Bear is not a flavored being marketed by any tobacco company in the U.S.

So why is the Campaign for Tobacco-Free Kids lying?

Simply put, because the actual facts do not support the pre-written script that the Campaign has created. They want to be able to attack Big Tobacco for targeting kids with outrageous flavors like gummy bear and cotton candy, yet these companies don't even make products with such flavors. So there's only one way out of this conundrum, and that's to lie.

And that's something the Campaign for Tobacco-Free Kids is doing a wonderful job of.

Tuesday, April 19, 2016

Anti-Smoking Groups are Not Capable of Telling the Truth; Now They're Telling Vapers that E-Cigarette Aerosol Contains Propylene Oxide, a Carcinogen

I have come to the conclusion that anti-smoking groups are simply not capable of telling the public the truth about electronic cigarettes and their health effects. From the "popcorn lung" scare to the formaldehyde scare, it has been one lie after another. And today, we can add yet another one.

Anti-vaping researchers and anti-smoking groups are now spreading the false information that when heated and vaporized, propylene glycol is converted into propylene oxide, which is recognized as a carcinogen.

For example, the Kenosha Racine and Walworth Counties Tobacco-Free Coalition claims that "Once heated into the vaporized form, propylene glycol is chemically changed into propylene oxide, which is a class 2B carcinogen as rated by the International Agency for Research."

The source of that claim was apparently an article from the always reliable Gizmodo.com, which stated: "when heated above a certain temperature, PG will convert to propylene oxide—a class 2B carcinogen as rated by the International Agency for Research."

Where did that claim come from? It appears to have come from a Popular Science article, which stated: "Furthermore, when heated and vaporized, propylene glycol--often used in e-cigarettes to form aerosol particles--can form propylene oxide, a recognized carcinogen."    

And where did that claim come from? Alas, from an article written by Dr. Stan Glantz, which stated that: "When heated and vaporized, propylene glycol can form propylene oxide, an International Agency for Research on Cancer class 2B carcinogen... ."  

So what was the original source of this claim? Dr. Glantz apparently got it from a research article which noted that under certain conditions, heating propylene glycol can result in the formation of propylene oxide.

The Rest of the Story

The problem is that there is something which Dr. Glantz and his colleagues are hiding and which the anti-smoking groups in Kenosha, Racine, and Walworth counties are also failing to reveal:

The "certain conditions" under which propylene glycol can be converted to propylene oxide are quite simple:
  •  A temperature of at least 980 degrees Fahrenheit.

Since propylene glycol boils at 371 degrees Fahrenheit, and since e-liquids are not heated above that temperature (or even close to it), these conditions can never actually be reached in the vaping process. Therefore, it is simply untrue that when heated in a vaping device, propylene glycol is converted into propylene oxide, a recognized carcinogen.

On the other hand, what Dr. Glantz and the anti-smoking groups are also hiding from you is the fact that in contrast to electronic cigarette vapor, propylene oxide is present in tobacco smoke. The temperature at the end of a burning cigarette can easily exceed 980 degrees Fahrenheit, and propylene oxide is a recognized constituent of tobacco smoke.

I find it quite appalling that anti-smoking groups and researchers are lying to the public about the presence of propylene oxide in e-cigarette vapor, but at the same time, failing to inform the public that this recognized class 2B carcinogen is present in tobacco smoke.

It has become apparent to me that anti-smoking groups and many researchers have lost interest in discouraging people from smoking. Instead, they are obsessively concerned with demonizing e-cigarettes. There is clearly something about the use of e-cigarettes that is driving anti-smoking advocates crazy. I have come to believe that what is driving us crazy is the possibility that maybe, just maybe, people are actually getting pleasure from nicotine in a way that isn't destructive to their health. I simply don't think this thought is something that anti-smoking groups can tolerate.

Hence, they must lie about electronic cigarettes. They must, like the CDC, insinuate that vaping products contain tobacco. They must inform the public that e-cigarettes are just as bad as real cigarettes.

The rest of the story is that vaping presents such an immense threat to the anti-tobacco movement that we are no longer capable of telling the truth. Our movement has deteriorated into a community of pathological liars who cannot stand the thought that there are smokers out there who are deriving pleasure from the use of nicotine without it killing them, and even worse, with the product actually improving their health.

Monday, April 18, 2016

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.

Friday, April 15, 2016

CDC Continues to Lie and Deceive the Public about Youth Tobacco Use

The Centers for Disease Control and Prevention (CDC) is a critical source of health information on most public health issues, but sadly, it is no longer a trustworthy source of information about youth tobacco use. The agency has been consumed by an obsessive vendetta against electronic cigarettes, which has blinded it to the severe problem of youth smoking and distorted its vision away from the protection of the public's health and towards the articulation of an ideology that shows a complete disregard for the health of our nation's youth.

The CDC's lack of honesty, transparency, and integrity when it comes to the issue of youth tobacco use was further demonstrated yesterday by its public claim that youth tobacco use has remained unchanged since 2011, despite the fact that its own report - also released yesterday - revealed that smoking among high school youth declined from 15.8% to 9.3% during the period 2011-2015, smokeless tobacco use decreased from 7.9% to 6.0%, cigar use declined from 11.6% to 8.6%, pipe tobacco use declined from 4.0% to 1.0%, and bidi use dropped from 2.0% to 0.6%.

With declines in all of these categories of tobacco use, how is it possible for the CDC to claim that the use of tobacco has actually stayed the same from 2011 to 2015?

Very easy. You just lie.

And that's exactly what the CDC did.

Rather than acknowledge the truth - which is that despite a dramatic increase in experimentation with vaping among youth over the past 5 years, smoking rates and the use of other forms of tobacco (other than hookah) has declined substantially, the CDC has distorted the truth by falsely telling the public that e-cigarettes contain tobacco and that when kids vape they are using tobacco. Through this deceptive and fraudulent manipulation, the agency is now able to tell the public that youth use of tobacco has stayed the same.

The Rest of the Story

The CDC's claim is categorically false. Youth use of tobacco has not stayed the same since 2011; it has dramatically declined.

To use tobacco, a youth would have to use one of the following products:
  • cigarettes or cigarillos;
  • smokeless tobacco;
  • pipe tobacco;
  • cigars;
  • bidis; or 
  • hookah.
Youth who are vaping are undeniably not using tobacco, since e-cigarettes and vaping products do not contain tobacco.

Since the overall use of the six types of tobacco by youth has declined substantially since 2011, it is simply untrue for the CDC to claim that the use of tobacco by youth has stayed the same, which is exactly what it told the public:

"No decline in overall youth tobacco use since 2011."
---Centers for Disease Control and Prevention; April 14, 2016.

"Overall tobacco use by middle and high school students has not changed since 2011...".
---Centers for Disease Control and Prevention; April 14, 2016.

The fact that for a technical legal reason (a strange definition of the term "tobacco products" in the Family Smoking Prevention and Tobacco Control Act of 2009), the FDA's Center for Tobacco Products is regulating (any day now) e-cigarettes as a "tobacco product" does not miraculously mean that tobacco magically appears in vaping products out of thin air.  Despite what the CDC says, there is no process that observes the laws of physics which can instantly teleport tobacco into an electronic cigarette liquid or cartridge that didn't have tobacco in it when it left the manufacturing plant.

While the CDC would be deceiving the public even if it stated that youth use of "tobacco products" has remained the same, the agency is going far beyond that. It is actually claiming that the use of "tobacco" itself among youth has stayed the same. This is categorically false.

Even if the CDC argued that the use of "nicotine-containing" products among youth has remained the same since 2011, it would still be deceiving the public. According to data from the Monitoring the Future study, the majority of electronic cigarettes being used by youth do not contain any nicotine. However, the CDC is claiming - incorrectly - that all e-cigarettes used by youth contain nicotine. The Monitoring the Future findings suggest the most youth who are using e-cigarettes are sticking to the use of e-liquids that just contain flavorings, but without nicotine.

The CDC claim that "one in four high school students use tobacco" is, quite fortunately, not true. It is not even true that one in four high school students uses nicotine. What is true is that one in four high school students uses either tobacco or electronic cigarettes.

It does not seem that the CDC's claim is simply the result of a careless mistake. It has all the trappings of a deliberate attempt to deceive the public into thinking that the public health gains associated with the dramatic decline in smoking have been completely offset by the increasing rates of experimentation with electronic cigarettes.

By essentially equating the use of cigarettes (which contain tobacco) with the use of e-cigarettes (which do not), the CDC is not only undermining the public's appreciation of the severe hazards of smoking (thus taking up a role that the tobacco industry used to play), but it is also revealing that the agency actually doesn't care whether youth use real cigarettes or fake ones. They're just lumping them together: both products that kill hundreds of thousands of people, including about half of the youth who use them over many years, and products which have not been demonstrated to have any substantial health risks, and about which the worst the CDC can say is that "they are not harmless water vapor." Neither is coffee.

Apparently, to the CDC, if a youth uses an electronic cigarette, it is just as bad as that youth using a real tobacco cigarette. This shows a reckless disregard for the health of our nation's youth. Parents should be absolutely thrilled if their kids are using fake cigarettes instead of real ones. That smoking rates have declined in the presence of huge increases in e-cigarette use is a major public health victory. If all cigarette use among youth was replaced by e-cigarette experimentation, it would be a public health miracle that would save literally millions of future lives. But the CDC appears to have less interest in saving lives than it does in demonizing e-cigarettes simply because they are not just harmless water vapor.

To be clear, none of this means that we should not ban the sale of e-cigarettes to minors, discourage kids from using vaping products, regulate the marketing of e-cigarettes to youth, and educate kids about the potential health risks and the not clearly defined potential long-term risks associated with vaping. But we can do all of the above things without lying to kids. We can do all of these things without deceiving the public into thinking that electronic cigarettes contain tobacco when they do not.

In fact, by not being straightforward with our nation's youth by explaining the differences between cigarettes and e-cigarettes, the difference between the vast majority of vaping products that do not contain tobacco and the few which do (such as products like the Pax vaporizer), and the differences between vaping liquids and cartridges which contain nicotine and those which do not, the CDC is squandering an opportunity to actually make a difference by reducing the risks associated with vaping among youth and reducing the risk of addiction to these products.

For six years, the CDC has been scaring youth about the health effects of e-cigarette use, yet its campaign is not working: as the CDC itself documents, e-cigarette use continues to skyrocket. Clearly, this approach is not working. Telling the kids the truth would be the first step towards an effective strategy to confront the problem. Furthermore, such an approach would not have the adverse effect of undoing years of public education about the severe health hazards caused by smoking.

For those who think I am exaggerating when I opine that the public has less appreciation of the severe hazards of smoking than in the past, consider the scientific evidence: less than half of the public understands that smoking is more harmful than vaping, and the percentage of the public who think that smoking is no more harmful than vaping is increasing.

There are two things that the CDC has never told youth, and never told the American public either?

a. that electronic cigarettes do not contain tobacco; and
b. that electronic cigarettes are not as hazardous as tobacco cigarettes;

It is completely unnecessary, and quite damaging as well as dishonest and non-transparent, to hide this critical information from the public, and from youth. The CDC is treating youth like ignorant babies who have to have every decision made for them. Our nation's youth are actually more likely to take steps to protect themselves if they can make the decision for themselves by being fully informed about the facts. Sweeping, exaggerated, and deceptive propaganda has never worked as an approach to improving adolescent health.

Most importantly, honesty and transparency are important cornerstones in the ethical code of public health. By eschewing these principles for the sake of trying to use scare tactics, the CDC is not only violating this code, but it is risking losing the public's trust and undermining its own credibility. That would be a disaster. If people realize that the CDC is lying to them about the contents of electronic cigarettes, then the public may not trust the agency about other issues as well, and that could have disastrous outcomes.