Thursday, January 29, 2015

California DPH Report on E-Cigs is Heavily Biased; Cherrypicks Studies Like the Tobacco Industry Used to Do

If I said the words "heavily biased report," "cherrypicks studies that agree with its position and ignores studies that don't," "uses studies in ways that the study authors say are inappropriate," most tobacco control advocates would assume I am talking about a historical Big Tobacco report. Little would they suspect that what I am actually referring to is a report by the California Department of Public Health.

Sadly, I am referring to precisely that. A newly-released report on electronic cigarettes from the California Department of Public Health purports to provide a scientific review of the topic. Today, I examine the information it presents about the efficacy of e-cigs for smoking cessation and the evidence upon which it bases its conclusion.

The report concludes that: "There is no scientific evidence that e-cigarettes help smokers successfully quit traditional cigarettes or that they reduce their consumption."

This conclusion is based on only one peer-reviewed, observational study, which "found that e-cigarette users are a third less likely to quit cigarettes, suggesting that e-cigarettes inhibit people from successfully kicking their nicotine addiction."

The Rest of the Story

The study upon which the report most heavily relies is the Vickerman study. This is the study which the report claims found that e-cigarette users are a third less likely to quit cigarettes. As I have explained in detail elsewhere, the data from the Vickerman study cannot be used to assess the effectiveness of e-cigarettes for smoking cessation. Instead of estimating cessation rates among a cohort of smokers who made quit attempts using these products, the study analyzed cessation rates of a large number of smokers who had previously tried to quit using e-cigarettes but failed, and then called a quitline because they had failed and wanted to try again. Then, they compared the quit rate among these smokers to that among smokers without such a history of a failed quit attempt using electronic cigarettes.

In other words, this study did not estimate quit rates among smokers trying to quit using e-cigarettes. Instead, it estimated quit rates among many smokers who were not using e-cigarettes in their quit attempt at all!

The truth is that many of the electronic cigarette users in the study did not use electronic cigarettes in their quit attempts! According to data provided in the paper, a full 28% of the sample of electronic cigarettes did not use these products in their quit attempts.

It should be clear to readers that this study was poorly designed to investigate the efficacy of electronic cigarettes.

Even the author of the study stated most clearly that it was not designed to examine the efficacy of e-cigarettes for smoking cessation, and that it could not and should not be used for that purpose: "The recently published article by Dr. Katrina Vickerman and colleagues has been misinterpreted by many who have written about it. It was never intended to assess the effectiveness of the e-cig as a mechanism to quit."

Moreover, Dr. Vickerman herself explained that her results do not in any way indicate that electronic cigarettes are less effective than NRT, stating: "It may be that callers who had struggled to quit in the past were more likely to try e-cigarettes as a new method to help them quit. These callers may have had a more difficult time quitting, regardless of their e-cigarette use."

While the California DPH report relies upon a survey, an unpublished presentation, and the Vickerman paper, none of which were designed to determine the efficacy of electronic cigarettes for smoking cessation, there have been three clinical trials which were designed specifically to answer this question. Two were conducted by Dr. Riccardo Polosa and colleagues in Italy. One was conducted by Dr. Bullen and colleagues in New Zealand. These three studies are the best and most rigorous scientific information we have on the efficacy of electronic cigarettes.

So here's a question:

In the California DPH's comprehensive report, how many of these 3 clinical trials did it consider in determining its conclusion regarding the effectiveness of electronic cigarettes for smoking cessation?

A. One
B. Two
C. Three

The answer is ....

....None of the above.

The report doesn't consider a single one of these clinical trials, none of which is cited in the report.

In conclusion, this report is severely biased. It draws conclusions about the efficacy of e-cigarettes from studies that were never designed to measure the efficacy of e-cigarettes. It cherrypicks the studies that support its pre-determined conclusion and excludes studies that don't support this conclusion. It doesn't cite a single one of the three clinical trials which provide the most rigorous evidence regarding the effectiveness of e-cigarettes for smoking cessation.

This is exactly the type of thing we used to see from the tobacco industry in the past. But the rest of the story is that a health agency is now using precisely the same shoddy science techniques. There is apparently so much hysterical zeal against electronic cigarettes that science has lost its rightful place in the tobacco control movement.

The CDHS report goes even further than most e-cigarette opponents by arguing that there isn't even any evidence that electronic cigarettes can help smokers reduce their consumption. But that is an outright lie. There is tremendous evidence that e-cigarettes help smokers reduce their consumption. In fact, even among smokers who had no interest in quitting, more than 50% were able to cut their consumption by at least one-half after trying e-cigarettes. Numerous other studies have documented the same phenomenon. Even the most vigorous e-cigarette opponents have acknowledged that e-cigarettes are often associated with a significant reduction in cigarette consumption.

I actually agree with many of the measures recommended by the CDPH report, such as requiring leakproof containers for e-liquids, requiring childproof packaging, and conducting public education campaigns to reveal the truth about these products (and especially, about the relative risks between smoking and vaping). However, I do not condone the use of shoddy science, reminiscent of the tobacco industry of old, in order to support the need for these actions. The truth is enough. And in public health, we should offer the public nothing but the truth.

Wednesday, January 28, 2015

Anti-Smoking Groups' Propaganda Campaign is Working: Policy Maker Says that "Hundreds of Thousands" of Vapers Will Die

Today brings evidence that not only is the misinformation coming from many electronic cigarette opponents unethical because it violates the public health principles of transparency and honesty, but the propaganda campaign is actually working.

In a Reuters article from Monday, state Senator Mark Leno is quoted as stating: "Whether you get people hooked on e-cigarettes or regular cigarettes, it’s nicotine addiction and it kills. We're going to see hundreds of thousands of family members and friends die from e-cigarette use just like we did from traditional tobacco use."

The Rest of the Story

There is absolutely no evidence to support the contention that e-cigarettes are going to kill hundreds of thousands of vapers. In fact, there is currently no evidence that e-cigarette use carries with it any mortality risk. Clearly, this policy maker is under the mistaken belief that e-cigarette use is as harmful as smoking.

Where could he possibly have gotten that idea?

Let's see .... could it be? ........SATAN?! (apologies to those who did not get the Church Chat reference)

The answer appears to be much simpler. He most likely got this ridiculous idea from the propaganda campaign being waged by electronic cigarette opponents. Over the past few days and months, I have documented one story after another of major anti-smoking groups and agencies disseminating the false claim that vaping is no less hazardous than active smoking. This propaganda has come from reputable health agencies and groups, including the FDA, the American Lung Association, the American Thoracic Society, and the American Legacy Foundation, as well as from numerous physicians and public health practitioners. It should therefore come as no surprise that policy makers are picking up on this, believing it, and then relying on it to formulate e-cigarette policy.

Making matters even worse, some of this misrepresentation and deception is occurring in the presence of severe financial conflict of interests which are being hidden from the media and the public.

Where is the error in simply being honest and truthful to American consumers?

Tuesday, January 27, 2015

New Head of Office of Medical Products and Tobacco at FDA Has History of Pharmaceutical Consulting

It appears that the FDA is following a pattern in seeking new directors and office heads. It is apparently looking to those who have financial conflicts of interest with Big Pharma. I have already discussed how Mitch Zeller - the head of the Center for Tobacco Products - came to FDA directly from a pharmaceutical consulting company. Yesterday, it was announced that the new head of the Office of Medical Products and Tobacco at FDA will be Dr. Robert Califf.

The press release describes Dr. Califf as follows:

"During his career, Dr. Califf has led many landmark clinical studies, and is a nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research. He is one of our nation’s leaders in the growing field of translational research, which is key to ensuring that advances in science translate into medical care. He was a member of the Institute of Medicine (IOM) committees that recommended Medicare coverage of clinical trials and the removal of ephedra from the market and of the IOM’s Committee on Identifying and Preventing Medication Errors. In addition, he served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology. Currently, he is a member of the IOM Policy Committee and liaison to the Forum in Drug Discovery, Development, and Translation."

The Rest of the Story

Despite the seemingly exhaustive review of Dr. Califf's many highly recognized roles, there is one small piece of information that was not provided.

It turns out that Dr. Califf has a strong conflict of interest by virtue of his long history of grant funding and consultancies for Big Pharma. These are precisely the companies he will now be regulating.

In a recent article published in the journal Metabolism, Dr. Califf is a co-author of a manuscript that reported the results of a clinical trial which tested the efficacy of two pharmaceutical agents in treating metabolic syndrome. The manuscript notes that: "The NAVIGATOR study was supported by Novartis, Inc., and was designed by an academic executive committee in collaboration with the sponsor."

In addition to this pharmaceutical funding, Dr. Califf also disclosed personal conflicts of interest with Big Pharma: "RMC has received consulting fees from Bayer, Bristol-Myers Squibb, CV Sight LLC, DSI-Lilly, Gambro,, Janssen, Kowa, Novartis, Pfizer, Regeneron, and Roche." He also acknowledged that: "his institution has received research grants from Bristol-Myers Squibb, Novartis, Amylin, Merck, Schering-Plough, Scios, Johnson & Johnson, and Eli Lilly."

It does appear to me that there is a question about whether there might be a conflict of interest for a scientist with a substantial number of personal conflicts of interest with Big Pharma to be brought in to head a department which is involved directly in the regulation of those very pharmaceutical companies.

It may be that Dr. Califf has to recuse himself from varous decisions that directly affect these particular companies. However, the list of companies is so long that there may not be all that many drug reviews that do not pose a conflict of interest. Perhaps more concerning than this individual case is the pattern that seems to be emerging. Do we really want a rotating door between the FDA and the pharmaceutical industry and its consultants?

Yet Another Public Health Practitioner Publicly Claims that Smoking is No More Hazardous than Vaping

In what is becoming a daily occurrence, yet another public health practitioner has publicly claimed that smoking is no more hazardous than vaping.

In a letter to the editor published in the New York Times, Joshua Muscat - a professor of public health sciences at the Penn State College of Medicine - writes:

"The biggest concern about e-cigarettes is their potential to increase nicotine addiction among young smokers, especially children, who would not normally try tobacco. It is not likely that e-cigarettes are safer, because their use may lead to increased and not decreased tobacco smoking in young people."

The Rest of the Story

Whether e-cigarettes lead to smoking among young people or not is irrelevant to the issue of whether e-cigarette use is safer than smoking. Moreover, there is no evidence that e-cigarette use leads to increased smoking among young people. If anything, there is some evidence pointing in the other direction. But the main point is that it is simply not true that vaping is as hazardous as smoking.

By disseminating to the public the falsehood that vaping is just as harmful as smoking, medical and public health practitioners are actually discouraging many smokers from quitting. They may even be causing many ex-smokers, who quit using e-cigarettes, to return to active smoking. After all, if vaping is no safer than smoking, then what's the point of using e-cigarettes? You're better off smoking and getting the full enjoyment of the experience.

Michael Shaw notes the absurdity of the position of many public health practitioners in a column published at Health News Digest. He writes: "The FDA approved products--patches, gums, and drugs--help "boost" that to about one in ten, an abysmal "success" rate of 10 percent. Yet, the official line, from the FDA and the CDC on down, is "stick with the FDA-approved methods; don't even try anything else!" Chief among that "anything else" are e-cigarettes, loved by users--because they do help you quit--but almost unanimously hated by officialdom. ... However, there are powerful forces against e-cigarettes, including the proverbial strange bedfellows. ... As to the strange bedfellows, e-cig opponents include many public health departments, disease trade associations, and a host of smoking cessation groups.  Why on earth should the American Lung Association be against e-cigs?"

That is a great question. Why are so many public health and anti-smoking groups against a product that is helping many smokers quit? But more importantly, why are so many public health and anti-smoking practitioners telling lies about the scientific evidence regarding the relative safety of vaping vs. smoking.

There is certainly room for a healthy debate about the appropriate role that e-cigarettes should play in public health promotion and the regulations that are necessary to maximize the potential benefits while minimizing the risks of these products. However, there is no room for lying to the public about the science.

ADDENDUM: Dr. Gil Ross has an excellent column in the Daily Caller which highlights the misinformation being disseminated by the California Department of Health Services. Note particularly this important point: "the official line, from the FDA and the CDC on down, is “stick with the FDA-approved methods; don’t even try anything else!” This amounts to advising desperate, addicted smokers to “quit, or die,” given the 90 percent failure rate of these products."

Monday, January 26, 2015

American Thoracic Society Physicians Claim There is No Evidence Smoking is More Hazardous than Vaping

In statements that even the tobacco industry would not make, two physicians with the American Thoracic Society have publicly claimed that there is no evidence smoking is any more hazardous than the use of non-tobacco-containing, non-combusted e-cigarettes.

In a letter to the editor in the New York Times, Dr. Frank Leone - a pulmonologist who is chair of the American Thoracic Society's Tobacco Action Committee - claims that there is no evidence that e-cigarettes are safer than real cigarettes. In fact, he claims that it is too early to even suggest that e-cigarettes are likely to be much safer than smoking.

Dr. Leone writes: "There is not sufficient evidence to conclude that e-cigarettes are a safer alternative to regular cigarettes or that e-cigarettes actually help smokers quit. ... it is too early to suggest labeling saying 'it is likely that e-cigarettes are much safer than smoking.' That isn't reassurance; it's a marketing tactic."

Meanwhile, in an article in the Journal of the National Cancer Institute, Dr. Dona Upson - a member of the Tobacco Action Committee of the American Thoracic Society - also claims that there is no evidence vaping is any less hazardous than smoking.

Dr. Upson is quoted as stating that: "we just don’t have any good, solid data showing harm reduction versus tobacco products."

The Rest of the Story

These are shocking claims, given that e-cigarettes contain no tobacco and merely heat and aerosolize a solution of nicotine, propylene glycol, and glycerine, while cigarettes burn tobacco at very high temperatures, producing more than 10,000 chemicals which include more than 60 human carcinogens.

The statements are also shocking given the fact that a multitude of data now demonstrate that e-cigarettes are less toxic than tobacco cigarettes, including studies showing that asthmatic smokers who switch to e-cigarettes experience dramatic improvement in their symptoms, that the levels of virtually all carcinogens are much lower in e-cigarette aerosol than in tobacco smoke, and that unlike smoking, vaping does not cause endothelial dysfunction or decrements in spirometric pulmonary function tests.

And the statements are even more shocking given that the tobacco companies themselves have acknowledged that smoking is much more hazardous than vaping. Obviously, it would be quite advantageous for the tobacco companies to lie to the public and repeat the claim that these physicians are making. But the tobacco companies are not doing that. Ironically, they are the ones telling the truth about the relative hazards of smoking vs. vaping.

Adding to the shock, Dr. Leone states that there is not evidence to even suggest that e-cigarettes are likely to be less hazardous than smoking. In other words, he is claiming that it is not likely that smoking is any more hazardous than vaping. Based on the existing scientific evidence, I view that claim as being patently false.

It is not clear exactly what the American Thoracic Society's Tobacco Action Committee is smoking, but whatever it is, they are undermining years of public education about the severe hazards of smoking. They are also discouraging quit attempts by smokers and helping to protect the cigarette market, as the hysterical information they are disseminating may well scare some vapers into returning to smoking and may discourage smokers from quitting who might well have quit using e-cigarettes.

On the bright side, I at least applaud Dr. Leone for speaking out against hospital policies that refuse employment to e-cigarette users.

This story once again demonstrates how ideology, and not science, has taken over in the tobacco control movement.

Friday, January 23, 2015

Confirmed: Formaldehyde Study Conducted Under Implausible Conditions; Conclusions Invalid

Using information on type of atomizer studied in the recent New England Journal of Medicine article which claimed that vaping produces formaldehyde levels that pose a greater cancer risk than active smoking, Dr. Konstantinos Farsalinos has confirmed that the conditions used in the study (at the 5 volt level) were implausible.

The study reported finding high levels of formaldehyde in the aerosol of electronic cigarettes, leading the authors to conclude that the cancer risk associated with vaping is higher than that associated with smoking. The formaldehyde was not detected at the low voltage setting (3.3V), but was detected in large quantities at the high voltage setting (5.0V).

It turns out that the atomizer had a resistance of 2.1 ohms. At a voltage of 5 volts, the power delivered would be about 12 watts. This is clearly in the red zone, where the atomizer coil may be damaged or burned and the e-liquid would definitely be overheated. This would create an extremely unpleasant taste, and no vaper could tolerate more than one puff under these conditions (known as "dry puff" conditions).

The Rest of the Story

The implications of this story are that the conditions used in the high voltage setting in the study were implausible. Thus, the cancer risk estimation in the study is invalid, as is its conclusion that vaping poses a higher cancer risk than active smoking because of the high levels of formaldehyde.

To borrow an apt analogy from Dr. Farsalinos, it is like totally charring a piece of meat, detecting high levels of carcinogens, and then concluding that people who eat meat are at a very high risk of developing cancer. While it is absolutely accurate that there are high levels of carcinogens in charred meat, no one eats meat under such conditions, so the cancer risk estimation is completely invalid.

If you overheat an atomizer, it is going to result in aldehyde formation. This is because at very high temperatures, propylene glycol degrades (is oxidized) to form formaldehyde due to incomplete combustion. This process is enhanced with the presence of metals.

While the high voltage conditions were implausible, the low voltage conditions were not. Thus, the only valid conclusion from the study is that at low voltage conditions, the atomizer tested did not produce any detectable levels of formaldehyde.

Unfortunately, the alarmist (and incorrect) conclusions of this study have already been widely disseminated in the media. Even if the information is corrected, it appears that the damage is done.

I believe that the damage is substantial because many smokers will now become convinced that there is no advantage to switching from tobacco cigarettes to electronic cigarettes. This will discourage many smokers from quitting. It also may cause some vapers to return to cigarette smoking, since they may be convinced that smoking is no worse for their health.

It is difficult to imagine even the tobacco companies of old disseminating such a false conclusion about the relative "safety" of smoking. What the authors concluded is that smoking is safer than vaping, at least in terms of carcinogenic risk. While the tobacco companies undermined conclusions about the hazards of smoking, I don't recall them ever stating that smoking was as benign as a behavior for which no serious adverse effects had been observed. Regardless, my point is simply to emphasize the magnitude of the fallacious conclusion of this study and the damage that it has already done to the protection of the public's health.

Wednesday, January 21, 2015

New Study Reports High Levels of Formaldehyde in Electronic Cigarette Aerosols

A new study released today by the New England Journal of Medicine reports finding high levels of formaldehyde in the aerosol of electronic cigarettes, leading the authors to conclude that the cancer risk associated with vaping is higher than that associated with smoking.

(See: Jensen RP, Luo W, Pankow JF, Strongin RM, Peyton DH. Hidden formaldehyde in e-cigarette aerosols. New England Journal of Medicine 372;4, January 22, 2015.)

The study examined the aerosol produced by a tank system electronic cigarette. The aerosol was collected and analyzed for formaldehyde. Two voltage settings were used: low (3.3V) and high (5.0V).

The main finding was that at low voltage, no formaldehyde was detected, but at high voltage, high levels of formaldehyde were detected. Using these levels, the authors extrapolate to derive an overall lifetime cancer risk from vaping, which they claim is higher than that from cigarette smoking.

The Rest of the Story

There's just one problem with the study, but this problem renders its conclusion invalid.

The conditions used to study the e-cigarette aerosol at the high voltage setting were unrealistic and under such conditions, a vaper would never be able to use the product. This is because the wattage being used was so high that the vaporizer was overheated (for a conventional e-cigarette it would likely damage or burn the coils), creating a horrible taste which a vaper could not tolerate. This is sometimes referred to as the "dry puff phenomenon."

Based on calculations by Dr. Konstantinos Farsalinos from data provided in the article, the resistance was no higher than 1.7 ohms. At a voltage of 5.0V, the wattage would be 14.7W. That is in the "red zone" where the vaporizer is being overheated and where, for a conventional e-cigarette, the coils would likely be damaged or burned.

Essentially, what this study demonstrates is that if you overheat a vaping system, it will produce high levels of formaldehyde. However, such conditions are not realistic, as they could not be tolerated by an actual vaper. Therefore, extrapolating from this study to a lifetime of vaping is meaningless.

On the other hand, the study does demonstrate a very important point. It is entirely feasible to produce an electronic cigarette or vaping system that does not deliver any measurable amount of formaldehyde. At the low voltage setting, no formaldehyde was detected. Rather than scaring people about the dangers of vaping and alarming them to the "fact" that vaping raises their cancer risk above that of smoking, we should instead be regulating the voltage and temperature conditions of electronic cigarettes so that the problem of formaldehyde contamination is completely avoided.

As I have argued before, instead of wasting its time and resources setting up a bureaucratic nightmare, where thousands of different products must submit pre-marketing applications, the FDA should simply promulgate basic safety standards. And one of those standards should set maximum voltage and temperature conditions for these products. That would minimize the health risks while maximizing the benefits.

ADDENDUM: Dr. Farsalinos has corrected me and pointed out that it is really the coil temperature, not the voltage, which needs to be controlled and regulated. 

California Department of Health Services Lies to the Public About Electronic Cigarettes

The California Department of Health Services (CDHS), under a grant funded by the Centers for Disease Control and Prevention (CDC), has produced a brochure entitled "Protect Your Family from E-Cigarettes: The Facts You Need to Know."

Here are some of the "facts" being disseminated by the CDHS:

1. "The aerosol is a mixture of chemicals and small particles that can hurt the lungs just like cigarette smoke."

2. "E-cigarettes are just as addictive as regular cigarettes."

3. "People can become addicted to nicotine from e-cigarettes and they may start using regular cigarettes."

4. "Studies show that e-cigarettes do not help people quit smoking cigarettes."

The Rest of the Story

The California Department of Health Services is lying to the public. Here is a brief analysis of each statement and an evaluation of its validity:

1. "The aerosol is a mixture of chemicals and small particles that can hurt the lungs just like cigarette smoke."

EVALUATION: Unsupported by scientific evidence

While it is true that there are a small number of chemicals in the aerosol of many electronic cigarette brands and there are certainly small particles, at present there is no evidence that these small particles can hurt the lungs just like cigarette smoke. In fact, there is strong evidence that electronic cigarette use does not produce the kinds of decrements in lung function observed with cigarette smoking.

2. "E-cigarettes are just as addictive as regular cigarettes."


It has been quite convincingly shown that electronic cigarettes are not nearly as addictive as regular cigarettes. The nicotine delivery from e-cigarettes is quite poor and inconsistent in most brands. The delivery of nicotine from e-cigarettes is much lower than in regular cigarettes. Patterns of use of the product, especially among youth, demonstrate that the addictive power of e-cigarettes is much lower than that of tobacco cigarettes.

3. "People can become addicted to nicotine from e-cigarettes and they may start using regular cigarettes."

EVALUATION: Unsupported by scientific evidence

It has not yet been demonstrated that people can become addicted to nicotine from e-cigarettes. Certainly, people who are already addicted to nicotine from smoking may remain addicted to nicotine when they switch to electronic cigarettes. But there is as yet no evidence that nonsmokers who try e-cigarettes are at significant risk of becoming addicted to nicotine. More importantly, there is no evidence that people who start out with e-cigarettes are progressing to cigarette smoking. In fact, existing studies have failed to find more than a couple of youths who have started smoking after having been introduced to nicotine for the first time through e-cigarettes.

4. "Studies show that e-cigarettes do not help people quit smoking cigarettes."


In fact, the opposite is true. Studies show that e-cigarettes do help people quit smoking. The existing studies suggest that e-cigarettes are about as effective as nicotine replacement therapy. It is possible that newer products are more effective for smoking cessation, but at very least, we can say that these products do help many people quit smoking.

While I commend the California Department of Health Services for putting out a pamphlet that warns parents that e-liquids are poisonous and urges them to keep these products away from young children, I condemn the Department for blatantly lying to the public. In their apparent zeal to demonize electronic cigarettes, the California Department of Health Services has crossed the line into unethical public health conduct, breaking one of the key principles: communicate honestly with the public.

That federal revenue is being used to support the dissemination of these lies makes this conduct even more egregious. I urge the CDC to cancel this contract with CDHS on the grounds that the Department is violating basic public health ethics by lying to the public.

Tuesday, January 20, 2015

Physician Recommends that Middle-Age Lifelong Nondrinkers Should Be Told to Start Drinking, But Hides Conflict of Interest With Big Alcohol

In the most recent issue of the journal Alcoholism: Clinical and Experimental Research, a physician counsels all doctors to promote moderate alcohol use (one drink per day) among middle age, lifelong nondrinking patients. The author, Dr. Emanuel Rubin, is a pathologist at Thomas Jefferson University in Philadelphia.

(See: Rubin, E. (2014), To Drink or Not to Drink: That Is the Question. Alcoholism: Clinical and Experimental Research, 38: 2889–2892. doi: 10.1111/acer.12585.)

The major conclusion of the article is as follows: "The strongest evidence for a beneficial effect of moderate alcohol intake is the documented reduction in all cause mortality and cardiovascular disease. Indeed, the protection against coronary artery disease is comparable to that produced by the administration of statins. In this context, alcoholic beverages do not require a prescription, are far cheaper, and are certainly more enjoyable. Although a physician's advice to a patient should always be individualized, including a consideration of a person's genetic background, the overwhelming evidence suggests that physicians should counsel lifelong nondrinkers at about 40 to 50 years of age to relax and take a drink a day, preferably with dinner. The “black swan” predicts that the risk/benefit ratio is highly favorable."

I don't know who the "black swan" is but he appears not to be a very good scientist. Calling "comparable" the scientific evidence linking statins to an improvement in heart disease risk with that linking moderate alcohol intake to lower cardiovascular disease mortality is scientifically unsound. The link between statin use and decreased cardiovascular disease is based on several double-blind, placebo-controlled, clinical trials, while the link between moderate alcohol intake and lower cardiovascular disease risk is based on observational studies that are plagued by the problems of selection bias and confounding.

People who do not drink at all are very different from those who drink moderately, and in ways that could influence heart disease risk. For example, there are often medical reasons why people don't drink alcohol. A number of medications recommend that alcohol not be used while on them. If these medical conditions and medications are associated with cardiovascular disease risk, which is highly plausible, then this would confound the relationship between observed heart disease risk and alcohol intake.

Moreover, even if it were true that a drink a day reduced heart disease risk, it does not necessarily follow that advising lifelong non-drinkers to start drinking would create net public health benefits. Since these are people who have not consumed alcohol for 20 to 30 years of adulthood (and perhaps not in childhood as well), it is quite possible that their ability to limit their alcohol intake once they start is not sufficient to keep them at only one drink per day. One of the reasons they are not drinkers may in fact be that they have a family history of alcoholism and are predisposed to alcoholism. A large increase in the number of drinking adults may well lead to an increase in youth alcohol use, since parental drinking is a known risk factor for underage drinking. Thus, for many reasons, Dr. Rubin's advice is premature and ill-advised.

The Rest of the Story

But that's not what this post is about.

This post is about the failure of the author to disclose a significant conflict of interest with Big Alcohol.

According to a 2011 report, Dr. Rubin was at one time a member of the Medical Advisory Council of the Alcoholic Beverage Medical Research Foundation (ABMRF), which is heavily funded by the alcohol industry.  Dr. Rubin is also listed as having been a recipient of grant funding from ABMRF (from 1987-1991 and in 1993). Dr. Rubin also served as an expert witness for Philip Morris on several occasions during the period 1991-2000. During this time, the Miller Brewing Company was owned by Philip Morris.

Moreover, it appears that the conflict of interest with Big Alcohol is indeed current, as Dr. Rubin himself lists himself as being a consultant to the Medical Advisory Board of ABMRF. He lists the relationship as "Current Consultantships - Medical Advisory Council, Alcoholic Beverage Medical Research Foundation 1992-present."

Clearly, Dr. Rubin has a conflict of interest by virtue of his relationship with Big Alcohol, including having been the recipient of grant funding from an alcohol industry foundation and having served on the board of that alcohol industry foundation.

However, nowhere in the article can I find any disclosure of this conflict. 

I can't even find a disclosure of this conflict in a 2004 article in Atherosclerosis that reports the results of a study designed to identify potential benefits of alcohol consumption.

And in a 2013 article that reports the results of an investigation into potential benefits of alcohol consumption, the conflict of interest disclosure statements reads: "No potential conflicts of interest were disclosed."

Interestingly, Dr. Rubin testified that the research conducted by the Council for Tobacco Research (CTR) was of high scientific quality and that the scientific review adhered to widely recognized scientific standards. As the CTR was recently found by a federal court to be part of a vast conspiracy of fraud and deceit by the tobacco industry, Dr. Rubin's testimony in these tobacco cases sheds doubt on his scientific objectivity and judgment.

But the most serious issue here is not the poor medical advice. All physicians are entitled to their opinions. What they are not entitled to do, however, is to issue national recommendations on an issue as important as alcohol use if they have severe financial conflicts of interest, especially if they fail to reveal those conflicts.

The conflict of interest disclosure guidelines for the journal (Alcoholism: Clinical and Experimental Research) seem pretty clear. The guidelines require the disclosure of "any potential sources of conflict of interest," and they do not limit the disclosure to only a certain number of years. Here is the full disclosure requirement guideline:

"Conflict of Interest: This publication requires that all authors disclose any potential sources of conflict of interest. Any interest or relationship, financial or otherwise, that might be perceived as influencing an author's objectivity is considered a potential source of conflict of interest. These must be disclosed when directly relevant or indirectly related to the work that the authors describe in their manuscript. Potential sources of conflict of interest include but are not limited to patent or stock ownership, membership of a company board of directors, membership of an advisory board or committee for a company, and consultancy for or receipt of speaker's fees from a company. The existence of a conflict of interest does not preclude publication in this journal."

"If the authors have no conflict of interest to declare, they must also state this at submission. It is the responsibility of the corresponding author to review this policy with all authors and to collectively list in the cover letter to the Editor, in the manuscript (in the footnotes, or Conflict of Interest or Acknowledgements section), and in the online submission system ALL pertinent commercial and other relationships."

The rest of the story is that this commentary deceives readers by failing to disclose the fact that the author was the recipient of grant funding from an alcohol industry foundation and that he served on a board of that foundation. It also fails to disclose that the author is currently a consultant to the board. Surely, these conflicts are relevant to the ability of readers to properly evaluate the validity of the article's recommendations. I suspect that there are thousands of readers of this article who would be very surprised to find out "the rest of the story."

Monday, January 19, 2015

Rest of the Story Expanding to Cover Alcohol

The Rest of the Story will be expanding to cover alcohol as well as tobacco. I am becoming increasingly aware of parallels between the two fields of public health, including issues regarding hidden conflicts of interest and biased reporting of science. I'll kick the week off tomorrow with an alcohol story, to be followed by another later in the week. I expect that tobacco will remain the main focus.

Tuesday, January 13, 2015

Local Health Officials Lie to the Public; Claim that Smoking is No More Hazardous than Vaping

Local health officials in Franklin County, Kentucky are lying to the public, claiming that cigarette smoking is no more hazardous than using electronic cigarettes. According to an article in the Frankfort State Journal written by two public health officials associated with the Franklin County Health Department:

"One claim of those selling e-cigs is that they are not as harmful as cigarettes; however, this is untrue."

The Rest of the Story

It is quite ironic that health department officials, rather than tobacco industry executives, are the ones who are lying to the public and telling them that smoking is not as hazardous as previously thought. It is ironic that health officials, and not the tobacco industry, are the ones who are undermining the public's appreciation of the serious health hazards associated with cigarette smoking.

If any tobacco company came out with the statement that smoking is not any more hazardous than e-cigarettes, I can assure you that anti-smoking groups all over the country would be attacking those companies and probably bringing them to court for prosecution under RICO, consumer protection statutes, and civil lawsuits. Yet here we have a situation where numerous public health officials are lying to the public, making this precise claim, but so far as I know, not a single mainstream tobacco control organization has called them on it.

Other than the ACSH, Smokefree Pennsylvania, and the Rest of the Story, I'm not aware of any other tobacco control organizations that have publicly acknowledged that many of our colleagues in public health are lying to the public.

It is worth emphasizing that lying is unethical generally, but it is also a specific violation of the ethical code of public health.

These groups should be forced to retract their statements and apologize to the public for the damage they have done to the public's health.

Monday, January 12, 2015

Why are Anti-Smoking Groups Recommending a Smoking Cessation Drug That Has Been Linked to Hundreds of Sudden Deaths?

Numerous health and anti-smoking groups continue to recommend the use of a smoking cessation drug, despite the fact that this drug has been linked with hundreds of sudden deaths.

The drug is Chantix, and the sudden deaths were suicides.

The Vancouver Sun revealed this Saturday that in Canada over the past seven years, Chantix has been linked to 30 suicides, 44 deaths, and more than 1,300 episodes of suicidal ideation or suicide attempts, depression, and aggressive behavior.

According to the article: "Numbers on the deaths and other side-effects come from a Health Canada database where doctors, pharmacists and drug companies report bad side-effects experienced by patients taking pharmaceuticals. But Health Canada admits on its website that side-effects are under-reported, and experts say the database could represent as little as one per cent of the patients who suffer complications.
“A small proportion of the adverse reactions that have occurred on this drug in Canada would be in the adverse reaction database. Essentially it is spontaneous, voluntary reporting,” said Barbara Mintzes, a pharmaceutical drug expert at the University of B.C."

"Even the incomplete numbers, though, are a concern, she said. When someone taking an anti-depressant attempts suicide, it’s initially not clear whether that’s caused by the pre-existing depression or the drug; but in the case of Champix, people are taking the drug to stop smoking — not for a mental health condition. “You are looking at a lot of deaths, suicides and attempted suicides, and suicidal ideation in a population that you would have no reason to think would be otherwise at high risk of suicide,” said Mintzes, an associate professor in the Faculty of Medicine’s School of Population and Public Health."

The article also revealed that in 2012, the British Columbia ministry of health fired eight scientists who were doing research on Chantix. Also that year, the health ministry cancelled an independent review of Chantix, allegedly because it didn't want the serious adverse effects associated with this drug to go public. A leaked email written by the co-director of the health ministry's drug evaluation unit stated:

"We’ve decided to keep (the review of) smoking cessation in-house, sorry about that. It’s getting political and we aren’t sure anyone wants to see a published evaluation."

The Rest of the Story

Imagine that there were reports linking the use of electronic cigarettes to hundreds of sudden deaths. Unquestionably, health and anti-smoking groups would be calling for the removal of e-cigarettes from the market. At very least, they would not be recommending the use of e-cigarettes for smoking cessation. How then can these groups recommend the use of Chantix?

This reveals the hypocrisy and bias of these anti-smoking groups. They recommend that smokers use Chantix, despite its having been linked with hundreds of sudden deaths, but they discourage smokers from using e-cigarettes, which have so far not been linked to any serious adverse health effects.

Moreover, there is a black box warning on Chantix which alerts patients to the potential for serious health effects, including suicidal ideation and suicide attempts. Given that warning, how can these anti-smoking groups continue to recommend the use of the drug?

It isn't this recommendation alone that troubles me. It is the hypocrisy of the anti-smoking groups. If e-cigarettes were linked to even a fraction of the sudden deaths to which Chantix has been linked, there is no way that these groups would be recommending the use of e-cigarettes.

Whether Chantix is causally linked to suicide is not relevant to my point because if e-cigarettes were linked - by anecdotal reports - to sudden deaths, even without definitive evidence of a clear causal connection, anti-smoking groups would not be recommending the use of this smoking cessation device. But under precisely the same conditions, they are recommending the use of Chantix.

I believe there are three major reasons for the hypocrisy and bias that we see being displayed.

First, there is a strong ideology in the anti-smoking movement against anything that even looks like smoking, regardless of the benefits and health effects of the product. Anti-smoking groups simply cannot recommend a behavior that looks like smoking, regardless of how many lives it might save.

Second, there is a strong pre-existing bias against electronic cigarettes. Anti-smoking groups have reached the pre-determined conclusion that e-cigarettes are evil, and no amount of scientific evidence of the net public health benefits of these products will cause the groups to change their mind.

Third, most of the major anti-smoking groups receive significant funding from Big Pharma, and Pfizer - the maker of Chantix - is a major donor to these groups. This creates an obstacle to anti-smoking groups publicizing the potential dangers of Chantix because they don't what to bite the hand that feeds them. However, this financial conflict of interest is hardly ever disclosed when these groups make their public recommendations against the use of e-cigarettes and for the use of Chantix.

The apparent actions of the British Columbia health ministry are a rather extreme demonstration of these severe biases. But we must remember that even by merely discouraging the use of e-cigarettes, anti-smoking groups are causing public health harm because they are opposing a bona fide strategy for smoking cessation that helps many smokers who would not be able to quit using traditional methods.

Thursday, January 08, 2015

Alaska Health Department Airs First Pro-Smoking Television Ad Since 1970

Since 1970, the television airwaves have been clear of pro-smoking advertisements. That is, until recently, when the Alaska Department of Health and Social Services began running a television spot that undoubtedly promotes smoking by strongly discouraging smokers who might otherwise quit from using electronic cigarettes. The commercial will likely also cause ex-smokers who have quit via electronic cigarettes to return to cigarette smoking. Worst of all, the commercial lies to the public by attributing to electronic cigarette diseases for which there is no evidence of an association with vaping.

The text of the commercial reads as follows:

"What's in an e-cig cloud? ... Nicotine, just like the other cigarettes. Ultrafine particles that can lead to asthma. Embalming fluid. Ugh. Lead. Doesn't that cause brain damage? Nail polish remover. ... Don't let Big Tobacco cloud your judgment."

The Alaska state health department also provides a fact sheet which implies that electronic cigarettes are no safer than real cigarettes. The health department justifies this conclusion based on a single study, which tested the effect of electronic cigarette vapor on bronchial cells in cell culture.

The Rest of the Story

There is no doubt that this commercial is extremely misleading and that it contains false information. It is designed to scare people so much about the health effects of vaping that they essentially view these products as no different from tobacco cigarettes in terms of health risk. The ultimate effect of this campaign is that many smokers in Alaska who might otherwise have quit smoking or cut down substantially by switching to electronic cigarettes will be dissuaded from doing so. Moreover, many ex-smokers who successfully quit via the use of electronic cigarettes may well return to smoking, since it appears from the commercial that e-cigarettes are not better for your health than tobacco cigarettes.

Let's start with the information that is outright false. The commercial implies that electronic cigarettes can cause "asthma" and "brain damage." This is an outright lie. There is absolutely no evidence that electronic cigarettes cause asthma or brain damage. In fact, Dr. Riccardo Polosa and colleagues have shown that electronic cigarettes actually improve symptoms of asthma in smokers who either completely or even partially switch to these products. No study has ever shown that electronic cigarettes cause brain damage. What we do know is that switching to electronic cigarettes can substantially improve the health of smokers.

Now let's move to the information that is downright misleading. Telling the public that electronic cigarettes contain embalming fluid and nail polish remover is misleading because it belies the fact that e-cigarettes merely contain small amounts of the main components of those products. Someone who uses an electronic cigarette is not inhaling embalming fluid any more than someone who purchases a new sofa is inhaling embalming fluid.

To demonstrate how misleading and damaging this commercial is, consider the very same commercial applied to nicotine gum:

"What's in nicotine gum? ... Nicotine, just like cigarettes. And 4-(methylnitro-samino)-1-(3-pyridyl)-1-butanone, a powerful carcinogen that causes lung cancer. N-Nitrosonornicotine. Doesn't that cause esophageal cancer? Don't let Big Pharma cloud your judgment."

The above commercial text is just as scientifically valid as that provided by the Alaska health department. However, if the Department aired such a commercial, it is very clear that such a campaign would be terribly misleading. It would also be terribly damaging, because it would likely scare people who might otherwise quit using nicotine gum not to proceed with their quit attempt. And it might dissuade people who have already quit using nicotine gum from continuing the gum use, which could likely lead to their returning to smoking.

If the tobacco industry put out such an advertisement, there is no question that we in public health would be condemning the campaign and arguing that it is a pro-smoking campaign. Anti-smoking groups would likely try to have the commercial pulled off television on the grounds that it is pro-smoking and thus violates the intent of the 1970 ban on television advertising of cigarettes.

Now consider the very same commercial applied to the nicotine inhaler:

"What's in a nicotine inhaler? ... Nicotine, just like cigarettes. Nickel, a metal which has been shown to cause cancer, respiratory failure, and heart disorders. Lead. Doesn't that cause brain damage? Don't let Big Pharma cloud your judgment."

Once again, the commercial text is just as scientifically valid as that provided by the Alaska health department. However, if the Department aired such a commercial, it is very clear that such a campaign would be terribly misleading. It would also be terribly damaging, because it would likely scare people who might otherwise quit using a nicotine inhaler not to proceed with their quit attempt. And it might dissuade people who have already quit using the nicotine inhaler from continuing the inhaler use, which could likely lead to their returning to smoking.

And once again, if the tobacco industry put out such an advertisement, there is no question that we in public health would be condemning the campaign and arguing that it is a pro-smoking campaign. Anti-smoking groups would likely try to have the commercial pulled off television on the grounds that it is pro-smoking and thus violates the intent of the 1970 ban on television advertising of cigarettes.

We could even run a similar commercial about the nicotine patch:

"What's in a nicotine patch? ... Nicotine, just like cigarettes. 4-(methylnitro-samino)-1-(3-pyridyl)-1-butanone, a powerful carcinogen that causes lung cancer. And doesn't that also cause lung immunosuppression? Don't let Big Pharma cloud your judgment."

Another untruthful aspect of the campaign is its denial that smoking is any more hazardous than vaping. Can you imagine if the tobacco industry made such a claim on a web site? The anti-smoking movement would be up in arms. How dare the tobacco industry undermine years of education about the hazards of cigarette smoking by telling the public that smoking may be no more hazardous than using an electronic cigarette. But this is exactly what the Alaska health department is doing.

My colleague Stan Glantz has praised the campaign, urging all other states to air the same commercial. However, I can't possibly condone a campaign that lies to the public, significantly misleads its audience, undermines years of public education about the health hazards of smoking, and has the effect of promoting smoking by discouraging smokers who would otherwise have quit using e-cigarettes not to do so. 

Tuesday, January 06, 2015

Latest UK Data Suggests Substantial Benefits of Electronic Cigarettes for Smoking Cessation

According to an article in The Guardian, electronic cigarettes were the fastest growing item in terms of supermarket sales in the UK in 2014: "E-cigarettes were the fastest-growing product in British supermarkets last year as consumers shrugged off the controversy over vaping. Sales of electronic cigarettes – or vapourisers – across the largest grocers rose 49.5% in 2014, despite clamour from health groups to ban the devices."

Data from the Smoking Toolkit Study (STS) show that there was a dramatic rise in the use of electronic cigarettes among adults in England that began in 2012 and continued through 2014. Contemporaneous data from the STS show that the period 2012-2014 marked a sudden reversal in the trend of declining annual smoking cessation rates.

From 2007-2011, annual quit rates declined steadily from 6.7% to 4.6%. But suddenly in 2012, things turned around. The quit rate jumped to 6.2%, remained at 6.1% in 2013, and rose further to 7.5% in 2014.

Moreover, the same trend was observed in the proportion of smokers trying to quit each year.

And to top it off, the same trend was observed in the proportion of smokers trying to quit who reported success in their quit attempt.

Of course, these is merely an ecological analysis. However, the pattern of these trends seems far too striking to be explained alternatively. The working hypothesis, it seems, should be that electronic cigarettes have played a major role in enhancing smoking cessation in the England, both by stimulating quit attempts and improving success in those quit attempts.

The Rest of the Story

The irony of this story is that policy makers in the UK wanted a virtual ban on electronic cigarettes, and health groups and many anti-smoking advocates in the U.S. favor policies that would put a huge dent in the growth of the electronic cigarette market (at the expense, of course, of increased tobacco cigarette sales).

This is probably the most profound example in my career of public health groups supporting policies that are antithetical to the overall goals of public health. Therefore, it warrants a careful examination of the reasons why anti-smoking groups are promoting such policies. Our search for these answers will continue at The Rest of the Story over the next few months.

The rest of the story is that the existing evidence suggests that electronic cigarettes are producing substantial public health benefits but causing very little in the way of public health harms. Based on the data available at the present time, I think it is safe to conclude that electronic cigarettes are having a very large net positive impact on the public's health. Unfortunately, anti-smoking groups are doing everything they can to negate this public health success story.

Monday, January 05, 2015

2014 Anti-Smoking Myth of the Year Award Goes to CDC, Dr. Stan Glantz, and Dr. Michael Fiore

The Rest of the Story is pleased to announce the recipients of the 2014 Anti-Smoking Myth of the Year Award. This year's award goes to:
  • The Centers for Disease Control and Prevention (CDC);
  • Dr. Stan Glantz; and
  • Dr. Michael Fiore
for publicly spreading the myths that electronic cigarettes have been found to be a gateway to smoking among youth and that electronic cigarette experimentation leads to a lifelong addition to nicotine.

The CDC was first to the punch, with its director misrepresenting cross-sectional CDC survey data as conclusive evidence that electronic cigarettes are a gateway to smoking. Specifically, CDC Director Dr. Thomas Frieden stated:

"What we are doing first is tracking, and we are seeing some very concerning trends. Use of e-cigarettes in youth doubled just in the past year, and many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes."

In addition, Dr. Frieden was quoted as stating that electronic cigarettes are "condemning many kids to struggling with a lifelong addiction to nicotine."

The Office on Smoking and Health (where I used to work) vigorously supported these statements and failed to offer any public corrections. Nor am I aware of any other CDC corrections or retractions of these claims.

More recently, Dr. Stan Glantz began disseminating the conclusion that e-cigarettes are a gateway to smoking. In an article published in USA Today, he stated definitively that electronic cigarettes are a gateway to smoking. He was quoted as stating: "There's no question that e-cigarettes are a gateway to smoking."

And even more recently, Dr. Michael Fiore rang in the new year with a public statement that electronic cigarettes can lead youth to a lifetime addiction to nicotine. He was quoted as stating: "One of the biggest concerns about e-cigarettes is that they will serve as a gateway drug to lifelong nicotine dependence and all of the harms we know result from cigarette smoking. We know that the adolescent brain is very sensitive to nicotine. Use of e-cigarettes, with its exposure to nicotine, puts these adolescents at risk of lifelong nicotine addiction."

The Rest of the Story

As I have repeatedly pointed out, there is absolutely no existing evidence that electronic cigarettes are a gateway to smoking among youth or that electronic cigarette experimentation is leading youth to a lifetime of addiction to nicotine. In fact, the only evidence to date suggests that among U.S. youth, electronic cigarettes are not a gateway to smoking and e-cigarette experimentation does not appear to lead to regular (greater than weekly) use, much less to a lifetime of addiction.

President John F. Kennedy once said: "The great enemy of truth is not the lie--deliberate, contrived, and dishonest--but the myth--persistent, persuasive, and unrealistic." Here indeed, the repeated statements of the CDC and a number of prominent anti-smoking researchers have effectively created a myth, one that has become persistent and persuasive, even though it lacks evidence. And as a result, the media and in turn, policymakers, are accepting this myth as truth and making poor policy decisions because of it.

Interestingly, what President Kennedy went on to say in that 1962 speech relates perfectly to the manner in which the anti-smoking movement is dealing with the scientific question of whether e-cigarettes are a gateway to smoking.

Kennedy went on to say: "Too often we hold fast to the cliches of our forebears. We subject all facts to a prefabricated set of interpretations. We enjoy the comfort of opinion without the discomfort of thought."

This is precisely what is occurring in the tobacco control movement. We are holding fast to the cliches of the fast (i.e., the knowledge that smokeless tobacco can act as a gateway to cigarette use). We are subjecting all evidence to a prefabricated set of interpretations. Even cross-sectional evidence is being interpreted as showing that youth are starting with e-cigarettes and then progressing to active smoking. The CDC and some anti-smoking researchers are enjoying the comfort of expressing their conclusions about the gateway hypothesis without having to actually "think" (i.e., to actually analyze and interpret the scientific evidence that bears directly on this question).

I will close as President Kennedy did: "The stereotypes I have been discussing distract our attention and divide our effort. These stereotypes do our Nation a disservice, not just because they are exhausted and irrelevant, but above all because they are misleading--because they stand in the way of the solution of hard and complicated facts. It is not new that past debates should obscure present realities. But the damage of such a false dialogue is greater today than ever before... ."