The Dangers of Funding Government Programs With Cigarette Tax Revenues: French Government Delays Tobacco Price Increase Because Too Many Smokers Have Quit

According to an article in the New York Times, the French government, in an effort to prevent too many smokers from quitting and therefore seeing a decline in cigarette tax revenue, has reached an agreement with tobacco manufacturers to delay a price increase that had been scheduled to take effect in July.

According to the article: "Governments have an ambivalent attitude about tobacco, on the one hand lecturing smokers at every turn to abandon nicotine, while with the other hand raking in cigarette sales taxes to finance their treasuries. The anomaly was underlined on Friday with a reported agreement by the French government and tobacco manufacturers to delay a scheduled price increase for three months because too many smokers have quit. In the first quarter of 2013, for the first time in 10 years, the value of French tobacco sales fell. ... The next price and tax increases were due in July, but the makers have agreed to take a short-term hit by delaying an estimated 5 percent price increase until October, according Les Echos, the French business daily.

“Neither the manufacturers nor the finance ministry has an interest in seeing the volume of sales continue to fall,” Les Echos wrote. Government policy is based on moderate and progressive price rises to encourage smokers to give up, without precipitating a fall in the value of tobacco sales that would also hit tax revenues, according to the newspaper."

The Rest of the Story

This story beautifully illustrates the folly of funding essential government programs using cigarette tax revenue. As I have repeatedly argued, this creates a dependence of the government on continued high levels of cigarette consumption and removes any incentive to substantially reduce smoking.

When cigarette smoking falls dramatically, it reduces revenue and therefore makes essential government programs fiscally insolvent. This creates an ironic incentive for the government to join the tobacco industry in helping to promote continued cigarette smoking. This story is a perfect illustration of this phenomenon.

New Study Warns of Dangers of Thirdhand Smoke in Nonsmoking Hotel Rooms Located in Hotels that Allow Smoking in Some Rooms

A study published online ahead of print in Tobacco Control warns of the dangers of thirdhand smoke (THS) exposure in nonsmoking hotel rooms in hotels with partial smoking bans (meaning that both smoking and nonsmoking rooms are available).

(See: Matt GE, et al. Thirdhand smoke and exposure in California hotels: non-smoking rooms fail to protect non-smoking hotel guests from tobacco smoke exposure.)

The methods are described as follows: "A stratified random sample of hotels with (n=10) and without (n=30) complete smoking bans was examined. Surfaces and air were analysed for tobacco smoke pollutants (ie, nicotine and 3-ethynylpyridine, 3EP)."

The results were as follows: "Compared with hotels with complete smoking bans, surface nicotine and air 3EP were elevated in non-smoking and smoking rooms of hotels that allowed smoking. Air nicotine levels in smoking rooms were significantly higher than those in non-smoking rooms of hotels with and without complete smoking bans. Hallway surfaces outside of smoking rooms also showed higher levels of nicotine than those outside of non-smoking rooms."

The study concludes as follows: "Partial smoking bans in hotels do not protect non-smoking guests from exposure to tobacco smoke and tobacco-specific carcinogens. Non-smokers are advised to stay in hotels with complete smoking bans. Existing policies exempting hotels from complete smoking bans are ineffective."

The Rest of the Story

Readers of the conclusions of this study might be surprised to find out that the study found no significant difference in air nicotine levels in nonsmoking rooms in hotels with partial smoking bans and those in nonsmoking rooms in hotels with complete smoking bans.

In fact, the most significant finding of the study with regards to significant health effects was that the mean level of air nicotine in nonsmoking rooms in hotels with partial smoking bans was 28.9 ng/m3 (95% confidence interval, 14.2-57.9), compared to a mean level of 20.5 ng/m3 (95% confidence interval, 7.4-54.2) in nonsmoking rooms in hotels with complete smoking bans. These confidence intervals greatly overlap and the differences in mean air nicotine levels are not significantly different.

In contrast, the mean air nicotine level in smoking rooms was 452.4 ng/m3.

A reasonable interpretation of these data is that there was no evidence that staying in a nonsmoking room in a hotel with a partial smoking ban posed any significant health effects, as it was not associated with any significant increase in exposure to airborne tobacco smoke.

How, then, can the authors conclude that designated nonsmoking rooms in hotels are not sufficient to protect nonsmokers?

Well, they rely upon the finding that nonsmoking rooms in hotels with partial smoking bans had slightly higher levels of surface nicotine. The surface nicotine levels averaged 3.7 ug/m2, as opposed to 1.4 ug/m2, and compared to an average of 51.8 ug/m2 in smoking rooms. This slight increase in surface nicotine resulted in higher finger nicotine levels. However, it did not result in increased nicotine exposure, as the urine cotinine levels were not significantly higher in nonsmoking confederates who stayed in hotels with a partial smoking ban compared to hotels with a complete smoking ban.

Thus, the study has demonstrated that there is no significant difference in nicotine exposure (and presumably exposure to other constituents of tobacco smoke) among nonsmokers who stay in a hotel with a partial smoking ban compared to those who stay in a hotel with a complete smoking ban.

That major finding would lead me to conclude that there is no significant health risk associated with staying in a nonsmoking room in a hotel that allows smoking in some rooms. It would also lead me to conclude that partial smoking bans do indeed work in terms of preventing tobacco smoke exposure for guests staying in nonsmoking rooms.

That the paper suggests the opposite is in conflict with the actual findings of the paper and suggests that there was a pre-determined conclusion and a pre-determined agenda that guided this research.

Live Blogging from the TMA Annual Meeting: Mitch Zeller Address

I am listening to Mitch Zeller, the new director of the FDA Center for Tobacco Products, address the TMA Annual Meeting. I will try to summarize his main points as he speaks:

1. The FDA is committed to enhancing communication with all stakeholders, including the tobacco industry.

2. The FDA has three immediate priorities:
a. To deal with the backlog of substantial equivalence determinations.
b. To deal with the menthol issue.
c. To issue regulations regarding alternative tobacco products (e.g., electronic cigarettes, dissolvable tobacco).

3. The FDA is close to releasing scientific guidance regarding substantial equivalence applications, and is close to making decisions on many of those applications.

4. The FDA is relatively close to releasing decisions and/or regulations regarding menthol cigarettes and alternative tobacco products. However, no definite timeline can be provided at this time.

5. In terms of modified risk products: although a product may greatly reduce harm at the individual level, the agency must look at population-level effects, including whether the marketing of the product will lead to higher rates of smoking initiation and/or lower rates of smoking cessation.

6. In terms of his long-term view of what the FDA can do to reduce tobacco-related disease, the development of tobacco product standards is critical and can play a major role.

In response to questions posed by the audience, here is a quick summary of my take-away:

1. It is clear that the agency is going to be doing something about menthol. It is not clear what, but my sense of Mitch's response to a question on this issue is that there is something underway at the agency regarding menthol.

2. The FDA is happy to meet with any and all stakeholders to obtain their input.

3. The CTP will be much more responsive to industry queries moving forward.

New Study Purports to Estimate Efficacy of Electronic Cigarettes By Studying Quit Rates for Select Group of Smokers who Failed to Quit Using E-Cigarettes

Imagine that you are a tobacco company and you are concerned about the potential threat posed by electronic cigarettes. You want to deflate the enthusiasm about these products by producing a study which shows that quit rates among smokers who try to quit using electronic cigarettes are very low and are in fact lower than quit rates for smokers who use other cessation methods.

Clearly, the proper way to conduct such a study would be to take a sample of smokers who made quit attempts using electronic cigarettes and compare their success with a sample of smokers who made quit attempts using other methods.

However, conducting such a study presents a risk: you might find that smokers who try to quit using e-cigarettes actually do better than those who try to quit using traditional methods, which you know have dismal success rates.

What, then, is a sure way of finding low quit rates that you can then report in a paper?

A great way to "manufacture" such a result would be to selectively choose a sample of smokers who tried to quit using electronic cigarettes and failed, and then to wait until they call a quitline and then see what proportion are able to quit at that point. Even though these smokers may not be actually trying to quit using electronic cigarettes when they call the quitline, you would count them as electronic cigarette users and attribute their cessation rates to the electronic cigarette group. You could then compare this group with smokers who did not fail a quit attempt using electronic cigarettes.

Or course, if a tobacco company conducted such a study in this way, it would be considered an example of scientific fraud. This is not objective science.

The Rest of the Story

Yesterday, a new study appeared online ahead of print in the journal Nicotine & Tobacco Research. To my shock, the study did exactly what the hypothetical tobacco industry study above did!

The study was purported designed to examine the efficacy of electronic cigarettes in smoking cessation. However, 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!

Here is how the study describes its methods and findings:

"This study ... describes differences among state quitline callers who used e-cigarettes for 1 month or more, used e-cigarettes for less than 1 month, or never tried e-cigarettes. ... Both e-cigarette user groups were significantly less likely to be tobacco abstinent at the 7-month survey compared with participants who had never tried e-cigarettes (30-day point prevalence quit rates: 21.7% and 16.6% vs. 31.3%, p < .001)."

The authors conclude that: "This study indicates that e-cigarette users were less likely than those who had never used to have quit tobacco at the time of the survey...".

But 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. The study systematically sampled a group of quitline callers who were unsuccessful using electronic cigarettes. These people tried and failed using electronic cigarettes. How do we know they failed? Because they wouldn’t have had to call the quitline if they weren’t still smoking. This is clearly a harder core group of smokers and it is no surprise that their cessation rates were lower after 6-months than the comparison group. The study tells us nothing about the effectiveness of electronic cigarettes, other than that they do not work for everyone. This is exactly the kind of biased research, designed specifically NOT to find an effect of electronic cigarettes, that is characterizing the anti-smoking movement today, guided by an ideology that is apparently opposed to anything that merely looks like smoking, no matter how much safer it may be. Apparently, the researchers had already reached a pre-determined conclusion and the study was apparently designed to find no effect. Any researcher sincerely interested in testing the efficacy of electronic cigarettes would not test the research question in this way.

That the organization which conducted this study had already drawn a pre-determined conclusion about electronic cigarettes is evidenced by its rant against these products, published back in September of last year, in which it warned that electronic cigarettes might kill "millions" of smokers. 

At that time, a director of the organization wrote: "E-cigs continue to gain market share with customers relying on assurances by the vendors that the product is safe. Those of us who work to help smokers quit remain skeptical and unconvinced. We remember all too well the light and ultra-light promotions by the tobacco industry back in the 70’s and 80’s. Like these, e-cigs are also being promoted as an alternative to quitting smoking. Let’s hope they don’t kill millions of Americans the way light and ultra-light cigarettes did 30 years ago."

If the tobacco industry conducted precisely this same study in order to conclude that electronic cigarettes are ineffective as a smoking cessation tool, we would call it scientific fraud. What should we call the same study, but conducted by a company that makes its money by convincing the public that traditional methods for smoking cessation should remain the mainstay of treatment?

To Many Anti-Smoking Advocates, Nicotine is the Problem, Rather than Disease and Death

According to an article in the Toledo Blade, electronic cigarettes have helped many smokers to quit, producing profound health benefits among patients with COPD and cancer who were unable to quit using traditional methods.

While this seems like something to applaud, the article notes that health officials are frowning upon, rather than praising, the tremendous health benefits that smokers have achieved from quitting or cutting down on tobacco cigarettes.

According to the article:

"Health officials argue the long-term effects of the unregulated products are unknown and require more research. “There are fewer chemicals in e-cigarettes and no carbon dioxide is emitted. Those certainly would be a reduction in harmful inhalants,” said Holly Kowalczk, a registered respiratory therapist at Promedica St. Luke’s Hospital. “However, some of the brands still contain harmful chemicals, such as diethylene glycol, which is used in antifreeze.” Ms. Kowalczk, who also is a certified tobacco treatment specialist, said it's unlikely that using e-cigarettes as a means to quit smoking will cure a smoking addiction. “Nicotine addiction has always been the problem. People trying to use e-cigarettes aren’t really addressing that issue,” Ms. Kowalczk said. “They’re still putting nicotine in their bodies and they’re still engaging in smoking behaviors.”"

The Rest of the Story

This is an open admission that illustrates the blind ideology that is leading many anti-smoking advocates and groups to oppose an innovation that is saving thousands of lives.

These advocates view nicotine as the problem, not disease and death. It is the addiction to nicotine that seems to bother these health officials, rather than the actual health effects of smoking. If research subsequently showed that nicotine has no serious long-term health effects, these advocates would still consider electronic cigarette use to be an evil and to consider it to simply be a "smoking behavior" because it involves nicotine use.

How ludicrous, however, for a health practitioner to argue that if a smoker quits smoking using e-cigarettes, that ex-smoker is still "engaging in smoking behaviors." No the person is not.

What do you call a smoker who substitutes electronic cigarettes completely for tobacco cigarettes?

The answer ...

... an ex-smoker.

Would this health practitioner also argue that someone who quits smoking using the nicotine patch (and continues to apply the patch for many months) has not actually quit smoking?

An additional problem with this practitioner's statement is that she asserts that electronic cigarettes still contain diethylene glycol. There is no evidence that this is the case. All of the lab testing of electronic cigarettes during the past two years of which I am aware has not detected diethylene glycol in these products. The practitioner is citing outdated data that only applied to one brand and probably resulted from the use of non-pharmaceutical grade propylene glycol, which is no longer in use by virtually all e-cigarette companies in 2013.

Why not simply state that you don't know, rather than pretend to be an expert on a topic about which you know very little? Why risk giving the public misinformation, which this practitioner is doing.

The rest of the story is that this admission illustrates the basic ideology that is leading anti-smoking advocates to oppose electronic cigarettes. As I stated previously, the health of smokers is not the paramount concern of all of our health professionals. Instead, the ideology of opposing anything that "looks" like smoking has overtaken in prominence the concern over the best interests of the health of smokers. The health of smokers is being sacrificed to the blind adherence to the ideology that anything that looks like smoking is evil.

Pulmonologist Unsure that Smoking is Any More Hazardous than Quitting Smoking via Electronic Cigarettes

It doesn't take a rocket toxicologist to understand that smoking burning tobacco, which contains more than 10,000 chemicals including 60 known human carcinogens - and which has already been demonstrated to cause more than 400,000 deaths each year in the U.S. - is much more harmful than vaping from a non-tobacco solution containing little more than nicotine and glycerin or propylene glycol.

If any tobacco company even hinted that smoking is as benign as inhaling vapor from a solution of propylene glycol with nicotine, that company would find itself in a courtroom the next day, defending itself against charges of fraud.

Apparently, however, a physician can make precisely the same claim with impunity.

Last week, a Stanford pulmonologist claimed that it is unclear that smoking is any more harmful than vaping. According to an article in the San Francisco Chronicle:

"There are a lot of public health questions surrounding the use of e-cigarettes, but one thing is not in question - they are becoming a popular alternative to tobacco cigarettes. ... But nicotine, whether from a cigarette or an e-cigarette, is "a known addictive agent that is not helpful in any way," said Dr. Daya Upadhyay, former assistant professor of pulmonary critical care at Stanford. So she says she encourages her patients to quit smoking entirely rather than switch to e-cigarettes. She added that e-cigarettes still contain toxic chemicals. "We can't say yet whether it's less harmful than tobacco," she said."

The Rest of the Story

Claiming that it is unclear whether smoking is any safer than vaping is equivalent to claiming that it is not clear whether smoking is any safer than using a nicotine inhaler.

Both electronic cigarettes and nicotine inhalers deliver essentially "clean" nicotine: nicotine with just a few other chemicals. Neither product has undergone long-term studies to determine whether they produce any long-term adverse effects in terms of respiratory irritation or carcinogenesis. Both products deliver nicotine via inhalation. While electronic cigarettes generally deliver nicotine from a propylene glycol or glycerin solution, nicotine inhalers generally add menthol. While the long-term effects of propylene glycol are not clear, neither are the long-term effects of menthol. The nicotine in both products is derived from tobacco, and thus contains trace levels of carcinogens: tobacco-specific nitrosamines.

Imagine, however, that a physician instructed a patient not to quit smoking using a nicotine inhaler because it is not clear that the use of the inhaler is any safer than continuing to smoke. This would almost certainly be considered malpractice.

But the rest of the story is that this is exactly the same advice that some physicians are apparently giving patients regarding electronic cigarettes. To instruct a patient that he or she should not quit smoking using electronic cigarettes because it is not clear that doing so is any safer than continuing to smoke is contrary to the overwhelming medical science. It is a claim that represents, in my opinion, malpractice. 

Perhaps the most important excerpt from the article is the following:

"Companies do not market the product as a smoking cessation tool because that would put it in a category of products, like nicotine gum or patches, that the Food and Drug Administration regulates. But a British study out last month showed that 75 percent of the 1,400 e-cigarette users who responded to a survey said they've entirely replaced tobacco cigarettes with e-cigarettes."

What is there not to like about that? Huge numbers of smokers are completely switching from tobacco to electronic cigarettes. In other words, thanks to e-cigarettes, they are successfully quitting smoking.

You would think that physicians and public health practitioners would be jumping for joy. But unfortunately, the health of smokers is not the paramount concern of all of our health professionals. Instead, the ideology of opposing anything that "looks" like smoking has overtaken in prominence the concern over the best interests of the health of smokers.

The rest of the story is that the health of smokers is being sacrificed to the blind adherence to an ideology: anything that looks like smoking is evil.

UK Study Fails to Find a Single Nonsmoker - Youth or Adult - Who Regularly Uses Electronic Cigarettes

In a second study that blows out of the water the anti-smoking groups' contention that electronic cigarettes appeal to nonsmokers, especially youth, and will lead to increased smoking, Action on Smoking and Health (ASH-UK) was unable to find a single nonsmoker in Great Britain - either youth or adult - who regularly uses electronic cigarettes.

The study, released this week, involved a survey of 12,171 adults and 2,178 children ages 11-18 in February and March of this year. Despite widespread awareness of electronic cigarettes among youth and adults, the survey failed to find a single adult or youth never smoker who regularly uses electronic cigarettes.

Awareness of electronic cigarettes was 67% among 11-18 year-olds and 83% among the 16-18 year-olds. Nevertheless, "among young people who have never smoked ... 0% report continued e-cigarette use and 0% expect to try an e-cigarette soon."

The study reports that: "Among adults, electronic cigarette current use ... remains at 0% among those who have never smoked."

The Rest of the Story

This study corroborates the evidence I reported yesterday from the U.S. which indicates that despite the dire warnings of anti-smoking groups and the FDA, electronic cigarettes apparently have little appeal to young people who do not already smoke, little appeal to adults who do not already smoke, and virtually no long-term appeal to anyone but smokers.

Electronic cigarettes are marketed towards smokers, not towards youth and/or nonsmokers. These products are intended to help smokers quit or cut down in order to improve their health. They are an alternative to tobacco cigarettes. There is little if any appeal to nonsmokers to use these products.

This evidence minimizes any public health concerns that electronic cigarettes might increase cigarette smoking. On the contrary, electronic cigarettes represent a promising intervention to reduce cigarette use. It is time that the FDA and anti-smoking groups open their eyes to the evidence, pay attention to the hundreds of thousands of vapers out there, and embrace the possibility that electronic cigarettes may be a life-saving harm reduction approach to the smoking problem.

National Study of Adults Can Find Only Six Nonsmokers Who Have Ever Tried Electronic Cigarettes

Anti-smoking groups continue to oppose electronic cigarettes, in part because they claim these products will increase smoking by inducing nonsmokers to become addicted to nicotine. A number of anti-smoking advocates expressed these concerns at an FDA-sponsored press conference in July 2009. At that press conference, anti-smoking advocates warned that "these products could encourage smoking" and alarmed the public about "the risk that electronic cigarettes may increase nicotine addiction among young people." The American Lung Association went so far as to "urge[s] the FDA to act immediately to halt the sale and distribution of all e-cigarettes...".

At the press conference, Dr. Jonathan Winickoff, chairman of the American Academy of Pediatrics' tobacco consortium, warned that electronic cigarettes are likely to appeal to young people and will encourage nicotine addiction, ultimately leading to the initiation of cigarette smoking. The FDA continues to this day to warn the public that electronic cigarettes may appeal to young people and lead them to become addicted to nicotine and then to start smoking.

The Rest of the Story

In an article published in the Journal of Environmental and Public Health and co-authored by Dr. Winickoff himself, the authors examined the use of electronic cigarettes and other "emerging" tobacco products among a national sample of 3,240 adults.

Despite all of the anti-smoking groups' dire warnings about the appeal of electronic cigarettes to nonsmokers, the study was able to find only 6 (six) nonsmokers who had ever used these products. This is 6 out of a total of approximately 2000 nonsmokers and 3240 total adults in the sample. It is unclear if any of these 6 reported continued use of electronic cigarettes.

(See: McMillen R, Maduka J, Winickoff J. Use of emerging tobacco products in the United States. Journal of Environmental and Public Health. Volume 2012 (2012), Article ID 989474, doi:10.1155/2012/989474.)

So much for electronic cigarettes being appealing to young adults and other nonsmokers. These findings seem to confirm what I have argued for months: that electronic cigarettes are marketed towards smokers, not towards youth and/or nonsmokers. These products are intended to help smokers quit or cut down in order to improve their health. They are an alternative to tobacco cigarettes. There is little if any appeal to nonsmokers to use these products.

It is a good thing that the FDA was prevented by the courts from following the American Lung Association's advice (and that of numerous other anti-smoking groups) and removing electronic cigarettes from the market. Such an action would certainly have led to the initiation of tobacco use among literally thousands of ex-smokers who had successfully quit using e-cigarettes but would have been essentially forced to return to tobacco cigarettes.

It is also a good thing that many vapers are ignoring the dire warnings from anti-smoking groups and that they have taken their chances on this product, which for many of them, has likely saved their lives.

It is worth mentioning that in addition to electronic cigarettes, the article examined the use of dissolvable tobacco products, snus, and waterpipes. Importantly, while very few nonsmokers reported using electronic cigarettes (0.3%) or dissolvable tobacco products (0.2%), a substantial proportion did report using snus (2.7%) or waterpipes (5.4%).

These data dispel any serious concern that electronic cigarettes or dissolvable tobacco products are appealing to nonsmokers and will lead eventually to nicotine addiction and the initiation of cigarette smoking. On the other hand, these data are consistent with the hypothesis that the same is not the case with snus and waterpipe tobacco use. 

Unfortunately, however, the authors do not make this distinction in their article. They lump all these forms of "tobacco use" together.

The article concludes by recommending that clinicians "offer counseling about the risks of these products as another form of tobacco use."

But that is a false statement, as electronic cigarettes are not a form of tobacco use. They contain no tobacco, as these authors should well know and should have pointed out. Why the need to lie to the public about the facts? It appears as if there is a pre-ordained agenda against electronic cigarettes.

But apparently, the arguments against electronic cigarettes are so weak that opponents need to lie to the public and claim that vaping is a form of "tobacco use" which they should know is simply not the case.

The rest of the story is that: (1) there is strong evidence that electronic cigarettes do not appeal to nonsmokers and that there is little reason to believe that they will lead to any substantial increase in cigarette smoking; and (2) opponents of electronic cigarettes continue to resort to lying to the public; in this case, misrepresenting electronic cigarettes as a form of tobacco use when in fact the product contains no tobacco.

In Ultimate Irony, Duke is Recognized for Smoking Cessation Programs

In an irony of epic proportions, Duke has been recognized by the North Carolina Prevention Partners for its model smoking cessation efforts.

According to an article in Duke Today: "Duke's tobacco cessation programs for employees have been recognized by the NC Prevention Partners with the designation as a Gold Star Standard Hospital. The Gold Star Standard recognizes Duke's efforts to refers employees to effective quit programs, provide comprehensive benefits such as nicotine replacement therapy and prescription medications and offer attractive incentives to encourage employees to quit tobacco use. ... 'Duke University Medical Center continues to set a high bar in terms of their cessation program for employees,' said Anne Thornhill, director at NC Prevention Partners. 'They are doing a great job in supporting their employees in quitting the use of tobacco. I applaud their great effort.'"

The Rest of the Story

The rest of the story is that for about 8 years (from 2004-2012), Duke served as a public relations arm for Philip Morris, accepting $37 million in funding from Big Tobacco to help the nation's leading tobacco company achieve its marketing goal of legitimizing itself as a corporation sincerely interested in helping smokers to quit.

According to Philip Morris: "Since 2004, PM USA has supported the Duke Center for Nicotine and Cessation Research. PM USA expects to provide a total of $37 million to the center through June 2012 to develop, evaluate and disseminate improved methods for quitting smoking."

According to the agreement between Duke and Philip Morris, the director of Duke's nicotine research center (or a designee) became a formal part of Philip Morris' public relations efforts, by virtue of appointment to the Advisory Board of the company's "smoker cessation support initiative."

The rest of the story is that rather than being a model for tobacco control for the nation, Duke is instead an example of exactly the opposite. It is perhaps a model, but a model for the most egregious violation of medical ethics. Duke allowed itself and its reputation and good name to be used as a public relations ploy for a tobacco company. Duke allowed itself to be used as a pawn in the public relations and marketing strategy of Philip Morris.

Clearly, since the purpose of this research funding was demonstrably not to dramatically reduce the number of smokers, its purpose was therefore to serve as a public relations ploy - by which Philip Morris could improve its public image by being able to argue that it really cares and that it is a responsible corporate citizen which is trying to help its customers break their addiction to its products. By associating its name with that of Duke University, Philip Morris used Duke to gain public relations marketing value from that association. Clearly, there was no sincere research interest operating here on the part of Philip Morris. This was public relations 101. Using corporate funding to secure public credibility and respect. It was part of Philip Morris' (and the other tobacco companies') playbook for decades.

The rest of the story is that Duke undermined its own scientific integrity and that of academia as a whole by allowing itself to serve as a pawn in the tobacco industry's public relations and marketing strategy. A university - and especially a medical center - should not play a role in marketing the most deadly consumer product. But that is exactly what Duke did.

Rather than being recognized as a model for tobacco control, Duke should instead be entered into the Hall of Shame as a medical center that put money over ethical integrity.

Pennsylvania Department of Health Says It Does Not Support Smokers Quitting, Will Not Acknowledge that Smoking is More Harmful than Non-Tobacco E-Cigarettes

According to an article in the Johnstown (PA) Tribune-Democrat, the Pennsylvania Department of Health, with all of its scientific expertise, is not sure that smoking cigarettes - which kills more than 400,000 Americans each year - is any more hazardous than using non-tobacco e-cigarettes, which have not been reported to ever have killed a single person.

According to the article, the Department of Health was quoted as stating: "Consumers may believe this is a safer way to smoke when, in fact, there is a lack of long-term studies that have been done on the product, therefore leaving the long-term effects unknown."

Not only did the Department of Health deny that vaping is any safer than smoking, but it also stated that it does not support smokers quitting using e-cigarettes.

According to the article: "The state Department of Health says that while there is currently no regulation on this, the department does not support their use for a number of reasons."

The Rest of the Story

This position of the Pennsylvania Department of Health is shameful for two reasons.

First, it is based on politics and not science. If the Department of Health is not sure that a non-tobacco product which merely heats propylene glycol and nicotine is any safer than cigarettes, which burn tobacco and emit thousands of chemicals and scores of carcinogens, then it needs to review some basic biology and chemistry textbooks.

Second, this position is untenable with protection of the public's health because a public health department should not oppose smokers quitting and potentially saving their lives simply because the method they used to quit simulates smoking behavior.

What an insult to the thousands of Pennsylvania smokers who have successfully quit smoking using e-cigarettes. The state Department of Health is telling them that have done a bad thing. What does the Department want these ex-smokers to do? Return to smoking their Marlboros?

If Physicians Prescribing a Drug Need to Monitor Those Patients for Death, What Business Does the FDA Have Approving that Drug?

Today, the Rest of the Story is questioning the wisdom of keeping a drug on the market when its required black box warning admonishes doctors to observe their patients for death.

Here is the start of the black box warning that appears on Chantix:

"All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide."

Attempted suicide? 

Let's get this straight. Physicians are instructed by the FDA to monitor their patients for attempted suicide, which is of course, in some cases, successful. In other words, doctors are being told that a significant possible side effect of the medication is death and that it behooves them to monitor their patients to see if they die from the drug.

The Rest of the Story

What good does it do to monitor a patient for death? How does that protect the patient?

One situation in which a black box warning may be appropriate is when monitoring of early side effects can prevent serious consequences. For example, if a side effect of a medication is liver damage, then monitoring a patient's liver enzymes for evidence of early liver injury can prevent serious disease by alerting the physician to this side effect so that the medication can be discontinued before it causes actual liver damage.

Chantix does not meet this criterion because its most worrisome side effect - sudden suicide - often occurs without warning, often in a matter of days following initiation of therapy. Relying on patients who become depressed to call their physician to report the symptoms is ineffective because one of the symptoms of depression is the inability to do just that. That the most worrisome side effect is not just depression but frank suicidality makes the black box warning ineffective in this regard.

I do not see how the benefits of keeping Chantix on the market outweigh the many deaths that it has caused. It is not like this is some sort of wonder drug that is very effective in helping people quit smoking, nor is it like this drug is so much more effective than other smoking cessation drugs on the market.

But most importantly, I don't see how the FDA can keep a drug on the market when it feels compelled to warn physicians that they need to carefully monitor their patients for possible death.

Financial Analyst: 1.5 Billion Fewer Cigarettes Smoked this Year Because of Electronic Cigarettes

Imagine an intervention that would reduce the consumption of cigarettes in the U.S. by 1.5 billion within one year. Anti-smoking groups would be praising that intervention and trying to expand it.

Well, according to Morgan Stanley tobacco analyst David Adelman, that intervention exists and it is called the electronic cigarette.

According to a Business Insider Australia article, in the current year, electronic cigarettes have reduced U.S. cigarette consumption by 1%, which projects to a reduction of 1.5 billion cigarettes for the year 2013: "Tobacco giant Lorillard recently said that e-cigarettes may have taken 1% of the U.S. cigarette volume. As you can see in the chart below, Adelman estimates that e-cigarettes will take the place of around 1.5 billion cigarettes this year, up from around 600 million last year."

Another indication of the increasing popularity of electronic cigarettes and the degree to which these products may reduce cigarette sales is the announcement last week that Philip Morris is entering the electronic cigarette space: "Altria Group Inc. announced Thursday that it plans to introduce its own electronic cigarette this year, putting the nation’s largest tobacco company into a growing category of alternative tobacco products. Henrico County-based Altria, owner of top U.S. cigarette maker Philip Morris USA, said it plans to sell an e-cigarette in an undisclosed market during the second half of 2013. ... Altria’s announcement comes as major tobacco companies are increasingly looking for new, novel products to help offset a long-term decline in traditional cigarette consumption in the United States."

The Rest of the Story

Ironically, the only ones attacking this intervention which has significantly reduced cigarette consumption and therefore improved the public's health are anti-smoking groups and health agencies, such as the FDA.

What's not to like about an intervention that has already reduced cigarette unit sales by 1% and promises to make an even greater dent in cigarette sales in the future?

Well, from the anti-smoking groups' perspective, there are two things not to like:
 
First, using electronic cigarettes looks like smoking.

Second, electronic cigarettes threaten not only cigarette sales, but also the sales of pharmaceutical smoking cessation products. The anti-smoking groups which oppose electronic cigarettes are largely funded by Big Pharma companies which stand to lose if electronic cigarettes continue to help thousands of smokers to quit or cut down substantially, and therefore increase in sales.

It is sad to think that if electronic cigarettes do continue to save lives, they will do so despite the best efforts of anti-smoking groups, rather than because of their efforts.

Why is the FDA Lying About Chantix Health Risks?

The FDA recently announced on its tobacco web site a new online resource dedicated to smoking cessation. The FDA describes this site as containing "resources" for those who are "trying to quit smoking." The site encourages smokers trying to quit to use drugs, and one of the drugs recommended is Chantix. On the Chantix information page, readers are informed that side effects of Chantix may include "nausea, trouble sleeping, change in dreaming, mood swings, depression, and suicidal thoughts." Readers are also informed that: "There have been rare reports of mood swings, depression, and suicidal thoughts."

The Rest of the Story

The rest of the story is that suicidal thoughts are not the only thing with which Chantix has been associated. It has also been associated with attempted and completed suicides -- hundreds of them.

In hiding the fact that Chantix has been associated with actual suicide attempts and suicides, the FDA is deeply misleading the public. And I would say that in this context, this omission of critical information amounts to a lie: a lie which appears to be deliberate since it is downplaying the risks of Chantix in an apparent attempt to avoid discouraging smokers from trying this pharmaceutical product.

There is a world of difference between suicidal ideation and attempted or completed suicide. Readers hearing about a rare side effect of suicidal thoughts are likely to infer that this is a minor effect that can be simply monitored and will not lead to any major problems. However, had the FDA informed readers that hundreds of users of this drug have actually committed suicide, readers will infer a completely different level of risk -- one that is likely to give them serious pause about trying the drug. So the effect of this misinformation is potentially quite severe.

So severe, in fact, that if Pfizer itself were to disseminate the same lie, it would be in contempt of the law. The FDA has emphatically required Pfizer to label its drug with a warning. That warning does more than merely mention that in rare cases, a few smokers have experienced some suicidal thoughts. Instead, the warning makes clear that Chantix has been associated with attempted and completed suicides.

Pfizer's Chantix warning states: "Serious neuropsychiatric events including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking CHANTIX."

In the very next paragraph, the warning reiterates that: "worsening of pre-existing psychiatric illness and completed suicide...have been reported in some patients attempting to quit smoking while taking CHANTIX in the postmarketing experience."

Clearly, if Pfizer put out the same warning that the FDA puts out on the Smokefree.gov web site, it would be in violation of FDA's mandate and would potentially incur punishment from the government as well as severe liability in litigation from consumers.

This raises the question of why the FDA is speaking with two voices: its drug regulation division is requiring Pfizer to truthfully inform the public that there have been reports of actual suicides among smokers trying to quit using Chantix. But apparently, the Center for Tobacco Products (which is presumably the division which contributes to the Smokefree.gov web site) is untruthfully telling the public that the drug has only been associated with suicidal ideation, not actual suicide attempts or complete suicides.

It is worth noting that at the same time that the FDA is using misinformation to downplay the risks of Chantix, it is using similarly deceptive techniques to exaggerate the risks of electronic cigarettes. The FDA has informed the public that electronic cigarettes pose a carcinogenic risk, as it contains "known carcinogens." So while the FDA is hiding the fact that Chantix has actually been associated with more than 300 deaths, it is suggesting to the public that electronic cigarettes may cause cancer, despite the absence of a single death associated with these products.

That the FDA is lying to the public about the risks associated with Chantix is disturbing not only because of the serious damage it could cause, but also because it suggests that the agency is being driven by politics and not science. A purely scientific presentation of the "facts" about Chantix would certainly inform the public that this drug has been associated with attempted and completed suicide, as indicated in the very warning that the FDA requires Pfizer to include in its product packaging. The failure to provide this information to the public indicates to me that concerns other than science have entered the picture.

Turkish Health Ministry Would Rather People Smoke Real Tobacco Cigarettes than Non-Tobacco Electronic Ones?

According to an article in the World Bulletin, the Turkish health ministry is planning to ban non-tobacco electronic cigarettes while allowing the real ones to continue to be sold unimpeded.

According to the article: "The Health Ministry is planning a national ban on electronic cigarettes at a time when the sale of the devices is booming, officials from the ministry have said. According to bureaucrats from the ministry, the import and sale of e-cigarettes will face an across-the-board ban, as will advertisements for the products. ... The Health Ministry says the products are essentially not different from analogue, or conventional, cigarettes. ... Electronic cigarettes are increasingly popular in Turkey among smokers who either want to quit or cut down on the habit."

The Rest of the Story

Why would a public health body prefer that smokers use real tobacco cigarettes than non-tobacco electronic ones which drastically reduce exposure to carcinogens and other toxins?

And how is it that a public health agency cannot tell the difference between fake cigarettes and real ones? No - it is not true that electronic cigarettes are "essentially not different from analogue, or conventional cigarettes."

It is particularly unfortunate that the health ministry plans to ban electronic cigarettes because according to the article, these devices have become increasingly popular in the country "among smokers who either want to quit or cut down on the habit." Why would the health ministry want to put the kabosh on that?

I'm convinced that part of the reason why many countries are taking nonsensical actions like this one against electronic cigarettes is that the FDA put out false propaganda in 2009 warning of the dangers of these products and has never retracted that misleading information.

New England Journal of Medicine Article Questions Ethics of Refusing to Hire Smokers

A perspective article published this month in the New England Journal of Medicine argues that it is unethical for companies to refuse to hire smokers.

(See: Schmidt H, Voigt K, Emanuel EJ. The ethics of not hiring smokers. New England Journal of Medicine, April 11, 2013; DOI: 10.1056/NEJMp1301951.)

The authors argue as follows: "Many health care organizations, such as the Cleveland Clinic and Baylor Health Care System, and some large non–health care employers, including Scotts Miracle-Gro, Union Pacific Railroad, and Alaska Airlines, now have a policy of not hiring smokers — a practice opposed by 65% of Americans, according to a 2012 poll by Harris International. We agree with those polled, believing that categorically refusing to hire smokers is unethical: it results in a failure to care for people, places an additional burden on already-disadvantaged populations, and preempts interventions that more effectively promote smoking cessation." ...

"it seems paradoxical for health care organizations that exist to care for the sick to refuse to employ smokers. Many patients are treated for illnesses to which their behavior has contributed, including chronic obstructive pulmonary disease, heart failure, diabetes, and infections spread through unprotected sex or other voluntary activities. It is callous — and contradictory — for health care institutions devoted to caring for patients regardless of the causes of their illness to refuse to employ smokers. Just as they should treat people regardless of their degree of responsibility for their own ill health, they should not discriminate against qualified job candidates on the basis of health-related behavior. The broader claim that it is fair to exclude smokers because they are responsible for raising health care costs is too simplistic. It ignores the fact that smoking is addictive and therefore not completely voluntary." ...

"all other diseases — and many healthful behaviors — also result in additional health care costs. ... People who engage in risky sports may have accidents or experience trauma routinely and burden coworkers with additional costs. Having babies increases premiums for fellow employees who have none. Many of these costs result from seemingly innocent, everyday lifestyle choices; some choices, such as those regarding diet and exercise, may affect cancer incidence as well as rates of diabetes and heart disease. We as a society have rejected the notion that individuals should be fully responsible for their own health care costs."

The article concludes as follows: "We believe that employers should consider more constructive approaches than punishing smokers. In hiring decisions, they should focus on whether candidates meet the job requirements; then they should provide genuine support to employees who wish to quit smoking. And health care organizations in particular should show compassion for their workers. This approach may even be a win–win economic solution, since employees who feel supported will probably be more productive than will those who live in fear of penalties."

The Rest of the Story

This article is a welcome addition to the public health literature. It makes a number of points which I have emphasized here at The Rest of the Story over the past several years. I applaud the authors for being willing to express this viewpoint and the Journal for highlighting the ethical aspects of this issue.

Colonel Benjamin Church Hypocrisy Hall of Shame Award

Awarded to: Mayor Michael Bloomberg       GOLD RANK

Awarded for: Proclaiming himself as a champion of the public's health while trying to deny any mandatory paid sick days for workers in New York City."

Other Hall of Shame Members:

PAM WALKER

St. Louis Health Director     GOLD RANK

 

PORTLAND CITY COUNCIL    DIAMOND RANK

 

BOB BUTTERWORTH

Attorney General of Florida  SILVER RANK

CAMPAIGN FOR TOBACCO-FREE KIDS

National Anti-smoking Organization  GOLD RANK

MICHAEL BLOOMBERG

Mayor of New York City        BLUE RANK

FRANK LAUTENBERG            
U.S. Senator, New Jersey   BRONZE RANK

KEMP HANNON

New York State Senator         DIAMOND RANK
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Today, I am announcing the 8th induction into the Colonel Benjamin Church Hypocrisy Hall of Shame.

Today's inductee - Mayor Michael Bloomberg - is actually being inducted into the Hall for a second time.  

Bloomberg was first inducted into the Hypocrisy Hall of Shame on June 12, 2012 when, just after proposing to ban the sale of sodas larger than 16 ounces, he spoke at the weigh-in ceremony for the 2011 Nathan's Famous Hot Dog Eating Contest and proclaimed: "It is a moment for all New Yorkers and all Americans to celebrate the inalienable rights bestowed on us by our forefathers: life, liberty, and the pursuit of happiness. For the contestants assembled here, that includes consuming as many hot dogs as humanly possible."

Mayor Bloomberg's comments praising the blatant over-consumption of hot dogs were not only witnessed by the 400,000 people at the event, but by an ESPN television viewing audience of 1.95 million viewers.

The winner of the 2011 hot dog eating contest consumed 62 hot dogs and buns in just 10 minutes. In the female competition, the winner consumed 50 hot dogs and buns in 10 minutes.

A single Nathan's hot dog has 297 calories and 18 grams of fat. The bun contains an additional 120 calories. Thus, a single serving delivers 417 calories and 18 grams of fat. This means that the winner of the hot dog eating contest consumed 25,854 calories and 1,116 grams of fat within 10 minutes.

Thus, Mayor Bloomberg participated in a ceremony that glamorized and promoted the over-consumption of already calorie- and fat-laden food to literally millions of people, including about half a million New Yorkers.

 Moreover, while Bloomberg was busy banning super size sodas, he was also busy declaring "New York City Donut Day." His proclamation established a day on which donuts were given out free throughout the city. Ironically, the donut give-away came just a day after Bloomberg's announcement that he wanted to ban super size sodas.

And this is the guy who proclaimed himself to be a public health champion by virtue of his wanting to limit soda consumption to 16 ounces.

In achieving his second induction into the Colonel Benjamin Church Hypocrisy Hall of Shame, Bloomberg moves up from a Blue Rank to the prestigious Gold Rank.

The Rest of the Story

The reason for Mayor Bloomberg's second induction into the Hall of Hypocrisy? While proclaiming himself a champion of the protection of the public's health, he opposed a simple measure that would have required medium and large-size employers in the city to provide full-time employees with a minimum of five paid sick days per year. According to advocates, this ordinance would provide paid sick leave for one million workers who do not have this benefit. 

According to an article in the New York Times: "New York City is poised to mandate that thousands of companies provide paid time off for sick employees, bolstering a national movement that has been resisted by wary business leaders. A legislative compromise reached on Thursday night represents a raw display of political muscle by a coalition of labor unions and liberal activists who overcame fierce objections from New York’s business-minded mayor, Michael R. Bloomberg, and his allies in the corporate world.

The legislation would also prohibit companies from firing workers who take a day off because they are sick.

How can anyone who proclaims to be a public health leader oppose a law to prohibit companies from firing workers for taking a sick day? And how could he oppose a measly five sick days a year? Clearly, what Bloomberg is protecting are corporate interests, not the public's health. He is therefore fully deserving of a second induction into the Colonel Benjamin Church Hypocrisy Hall of Shame.

The Mainstream Tobacco Control Movement and Smoking Among African Americans: Some Diversity But Little Inclusivity or Participation

No More than Token Support for Policy Change and Withholding of Evidence-Based Treatment

1. No More than Token Support for Policy Change

When the Campaign for Tobacco-Free Kids negotiated the Family Smoking Prevention and Tobacco Control Act with Philip Morris (with Congressional mediation), it had a perfect opportunity to advance a policy initiative that truly would have made a difference in reducing smoking among African Americans: banning flavored cigarettes. After all, approximately 80%-85% of African Americans smoke flavored cigarettes. This disproportionate preference for menthol cigarettes applies both to youth and adult African American smokers.

However, the Campaign agreed to exempt the one flavor that is preferred by the 80%-85% of African American smokers, and instead, to only ban flavors that are not actually used, such as banana, pineapple, coconut, cherry, lime, lemon, chocolate, vanilla, and raspberry. Moreover, when the Senate HELP Committee considered an amendment that would have eliminated the menthol exemption, the Campaign for Tobacco-Free Kids opposed this amendment.

Now, as essentially an after-thought, the Campaign has co-signed a petition to urge the FDA to ban menthol cigarettes. But I'm afraid that it is too little, too late. The FDA's decision has already been made, and it was made at the negotiating table when the Campaign agreed to the menthol exemption and in the Senate HELP Committee when the Campaign opposed the removal of the menthol exemption.

Thus, the Campaign's signing on to this petition represents no more than token support for policy change to reduce tobacco-related morbidity and mortality among African Americans.

2. Withholding of Evidence-Based Treatment

The state-of-the-art, evidence-based tool to promote smoking cessation among African American smokers is the Pathways to Freedom project. Unlike most other smoking cessation programs, Pathways to Freedom is truly culturally competent because it considers not only health issues, but also history, community culture and context, racial discrimination, literacy, and multigenerational appeal. In addition, unlike most other programs, Pathways to Freedom includes spirituality, community outreach, and community mobilization.

The evidence is clear. Use of Pathways to Freedom by an NCI telephone cessation hotline resulted in a one-year quit rate of 25% for the intervention group compared to 15.4% in the control group. The intent-to-treat analysis percentages were 15% and 8.8%, respectively.

Yet in spite of this evidence, Pathways to Freedom has not been adopted by the CDC as well as by most smoking cessation quitlines and services. Special populations, and in this case the African American community, continue to be ignored.

The Rest of the Story

What ties these two phenomena together? Why was a menthol ban considered but quickly dismissed? And why the failure in dissemination of Pathways to Freedom to African American smokers after clear evidence of its being the state-of-the-art intervention available?

In my view, these failures are a result of a tobacco control movement that has largely been co-opted by a few large national organizations. While these organizations recognize the importance of communities of color, the extent of this recognition has been diversity (including representatives of these minority groups), but has not been extended to inclusivity and participation (actually integrating members of these communities into the decision-making process). Here, of course, I am borrowing from Dr. Bob Robinson's innovative diversity model.

The most egregious violation of participation was the development of the Family Smoking Prevention and Tobacco Control Act, in which African American groups were denied a place at the table. The Campaign essentially negotiated this bill by itself, with input from the major voluntary health groups, but few others. This made it easy, come negotiating time, for the Campaign to throw African American smokers under the bus in order to make the political sacrifice necessary to appease Philip Morris. I doubt it would have been as much of a no-brainer compromise had African American groups been able to actually participate in the negotiating process.

In fact, after the menthol exemption was announced, several African American groups (including the Black Congressional Caucus) voiced their displeasure. The response was merely to call for a committee to consider the menthol issue, but we have seen how meaningless an exercise that was. 

There is precedent for what a community-participatory process might look like in tobacco control. California's tobacco control program has long included a focus on not only the inclusion but the equal participation of communities of color in all aspects of the tobacco control movement, including research, program and policy development and implementation, evaluation, planning, and training. (The SOL project is just one current example of many exemplary California programs).

If only our national organizations, including CDC and the Campaign for Tobacco-Free Kids, could take a lesson from California.

(See my 2005 discussion of the co-optation of the tobacco control movement by a few national organizations, turning what used to be a true grassroots movement into little more than a one-man propaganda machine.)

While FDA Worked to Get Electronic Cigarettes off the Market and Obsessed about Substantial Equivalence Applications, It Ignored Information that Could Have Prevented Deadly Meningitis Outbreak

Evidence reported today by the Boston Globe reveals that the Food and Drug Administration (FDA) apparently ignored information, provided by multiple sources over many years, that could have prevented a massive meningitis outbreak caused by a Massachusetts compounding pharmacy.

According to the article:

"House lawmakers said Tuesday that the Food and Drug Administration had numerous opportunities over nearly a decade to stop the Massachusetts pharmacy responsible for a deadly meningitis outbreak that has killed more than 50 Americans. Republicans and Democrats took turns chastising the FDA for not being aggressive enough in going after compounding pharmacies like the New England Compounding Center, the specialty pharmacy which produced tainted pain injections that have sickened more than 700 people and killed 53 others." ...

"The NECC halted operations in October and faces over 100 lawsuits in federal court. But more than half a year later, lawmakers in Washington continue to debate who should be held accountable for the outbreak and whether it could have been prevented. Republicans said Tuesday that the FDA should have shut down the NECC based on complaints from doctors, patients, hospitals and state pharmacy regulators. The FDA first inspected the NECC in 2002 and issued a warning letter in 2006 over the pharmacy’s production of copies of manufactured drugs without patient prescriptions. Between 2007 and 2012 the FDA continued to receive complaints about the company from anonymous whistleblowers and state pharmacy regulators, according to internal documents released by the committee."

"‘‘Ten years of warning signs, alarm bells, and flashing red lights were deliberately ignored,’’ said Rep. Tim Murphy, R-Pa., who chairs the House Energy and Commerce Subcommittee on Oversight and Investigations. Murphy and other Republicans pointed to correspondence in thousands of pages of FDA documents turned over to the committee."

The Rest of the Story

The rest of the story is that while the FDA worked to get electronic cigarettes off the market and obsessed about thousands of essentially meaningless substantial equivalence applications, it ignored information that could have prevented a deadly meningitis outbreak.

This story just adds to my earlier commentaries about the misplaced priorities of the FDA and the wisdom of placing tobacco jurisdiction in the hands of an agency that is already having a difficult enough time completing its traditional mission of protecting the nation's food and drug supply.

Apparently, the FDA had substantial evidence of the lack of safety of the New England Compounding Center yet ignored these warnings. At the same time, the agency was trying to ban electronic cigarettes without any substantial evidence showing that they posed a significant risk to the public's health. And also at the same time, the agency was obsessing about thousands of applications to make minor changes in tobacco products, changes which would have no substantial impact on the public's health given the magnitude of the risk associated with cigarette smoking in the first place.

Because of the misplaced priorities of the FDA, the FDA has done nothing substantial to protect the public's health from the known hazards of cigarettes. As I opined on Monday, not a single one of the actions that the FDA boasts about did anything to substantially reduce tobacco-related disease or death.

The problem is not just with the FDA, but with the Tobacco Act in the first place. It was never intended to protect the public's health. It was intended to take politically easy steps by which politicians and anti-smoking groups could claim victory, but without having to actually make a dent in cigarette sales. While the FDA is busy processing substantial equivalence applications, it and the anti-smoking groups can pretend that they have accomplished something meaningful, but the only thing happening is that they are putting a huge and unnecessary delay in front of tobacco companies. This is no public health achievement.

I can't help but take readers back to a 2009 column by Igor Derysh in the Congress Examiner, which called the FDA legislation a "cheap political ploy" that allows politicians to tell the American public that they did something about the problem when they actually did nothing to actually make a difference in smoking, other than perhaps get rid of the banana-flavored cigarettes that are such a pervasive problem. Noting that the bill gets rid of all the flavorings that are not used but exempts the one flavoring (menthol) that is actually used to addict thousands of young people, Derysh concludes: "Protecting the public, my ass."

Derysh writes: "Earning cheap political points by going after easy targets has always been high on Congress' agenda. Respecting the American public has not. And so, when the recent tobacco regulation bill passed overwhelmingly in Congress it was both a cheap political ploy and another example of Congress disregarding the possible intelligence of the American people. The bill itself transferred regulation of the tobacco industry to the Food and Drug Administration (a government agency that is run by the same people that it regulates), strengthens warning labels, demands that tobacco companies disclose their ingredients, and bans flavored cigarettes. All flavored cigarettes except for menthol cigarettes. Menthol cigarettes of course have a considerably higher amount of harmful chemicals than others do and are targeted towards the black community just like guns. Protecting the public, my ass."

"The passage of the Tobacco Control Act is just another attack on the intelligence of the American individual. We do not need to be told that cigarettes are bad for you, we are bombarded with that message all day long. What we need is a Congress that accomplishes something worthwhile or just stays the hell home instead of celebrating cheap victories in which they banned banana flavored cigarettes."

FDA Boasts About "Accomplishments," But So Far Has Not Accomplished a Single Thing to Protect the Public's Health

In a promotional flyer on its web site, the FDA boasts about its timeline of accomplishments to protect the public's health under the Family Smoking Prevention and Tobacco Control Act.

Here is its list of its so-called accomplishments:

September 2009: Banned flavored cigarettes making them less appealing to kids
March 2010: Restricted youth access to tobacco products
June 2010: Banned misleading advertising to avoid misperception that products are safer
June 2010: Established new smokeless tobacco warnings to communicate health risks
June 2011: Issued new cigarette health warnings to highlight product dangers (under litigation)
March 2012: Established list of harmful and potentially harmful constituents
March 2012: Issued draft guidance on submitting a Modified Risk Tobacco Product Application

The Rest of the Story

None of these interventions has or will do anything substantial to protect the public's health. Here is my analysis of each of these actions:

September 2009: Banned flavored cigarettes making them less appealing to kids

The ban on flavored cigarettes did not affect a single cigarette brand produced by the Big Tobacco companies. The brands being smoked by more than 99% of youth are not brands which were eliminated by the FDA. Thus, this action had no significant effect on reducing youth smoking.

In fact, the one flavoring that FDA could have banned but chose instead to exempt from regulation was menthol, and menthol cigarettes make up about half of the youth market.

Thus, far from being an accomplishment, the regulation of flavored cigarettes by the FDA has been a dismal failure.

March 2010: Restricted youth access to tobacco products
The restrictions on youth access to tobacco products will have no effect on youth smoking. Multiple studies have shown that youth access restrictions do not work. There are many ways by which youth obtain cigarettes and purchasing them is the usual method for fewer than half of youth smokers. Several meta-analyses have demonstrated that youth access restrictions have no effect on youth smoking rates.

Thus, far from being an accomplishment, the restriction and enforcement of youth access to tobacco products has been a waste of resources.

June 2010: Banned misleading advertising to avoid misperception that products are safer
The ban on misleading advertising (terms such as "lights") had already been put into effect by Judge Kessler as part of the remedies in the Department of Justice's RICO suit against Big Tobacco. Moreover, the regulation has had little effect because cigarette companies simply used different color schemes to indicate which products were "regulars," "lights," etc.

While anti-smoking groups complained that tobacco companies were circumventing the law, I have explained that they were well within their rights under the law and that had the FDA not wanted companies to use color schemes, then it should have prohibited companies from doing so. It failed to take such an action. The blame must not be put on the cigarette companies, but on the politicians and health groups that crafted and supported the Tobacco Act and on the FDA itself.

Thus, far from being an accomplishment, the regulation of misleading descriptors by the FDA has been a demonstrated failure.

June 2010: Established new smokeless tobacco warnings to communicate health risks
Substantial research demonstrates that these warnings will have no effect in reducing the use of smokeless tobacco. If anything, smokeless tobacco use among youth has increased since the FDA took this action.

Far from being an accomplishment, this action had no effect whatsoever.

June 2011: Issued new cigarette health warnings to highlight product dangers (under litigation)
These warning labels never saw the light of day as the FDA crafted warnings that were unconstitutional, as they violated the First Amendment. Even had they been upheld by the courts, they would have had no more than a marginal effect on cigarette smoking. In fact, the lack of evidence that graphic warning labels have any substantial effect in stimulating smoking cessation was what doomed this regulation in the courts.

Far from being an accomplishment, the graphic warning regulation was a policy and legal failure.

March 2012: Established list of harmful and potentially harmful constituents
The list of harmful and potentially harmful constituents was an exercise in futility. It accomplished nothing.

There is nothing that will be learned from the exercise that will either:

(1) provide meaningful or helpful information to consumers; or

(2) provide critical information to the Agency to allow it to develop a strategy to produce substantially safer cigarettes.

If anything, this information is potentially deceptive, as:

1. These constituents represent only a small fraction of the chemicals present in tobacco smoke.

2. No one actually knows which constituents, and in what combinations or at what levels, are responsible for each of the many diseases caused by tobacco smoke.

3. Lowering levels of certain of these constituents may have no effect on overall health risks.

4. Products with lower levels of certain of these constituents may or may not be safer than other cigarettes.

It must be remembered that there are between 10,000 and 100,000 chemicals in tobacco smoke, most of which have not yet been identified. Most likely, the majority of hazardous chemical constituents of tobacco smoke have not yet been identified. It is naive to think that by controlling levels of certain of these 20 selected chemicals, one can control the level of risk posed by different brands of cigarettes.

The entire strategy makes no scientific sense, is not founded in any scientific evidence base, is misleading and deceptive at the core, and represents a tremendous waste of time and resources. This is regulation for regulation's sake, and there is no public health benefit of these regulations. If anything, it is a huge distraction from the types of public health efforts that are actually needed to effectively address the problem of tobacco-related morbidity and mortality.

Rather than representing an accomplishment, the list of harmful constituents was a useless exercise.

March 2012: Issued draft guidance on submitting a Modified Risk Tobacco Product Application

The FDA's guidance on modified risk products do nothing to protect the public's health. Instead, they actually harm the public's health by making it more difficult for truly reduced risk products to reach the market. This guidance serves to protect the existing high-risk products on the market from challenge by safer products. The FDA guidance on modified risk tobacco products: (1) makes it almost impossible for new reduced risk products to be successfully developed and marketed; (2) makes it extremely difficult for existing potentially-reduced risk products to successfully achieve a modified risk status; and (3) makes it extremely unattractive for existing potentially-reduced risk products to successfully achieve modified exposure status.

Far from being a public health accomplishment, the modified risk product guidance harms the public's health by ensuring that the most hazardous tobacco products will remain unchallenged by much safer ones.

New Study Shows that Quitline Cessation Counseling is of No Value for Young Adult Smokers

An article published in the May issue of Nicotine & Tobacco Research reports the results of a clinical trial of a quitline-based smoking cessation counseling intervention among young adult smokers ages 18-24. The article reports no significant effect of the intervention on attempted quitting or successful quitting.

(See: Sims TH, McAfee T, Fraser DL, Baker TB, Fiore MC, Smith SS. Quitline cessation counseling for young adult smokers: a randomized clinical trial. Nicotine & Tobacco Research 2013; 15(5): 932-941.)

The study's methods are described as follows: "This was a 2-group randomized clinical trial. The quitline-based counseling intervention (CI) included up to 4 proactive telephone counseling sessions; participants in the self-help (SH) group received only mailed cessation materials. Participants included 410 young adults who had smoked at least 1 cigarette in the past 30 days and who called the Wisconsin Tobacco Quit Line (WTQL) for help with quitting. Primary study outcomes included whether or not a quit date was set, whether or not a serious quit attempt was undertaken, and self-reported 7-day point-prevalence abstinence at 1-, 3-, and 6-month postenrollment."

The results were as follows: "Relative to self-help, quitline counseling motivated young adults to set a quit date but abstinence rates were not improved."

The Rest of the Story

Although quitlines are the mainstay of current tobacco control approaches to smoking cessation, this study shows no evidence that this approach has any value for the young adult smoking population. Yong adults who participated in the quitline counseling program were no more likely to try to quit and were no more likely to actually quit.

It is interesting that rather than concluding that more effective methods of motivating young adult smokers to quit are necessary, the study concludes that: "Research is needed on how to motivate young adult smokers to seek cessation treatment including quitline services."

If quitline services don't work for this population, then why do we need better ways of getting young adult smokers to use quitline services?

The answer appears to be simple:

We don't. However, one of the study authors has a conflict of interest by virtue of having owned stock in Free & Clear, the quitline vendor used by the vendor in this study. This study author was also employed by Free & Clear in the past. And the University of Wisconsin paid Free & Clear through a grant subcontract during the study, which supported this co-author.

Thus, this conflict of interest has the appearance of creating a bias in the paper's recommendations. Rather than stick with the study findings, the paper ignores those findings and recommends that we continue to focus on quitlines as a smoking cessation intervention for young adults. This flies in the face of the evidence presented within the paper itself, which shows no benefit, even with a rather intensive counseling intervention.

It is also interesting that two of the co-authors (Dr. Fiore and Dr. Baker) report no conflicts of interest.

However, in a 2008 article, Dr. Fiore acknowledged: "In the past 5 years, Dr Fiore reports that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis. In 1998, the UW appointed him to a named chair, made possible by an unrestricted gift to the UW from GlaxoWellcome."

Also in 2008, Dr. Baker reported that: "reported that he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."

Why weren't these financial conflicts of interest with Big Pharma disclosed in the current article? Certainly they represent a conflict because Big Pharma stands to lose substantially if quitlines drop out of favor as a focus for the nation's smoking cessation strategy. And although it appears that neither of these co-authors has maintained pharmaceutical company funding or consulting over the past 5 years, I see no reason why these prior conflicts are not relevant to readers of the study.

If a former tobacco industry consultant published an article, would anti-smoking advocates be comfortable with that individual not disclosing his prior financial relationship with Big Tobacco? I doubt it.

The rest of the story is that: (1) this article provides evidence that quitline-based cessation counseling is of no value for young adult smokers; (2) that there is an apparent bias in the article's recommendation that appears to be related to a financial conflict of interest of one of the study authors; and (3) that two of the study authors are failing to report a prior conflict of interest that is very relevant to the current study.

Electronic Cigarettes Will Normalize Smoking? This Couldn't Be Further from the Truth, According to Tobacco Market Analysts

A large number of anti-smoking groups and advocates are opposed to electronic cigarettes because they are afraid these products will serve to "normalize" smoking.

But tobacco market analysts predict that not only will electronic cigarettes fail to normalize smoking, but they will do quite the opposite: de-normalize smoking by substantially reducing cigarette consumption.
 
In a recent analysis, Bonnie Herzog - senior analyst - and Jessica Gerberi - Associate Analyst - of Wells Fargo Securities pointed to the fact that convenience store unit sales of cigarettes declined to the lowest level in the past year, which they argue could be due to electronic cigarettes. They also suggest that within a decade, e-cigarettes could actually surpass tobacco cigarettes in consumption: "Unit sales were at the lowest they've been in the past year and we believe could be partially due to the increasing popularity of e-cigarettes, whose consumption we believe could surpass traditional cigs within the next decade."

The Rest of the Story

Contrary to the apparent thinking of many anti-smoking groups and advocates, the most important factor in the normalization or de-normalization of cigarette smoking is the prevalence of smoking. The more smokers, the more smoking is normalized. A substantial decline in cigarette consumption, as predicted by these analysts, would do more than any other intervention to de-normalize smoking.

Thus, in contrast to the assertions of many anti-smoking groups, electronic cigarettes represent the greatest threat to the normalization of smoking in many years.

Even many experts in tobacco control fail to appreciate this basic and important point. For example, Stan Glantz recently argued on his blog that: "It may well be that e-cigarettes have the effect of keeping people smoking conventional cigarettes." If these market analysts are correct, then Stan's argument is 180 degrees wrong. Cutting cigarette consumption so much that it is seriously challenged by electronic cigarette consumption is hardly "keeping people smoking conventional cigarettes." It is quite the opposite.

Duke Center for Smoking Cessation Hiding Its Funding from Philip Morris, Violating Basic Public Health Ethics

One of the great cover-ups in history in tobacco control is occurring before our very eyes. Ironically, this time it is not a tobacco company engaging in the deceptive cover-up, but an anti-smoking organization: the Duke Center for Smoking Cessation (CSC).

Most organization web sites have an "About Us" link that provides historical information about the group, such as who founded it and what its funding sources have been. I couldn't find any such page on the CSC web site.

Most organizations have a funding, sponsors, or disclosure page where they list the sources of their financial support over the years. I couldn't find any such page on the CSC web site.

In fact, if you casually peruse the CSC web site, you will get the impression that this is a legitimate, run-of-the-mill anti-smoking organization that is dedicated to smoking cessation.

But that couldn't be further from the truth.

The Rest of the Story

If you look at the web site of the Duke Center for Smoking Cessation, you will be hard-pressed to identify one of the major founding corporate supporters of the center: Philip Morris. Despite extensive searching, I was unable to find any prominent page on the site with a disclosure that the Center received $37 million from Philip Morris between 2004 and 2012 (as acknowledged and boasted by Philip Morris). A search for "Philip Morris" on the web page's search engine came up empty.

According to Philip Morris: "Since 2004, PM USA has supported the Duke Center for Nicotine and Cessation Research. PM USA expects to provide a total of $37 million to the center through June 2012 to develop, evaluate and disseminate improved methods for quitting smoking."
 
There is a donation page, but little would potential donors know that they are adding themselves to a list that is dominated by the nation's largest tobacco company. Nowhere on this page does it disclose that the Center was largely created and supported by a $37 million grant from Philip Morris.

The schedule of activities for the Center's 2012 research conference fails to acknowledge or disclose this whopping amount of funding for the Center from Philip Morris.

The information page for the conference fails to acknowledge this massive Philip Morris financial support.

The summary page for the Center's director also fails to disclose the Philip Morris funding.

A couple of lapses in disclosure might be attributed to poor memory, or to a minor oversight, but the extent of the Center's hiding of Philip Morris' support from 2004-2012 is, in my opinion, beyond a simple mistake.

In my opinion, what we have here is an immense cover-up of the Center's wrongdoing.

The mistake Duke made is that it allowed itself and its reputation and good name to be used as a public relations ploy for a tobacco company. Duke allowed itself to be used as a pawn in the public relations and marketing strategy of Philip Morris.

Clearly, since the purpose of this research funding was demonstrably not to dramatically reduce the number of smokers, its purpose was therefore to serve as a public relations ploy - by which Philip Morris could improve its public image by being able to argue that it really cares and that it is a responsible corporate citizen which is trying to help its customers break their addiction to its products. By associating its name with that of Duke University, Philip Morris used Duke to gain public relations marketing value from that association.

This research center couldn't have been any better planned for Philip Morris than had it been designed by Philip Morris' own public relations department.

Actually, in a way it was, because Duke University served as a PR arm for Philip Morris, by virtue of its accepting this tobacco money to conduct a research program that had the effect of diverting attention away from areas where we could really make a difference in getting people to quit smoking (such as developing aggressive, anti-smoking media campaigns rather than studying the biology of nicotine addiction).

For tax or accounting purposes, Philip Morris should really have classified these research dollars under "public relations." And they sure got their money's worth.

The rest of the story is that Duke undermined its own scientific integrity and that of academia as a whole by allowing itself to serve as a pawn in the tobacco industry's public relations and marketing strategy. A university - and especially a medical center - should not play a role in marketing the most deadly consumer product. But that is exactly what this Duke center did for 8 years.

Now, rather than acknowledge its mistake and apologize for the disservice it did to the public's health and to the integrity of academia and of scientific research, the Center appears to be attempting to erase this sorry chapter in tobacco control history.