Tuesday, April 30, 2013

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.

Monday, April 29, 2013

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.

Thursday, April 25, 2013

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.

Wednesday, April 24, 2013

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.

Monday, April 22, 2013

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:

St. Louis Health Director     GOLD RANK
Attorney General of Florida  SILVER RANK

National Anti-smoking Organization  GOLD RANK

Mayor of New York City        BLUE RANK

U.S. Senator, New Jersey   BRONZE RANK

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.

Thursday, April 18, 2013

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.)

Wednesday, April 17, 2013

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."

Monday, April 15, 2013

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.

Friday, April 12, 2013

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.

Thursday, April 11, 2013

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.

Wednesday, April 10, 2013

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.

Tuesday, April 09, 2013

Obama Cigarette Tax Proposal Would Make Menthol Ban Much Less Likely

If Congress enacts the President's proposal for an increased tax on cigarettes to fund pre-school education, it would make it much less likely that that the FDA promulgates a ban on menthol cigarettes.


Because a menthol ban would threaten to substantially decrease cigarette sales, thus depleting pre-school education funds. Overnight, Congress would be putting supporters of pre-school education into the ironic position of having to oppose a ban on menthol cigarettes or else face cuts to their programs. This is a poignant example of the kind of perverse effects that this tax proposal would have.

To summarize my reasons for opposing this proposal to fund pre-school education by increasing cigarette taxes: (1) it is a regressive tax that disproportionately hurts the poor; (2) it is unfair because the benefits do not accrue to those who bear the burden of paying the tax; (3) it is unacceptable because it makes children's early education dependent upon sustaining high levels of cigarette smoking; and (4) it removes any incentive for the federal government to substantially reduce cigarette consumption.

Despite these problems, the proposal is being widely supported by anti-smoking groups, including the Campaign for Tobacco-Free Kids which touts it as a "win-win-win" scheme.

The Rest of the Story

It is unfortunate that anti-smoking groups are incapable of anything other than knee-jerk support for any and all cigarette taxes. They have never met a cigarette tax increase that they didn't like, no matter who pays the tax, what the funds are used for, how regressive or unfair it is, how inappropriate the resulting fiscal dependence on smoking might be, and how sensible potential alternative funding sources, or alternative uses of the cigarette tax revenues might be.

Cigarette taxes should be used to compensate for the costs they impose on society. In other words, they should be used for smoking-related programs. For example, using cigarette tax revenues to fund expansion or improvement in treatment for smoking-related diseases makes sense from a tax policy perspective. It is fair, because the benefits accrue to precisely those who are paying the tax. It is sensible, because the money is being used to compensate for costs imposed specifically by smoking. It also avoids the problem of creating a dependence on continued smoking, because as smoking declines, the need for the revenue also declines, as there will be less smoking-related disease. To some extent, it is a self-regulating system.

In contrast, using the cigarette tax to fund pre-school education creates an unacceptable conundrum. If we reduce smoking, then we lose money that is needed to pay for children's education. The more people continue to smoke, the fewer children who will have access to early education programs. As smoking rates fall, there is no direct decline in the need for children's education.

I find it unfortunate that anti-smoking groups are so narrow-minded in their thinking that they do not seem capable of considering the broader implications of what they are supporting and the sensibleness of their proposal in light of available alternatives. It is as if these groups have blinders on which preclude them from seeing any issue or consideration other than smoking. They are blind to effects on the poor, fairness, and long-term implications, for example.

In my view, tobacco control was never intended to be a field all its own. It was intended to be a part of a broader public health perspective. Unfortunately, it is increasingly becoming separate from public health. It is becoming more and more narrow-minded.

It's time to take the blinders off. There's a whole world out there which we are not seeing.

Monday, April 08, 2013

President Obama Proposes Tying Pre-Kindergarten Education to Continued High Sales of Tobacco Products

Faced with a budget crisis and difficulty finding a way to fund pre-kindergarten education, President Obama has proposed to put the burden of funding pre-school education on the nation's smokers. His proposal would fund education programs for four year-olds from revenues derived from an increased tax on cigarettes and other tobacco products.

According to a Bloomberg article: "Obama’s 2014 budget proposal, to be released April 10, would finance a pre-kindergarten program for 4-year-olds with higher taxes on cigarettes and other tobacco products."

Also according to the article, anti-smoking groups are widely supporting the proposal:

"Anti-smoking organizations praised Obama’s proposal. “A significant tobacco-tax increase is a win-win-win for the country -- a health win that will reduce tobacco use and save lives, a financial win that will raise revenue to fund an important initiative and reduce tobacco-related health-care costs, and a political win that is popular with voters,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids in Washington."

The Campaign for Tobacco-Free Kids praised the proposal in its own press release, stating: "It is great news for our nation's health, and especially for the health of our children, that President Obama plans to propose an increase in the federal tobacco tax to pay for early childhood education initiatives."

In contrast, the cigarette companies are opposing the proposal:

"“It is unfair to single out adult tobacco consumers with another federal tobacco-tax increase to pay for a broad, new government-spending program,” said David Sutton, a spokesman for Richmond, Virginia-based tobacco-maker Altria Group Inc. (MO)."

The Rest of the Story

Ironically, I agree with Altria's statement and disagree with the Campaign for Tobacco-Free Kids' statement on this proposal.


For three major reasons:

1. The Tax Proposal is Unfair

First, it is unfair to put the burden of funding pre-school education on the nation's smokers, especially when they will pay the tax but will not benefit directly from it. Asking wealthier Americans or corporations to shoulder the burden of funding pre-school education is fair, but asking some of the poorest Americans to shoulder that burden is not.

Many smokers already spend 25% of their income on cigarettes and asking them to spend even more than that is not going to help their families or their children in any way.  We can blame the smokers all we want, but the reality is that all of us have various vices or unhealthy behaviors in which we engage. It is not fair to single out smokers every time we have a budget shortfall, unless the tax revenues will directly benefit smokers in some way (for example, by funding research and better treatment into smoking-related diseases).

David Sutton is right when he argues that it is not fair to single out smokers to pay for a "broad, new government-spending program." If this were a narrow program designed to address tobacco-related diseases specifically, then it would be fair. But since the revenues do not directly benefit smokers, it is an unfair proposal.

2. The Proposal Permanently Ties Pre-School Education to Continued High Rates of Smoking

In the future, what would happen if smoking rates dramatically drop? The answer is that pre-school education programs would have to be cut because of declines in cigarette tax revenue. Thus, the President's proposal creates a situation in which the maintenance of pre-school education becomes dependent on continued high rates of cigarette smoking.

This has several perverse effects. One is that it takes away any incentive for the federal government to substantially cut cigarette smoking. Doing so would result in de-funding pre-school education and who would want to do that? A second effect is that it creates a government dependence on cigarette smoking for one of the most critical services that the government provides: pre-school education.

Essentially, this proposal would allow smokers to boast that it is thanks to them that our nation's 4 year-olds are being educated. Can you imagine bumper stickers like: "Support Pre-School Education: Smoke Early and Often," or "I Support Kids: I Smoke."

This is how perverse the effects of the proposed tax would be.

3. The Proposal Undermines the Principle of Using Cigarette Tax Increases to Fund Comprehensive Anti-Smoking Campaigns that Directly Benefit Smokers

The gold standard in tobacco control is, or at least ought to be, the implementation of comprehensive anti-smoking campaigns which include programs that directly benefit smokers, such as providing encouragement or assistance with smoking cessation, improved screening and treatment for smoking-related diseases, and research into better treatments for these diseases. Such programs should implement best practices, such as providing "Pathways to Freedom" to all African American smokers who are trying to quit. They should implement anti-smoking media campaigns and should include support for specific tobacco control infrastructure and programs in communities of color. Cigarette taxes are an appropriate and fair way to fund these campaigns because although smokers shoulder the burden of funding the programs, they directly benefit from them. Also, the programs do not have perverse effects because there is no disincentive to reduce cigarette smoking. As smoking rates drop and revenue declines, the need for the revenue diminishes. Eventually, the goal of such programs is actually to put themselves "out of business."

By pushing this proposal, the anti-smoking groups - especially the Campaign for Tobacco-Free Kids - are continuing their erosion of the important principle that cigarette tax increases should only be supported if the revenue is used to directly benefit smokers. Cigarette tax increase proposals should include provisions that allocate the revenues specifically to smoking-related programs.

Stan Glantz has written two recent commentaries on his tobacco control blog that share my opinion that cigarette tax increases should only be supported by public health groups if the revenues are allocated to smoking-related purposes, including programs that will directly benefit smokers:

Commentary 1

Commentary 2

In the second commentary, Glantz summarizes his opinion, which accords with mine:

"I do, of course support increasing the tobacco tax. It is just that it has to be the right tobacco tax.
And what would a right tobacco tax look like?  All the money should go to pay for things related to smoking."

Friday, April 05, 2013

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

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

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

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

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

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

The Rest of the Story

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

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

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

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

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

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

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

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

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

Wednesday, April 03, 2013

Metals in Electronic Cigarette Vapor are Below USP Standards for Metals in Inhalation Medications

As I reported on Monday, a study published last week in the online journal PLoS ONE sounded the alarm about potential dangers of electronic cigarettes. The article reported the detection of trace amounts of metals in the aerosol from one brand of electronic cigarette.

(See: Williams M, Villarreal A, Bozhilov K, Lin S, Talbot P. Metal and silicate particles including nanoparticles are present in electronic cigarette cartomizer fluid and aerosol. PLos ONE 2013; 8(3): e57987.)

The study reported that: "The aerosol contained particles greater than 1 micrometer comprised of tin, silver, iron, nickel, aluminum, and silicate and nanoparticles (less than 100 nanometers) of tin, chromium and nickel. The concentrations of nine of eleven elements in EC aerosol were higher than or equal to the corresponding concentrations in conventional cigarette smoke. Many of the elements identified in EC aerosol are known to cause respiratory distress and disease."

While the article scared many vapers by comparing the metal levels in e-cigarette vapor to that in cigarette smoke, it failed to inform readers that the levels of metals in electronic cigarettes are generally comparablle to those in nicotine inhalers. Today, I compare the levels of metals reported by Williams et al. to the USP standards for metals in inhalation medicines.

The Rest of the Story

The Williams et al. article reported the following levels of metals in 10 puffs of an electronic cigarette (all are in micrograms):

Lead: 0.017
Copper: 0.203
Chromium: 0.007
Nickel: 0.005

Since 10 puffs is equivalent to about 1 cigarette, and assuming that a vaper inhales the equivalent of 2 packs of cigarettes per day, that would be a total of 200 puffs per day. We can then multiply each of the above values by 20 to determine the total daily intake of each metal, in micrograms, as follows:

Lead: 0.34
Copper: 4.06
Chromium: 0.14
Nickel: 0.1

Now, here are the USP standards for the maximum allowable daily exposures for each of these metals from inhalation medicines, in micrograms (from the United States Pharmacopeial Convention, Revision Bulletin, Elemental Impurities--Limits, February 1, 2013) :

Lead: 5.0
Copper: 100
Chromium: 25
Nickel: 1.5

You can see that the total daily intake of these metals from the electronic cigarette brand tested by Williams et al. is far below the USP standard for each of the metals. The elemental impurities table does not contain values for the other metals reported in the article, but it does appear that for the ones listed, there don't seem to be safety concerns.

Once again, there is no question that the presence of trace levels of metals in electronic cigarette vapor needs to be addressed. Quality control measures need to be in place to minimize the presence of metals in electronic cigarette aerosol. However, there is no reason to sound the alarm from the data reported in the present study because it fails to compare the detected levels with regulatory standards for pharmaceutical products, including FDA-approved nicotine inhalers.

(Special thanks to Bill Godshall for providing the USP standards.)

Tuesday, April 02, 2013

New Study Documents Effectiveness of Electronic Cigarettes for Smoking Cessation Among 1,000 Ex-Smokers

Anti-smoking groups and advocates continue to argue that there is no evidence that electronic cigarettes can be helpful in smoking cessation, but according to a new study published in the journal Addiction, there are at least 1,000 ex-smokers who would beg to differ. The article reports the results of a survey of committed e-cigarette users, recruited from two e-cigarette company web sites, and finds that these devices were highly successful in helping about 75% of these users to quit smoking. 

(See: Dawkins L, Turner J, Roberts A, Soar K. 'Vaping' profiles and preferences: an online survey of electronic cigarette users. Addiction 2013; doi: 10.1111/add.12150.)

There were 1,347 respondents to this online survey. The main finding was that: "Seventy-four percent of participants reported not smoking for at least a few weeks since using the e-cigarette and 70% reported reduced urge to smoke." In addition, "a further 14% reported that their cigarette consumption had decreased

Thus, a total of 88% of the respondents had either quit smoking or cut down substantially on the amount they smoked.

Fifty-seven percent of the sample reported not having smoked for months after quitting using the e-cigarette.

The article concludes: "Survey respondents were predominantly ex-smokers who wanted a complete alternative to smoking. The majority of respondents reported that e-cigarette use (vaping) had dramatically reduced their craving for cigarettes and helped them to stop or substantially reduce their tobacco consumption. ... E-cigarettes were generally considered to be satisfying to use, associated with very few side
effects, healthier than smoking, and responsible for improved cough and breathing."

The article's final recommendation is as follows: "the results of this study, and previous studies, suggest that e-cigarette users who respond to online surveys vape as a complete or partial alternative to smoking. There was little evidence for dual use (smokers continuing to smoke at previous levels and adding nicotine via e-cigarette) or addictive potential in this sample. Although absolute safety and product quality should be more thoroughly evaluated, the implications of these findings for policy-makers, regulators and health-care providers are clear: prohibiting or discouraging the use of e-cigarettes could be detrimental to public health if smokers are deprived of a highly endorsed and well-tolerated method of smoking cessation."

The Rest of the Story

Obviously, this sample is a biased one so the study cannot be used to draw quantitative estimates of the proportion of smokers whot will quit smoking using e-cigarettes. That, of course, was not the purpose of the study. What the study does demonstrate is that these devices do have great potential. They are, in fact, an effective smoking cessation tool for many smokers. Clinical trials are needed to quantify the quit rates that can be achieved with these products, but this article should put to bed the argument that there is no evidence that electronic cigarettes can help smokers quit.

The survey also adds important information on the side effects of electronic cigarettes. Very few users reported adverse health effects. The most common side effects were mouth and throat irritation.

Also of importance, the study finds that a large percentage of e-cigarette users actually experienced an improvement in their health, as evidenced by decreased cough and improved breathing. Seventy percent of users reported a substantial reduction in cough, and 72% report a substantial improvement in their breathing.

Essentially, anti-smoking advocates and organizations are working to take these breathing improvements and improved respiratory status away by discouraging e-cigarette use.

The most important finding of the study is that electronic cigarettes are being used as a complete or partial alternative to cigarette smoking and that there is little evidence for dual use. This destroys the main argument of the anti-smoking groups - like the American Legacy Foundation and Americans for Nonsmokers' Rights - which continue to oppose electronic cigarettes.

The rest of the story can best be stated by repeating the recommendation made by the study: "prohibiting or discouraging the use of e-cigarettes could be detrimental to public health if smokers are deprived of a highly endorsed and well-tolerated method of smoking cessation."

Monday, April 01, 2013

New Study Sounds Alarm about Metals Detected in Electronic Cigarettes, But Fails to Inform Readers that Nicotine Inhalers Have Similar Levels of the Same Metals

A study published in the online journal PLoS ONE sounds the alarm about potential dangers of electronic cigarettes. The article reports the detection of trace amounts of metals in the aerosol from one brand of electronic cigarette.

(See: Williams M, Villarreal A, Bozhilov K, Lin S, Talbot P. Metal and silicate particles including nanoparticles are present in electronic cigarette cartomizer fluid and aerosol. PLos ONE 2013; 8(3): e57987.)

The study reported that: "The aerosol contained particles greater than 1 micrometer comprised of tin, silver, iron, nickel, aluminum, and silicate and nanoparticles (less than 100 nanometers) of tin, chromium and nickel. The concentrations of nine of eleven elements in EC aerosol were higher than or equal to the corresponding concentrations in conventional cigarette smoke. Many of the elements identified in EC aerosol are known to cause respiratory distress and disease."

The Rest of the Story

The casual reader of this article will take away from it that electronic cigarettes are harmful and that they are more dangerous than tobacco cigarettes because they contain high levels of hazardous metals.

But the study is misleading because of a serious flaw: the failure to compare levels of metals in electronic cigarette vapor to those in FDA-approved nicotine inhalers, which are widely recognized as safe for use by consumers.

The rest of the story is that those FDA-approved nicotine inhalers also produce aerosol that contains detectable levels of metals and in some cases, the levels of metals are higher than those in electronic cigarettes.

But curiously, this study ignores that fact and while it calls out the dangers of electronic cigarettes, it fails to also warn the public about the similar dangers of using nicotine inhalers, like Nicorette.

Here is the rest of the story:

This study reported a nickel level of 0.005 micrograms in 10 puffs of the electronic cigarette vapor.

The Nicorette nicotine inhaler was found to contain nickel at a level of 0.013 micrograms per 10 puffs.

Thus, the level of nickel in the electronic cigarette vapor was 2.6 times lower than in an FDA-approved nicotine inhaler.

The study reported a lead level of 0.017 micrograms in 10 puffs of the electronic cigarette vapor.

The Nicorette nicotine inhaler was found to contain lead at a level of 0.003 micrograms per 10 puffs.

Thus, the level of lead in the electronic cigarette vapor was 5.7 times higher than in an FDA-approved nicotine inhaler.

However, it should be noted that only one brand of electronic cigarette was tested in this study, and in the Goniewicz et al. study, 12 brands were tested and only one had a lead level substantially higher than present in the Nicorette inhaler.

There is no question that the presence of trace levels of metals in electronic cigarette vapor needs to be addressed. Quality control measures need to be in place to ensure that joints are properly soldered, that there are not loose or exposed wires, that the juice does not contact metals, and that proper steps are taken to minimize or eliminate the presence of metals in electronic cigarette aerosol. However, there is no reason to sound the alarm from the data reported in the present study because it fails to provide any comparison between electronic cigarettes and other types of inhalers, including the FDA-approved nicotine inhalers.