Saturday, September 27, 2014

Discontinuation of Crowdfunding Campaign for BSCiTS Study

It is with great regret that we announce that we are discontinuing the Behavioral Study of Cigarette and Tobacco Substitution (BSCiTS) fundraising campaign, and canceling the proposed study. For those of you who have donated to the campaign, your donations will be returned to you.

Although we officially launched the BSCiTS campaign just a week ago, our team at Boston University has invested substantial intellectual, logistical, and spiritual effort into this project for more than a year. We truly believed this campaign would be a success, and we want to extend our sincere gratitude to those from the vaping community and electronic cigarette industry who supported the development and launch of the campaign, as well as the administrative and development offices of Boston University School of Public Health.

We would like to explain our reasons for discontinuing BSCiTS.

1. Divisiveness within the e-cigarette community. The passion of the engaged, vocal members of the vaping community and e-cigarette industry is what inspired us to develop the BSCiTS project in the first place. Unfortunately, however, we discovered that there is great divisiveness within the e-cigarette community regarding the role of research—including what type of research should be done, who should do it, and who should pay for it. We welcomed feedback and suggestions about creating an optimal study design for BSCiTS, and we sought to be responsive to concerns about study methodology. However, the tone of feedback directed at our team quickly became hostile. Our integrity as researchers was questioned, and criticism quickly shifted from concerns about study methods to personal attacks.

2. BSCiTS was sparking further divisiveness. Our campaign was only public for a week, but in that short period of time it became evident it was exacerbating other, deeper fissures and ideological differences within the e-cigarette community. We were disturbed to find one organization in particular actively undermining our campaign efforts. It became apparent there is disagreement in the e-cigarette community about the need for rigorous research of the caliber that the FDA will require.

3. Initial reception from e-cigarette industry was not positive enough. Though we received much encouragement to develop and launch the BSCiTS campaign, the response from industry to our funding appeal was lukewarm. We are not confident that BSCiTS could receive enough financial support from independent e-cigarette companies to fund a rigorous study design.

4. Pressure to compromise study objectivity. Finally, and most importantly, we received pressure from a major e-cigarette advocacy group to alter our proposed study design in order to produce a more positive outcome. Attempting to exert influence on independent researchers to produce more favorable results is deeply unethical and extremely problematic. Moreover, this is hypocritical given the e-cigarette community’s rejection of biased research studies produced by tobacco companies and public health professionals alike. We are unwilling to compromise our scientific integrity in order to conduct a study on behalf of the e-cigarette community. We came to realize that the current climate within the e-cigarette community is not conducive to conducting objective behavioral research at the level of rigor upon which we insist. Ultimately, we have to place our own scientific integrity ahead of the desire to successfully secure research funding. 

It is a sad day for us. We want to reiterate how much we appreciate those in the e-cigarette community—from individual vapers to entire companies—who believed in BSCiTS. Your encouragement and support has been incredibly meaningful. 

Yours sincerely, 
Michael Siegel, MD MPH and Sarah Roberts, MPH

Thursday, September 25, 2014

CDC Rejoices that Fewer Smokers are Trying to Quit

According to new data published by the CDC in the journal Nicotine & Tobacco Research, the trend of increasing use of electronic cigarettes among adult smokers halted in 2013.

According to an article by the AP's Mike Stobbe, "The proportion of adults who have ever used e-cigarettes rose from about 3 percent to 8 percent from 2010 to 2012. But there was no significant change last year, according to the Centers for Disease Control and Prevention study."

These data are consistent with financial analyst reports showing that there has been a decline in the sales of traditional cig-a-like type electronic cigarettes in retail stores.

According to multiple news articles, the CDC responded to this news by "rejoicing": that is, the agency expressed happiness that the use of electronic cigarettes by smokers is declining or leveling off.

According to the AP article: "[CDC lead author Brian King] called the leveling off in adults who have ever tried e-cigarettes "a positive note."

The Rest of the Story

A positive note? Are you serious?

The CDC is actually stating that the finding that fewer smokers are trying to quit smoking by switching to e-cigarettes is a good thing.

In other words, the CDC is happy that the combustible tobacco market is regaining strength compared to the non-combustible market. The CDC is happy that cigarette sales are facing less and less competition from the fake, but much safer cigarettes that greatly reduce a smoker's health risks, even if the person does not quit smoking completely, but greatly reduces his or her cigarette consumption.

That financial analysts had predicted that e-cigarette use might overtake smoking in the next decade would have been great news. In fact, it would have been a public health miracle - one of the greatest public health victories of our lifetime. The fact that this is apparently not going to occur is not good news, it is a tragedy.

That the CDC is rejoicing in the protection of the combustible tobacco market from competition from much safer electronic cigarettes is also tragic. Because it shows that the nation's lead prevention agency has completely lost sight of its public health mission. Instead, the CDC seems committed to an ideological mission of demonizing electronic cigarettes because they "look like" tobacco cigarettes and apparently, cannot condone the use of a product which looks like a cigarette, even if it may be saving the life of the individual using the product.

This is particularly sad for me to see, because I used to work at the Office on Smoking on Health at CDC, and at the time I worked there, we worked endlessly to promote and encourage smoking cessation attempts. To rejoice because fewer smokers are trying to quit smoking using e-cigarettes is a tragic turn of events.

Monday, September 22, 2014

New Study Claims to Have Found that E-Cigarettes are Unhelpful in Smoking Cessation among Cancer Patients

A new study published online ahead of print in the journal Cancer reports that e-cigarettes are not helpful for smoking cessation among patients with cancer.

(See: Borderud SP, Li Y, Burkhalter JE, Sheffer CE, Ostroff JS. Electronic cigarette use among cancer patients: Characteristics of e-cigarette users and their smoking cessation outcomes. Cancer. Published online ahead of print on September 22, 2014. doi: 10.1002/cncr.28810.)

The study enrolled 1,074 patients with cancer who were smokers and were therefore referred to a tobacco treatment program at a comprehensive cancer center during the years 2012 and 2013. Smoking status, nicotine dependence, and e-cigarette use was assessed at baseline and the patients were followed for six-month. The primary outcome was smoking cessation, measured as seven-day abstinence at follow-up.

The researchers reported that patients who used e-cigarettes were no more likely to have quit smoking at follow-up than patients who did not use e-cigarettes.

The study concludes that e-cigarettes are not helpful for smoking cessation among cancer patients.

The press release announcing the study results is titled "E-Cigarettes Unhelpful in Smoking Cessation among Cancer Patients."

These results were widely publicized in the media, with negative headlines such as: "E-Cigarettes Don't Help Cancer Patients Quit Smoking."

The Rest of the Story

It is easy to see why this methodology is inappropriate to assess smoking cessation rates among smokers who use e-cigarettes in an attempt to quit smoking.

Suppose that there are 1000 e-cigarette users who enter the cancer center with a diagnosis of cancer. Of these, an amazing 900 were able to quit smoking. However, 100 were very resistant smokers and could not quit smoking, even with e-cigarettes. Note that it would be these 100 resistant smokers who would be enrolled in the study. The 900 ex-smokers who quit using e-cigarettes would not be eligible for the study, because they no longer smoke.

Now, if those 100 resistant smokers were then followed for six months, we would expect that very few of them would quit smoking because all of them had already tried e-cigarettes and failed.

In other words, the blatant flaw in this study is that it enrolled smokers who had already made quit attempts using e-cigarettes in the past. By definition, this resulted in a sample of smokers who were more resistant to quitting. One would expect to find lower quitting rates among this population of e-cigarette users.

To be valid, the study needs to examine e-cigarette smokers who have not tried these products before and are trying them for the first time in an attempt to quit smoking. Otherwise, the study cannot truly claim to draw conclusions about how helpful e-cigarettes are for smoking cessation among cancer patients.

These flaws are also noted by Dr. Robert West, director of tobacco research at University College London, who pointed out that: "the study was not able to assess whether or not for cancer patients who smoke using an e-cigarette to try and quit is beneficial "because the sample could consist of e-cigarette users who had already failed in a quit attempt, so all those who would have succeeded already would be ruled out"."

Peter Hajek, director of the Tobacco Dependence Research Unit at Queen Mary, University of London, also noted this critical flaw in the study: ""The authors followed up smokers who tried e-cigarettes but did not stop smoking, and excluded smokers who tried e-cigarettes and stopped smoking," he said. "Like smokers who fail with any method, these were highly dependent smokers who found quitting difficult. The authors concluded that e-cigarette (use) was not helpful, but that would be true for any treatment however effective if only treatment failures were evaluated."

Once again, shoddy research by opponents of electronic cigarettes has led to a situation where false conclusions are being disseminated widely to the media and the public. Most unfortunately, damage is being done to the public's health because news headlines like this are likely to dissuade many smokers from trying to quit using e-cigarettes. Of course, this means they will continue smoking the toxic real ones.

It's not clear to me why researchers who oppose electronic cigarettes are so anxious to condemn these products that they are willing to use inappropriate research designs to fulfill such an aim.

Sunday, September 21, 2014

Rest of the Story Announces Fund-Raising Campaign for Research on Effectiveness of Electronic Cigarettes

As we've discussed here for the past several months, there’s a great debate about electronic cigarettes right now, involving consumers, public health officials, scientists, and doctors. The basic question is this—Do e-cigarettes help people fight their addiction to cigarettes, or do they actually make it more difficult for smokers to cut back or quit?

For the past 25 years, I have conducted nearly 100 published studies about smoking, and as both a researcher and a physician, I have struggled to find effective ways to help smokers fight this powerful addiction. Along comes a product that—for the first time—might be able to help smokers overcome their biological addiction to nicotine, but also address their psychological addiction to the act of smoking.

How has the public health community reacted to e-cigarettes? As you would expect, opinions differ. Some public health officials have gone so far as to call for a complete ban on these products, but other experts believe that e-cigarettes should be embraced as a method to help smokers cut back or quit. Unfortunately, as it stands now, we don’t have the data we need to determine the changes in smoking behavior that result from the use of electronic cigarettes.

The FDA has proposed “deeming regulations” which would require virtually every electronic cigarette on the market to file an application demonstrating that product’s benefit to the public health. To be clear, with these regulations in place, every one of these applications will require data that demonstrates the effects of e-cigarettes on smoking behavior. Many independent e-cigarette companies cannot afford to conduct this research on their own—but we are confident that, if the e-cigarette community will join forces, we can raise enough money to conduct a rigorous study that will provide the data that the FDA needs

That's why today, I am announcing the start of a fund-raising campaign to help us conduct what we hope will be the most rigorous research conducted to date on the effect of e-cigarettes on smoking behavior. The research is called BSCiTS (The Behavioral Study of Cigarette and Tobacco Substitution).

In BSCiTS, we hope to conduct a six-month, randomized study that looks at changes in smoking behavior over time when smokers who wish to quit or cut down are offered a free, ten-week supply of either nicotine patches or electronic cigarettes.

While two trials have been conducted in other countries, none have yet been reported in the U.S. However, we believe that the FDA will require research from the U.S. in the new product applications.

Three things make this study different from prior research conducted in other countries. First, we will be working with smokers who actually want to cut back or quit. Second, we will be testing the most up-to-date e-cigarette products on the market. Third, our study - if funded a the desired level - will involve the largest sample of smokers to date, making it the most rigorous and scientifically important study yet conducted.

There are two important disclaimers. First, our research team reserves the right to alter the scope of the proposed research project to keep it in line with the funds raised. This might mean reducing how many smokers can be enrolled in the study, or how long we can follow them over time. Alternatively, if the funds we raise are insufficient, we might choose to conduct a survey study to answer these questions. Whatever the case, the purpose of our research will remain the same: to examine changes in smoking behavior associated with the use of electronic cigarettes, in comparison to the nicotine patch.

Second, we are unable to accept donations from tobacco companies or electronic cigarettes companies that are owned or affiliated with tobacco companies.

We need your help to accomplish this. By donating to this study, you will have a direct impact on one of the most critical public health questions of our time.  Let’s put an end to the debate about e-cigarettes and find out, once and for all, exactly how they impact the behavior of smokers.

To donate to this research, please see our BSCiTS web site

All donations are considered gifts to Boston University and are tax-deductible.

Thursday, September 18, 2014

New Data from the UK Show that Despite Dramatic E-Cigarette Experimentation among Youth, There are Few Regular Users and Very Few Nonsmoking Regular Users

Data released yesterday by Action on Smoking and Health (UK) show that although electronic cigarette use is widespread and increasing among youth, it has not resulted in regular use among a substantial proportion of youth and among nonsmokers, there are very few regular users.

Specifically, the survey of 2,000 11-18 year-olds in 2014 found that:

"Only 1.8% of children are regular users; 90% of regular or occasional users are young people who are already smokers or ex-smokers; 91% of young people have not tried an electronic cigarette even once; and this is despite the fact that over 80% of young people are now aware of e-cigarettes (up from under 70% in 2013)."

Overall, ASH reported that "98% of children who have never smoked have never even tried an electronic cigarette."

The Rest of the Story

This study confirms that in the UK, despite substantial experimentation with e-cigarettes by youth, this experimentation does not appear to be leading to regular e-cigarette use by a large proportion of youth, and those who are regular users are overwhelmingly youth who are already smokers or who smoked in the past.

In other words, there appears to be strong evidence that in the UK, electronic cigarette use is not serving as a gateway by which nonsmokers are becoming addicted to nicotine and then progressing to real cigarette smoking.

These data cast further doubt on the statements made by CDC officials and a number of tobacco control researchers, who have publicly concluded that e-cigarettes are a gateway to smoking.

Unquestionably, there is still the need to regulate the sale and marketing of electronic cigarettes to minors. Sadly, and ironically, the only ones who seem to oppose laws to ban the sale of e-cigarettes to minors are the supposedly "anti-smoking" groups.

Similar data from the U.S. would be very helpful. But unlike prior reports, these ones should quantify not only experimentation, but also regular use, stratified by prior status as smokers versus nonsmokers.

Wednesday, September 17, 2014

Anti-Smoking Groups Reveal Real Reason they Opposed Ban on E-Cig Sales to Minors: Money and Protection of Cigarette Sales

Last week, the Missouri legislature overturned a veto by Governor Jay Nixon of a bill to ban the sale of electronic cigarettes to minors. Ironically, the bill was vigorously opposed by anti-smoking groups, including Tobacco-Free Missouri and the American Cancer Society and American Heart Association.

The bill is quite simple. It classifies electronic cigarettes as a non-tobacco product and bans the sale of these products to minors.

The health groups opposed this legislation because it classified electronic cigarettes separately from real cigarettes and they wanted the two products classified exactly the same.

Today, I reveal the true reasons behind the anti-smoking groups' ironic position on this legislation. After all, why would they oppose a law to ban the sale of e-cigarettes to minors?

The Rest of the Story

The rest of the story was revealed in an article at the KCUR web site:

"“It was operating under the guise of protecting youth, but really it just created a special carve-out for a special interest,” says Traci Kennedy, executive director of Tobacco-Free Missouri. Tobacco-Free Missouri opposed the law, along with the American Cancer Society, the American Heart Association and other health groups. While the law doesn’t plainly forbid regulation of e-cigarettes, these groups point out that, by defining e-cigarettes as not tobacco, it keeps them from being subject to the same taxes and health-requirements as traditional cigarettes."

In other words, there are two reasons why the anti-smoking groups opposed this law:

1. Money

The anti-smoking groups opposed the law because they want to see electronic cigarettes taxed, just as tobacco products are taxed. Anti-smoking groups receive a considerable amount of money from tobacco tax revenue so it is not surprising that these groups would want to see heavy taxes imposed on electronic cigarettes. This is a ludicrous position from a public health perspective, however. Why would we want to give cigarettes even more of a competitive advantage in the marketplace by reducing the cost advantage to the fake cigarettes? The only one protected by such a move is Big Tobacco and their cigarette profits. Which leads us to the second reason for the anti-smoking groups' opposition to the bill.

2. Protecting Cigarette Sales

Ironically, what the anti-smoking groups are promoting is the protection of cigarette sales from competition from electronic cigarettes. They are concerned about e-cigarettes escaping from the "health requirements" to which traditional cigarettes are subject. But what health requirements are there for traditional cigarettes? Maybe I need to be educated by Tobacco-Free Missouri, but the most recent data I've seen show that those tobacco cigarettes are killing more than 400,000 people each year in the United States. And I'm not aware of any meaningful health requirements for these products. 

What Tobacco-Free Missouri and its allies are saying is that they do not want electronic cigarettes to enjoy any competitive advantage in the marketplace. Essentially, these anti-smoking groups are acting in a way to protect cigarette sales from competition. God forbid that there remain a cost incentive for smokers to switch to electronic cigarettes and quit smoking. God forbid that there is a public perception that e-cigarettes are much safer than real cigarettes and that smokers therefore quit smoking and switch to vaping.

The only one I would expect to take the position of the Missouri anti-smoking groups is Big Tobacco itself, because the cigarette companies have a financial incentive to protect their cigarette profits. But ironically, even Big Tobacco supports this ban on the sale of e-cigarettes to minors. Even Big Tobacco is not trying to protect its own cigarettes from competition from e-cigarettes.

It is shameful that anti-smoking groups in Missouri are willing to sacrifice the health of Missouri children because they want to stifle competition against cigarettes.

Tuesday, September 16, 2014

UK Professor and Government Health Adviser - An E-Cigarette Opponent - Steps Down After Crude Verbal Attacks on Vapers

Up until two days ago, Professor John Ashton was president of the Faculty of Public Health, an independent health advisory body which provides public health recommendations to health ministers and other UK government officials.

The Faculty of Public Health has been a strong opponent of e-cigarettes in the UK. In its policy statement, it recommends a complete ban on e-cigarette advertising. It also asserts that the tobacco industry is using e-cigarettes to promote cigarette smoking, that electronic cigarettes may be a gateway to smoking among youth, and that there is no solid evidence that e-cigarettes can help smokers quit. This despite its acknowledgment that there is no evidence for a gateway effect and that there is evidence that e-cigarettes are as effective as NRT for smoking cessation.

But today, I report that opponents of electronic cigarettes are using more backhanded tactics than simply drawing unsupported scientific conclusions or distorting the science to support its preconceived position.

The Rest of the Story

Apparently, some opponents of electronic cigarettes are so guided by a strong ideology against anyone who does anything that looks like smoking that their real attitudes surface in a seeming hatred of vapers. This was the case with the president of the Faculty of Public Health.

Recently, Professor Ashton went on what the Daily Mail called "a venomous spat" on Twitter. He made a number of rude and offensive comments about individual vapers, which cannot be repeated here. For details, see the Daily Mail article or this summary of the story.

I believe that this story reveals the venom that many e-cigarette opponents have for the act of smoking and anything that looks like it. And that ideological venom is what is keeping them from forming opinions based on the actual scientific evidence. Professor Ashton's apparent hatred for vapers can only be rooted in an ideology that despises the physical act of smoking, regardless of whether what is being "smoked" contains tobacco or not or whether the behavior is killing the person or perhaps saving his life. In other words, this is a great example to demonstrate the way in which ideology, not science or public health, guides the opinions and statements of many electronic cigarette opponents.

One might argue that this is just one errant professor. However, as it acknowledges on its web site:

"The Faculty of Public Health is the standard setting body for specialists in public health in the United Kingdom. The Faculty of Public Health is a joint faculty of the three Royal Colleges of Physicians of the United Kingdom (London, Edinburgh and Glasgow) and also a member of the World Federation of Public Health Associations. The Faculty of Public Health is an independently constituted body with its own membership and governance structure. The Faculty of Public Health is the professional home for more than 3,300 professionals working in public health. Our members come from a diverse range of professional backgrounds (including clinical, academic, policy) and are employed in a variety of settings, usually working at a strategic or specialist level. The Faculty of Public Health is a strategic organisation and, as such, works collaboratively, drawing on the specialist skills, knowledge and experience of our members as well as building relationships with a wide range of external organisations."

Thus, this is not just some fringe professor. This is the (former) head of a prestigious public health body that gave advice to the ministers on the electronic cigarette issue and whose advice was seriously considered in formulating e-cigarette policy in the UK.

Monday, September 15, 2014

“Stand Up To Cancer” Not Standing Up to Cigarette Promoters; Special Guest Commentary by Dr. Alan Blum

Tuscaloosa, AL, September 4, 2014--Several of the sponsors of this Friday’s “Stand Up To Cancer” national fundraising telethon are doing more to promote cigarette companies than to prevent or cure cancer, according to an analysis of the organization behind the event by a physician and veteran anti-cancer advocate at The University of Alabama.

“This effort to solicit money for cancer research is compromised by the inclusion of corporations and foundations closely allied with the manufacturers of cigarettes, the nation’s leading avoidable cause of cancer,” said Alan Blum, MD, professor of Family Medicine and Director of The University of Alabama Center for the Study of Tobacco and Society. “The National Cancer Institute attributes 40 percent of premature deaths from cancer to cigarette smoking,” noted Dr. Blum, “so a minimum standard for standing up to cancer ought to be not aiding and abetting the number one cause of cancer.”

SIEMENS, a multinational engineering and electronics corporation that has cultivated an image as a medical equipment and health-care company in advertisements in major magazines and newspapers (with headlines such as “More health care stories with happier endings”), is also a leading manufacturer of cigarette-making machinery and barcode tracking technology for improved efficiency of cigarette distribution. Among SIEMENS’s customers is Philip Morris USA, maker of the best-selling cigarette brand Marlboro. 

According to SIEMENS’s website, the company’s “Tobacco segment includes machines for the manufacturing and packaging of cigarettes at speeds of 4,000 to 20,000 cigarettes per minute,” and its “Simotion Motion Control System is now gaining a foothold in the cigarette manufacturing industry.” Thus, a single such SIEMENS machine could produce 1.2 million cigarettes (or 60,000 packs) during the Stand Up To Cancer telecast, Blum said. SIEMENS is listed as one of the event’s “Champions.”

The Safeway Foundation, a Hero level Partner of Stand Up To Cancer, is funded by Safeway, Inc, which was the third-largest supermarket chain in the United States until its acquisition in July by Albertsons. (The company is now the second-largest in the United States.) In contrast to Wegmans, Target, CVS and other retail chains that have ended the sale of tobacco products, Safeway continues to sell cigarettes in its more than 1,330 stores. The company’s slogan is “Ingredients for life. Creating better lives, vibrant neighborhoods, and a healthier planet.” A carton of Marlboro cigarettes sells for $70 at the company’s stores in Portland, Oregon.

Another Champion level Partner of Stand Up To Cancer is the Steve Tisch Foundation. A significant part of the Tisch family fortune was derived from the manufacture and sale of cigarettes. Between 1967 and 2008, the Tisch family-run Loews’ Corporation controlled the nation’s third leading cigarette manufacturer, Lorillard. The company, which is about to merge with the number two cigarette maker Reynolds-American, produces Newport, the nation’s top-selling menthol brand and the leading cigarette smoked by African-Americans, who experience a higher prevalence of lung cancer than the overall population, Blum said. In 1994 at a U.S. House of Representatives hearing on cigarettes, Lorillard chief executive officer Andrew Tisch (first cousin of Steve Tisch) famously testified under oath that he did not believe either that nicotine is addictive or that cigarette smoking causes lung cancer.

Four of the eight Publishing Partners of Stand Up To Cancer own mass circulation magazines that advertise cigarettes in almost every issue, long after most publications have turned down such advertisements as contrary to the health of their readers, Blum said.

The August 18, 2014, College Football Preview issue of TIME, Inc.’s Sports Illustrated includes an advertisement for Stand Up To Cancer, with this text: “When we all come together cancer doesn’t stand a chance.” Also in the issue are four color cigarette ads—three for Reynolds-American’s Camel brand (one of which reads “Passionate. Inspired. Original. Taste It All” and another that boasts “It starts with a spark, and the promise to fan the flames.”), and one for Newport promoting a “Wheel of pleasure” sweepstakes with “Hundreds of fantastic prizes waiting to be won,” including a 2015 Ford Mustang. A fifth ad is for Lorillard’s blu electronic cigarette. In its 60-year history, Sports Illustrated has rarely, if ever, published an article on the harmfulness of cigarette smoking or the athletes who have died from smoking, Blum said. A report last month in Gawker alleged that the media corporation rates its journalists for their friendliness to advertisers and included an internal TIME, Inc. document obtained by the Newspaper Guild with this ranking criterion for reporters: “Produces content that [is] beneficial to advertiser relationship." (http://gawker.com/time-inc-rates-writers-on-how-beneficial-they-are-to-1623253026.)

The current September issue of TIME features a prominent ad for Reynolds-American’s American Spirit “organic tobacco and organic menthol” cigarette brand that touts “100 percent Additive-Free Natural Tobacco” above this Food and Drug Administration-required sentence in smaller type: “Organic tobacco does NOT mean a safer cigarette.” Entertainment Weekly and People are two of TIME, Inc.’s well known magazines that run cigarette ads. Information on the revenue TIME, Inc. receives from cigarette advertising is not publicly available.

In the latest September issues of WIRED and Vanity Fair, published by Stand Up To Cancer Publishing Partner Conde Nast, the same ad for the event appears, as well as a nearly identical Camel cigarette ad (“Inspired. Passionate. Original. Taste It All.”) Other Conde Nast magazines that accept cigarette ads include Vogue, Glamour and GQ.

Mass circulation magazines with cigarette ads published by Stand Up To Cancer Publishing Partner American Media, Inc. include Playboy and The National Enquirer. The popular women’s periodical Cosmopolitan, which accepts cigarette advertising, is published by Hearst Magazines, another Stand Up To Cancer Publishing Partner.

In its three previous telethons, Stand Up To Cancer has raised more than a quarter of a billion dollars for cancer research. Dr. Blum noted that 2014 marks the 50th anniversary of the landmark U.S. Surgeon General’s Report on Smoking and Health, which confirmed the causal link between cigarette smoking and lung cancer. “It is shameful,” Blum said, “that after decades of efforts to end the leading cause of cancer, the organizers of this cause would welcome the participation of manufacturers, promoters and sellers of cigarettes.”

ABOUT DR. BLUM: As editor of the Medical Journal of Australia and the New York State Journal of Medicine in the 1980s, Dr. Blum published the first analysis of tobacco industry sponsorship of sports and the arts around the world, as well as a report revealing U.S. tobacco industry subsidiaries and suppliers in all 50 states. In the 1990s, he and the 5,000-physician member health advocacy organization he founded, DOC (Doctors Ought to Care [1977-2002]), published the results of two investigations of tobacco industry influence. “Sick Bedfellows” listed 10 major pharmaceutical and health-related companies with longstanding business ties to cigarette manufacturers. “Healthcare Hypocrites” revealed that more than 20 board members of tobacco companies were simultaneously serving on the boards of health care institutions, medical schools, or health insurance companies. In conjunction with the Interfaith Center for Corporate Responsibility, DOC helped get corporations such as Kodak, Kimberly-Clark and 3M to end their business relationships with the tobacco industry.

ABOUT THE CENTER: The Center for the Study of Tobacco and Society at The University of Alabama holds the most comprehensive collection on the tobacco industry and the antismoking movement. The Center’s most recent exhibition, to commemorate the 50th anniversary of the U.S. Surgeon General’s Report, “The Surgeon General vs. The Marlboro Man: Who Really Won?” was on view this year at the Lyndon Baines Johnson Presidential Library and the Texas Medical Center Library in Houston after debuting at the Gorgas Library of The University of Alabama. The Center’s latest film, “Blowing Smoke: The Lost Legacy of the Surgeon General’s Report” is available free online at https://docs.google.com/file/d/0B1j5VTNHmZZmcFJWLW1wbDF3Mms/

See also the following media coverage of this issue:

The Cancer Letter, Matthew Ong, September 12, 2014:
"Tobacco Interests Contribute a Portion of the $109 Million Raised by SU2C"

Knight Science Journalism Tracker, Paul Raeburn, September 12, 2014 "'Stand Up To Cancer' didn't stand up to tobacco"

al.com, Alan Blum, MD, September 9, 2014:
"'Stand Up To Cancer' Not Standing Up to Cigarette Promoters":

Thursday, September 11, 2014

Columbia Scientists Claim that E-Cigarettes May Be Gateway to Illicit Drug Use and Addiction

According to a press release issued by Columbia University Medical Center, a team of researchers from Columbia University have concluded that electronic cigarettes may serve as a gateway not only to cigarette smoking, but also to illicit drug use and addiction, such as cocaine addiction.

According to the press release: "Like conventional cigarettes, electronic cigarettes (or e-cigarettes) may function as a “gateway drug”—a drug that lowers the threshold for addiction to other substances, such as marijuana and cocaine—according to the 120th Shattuck lecture, presented to the Massachusetts Medical Society by Columbia researchers Denise and Eric Kandel and published today in the online edition of the New England Journal of Medicine." ...

"In the lecture, the Kandels review Denise Kandel’s earlier work on the gateway hypothesis and on the role of nicotine as a gateway drug, reported in a Science paper in 1975. They also review subsequent studies in which they tested the gateway hypothesis experimentally in a mouse model. In those studies, conducted in collaboration with Amir Levine, Yan You Huang, Bettina Drisaldi, Edmund A Griffin, and others at CUMC, they found that when mice are exposed to nicotine, it alters their brain biochemically and induces activation of a reward-related gene. As a result, nicotine primes the animals’ subsequent response to cocaine, providing a molecular basis for nicotine as a gateway drug for cocaine. Dr. Denise Kandel’s further analysis of 2004 epidemiologic data from a large, longitudinal sample suggested that nicotine also primes human brains to respond to cocaine." ...

"“E-cigarettes have the same physiological effects on the brain and may pose the same risk of addiction to other drugs as regular cigarettes, especially in adolescence during a critical period of brain development. ... Nicotine clearly acts as a gateway drug on the brain, and this effect is likely to occur whether the exposure comes from smoking cigarettes, passive tobacco smoke, or e-cigarettes.” ... “The effects we saw in adult mice are probably even stronger in adolescent animals,” said Dr. Eric Kandel. “E-cigarettes may be a gateway to both combustible cigarettes and illicit drugs.”"

The Rest of the Story

There is no justification for drawing this sweeping conclusion based solely on studies of mouse brains, without a shred of clinical or epidemiologic evidence that suggests e-cigarettes serve as a gateway to smoking or illicit drug addiction. And I think it is inappropriate to engage in this kind of scaremongering.

This story further illustrates the depths to which electronic cigarette opponents are sinking. They cannot defend their opposition to e-cigarettes based on actual sound scientific research or reasoning. Thus, they have to either twist and distort the science or grossly extrapolate from studies that actually have little relevance to the clinical situation at hand.

Wednesday, September 10, 2014

Everyone Agrees: FDA Should Eliminate Pre-Market Review for Electronic Cigarettes, At Least Until Effective Date of Regulations

In three separate sets of comments submitted to the FDA regarding the proposed deeming regulations, three major players in the e-cigarette space have offered the identical piece of advice for the agency:

Do not apply pre-market review requirements for electronic cigarettes, at least until the effective date of the final regulations.

Here is what each of the three companies/associations had to say regarding this issue in their submitted comments:

1. Altria Client Services (on behalf of Nu Mark): "Nothing in the FSPTCA [Family Smoking Prevention and Tobacco Control Act] requires FDA to engage in all-or-nothing deeming for all purposes. Rather than deem an entire class of tobacco products categorically subject to the FSPTCA for all purposes, FDA has multiple options for proceeding in a reasoned, scientifically sound, and incremental manner. For example, FDA should exercise its statutory authority to deem e-vapor products commercially marketed before the Final Rule for certain purposes under the FSPTCA. Such products would be subject to age restrictions, warning labels, and disclosure requirements, without subjecting them to premarket authorization. Only those e-vapor products commercially marketed after issuance of the Final Rule would be subject to ... premarket authorization."

2. Lorillard: "FDA should exercise enforcement discretion not to require premarket review of electronic cigarettes introduced into United States commerce on or before the effective date of the final deeming regulation.

3. American E-Liquid Manufacturing Standards Association: "FDA should use the effective date of the final rule for the Deeming Regulations as the new "Grandfather Date" for e-cigarettes and e-liquid products and model the substantial equivalence requirements for these products based on the Section 510(k) pathway for medical devices."

The Rest of the Story

All three of these entities have offered common sense advice with which I wholeheartedly agree. In fact, this advice may be the single most important change that I recommend in the proposed deeming regulations.

As currently proposed, the deeming regulations will require virtually every e-cigarette product on the market to submit a pre-market review application, in which the company must demonstrate that the introduction of the product into the market is beneficial for the public's health. The data required to demonstrate this is complex, as it requires a consideration of not only the benefits of the product to intended users (adult smokers), but also the consequences of the product's availability in the market to others, such as nonsmokers and youth. The complexity and burden of this requirement makes it unfeasible for most e-cigarette companies, which are small and do not have adequate resources for such an undertaking. The result would be to pull tens of thousands of products from the market and constrict the market severely. In addition, it would create an absolute bureaucratic, nightmarish mess.

Instead, as Altria Client Services, Lorillard, and AEMSA have all recommended, the FDA should scrap the requirement for pre-market review of electronic cigarettes, at least until the effective date of the final regulations. After that time, applications for new products would be required, unless they could show substantial equivalence compared to a product already on the market (as of the final regulation effective date).

Actually, I would go one step further. I don't see a need for pre-market review of new electronic cigarette products, as it is the older ones which pose the most concern and the product quality has improved with innovation and time. Moreover, such requirements would stifle innovation. Instead, if I were the FDA, I would simply establish a set of safety standards that all products must meet. These standards would address issues such as battery safety, quality of ingredients used, type of ingredients used, temperature regulation, quality and safety of metal parts, and child-safety of packaging.

Tuesday, September 09, 2014

A Policy Supporting Death: European Respiratory Society Would Rather that Smokers Die than Switch to Electronic Cigarettes

According to a published research article and a European Lung Foundation press release, the European Respiratory Society is opposed to the use of e-cigarettes in any setting in which they are unregulated (which currently includes the United States and most countries).

According to the press release: "The ERS agrees with the recent report from the World Health Organization (WHO) and is opposed to the use of unregulated e-cigarettes. While the short-term negative impact on health appears not as great as tobacco cigarettes, the long-term effects of e-cigarettes are not known. As a Society grounded in scientific principles, ERS believes that the precautionary principle should be applied when scientific evidence is inconclusive and insufficient."

The Rest of the Story

What does it mean to be "opposed" to the use of unregulated e-cigarettes? It means that the European Respiratory Society is opposed to the use of e-cigarettes in any setting in which they are unregulated, such as the current situation throughout most of the world, including in the United States.

The European Respiratory Society, then, is opposed to the use of e-cigarettes at the present time in the United States. What this means is that the ERS would rather see smokers continue to use tobacco cigarettes than quit smoking by switching to electronic cigarettes.

Importantly, the ERS did not qualify its statement. It did not state that it is opposed to the use of e-cigarettes by smokers who may be able to quit without them. It did not state that it is opposed to the use of e-cigarettes except among smokers who cannot quit without them. It simply stated its blanket opposition to any and all use of electronic cigarettes by smokers.

This is a disastrous and irresponsible public position.

What it means is that the ERS would rather that a smoker who cannot quit using other means continue smoking than switch to electronic cigarettes. The ERS clearly states that it opposes the use of electronic cigarettes, period. Thus, it implies that it opposes the use of electronic cigarettes by a smoker who is unable to quit via any other smoking cessation method. For such an individual, the ERS statement implies that it would actually prefer the smoker to continue smoking than to quit via the use of electronic cigarettes.

This story is particularly alarming, because it shows that for some anti-smoking groups, it really is no longer about health. It is solely about ideology. And apparently, the European Respiratory Society will cling to its precautionary ideology while smokers go to their graves.

Monday, September 08, 2014

Fascinating Op-Ed in Richmond Times-Dispatch Reveals that Lack of Current E-Cigarette Regulation is the Fault of Anti-Smoking Groups

Revealing an all-but-forgotten piece of legislative and political history, Drs. Alan Blum and Amy Muhlberg provide the "rest of the story" regarding the FDA's failure to regulate electronic cigarettes for the past five years, leading to its inability to develop a sound, coherent, and informed approach to maximizing the benefits while minimizing the risks of these innovative products. Their insightful comments appear in an op-ed piece published in Saturday's Richmond Times-Dispatch.

Drs. Blum and Muhlberg reveal this fascinating piece of history regarding the development of the 2009 Family Smoking Prevention and Tobacco Control Act:

"By 2009, it wasn’t clear if e-cigarettes met the bill’s definition of tobacco products. There were differing opinions among e-cigarette manufacturers about how to proceed, but there was consensus that if e-cigarettes had to be regulated by the FDA, it would be better to be considered a tobacco product than a medical product."

"During the Senate committee debate on the bill, Republican members offered for consideration language that would grant the FDA authority to regulate e-cigarettes as tobacco products and restrict the agency from regulating them as medical products. But the sponsors of the bill and the FDA leadership under the new administration wanted the option to use the FDA’s medical product regulatory authority, so they were not open to including “regulate once but not twice” language. The amendment was withdrawn." ...

"If the FDA had been willing to agree in 2009 that they were tobacco products and not medical products, the agency would have had vast authority over e-cigarettes. For the past five years, the FDA could have acted against adulterated or misbranded products, required manufacturer registration and ingredient-reporting, and inspected manufacturers, among other actions. It’s impossible to know how much ground was lost because of the FDA’s overreaching position that e-cigarettes were possibly medical products."

The Rest of the Story

It is interesting to find out that the "wild, wild West" that anti-smoking groups have complained so much about (i.e., the lack of current regulation of e-cigarettes because they fall into the cracks of the FDA Tobacco Act) is actually their own fault. Had these groups pressured the sponsors of the Tobacco Act to regulate e-cigarettes as tobacco products back in 2009, these products would have been introduced to the U.S. market under a regulated framework, in which, at very least, the FDA would have been able to inform itself about the products by collecting key information, such as ingredients and basic quality control information.

Instead, we are now faced with the "deeming regulations," a disastrous proposal under which most of the existing e-cigarette market may be destroyed and the market essentially handed over to Big Tobacco, which are the only companies large enough to successfully complete the new product applications which will be required for every single e-cigarette product on the market.

This is yet another example of the anti-smoking groups bemoaning a situation for which they are actually responsible. For example, the anti-smoking groups have complained about the menthol loophole, but it was the Campaign for Tobacco-Free Kids and friends which insisted upon this loophole in the first place. The anti-smoking groups complained about the introduction of Marlboro No. 54, but again, it was the Campaign and its friends that made this introduction possible by exempting menthol as the only characterizing flavor allowed in cigarettes.

Now, thanks to Drs. Blum and Muhlberg, we find out that all the complaining by the anti-smoking groups about the "wild, wild West" of e-cigarette marketing in an unregulated environment is bogus, as these groups failed to insist on an amendment which would have regulated e-cigarettes as tobacco products. Instead, these groups - back in 2009 - were actually fighting to get e-cigarettes off the market entirely. Regulating them as tobacco products would have meant institutionalizing their entrance and penetration into the market. It would have risked having these safer products compete with much more hazardous products like regular tobacco cigarettes. And that, by the reasoning of Tobacco-Free Kids and Friends, would have been a disaster.

You see, the goal of the Tobacco Act was not to save lives, but to gain a political victory for the anti-smoking groups. The goal was to put a feather in the cap of the anti-smoking groups' national leaders, rather than to establish a rational, science-based policy designed to reduce cigarette smoking, make cigarettes safer, and promote the public's health.

Friday, August 08, 2014

Based on a Lie, Senator Durbin and Colleagues Want to Put Thousands of Vape Shops Out of Business

In a letter sent to the FDA Commissioner on August 1, Senator Dick Durbin (D-IL) and 12 Congressional colleagues demand an immediate ban on e-cigarette flavorings, based on what they purport is evidence that electronic cigarettes are a gateway to smoking.

They write: "What’s even more troubling is that these products serve as a gateway to traditional tobacco products.  A recent JAMA Pediatrics study found that middle and high-school students who used e-cigarettes were more likely to smoke traditional cigarettes and less likely to quit smoking." In support of this statement, they cite the Glantz and Dutra cross-sectional study of e-cigarette use and smoking among youth.

As I pointed out earlier this week, the truth is that this paper provides no evidence whatsoever that e-cigarette use is a gateway to smoking. Instead, it is entirely possible - and quite likely - that youths who use e-cigarettes are more likely to be heavier and more resistant smokers. I argued that by relying on this false evidence, the politicians are essentially lying to the American public. They are misrepresenting the scientific evidence, twisting it to try to support their pre-determined conclusion.

The Rest of the Story

Today, I reveal that to make matters worse, these politicians are not only lying about the scientific evidence, but they are using that lie to try to put thousands of vaping shops out of business. Specifically, the letter to the FDA calls for an immediate ban on e-cigarette flavorings. If such a ban is implemented, it will immediately put thousands of vaping shops out of business. In addition, it will eliminate the overwhelming majority of electronic cigarettes on the market. Such a regulation would essentially mean that there can be no variation in the ingredients of e-cigarette liquid. Every brand would be the same.

I think that if you are going to put thousands of people out of work, you ought to be doing it based on solid scientific evidence of the harm of their products. To do it based on a lie is inexcusable.

Wednesday, August 06, 2014

Wall Street Journal Op-Ed Debunks the E-Cigarette Gateway Myth

In an op-ed published today in the Wall Street Journal, I highlight the fact that many legislators and health organizations have demonized electronic cigarettes, largely on the basis of the erroneous conclusion that there is scientific evidence demonstrating that these products are a gateway to cigarette smoking among youth. The piece points out that there actually is no such scientific evidence and in fact, it presents evidence to the contrary.

As I point out in the piece, the CDC is partly responsible for the backlash against e-cigarettes because it publicly concluded that e-cigarettes are a gateway to smoking:

"Last September, in an interview with Medscape (a website for medical professionals), Thomas Frieden, director of the Centers for Disease Control and Prevention, said that "many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes." The same month he was quoted by the Associated Press as warning that e-cigarettes are "condemning many kids to struggling with a lifelong addiction to nicotine."

I then explain that the gateway hypothesis is actually unsupported by any scientific evidence and that there is some evidence which is inconsistent with the hypothesis.

I conclude as follows: "By promoting a message that flies in the face of the government's own statistics--which show a sharp decline in youth smoking concurrent with a dramatic increase in e-cigarette experimentation--some federal public health official appear to be trying to create a "gateway" narrative where none exists."

"The government has an obligation to carefully scrutinize any new consumer product that is presented as an alternative to smoking. But government agencies and public health officials have no business discouraging or disparaging e-cigarettes in the absence of any data that they are causing harm. This is especially the case when these products have so much potential to curb cigarette smoking, the public health scourge that still claims half a million lives a year."

Politicians Lie to the Public About the Scientific Evidence Regarding Whether E-Cigarettes are a Gateway to Smoking

In a press release issued Monday by 13 members of Congress, a group of politicians claimed that there is "more" evidence that electronic cigarettes are a gateway to smoking.

The press release was entitled: "Members of Congress: More and More Children Being Exposed To E-Cigarette Marketing Are Picking Up Habit; FDA Urged to Protect Children as More Evidence Shows E-cigarettes Serve as Gateway to Tobacco Products."

After claiming that there is now abundant scientific evidence that electronic cigarettes are a gateway to smoking, these politicians go on to urge the FDA to ban flavorings in e-cigarettes and to ban the online sale of these products.

The Rest of the Story

What is the new "evidence" that e-cigarettes are a gateway to smoking? According to the letter sent by these politicians to the FDA: "What’s even more troubling is that these products serve as a gateway to traditional tobacco products.  A recent JAMA Pediatrics study found that middle and high-school students who used e-cigarettes were more likely to smoke traditional cigarettes and less likely to quit smoking.[2]"

The reference which supports this assertion is a study by Dutra and Glantz which purports to provide data showing that electronic cigarettes are "aggravating the tobacco epidemic among youth."

The article reports the results of a cross-sectional sample of adolescents interviewed in 2011 and 2012 in the National Youth Tobacco Survey. Youths were asked to report their smoking status as well as their e-cigarette use, both any use and current use (at least once in the past month).

The study finds that e-cigarette use is associated with smoking status. In addition, e-cigarette use is associated with heavier smoking and with fewer periods of smoking abstinence.

The study concludes that "e-cigarette use is aggravating rather than ameliorating the tobacco epidemic among youths."

(See: Dutra LM, Glantz SA. Electronic cigarettes and conventional cigarette use: a cross-sectional study. Published online March 6, 2014. JAMA Pediatr. doi:10.1001/jamapediatrics.2013.5488.)

The authors of this study make one of the most cardinal errors in all of epidemiology. They ignore the principle that "correlation does not equal causation."

Here, they find a correlation between e-cigarette use and higher and more sustained levels of smoking. But because this is a cross-sectional study, they cannot determine which came first. In other words, what is the direction of the causal relationship? Does the e-cigarette use precede, and cause, the smoking? Or does the smoking precede, and cause, the e-cigarette use?

The problem is that in this cross-sectional study, there is no way to determine the direction of the observed relationship.

The authors admit this in the paper. They write: "This is a cross-sectional study, which only allows us to identify associations, not causal relationships."

Furthermore, later in the paper they reinforce this point more specifically, writing: "the cross-sectional nature of our study does not allow us to identify whether most youths are initiating smoking with conventional cigarettes and then moving on to (usually dual use of) e-cigarettes or vice versa...".

Thus, the authors readily acknowledge that it is impossible from this study to determine whether or not e-cigarettes lead to smoking or whether smoking leads to e-cigarette experimentation.

Nevertheless, this does not stop the authors from drawing a conclusion. They conclude, despite their acknowledged inability to draw such a conclusion, that: "e-cigarette use is aggravating rather than ameliorating the tobacco epidemic among youths."

In other words, despite acknowledging that they cannot tell from their study whether e-cigarette use precedes smoking or whether smoking precedes e-cigarette use, they nonetheless draw the conclusion that e-cigarette use precedes smoking.

The truth is that this paper provides no evidence whatsoever that e-cigarette use is a gateway to smoking. Instead, it is entirely possible - and quite likely - that youths who use e-cigarettes are more likely to be heavier and more resistant smokers.

By relying on this false evidence, the politicians are essentially lying to the American public. They are misrepresenting the scientific evidence, twisting it to try to support their pre-determined conclusion.

The rest of the story is that there simply is no evidence at the current time that electronic cigarettes are serving as a gateway to youth smoking. It may actually be the case that electronic cigarettes serve as an inhibitor of smoking initiation by getting a youth used to a flavorful experience, thus making it less likely - not more likely - that the youth will move on to the harsh taste of tobacco.

These politicians should stop lying to the American public in order to support their pre-determined agenda. Science, not politics, should guide public health policy in this nation.

Thursday, July 31, 2014

Many Anti-Smoking Advocates Actually Do Not Want Smokers to Quit Smoking Using E-Cigarettes

One lesson that has become apparent in the past few months is that for many anti-smoking advocates and groups, it doesn't matter whether you quit, the only thing that is important is how you quit. According to the thinking of these groups, there is a right way to quit and a wrong way to quit. Forget about the fact that you've just quit smoking and possibly saved your life. If you quit the wrong way, you are to be scorned.

And what are the right and wrong ways to quit? The wrong way to quit is using electronic cigarettes, which have been so effective in reducing cigarette consumption that some tobacco analysts have predicted that there could be as much as a 50% decline in the combustible tobacco market due to e-cigarettes. The right way to quit is using FDA-approved medications that have been proven to be quite ineffective, with long-term success rates of less than 10%.

In fact, it appears that many anti-smoking advocates and groups do not actually want smokers to quit using e-cigarettes. They would rather smokers continue to smoke than to use a device which looks like a cigarette but is actually much safer. After all, for most smokers who quit using e-cigarettes, advice telling them not to use the e-cigarette is tantamount to instructing them to return to cigarette smoking. The chances that such smokers will succeed with FDA-approved methods is near nil. In fact, the very reason that most of them have tried e-cigarettes in the first place is because they had tried FDA-approved methods in the past and failed or they had little confidence that such methods would work.

A recent op-ed piece from the Grand Island Independent demonstrates this phenomenon. In the article, a physician with the St. Francis Cancer Treatment Center strongly discourages smokers from using e-cigarettes to quit smoking. Instead, he insists that smokers rely only upon FDA-approved drugs.

After blasting electronic cigarettes, the author writes:

"The best advice for smokers is to stop using any form of tobacco and/or nicotine as soon as possible. Smokers who want to quit can try stopping on their own with or without other guidance. They can also try one or more of the options that can help them quit, such as a telephone quitline; one or a combination of the seven FDA-approved cessation medications (five nicotine replacements [gum, patch, inhaler, lozenges, and nasal spray] and two prescription medications [bupropion and varenicline]); and/or counseling from their physician, nurse, pharmacist, or other qualified health care professional."

This advice is all fine and dandy for smokers who feel confident that they can quit using FDA-approved drugs. However, what about smokers who don't have the self-efficacy to quit using such drugs? What about smokers who have tried and failed with these approaches and are quite sure that it would be a waste of time to try the same dismal methods again? And what about smokers who are particularly excited about the possibility of using electronic cigarettes in a quit attempt?

In my mind, it is virtually malpractice to recommend to such patients that they stick with the traditional FDA-approved therapy and do not give electronic cigarettes a chance.

Not only does this column provide bad medical advice, but the advice itself is based on misinformation. For example, the article claims that e-cigarettes have been shown to be a gateway to smoking: "Most dangerous of all is the appeal to children. Vapor is less irritating than smoke, and comes in flavors such as bubble gum, cola and chocolate. Some children who would not try regular cigarettes will be tempted by e-cigarettes. As soon as they start, they will become addicted to nicotine and suffer from the health effects and expense of that addiction. Others who start with e-cigarettes will go on to use real cigarettes, and face the deadly diseases they cause."

There is absolutely no evidence that youth who try e-cigarettes will progress to cigarette smoking and face the deadly diseases associated with tobacco cigarettes. But if you just make up this evidence, then of course it makes sense to argue against electronic cigarettes. Anyone can make a persuasive argument if they are allowed to just make up the supporting evidence.

At the Rest of the Story, I don't have that luxury. I make the call based on what I see as the most credible scientific evidence available. And at the current time, I believe that for many smokers, electronic cigarettes are a reasonable option for smoking cessation or dramatic smoking reduction. These benefits of electronic cigarettes are demonstrable and there is no evidence that they are being undermined by these products serving as a gateway to tobacco cigarette addiction. In fact, all the evidence at the current time points to a strong relationship between e-cigarette use and decreased overall use of tobacco products, not the other way around.

Wednesday, July 30, 2014

Electronic Cigarette Opponents Continue to Misrepresent the Science to Support their Positions

In an op-ed piece published last Sunday in the Augusta Chronicle, the director of the Georgia Regents University Cancer Center warns of many potential public health hazards of electronic cigarettes, focusing most directly on what he argues is the likelihood that many youth who try these devices will progress to traditional tobacco cigarette smoking.

The author writes:

"The electronic cigarette has been designed with the same primary purpose as a cigarette: to introduce nicotine into the human bloodstream. What happens, however, to the vaper who determines that the controlled doses offered by an e-cigarette no longer are satisfying that craving? Chances are, many of them will look toward a more efficient delivery system – the traditional cigarette. The CDC survey found that 76.3 percent of students who had tried e-cigarettes in the past 30 days also had smoked conventional cigarettes."

The Rest of the Story

First of all, the truth is that electronic cigarettes were not designed with the same primary purpose as a cigarette. Yes, the cigarette was designed to deliver nicotine into the human bloodstream as quickly and consistently as possible. However, in contrast, the primary purpose for which the electronic cigarette was designed was to get smokers off of cigarettes. The primary purpose of these products is clearly not to deliver nicotine most effectively to the bloodstream. To do that, one would design a product that burns tobacco at a high temperature. Instead, the primary purpose of an electronic cigarette is to simulate as much as possible the behavior of smoking, but without delivering the tar, which is the component that actually causes tobacco-related disease and death.

In fact, electronic cigarettes are a rather poor method for delivering nicotine to the bloodstream. Real cigarettes have already cornered the market on that goal. Moreover, most electronic cigarettes do not deliver controlled doses of nicotine. To get that, you need to buy a real cigarette!

This article, however, is not merely misleading about the purpose of electronic cigarettes. It actually distorts and misrepresents the science.

Specifically, the article argues that nonsmokers (presumably youth) who use e-cigarettes are likely to progress to cigarette smoking. After making this assertion, the article cites as supporting evidence a CDC survey which found that the vast majority of students who had tried electronic cigarettes in the past 30 days had also smoked conventional cigarettes. In other words, the article is trying to use the CDC survey as evidence that indeed, youth nonsmokers who try electronic cigarettes are indeed progressing to smoking.

The problem is that the survey was a cross-sectional one. You cannot determine from this survey whether youth who tried electronic cigarettes later transitioned to real cigarettes or whether it just so happens that the overwhelming majority of youths who have experimented with e-cigarettes are youth who were already smokers.

However, by citing the survey in this manner, the article deceives the reader by making it sound like the CDC survey supports the writer's contention that youth e-cigarette experimenters who never smoked are progressing to established smoking. The reader who is not intimately familiar with the CDC survey will assume that the survey showed that youth e-cigarette experimenters are going on to smoke in high numbers. But the survey didn't identify a single youth who progressed from nonsmoking to smoking due to electronic cigarettes. It simply didn't measure that phenomenon.

By misrepresenting the results of the science, the article is able to provide seeming scientific support for its unfounded assertion that e-cigarettes are serving as a gateway to youth smoking.

Of course, this misrepresentation of the scientific evidence by electronic cigarette opponents is nothing new. I have documented numerous examples of this sleight of hand over the past few months on this blog. In fact, the greatest magician has been the CDC itself, which used its cross-sectional survey to conclude, and to disseminate widely the conclusion that e-cigarettes are a gateway to a lifetime of addiction to cigarette smoking.

Why is it that electronic cigarette opponents are consistently misrepresenting the science to support their positions? The answer is simple: because the actual science just doesn't support their position. When the truth doesn't support your position, you have to fudge things if you want to retain that position. And that's the rest of the story.

Monday, July 28, 2014

Evidence from UK Casts Doubt on Assertion that Electronic Cigarettes are a Gateway to Youth Smoking Addiction

The Centers for Disease Control has asserted that electronic cigarette use among youth is a gateway to a lifetime of addiction to smoking. This assertion, which has been picked up by politicians and health groups throughout the country, is being used to justify extreme proposals, such as those to ban e-cigarette advertising and to ban all e-cigarette flavorings.

But is there any truth to the assertion that electronic cigarettes are a gateway to youth smoking? New evidence from the UK suggests not. Despite the widespread proliferation of electronic cigarettes throughout England during the past few years, and a concomitant increase in youth experimentation with these products, smoking rates among 11 to 15-year olds has declined to an historic low of just 3%.

Commenting on these results, Deborah Arnott - the chief executive of ASH - stated:

"Some people have been worried that electronic cigarettes could be a gateway into smoking for young people. These figures show that has not happened so far. But we need to keep monitoring use in young people, and make sure advertising and promotion of electronic cigarettes doesn’t glamourise their use."

The Rest of the Story

These data add to the increasing evidence that the dramatic increases in youth experimentation with electronic cigarettes are not leading to increased smoking. The gateway hypothesis - that e-cigarette use leads to smoking - does not appear to be supported by any evidence at the current time.

Why is it that youths who experiment with electronic cigarettes do not seem to be progressing on to cigarette smoking?

There is a good theoretical explanation: the flavors.

It is difficult enough for youth to initiate cigarette smoking because of the harsh taste of the smoke. This is precisely why menthol cigarettes are so popular among youth. Menthol acts as an anaesthetic which makes it easier for a new smoker to tolerate the harsh taste. For smokeless tobacco products, adding flavorings appears to make these products more appealing to youth, probably for this very reason.

The problem with e-cigarette experimentation, for the prospects of cigarette smoking initiation, is that youth are getting used to sweet and flavored products. It is going to be extremely difficult to go from the sweet and flavored taste of the electronic cigarette to the harsh taste of a tobacco cigarette. That transition is not favored, at least not on a theoretical basis. Why would a youth switch from a cherry e-cigarette to a Marlboro?

It may actually be the case that electronic cigarettes serve as an inhibitor of smoking initiation by getting a youth used to a flavorful experience, thus making it less likely - not more likely - that the youth will move on to the harsh taste of tobacco. It is difficult enough to enjoy the initial experiences with tobacco cigarettes, but it would be expected to become that much less enjoyable if one has become accustomed to a flavored nicotine product like electronic cigarettes.

Ironically, banning the flavors in electronic cigarettes could have the perverse effect of decreasing e-cigarette use but increasing use of real tobacco cigarettes. Hopefully, the FDA will examine this issue closely before taking the advice of anti-smoking groups and advocates, who are already calling for a ban on e-cigarette flavorings.

Thursday, July 24, 2014

What's Wrong Here? Michigan Medical Society Opposes Bill to Ban E-Cigarette Sales to Minors

The Michigan Medical Society has opposed legislation that would protect the public's health by prohibiting the sale of electronic cigarettes to minors.

If that sounds strange, I'll repeat it so that you realize this is accurate.

The Michigan Medical Society - representing the state's physicians - is opposed to legislation that would do nothing more or less than ban the sale of electronic cigarettes to minors.

Even the e-cigarette industry itself supports this legislation. How ironic, then, that the state's physicians, along with other "anti-smoking" groups, are opposing this bill, which was enacted by the legislature and awaits the governor's signature. The "anti-smoking" and "health" groups are urging the governor to veto the bill.

How is it that anti-smoking advocates and health groups, including the state's physicians, could possibly oppose a simple ban on the sale of e-cigarettes to minors?

The Rest of the Story

As is so often the case, the answer is money.

In banning the sale of e-cigarettes to minors, the legislation defines e-cigarettes the way they should be defined: as vapor products or alternative nicotine products.

However, the "health" advocates want e-cigarettes to be defined as tobacco products. Even though they are not tobacco products and do not contain any tobacco.

Why?

For two reasons.

First, the advocates want e-cigarettes to be taxed, and it would be easier to tax these products if they are defined as tobacco products. It's hard to turn down a revenue stream when you see one, and "anti-smoking" advocates are apparently no different. They see a nicotine-containing product that some people are using for pleasure, and they immediately want to tax it, regardless of the fact that taxing e-cigarettes will increase cigarette use and kill people by removing the economic incentive for smokers to switch from real cigarettes to e-cigarettes.

Second, the advocates want the same type of marketing and other restrictions that apply to cigarettes to apply equally to e-cigarettes. They are afraid that defining electronic cigarettes honestly might put a damper in those plans.

But e-cigarettes should not be treated the same as cigarettes. Doing so removes the incentive for people to switch from real cigarettes to e-cigarettes and therefore will increase smoking, and with it, death.

The rest of the story, then, is that health advocates in Michigan are so blinded by ideology (that anything that looks like a cigarette is evil) that they are on the exact opposite side of the issue as they should be. First, they are opposing the prohibition of the sale of e-cigarettes to minors. Second, they are in favor of protecting the sale of tobacco cigarettes by removing all competitive advantage that e-cigarettes hold in the marketplace.

Dr. Ken Warner, a nationally recognized tobacco control expert, doesn't buy it. He was quoted as stating:  

"Would I like (e-cigarettes) to be regulated by a organization like FDA that can make those subtle distinctions among tobacco products? Yes. Do I want them to be regulated exactly like other tobacco products? No, because not all tobacco products are the same, and too many people think they are and act like they are."

Former Michigan legislative aide and public policy expert Ken Braun also sees through the anti-smoking groups' smokescreen:

"Inhaling tons of smoke from burning sticks full of harsh chemicals and dried leaves has been proven to be a highly efficient method of creating many murderous cancers. But while very addictive, not healthy, and not something we should be letting children purchase, nicotine use by itself is but a tiny fraction of tobacco’s threat. Confusing these problems is like comparing shoplifting a t-shirt with aggravated murder. Reporting recently on the toxicology of e-cigarettes, the British National Health Service stated the vapors contain 1/1000th the hazardous chemicals of real cigarettes. Those anti-smoking billboards on roadsides showing people with chunks of their face and lungs missing are showing the ravages of tobacco smoke, not nicotine use. To conflate the two ... is - at best - blindingly stupid regarding the facts ... . At worst, it is profoundly immoral propaganda that confuses and distracts people with a lethal addiction regarding a life-saving alternative. We now have the ability to separate smoking death from nicotine addiction. That should be a goal of health policy, not an obstacle."

"Half a dozen smokers have contacted me since I began writing about this issue, each speaking of a much healthier lifestyle with clean lungs from switching to e-cigarettes. Their clothing smells normal and they no longer assault bystanders with tobacco smoke. They have their life back because they know the difference between tobacco and nicotine. It’s a shame lying politicians seek to confuse other tragic people who seek such peace."

Wednesday, July 23, 2014

D.C. District Court Invalidates TPSAC Menthol Report Because of Conflicts of Interest of Panel Members

A D.C. District Court judge has invalidated the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) report on menthol because of severe financial conflicts of interest of several of its panel members.

The decision comes in response to a lawsuit brought by Lorillard on two grounds. First, the companies alleged that three TPSAC members (Drs. Benowitz, Henningfield, and Samet) were conflicted because "they have made tens of thousands of dollars as paid expert witnesses in litigation against tobacco products manufacturers." Second, the companies alleged that Drs. Benowitz, Henningfield, and Samet are conflicted because of "their continuing financial relationships with pharmaceutical companies that make smoking-cessation products."

As a result of the decision, the FDA will not be able to rely upon the findings and conclusions of the TPSAC menthol report. In addition, the Court instructed the agency to reconstruct TPSAC by replacing any members who have conflicts of interest. Dr. Samet is the only current TPSAC member who appears to be implicated by this instruction.

In October 2011, commenting on Lorillard's lawsuit, I wrote:

"I believe that the second grounds - the existence of severe financial conflicts of interest by virtue of these panelists financial connections to pharmaceutical companies that manufacture smoking cessation products - is entirely compelling. In fact, I revealed these conflicts of interest and called for the resignation of Drs. Henningfield, Benowitz, and Samet from the TPSAC panel in the first few days after the TPSAC members were announced by the FDA."

In fact, I went so far as to call for the removal of four FDA Tobacco Products Scientific Advisory Committee (TPSAC) panel members - Dr. Neal Benowitz, Dr. Jack Henningfield, Dr. Dorothy Hatsukami, and Dr. Jonathan Samet - because they had significant conflicts of interest with pharmaceutical companies that made it impossible for them to offer objective advice to the Agency on federal tobacco regulatory policy matters.

In September 2010, I pointed out specifically that:  

"The next major issue that TPSAC will consider (after menthol), in fact, is dissolvable tobacco products. Now that GlaxoSmithKline has come out in strong opposition to these products and directly petitioned the FDA to remove these products from the market, it is not possible for any TPSAC member who has a financial conflict of interest with Glaxo (or similar companies that manufacture smoking cessation products) to impartially participate in discussions on this matter."

The Rest of the Story

As I had suggested in my September 2010 column, Judge Richard Leon's decision was based in large part on his finding that Dr. Benowitz's ongoing conflict of interest with pharmaceutical companies rendered him unable to objectively consider the issue of dissolvable tobacco products (DTPs).

"The FDA erred in concluding that current, ongoing financial relationships with drug manufacturers did not constitute a conflict. Since manufacturers of smoking-cessation drugs compete with manufacturers of DTPs, ... and since Dr. Benowitz stood to profit from the sale of NRT drugs, he faced a conflict with regard to providing advice in the TPSAC's report on DTPs. ... the TPSAC was charged with studying the public health impact of a drug (i.e., DTPs), and Dr. Benowitz had an ongoing business relationship (i.e., consulting work) with companies developing "alternative" or competing drugs (i.e., smoking-cessation drugs). Accordingly, I find that the FDA's conclusion with regard to Dr. Benowitz was a 'clear error of judgment.'"

Judge Leon also found that a similar conflict existed on the menthol issue because a ban on menthol would increase the market for smoking cessation drugs by causing many smokers to want to quit. Thus, having a current financial interest in a pharmaceutical company was a clear conflict of interest.

While I still disagree with Leon's finding that serving as an expert witness is a relevant conflict because I do not see any relevant financial interest in the absence of the pertinence of a matter to a specific legal contract for hire of an expert, I do agree completely with his decision regarding the pharmaceutical conflicts of interest.

Perhaps the most discouraging aspect of the story is that the FDA failed to acknowledge these conflicts of interest. I explained in a previous post why the guidelines used by the FDA to determine eligibility for the TPSAC were inappropriate. Hopefully, this decision - having exposed the ridiculousness of those guidelines - will force the FDA to reformulate the guidelines so that they do actually screen out expert panelists with relevant conflicts of interest.

Will this decision have any impact on the regulation of menthol by the FDA? No. There are plenty of other sources that the agency could rely on for information if it wishes to regulate menthol. The bottom line is that the FDA is not going to ban menthol, with or without the TPSAC report.

The major implication of this decision is that it exposes the degree to which financial conflicts of interest are plaguing the current tobacco control movement. It should force anti-smoking groups and federal agencies to take conflicts of interest more seriously.

For years, the anti-smoking groups and public health agencies have taken tobacco industry conflicts of interest seriously. Now it is time to have some integrity and fairness and to consider all corporate conflicts of interest, whether they involve Big Tobacco or Big Pharma.

Tuesday, July 22, 2014

After Years of Research, the Worst that E-Cigarette Opponents Can Say Is: "They are Not Harmless"

While there is still a lot we do not know about the exact magnitude of any long-term risks associated with electronic cigarette use, vapers should be quite reassured that after at least five years of research into the health effects of vaping, the worst that electronic cigarette opponents can say is: "Well ... they're not harmless."

In a news article, SAMHSA (the Substance Abuse and Mental Health Services Administration) attempted to demonize electronic cigarettes, providing a quite biased and one-sided look at the risks associated with these products. The article fails to report the results of surveys and clinical trials, which have shown that e-cigarettes are a bona fide smoking cessation aid that have helped thousands of smokers to quit.

Despite its obvious bias against electronic cigarettes, what was the worst thing that SAMHSA could say about the health risks of vaping:

"“There’s so much we don’t yet know about e-cigarettes,” said Douglas Tipperman, M.S.W., a public health advisor at SAMHSA. “They are not harmless. We don’t know the health impact at the individual or the population level.”

The Rest of the Story

If "they are not harmless" is the worst that opponents can say about electronic cigarettes in 2014, then there doesn't seem to be much of a controversy over whether these products are much safer alternatives to smoking. Likewise, there doesn't appear to be much of a controversy over whether switching to e-cigarettes is a wise choice for smokers who want to quit but feel unable to do so cold turkey (which is, of course, the best option).

The SAMHSA article is full of ridiculous statements and poor reasoning, such as the conclusion that electronic cigarettes are repeating the Big Tobacco story because their ads use celebrities:

"Similarities are evident between advertisements for the e-cigarettes of today and the cigarette ads from the 1950s. For example, both sets of ads use celebrities to appeal to their target audiences."

By that reasoning, Rolex, Pantene, and Save the Seals are also targeting youth for a lifetime of addiction, taking a page out of Big Tobacco's playbook.

The weakness of the scientific argumentation of those opposed to electronic cigarettes demonstrates that in 2014, there simply is not much of a scientific argument to fall back on in opposing this innovation. The science isn't going to do it, so opponents have to rely on trite and meaningless assertions like:

"They aren't harmless."

"There's a lot we don't know about them."

"They still have nicotine in them."

"Their ads use celebrities."

Hopefully, the FDA will look towards a little higher level of scientific evidence and reasoning before it promulgates its final e-cigarette regulations.

Monday, July 21, 2014

In the Face of Contrary Evidence, the CDC Still Denies that Electronic Cigarettes Can Help Anyone to Quit Smoking

In her article on CDC's "Tips from Former Smokers" anti-smoking campaign, Nancy Wride of Elements Behavioral Health made an interesting observation. On its web site describing a variety of possible strategies to quit smoking, the CDC does not list electronic cigarettes. Wride therefore asked the CDC why electronic cigarettes are not included on its web site as a potential smoking cessation aid.

The CDC's response:

"while we have heard from some former smokers who say e-cigarettes helped them quit, there is not yet any conclusive scientific evidence that e-cigarettes can work as a cessation aid."

The Rest of the Story

In other words, what the CDC is saying is:

"While we have heard from former smokers who say e-cigarettes helped them quit, we have to ignore their statements because we just can't bring ourselves to admit that something which looks like a cigarette could possibly be a good thing and could have positive benefits like helping a smoker get off of tobacco cigarettes."

The CDC's statement is wrong on its face. If there is reputable evidence from former smokers that e-cigarettes helped them quit smoking, then there is indeed conclusive scientific evidence that e-cigarettes "can work" as a cessation aid.

In fact, there are literally thousands of testimonials from ex-smokers as well as thousands of identified ex-smokers in surveys who testify that for them, e-cigarettes did work as a cessation aid. There is no legitimate scientific debate over whether e-cigarettes can work as a cessation aid. They can work, and they have worked for literally thousands of smokers.

Since the CDC admits, in the first part of its statement, that e-cigarettes have indeed worked as a cessation aid for some former smokers, it is clearly lying in the second part of its statement, in which it claims there is no scientific evidence that e-cigarettes can work as a cessation aid.

Why is the CDC unable to tell the truth? Why can't the agency even issue a statement that is internally consistent on this issue? Why is the CDC ignoring the wealth of evidence that it admits exists, which shows that many ex-smokers have used electronic cigarettes effectively as a smoking cessation aid?

One possible answer appears in Wride's column. She writes:

"So why doesn’t the CDC include e-cigarettes among its cessation and quitting tips? “The real reason is that they don’t condone anything that looks like smoking, even if it delivers none of the smoke and even if it delivers no nicotine,” Siegel said. “It is the ideology of the smoking action that they oppose.”"

In a recent column in Forbes magazine, Jacob Sullum reviews some of the evidence which demonstrates that many former smokers have quit smoking successfully using electronic cigarettes as a cessation aid. Sullum writes:

"The new survey [published by the E-Cigarette Forum] ... provides further evidence that e-cigarettes help smokers quit... . Eighty-nine percent of the respondents reported that they had smoked at least 10 cigarettes a day before they started vaping, and 88 percent said they were not currently smokers. Those findings are similar to the results of another survey focusing on people who participate in online vaping forums, reported last April in the International Journal of Environmental Research and Public Health. That study, which included more than 19,000 vapers from around the world, found that almost all of them (99.5 percent) were smokers when they started vaping. Four-fifths of them had stopped smoking completely, while the rest had reduced their cigarette consumption, on average, from 20 to four per day."

"It should be emphasized that neither of these studies was designed to capture a representative sample of all vapers. Instead they focus on the most enthusiastic among them, whom you would expect to have had especially satisfying experiences with e-cigarettes. The high success rates in these surveys therefore are unlikely to be seen among the broader group of smokers who try to quit with e-cigarettes, let alone among smokers who merely try the product out. But these surveys do indicate that e-cigarettes have helped many smokers quit."

"It borders on bizarre that critics like [West Virginia Senator Jay] Rockefeller continue to question the existence of those former smokers, even while arguing that e-cigarettes should be restricted or banned based on the entirely hypothetical risk that vaping will lead to smoking among teenagers who otherwise never would have tried tobacco."

The CDC is even worse. It actually acknowledges the existence of these former smokers, but still argues that there is no evidence that electronic cigarettes have helped any smokers quit.

Clearly, the actual scientific evidence doesn't matter to an agency that is being guided purely by ideology and which has come to a pre-determined conclusion that e-cigarettes are evil. Today's story demonstrates how a strong pre-existing schema, propped up by ideology, leads to such preposterous scientific statements such as arguing that although many ex-smokers have used e-cigarettes successfully as a cessation aid, there is no evidence that any ex-smokers have used e-cigarettes successfully as a cessation aid.