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.

Wednesday, July 16, 2014

Acquisition of Lorillard Demonstrates that Reynolds American Agrees that Democratic Senators are Full of Hot Air

For several months, a group of Democratic senators - led by Dick Durbin (D-IL), Richard Blumenthal (D-CT), and John Rockefeller (D-WV) - have been blasting the e-cigarette industry for using flavors in their products. This group of senators has called for a ban on flavorings in e-cigarettes, supposedly because of their sincere interest in curtailing "marketing tactics aimed at luring children and teenagers into ... nicotine addiction."

The Rest of the Story has called their bluff, pointing out that what these senators really mean is that they want to stop tactics (flavored e-cigarettes) aimed at luring children into fake cigarette addiction, but not tactics (flavored cigarettes) that are aimed at luring children into actual cigarette addiction. These same senators either supported the menthol exemption to the flavored cigarette ban and/or have failed to introduce or sponsor legislation that would ban menthol flavoring from cigarettes.

In other words, these politicians are full of hot air. They are pretending to be truly concerned about the health of children, but in reality, they are simply trying to score an easy political victory. They want to have the appearance of protecting children from nicotine addiction, while not actually having the courage to stand up against Big Tobacco and pull the plug on menthol. The truth is that they are spineless and disingenuous. Children's health is not their true aim; political victory is.

The Rest of the Story

The acquisition of Lorillard by Reynolds American demonstrates that Reynolds shares my view of these politicians as being merely full of hot air. Specifically, the acquisition shows that Reynolds is confident that these politicians will not push the FDA to ban menthol, nor will they introduce Congressional legislation that would ban menthol cigarettes. The chief asset that Reynolds is acquiring, after all, is Newport. If Reynolds truly believed that there was any risk that Senator Durbin would back up his words with action, then it would never had made this deal. If Reynolds had any real fear that the FDA were going to ban menthol, the acquisition would not have occurred.

One thing we can learn from this deal, then, is that the future of menthol cigarettes is bright and rosy. Even after ditching Blu, the acquisition of Camel and Newport was viewed to be worth billions. Clearly, Reynolds is counting on a continuing profitable market for menthol cigarettes.

I agree with Reynolds' reasoning. The Congress has made its intent clear: menthol cigarettes were exempt from the flavoring ban because there is no real intent among the Congressmembers to actually put a dent in cigarette sales. The Family Smoking Prevention and Tobacco Control Act was window dressing, disguised as a strong anti-smoking measure, but actually doing almost nothing to tackle youth smoking. And the FDA, in five years of jurisdiction over cigarettes, has done next to nothing to reduce youth smoking or to set standards that would make cigarettes safer.

It is safe to say that neither Congress nor the FDA has the guts to actually take on Big Tobacco and ban menthol. At the end of the day, the federal regulation of cigarettes is all about making it look to the public like the federal government has the problem under control. In reality, our government is spending more time trying to keep electronic cigarettes off the market then it is trying to reduce cigarette smoking or to make it safer.

At the end of the day, we can thank politicians like Senator Durbin for providing such a high valuation for Newport that the acquisition became profitable. If these senators actually meant what they are telling the public, then no one would want to touch Newport with a ten foot pole.

Tuesday, July 15, 2014

Pennsylvania Legislators Calling on Smokers to Fund Public Education for Philadelphia Children

"Support public education: Buy cigarettes."

That might as well be the slogan for T-shirts that come out of the Pennsylvania legislature's solution to the problem of adequately funding Philadelphia's public schools.

Faced with a $93 million budget deficit for Philadelphia's school system, state legislators have decided to ask smokers to make up the budget deficit by providing extra tax revenue to support public education.

According to an article in the Philadelphia Inquirer: "The tax, anticipated to bring in $1.6 million per week, could raise $45 million this year and $83 million in the first full year. The Philadelphia School District has a $93 million budget deficit."

The Rest of the Story

I have no problem with a $2 per pack cigarette tax in Philadelphia to reduce smoking rates and to fund an aggressive anti-smoking campaign that would also provide money for research to prevent and treat smoking-related diseases and subsidize the treatment of smoking-related diseases. However, the idea of making public education permanently dependent upon continued high sales of cigarettes is bordering on insane.

For one thing, it puts the government in the business of promoting smoking. It removes any incentive for the legislature to support any strong actions to reduce smoking. Were that to happen, the Philadelphia school system would go under. Does it not seem somewhat perverse that in order to support public education for Philadelphia children, we need to hope that people continue to smoke at high rates?

The Pennsylvania governor and legislators are grown adults, and they should be able to deliver a budget that finds $93 million to fund the Philadelphia School District without tying that funding permanently to cigarette smoking. They should be forced into a closed chamber and not allowed to come out until they come up with the needed funding in a way that doesn't force smokers to shoulder the burden of supporting public education and tie such funding to continuing high rates of smoking.

Hint: The solution isn't too difficult. Pennsylvania corporations are enjoying $2.4 billion in annual tax breaks. Closing a fraction of those loopholes would fully fund the Philadelphia school system.

Friday, July 11, 2014

Disgrace of the Year: Leading Lung Health Groups Call for Ban on Fake Cigarettes, But Want Real Ones to Remain on the Market

Yesterday, a group of international lung health organizations issued a position statement on electronic cigarettes, which called for a ban (or severe restrictions) on these products until more is known about their health effects. In contrast, these organizations did not express any problem with real tobacco cigarettes remaining on the market, even though they kill millions worldwide each year, and electronic cigarettes are not known to have killed a single person ever.

According to a press release from the American College of Chest Physicians: "Experts from the world’s leading lung organizations have released a position statement on electronic cigarettes, focusing on their potential adverse effects on human health and calling on governments to ban or restrict their use until their health impacts are better known."

"Produced by the Forum of International Respiratory Societies (FIRS), the position statement will be presented July 9 at a meeting hosted by FIRS and the NCD (Noncommunicable Disease) Alliance, “Shared Drivers, Shared Solutions: NCDs, Lung Health and Sustainable Development.” ... FIRS, established in 2001, is an organization composed of the world's leading international respiratory societies working together to improve lung health globally, including the American College of Chest Physicians (CHEST), the American Thoracic Society (ATS), the AsociaciĆ³n Latinoamericana del Thorax (ALAT), the Asian Pacific Society of Respirology (APSR), the European Respiratory Society (ERS), the International Union Against Tuberculosis and Lung Disease (The Union), and the Pan African Thoracic Society (PATS)."

The Rest of the Story

This has to be one of the most disgraceful moves of the year by any medical or public health group. Even the multinational tobacco companies do not have the gall to promote a ban on electronic cigarettes so that their deadly tobacco cigarettes will not be threatened by this potentially substantial competition. In fact, the position of these supposed lung health groups is far more extreme than any Big Tobacco position, as the tobacco companies have entered the e-cigarette business and are not using their lobbying power to try to remove these products from the market. Sadly, it is these lung health groups that apparently want electronic cigarettes taken off the market so that deadly tobacco cigarettes can maintain their monopoly on smokers.

Despite strong evidence that vaping is much safer than smoking, that e-cigarettes do not contain any tobacco or involve any combustion, that tens of thousands of smokers are successfully using these products to quit smoking or cut down substantially on the amount they smoke, and that smokers with obstructive lung disease who switch to electronic cigarettes experience and immediate improvement in their respiratory symptoms, it appears that the American College of Chest Physicians and its partner organizations in FIRS would rather see tens of thousands of vapers return to cigarette smoking than to maintain a much healthier, smoke-free or greatly smoke-reduced lifestyle.

Apparently, the American College of Chest Physicians would rather that smokers die from the known risks of tobacco cigarettes than greatly improve their health by switching to electronic cigarettes, which has unknown long-term risks - although they are certainly orders of magnitude safer than real cigarettes. At least the smokers will know what they're dying from.

Some knowledgeable analysts have predicted that if promoted, electronic cigarettes could actually replace nearly half of the combustible tobacco cigarette market. This would be the greatest public health achievement of my lifetime. Sadly, the American College of Chest Physicians and its partners do not want to see this happen. They would rather stick with the status quo, where smokers will continue to die in the millions each  year, but at least they will not be taking any "unknown" risks.

What is so scary to these lung groups about the prospect of so many smokers quitting or cutting down substantially on their smoking? A cynic might say that it would cause these physicians to lose a huge number of patients. That these groups are trying to protect their own payment streams is as rational an explanation for their behavior than any science- or public health-based explanation I can ponder.

The truth is that these groups are stuck - trapped in a blinding ideology in which science plays absolutely no role and positions are based on pure, raw emotion. And the emotion against anything which looks like a cigarette is apparently so strong that it drowns out even the most solid evidence of the life-saving potential of a product that resembles smoking but delivers nicotine with only a minute fraction of the dangerous chemicals, and which, with proper manufacturing, appears to deliver only one chemical of any significant health concern.

The rest of the story is that the FIRS groups have committed a disgraceful act, which, if their advice is adopted, will result in a substantial increase in the number of smokers and with that, an increased amount of disease and death.

Tuesday, July 08, 2014

Outstanding Commentary on the Folly of Anti-Smoking Groups' Opposition to Electronic Cigarettes

Tony Newman, the media relations director for the Drug Policy Alliance, has written a cogent piece which is a must-read for anyone who has been following The Rest of the Story and its exposition of the strong opposition to vaping from numerous (supposedly) anti-smoking advocates and groups.

I can't add anything to this fine piece, so I'll leave it for readers to examine. I'll just close with the final paragraph of Newman's piece, which summarizes the situation incisively:

"Anti-smoking advocates have become so used to demonizing smoking and so afraid of giving an inch that they are waging a war against a practice that is actually accomplishing the goal of reducing or eliminating people's smoking. They should know better than most that a tool that may help millions of people stop smoking cigarettes should be celebrated and embraced -- not restricted and stigmatized."

Monday, July 07, 2014

Maryland Hospital Will Not Hire Ex-Smokers, If They are Still Using Electronic Cigarettes

Anne Arundel Medical Center in Annapolis wants to encourage smokers to quit, but only in the way the hospital says they should quit. Specifically, smokers who successfully quit smoking using electronic cigarettes will not be eligible for employment if they are continuing to use e-cigarettes to stay smoke-free. Moreover, smokers who are currently attempting to quit using e-cigarettes will not be eligible for employment, no matter how successful they might be in quitting or cutting down using these products.

Starting next July, Anne Arundel Medical Center will not hire anyone who uses nicotine in any form. According to an article in the Baltimore Sun: "Anyone who wants a job next year at Anne Arundel Medical Center — whether as a surgeon or security guard — will have to prove they don't smoke or use tobacco.
The Annapolis hospital's new hiring policy might be controversial, but it is legal in Maryland and more than half of the United States. ... Anne Arundel Medical Center, like a growing number of health systems, universities and other businesses, will require a urine test for nicotine use for all applicants starting next July. The policy ... covers not only cigarettes, but cigars, pipes, snuff and e-cigarettes."

The Rest of the Story

This is not a public health policy. It is a moral crusade.

If it were a public health policy based on some sort of health principles, then it certainly would not penalize ex-smokers who quit using electronic cigarettes. In contrast, it would actually reward these individuals for having quit smoking and perhaps saved their lives.

It the policy were based on health principles, then it certainly would not exempt current employees. Clearly, the hospital doesn't care that much about the health principle, since it will continue to employ smokers with no questions asked.

If the policy were based on health principles, it would encourage smokers to quit, and therefore, it would reward smokers who are trying to quit using nicotine patches, nicotine gum, or electronic cigarettes, rather than exclude these individuals from employment.

If the policy were based on health principles, then it would certainly include other behaviors, such as those related to obesity, which have large health care costs and which set a "bad example." It would certainly include alcohol use as well.

The rest of the story is that this is not an employment policy based on health principles. Instead, it is part of a moral crusade against a particular health behavior (i.e., a vice) which is being punished in a discriminatory fashion.

Thursday, July 03, 2014

"Groundbreaking" Legislation in New Jersey Provides No Human Health Protection While Sacrificing the Health and Lives of Casino Workers

According to an article in the Sand Paper, the New Jersey state legislature has passed legislation that would ban smoking in all state parks and beaches, with no exceptions. Smoking would also be banned in municipal parks, but localities would be allowed to designate 15% of the park as a smoking area.

According to the article: "“The bill first has to be signed by Gov. Christie,” said Karen Blumenfeld, executive director of Global Advisors on Smokefree Policies. ... “This law is nationally groundbreaking as New Jersey will become the first state in the United States to require that all state, county and local parks, recreation areas and beaches be 100 percent smoke-free,” said Blumenfeld. “It provides for consistent, uniform healthful environments from town to town.  New Jersey is ready for a 100 percent smoke-free parks and recreation areas policy statewide. ... One hundred percent smokefree parks and recreational areas also generate health, environmental and economic health benefits. It normalizes smokefree environments where children engage in recreational activities, reducing the likelihood they’ll start smoking.” She said there is no safe level of secondhand smoke even outdoors, especially for children and seniors. “Studies show outdoor smoke levels can be as high as indoor smoking-permitted locations,” said Blumenfeld."

The Rest of the Story

I doubt that the smoke levels in New Jersey parks were anything like the levels that are being experienced by the tens of thousands of the state's casino workers.

Vince Rennich is a casino floor worker who at age 47 was diagnosed with lung cancer due to 25 years of heavy exposure to secondhand smoke, which he described as working in "a modern-day coal mine." "A good majority of the time, I'm surrounded in a cloud of smoke," he said.

While New Jersey anti-smoking groups and policy makers pat themselves on the back for what they claim is "groundbreaking" public health protection, New Jersey remains one of the two worst states in the country in terms of failure to protect a huge segment of its workers - casino workers - from the devastating health effects of heavy and chronic secondhand smoke exposure.

While the new law may provide for "consistent, uniform healthful environments from town to town," it doesn't do so if that town is named "Atlantic City."

In my opinion, New Jersey has no business pretending that achieving "100 percent smoke-free parks and recreation areas" is some sort of huge public health victory when the reality is that thousands of its casino workers continue to suffer disease and disability from exposure to high levels of secondhand smoke.

Banning smoking in public parks and beaches may have environmental benefits, but in terms of human health, there is no evidence that these policies are actually addressing any substantial public health problem. In contrast, the problem of secondhand smoke exposure in New Jersey's casinos is truly a life and death issue.

The rest of the story is that New Jersey lawmakers and anti-smoking groups should be ashamed of celebrating the "groundbreaking" human health protection represented by eliminating all wisks of tobacco smoke in public parks while doing nothing to eliminate the literal clouds of smoke that enshroud the state's casino workers who are simply trying to make a living and support themselves and their families, but have to breathe in high levels of carcinogens in order to make a living.

I'm sure those casino workers will sleep well at night knowing that never again will they have to walk by a smoker in a park.

In Ironic Twist, Glantz is Acting as Tobacco Front Group While Defamed "Front Groups" are Trying to Make Cigarettes Obsolete

Sometimes, reality isn't what it seems. And once in a rare while, it is exactly the opposite. That is the case in today's Rest of the Story.

Yesterday, I revealed that Dr. Stan Glantz has accused electronic cigarette associations of being front groups for Big Tobacco, insinuating that they are masquerading as grassroots vapers' groups but in reality are working to protect Big Tobacco profits.

Today, I show that ironically, it is Dr. Glantz who is working to protect Big Tobacco profits, while the electronic cigarette groups are working to make cigarettes obsolete.

The most telling point is Dr. Glantz's opposition to legislation that classifies electronic cigarettes as being separate from tobacco products. The electronic cigarette associations have been lobbying local and state governments not to classify e-cigarettes as tobacco products. This makes perfect sense because they are not tobacco products. They contain no tobacco. They are orders of magnitude safer than cigarettes and should not be treated in the same category for regulatory purposes.

Obviously, it is to the great disadvantage of cigarette profits to have e-cigarettes classified and treated separately. For example, if e-cigarettes are taxed as heavily as cigarettes, then cigarettes are protected from competition and have a huge market advantage. If e-cigarette use is not allows in the same places where smoking is allowed, then cigarettes also are protected from competition and gain a huge market advantage.

By opposing the classification of e-cigarettes as tobacco products, the e-cigarette associations have been everything they can to avoid regulations that treat these products in the same way. The reason is simple: such regulations would give cigarettes a huge competitive advantage in the market place. Laws that categorize e-cigarettes the same way as tobacco products are essentially protective legislation for tobacco cigarettes. By fighting such a classification, e-cigarette associations are doing what they can to reject the idea of this protective legislation so that they can gain the upper hand on cigarettes and eventually, make these products obsolete.

Ironically, Dr. Glantz (and numerous anti-smoking groups) are supporting the protective legislation. Which raises the question: Who is acting more as a Big Tobacco front group? The e-cigarette associations, which are fighting protective legislation for tobacco cigarettes, or Glantz and the anti-smoking groups, which are trying to get protective legislation ensconced in every state throughout the country, so that cigarette profits are protected nationwide?

Wednesday, July 02, 2014

More Defamatory Accusations from Glantz: This Time, Vaper Associations are Attacked

Vapers Club, Vapers Forum, Vapers Place, Utah Vapers, Consumer Advocates for Smoke-free Alternatives Association, Tobacco Vapor Electronic Cigarette Association

What do all of these organizations have in common?

According to Dr. Stan Glantz, they are all tobacco front groups because they "bear an uncanny resemblance" to front groups that the tobacco industry historically formed to oppose clean indoor air legislation.

Dr. Glantz writes: "It turns out that ABC spiked a second documentary, prepared for its documentary program Turning Point, "Tobacco Under Fire." The first segment, which deals with advertising, is mostly of historical interest (to show that we have actually made some progress, although nothing close to most other countries, which have ad bans). The second segment, dealing with how the tobacco companies create front groups, however, is highly relevant today, since the "grassroots" vaper associations bear uncanny resemblances to what the tobacco companies did in (generally ineffective) efforts to organize smokers to oppose clean indoor air laws and other tobacco control policies."

In other words, the efforts of grassroots organizations like these vaper associations are not genuine displays of the opinions of vapers. Instead, these organizations are merely front groups created by the tobacco industry in order to have the appearance of a grassroots group, but actually intended to lobby for the tobacco industry's interests.

The Rest of the Story

Fortunately, Dr. Glantz is living in the past. While it is quite true that the tobacco companies used to form front groups to masquerade as genuine grassroots organizations in order to oppose smoke-free laws, the fact that Big Tobacco acted this way in the 1980s and 1990s does not mean that any organization that supports electronic cigarette use in 2014 is a Big Tobacco front group.

In fact, the accusation is a defamatory one because it is intended to harm the credibility of these groups and it is not based on any careful attempt to present the truth.

Nearly all of the vaper groups and associations are genuine grassroots organizations that truly represent the interests of the vaping community, not Big Tobacco. The accusation makes no sense even on its face - these groups are trying to replace tobacco cigarettes with electronic ones. Why would Big Tobacco fund groups that are trying to make tobacco cigarettes obsolete?

This is just another example of the defamatory tactics that a number of electronic cigarette opponents are using to try to discredit these products and their potential role in public health.

Monday, June 30, 2014

Researcher at UCSF Tobacco Research Center Involved in Unethical Facebook Research

A scientist who is currently with the UCSF Center for Tobacco Control Research and Education (home of Dr. Stan Glantz) is part of a research team that conducted an unethical experiment on hundreds of thousands of Facebook users, whose Facebook news feed content was manipulated without their informed consent in order to try to trigger their emotions.

The purpose of the experiment was to determine whether manipulation of an individual's Facebook news feed by blocking either positive or negative emotional content could affect the mood and emotional expression of that person. In short, the experiment sought to determine whether emotion is "contagious."

The paper defends its ethical standards by arguing that it "was consistent with Facebook's Data Use Policy, to which all users agree prior to creating an account on Facebook, constituting informed consent for this research."

Regarding the engagement of Facebook users in research, Facebook's Data Use Policy states the following:

"We use the information we receive about you in connection with the services and features we provide to you and other users like your friends, our partners, the advertisers that purchase ads on the site, and the developers that build the games, applications, and websites you use. For example, in addition to helping people see and find things that you do and share, we may use the information we receive about you: ... for internal operations, including troubleshooting, data analysis, testing, research and service improvement."

The policy also states: "We give your information to the people and companies that help us provide, understand and improve the services we offer. For example, we may use outside vendors to help host our website, serve photos and videos, process payments, analyze data, conduct and publish research, measure the effectiveness of ads, or provide search results."

The Rest of the Story

This research violates basic ethical standards of informed consent for two reasons:

1. The subjects did not consent to participate in the study.

In fact, the subjects had no idea that they were part of an experiment involving artificial manipulation of their news feed for the purposes of potential inducing happiness or sadness as part of a research study. This potential use of their Facebook account is simply not mentioned in the Data Use Policy. The policy states that the information provided by users may be used for research purposes. It also states that the information may be shared with outside vendors to conduct research. However, nowhere does the policy state that users agree to intentional manipulation by Facebook staff for research purposes.

In other words, while the policy allows Facebook to collect and use user information for research purposes, it does not allow Facebook to conduct interventions in which it manipulates feeds shared with users in order to try to control their emotions as part of a research experiment.

Thus, before even getting to the issue of informed consent, the subjects in this research did not even consent to the research in the first place.

2. The subjects did not provide informed consent for their participation in the research.

Contrary to the assertion of the authors of this paper, simply being aware that the information one provides to Facebook may be used for research purposes does not constitute informed consent. The fact that users agreed to a Data Use Policy which notes that information may be used for research purposes does not, as the authors state, "[constitute] informed consent for this research."

In order to represent informed consent, there are several other elements which must take place. These are explained best by Professor James Grimmelmann over at The Laboratorium:

"The standard of consent for terms of service is low. But that “consent” is a legal fiction, designed to facilitate online interactions. (See Nancy Kim and Margaret Jane Radin’s books for more.) It’s very different from informed consent, the ethical and legal standard for human subjects research (HSR). The Federal Policy for the Protection of Human Subjects, a/k/a the Common Rule, requires that informed consent include:
(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
(2) A description of any reasonably foreseeable risks or discomforts to the subject; …
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject;
(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Facebook’s actual Data Use Policy contains none of these, only general statements that “we may use the information we receive about you … for internal operations, including troubleshooting, data analysis, testing, research and service improvement.” and “We give your information to the people and companies that help us provide, understand and improve the services we offer. For example, we may use outside vendors to … conduct and publish research.” Neither of these comes close to a “description of the procedures to be followed” or a “description of any reasonably foreseeable risks or discomforts,” and the Data Use Policy doesn’t even attempt to offer a contact for questions or an opt-out."

It is clear, then, that this study violated the principles of informed consent, as subjects did not provide informed consent prior to being enrolled in the research.

There is a provision for waiver of informed consent; however, the conditions for such a waiver were not met because: (1) the level of risk was not minimal; (2) the waiver did affect the rights and welfare of the subjects; (3) the research could still practicably have been carried out with informed consent; (4) subjects were not provided with information after the study to explain what occurred.

An Unethical Experiment

Because this research was funded by the federal government (by the Army Research Office, according to Cornell), it is subject to the human subjects research requirements. In addition, the involvement of two researchers at academic (federally-funded) institutions requires that the research be approved by an Institutional Review Board. Apparently, the research was approved by an academic IRB, a decision which I publicly question, for the above reasons.

The rest of the story is that despite the Common Rule and the intense efforts to try to prevent human subject violations in research, there are still occasional studies which find their way through the cracks. This is one bad example. It is an example of an unethical experiment that should never have been approved by an IRB in its current form because it blatantly violates the ethical principles of both consent and informed consent.