Thursday, February 25, 2010

Thirdhand Smoke Cancer Hysteria

The anti-tobacco extremists’ motto: if you can measure it, it must be deadly. Last week, a group of chemists and toxicologists published a largely theoretical study claiming that “infants and children are particularly at risk” from thirdhand smoke. The first author was Mohamad Sleiman; another, James Pankow, claimed several weeks ago that smokeless tobacco users were overdosing on wintergreen flavor.

The report appeared in the Proceedings of the National Academy of Sciences, a scientific journal that usually publishes solid research studies. Not this time.

Sleiman claims that nicotine residues in thirdhand smoke, which can become attached to skin, dust and items in houses or cars, can react with nitrous acid, which is formed by unvented combustion appliances (such as a gas cooktop) and smoking. The reaction produces NNK, which is a tobacco-specific nitrosamine (TSNA) that is considered a cancer-causing agent.

The report is largely theoretical, since it is very difficult to isolate and measure tiny levels of these chemical agents. For example, Sleiman estimated that smoking might expose human skin to as much as 15 nanograms of NNK per SQUARE METER. Keep in mind that a square meter is about 9 square feet. This is about 5 times the surface area of a normal adult. He also estimated that about 15 nanograms of NNK could be present over 9 square feet of furniture surfaces.

A nanogram is one billionth of a gram, and a gram is less than 4 hundredths of an ounce. So we are talking about vanishingly small amounts.

Sleiman didn’t discuss how infants and children could actually consume a 15 nanogram dose of NNK from that 9 square foot surface. He collected the residue by using special solvents, including methanol, so uptake by humans is likely to be very inefficient, perhaps negligible.

But let’s assume for a moment that a person is exposed to, and completely consumes, Sleiman’s dose of 15 nanograms of NNK every day for decades. What potential cancer-causing effect might this have?

The answer might come from what we know about NNK in a product used by millions of American men -- smokeless tobacco. In 2003, I published a study reporting the level of NNK in American moist snuff. I found that a typical 1-can per day user may be exposed to one thousand times more NNK, about 15-30 micrograms (actual consumption is probably far lower). Readers of this blog know that there is very little evidence that lifelong use of smokeless tobacco is associated with any cancer.

I am not the only tobacco researcher who is critical of the Sleiman study. Even Steven Hecht, a Minnesota professor who holds extreme positions with respect to smokeless tobacco, has doubts: “I personally feel that exposure by this route would be minimal…”

How harmful is thirdhand smoke? It probably carries about as much risk as third hand rain.

Friday, February 19, 2010

The Invention of Thirdhand Smoke

Last year, Massachusetts pediatrician Jonathan Winickoff and his colleagues invented the notion of “thirdhand smoke,” which they defined as “residual tobacco smoke contamination that remains after the cigarette is extinguished.” Winickoff described thirdhand smoke as particles and volatile compounds that cover every surface of a smoker’s home, exposing people to toxic agents for “days, weeks or months.”

Winickoff sought to prove the existence of thirdhand smoke. He analyzed a survey of about 1,500 American adults called the "Social Climate Survey of Tobacco Control"; he described this as “an annual cross-sectional survey that was designed to operationalize the concept of the social climate on tobacco into a comprehensive set of quantifiable social and environmental indicators across social institutions that characterize society.” In plain English: “a survey designed to demonize tobacco and its users in every facet of society.” Winickoff published his results in the journal Pediatrics.

Survey participants were asked whether they agreed with this statement: “Breathing air in a room today where people smoked yesterday can harm the health of infants and children.” Six out of ten participants agreed, so Winickoff declared thirdhand smoke a reality.

Winickoff was brazenly honest about why this “notion” or “concept” (his words) was developed. “Emphasizing that thirdhand smoke harms the health of children may be an important element in encouraging home smoking bans. Health messages about thirdhand smoke contamination could be easily incorporated into current tobacco control campaigns, programs, and routine clinical practice.”

I have described the evolution of thirdhand smoke from a notion to an established fact. It gets worse. Next week I’ll describe a new, largely hypothetical toxicology study claiming that nicotine residues in thirdhand smoke are being theoretically transformed into dangerous chemicals.

Thursday, February 11, 2010

Clinical Trial Evidence: Snus Is Superior Cigarette Substitute

New Zealand Researchers have published clinical trial results demonstrating that snus is a better cigarette substitute than nicotine gum. The study appears in the online edition of Nicotine and Tobacco Research.

The authors are Brent Caldwell, Carl Burgess and Julian Crane from the Department of Medicine at the University of Otago in Wellington, New Zealand. After observing smoking patterns and consumption for one (lead-in) week, Caldwell’s group gave 63 smokers three different cigarette substitutes, each for two weeks. The substitutes were Swedish snus (4-gram pouches in three flavors), Habitrol nicotine gum (containing 4 milligrams of nicotine) and a new product called Zonnic (a peppermint pouch containing 4 milligrams of nicotine embedded in microcrystalline beads). The latter product is a new medication developed by a Swedish company called Niconovum, which was purchased by R.J. Reynolds in December.

The researchers collected information from the participants about the “acceptability and the willingness of smokers to use” the substitutes. They asked five questions gauging satisfaction, and they reported that “subjects scored Zonnic and snus more highly than gum for four out of the five…” All three products significantly reduced craving for cigarettes, and all three “…enabled subjects to reduce their smoking significantly compared with the lead-in week.”

Participants ranked Zonnic and snus higher than nicotine gum for both quitting and reducing smoking. “At the conclusion of the study, subjects were asked to rank the three products in order of overall preference. For their first choice, an equal number (40%) chose snus or Zonnic, while 20% chose gum” This is great news, because prohibitionists have argued that snus will never be accepted outside Sweden as a cigarette substitute.

Caldwell’s study was funded by the Asthma & Respiratory Foundation of New Zealand. It is refreshing to learn of a health organization that places a higher priority on finding solutions to smoking than on tormenting tobacco companies and users.

The FDA will soon be in a position to approve safer cigarette substitutes. This is the kind of evidence that the agency cannot ignore.

Thursday, February 4, 2010

FDA: E-cigarettes Are Harmful

In a dramatic turn of events, the FDA convinced a federal appeals court to temporarily suspend federal judge Richard J. Leon’s ruling that the agency must regulate e-cigarettes as tobacco products rather than drug-delivery devices. The lower court ruling was discussed in a previous post, here.

If e-cigarettes are regulated as drug-delivery devices, the FDA would effectively ban them until manufacturers conduct clinical trials costing millions of dollars, delaying availability for 5 to 10 years. If the FDA prevails, all those e-cigarette users who are former smokers will have to quit nicotine, smoke regular cigarettes, or buy e-cigarette replacement units and cartridges on a black market that is sure to arise.

According to the media, Judge Leon based his decision on a 2000 case (FDA v. Brown & Williamson) in which the Supreme Court ruled that cigarettes and smokeless tobacco products could not be regulated as drugs or devices. But that is only part of the story. Judge Leon demonstrated that e-cigarettes are appropriately regulated under the 2009 Tobacco Act, which was written by tobacco prohibitionists. Leon ruled that they are “‘tobacco products,’ which Congress defined expansively as ‘any product made or derived from tobacco that is intended for human consumption’…Congress enacted the Tobacco Act to confer FDA jurisdiction over any tobacco product – whether traditional or not – that is sold for customary recreational use, as opposed to therapeutic use.”

The news report quoted the FDA as saying that Judge Leon was “quite wrong to believe that no injury would result from the use of these harmful and addictive products.” This statement is wholly unfounded. Tobacco harm reduction experts have been monitoring use of e-cigarettes -- there have been no reports of adverse health effects. This is in stark contrast to a mountain of evidence that cigarette smoking is associated with diseases killing 400,000 Americans every year.

FDA officials apparently believe that banning e-cigarettes is much more important than saving the lives of American smokers. The federal appeals court should put a stop to this travesty by affirming Judge Leon’s decision.

Monday, February 1, 2010

Tobacco Harm Reduction in the New York Times

On January 31, the New York Times published an article on tobacco harm reduction written by Duff Wilson and Julie Creswell. It focused on a series of submissions to the FDA by Altria, the parent corporation of Philip Morris and U.S. Smokeless Tobacco.

The article suggests that Altria’s argument for FDA endorsement of tobacco harm reduction is a cynical and insincere strategy: “…by focusing the F.D.A.’s attention on smokeless products, a much smaller but growing industry, Altria and other tobacco companies are diverting regulators’ attention from the source of the real public health problem: cigarettes.”

This post takes a critical look at the Times article.

The piece describes Altria as a “corporate pariah blamed for the deaths of millions of people,” noting that cigarette smoking is addictive and causes disease. Altria and other cigarette manufacturers have acknowledged these facts; they believe that the FDA should oversee a program that fully informs smokers about safer smokeless options.

Tobacco prohibitionists were quoted in the article. Stanton Glantz (University of California at San Francisco): “If you look at how they’re marketing smokeless now, they’re marketing for dual use, and to protect the cigarette market, which is their big money maker.”

By this, Glantz acknowledges that manufacturers are marketing smokeless tobacco to smokers. But Glantz seems to believe that Altria has power to “protect the cigarette market” by keeping smokers from switching entirely to smokeless tobacco. If smokers are informed that smokeless products are vastly safer, many will switch, significantly reducing the 400,000 smoking-related deaths that occur in the U.S. annually.

Gregory Connolly (Harvard University): “[Altria is] taking the FDA debate and making it on smokeless rather than ‘light’ cigarettes, which is where the real harm is.”

Kudos to Connolly for implicitly acknowledging that there is no “real harm” in smokeless tobacco. That is precisely why Altria wants FDA permission to tell smokers the truth.

Wilson and Creswell report that Matthew Myers (Campaign for Tobacco-Free Kids) “argues that there is no evidence that smokeless products are effective tools to help people quit smoking.”

This is utter nonsense. Smokeless tobacco is established as a gateway to smoking cessation for men and women in Sweden, and in Norway. In 2008, I provided the first population-level evidence that American men have quit smoking by switching to smokeless tobacco. Using data from the 2000 National Health Interview Survey, which the CDC uses to estimate smoking prevalence in the U.S., Carl Phillips and I estimated that 359,000 American male smokers had tried to quit by switching to smokeless, and 73% (261,000) were successful, the highest percentage of all methods. In comparison, the nicotine patch was tried by 2.9 million smokers, but only 35% were successful. Of the 964,000 smokers who tried nicotine gum, only 34% succeeded.

As I predicted in an earlier post, Kenneth Warner (University of Michigan) attacked the use of flavors in smokeless tobacco products: “The flavors are designed to attract kids.”

This may be evidence of an overzealous imagination. Tobacco manufacturers are prohibited by law from marketing to children. But prohibitionists are adept at making draconian policies seem palatable by pitching them as “protecting children.” Prohibitionists promote a flavor ban because they know that unflavored smokeless products won’t appeal to many smokers. Banning all flavors in smokeless tobacco makes about as much sense as banning flavors in alcoholic beverages.

Wilson and Creswell avoided discussion of the scientific and medical issues in Altria’s FDA submission, instead focusing on the shrill complaints of tobacco prohibitionists. I suggest that you read the documents, available here; they are accurate and based on scientific and medical literature. I also invite you to read my FDA submission, entitled “Tobacco Harm Reduction: Medical, Scientific and Public Health Rationale”.