Friday, January 18, 2019

It’s Time for Tobacco 21


A December 19 “teen vaping epidemic” presentation by U.S. Surgeon General Jerome Adams at the University of Texas MD Anderson Cancer Center was particularly noteworthy for one passage (here): 



“We want the science to be an important part of that policy discussion.  I think the science is clear that raising the age of which youth can purchase these tobacco products to 21 has clear public health benefits.  There’s no doubt about that.  The science part of this policy equation is clear: Tobacco 21 works.”



To my knowledge, this is the first time the Surgeon General has publicly supported Tobacco 21.  Perhaps his landmark endorsement will prompt Congress to legislate that the minimum age for tobacco purchase match that for alcohol.



There are compelling reasons to make Tobacco 21 the law of the land.  First and foremost, it would delegitimize tobacco sales to 18-year-old high school students.  While they constitute 14% of all high school students, they account for one-quarter of high school smokers and smoker-vapers (here).  Legal buyers – not manufacturers and retailers – are the primary source for tobacco products used by underage high schoolers (here).



Another argument for Tobacco 21 is the track record of Alcohol 21, which was adopted by all states by 1988 (here).  There is no doubt this law has played an important role in the decline of high school drinking and binge-drinking (trend here), even though current prevalence is far from optimal.



I have to acknowledge my discomfort with treating 18-20-year-olds as children, but the Tobacco 21 website provides this persuasive information:



“For 600 years of English common law and throughout most of U.S. legal history, the age of 21 was regarded as the age of full adult status.  Until 1971 the legal minimum voting age was 21 and many states maintained age 21 as their legal drinking age.  It was not until the Vietnam War with the unpopular, forcible draft of disenfranchised 18-year-olds, that the age to vote in the U.S. was shifted downward to 18 by the 26th Amendment to the U.S. Constitution.  During that period 25 states also moved to reduce the age to purchase and consume alcoholic beverages.  The result was a dramatic increase in highway crashes, injuries and deaths caused by intoxicated drivers in the 16-20 age group.”



Data from the National Highway Traffic Safety Administration reveals that in 1988 there were 10,200 drivers age 16-20 years involved in a fatal accident, and 25% of them had a blood alcohol concentration (BAC) of 0.08% or higher (here).  By 2016 the number of drivers in that age group involved in fatal accidents was 4,400, and 15% had a BAC of 0.08% or higher.  Alcohol 21 is only one of many factors that contributed to that reduction, and those numbers are still unacceptably high, but the trend suggests that Tobacco 21 will result in a reduction in teen tobacco use.



Tobacco 21 has been endorsed by most major medical organizations (here), and it has been adopted by six states: Hawaii (2015), California (2016), New Jersey (2017), Oregon (2017), Maine (2017) and Massachusetts (2018) (here).  While the remaining states could adopt Tobacco 21 at will, congressional action would have a more immediate, profound effect in limiting high school students’ access to tobacco products.





Friday, January 11, 2019

Intolerable False Statements by FDA’s Mitch Zeller


Mitch Zeller, director of the FDA Center for Tobacco Products, should stop making false statements about smokeless tobacco.

The FDA earlier this week expanded its smokeless tobacco campaign, arranging a series of interviews for Zeller (example here), whose script included two provably false statements.

   “Every year more then [sic] 2,000 new [mouth or throat] cancer [cases] are diagnosed in the United States solely caused by smokeless tobacco use.”

This number is a pure fabrication.  No medical authority, including the FDA, has ever produced such a figure, which is more than 50% higher than the agency’s estimate of two years ago (here). Even that number was a gross exaggeration, due to a serious technical error confusing the historical risks of dip and chew (essentially zero) favored by American men with the higher risks of dry powdered snuff preferred by women (here).

The Zeller number is further undercut by last year’s American Cancer Society report which omitted smokeless tobacco as a cause of cancer (here).   

Zeller also produced this false statement in his latest publicity tour:

2.     …“a white spot inside your lip or gum that you know if you’re seventeen eighteen years old and you see that and you don't pay any attention to it, it can progress to things like cancer.”

A white patch, as I have documented (here), is simply a reaction to the irritating effect of the tobacco, similar to the development of calluses on a worker’s hand.  The link between white patches and cancer is virtually zero for dippers and chewers.

As director of an FDA center, Zeller has a profound responsibility to enhance public health and adhere to scientific truth.  He damages his own credibility and that of his agency by making false statements. 

Wednesday, January 9, 2019

The War Against Vaping: Déjà Vu All Over Again


A document in the University of California San Francisco tobacco industry archives describes the hostile reaction in 1995 to my smokeless tobacco harm reduction strategy for smokers (here).  Opponents used messaging they would later redeploy against e-cigarettes: (1) all tobacco is dangerous, (2) medicines work, so substitutes aren’t needed, and (3) the children.

In a CNN “Your Health” segment on October 21, 1995, correspondent Loretta Lepore “met a doctor who actually prescribes tobacco pouches as a way to satisfy the craving for nicotine without lighting up.”

Lepore: “One, two, the count climbs to forty-six million U.S. smokers.  Charles Mayfield, a genetic cancer researcher was one, until his toddler demonstrated the error of his way.”

Mayfield: “He used to walk around with a piece of paper rolled up like a cigarette…And, I mean, that had a devastating effect on me and my conscience.”

Lepore: “Mayfield quit smoking, but he hasn’t overcome his nicotine addiction.  Now he gets his fix from smokeless tobacco.”

Dr. Brad Rodu: “It’s a discreet, paper pouch that fits invisibly between the cheek and gum.”

Lepore: “Oral pathologist Brad Rodu recommends all smokers make the switch.  He says it’s the smoke that causes fatal lung and heart disease.”

Mayfield: “I’m using smokeless tobacco right now, and no one can even tell.”

Lepore: “While the use of smokeless tobacco socially acceptable to some, many view Rodu’s approach as medically unacceptable.”

Dr. Scott Tomar (CDC): “To recommend to smokers that they switch to smokeless tobacco is simply maintaining their addiction.”

Lepore: “Instead, Tomar recommends an already approved nicotine replacement therapy.”

Tomar: “Nicotine patch and gum, both have been found to be effective in treating nicotine addiction.”

Rodu: “Nicotine patch and gum don’t provide nearly the same level, or nearly the same spike that smokers crave, and so are not effective for many smokers [Note: “ineffective” is more accurate, here and here]

Lepore: “And there’s another concern.”

Dr. Clark Heath (American Cancer Society): “Smokeless tobacco carries with it a sharply increased risk of cancer.” [Totally wrong with respect to dip and chew here]

Lepore: “A four to five fold increase over non-smokers.  Aside from health concerns, Dr. Rodu’s critics are also raising ethical questions about his approach.  Mainly, should doctors be advising patients to choose another addiction?  And if a patient gets sick from smokeless tobacco, is the doctor legally responsible?”

Rodu: “Since when is it unethical to reduce the smoker’s risk for all tobacco-related diseases, including oral cancer?”

Lepore: “A 1981 study published in the New England Journal of Medicine says 26 out of 100,000 smokeless tobacco users contract oral cancer each year.  The five-year survival rate for oral cancer is 50 percent.  In part, because it’s easier to detect than lung and other forms of cancer.  So according to Dr. Rodu’s theory, if all smokers switch to smokeless tobacco, the United States would see 6,000 cancer deaths each year [Note: this was a gross overestimate, based on falsified research, here and here], versus 420,000 smoking-related deaths reported annually.”

Lepore: “Dr. Donald Miller, an oncologist and Rodu colleague at the University of Alabama at Birmingham.”

Miller: “I have wondered many times why I didn’t think of this.  It is an outstanding idea that really has the opportunity to change the way society thinks about cancer risk.”

Lepore: “Critics say there’s also the risk non-smokers, especially teenagers, will start using smokeless tobacco, perceiving it to be safe.  But Dr. Rodu stresses his approach is for smokers only.”

This transcript was circulated by Vincent Gierer, Chairman of the Board and CEO of US Tobacco, to employees of the world’s largest smokeless tobacco company in 1995.  Gierer challenged the baseless claims that my research was an industry ploy:

“Obviously, Dr. Rodu’s thesis may cause considerable controversy, since some people may view his advice as favorable to our Company and our products.  Whatever your personal opinion of his thesis may be, I want to make clear the Company’s position regarding Dr. Rodu’s [book] publication.  The Company’s longstanding policy is not to make health claims about its products, nor to comment on health claims regarding other tobacco products.”