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.”

Friday, December 28, 2018

Vaping Is Not the Real Health & Safety Threat in Kentucky High Schools


Foundation for a Healthy Kentucky (FHK) and Kentucky Youth Advocates (KYA) recently launched a campaign to discourage e-cigarette use by youth (here).  KYA executive director Dr. Terry Brooks predicted that “unless we as a commonwealth treat e-cigs as the health threat it is — in terms of now and in the future — then in 2038, Kentucky will still be the cancer capital of the nation.”  According to Ben Chandler, FHK chairman and CEO, “the fact that youth e-cig use is often a gateway to cigarette smoking makes immediate action imperative.”

Does evidence support the claim that e-cigarettes are a gateway to cigarettes? No.  Since the campaign cites the biennial Kentucky Youth Risk Behavior Survey, I have used KYRBS data to illustrate smoking and vaping among high school students in the Commonwealth from 2005 to 2017.

The chart at left shows that current (past-30-day) smoking declined from 26% in 2005, to 24% in 2011.  E-cigarettes were not widely available during that period.  In contrast, during the e-cigarette era (2011 to 2017), current smoking dropped from 24% to 14%.  The prevalence of current vaping, collected only in the latter two years, was 23% and 14% respectively. 

With the data showing show an unprecedented decline in smoking rates, there is no e-cigarette crisis among Kentucky high schoolers. 

KYA asserts that they “are laser-like in our efforts to…protect kids from abuse and neglect,…help kids grow up healthy and strong…” (here)  If that’s the case, they shouldn’t ignore behaviors that are far more dangerous than vaping.  For example, 27% of Kentucky high schoolers were current drinkers, 13% were current binge drinkers, and 16% were current marijuana users.  Additionally:


Prevalence (%) of Risky Behaviors Among Kentucky High School Students (KYRBS, 2017)


Past 30 Days


Rarely/never wore a seatbelt (as an occupant)9%
Rode with driver who had been drinking14%
Drove after drinking4%
Texted or emailed while driving35%
Carried a weapon (e.g. gun, knife, club)21%


Past 90 Days
Had sexual intercourse29%
..…and used condom, 51% of previous


Past Year


Involved in physical fight21%
Physically bullied on school property21%
Electronically bullied18%


Felt sad or hopeless29%
Considered suicide15%
Made suicide plan13%
Attempted suicide8%

Kentucky health organizations should stop obsessing about a mythical high school vaping crisis and focus instead on stopping other behaviors and activities that State data define as immediate health and safety threats.