Wednesday, June 8, 2022

There Never Was a Tobacco/Nicotine Addiction “Secret”


Mitch Zeller, former director of the FDA Center for Tobacco Products, provided valuable insights on the war against tobacco harm reduction in a May 19 presentation at the Johns Hopkins University Bloomberg School of Public Health.  His slide presentation is available here.

Zeller justifies tobacco regulation primarily on perceived industry misdeeds, which he illustrates with quotes from the 1960s, 70s and 80s from industry documents: “Tobacco products uniquely contain and deliver nicotine, a potent drug with a variety of physiological effects,” “Nicotine is addictive,” “Think of a puff of smoke as the vehicle of nicotine.”

Zeller implied that corporate executives knew but covered up critical nicotine facts, like nicotine was the active, addictive ingredient in tobacco.

Everybody knew about the nicotine addiction “secret.” 

Nicotine is one of the most thoroughly studied drugs in the history of medicine. A mere 80 years after Columbus discovered tobacco and the New World in 1492, crude nicotine was isolated and identified.  It was chemically purified in 1828, and its molecular formula was determined in 1843.  British scientists described the effects of nicotine on the nervous system as early as 1889.  From the 1930s to the 1950s, many medical authorities already considered tobacco use to be habit-forming or addictive. In 1936, tobacco use was described as “a form of drug addiction, even though a pleasant one, not affecting criminal statistics.”

In 1942, L. M. Johnston conducted some remarkable experiments where nicotine was successfully injected into smokers to satisfy their cigarette cravings.  Johnston reported these findings in the renowned British medical journal The Lancet, where he also discussed nicotine tolerance, craving and withdrawal symptoms, concluding: “Clearly the essence of tobacco smoking is the tobacco and not the smoking. Satisfaction can be obtained from chewing it, from snuff-taking, and from the administration of nicotine.”

By the 1950s, the topic of nicotine addiction had moved beyond medical journals to books for the general public.  The Habit of Tobacco Smoking (by W. Koskowski, Staples Press Ltd.) appeared in 1955, followed in 1959 by A. King's The Cigarette Habit: A Scientific Cure (Doubleday and Co.).

During the 1960s and 1970s, when, according to anti-tobacco zealots, suppression of tobacco industry research on nicotine peaked, nicotine was the subject of thousands of independent research articles. Medline, the National Library of Medicine's computerized data base, lists 1,000 such studies between 1966 and 1976. The number increased to 1,500 in the period from 1976 to 1984, and to nearly 4,000 during the next decade. Many of the 1970s and 1980s research reports provided scientific validation of what smokers had been saying for nearly a century:

It's hard to quit smoking.



Wednesday, June 1, 2022

FDA Commissioner Misleads with Grossly Inaccurate Tobacco & Vaping Tweet


FDA Commissioner Dr. Robert Califf on May 27 tweeted a grossly inaccurate statement (here): “I worry that our academic centers & professional societies are not activated enough on the tobacco issue.  Almost 500,000 Americans will die this year from tobacco related illness and millions of teenagers are becoming addicted to nicotine through vaping.”

There is no evidence that vaping is enslaving “millions of teenagers.”  The number of high school students who reported vaping in the past 30 days in 2021 was 1.72 million (here), a 58% reduction from the peak of 4.1 million in 2019.  Additionally, not all of these teens are or were “addicted”, as the majority in both years used e-cigarettes infrequently.  Only 467,000 in 2021 had not used cigarettes or other tobacco and had vaped 20+ days, which is the baseline for even considering addiction.

As to the commissioner’s assertion that “Our academic centers & professional societies are not activated enough on the tobacco issue,” the FDA Center for Tobacco Products transfers to the National Institutes of Health $200-300 million annually – funds that end up in the coffers of those “academic centers & professional societies,” and that’s on top of the massive NIH annual budget allotment for tobacco research (here and here).  This network of heavily funded academicians is hyperbolically active in producing articles and press releases that exaggerate and distort vaping risks, especially in comparison to smoking, which actually does kill some 500,000 Americans each year. 

Dr. Califf, a cardiologist, is absolutely wrong in using the term “tobacco” when he refers to cigarette smoking.  When he tweets about COVID-19, he focuses on that virus and its variant; he doesn’t say RNA virus (here).  When he tweets about the infant formula crisis, he focuses on Abbott Nutrition’s deficiencies, not on the product category (here).  It is crystal clear that the commissioner knows the difference between various tobacco products, as seen in his agency’s April 28 tweet announcing its menthol and flavor bans for cigarettes and cigars (here).     

Health organizations have been conflating “tobacco” and “cigarette smoking” in their public statements for years (here, here and here), but those organizations are faceless.  Dr. Califf is a physician and the commissioner of the federal agency that regulates products accounting “for about 20 cents of every dollar spent by U.S. consumers.” (here)  He should not be tweeting misinformation, especially when on April 29 he tweeted, “I believe that misinformation is now our leading cause of death, and we must do something about it.” (here)

Indeed, the FDA commissioner must do something about it.



Tuesday, May 24, 2022

Population Evidence For & Against Menthol Addictiveness


Last week I reviewed the FDA’s evidence concerning menthol’s possible role in furthering addiction, as discussed in the agency’s proposed menthol ban.  I noted that the FDA rationale “is primarily based on nicotine and menthol experiments on rats and mice, plus laboratory tests on tissue samples.  The FDA presents no evidence for menthol’s effects on actual smokers.”

One individual responded to my post by arguing that evidence shows that menthol can enhance addictiveness in humans; they provided a link to a single study.

There is, in fact, considerable population-based evidence of the effects of menthol smoking on addiction in humans, but the FDA failed to cite any of that, likely because the evidence is entirely contradictory.  While some studies show that menthol enhances addictiveness, other studies indicate the opposite.  A single study sometimes offers both positive and negative findings.

The FDA conducted its own review (available here) of the literature on this subject, spanning the period 1980 to April 30, 2021.  In its proposed ban, the FDA published these conclusions:

“The weight of evidence supports that the sensory effects of menthol contribute to positive smoking experiences that facilitate repeated use. Evidence also supports that menthol in
cigarettes is associated with progression to regular cigarette smoking in youth and young adults and greater dependence in youth. However, evidence is not sufficient to support a conclusion of an association of menthol in cigarettes with dependence among adults due to inconsistent findings.  Similarly, evidence is not sufficient to support a conclusion of an association of menthol in cigarettes with altered smoking topography. In the case of cessation, the weight of evidence suggests that menthol in cigarettes is likely associated with reduced cessation success in the general population and is associated with reduced cessation success among Black cigarette smokers.”

Thus, even the FDA acknowledges the lack of convincing evidence to support an outright menthol ban.  While the agency points to effects in youth and young adults, smoking has almost disappeared among both groups (here and here). 

More mixed results have been published since the FDA’s April 2021 research cut-off, including a comprehensive review that found:

“Forty-three demographically adjusted studies (22 rated 'good', 20 rated 'fair', and one study rated 'poor' individual study quality) comparing menthol and non-menthol smokers were qualitatively synthesized across the following measures (study count; strength of evidence): duration of abstinence (2; low); quit attempts (15; insufficient); rate of abstinence/quitting (29; moderate); change in smoking quantity/frequency (5; insufficient); and, return to smoking/relapse (2; insufficient). Overall, the qualitative synthesis failed to show a consistent trend for an association between menthol cigarette use and smoking cessation across outcomes. Meta-analyses found no difference between menthol and non-menthol cigarette use and either quit attempts or abstinence.” (emphasis added)

The population evidence is clear: The addictive action of menthol remains ambiguous.