No Guardrails in JAMA for Tobacco Prohibitionists

 

In the July issue of JAMA, Robert Jackler and Pamela Ling discussed Medscape’s agreement with Philip Morris International to produce continuing medical education on tobacco harm reduction. I objected to their screed in a letter to the JAMA editor, noting that Jackler/Ling made false claims about the course content and about me personally. I underscored that JAMA’s stated goal is, “To maintain the highest standards of editorial integrity and quality independent of any special interests,” and, “To foster responsible and balanced debate on important issues that affect medicine, health, health care, and health policy.”

Flouting those hallowed goals, three and a half months later my letter was rejected.  Here it is in full.

The Viewpoint article by Robert Jackler and Pamela Ling criticizes a financial agreement whereby Philip Morris International (PMI) paid Medscape to produce free continuing medical education programs on tobacco harm reduction (1).  I am writing because I designed the course material they incorrectly criticized, and because they twice mischaracterized me as “tobacco conflicted.”

Jackler and Ling write in error that my 1994 study in Nature (2) found “no added mortality from oral tobacco use.” My colleague and I doubled the conventional risk for oral cancer and applied it to male smokeless tobacco (ST) users age 35+ years; the average loss in life expectancy was 15 days, compared with a loss of eight years for smokers. Furthermore, a 2016 study in the American Journal of Epidemiology by over 20 government-funded coauthors revealed that American men who used moist snuff or chewing tobacco had no excess risk for oral cancer (3).   

Page 24 of Jackler and Ling’s supplement documents that they err repeatedly by writing, “This course states chewing tobacco has ‘no significant risk of mouth, lung and other cancers, heart disease or stroke,’ citing a much criticized 2002 review by a tobacco-conflicted course faculty member…”  First, they omit ‘emphysema’ from the quote.  Second, it was ST, not chewing tobacco.  Third, I didn’t cite my 2002 review (4), and that review wasn’t “much criticized;” I cited two other studies (5,6).

Jackler and Ling complain that my “expert opinion” disagreed with the CDC’s claim that “Nicotine can harm brain development…until about age 25.” (7).  They cite a review containing “a sizable body of human data (8),” but it actually contains no evidence of harm to brain development among human smokers, which is not surprising, as none exists.  There are 29 million current and 56 million former smokers in the U.S., the vast majority started as teens.  No study has ever demonstrated that their brain development was harmed by nicotine.

­­­­­­­­Jackler and Ling claim without citation that course faculty highlighted “controversial reviews from the UK stating that e-cigarettes are 90-99% safer.”  Instead, as their supplement reveals, I said that the harms of vaping are unlikely to exceed 5% of smoking, and I provided citations to reports from Public Health England (9) and the British Royal College of Physicians (10), one of the world’s oldest and most prestigious medical societies.

Jackler and Ling are correct on one point.  My statement, “The health goal for all smokers should be smoke-free, not tobacco/nicotine abstinent,” is “remarkable,” because 480,000 American smokers are dying prematurely every year due to the smoke, not the nicotine.

 

 

 

References

1. Jackler RK, Ling PM.  The tobacco industry has no business funding continuing medical education.  JAMA. 2024. Published online July 08, doi:10.1001/jama.2024.9241

2. Rodu B, Cole P.  Tobacco-related mortality.  Nature. 1994;370:184,  https://pubmed.ncbi.nlm.nih.gov/8028661/

3. Wyss AB, Hashibe M, Lee Y-C, Chuang S-C, Muscat J, Chen C et al. Smokeless tobacco use and the risk of head and neck cancer: pooled analysis of US studies in the INHANCE consortium. Am J Epidemiol. 2016;184(10):703-716. doi: 10.1093/aje/kww075.  

4. Rodu B, Cole P.  Smokeless tobacco use and cancer of the upper respiratory tract.  Oral Surgery, Oral Medicine, Oral Pathology. 2002;93:511-515,  https://pubmed.ncbi.nlm.nih.gov/12075196/

5. Rodu B, Plurphanswat N.  Mortality among male smokers and smokeless tobacco users in the U.S. Harm Reduction Journal. 2019;16:50. https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-019-0321-7

6. Fisher M, Tan-Torres SM, Gaworski CL, Black RA, Sarkar MA. Smokeless tobacco mortality risks: an analysis of two contemporary nationally representative longitudinal mortality studies. Harm Red J. 2019;16:27. https://doi.org/10.1186/s12954-019-0294-6.

7. Centers for Disease Control and Prevention.  Health effects of vaping. May 15, 2024  https://www.cdc.gov/tobacco/e-cigarettes/health-effects.html

8. Castro EM, Lotfipour S, Leslie FM. Nicotine on the developing brain. Pharmacol Res. 2023;190:106716. doi:10.1016/j.phrs.2023.106716

9. Public Health England.  E-cigarettes: an evidence update. A report commissioned by Public Health England.  August 2015 https://assets.publishing.service.gov.uk/media/5b6c3f57ed915d30f140f822/Ecigarettes_an_evidence_update_A_report_commissioned_by_Public_Health_England_FINAL.pdf

10. Royal College of Physicians.  Nicotine without smoke: Tobacco harm reduction.  2019 https://www.rcp.ac.uk/improving-care/resources/nicotine-without-smoke-tobacco-harm-reduction/

 

 

 

FDA Briefs U.S. Supreme Court on the Nicotine Brain Fallacy

Responding to a petition from the FDA, the Supreme Court agreed to review the Fifth Circuit Court of Appeals decision in the Triton case (formally known as Wages & White Lion Investments, LLC).  The Circuit Court, sitting en banc, had found that the FDA failed to follow proper administrative procedures in considering Triton’s vaping pre-market tobacco application (PMTA), and the agency’s denial order was vacated.

Appealing that decision, the FDA filed a brief to the Supreme Court, available here.  I will not comment on the myriad legal and regulatory implications of the case, but in their “scientific” discussion, lawyers for the FDA made numerous false statements about nicotine and e-cigarettes, such as:

“Nicotine is a highly addictive drug that can harm the developing adolescent brain.  Studies have found that e-cigarette use may be associated with diseases such as asthma, chronic bronchitis, emphysema, and chronic obstructive pulmonary disease.  And e-cigarette users may progress to conventional tobacco products, which can endanger human health even more.” (emphasis added, legal references removed)

I have repeatedly warned the tobacco harm reduction (THR) community that the NIH-funded bad-science tsunami would result in federal and state regulations aimed at stifling safer cigarette substitutes (here, here and here).  Now we have a concrete example.

Over the years, I have exposed distorted and false research findings concerning e-cigarette use and respiratory conditions (here, here and here), so today I will focus on the nicotine brain fallacy, which I first discussed four years ago (here):

“Let me be crystal clear.  The harm in brain development federal officials talk non-stop about only happens in laboratory torture of mice.  Mouse studies are well known to be of questionable value in predicting human effects.  There is absolutely no scientific evidence to support the claim that nicotine causes harm to human brain development, so it is astounding that federal officials traffic in this false narrative.  This nonsense is an affront to 34 million adult current smokers and 55 million former smokers in the U.S., virtually all of whom started when they were teenagers.  There is no evidence that their brain development was harmed.”

The facts remain the same today, and still the unfounded attacks on THR continue. For example, the Journal of the American Medical Association (JAMA) recently published a viewpoint authored by tobacco prohibitionists Robert Jackler and Pamela Ling (here).  Criticizing Medscape for creating continuing medical education courses on THR, they also attacked my design of the course content, complaining that my “expert opinion” conflicts with the CDC’s claim that “nicotine can harm brain development…until about age 25.”  They cited a review that purportedly contains “a sizable body of human data,” but that treatise actually offers no evidence of harm to brain development in human smokers.  The fact is that no study has ever demonstrated that human brain development is harmed by nicotine. 

It is a travesty that bad science and fraudulent claims against THR have persisted for so long. No court, including the Supreme Court, is likely to end the onslaught of misinformation that remains the hallmark of the powerful, government-funded tobacco prohibition movement.