Tuesday, April 16, 2024

Are Vape Aerosols Really Toxic?


My readers know that I have focused on exaggerated or fraudulent population-based research on vapor products.  But anti-tobacco crusaders have also published numerous studies, predominantly funded by the National Institutes of Health, that widely exaggerate the toxicity of vape aerosols and, through university press releases taken up verbatim by uncritical media, spread like an uncontrollable virus. 

There is an antidote, in the form of Dr. Roberto Sussman, an astrophysicist based at the Institute of Nuclear Sciences, National Autonomous University of Mexico.  He offers the following review that I am proud to post.  BR


The easy publication and wide media diffusion of questionable and unreliable studies is a widespread phenomenon that generates the misperception that e-cigarette aerosols are much more toxic than the evidence shown by well-designed and conducted studies.

Dr Califf has apparently ignored three extensive reviews:

  • Soulet, S. and Sussman, R.A. Critical Review of the Recent Literature on Organic Byproducts in E-Cigarette Aerosol Emissions.  Toxics, 10, 714.
  • Soulet, S. and Sussman, R.A. Critical Review of Recent Literature on Metal Contents in E-Cigarette Aerosol. https://www.mdpi.com/2305-6304/10/9/510 Toxics, 10, 510.
  • Sussman, R.A., Sipala, F., Emma, R., and Ronsisvalle, S. Aerosol Emissions from Heated Tobacco Products: A Review Focusing on Carbonyls, Analytical Methods, and Experimental Quality. Toxics 2023, 11, 947.

The reviews provide a critical evaluation of 65 emission studies published between 2018 and 2022 (12 on metals, 36 on organic byproducts and 17 on heated tobacco products, HTPs). The first 2 reviews concern the presence of metals and organic byproducts in e-cigarette aerosols.

To evaluate the 65 reviewed studies, my colleagues and I considered the following 5 conditions of experimental quality: (1) reproducibility and replicability of experiments; (2) consistency between supplied power, coil resistance, airflow rate and puffing parameters; (3) tested devices must be in good conditions; (4) appropriate evaluation of exposure and (5) analytic methods.

We show in the e-cigarette reviews that all studies reporting high levels of toxicants (metals or organic in comparison with toxicological markers) exhibit moderate to severe flaws of experimental design, failing to comply with at least 3 of the 5 quality conditions, making their toxicity assessments either questionable or completely unreliable. As a contrast, all studies complying with (at least) 4 of the 5 quality conditions reported low toxicity levels (below toxicological markers and way below tobacco smoke). Our HTP review showed that all except 2 of the studies (9 industry-funded and 8 independent), are reliable. We also comment and criticize various claims that question the relative safety of HTP aerosols in reference to tobacco smoke. 

We believe that these reviews completely demolish all claims of alleged high toxicity of vape aerosols, particularly pronouncements like “contain toxic compounds,” some of which constitute rhetoric devoid of evidence or in some cases they are based on studies that we documented are unreliable.

There are numerous questionable and/or unreliable studies – all funded by the NIH and other public institutions in the US – that are widely cited in order to promulgate the sense of a toxic crisis.  Here are some of the worst offenders (citation numbers taken from Google Scholar):

Olmedo, P., Goessler, W., Tanda, S., Grau-Perez, M., Jarmul, S., Aherrera, A., ... & Rule, A. M. (2018). Metal concentrations in e-cigarette liquid and aerosol samples: the contribution of metallic coils. Environmental health perspectives, 126(2), 027010.  329 citations

Bitzer, Z. T., Goel, R., Reilly, S. M., Elias, R. J., Silakov, A., Foulds, J., ... & Richie Jr, J. P. (2018). Effect of flavoring chemicals on free radical formation in electronic cigarette aerosols. Free Radical Biology and Medicine, 120, 72-79. 151 citations

Kim, S. A., Smith, S., Beauchamp, C., Song, Y., Chiang, M., Giuseppetti, A., ... & Kim, J. J. (2018). Cariogenic potential of sweet flavors in electronic-cigarette liquids. PloS one, 13(9), e0203717. 109 citations

Zhao, D., Navas-Acien, A., Ilievski, V., Slavkovich, V., Olmedo, P., Adria-Mora, B., ... & Hilpert, M. (2019). Metal concentrations in electronic cigarette aerosol: Effect of open-system and closed-system devices and power settings. Environmental research, 174, 125-134.  94 citations

Bitzer, Z. T., Goel, R., Reilly, S. M., Foulds, J., Muscat, J., Elias, R. J., & Richie Jr, J. P. (2018). Effects of solvent and temperature on free radical formation in electronic cigarette aerosols. Chemical research in toxicology, 31(1), 4-12. 88 citations

Son, Y., Mishin, V., Laskin, J. D., Mainelis, G., Wackowski, O. A., Delnevo, C., ... & Meng, Q. (2019). Hydroxyl radicals in e-cigarette vapor and e-vapor oxidative potentials under different vaping patterns. Chemical research in toxicology, 32(6), 1087-1095. 67 citations 

Son, Y., Bhattarai, C., Samburova, V., & Khlystov, A. (2020). Carbonyls and carbon monoxide emissions from electronic cigarettes affected by device type and use patterns. International journal of environmental research and public health, 17(8), 2767. 64 citations

Ooi, B. G., Dutta, D., Kazipeta, K., & Chong, N. S. (2019). Influence of the e-cigarette emission profile by the ratio of glycerol to propylene glycol in e-liquid composition. ACS Omega 4 (8): 13338–13348, PMID: 31460462. 62 citations

Korzun, T., Lazurko, M., Munhenzva, I., Barsanti, K. C., Huang, Y., Jensen, R. P., ... & Strongin, R. M. (2018). E-cigarette airflow rate modulates toxicant profiles and can lead to concerning levels of solvent consumption. ACS omega, 3(1), 30-36. 60 citations

Tehrani, M. W., Newmeyer, M. N., Rule, A. M., & Prasse, C. (2021). Characterizing the chemical landscape in commercial e-cigarette liquids and aerosols by liquid chromatography–high-resolution mass spectrometry. Chemical research in toxicology, 34(10), 2216-2226.  57 citations 

El-Hellani, A., Al-Moussawi, S., El-Hage, R., Talih, S., Salman, R., Shihadeh, A., & Saliba, N. A. (2019). Carbon monoxide and small hydrocarbon emissions from sub-ohm electronic cigarettes. Chemical research in toxicology, 32(2), 312-317. 48 citations

Fowles, J., Barreau, T., & Wu, N. (2020). Cancer and non-cancer risk concerns from metals in electronic cigarette liquids and aerosols. International journal of environmental research and public health17(6), 2146. 47 citations

Williams, M., Li, J., & Talbot, P. (2019). Effects of model, method of collection, and topography on chemical elements and metals in the aerosol of tank-style electronic cigarettes. Scientific Reports9(1), 13969. 46 citations

Here are two studies (one of them cited above) with misleading conclusions that have been widely cited, while corresponding articles dealing with their deficiencies have been ignored.

Misleading: Williams, M., Villarreal, A., Bozhilov, K., Lin, S., & Talbot, P. (2013). Metal and silicate particles including nanoparticles are present in electronic cigarette cartomizer fluid and aerosol. PloS one8(3), e57987. 825 citations

Ignored: Farsalinos, K. E., Voudris, V., & Poulas, K. (2015). Are metals emitted from electronic cigarettes a reason for health concern? A risk-assessment analysis of currently available literature. International journal of environmental research and public health, 12(5), 5215-5232. 118 citations

Misleading: Olmedo P, Goessler W, Tanda S, et al. Metal Concentrations in e-Cigarette Liquid and Aerosol Samples: The Contribution of Metallic Coils. Environ Health Perspect. 2018 Feb 21;126(2):027010. doi: 10.1289/EHP2175. PMID: 29467105; PMCID: PMC6066345. 329 citations

Ignored: Farsalinos KE, Rodu B. Metal emissions from e-cigarettes: a risk assessment analysis of a recently-published study. Inhal Toxicol. 2018 Jun-Jul;30(7-8):321-326. doi: 10.1080/08958378.2018.1523262. Epub 2018 Nov 2. PMID: 30384783. 15 citations

Another important distinction between the last two articles can be seen by their Altmetrics Score, which is a measure of how much attention they have received.  The Altmetrics Score of the Olmedo et al article is 46,891.  In contrast, the score of the article by Farsalinos and Rodu is 139.

Stay tuned.  We have submitted a review of 98 studies (some widely cited) that have tortured cells/rodents by exposing them to overheated and carbonyl-loaded aerosols, which evidently renders their assessment of vaping safety totally unrealistic and unreliable.

The articles I have highlighted represent just the tip of the anti-tobacco harm reduction iceberg that is killing smokers all over the world.

Thursday, April 11, 2024

Harm Reduction in the U.S.: Center Stage (Narcotics) and End Stage (Tobacco)


The International Drug Policy Consortium (IDPC) “is a global network that works collectively to promote person-centred, rights-affirming drug policies at the national, regional and international levels.”  The IDPC published a summary of the 67th session of the United Nations Commission on Narcotic Drugs, which ended March 22, reporting that “member states resorted to voting on resolutions for the first time in modern history, and finally included the words ‘harm reduction.’”

The entire summary is worth reading, but I want to point out what it describes as a transformative moment for American representatives:

“All eyes then turned to the overdose prevention resolution from the USA – signalling their 180-degree transformation on harm reduction at the UN, driven by the appalling human toll of a domestic overdose epidemic (quite a shift given that, for decades, the USA have been the most vociferous barrier to this term being accepted in Vienna).”

Yes, you read that correctly.  Due to drug overdose deaths totaling over 100,000 every year, per the CDC, the U.S. is finally endorsing harm reduction for opioids and other killers.

With that turnaround, you might think that the Biden administration would consider harm reduction for cigarettes, which have killed 480,000 users every year for decades.  Like those smokers, you would be dead wrong.



Tuesday, April 2, 2024

Tobacco Harm Reduction Is A Life-Saving Policy, No Matter Who Promotes It


Dr. Joanna Cohen recently authored a misleading and factually incorrect commentary on tobacco harm reduction in The Hill.  Here is my rebuttal, in bold.

Cohen: “So why should we trust cigarette companies to help reduce tobacco use?”

No one trusts cigarette companies.  That’s why Congress gave the Food and Drug Administration regulatory authority over tobacco in 2009.  Cohen misrepresents the principle public health goal, which isn’t to reduce tobacco use, but to prevent the 480,000 premature American deaths that result each year from smoking. That number hasn’t appreciably changed for the 15 years the FDA has had regulatory authority.

Cohen: “For the last several years, the tobacco industry has been co-opting the term ‘harm reduction’ from public health, using it to frame electronic devices and e-cigarettes as the be-all, end-all of smoking cessation tools.”

False.  Harm reduction wasn’t co-opted, because Cohen and most public health officials never applied it to tobacco.  They insisted that smokers quit only through total nicotine and tobacco abstinence.  Conversely, cigarette manufacturers did ultimately acknowledge that their products were deadly, and that there were vastly safer smoke-free ways to consume nicotine.  In the mid-2000s, they started acquiring smokeless tobacco companies, which produced those safer products, and more recently, pushed by disruptive technology and new competitors, they adopted vapor and heat-not-burn tobacco products, which are also significantly safer than cigarettes.

Cohen and company are the only ones calling e-cigarettes “the be-all, end-all of smoking cessation tools.”  They seemingly forget that only 5% of all smokers achieve nicotine/tobacco abstinence in any given year. 

Cohen: “Such [harm reduction] methods include restricting tobacco advertising and promotion, increasing the price of tobacco products, and establishing 100 percent smoke-free public spaces. These all support people who are ready to quit without requiring abstinence.”

How do those steps support people who are ready to quit without requiring nicotine abstinence?  Cohen merely recycles failed measures that limit smokers’ options of ‘quit or die.’       

Cohen: “It is critically important, however, to note that, to date, no company in the U.S. has sought out FDA authorization to market these products as approved cessation devices.”

No, it’s not.  Authorization as a cessation device would not be handled by the FDA tobacco center, but by the drugs or medical device centers.  The FDA approved nicotine medications decades ago, even though, to meet FDA requirements for approval, they’re expensive and ineffectively low-dose, require warnings far greater than those on cigarettes, and don’t provide the nicotine spike that smokers get when they light up.  With a regulatory framework like this, no wonder nicotine medications are successful for only about 7% of smokers who try them. For what other medications does the FDA accept a 93% failure rate?  Let alone medications to treat a condition that will unnecessarily kill 480,000 Americans this year.  It is outrageous that the agency and most of the public health community promotes this failed strategy when safer, popular harm reduction tools are readily at hand.

Cohen: “…enabling tobacco to remain the leading preventable cause of death around the world.” 

Cohen knows that tobacco is not a synonym for smoke, but she repeats the egregious conflation, proving again she chooses to ignore that nicotine is the reason people smoke, but not the reason that smokers die.

Cohen: “tobacco industry allies baselessly position e-cigarettes and heated tobacco products as the only viable harm reduction method for people who want to stop smoking. They discount existing FDA-approved cessation methods entirely.”

This statement is full of falsehoods.  Tobacco harm reduction proponents are not industry allies; they are allies of those 480,000 smokers who will die prematurely this year.  The FDA-approved cessation methods Cohen et al. diss have only a woeful 7% percent success rate, as noted above.  Many other alternatives to cigarettes are already available, and many others are under development.

Cohen: “…we know that nicotine can still be extremely addictive.”

Yes, nicotine can be addictive, which is why her goal of nicotine-and-tobacco abstinence is so misguided.  Harm reduction proponents recognize that many smokers cannot achieve Cohen’s abstinence nirvana, so they promote practical solutions that save lives.

Cohen: “a whole new generation of consumers, including children and young people enticed by appealing flavors, who may spend the rest of their lives trying to curb a nicotine addiction.”

Everyone shares Cohen’s concern for children, and society should discourage them from adopting dangerous adult behaviors.  If Cohen was consistent, however, she would call for sanctions on companies selling alcohol, which poses a far greater threat to teen health, and she would focus on marijuana, used by 25 percent of all teens over the past 30 years.

Cohen worries that teens “may spend the rest of their lives trying to curb a nicotine addiction,” but nicotine is no more dangerous than caffeine, another addictive substance.  Cohen’s prescription – a ban on nicotine and tobacco – is doomed to fail, just as the complete ban on marijuana use failed for 30 years.

Cohen: “This playbook isn’t new. For decades, the tobacco industry refused to acknowledge that cigarettes are deadly…” 

Actually, the playbook changed dramatically, as cigarette manufacturers now acknowledge that combustible products kill.  But by denigrating safer tobacco products, Cohen et al.  prolong cigarettes’ dominance of the tobacco/nicotine market. 

In summary, do not mistake Cohen’s distorted idea of harm reduction as anything more than cigarette market prolongation.