Friday, January 05, 2024

National Academies Replaces Big Alcohol-Conflicted Researcher on Review Panel with Another Big Alcohol-Conflicted Researcher

Just over one month ago, I reported that the National Academies had appointed to their newly formed expert committee to review the health effects of alcohol two scientists who were principal investigators of a research grant funded by the alcohol industry to the tune of $67 million (Dr. Eric Rimm and Dr. Kenneth Mukamal). After New York Times reporter Roni Rabin exposed these conflicts of interest in an article, the National Academies announced that it had pulled both Dr. Rimm and Dr. Mukamal from the panel and would replace them.

The National Academies recently announced the replacement panelists, and one of them is Dr. Luc Djousse, an associate professor of medicine at Harvard Medical School. 

Shockingly, it turns out that Dr. Djousse also has a conflict of interest with Big Alcohol, as he has received research funding from the Alcohol Beverage Medical Research Foundation, an alcohol industry front group that funnels money from the industry to researchers, serving as a "middle-man" that hides the connection between Big Alcohol and the research.

Furthermore, Dr. Djousse is a member of the International Scientific Forum on Alcohol Research (ISFAR), a supposedly "independent" panel that reviews alcohol research studies. However, ISFAR was funded by the alcohol industry and most of its panelists have conflicts of interest with Big Alcohol. Dr. Djousse's biography on the ISFAR site fails to reveal that he has received funding from the alcohol industry - specifically, the Alcoholic Beverage Medical Research Foundation. Not surprisingly, ISFAR is critical of any study that reports harmful effects of moderate drinking and praises any study that finds benefits of moderate drinking. In its reviews, ISFAR does not reveal the conflicts of interest of panel members.

Even worse, Dr. Djousse has not always been forthright about disclosing his previous funding from the alcohol industry. For example, in a paper published in 2019, he discloses current research funding but not his previous alcohol industry funding. That article, as well as many others that Djousse has authored, touts the health benefits of moderate alcohol consumption. 

Finally, Dr. Djousse is a close colleague of Dr. Mukamal's and has co-authored papers with him that tout the benefits of moderate alcohol consumption. Having him on the panel is the next closest thing to having Dr. Mukamal on the panel himself.

The Rest of the Story

Because of his conflicts of interest, Dr. Djousse should be removed from this panel in order to preserve the integrity of both the panel and of the National Academies itself.

Moreover, the fact that the National Academies has now twice selected researchers with conflicts of interest with the alcohol industry to serve on this panel suggests that something more sinister is going on than simply a coincidence. The National Academies has now selected three different panelists, all of whom have received alcohol funding and all of whom have published articles touting the benefits of moderate alcohol consumption. At the same time, the National Academies has failed to appoint to the panel any of the numerous non-conflicted researchers who were nominated. And even after it was called out publicly for appointing members with conflicts of interest with Big Alcohol, the National Academies simply replaced one conflicted panelist with another conflicted panelist who was a close colleague of the first conflicted panelist.

When this happened once, I was suspicious that there was something going on behind the scenes because the appointments of Dr. Rimm and Dr. Mukamal have the appearance of suggested that some sort of alcohol industry influence was taking place. But now that this has happened a second time, I think that a formal investigation into the formation of this panel is warranted. It smells of alcohol industry influence in some form. In the absence of an investigation, the conclusions of this panel will be forever tainted and cannot be trusted or viewed as impartial.

If the National Academies fails to remove Dr. Djousse from the panel, it will be a slam dunk case of their promoting the interests of the alcohol industry over objective scientific review.

Thursday, November 30, 2023

Why is the National Academies Appointing Alcohol-Industry Funded Researchers to Serve on Panel to Review the Health Effects of Alcohol?

I have always thought of the National Academies (full name is the National Academies of Sciences, Engineering, and Medicine [NASEM]) as being a highly reputable, impartial entity that objectively reviews scientific issues by appointing panelists who do not have conflicts of interest with industry that could create the appearance of bias. The National Academies has a detailed policy that disallows panel members who have a conflict of interest by virtue of funding by industries whose interests could be affected by the results of the panel review.

Well, that view of the National Academies has just flown out the window. Why? Because they have recently appointed to their newly formed expert committee to review the health effects of alcohol two scientists who were principal investigators in a research grant funded by the alcohol industry. And this was not minor funding. It was funding to the tune of $67 million! 

According to the National Academies web site listing the members of the panel entitled "Review of Evidence on Alcohol and Health," the chair of the panel is Dr. Eric Rimm and a second member of the panel is Dr. Kenneth Mukamal. 

For background, this panel is being convened as part of a larger process to develop dietary guidelines and those guidelines will presumably address the issue of alcohol consumption. The alcohol industry is presumably hoping for a recommendation that moderate alcohol consumption be part of a healthy diet, based on its view that there could be some cardiovascular benefits of moderate alcohol use.

The Rest of the Story

The last person one could possibly want on this panel is someone who lobbied the alcohol industry to provide funding for a clinical trial of the health benefits of alcohol use for which he would likely serve as the principal investigator and was awarded that funding. Well, that person - Dr. Kenneth Mukamal - was indeed appointed to the panel.   

In 2017, the New York Times reported that: "the National Institutes of Health is starting a $100 million clinical trial to test for the first time whether a drink a day really does prevent heart attacks. And guess who is picking up most of the tab? Five companies that are among the world’s largest alcoholic beverage manufacturers — Anheuser-Busch InBev, Heineken, Diageo, Pernod Ricard and Carlsberg — have so far pledged $67.7 million to a foundation that raises money for the National Institutes of Health, said Margaret Murray, the director of the Global Alcohol Research Program at the National Institute on Alcohol Abuse and Alcoholism, which will oversee the study." 

The principal investigator of the study, which was called "MACH" (Moderate Alcohol and Cardiovascular Health), was Dr. Kenneth Mukamal from the Harvard Medical School. According to an article in the Harvard Crimson (and supported by numerous other articles as well as by an NIH review committee), "Mukamal and his colleagues pitched the study to alcohol industry groups at high-end hotels, telling them the study “represents a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases,” the New York Times reported in March."

At a meeting with alcohol industry representatives in February 2014, Dr. Mukamal pitched the idea of a clinical trial of the benefits of drinking in an effort to solicit alcohol industry funding for the trial. In his presentation, Dr. Mukamal included a slide entitled "The Ultimate Goal." It was a newspaper headline from a Boston Globe article that stated "Mediterranean diet shows key benefits." Presumably, Dr. Mukamal was trying to convince the alcohol industry that this trial would allow the industry to reap the rewards from similar newspaper articles reporting the benefits of a diet that includes moderate alcohol consumption. In another slide, entitled "The Bottom Line," the presentation again explains that the primary purpose for the study is to "convince clinicians, patients, and policymakers that alcohol consumption in moderation is safe and a healthy part of diet..."

Later, in November 2014, Dr. Mukamal wrote an email to NIAAA stating: "I think that our chances with brewers and distillers would only go up with buy-in from other sources, including wine, if we can find any." Clearly, Dr. Mukamal was part of an effort, in collaboration with NIAAA, to seek alcohol industry funding that would support his role in the clinical trial.

Eventually, the alcohol industry contributed $67 million to which NIAAA added $33 million and the $100 million MACH trial was initiated under the leadership of Dr. Mukamal. However, the NIH halted the trial in June 2018 after an NIH review committee report concluded that:

"To understand the context that led NIAAA to embark on the MACH trial, the ACD WG considered the nature and extent of interactions among NIAAA staff, select extramural investigators, and industry representatives before FNIH received approval to secure funding to support the trial. There was early and frequent engagement among these parties which appear to be an attempt to persuade industry to support the project. Several members of NIAAA staff kept key facts hidden from other institute staff members and the FNIH. The nature of the engagement with industry representatives calls into question the impartiality of the process and thus, casts doubt that the scientific knowledge gained from the study would be actionable or believable. There were sustained interactions between the eventual principal investigator of the MACH trial and members of the NIAAA leadership prior to and during the development of FOAs for planning and main grants to fund the program. These interactions appear to have provided the eventual principal investigator with a competitive advantage not available to other applicants, and effectively steered funding to this investigator. Interactions among several NIAAA staff and industry representatives appear to intentionally bias the framing of the scientific premise in the direction of demonstrating a beneficial health effect of moderate alcohol consumption."

To make matters worse, Dr. Mukamal appears to have lied in publicly denying that he solicited funding from the alcohol industry. According to a New York Times article: "Dr. Mukamal, who has published dozens of papers on the health benefits of alcohol consumption, said he was not aware that alcohol companies were supporting the trial financially. “This isn’t anything other than a good old-fashioned N.I.H. trial,” he said. “We have had literally no contact with anyone in the alcohol industry in the planning of this.”"

Thus, not only does Dr. Mukamal have a severe conflict of interest by virtue of having colluded with NIAAA to secretly solicit and obtain alcohol company funding and by having been awarded that alcohol industry funding, but he also appears to have lied about it.

In conclusion, there is no doubt that Dr. Mukamal should be removed from the National Academies panel in order to preserve the integrity of both the panel and of the National Academies itself.

Although Dr. Rimm was not involved in the solicitation of funding, he did serve as a principal investigator of the MACH trial. Thus, he has been funded by the alcohol industry and this conflict of interest should disqualify him from participating in, much less chairing the panel. 

Dr. Rimm should be removed from the National Academies panel in order to preserve the integrity of both the panel and of the National Academies itself.

The final blow, and perhaps the biggest reason to exclude both Dr. Mukamal and Dr. Rimm from the panel, is that neither has been forthright about this conflict of interest in papers they have published subsequent to the trial. For example, in this 2020 paper of which both Dr. Mukamal and Dr. Rimm are co-authors, there is no visible disclosure that they had conducted research funded by the alcohol industry. In a section of the paper entitled "Author Relationship with Industry," two of the co-authors disclose their relationships, but Dr. Mukamal and Rimm do not. In fact, the section ends by stating: "All other authors have reported that they have no relationships relevant to the contents of this paper to disclose." However, one of the facts presented in the paper is that wine has high anti-inflammatory potential!

Furthermore, in an article that appears in this month's issue of the European Journal of Epidemiology, both Dr. Mukamal and Dr. Rimm are co-authors and neither discloses their prior research that was funded by the alcohol industry. The conflict of interest section states only that: "We declare that we have no conflicts of interest." Here, there isn't even a remote argument that the conflict of interest is not relevant to the topic of the study because the article is specifically about the health effects of moderate alcohol consumption! This conflict of interest of both investigators should have been disclosed in the paper.

It would be interesting to know whether Dr. Mukamal and Dr. Rimm disclosed their having received alcohol industry funding in the disclosure they submitted for the National Academies panel. Unfortunately, these disclosures are not made public by the National Academies.

Thursday, August 31, 2023

American Lung Association Wants to Keep Smokers Misinformed About the Relative Risks of Different Tobacco Products

In comments submitted to the FDA in response to the Center for Tobacco Products' (CTP) draft strategic plan, the American Lung Association expressed its opposition to one of the strategic goals, which was to "inform adults who smoke about the relative risks of tobacco products." This goal primarily expressed the desire of the CTP to inform smokers that electronic cigarettes are much safer than real cigarettes and therefore may be considered as a safer alternative for smokers who are unable to quit using other cessation methods.

The American Lung Association does not approve of this goal, writing: "Remove language from the description for this goal that references informing adults about the relative risk of tobacco products. As mentioned in our comments above, the description for this goal included language “and to inform adults who smoke about the relative risks of tobacco products.” The Lung Association strongly recommends this language be removed from the description.

Earlier in its comments, the Lung Association wrote: "the Lung Association strongly urges reconsideration of and revision to part of goal four, notably any promotion of the so-called “relative risk” of tobacco products. CTP should have no part in the industry’s efforts to sustain addiction through the failed and flawed notion that adult smokers should switch to e-cigarettes."

The Rest of the Story

The rest of the story is that the American Lung Association opposes telling the public the truth. 

This is highly ironic, given the extent to which the Lung Association and other tobacco control organizations went to punish the tobacco industry for lying to the public and hiding critical health information. It is also unethical because it violates the public health code of ethics, which calls for honesty and transparency in public health communications. We do not hide critical health information from the public. And we certainly do not hide information about the relative risks of various health behaviors.

Can you imagine if the American Lung Association said the same thing about methadone or buprenorphine? CTP should have no part in the drug industry's efforts to sustain addiction through the failed and flawed notion that adult heroin users should switch to methadone or buprenorphine.

How about the American Lung Association saying the same thing about needle exchange programs? CTP should have no part in the drug industry's efforts to sustain diction through the failed and flawed notion that adult heroin users should be provided with places that exchange clean needles for contaminated ones.

Or what if the American Lung Association said the same thing about condoms? CTP should have no part in the sex industry's efforts to sustain sexual behavior through the failed and flawed notion that adolescents who are having sex should use condoms.

As ridiculous and misguided those statements sound, the American Lung Association is actually making precisely the same statement regarding the use of electronic cigarettes. Even worse, the issue here is not even whether e-cigarettes should be promoted for smoking cessation. It is simply whether smokers should be told that e-cigarettes are safer than tobacco cigarettes.

This is about as damaging a recommendation as I have ever seen from a supposed public health organization. I must condemn it in the strongest terms. 

Monday, July 31, 2023

University of Maryland Doctor Tells Public He's Not Sure Smoking is Any More Hazardous than Vaping

In an article published today by ABC News, a physician from the University of Maryland is quoted as telling the public that he isn't sure that smoking is any more hazardous than vaping.

According to the article: "'We just cannot make a conclusion that it [vaping] is safer than cigarettes,' said Dr. Jason Rose, a Pulmonary and Critical Care Physician who is also the Associate Professor of Medicine and Associate Dean for Innovation & Physician Science at The University of Maryland."  

Of course, stating that you're not sure if vaping is safer than cigarettes is equivalent to saying that you're not sure smoking is any more hazardous to your health than vaping. This is obviously a ridiculous statement that is completely refuted by a multitude of scientific evidence as well as by the documented experiences of millions of ex-smokers who quit smoking by switching to vaping. Even the most vigorous opponents of e-cigarettes acknowledge that vaping is safer than smoking (as long as you are not engaging in dual use).

While the cardiovascular harms of e-cigarettes are probably moderately lower than smoking, the risks of cancer and COPD are astronomically lower. Many papers have documented the subjective and objective clinical improvement in respiratory function in smokers who quit smoking by switching to electronic cigarettes. Many papers have documented the much lower levels of carcinogens in e-cigarettes, some by actually measuring biomarkers in the blood or urine of smokers and vapers. 

Well, that is not the only guffaw in this article. In the same article, two other physicians strongly discourage smokers from quitting smoking with the use of e-cigarettes, even though e-cigarettes have been demonstrated to be the single most effective pharmacotherapeutic strategy for smoking cessation. 

According to the article: "Doctors are increasingly discouraging people from using e-cigarettes given the mounting evidence about the significant negative health impact of vaping-- even as a smoking cessation tool. For current smokers, 'there are other very powerful, safe and FDA approved interventions,' Dr. Petros Levounis, the President of the American Psychiatric Association and Chair of the Department of Psychiatry at Rutgers New Jersey Medical School, said."

Another physician is quoted as stating that e-cigarettes "are not ideal and there are other options that are proven by science that are safe and effective." This physician also fails to inform the public that e-cigarettes have been documented in clinical trials to be significantly more effective than any of those other options for smoking cessation.

To add the final blow, the article suggests that e-cigarettes can cause severe lung damage, tying e-cigarettes to the EVALI outbreak of 2019: "But studies show that e-cigarettes may cause harm by affecting the whole body. A medical condition called EVALI – E-cigarette or Vaping-use Associated Lung Injury - not only causes damage to the lungs but can also cause issues in other organs' systems."

No e-cigarette has ever been shown to cause EVALI. As the article later notes (in perhaps the only accurate statement in the whole article): "A CDC evaluation found that ingredients associated mostly with illicit THC vaping products played a major role in the 2019 EVALI outbreak that peaked in September 2019."

The article goes on to quote the parent of a teenager who suffered from EVALI. The article infers that the teenager's harrowing experience and near-death hospital admission was due to the use of e-cigarettes, failing to disclose that--almost certainly--his condition was caused by his use of illicit, black market THC oils that were spiked with vitamin E acetate.

The Rest of the Story

I am incredulous. Never did I imagine that in 2023, I would still be writing blog posts about physicians lying to the public by telling them that smoking is no more hazardous than vaping. Nor did I imagine that I would still be writing blog posts about physicians and medical groups discouraging smokers from quitting smoking by switching to e-cigarettes, even though it has been proven to be the most effective strategy for smoking cessation (with the exception of cold turkey quitting) and data show that more than 4 million ex-smokers in the U.S. quit smoking successfully by switching completely to vaping.

The lack of progress in educating physicians and the public about the relative harms of smoking compared to vaping is tragic. As a result, the health and lives of tens of thousands of Americans are being put at risk because they falsely believe that there is no benefit to quitting smoking via switching to vaping. 

A large part of the blame goes directly to the CDC--and especially the Office on Smoking and Health (where I used to work)--which have repeatedly misled the public by mis-communicating the risks of smoking compared to vaping. It is a shame that the nation's leading prevention agency--and the office responsible for tobacco prevention specifically--have carried on a campaign of deception that is now carrying into its 14th year!


Friday, July 28, 2023

Great Article on the CDC's Misinformation Campaign About Electronic Cigarettes

A very well-researched and well-documented article on the CDC's misinformation campaign about electronic cigarettes by my friend and colleague over at Handwaving Freakoutery: "Real Talk About Nicotine: How CDC Propaganda Leads to Bad Medicine and Kills People."

Medical Journal Retracts Vaping Study for Political, Rather than Scientific Reasons

The journal BMC Public Health has announced that it will be retracting a paper it published last October which concluded that the use of electronic cigarettes has helped accelerate the decline in cigarette smoking. 

The study, entitled "Population-level counterfactual trend modelling to examine the relationship between smoking prevalence and e-cigarette use among US adults," analyzed U.S. population-based data on trends in e-cigarette consumption and smoking prevalence from approximately 8 years prior to when e-cigarettes became popular in the U.S. through 2019. The authors used adult cigarette prevalence trends from 1999-2009 to establish a baseline and then generated the counterfactual (what would have been expected in the absence of e-cigarettes) by continuing these trends through 2019. They then compared the predicted trend in smoking prevalence from 2010-2019 with the actual trend. 

They found major discrepancies between the predicted and observed prevalence of smoking, with smoking rates dropping much more rapidly than expected. The magnitude of the "excess" decline in smoking correlated highly with greater prevalence of e-cigarette use. Furthermore, discrepancies between expected and observed levels of smoking were greater among subgroups with higher levels of e-cigarette use: young adults, adult males, and non-Hispanic White adults. The article concluded that: "Population-level data suggest that smoking prevalence has dropped faster than expected, in ways correlated with increased e-cigarette use."

The data were obtained from the National Health Interview Surveys, which are publicly available. The authors are affiliated with Pinney Associates, which does consulting work for Juul, an e-cigarette company in which the tobacco company Altria has a 35% stake. The authors fully disclosed the funding for the study--which was provided by Juul--as well as their conflicts of interest (i.e., their consulting work for Juul) in the paper. 

Apparently, the journal received a letter to the editor complaining that the paper's conclusions were invalid and calling for its retraction for two reasons:

1. The assumption that e-cigarette prevalence was zero in 2010 is incorrect, as e-cigarettes were widely available in the U.S. going back to 2007.  

2. The paper was funded by Juul, which has a financial interest in the results of the paper. 

However, the authors provided a supplemental table in the paper showing that even if one eliminates the assumption that e-cigarette use was zero in 2010 and simply rely on survey-measured e-cigarette prevalence values, there is still a strong and significant correlation between the discrepancy between predicted and actual smoking and the prevalence of e-cigarette use for two subgroups: males and young adults (the two groups with the highest levels of e-cigarette use).

Additionally, the authors fully disclosed their funding and conflicts of interest which were known to the journal's editorial staff and the reviewers prior to the decision to accept the manuscript for publication. Moreover, this particular journal does not have a policy that precludes consideration of papers that are funded by the tobacco industry or for which the authors report conflicts of interest.

Despite these two critical facts, the journal nevertheless wrote a letter to the authors stating that it made the decision to retract the article. On July 18, the journal told the authors that their response to the letter to the editor was not sufficient to address the letter writer's concerns. The reason given by the journal for the retraction was as follows:

The assumption that e-cigarette prevalence was zero in 2010 is not supported, and although the sensitivity analysis showed that there was still a significant correlation between the magnitude of the discrepancy between predicted and observed smoking prevalence and the level of population e-cigarette use for males and young adults when this assumption was eliminated, the relationship between cigarette use and the smoking prevalence disparity among young adults is most likely due to e-cigarette marketing.

The pivotal argument in the letter is as follows (I bolded it because of its importance): "In fact, bodies of literature are emerging globally about the effect of the tobacco industry’s marketing campaigns aimed at younger generations, using social media and influencers, which are associated with an increase in uptake of e-cigarettes (and dual use of e-cigarettes and tobacco products) in younger age groups. In my opinion, the effect of this strategic marketing seems a much more likely explanation of the association between younger age and increased e-cigarette use found by Foxon et al. than that e-cigarettes are particularly effective at helping younger age groups quit smoking."

The letter stated the final reason for the retraction as: "After careful consideration, and in light of the EBM’s feedback, the journal has taken the decision to retract the article in line with COPE guidelines. Our investigation has concluded that since the paper’s conclusions are based on assumption of ‘0’ prevalence of e-cigarette use in 2010 the results are non-significant."

The Rest of the Story

There is no valid scientific basis for the retraction of this paper. The journal states that it is retracting the article because the assumption that e-cigarette prevalence was zero in 2010 renders its results invalid. However, the results do not rely on the assumption that smoking prevalence in 2010 was zero. In fact, when the authors made no assumptions at all about e-cigarette prevalence and simply used the survey data on e-cigarette prevalence, they found a gaping difference between predicted and observed smoking prevalence among young adults and among males and in both cases, the magnitude of this gaping difference was highly and significantly correlated with the prevalence of e-cigarette use. The authors also documented to the journal editors that even if they changed the main assumption so that e-cigarette prevalence was 0 back in 2006 or 2007 or 2008 or 2009, the results were essentially unchanged. 

Moreover, the validity of the paper's findings does not rely upon any assumptions about e-cigarette prevalence in the first place. The main finding of the paper is that there is a large discrepancy between predicted and observed smoking prevalence in the past decade, with observed smoking prevalence being substantially less than would have been expected based on pre-existing trends. And the magnitude of the discrepancy is greatest among males and young adults. There needs to be some explanation for these two findings. It is beyond refutation that one critical change that occurred during the past decade was that there was a dramatic increase in adult e-cigarette use and that this increase was most dramatic among males and among young adults. Thus, even without calculating any correlation between e-cigarette prevalence and the magnitude of the smoking prevalence discrepancies one can reasonably posit that the use of e-cigarettes is a likely explanation for the greater than expected declines in adult smoking. This is especially true given data from the NHIS suggesting that during the past decade, no fewer than 4 million adult smokers quit smoking successfully using e-cigarettes.

The journal editors simply dismissed the sensitivity analysis showing that the paper's findings are not dependent upon the assumption of 0 e-cigarette use in 2010. That analysis is presented within the paper itself, yet the editors dismiss it. And the primary reason they dismiss it is because they believe there is an alternative explanation for the correlation between e-cigarette use and the discrepancy in observed vs. predicted smoking prevalence among young adults. Specifically, the editor argues that this finding is explained by e-cigarette marketing, which resulted in increases in youth e-cigarette use. But that is no explanation at all. The only thing that e-cigarette marketing might explain is why there was an increase in youth vaping. In no way does that invalidate the finding that there is a gaping discrepancy between actual and expected smoking prevalence among young adults which correlates with the magnitude of e-cigarette use.   

Moreover, the paper also found that without making any assumption about 0 e-cigarette use in 2010, there was a gaping discrepancy in observed vs. predicted smoking among males in the United States that was correlated strongly and significantly with the magnitude of e-cigarette use. The journal editors do not provide any refutation of, or alternative explanation for this finding.

Importantly, the journal editors are also incorrect when they state that they are retracting the article "in line with COPE guidelines." The relevant COPE guideline states that a paper may be retracted only if the editors "have clear evidence that the findings are unreliable, either as a result of major error (eg, miscalculation or experimental error), or as a result of fabrication (eg, of data) or falsification (eg, image manipulation)." None of those is present in this case, and the editors do not contend that a major error, miscalculation, experimental error, fabrication of data, or falsification of data is present. Thus, the editors are not adhering to COPE guidelines at all.

Essentially, the paper is being retracted because the editors do not agree with the conclusion reached by the authors given the findings presented in the paper. This is not a valid reason to retract a paper. There are always alternative explanations for a paper's findings and if editors started retracting every such paper, they would be purging about 95% of the publications in their journals.

You, like me, may find this an egregious example of an attempt to purge the scientific literature of a paper that the editors, after the fact, have decided that they don't like the study findings. You may be wondering what is really behind this because the scientific explanation given falls flat on its face.

Well, the editor has given us a clue in another statement they make in the letter to the study authors explaining that a letter to the editor has been received. That statement, which quotes a WHO document, reads: 

"At the time of writing, the evidence is insufficient to recommend the use of ENDS as cessation devices at the population level."

This conclusion is not only irrelevant to the issues at hand, but it has the appearance of revealing the true reason for the editor's disdain for this paper which they accepted for publication. Apparently, the editor sides with the WHO in believing that electronic cigarettes should not be recommended for smoking cessation. In other words, the editor appears to have a disdain for electronic cigarettes themselves, and this appears to have translated into a disdain for the article reporting the dramatic and unprecedented effects of e-cigarettes on adult smoking cessation.

I therefore read this story as indicating that the paper was retracted for essentially political, rather than scientific reasons.

Monday, July 17, 2023

American Heart Association Still Refuses to Tell the Truth About EVALI and Makes No Specific Recommendation that Youth Avoid Vaping THC Products

In an American Heart Association (AHA) "scientific statement" published this week in the journal Circulation, the AHA continues to confuse the public about the so-called EVALI (e-cigarette or vaping-associated lung injury) outbreak that occurred in 2019, suggesting that it may be due to "flavoring agents," "viruses," or "bacteria" and that no specific agent has been identified as the cause. 

Despite the fact that vitamin E acetate was found in a miraculous 94% of bronchoalveolar lavage fluids of EVALI patients, that no putative contaminant has ever been found in a non-tainted nicotine-containing e-cigarette, that the outbreak subsided quickly after illicit drug makers removed vitamin E acetate from THC oils, and that not a single EVALI case was ever demonstrated to be attributable to a store-bought (i.e., legal) electronic cigarette, the AHA continues to cloud the public's mind about the outbreak, leaving open the hysterical claim that legal e-cigarettes may cause devastating and deadly lung disease.

Perhaps more troubling, the AHA fails to make any recommendation to educate youth about the dangers of using THC vaping products, to educate youths so that they understand that vaping THC does have potentially deadly risks, or to run any public education campaign to publicize the widely recognized conclusion of the FDA that EVALI was caused specifically by vitamin E acetate oil that was added as a thickening agent to THC black-market vaping products.

Instead, by continuing to obscure the connection between THC vaping and EVALI, the AHA suggests that EVALI may be caused by legal, store-bought, nicotine-containing e-cigarettes. This undermines the important public health message that youths need: do not vape black market THC vapes off the street (or from any source). Why is it that an organization that is supposedly committed to reducing heart and lung disease would refuse to warn youth about the dangers of vaping THC products? The only apparent explanation is that this would undermine the public hysteria created by the AHA and other groups about the links between e-cigarettes and severe lung disease.

In addition to its difficulty acknowledging the truth about the lack of evidence that legal e-cigarettes pose any risk of severe, life-threatening, acute lung injury, the AHA continues to repeat other hysterical claims, such as that e-cigarettes can cause popcorn lung. This despite the absence of any cases of bronchiolitis obliterans having been reported in any e-cigarette user, not to mention the lack of evidence that popcorn lung is a problem in actual, real cigarette smokers.

The Rest of the Story

The real clincher comes near the end of the article, when - after scaring the public about all the severe, acute and chronic lung diseases that can supposedly be caused by e-cigarettes, the AHA finally tells the truth, acknowledging that the actual science precludes them from validly going beyond the weak statement that: "claims that ENDS products present absolutely no health risks are false according to the limited, but growing, evidence available." 

So the rest of the story is that the best the AHA can muster up based on solid science is that e-cigarettes are not completely harmless! I could have told you that in 2007 when they were first introduced to the U.S. market and only a handful of safety studies had been conducted. 

So now, 17 years later and after millions of dollars have been spent trying to tie e-cigarette use to every possible adverse effect under the sun, the most that the AHA can say is that based on the limited evidence available, we can conclude that e-cigarettes are not 100% safe! 

The subterfuge here is so blatant and the contrast between the science-based statements and hysteria-based statements so vivid that one has to question the intent of the organization. Is it truly trying to save the lives of adolescents who are at the greatest risk, or is it trying to drum up as much possible hysteria about e-cigarettes in the minds of the public? 

I'll suggest one thing: if the true aim is to try to save the lives of adolescents who are at the greatest risk, any further confusion of the public about the fact that EVALI was due to illegal, black market, THC vapes is irresponsible. This generation of youth needs to be warned about the risks of vaping black market products they obtain from friends or off the street, especially those which contain THC. Hiding this message only puts them at the greatest risk of harm from vaping products.

Tuesday, March 21, 2023

Idaho Public Television and State Health Officials Lie to the Public by Telling them Smoking is Not More Harmful than Vaping

In a public education campaign entitled "Do You Know Vape?" Idaho Public Television in collaboration with the state health districts is informing the public that: "Vaping is not safer than cigarette smoking."

The campaign is also making several other alarming claims, including that:

  • third-hand aerosol from vaping (i.e., particles that stick to surfaces) can cause "asthma, respiratory illness, increased risk of disease, headaches and increased risk of cancer"; and

The Rest of the Story

Rather than calling this a public "education" campaign, Idaho Public Television should more accurately call this a public "miseducation" campaign.

First, it is simply not true that vaping is no safer than smoking. There are a multitude of studies showing that vaping is much safer than smoking. I won't repeat all the evidence here but it can be found throughout my blog. Even scientists who are profoundly anti-vaping admit that vaping is much safer than smoking. 

Imagine if the tobacco industry made the same statement, except changing the syntax to read: "Cigarette smoking is no more harmful than vaping." According to the Idaho health officials, that would be a perfectly accurate statement for Big Tobacco to make. It's a wonder that the cigarette companies haven't truthfully told their customers and potential customers that: "According to health officials in Idaho, cigarette smoking poses no more health risks than just vaping, which does not contain any tobacco or involve combustion and the production of smoke." That would be a truthful statement.

Second, there is no clinical evidence that vaping causes brain, bone, or lung injury to young people. It is true that vaping THC, if it is contaminated with vitamin E acetate, can cause severe lung injury, but it is clearly the message given by this statement that e-cigarette use can cause lung injury. While it is true that in animal models, nicotine exposure can inhibit brain development, I am not aware of any clinical evidence that vaping causes brain injury among adolescents. And while it is true that in a Petri dish, e-cigarette aerosol may inhibit bone healing, I am aware of no clinical evidence that vaping causes bone injury in young people.

Third, there is absolutely no evidence that third-hand exposure to vaping aerosol causes any health effects, much less cancer.

Fourth, there is no evidence that vaping causes lung cancer.

It is a great disservice to the protection of the public's health to put out this type of misinformation. What this does is to discourage adult smokers from quitting by switching to e-cigarettes. After all, if smoking is no more dangerous than vaping, then why bother switching? You might as well stick with the real thing. This misinformation also encourages ex-smokers who have quit smoking (by switching to vaping) to return to cigarette smoking. Why bother taking the risk of getting scary diseases like popcorn lung when you can just go back to smoking and not have to worry about it? No anti-smoking group has ever put out a warning about smoking causing popcorn lung!

My own research has demonstrated that the hysterical misinformation that aims to scare the public into thinking that vaping is no safer than smoking has caused demonstrable damage to the public's health by resulting in an increase in cigarette consumption. In other words, this is harmful not only because it violates the public health code of ethics (lying is against the public health code of ethics) but because it is actually killing people.

Thursday, February 23, 2023

ISFAR Criticizes New Alcohol Guidance Issued by Canadian Centre on Substance Use and Addiction But Fails to Reveal Its Conflicts of Interest with Big Alcohol

Earlier this year, the Canadian Centre on Substance Use and Addiction released a new guidance on alcohol use. The guidance was notable for concluding that there is a dose-response relationship between the amount of alcohol one consumes and one's risk of disease or injury and therefore, greater amounts of alcohol consumption are associated with poorer health outcomes. In particular, the guidance concluded that drinking no alcohol is safer than drinking a low or moderate amount of alcohol.

The International Scientific Forum on Alcohol Research (ISFAR) has just published a stinging critique of the new guidance. The critique essentially trashes the guidance and accuses the authors of severe bias. For example, in the critique, Forum member R. Curtis Ellison stated: “I am appalled by the conclusions of the authors of this paper.  They present a pseudo-scientific amalgamation of selected studies of low scientific validity that fit their preconceived notions and ignore many high-quality studies whose results may not support their own views”. 

The Rest of the Story

The truth is that it is ISFAR that is severely biased, not the authors of the new guidance. But much worse than that, ISFAR is plagued by severe financial conflicts of interest with Big Alcohol. And even worse than that, ISFAR fails to disclose these severe conflicts of interest in its critique. They are therefore not apparent to readers or reporters, unless they go digging through the "fine print" on the website. Furthermore, many of the Forum members have conflicts of interest with Big Alcohol, and those conflicts are not revealed on the web site, not even on the page with their biographies.

For starters, ISFAR as an organization has a history of alcohol industry funding. ISFAR used to be affiliated with the Institute on Lifestyle & Health at the Boston University School of Medicine, directed by Dr. Ellison. This institute was financially supported by the alcohol industry: "Since its establishment, the Institute at Boston University has been funded by unrestricted, educational donations from more than 100 organizations, including companies in the alcoholic beverage industry and associations of grape growers, wine growers and wineries." This funding by alcohol companies apparently continued at least until 2014. In that year, Dr. Ellison admitted that: "the Institute now receives some support from the beverage industry for assistance in the development of critiques (assimilating the views of its 41 Forum members) and operating the website."

Secondly, many of the ISFAR forum members have financial conflicts of interest because they either work for the alcohol industry or have received funding from the industry. For example:

R. Curtis Ellison: As discussed above, in the past Dr. Ellison has received funding from the alcohol industry. As explained in a 2014 article in the journal Addiction: "The co-director of ISFAR, Dr R. Curtis Ellison, receives unrestricted educational donations from the industry through the Institute on Lifestyle and Health, Boston University School of Medicine, which he directs 8, and the Institute receives about 10% of its funding from the alcohol industry 9-11. For example, in 2005, it received a $50 000 grant from the Brown–Forman Corporation, a producer of wine and spirit brands, and $25 000 from the Wine Group, Inc. 12. ISFAR also worked with ICAP to organize a Symposium on Moderate Alcohol Consumption. ISFAR's other co-director serves as the Executive Director of AIM, which receives funding from the alcohol industry via a number of different mechanisms such as subscriptions and project grants 8."

Henk Hendriks: Dr. Hendriks has received funding from the alcohol industry for his work. In a recent paper, it was disclosed that: "This work was supported by an unconditional grant from the Alcohol Task Force of the European branch of the International Life Sciences Institute (ILSI Europe). Industry members of this task force are Allied Domecq, Brasseries Kronenbourg, Diageo, Heineken, and Moët et Chandon." This severe conflict of interest is not revealed in the critique, nor is it disclosed in Dr. Hendriks' biography on the ISFAR site.

Creina Stockley: Dr. Stockley is highly conflicted because she used to work for the alcohol industry. Specifically, she was with the Australian Wine Research Institute, which is the wine industry's own research institute. Although her biography mentions that she worked at the Institute until 2018, it does not reveal that the Institute is part of the alcohol industry.

Luc Djousse: Dr. Djousse's biography fails to reveal that he has received funding from the alcohol industry - specifically, the Alcoholic Beverage Medical Research Foundation.

Ramon Estruth: Dr. Estruth's biography states that he is a member of the Advisory Board for "ERAB." The reader is not told what ERAB stands for, hiding from the public the fact that ERAB is "supported by The Brewers of Europe, the voice of the brewing industry in Europe, whose members are the national brewing trade associations, representing more than 90% of European beer production."

Lynn Gretkowski: Dr. Gretkowski's biography fails to disclose that in the past, she has apparently received alcohol funding.

Arthur Klatksy: Dr. Klatsky's biography fails to disclose that in the past, he has apparently received alcohol funding.

Fulvio Mattivi: Dr. Mattivi's biography fails to disclose that he has received alcohol industry research funding.

Erik Skovenborg: Dr. Skovenborg's biography fails to disclose that he was on the Board of ERAB, which is funded by the alcohol industry.

Pierre-Louis Teissedre: Dr. Teissedre's biography fails to disclose that his research group received alcohol industry funding.

Andrew Waterhouse
: Dr. Waterhouse's biography hides the fact that he has received alcohol industry research funding.

The rest of the story is that ISFAR is little more than an alcohol industry front group that attempts to portray itself as a neutral and objective body, but which in fact has a long history of having received alcohol industry funding and which includes numerous members who have financial conflicts of interest with the alcohol industry. Furthermore, ISFAR is hiding these conflicts of interest from the public and from reporters because they are not disclosed, or not readily disclosed on the website. 

Scientifically, ISFAR doesn't have a foot to stand on either.

One major basis for the Centre's conclusions is that alcohol is a carcinogen and for at least several types of cancer, there is no threshold for the increased risk associated with alcohol consumption. According to the report:

"Cancer is the leading cause of death in Canada. However, the fact that alcohol is a carcinogen that can cause at least seven types of cancer is often unknown or overlooked. The most recent available data show that the use of alcohol causes nearly 7,000 cases of cancer deaths each year in Canada, with most cases being breast or colon cancer, followed by cancers of the rectum, mouth and throat, liver, esophagus and larynx. According to the Canadian Cancer Society, drinking less alcohol is among the top 10 behaviours to reduce cancer risk."

As there is no threshold of alcohol consumption for increased risk of at least three types of cancer, alcohol use definitively increases cancer risk among anyone who consumes it, even at low levels. Thus, it is scientifically sound to argue that drinking alcohol - even at low levels - presents greater health risks than not drinking any alcohol.

But regardless of the clarity of the science, the story here is a continuing attempt on the part of ISFAR to deceive the public, hiding its conflicts of interest with Big Alcohol, all in an effort to trash objective science and promote the interests of alcohol companies.

Wednesday, May 11, 2022

New Study Finds that Switching from Smoking to Vaping Reduces Heart Disease Risk by 34%

A new study published just days ago in the journal Circulation reported that adults who exclusively use electronic cigarettes experience a 34% reduction in their risk of heart disease. 

(See: Berlowitz JB, et al. E-cigarette use and risk of cardiovascular disease: A longitudinal analysis of the PATH study (2013-2019). Circulation 2022; DOI: 10.1161/CIRCULATIONAHA.121.057369.)

The study used a longitudinal design, following approximately 32,000 adults over a six-year period from 2013 to 2019. E-cigarette use and tobacco cigarette use were assessed periodically, as was self-reported heart disease, including a heart attack, heart failure, or stroke. The study examined the risk of incident heart disease for smokers compared to exclusive e-cigarette users, dual users, and nonsmokers, while controlling for age, sex, race/ethnicity, education, body mass index, hypertension, high cholesterol, diabetes, and family history of heart disease.

Compared to nonsmokers, smokers experienced a risk of heart disease that was 1.8 times higher and this difference was statistically significant. Compared to nonsmokers, exclusive e-cigarette users experienced a risk of heart disease that was not statistically different. Thus, the study confirmed a strong link between smoking and heart disease, but did not find any evidence of a link between vaping and heart disease.

Compared to smokers, exclusive e-cigarette users experienced a risk of heart disease that was 34% lower and this difference was statistically significant.

Importantly, the health benefits of switching to vaping were only present for exclusive e-cigarette users. Dual users of both e-cigarettes and cigarettes did not experience any decline in their risk of heart disease.

The Rest of the Story

Public health organizations should be ecstatic about the results of this research. It is ground-breaking research because it provides the first longitudinal assessment of heart disease risk that compares smokers and exclusive vapers. The finding of a 34% decline in heart disease risk among vapers is a game changer. We already knew that vaping was much safer than smoking. However, this is the first time that we have an estimate that quantifies the difference in terms of disease risk. A 34% reduction in heart disease risk is a critically important finding that has major and immediate implications for electronic cigarette policy.

Despite this great news, the American Heart Association chose not to emphasize the tremendous health benefits of quitting smoking and switching to electronic cigarettes. Instead, the American Heart Association headlines seemingly boasted about the finding that dual use had no observed health benefits.

In fact, the headline of the American Heart Association's press release about this study reads: "No health benefits among adults who used both e-cigarettes and traditional cigarettes." Moreover, the press release actually downplayed the finding that vapers experienced a 34% decline in heart disease risk. 

The American Heart Association's irresponsible reporting of the results of this study should come as no surprise, as the organization has had a strong bias against vaping for the past decade. It is almost inconceivable to me that the American Heart Association would boast about the lack of health benefits for dual users while nearly ignoring the game changing finding that switching from smoking to exclusive vaping appears to substantially reduce heart disease risk. For an organization whose mission is to reduce heart disease, their actions suggest exactly the opposite desire. The American Heart Association's continued demonization of vaping is - we now know - contributing to an increase, not a decrease, in heart disease because it is discouraging smokers from switching to vaping.

These research findings are critically important because they completely change the picture regarding the FDA's calculus in evaluating pre-market tobacco applications for e-cigarettes. In order to deny applications, the FDA has to conclude that the benefits of introducing the product will outweigh the costs of youth use of the product. This research establishes that the benefits of electronic cigarette use for smokers are immense. It is hard to imagine how this benefit could be outweighed by youth e-cigarette use, with the exception of products that have a high addiction potential, such as those which use nicotine salts or have very high nicotine levels.

At this point, the sound thing for the FDA to do is to simply approve the applications for all products that do not use nicotine salts and do not have nicotine levels above a certain level (for example, 20-24 mg). Unfortunately, it currently appears that the FDA is basically going to deny applications for all pod systems and for all flavors other than tobacco. This will decimate the e-cigarette market, lead to a potentially dangerous black market, and ultimately, increase disease rates by discouraging smokers from switching to vaping and causing many ex-smokers to return to smoking.

This study should cause the FDA to stop everything they are doing and re-assess the balance between the benefits and costs of making vaping products available to adult smokers. Rather than ban 99% of these products, which the agency seems poised to do, it should allow most of these products to remain on the market. However, I believe that the agency should also promulgate a rule that limits the sale of all tobacco and nicotine products to stores that exclusively sell these products and are only open to adults ages 21 and older. This is the best way to balance the risks and benefits of vaping.

Unfortunately, I have little doubt that the FDA will continue with its plan to eliminate 99% of the e-cigarette market. With that plan, they are also going to eliminate tens of thousands of lives.

Sunday, January 26, 2020

CDC is Concealing and Suppressing Information on Youth Marijuana Vaping to Over-hype Harms of E-Cigarettes

The Centers for Disease Control and Prevention (CDC) is concealing and suppressing information on the number one cause of severe, vaping-related health harm to youths in order to deceive the public into thinking that e-cigarettes are at the top of the list.

In fact, the number one cause of severe, vaping-related health damage to youths is not electronic cigarettes, although you would not know that from reading the CDC's literature on youth vaping.

The Rest of the Story

The chief cause of substantial health harms to youth from vaping is actually not e-cigarettes. It is marijuana or THC vaping.

The hundreds of youth who have become severely ill with respiratory failure from the EVALI outbreak have been harmed not by e-cigarettes, but by vaping marijuana carts.

The deaths that have occurred among youths from the EVALI outbreak were caused not by e-cigarettes, but by vaping THC.

Substantial numbers of youths have been affected by psychosis due to vaping THC and in some cases, groups of youths have actually had to be taken to emergency rooms because of the vaping of THC products that may have been contaminated with synthetic marijuana or other drugs.

This is by no means to minimize the harm being caused by addiction to devices such as JUUL which deliver high concentrations of nicotine salts. However, it is to point out that what is actually causing serious acute health harm to adolescents is THC vaping, not the use of e-cigarettes.

For some reason, the CDC has been concealing this critical information from the public. For three years in a row (2016-2018), the CDC's National Youth Tobacco Survey (NTYS) showed that the overwhelming majority of youths who were heavy e-cigarette vapers (use on 20 or more days per month) were also vaping marijuana. However, in all three years, the CDC failed to report these data.

In fact, had the CDC reported these data in 2016, it is possible that steps could have been taken that would have averted much of the disease and death caused by EVALI in 2019 because the problem of youth marijuana vaping would not have fallen off the radar screen.

Even if you look at all youth vapers (anyone who has used an e-cigarette in the past 30 days), more than half of these youth are vaping marijuana, not just nicotine-containing e-cigarettes.

Here are the data which the CDC has concealed:

Percentage of CURRENT youth e-cigarette users reporting ever use of THC vapes:
2016: 39%
2017: 52%
2018: 54%

Percentage of HEAVY youth e-cigarette users reporting ever use of THC vapes:
2016: 62%
2017: 73%
2018: 71%

What percentage of youth e-cigarette users reported having also vaped THC in 2019?

The answer is ...

... we have no idea.

Why? Because the CDC did not even ask the question about marijuana/THC vaping in the 2019 National Youth Tobacco Survey!

Why would the CDC intentionally take this question off the survey, when it had included the question in the 2016, 2017, and 2018 surveys?

If you put everything together:
  • the fact that the CDC concealed the information on youth THC vaping for three straight years;
  • the fact that the CDC blamed the EVALI outbreak on e-cigarettes rather than on THC vaping for months before finally having to admit that e-cigarettes were not to blame; and
  • the fact that the CDC intentionally removed the THC vaping question from the 2019 NYTS,

one can only get the impression that the CDC is intentionally hiding from the public the extent of the youth marijuana vaping problem because it wants the public to incorrectly believe that e-cigarettes--not THC vapes--are the greatest and most serious vaping-related health risk faced by our nation's youth.

The CDC cover-up of the role being played by THC vaping in the youth vaping epidemic has had serious consequences. Arguably, it contributed to the sudden and unexpected outbreak of respiratory disease that took the public health world by storm last year, something that could potentially have been avoided or reduced had health practitioners and agencies throughout the country been aware of the severe health risks being posed by youth THC vaping.

It could also have helped avoid misguided policies - such as the e-cigarette flavor bans that are sweeping the nation - which are going to push youth towards more THC vaping as flavored e-liquids become less available.

The CDC had better add the THC vaping question back into the 2020 survey because I am predicting that the proportion of youth vapers who report the use of marijuana/THC vapes is going to rise significantly in 2020 and beyond because of the widespread bans on flavored e-liquids.

The rest of the story is that the CDC is concealing and suppressing critical health data on youth marijuana use, apparently in an attempt to over-hype the harms of e-cigarettes. This is causing significant adverse public health consequences. Unless heath practitioners and agencies understand that the problem of youth vaping is not solely a problem of youth e-cigarette use, they will be unable to craft an effective policy to protect the health of our nation's youth.

Wednesday, January 08, 2020

Tobacco Researcher Claims that Smoking May Be Safer than E-Cigarettes

Imagine if a tobacco company came out today and publicly claimed that smoking might very well be safer than using an e-cigarette. It would be a completely irresponsible statement and the company would rightly be vigorously criticized and attacked for asserting that its deadly products, which kill more than 400,000 people each year, are potentially safer than e-cigarettes, which do not contain tobacco, involve no combustion, and have been documented to have much lower levels of thousands of different chemicals compared to cigarettes.

In a strange an shocking irony, that exact claim was made today, but it came not from Big Tobacco but from a tobacco researcher. According to a press release issued by Virginia Commonwealth University (VCU), one of its professors--who is a tobacco researcher and studies electronic cigarettes--claimed that smoking may actually be safer than vaping. The professor was quoted as stating:

"The fact is: we don't know whether e-cigarette use is as lethal as combustible cigarette use, less lethal than combustible cigarette use, or more lethal than combustible cigarette use."

The Rest of the Story

I agree that we cannot precisely quantify how much safer e-cigarettes are compared to smoking. However, there is overwhelming evidence that smoking is more hazardous than vaping. One of the most compelling lines of evidence is a series of studies showing that when smokers switch to e-cigarettes, they experience immediate and dramatic improvement in both their respiratory and cardiovascular health, measured both subjectively and objectively. Also compelling is evidence that e-cigarette aerosol contains much lower levels of thousands of chemicals, including scores of carcinogens, compared to tobacco smoke and that e-cigarette users have demonstrably lower levels of toxic chemical biomarkers than smokers. And this isn't even to mention the evidence from thousands of vapers who testify that their health has improved substantially since switching from smoking to vaping.

Tobacco companies can now have a field day with their cigarette advertising. They could legally and truthfully take out an advertisement stating:

"Smoke Marlboro. According to a professor at Virginia Commonwealth University, smoking may be safer than using e-cigarettes, which contain no tobacco and involve no combustion."


"Let's face it. People have been smoking for decades so we know exactly how many people are going to die each year. But we have no idea how many people are going to die from e-cigarette use. Take the more predictable and potentially safer path, according to a professor at Virginia Commonwealth University: smoke, don't vape."

With enemies like this anti-tobacco researcher, the tobacco companies no longer need friends. He has given Big Tobacco the most amazing public endorsement it could have ever asked for, and something that it could never have claimed to be true itself.

Thursday, January 02, 2020

Vape Shops Saved for Now: Dodged One Bullet, But Now Must Dodge Another One

I am expecting the FDA to announce this afternoon that it plans to enforce a ban on the sale of all flavored e-cigarette pods and cartridges for closed vaping systems, with the exception of tobacco and menthol flavors, but that it is exempting e-liquids and vape juices sold for open systems. This means that the restriction will primarily affect the vaping products sold by convenience stores, but not all of the products sold by vape shops.

The decision of the FDA not to ban all flavored e-cigarettes is a huge victory for public health. By allowing vape shops to continue selling flavored vape liquids, the FDA is preventing hundreds of thousands of ex-smokers from being forced to return to smoking. It also ensures that this important off-ramp from smoking remains available to adult smokers.

However, the battle is not yet over because if the FDA implements the PMTA deadline in May of this year, it will wipe out most of the vaping industry, handing it over to the tobacco companies. The results would be devastating to the public’s health, as many ex-smokers would return to smoking and many more would turn to a new black market for these products.

Hopefully, the FDA will re-think its overall approach to tobacco product regulation and announce a more sensible policy—one that regulates products based on their level of risk. Such a policy would remove the addictive nicotine from combustible cigarettes and restrict their sale to tobacco shops open only to adults. It would also directly regulate e-cigarette safety by issuing standards, including a maximum nicotine level for e-liquids that use nicotine salts, battery safety, and temperature regulation.

This proposal is unlikely to curb the rise in underage vaping because teens who use JUUL can simply switch over to the menthol or tobacco flavors. Since the proposal does not restrict the nicotine level in these products—something I have been calling for since my Congressional testimony last fall—JUUL can continue to sell pods with more than 50 mg/mL of nicotine, a ridiculously high level that is contributing to youth addiction to this product.

The FDA needs to stop focusing on the flavorings and for once, focus on the nicotine, which is the problem. The epidemic we have is not one of youth flavor use, but of youth addiction to the JUUL device, and that is occurring not because JUUL is flavored but because JUUL has more than 50 mg/mL of nicotine salts, compared to less than 25 mg/mL in most other products on the market, which use freebase nicotine rather than nicotine salts.

All of the recent restrictions we have seen on the sale of flavored e-cigarettes are about politics rather than protecting the health of Americans. If policy makers were interested in protecting the health of Americans, the first thing they would do is to get the nicotine out of combustible cigarettes and restrict their sale to tobacco shops that are only open to adults. And the second thing they would do is limit the level of nicotine salts in electronic cigarettes, especially JUUL, because it’s the high levels of nicotine salts--not the flavors--that is causing the problem of youth addiction to vaping.

All in all, the announced policy is a huge victory for the public’s health, compared to what would have happened had the FDA banned all flavored e-cigarettes. Now, attention must turn to the problem of the May 2020 PMTA deadline, which will decimate the vape shops, severely constrict the vaping market, and result in devastating health effects for hundreds of thousands of ex-smokers who will either be forced to return to smoking or forced to buy products from--ironically--a completely unregulated black market.

Tuesday, December 24, 2019

American Academy of Family Physicians Bemoans Fact that Many People Correctly Link Respiratory Disease Outbreak to THC Vapes

The American Academy of Family Physicians (AAFP) has released the results of a survey it commissioned to examine public attitudes regarding what CDC has incorrectly called the EVALI (e-cigarette, or vaping-associated lung illness) outbreak. The AAFP reports the results as follows:

"In the online survey of 1,000 people aged 16 to 30 who vape, 93% of respondents said they were aware of the EVALI outbreak, and 65% said they were closely following news regarding the issue. More than 70% of respondents indicated they planned to be more careful about the products they buy and to reduce their use of vape products, and 86% were confident that they understood the health risks associated with vaping."

"Survey results, however, showed a different reality regarding that understanding of risk. More than half of respondents said that only people who vape cannabis products were at risk of vaping-related illnesses and death. However, of 1,782 hospitalized patients with complete information in the CDC report, 20% reported not using cannabis products."

"What's disturbing is that people aren't aware of their risks," Natasha Bhuyan, M.D., a family physician in Phoenix, told AAFP News. "They think that people are only at risk if they are using cannabis products or black-market products. They think, 'My apple-flavored vape juice is just fine.' But it could be just as dangerous as whatever else is out there."

The Rest of the Story

What a depressing way to enter the holidays. The AAFP - the official national membership organization of the nation's family physicians - is upset because many people correctly link the EVALI outbreak with the use of THC vaping products! What this means is that the AAFP would rather that the public be misinformed about the cause of the EVALI outbreak. The AAFP would rather have people believe that e-cigarettes are causing the outbreak even though that is not true.

This is deeply disturbing to me. It's also terribly scary. It basically means that the evidence-based practice of medicine is severely threatened. This is truly dangerous territory because what the AAFP is doing is allowing their pre-existing biases drive their clinical recommendations rather than the scientific evidence.

As those who have followed the Rest of the Story well know, there is now nearly definitive evidence that the EVALI outbreak is caused by the inhalation of THC and CBD vaping products containing vitamin E acetate oil, which has been used as a thickening agent in some of these products and which is toxic to the lungs because it destroys surfactant, which is necessary to keep the alveoli open. It also may release a toxic chemical that causes direct lung injury, and the oil itself may impair the ability of the alveoli to function properly. In addition, the body's inflammatory response to the presence of this oil may further contribute to respiratory damage.

There is absolutely no evidence that electronic cigarettes are playing a role in the outbreak. Vitamin E acetate oil is not used in any legal e-cigarettes. Moreover, if e-cigarettes were playing a role in the outbreak, we would not be seeing the drastic reduction in the number of cases that is occurring. After all, nothing has changed in the e-cigarette market, so why would the cases just disappear? Clearly, what is causing the outbreak to wane is the decreased production and distribution of vitamin E acetate oil-laden THC and CBD vape cartridges.

The spokesperson for the AAFP is giving exactly the opposite advice of both the CDC and FDA. The CDC and FDA have explicitly warned people not to vape THC products, especially those purchased on the black market. The AAFP is directly refuting that, claiming that all e-cigarettes are involved in the outbreak and implying that people who use apple-flavored vape juice in their e-cigarettes are just as much at risk for respiratory failure as those who use black market THC vape carts like Dank Vapes, which alone is associated with 56% of the reported cases.

Sadly, the AAFP has left the realm of evidence-based medicine. Compounding their irresponsible recommendations regarding the EVALI outbreak is the misinformation they are providing on their fact sheet about e-cigarettes, which contains two outright lies:

First, the "fact" sheet informs the public that e-cigarettes are not safer than tobacco cigarettes. There is overwhelming evidence that although e-cigarettes are not safe in any absolute sense, they are certainly safer than smoking.

Second, the "fact" sheet informs the public that e-cigarettes cannot be used to quit smoking. This completely ignores the fact that National Health Interview Survey data from 2018 revealed that more than 3 million adult smokers have quit smoking completely using e-cigarettes.

The rest of the story is that the American Academy of Family Physicians has left the realm of evidence-based medicine and, at least with respect to e-cigarettes, is now being driven by ideology rather than science. We can only hope that the AAFP will take some time to reflect on this during the holidays and will return to an evidence-based approach in 2020.

Sunday, December 22, 2019

Newest CDC Data Confirm that Respiratory Disease Outbreak was Caused by Vitamin E Acetate Oil in THC Vaping Cartridges

The CDC has released new data which almost definitively confirm that the respiratory disease outbreak was caused by vitamin E acetate oil in THC vaping products (and perhaps some CBD vaping products as well).

I came to the same conclusion on August 25th, as did many experts from the cannabis industry who helped to inform my conclusion. Why it took the CDC four additional months of intensive investigation to discover something that cannabis industry experts had recognized much earlier is mystifying.

Previously, CDC had tested lung fluids from 29 of the case patients. All 29 contained vitamin E acetate. This past Thursday, CDC reported the results of testing of 51 probable or confirmed case patients from 16 states. Vitamin E acetate was detected in 48 (94%) of the case patients.

Importantly, the three cases in which vitamin E acetate was not detected were not confirmed cases, and each had other potential explanations for their illnesses. One had a multi-drug overdose, one had a fungal infection, and one may have had a bacterial lung infection.

The most critical finding of the study was that 9 out of 11 patients who denied having used THC were found to have THC in their lung fluids.

Overall, every single confirmed case patient (100%) had vitamin E acetate detected in their lung fluids.

The investigators tested lung fluids from 99 healthy people, including 18 e-cigarette users, and none had vitamin E acetate detected. In addition, they did not find vitamin E acetate in any of the nicotine-containing e-liquids tested.

The Rest of the Story

These new data should pretty much put to rest the story that many state health departments and anti-nicotine groups have been telling for the past several months: that traditional e-cigarettes are causing severe lung injury and that getting these products off the market is necessary as an emergency response to the vaping-associated lung illness outbreak.

On the contrary, the actions that would have been helpful in stemming the tide of this outbreak more quickly were: (1) explicitly warning the public about the dangers of vaping THC, especially black market products; and (2) taking steps to identify and dismantle the production and distribution channels that were disseminating the dangerous products.

The federal agencies that appear to have done their job properly are the FDA and DEA, which have been investigating the distribution channels for black market THC vaping products and have closed down 44 web sites that were illegally selling THC vape carts. In contrast, CDC has done everything in its power to hide the truth from the public and to continually invoke electronic cigarettes as being involved in the outbreak. The very name that the CDC gave to the outbreak was a complete misnomer: "e-cigarette, or vaping-associated lung illness."

While a few state health departments responded appropriately, most have been using the outbreak as an excuse to further demonize e-cigarettes, while downplaying the role of marijuana vaping and of black market THC vaping products. These actions have almost certainly resulted in more cases of the illness than would have occurred if these health agencies had simply told the public the truth and not allowed their bias against electronic cigarettes to have gotten in the way.

Thursday, December 19, 2019

Massachusetts Department of Public Health Issues Emergency Order Banning the Sale of All Pets for Four Months

In response to an outbreak of multi-drug resistant Campylobacter infections associated with the purchase of puppies from pet stores, the Massachusetts Department of Public Health has issued a temporary, four-month ban on the sale of all animals by pet stores throughout the Commonwealth.

The CDC concluded that the outbreak is being caused by puppies sold by pet stores based on the finding that 88% of the case patients reported contact with a puppy and 71% of these reported contact with a puppy from a pet store.

The CDC conclusion is as follows: "Epidemiologic and laboratory evidence indicate that contact with puppies, especially those at pet stores, is the likely source of this outbreak."

Nevertheless, the CDC has warned that: "No single strain of puppy has been identified that explains all cases of this outbreak. Therefore, the CDC recommends that anyone concerned about the illness avoid exposure to all animals." 

The CDC has termed the outbreak PAAGI - which stands for Puppy, or Animal-Associated Gastrointestinal Illness.

Although the CDC has concluded that puppies purchased at pet stores are the likely cause of the illness, the Massachusetts Department of Public Health has issued an emergency order that immediately banned the sale or transfer of all animals. This includes the sale of all animals from Massachusetts pet stores as well as online sales of animals. In addition to not being able to sell animals, all pet stores had to clear their shelves of all inventory.

Already, the ban has resulted in the closure of hundreds of pet stores in the state. Numerous store owners have explained that they spent tens of thousands of dollars on the inventory in their stores and having to clear this inventory and close their stores, even temporarily, is an economic impact that they simply cannot withstand. Some of the store owners had literally put their life savings into their small businesses, which has now all gone for naught.

Asked why the state banned the sale of all animals, when the CDC concluded that the outbreak was linked to puppies, a spokesperson from the Massachusetts Department of Public Health stated: "Twelve percent of patients reported exclusively having contact with animals other than puppies. It was therefore necessary to ban the sale of all animals, not just puppies. Until we know the exact cause of the outbreak, people should refrain from contact with all animals." When asked why it was necessary to force hundreds of small businesses to shut down when the evidence clearly points to puppies alone as the cause of the illness, the spokesperson said: "The health of our children has to take precedence over economic interests."

Several other states have followed the lead set by Massachusetts, except that instead of banning the sale of all animals, they have only banned the sale of cute animals. For example, a Montana official noted that: "Kids are attracted to animals because they are cute. Pet stores are clearly targeting youth by marketing cute animals. Cute animal ownership by youth has reached epidemic proportions and there is evidence that many youth have become addicted to their pets. It is now clear that owning a pet can cause severe illness or even death due to infection with multi-drug resistant bacteria."

Health officials in Washington noted that "there is no such thing as a safe pet. Until the FDA has approved pets for sale, consumers should refrain from buying these animals."

New York State declared a public health emergency because of the outbreak, but chose to ban only cute animals, not all animals. A Boston University animal researcher questioned this decision, saying that: "There is no evidence that this outbreak is only associated with the sale of cute animals. Thus, there is no public health justification for banning the sale of only cute animals. State health officials are simply taking advantage of this outbreak in order to get cute animals off the market."

Early reports indicate that many families are now purchasing pets off the black market instead of at stores which are regulated. The animals sold on the black market are not tested for diseases, nor is it clear whether they have received the proper immunizations. As a result, families that buy pets off the black market are putting themselves at great risk. According to pet store owners in Washington State: "A new black market has emerged for cute pets. No one wants to purchase the non-cute breeds. We have lost 90% of our sales."

In defending the ban, Washington health officials argued that anyone who wants a pet can simply switch over to a non-cute variety. A health department spokesperson stated: "We are not depriving people who want pets to have them. They can just switch over from the cute pets to the non-cute ones. Cute pets are only marketed to kids anyway. Adults who want pets should just buy the non-cute ones."

A new study published earlier this week has linked the ownership of puppies to depression. The study found that people who experience sadness or depression are more likely to own a puppy. The investigators concluded that: "This is strong evidence that buying a puppy can lead to depression. Puppies have not been found by the FDA to be safe and effective."

Critics of the study pointed out that it is very possible that people who are feeling sad or depressed buy a puppy specifically to cheer them up. Despite this possibility of reverse causation and a statement in the fine print of the paper stating that "Because of the cross-sectional nature of this study, causation cannot be proven," the investigators issued a press release with the headline: "New Study Demonstrates that Buying a Puppy Can Lead to Severe Depression."

Although the FDA has had jurisdiction over the sale of animals for the past 10 years, the only regulations it has promulgated involve safety standards for puppies. Any store that wants to continue to sell puppies must submit a "Pre-Market Puppy Application," or PMPA, by May 2020 or it must take its puppies off the market. However, stores that sell pit bulls, boa constrictors, and alligators can continue to sell these more dangerous animals without submitting a single page of paperwork to the FDA.

(Thanks to Michael S. Cox for the tip.)