National Academies Report on Effects of Moderate Drinking is a Death Knell for Recommending Moderate Alcohol Consumption

The viability of recommending moderate alcohol consumption as a step to reduce all-cause mortality was given a death blow yesterday by the release of a report by a National Academy of Sciences expert panel which concluded that low-dose (moderate) drinking increases the risk of breast cancer and may increase the risk of colon cancer as well.

The long-awaited report concluded that although moderate drinking appears to reduce all-cause mortality, primarily through a reduction in cardiovascular disease, it also increases breast cancer risk and there is some evidence that it increases colon cancer risk as well. The panel concluded that there was moderately strong evidence that low levels of alcohol consumption increase breast cancer risk and some evidence, although not strong, that low levels of alcohol consumption increase colon cancer.

A major purpose of the report is to inform the next Dietary Guidelines for Americans. The alcohol industry has a vested interest in the Dietary Guidelines including a recommendation of moderate drinking as part of a healthy diet. They funded an ill-fated clinical trial of the health effects of moderate drinking which was halted by NIH after an investigation revealed impropriety in the NIAAA's solicitation of funding directly from the industry, which violates NIH policy.

The Rest of the Story

This report is a death knell for the alcohol industry’s hopes of ever having moderate drinking recommended as part of a health diet. The report concluded that moderate drinking increases the risk of breast cancer and may also increase the risk of colon cancer. Even though the report suggests that moderate drinking may lower all-cause mortality, there is no way that physicians—or any public health body—can issue a recommendation for healthy people to take an action that knowingly increases their risk of cancer, which could be fatal. 

A key principle of medicine is “to do no harm.” We do not recommend preventive measures that significantly increase the risk of one disease in order to prevent another disease. We cannot knowingly recommend that people consume a known, strong carcinogen as a method to reduce their risk of cardiovascular disease. There are other safe, effective, and proven ways to reduce cardiovascular risk without increasing your risk of cancer.

Recommending moderate alcohol consumption to reduce cardiovascular disease, in light of the findings of this report, would be unethical. 

Imagine walking into a doctor's office and asking your doctor for recommendations about how to decrease your risk of cardiovascular disease. And the doctor says: "Boy have I got the carcinogen for you. Take this carcinogen once or twice a day, depending on your sex, and your cardiovascular risk will go down." 

But this is precisely what would be happening if a physician--or a public health body such as the National Dietary Guidelines--recommended moderate alcohol use to reduce cardiovascular disease risk. 

The only time when we can recommend that people take a medication or product that is effective in treating a disease but may have side effects by increasing the risk of another disease is when the patient already has the disease. And in those circumstances, the FDA is very careful about weighing the risk levels, the alternative treatments available, and the severity of the disease. We absolutely cannot recommend that healthy people take a medication or product that is effective in preventing a disease but increases the risk of another disease. In other words, medication or product side effects can potentially be tolerated for medical treatment. But they are unacceptable in medical prevention. The reason is that with prevention, the patient is healthy and to expose them to a higher risk of cancer would be doing harm. This violates a central tenet of medicine and public health.

Knowing that this report concludes that the link between moderate drinking and a potentially fatal cancer is real, there is no way that any public health body can possibly recommend moderate drinking as part of a dietary guideline. Given the findings of this report, doing so would be a serious breach of medicine and public health ethics.

Misinformation By Parents Against Vaping E-Cigarettes Appears to Be Part of a Longer-Term Campaign of Deception

Yesterday, I reported that Parents Against Vaping E-Cigarettes (PAVE) is essentially lying on its website about the prevalence of daily e-cigarette use among youth. The site claims that "More than 1 in 4 youth use e-cigarettes daily." Using data from the 2024 National Youth Tobacco Survey (NYTS), I showed that the actual proportion of youth who use e-cigarettes daily is 1.6%, meaning that PAVE is exaggerating this statistic by a factor of 16.

I had assumed that this was just a one-time error and that PAVE was just misreporting data from the 2024 National Youth Tobacco Survey.

But how wrong I was.

The Rest of the Story

With the use of the Wayback Machine, I was able to find that PAVE made the identical fallacious claim nearly one year ago that it stated was based on the results of the 2023 National Youth Tobacco Survey. Their web site on February 11, 2024 stated: "More than 1 in 4 youth use e-cigarettes daily" and attributed this to the 2023 NYTS.

So it appears that this deception has now been going on through two cycles of the release of the NYTS. 

Unfortunately, this misinformation seems to be spreading rapidly, probably from PAVE to other organizations and even supposedly reputable health agencies. The PAVE misinformation appears to have first appeared on or around February 11, 2024. On March 1, 2024, the New Haven Health Department included this fallacious claim in a letter to the city council. The letter stated: "Nationally, more than 1 in 4 youth use e-cigarettes daily and almost 9 out of 10 use flavored e-cigarettes." The fact that the second claim follows the first on the PAVE website suggests that this may be where the New Haven Health Department obtained this erroneous information.

Beacon Mental Health appears to have picked up the claim shortly before November 7, 2024, and used it to promote a conference on vaping and youth that it was cosponsoring with the North Kansas City Hospital. In promoting this November 7 event, they asked: "Did you know that nationally, more than 1 in 4 youth use e-cigarettes daily?"

The Wilson Area School District (Easton, PA) picked up the same claim: "Teen vaping has become a serious health issue in the United States. According to the annual National Youth Tobacco Survey,  more than 1 in 4 youth use e-cigarettes daily and almost 9 out of 10 use flavored e-cigarettes."

The same claim was picked up by the Johnson County (KS) government: "More than 1 in 4 youth use e-cigarettes daily." This was almost certainly derived from PAVE, as they appear to have copied it directly from PAVE's web site.

This story shows how misinformation can spread rapidly over the internet and eventually come to dominate public "knowledge." This is why it is so important for public health organizations like PAVE to be honest and accurate in their communications.

Why Does Parents Against Vaping E-Cigarettes (PAVE) Have to Lie in Order to Scare Parents?

If I seriously thought that one-fourth of today's youth were vaping e-cigarettes daily, I would be quite alarmed. Daily use suggests possible addiction and so if 25% of all youth were vaping daily, we would be talking about 6.25 million middle-school and high-school students who are vaping every day. Moreover, the overwhelming majority of every day youth e-cigarette users are not just vaping nicotine, but they are also using THC vapes, mostly off the black market. So if this statistic were true, it would drastically change my assessment of the relative benefits of electronic cigarettes for adult smoking cessation compared to the risks for youth vaping and addiction.

Well, according to Parents Against Vaping E-Cigarettes (PAVE), this very statistic is in fact true! According to PAVE: "More than 1 in 4 youth use e-cigarettes daily." So it's actually more than 25% of youth who are daily e-cigarette users. This means there are well over 6 million youth daily vapers. Even worse, only 3.2% of adults vape daily, so the proportion of youth who vape daily is 8 times higher than the proportion of adults who vape daily. Perhaps even more alarming, this means that for 2 adult vapers, there is one youth daily vaper.

The Rest of the Story

There's only one problem with this statistic from PAVE ...

...

...

... It isn't true!

According to data from the 2024 National Youth Tobacco Survey, the proportion of youth who use e-cigarettes daily is not 25%, it is 1.6%. So PAVE is off by a factor of 16. Another way of saying this is that PAVE has inflated the proportion of youth who use e-cigarettes daily by 16 times its actual value in an apparent effort to create quite a scare among parents and the public at large.

Compare PAVE's "facts" with those of the FDA:

PAVE - More than 25% of youth use e-cigarettes daily.

FDA - Only 1.6% of youth use e-cigarettes daily. 

So how does PAVE get this 25% number? Well, you might call it sleight-of-hand. It turns out that of youth e-cigarette users, more than 25% are daily users (26.3%). However, only 5.9% of youth are e-cigarette users, so the proportion of youth who are daily e-cigarettes users is 26.3% times 5.9%, which is 1.6%.

The truth is that PAVE is not telling the truth when they claim that more than 1 in 4 youth use e-cigarettes daily. The truth is that 1 in 62 youth use e-cigarettes daily.

So why lie? 

Possibly it's because 1 in 4 youth sounds way more alarming than 1 in 62 youth. Somehow 1 in 62 youth doesn't quite have the same kick as 1 in 4. 

But why the need to lie in the first place? Possibly it's because the youth e-cigarette craze has subsided somewhat and the truthful statistics just aren't alarming enough to make youth vaping the kind of catastrophic problem that PAVE would like to promote it as.

The problem is that truth, honesty, and transparency are three important core values of public health. We do not misrepresent statistics in order to scare people. We do not provide false statistics to the public in order to increase public concern about public health problems. In other words, the ends of getting the public to take action do not justify the means of lying to or deceiving the public.

Obsession with Youth Vaping Has Made Us Lose Sight of Far More Serious Threats to the Health of Adolescents and Young Adults

While public health agencies and anti-tobacco groups have made youth vaping nearly the sole focus of their adolescent health agendas over the past decade, far more serious substance abuse threats to the health of teens and young adults are escaping attention and wreaking greater havoc on the current generation of young people. 

For example, a new article just published in the American Journal of Medicine reveals that over the past two decades, the death rate from alcohol in the United States has doubled. The largest increase in the death rate from alcohol was among young people ages 25-34, among whom the rate nearly quadrupled.

According to a press release accompanying the article: "Results of the clinical research study, published in the American Journal of Medicine, reveal that alcohol-related deaths in the U.S. have surged dramatically in the last two decades, with the mortality rate nearly doubling from 10.7 per 100,000 in 1999 to 21.6 per 100,000 in 2020. The total number of alcohol-related deaths soared from 19,356 to 48,870, a dramatic twofold increase. Every age group has suffered increases, with the most alarming spike – nearly fourfold – in those aged 25 to 34.

According to data from Dr. Charles Gardner, approximately 4,000 teenagers die every year from alcohol (due primarily to binge drinking, motor vehicle crashes, and other injuries). Another 1,900 die from opiate overdose (due primarily to fentanyl). According to CDC, there were another 2,200 teenage deaths in 2022 from suicide. Thus, the combination of alcohol, opiates, and suicide are resulting in the deaths of approximately 8,000 teenagers each year. 

In contrast, the number of teen deaths from electronic cigarettes during the past two years is approximately 0.

Even if one includes the deaths that did occur due to vaping during the so-called EVALI outbreak, 0 of those deaths were due to e-cigarette use. They were due to the use of illicit THC vape carts.

The Rest of the Story

While many anti-tobacco groups lament the near disappearance of cigarette smoking due to the vaping fad among teens and would have us believe that vaping is an epidemic every bit as devastating as smoking, I believe that these groups have contributed to an obsession with youth vaping that has overshadowed more serious threats to adolescent health and allowed these threats to blossom unchecked because of the diversion in our focus. 

Because of these misplaced priorities, health agencies instructed youth not to use e-cigarettes during EVALI, rather than to avoid buying THC vape carts off the black market. Because of these misplaced priorities, public officials have banned flavored e-cigarettes, and in some places the sale of all e-cigarettes, while leaving the sale of flavored real cigarettes unchecked. Because of these misplaced priorities, the FDA has devastated the e-cigarette market, while leaving the deadly cigarette market completely unchecked. Because of these misplaced priorities, schools are using video surveillance to make sure no one is vaping in the bathroom, while letting kids use alcohol to their hearts content and while an opioid overdose epidemic rages. 

Don't get me wrong. I'm not saying that youth vaping is not a problem that needs to be addressed. But I think it needs be be addressed in a more reasonable (and more effective) way, as part of a more holistic approach to adolescent health that prioritizes the substances and behaviors that are the greatest threats to the lives of our children.

New Article in American Journal of Medicine Claims that Youths Who Use E-Cigarettes are 5 Times More Likely to Become Cigarette Smokers

I've only been back at this for one day and the very first new article that I came across makes the preposterous claim that use of e-cigarettes increases by 5-fold the initiation of cigarette smoking among youth. The article, published as a commentary in the American Journal of Medicine, states as follows: "E-cigarette use by adolescents increases by up to 5-fold their initiation of tobacco cigarette smoking."

The Rest of the Story

It is difficult to believe that anyone could look at the actual data on the prevalence of youth cigarette smoking in 2024 and make the claim that vaping by youth leads to a 5-fold increase in smoking initiation. If that were true, then given the tremendous rise in vaping that we have observed over the past decade, one would certainly expect to see that translate into a substantial increase in the prevalence of youth smoking. As I pointed out yesterday, an analysis by Dr. Brad Rodu demonstrated that in 2011, smoking prevalence among high school students was 15.7%, while the prevalence of vaping was just 1.4%. By 2022, the prevalence of vaping among high school students had skyrocketed up to 14.1%, yet smoking among high school students dropped to just 2.0%. And by 2024, smoking prevalence among high school students was only 1.7%.

These data definitively refute the contention that e-cigarettes are a gateway to smoking among youth and are completely inconsistent with the claim that e-cigarette use leads to a 5-fold increase in youth smoking initiation rates. 

Interestingly, the article in question fails to provide any citation or source for its preposterous claim that vaping is greatly accelerating the initiation of smoking by youth. Apparently, we are supposed to just take it on faith that this is true.

The article also makes two additional assertions that are hard for me to believe are still being made in 2024. 

First, the article claims that: "At least 4.5% of adults, 10% of high school students, and 4.6% of middle school students now use tobacco e-cigarettes." The problem with this statement is that there are no such things as "tobacco e-cigarettes." By definition and by intention, electronic cigarettes do not contain any tobacco. That is the entire point! If an e-cigarette did contain tobacco then I would not consider it to be an e-cigarette; it would be a heated tobacco product. Even the American Cancer Society admits that e-cigarettes do not contain tobacco. 

It has now been 17 years since e-cigarettes were first introduced in the United States. One would have thought that by now, smoking cessation experts of all people would appreciate the fact that the unique selling proposition for e-cigarettes is that they do not contain tobacco.

Second, the article claims that: "Nonetheless, in one trial, up to 80% of those who ceased tobacco cigarette smoking for 12 months with e-cigarettes continued to smoke e-cigarettes." This is apparently news to the authors of this commentary but you do not smoke an e-cigarette. You vape an e-cigarette. This is why e-cigarette use is referred to as vaping rather than smoking. E-cigarettes do not produce any smoke because they involve no combustion. Again, that is the entire point!  

It has now been 17 years since e-cigarettes were first introduced in the United States. One would have thought that by now, smoking cessation experts of all people would appreciate the fact that the unique selling proposition for e-cigarettes is that they do not involve any combustion and therefore do not produce any smoke; hence, you cannot smoke an e-cigarette. 

The question arises, then, whether the authors of this commentary are really so uninformed about the nature of e-cigarettes that they simply are not aware that these products do not contain tobacco and do not involve combustion, or whether they are intentionally using smoking-related terminology to create the impression that vaping and smoking are essentially equivalent.

American Heart Association and American Cancer Society are Still Spreading Misinformation about Vaping

After the start of the COVID-19 pandemic, I took an almost complete break from blogging about tobacco policy to concentrate on some other public health topics. Now that more than 4 years have passed, I decided to take a look at the websites of some of the major national health organizations to see whether they have started to accurately communicate the facts about vaping and smoking. I figured that during the past 4 years there has been so much definitive science about the relative risks of vaping and smoking, the cause of EVALI, the question of whether youth vaping is a gateway to smoking, and the effectiveness of vaping in helping smokers quit that the major anti-tobacco groups would by now be communicating accurately to the public. I also figured that with all the public attention being given to misinformation, these groups would certainly be a lot more careful about the validity of the public claims they were making.

I start today by reviewing recent "fact" sheets from the American Heart Association and the American Cancer Society.

American Heart Association

In a 2024 article entitled "Is Vaping Better than Smoking," the American Heart Association makes the following claims:

1. "E-cigarette promoters claim the devices can help people quit smoking. But much more evidence is needed to determine if they are an effective way to quit. Research suggests that users are more likely to continue smoking along with vaping, which is referred to as dual use."

2. "Many people think vaping is less harmful than smoking. While it’s true that e-cigarette aerosol doesn’t include all the contaminants in tobacco smoke, it still isn’t safe."

3. "E-cigarettes have been linked to thousands of cases of serious lung injury, some resulting in death. While the exact cause is still not confirmed, the CDC recommends that people not use e-cigarettes."

4. "E-cigarettes’ biggest threat to public health may be this: The increasing popularity of vaping may “re-normalize” smoking, which has declined for years. Reversing the hard-won gains in the global effort to curb smoking would be catastrophic."

American Cancer Society

In a November 7, 2024 article on the risks of vaping and smoking, the American Cancer Society makes the following claims:

1. "Misconception: Many people believe vaping doesn’t carry the same health risks as cigarette smoking because e-cigarettes do not contain tobacco."

2. "Misconception: Some people also think vaping is safer than smoking because they believe the vapor from e-cigarettes does not contain the same harmful chemicals as smoke."

The Rest of the Story

Let's analyze each of the above claims. Below are the claims followed by the actual facts.

American Heart Association

In a 2024 article entitled "Is Vaping Better than Smoking," the American Heart Association makes the following claims:

1. "E-cigarette promoters claim the devices can help people quit smoking. But much more evidence is needed to determine if they are an effective way to quit. Research suggests that users are more likely to continue smoking along with vaping, which is referred to as dual use."

The Truth: There is plentiful evidence that e-cigarettes can help smokers quit. The most recent evidence found that among smokers who tried vaping daily in an attempt to quit smoking, more than one-fourth (28%) quit smoking successfully. In the most recent clinical trial of vaping as a smoking cessation aid, subjects who were randomly assigned to receive e-cigarettes were twice as likely to quit smoking as those who did not receive e-cigarettes. As of 2022, there were 6.1 million e-cigarette users who had quit smoking by switching to vaping. If 6 million successful ex-smokers is not enough evidence to show that e-cigarettes are an effective way to quit, then no data ever will be for the American Heart Association. This is blatant misinformation.

2. "Many people think vaping is less harmful than smoking. While it’s true that e-cigarette aerosol doesn’t include all the contaminants in tobacco smoke, it still isn’t safe."

The Truth: This is intentional misinformation. The American Cancer Society avoids telling an overt lie by failing to explicitly answer the question. They intentionally use the word "safe" rather than "safer." However, few readers are going to pick this up and the implication of the first sentence is that the belief that vaping is less harmful than smoking is untrue. The clear intention here is to mislead the public into believing, falsely, that vaping is just as harmful as smoking. Even my long-time hero and mentor - Dr. Stan Glantz - acknowledges that smoking is more dangerous than vaping. And the Food and Drug Administration has concluded unequivocally that smoking is more hazardous than vaping.

 3. "E-cigarettes have been linked to thousands of cases of serious lung injury, some resulting in death. While the exact cause is still not confirmed, the CDC recommends that people not use e-cigarettes."

 The Truth: This is essentially an outright lie. Vaping THC carts, not e-cigarettes, was shown to be the cause of the so-called EVALI outbreak of serious lung injury that resulted in many deaths. The cause has been confirmed. The lung injury was caused by vitamin E acetate, a substance added to black market THC vapes to create the illusion of a more concentrated product so that it would reap in more money on the street. There is no evidence that e-cigarettes (nicotine-containing vapes produced for what at the time was an entirely legal market) have caused a single case of severe or fatal lung injury.

4. "E-cigarettes’ biggest threat to public health may be this: The increasing popularity of vaping may “re-normalize” smoking, which has declined for years. Reversing the hard-won gains in the global effort to curb smoking would be catastrophic."

The Truth: This statement is the exact opposite of the truth. Rather than re-normalize smoking, vaping has hastened the near complete elimination of smoking among youth. A brilliant analysis by Dr. Brad Rodu has revealed that the use of electronic cigarettes among youth has not served as a gateway to increased smoking but on the contrary has led to the virtual disappearance of smoking among high school youth. In 2011, smoking prevalence among high school students was 15.7%, while the prevalence of vaping was just 1.4%. In 2022, the prevalence of smoking among high school students dropped to just 2.0%, even though past-month vaping prevalence increased to 14.1%. It should be noted that in 2024, e-cigarette use among high school students dropped to 7.8%, while smoking declined further to 1.7%. Second only to e-cigarettes causing popcorn lung and possibly to e-cigarettes causing EVALI, the claim that youth vaping is a gateway to smoking has to go down in history as one of the greatest tobacco-related myths of all time not propagated by Big Tobacco.

American Cancer Society

In a November 7, 2024 article on the risks of vaping and smoking, the American Cancer Society makes the following claims:

1. "Misconception: Many people believe vaping doesn’t carry the same health risks as cigarette smoking because e-cigarettes do not contain tobacco."

The Truth: Like the nearly identical claim by the American Heart Association, this appears to be intentional misinformation. The clear implication is that these people--who believe vaping doesn't carry the same health risks as smoking--are wrong. Thus, the American Cancer Society is suggesting to readers that vaping does carry the same health risks as cigarette smoking. The truth, however, is that the Food and Drug Administration has concluded unequivocally that smoking is more hazardous than vaping.

2. "Misconception: Some people also think vaping is safer than smoking because they believe the vapor from e-cigarettes does not contain the same harmful chemicals as smoke."

Like the claim above, the clear implication is that these people--who think vaping is safer than smoking--are wrong. Thus, the American Cancer Society is again suggesting to the public that vaping is just as hazardous as smoking. This is unequivocally false.

Conclusion

In this age of misinformation as well as distrust of health authorities, it is more important than ever that public health organizations communicate accurately, honestly, and transparently with the public. After being away from blogging about tobacco issues for about 4 years, it is extremely disappointing for me to come back and find the situation no better than when I left. It is difficult for me to believe that this has now been going on for 15 years. It all started with that 2009 press conference when the FDA announced it was seizing e-cigarette products of Smoking Everywhere and NJOY. That was when what was to become a decade and a half long campaign of disinformation about electronic cigarettes began. It is disheartening to know that we are still talking about this campaign of disinformation in the present tense. And so the battle for truth and honesty within public health continues.

New Data Show that E-Cigarettes are Saving Lives and Debunk Claims by Opponents that Vaping is a Gateway to Smoking

The claim by opponents of e-cigarettes that vaping is a gateway to smoking and will increase the long-term hazards of tobacco product use have now been completely debunked by longitudinal trend data demonstrating that the truth is the exact opposite.

The results of a Gallup poll conducted last month revealed that adult smoking prevalence has reached an all-time low (11%) and that the decline in smoking has been driven largely by a dramatic drop in smoking among young adults. The prevalence of smoking among adults ages 18-29 was only 6%.

The Rest of the Story

What caused this dramatic decline in smoking among adults, and especially young adults? The data suggest that use of electronic cigarettes is the primary reason for the dramatic declines in smoking observed over the past few years. The amount of decline in smoking prevalence is very similar to the increase in e-cigarette use. Among adults, approximately 7% reported vaping in the past week. Among young adults, approximately 18% reported vaping in the past week.

These data confirm the results of numerous other studies which have demonstrated that cigarettes and e-cigarettes are economic substitutes. This means that e-cigarettes have served as a much lower risk alternative option for youth who most likely otherwise would have smoked cigarettes. And because of this substitution effect, it is very difficult to find a young adult today who is smoking tobacco cigarettes. Another way of putting this is that we have almost completely eradicated tobacco use among young adults. And of course, this means that as these young people age, we are on a path to eradicate cigarette smoking entirely.

The public health benefits that will accrue from these long-term trends will be mind-boggling. While not supported by most tobacco control organizations and agencies, the advent of electronic cigarettes will -- if trends are allowed to continue -- one day be looked at as the end game strategy that made smoking history. 

Sadly, many of the tobacco control groups and health organizations that have opposed vaping from the beginning and made many false claims about both the gateway effect and the health effects of e-cigarettes will not be able to take credit for the millions of lives that will be saved because of this innovation. If anything, they have done everything they can to prevent this life-saving intervention from taking place.

And ironically, it was the regulation of vaping products that almost brought the whole project to an end. What saved the day was the loophole in the regulation that allowed disposable e-cigarettes to remain on the market.

It will be very interesting to hear what the major tobacco control groups say now that there is very clear evidence that vaping was responsible for decimating smoking among today's generation of young adults. Since it is rare for people to start smoking as adults, the prevalence of smoking among this cohort of young people will almost certainly not rise above 6%. This is undoubtedly the greatest public health victory of my lifetime.

Why is Congress Interfering With Science to Protect the Alcohol Industry?

Background

In 2004, the U.S. Department of Health and Human Services created an interagency committee to direct federal efforts to reduce underage drinking. The committee, which is called the Interagency Coordinating Committee on the Prevention of Underage Drinking (ICCPUD), is led by the Substance Abuse and Mental Health and Mental Health Services Administration (SAMHSA) and includes agencies such as the Centers for Disease Control and Prevention (CDC), the Surgeon General, and the National Institute on Alcohol Abuse and Alcoholism (NIAAA), which is part of the National Institutes of Health (NIH). 

The ICCPUD recently decided to undertake a study, which it calls the Alcohol Intake and Health Study, to review the scientific evidence on the health effects of alcohol. In part, this study is intended to inform the upcoming development of the 2025 Dietary Guidelines, which will presumably make a recommendation regarding the use of alcohol as it relates to health. The current guideline (2020-2025) recommended as follows: "A healthy dietary pattern doesn’t have much room for extra added sugars, saturated fat, or sodium—or for alcoholic beverages. ... Adults of legal drinking age can choose not to drink, or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed. Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant."

After the ICCPUD had begun its review process, the alcohol industry successfully lobbied Congress to fund another study, this one to be conducted by the National Academy of Sciences, Engineering, and Medicine (NASEM), to also review the health effects of alcohol consumption with an eye towards informing the 2025 Dietary Guidelines.

The NASEM study was tainted by alcohol industry influence from the start. As I revealed this past January, NASEM selected two researchers with severe conflicts of interest with the alcohol industry to be on its review panel. These two alcohol industry-funded researchers (Dr. Kenneth Mukamal and Dr. Eric Timm) were principal investigators in a research grant funded by the alcohol industry, to the tune of $67 million, which promised in advance to produce findings showing that moderate alcohol consumption is good for one's health. The principal investigator actually courted the alcohol industry funding by essentially promising Big Alcohol positive results (meaning a positive overall effect of moderate drinking on health). 

After the story of this scandal was broken by Roni Rabin of the New York Times, NASEM backtracked and removed the two conflicted researchers from the panel. However, one of the scientists they chose as a replacement (Dr. Luc Djousse) was another conflicted researcher with a history of alcohol industry funding. This scandal, too, was broken by Roni Rabin, but this time NASEM did not relent.

The Story

Three weeks ago, 25 members of Congress wrote a letter to the director of the NIAAA suggesting that it was inappropriate for ICCPUD to study the health effects of alcohol use, that this was duplicative of the work by NASEM, and questioning the appointment of four specific researchers to serve on a scientific review subcommittee to inform ICCPUD's consideration of the scientific issues around alcohol consumption and health. In addition, the letter claimed that: "ICCPUD participants have already formed an opinion and are working towards a predetermined result." Two of the researchers who the Congressmembers called out were Dr. Tim Naimi and Dr. Kevin Shield.

Ultimately, the letter asserts that the ICCPUD is not an appropriate body to be reviewing the health effects of alcohol, asking: "Is an interagency coordinating committee tasked with stopping underage drinking an appropriate venue to conduct a comprehensive review of legal adult alcohol consumption?"

The Rest of the Story

This letter is an absolutely inappropriate intrusion into the scientific workings of the federal public health agencies that are entrusted with protecting the nation's health. Congress has no business interfering with research being conducted by the National Institutes of Health, with the sole exception of impropriety in the research, such as undue financial influence by corporate interests or research misconduct. 

Here, the opposite is occurring. These members of Congress are clearly intervening to protect the interests of the alcohol industry, whether intentionally or not. It certainly has the appearance of undue alcohol industry influence and there is enough evidence of wrongdoing in the degree of alcohol industry influence on the 2025 Dietary Guidelines that I believe the Inspector General of the House should conduct an investigation to determine whether the alcohol industry played any role in this unseemly and political encroachment on the ability of the NIH to conduct independent and unbiased research.

The question of whether an interagency coordinating committee tasked with stopping underage alcohol use is an appropriate venue to conduct a review of the health effects of alcohol is laughable. Are these members of Congress seriously suggesting that CDC, NIH, DHHS, NIAAA, NIDA, and SAMHSA are not the appropriate agencies to be involved in a review of the scientific evidence regarding alcohol use and health? 

If, in fact, these members of Congress are successful in their attempt to intimidate these federal public health agencies into halting their scientific review of the health effects of alcohol, it would be a travesty because it would be yet another example of politics interfering with science. And the very thing that these members of Congress are purporting to try to prevent--conflict of interest--is precisely what they are introducing into the process by suggesting that NASEM is the only body that should conduct this review. The NASEM review is being conducted at the behest of the alcohol industry in the first place. That is the likely explanation for the attempt to pack the expert panel with alcohol industry-funded researchers and for the replacement of the experts whose conflicts of interest were called out with another scientist who has a conflict of interest by virtue of previous funding from Big Alcohol.

Incidentally, Dr. Tim Naimi and Dr. Kenneth Shield are unassailable in terms of their qualifications to review the health effects of alcohol and in terms of their scientific objectivity and absence of conflicts of interest.  

Dr. Naimi "received his bachelor’s degree from Harvard College, his M.D. degree from the University of Massachusetts, and his M.P.H degree from the Harvard School of Public Health. He completed a combined internal medicine-pediatrics residency program at the Massachusetts General Hospital, the Epidemiologic Intelligence Officer program with the Centers for Disease Control and Prevention (CDC), and a preventive medicine residency with the CDC. Prior to his time at Boston Medical Center, Dr. Naimi worked as a clinician for the U.S. Indian Health Service, and as a senior epidemiologist with the Alcohol Team at CDC. His current research interests, for which he receives grant support from the National Institutes of Health and CDC, include binge drinking, youth drinking, health effects of low-dose ethanol, and substance use policy including the impact of alcohol control policies, cannabis policies, and opioid policies on substance use and other health outcomes. He has co-authored more than 100 published manuscripts and book chapters." Moreover, he has never received any funding from the alcohol industry so he is clear of any financial conflicts of interest that would disqualify him from being a part of the scientific review subcommittee, unlike Dr. Djousse.

Dr. Shield "is a scientist with the Institute for Mental Health Policy Research at the Centre for Addiction and Mental Health (CAMH), and an assistant professor in the epidemiology division of the Dalla Lana School of Public Health at the University of Toronto. Dr. Shield is also the head of the World Health Organization (WHO)/Pan American Health Organization (PAHO) Collaborating Centre in Addiction and Mental Health at CAMH. Dr. Shield’s multi-disciplinary public health surveillance research programs generate scientific data that inform individuals, clinicians and policymakers on how best to reduce the public health harms caused by alcohol and other drugs." He conducts research to estimate "the first- and second-hand mortality and morbidity attributable to alcohol consumption at the country and global levels," which is a perfect fit for the review subcommittee. Most importantly, he has no history of alcohol industry funding; thus, there is no financial conflict of interest as there is with Dr. Djousse.

The Congressional letter makes the error of asserting that if a researcher has previously asserted a position on a scientific issue, that represents a conflict of interest. This is a bogus argument because if true, it would mean that no scientist could ever conduct more than one study on a topic before having a conflict of interest. If such an absurd policy were adopted, the only scientists who could serve on review panels would be those who don't know a thing about the topic being discussed!

In the field of scientific ethics, the worldwide accepted consensus is that conflicts of interest occur when an investigator has financial interests (including research funding) with an entity (typically a corporate entity) whose financial status could be affected by the results of the research. Thus, funding by the alcohol industry is a clear conflict of interest. Having written a previous scientific article about a topic is not.

Ironically, despite my previous criticism of the NIAAA for its previous relationship with the alcohol industry, the Institute appears to be holding fast to scientific principles and not allowing the alcohol industry to direct its work. I praise Dr. Koob (NIAAA director) for changing the ethic in his institute and not allowing politics to interfere with science. I trust that he will ignore or dismiss this undue intrusion into the scientific working of his institute.

Note: This commentary is being submitted as a formal complaint to the Office of the Inspector General of the U.S. House of Representatives.

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.

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.

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. 

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!

 

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.

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.

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:

• vaping causes brain, bone, and lung injury to young people;

• 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

•  vaping exposes users to metals in the lungs that can cause lung cancer.

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.