Thursday, February 21, 2019

SRNT Under Fire for Accepting Sponsorship Money from E-Cigarette Company for Annual Meeting

Controversy is brewing in San Francisco this week as it was revealed that the Society for Research on Nicotine and Tobacco (SRNT) accepted money from an e-cigarette company to sponsor its annual meeting which is being held this week.

It was reported this morning that SRNT accepted funding from GreenSmokeKloud, an e-liquid distributor whose products are competing with nicotine replacement therapy and Chantix for a share of the smoking cessation market.

Critics pointed out that sponsorship of the conference by GreenSmokeKloud presents a severe conflict of interest because its products are being used for smoking cessation and the SRNT conference involves numerous presentations dealing with the effectiveness or lack of effectiveness of e-cigarettes and vaping products similar to or including those manufactured by GreenSmokeKloud.

Stanley Glanton, a professor at CFSU, told The Rest of the Story that: "This is a clear-cut conflict of interest. You can't have a conference sponsored by a company that makes products which are being discussed at scientific sessions. How can we have an objective conversation about electronic cigarettes and the epidemic of youth vaping when GreenSmokeKloud signs are all over the place and conference attendees know that this company is a major sponsor of the conference?"

Several tobacco control researchers pointed out that the Food and Drug Administration is actually presenting at the conference and the FDA has regulatory jurisdiction over vaping products, creating a further conflict of interest. They also pointed out that a major theme of the research being presented is what should be the appropriate role of vaping products in smoking cessation efforts and that GreenSmokeKloud has a vested interest in the outcome of those discussions.

"You might as well just give them a seat at the table," complained one smoking cessation researcher. "They may not be physically or consciously affecting the presentations, but subconsciously everyone knows that GreenSmokeKloud is sponsoring the conference and if we diss them in our presentations, it's unlikely that they will sponsor SRNT next year. It's inappropriate that whether SRNT can get the same sponsorship money next year may actually depend on what is said or not said in the scientific presentations."

Another tobacco researcher agreed: "If the consensus at this conference is that vaping products are really not an effective smoking cessation tool and there is too much risk of youth addiction, you can bet that GreenSmokeKloud will back out of next year's conference. Let's not forget that this is a corporation whose primary goal is to make money. If their products are not cast in a positive light, they will have no incentive to return next year."

Although each speaker discloses their conflicts of interest, some conference attendees have suggested that every speaker should be required to disclose that GreenSmokeKloud is a sponsor of the conference itself. According to Dr. Glanton: "It needs to be remembered that GreenSmokeKloud is casting a cloud on this entire conference. If a vaping company is sponsoring the conference, attendees should be reminded of that at the beginning of each and every presentation, especially if the talk is evaluating e-cigarettes in terms of their use in smoking cessation."

The Rest of the Story

Wait a minute. I apologize. I just received word that I got the story slightly wrong. GSK is indeed sponsoring the conference, but GSK doesn't stand for GreenSmokeKloud, it stands for GlaxoSmithKline, and it's not producing vaping products for smoking cessation, it's producing nicotine replacement products for smoking cessation. Also, Pfizer is another conference sponsor and they produce Chantix, a drug that is marketed for smoking cessation.

Indeed, according to the official SRNT program, GlaxoSmithKline and Pfizer are both major sponsors of the conference.

After the tobacco researchers quoted above were informed of my mistake, they all retracted their statements and told me that they saw nothing wrong with these pharmaceutical companies sponsoring the conference, even though they make products whose effectiveness is being discussed at the conference and their financial well-being depends on the consensus that may develop at the conference based on the content of the presentations that directly address their effectiveness.

"We don't see any conflict of interest here and the financial support of these corporations is necessary to continue to hold these important conferences," one of the researchers told me.

Since being informed of my mistake, everything has calmed down and it is back to business as usual at the SRNT conference.

Monday, February 18, 2019

Landmark Study Fails to Find Any Evidence that Vaping is a Gateway to Smoking among Youth

A landmark study, published on January 25 in the Journal of the National Cancer Institute, found no evidence that vaping is a gateway to smoking among youth. The data come from the largest, longitudinal study of youth smoking initiation -- the PATH (Population Assessment of Tobacco and Health) study -- and include two waves of observations on nearly 12,000 U.S. youth.

The surveys asked numerous questions about both vaping and smoking behavior, including the frequency of these behaviors. It also assessed numerous risk factors for smoking that can be controlled for in multivariate analyses of smoking initiation rate differences between various groups. The baseline survey was conducted in 2013/2014 and the one-year follow-up survey occurred in 2014/2015. 

The main reported finding of the study was that ever use of e-cigarettes at baseline is a risk factor for ever use of cigarettes at follow-up. This is consistent with the findings of several other studies.

The Rest of the Story

Buried deep within the article is the rather startling, but most critically relevant finding of the entire study: The investigators were unable to report a single youth out of the 12,000 in the sample who was a cigarette naive, regular vaper at baseline who progressed to become a smoker at follow-up. Why? Because the number of these youth was so small that it was impossible to accurately quantify this number.

Based on my own calculations from the data presented, out of the 12,000 youth, there were only 21 who were even past 30-day e-cigarette users at baseline (cigarette naive) who progressed even to ever smoking at follow-up. These youth reported using e-cigarettes only 1-5 days in the past 30 days at baseline, so it is not even clear that they were regular vapers. They literally could have tried an e-cigarette once 30 days earlier.

It is possible that vaping was not a gateway to smoking for any of these 21 youth, but even if it was, they represent just 0.2% of the youth population.

In addition, the study found that although ever use of e-cigarettes increased the risk of smoking initiation, recent use of e-cigarettes (within the past 30 days) did not increase the risk of smoking initiation. This finding is consistent with the hypothesis that youth who try e-cigarettes and do not particularly enjoy them such that they become regular users are the ones who are more likely to try smoking, but that youth who actually become vapers are not any more likely to subsequently try a real cigarette.

The bottom line is that despite the widespread claims that vaping is a gateway to smoking initiation among youth, the most definitive study to date of this issue fails to provide any evidence to support that contention. If anything, it provides evidence suggesting that vaping acts as a kind of diversion that can keep some youth away from cigarette smoking.

We will certainly need to await the results from future waves of the PATH study to have a clearer idea of the trajectory of youth vaping and smoking, but at the present time, I do not believe there is any evidence that vaping serves as a gateway to smoking among youth. In contrast, the evidence to date suggests that a culture of vaping is replacing, not enhancing, a culture of smoking.

Saturday, February 09, 2019

Researchers Tell Public that Vaping Causes COPD as Scientific Rigor in Tobacco Control Drops to an All-Time Low

Based on the results of a cross-sectional study showing an association between using e-cigarettes and reporting that one has ever been told they have COPD (chronic obstructive lung disease), a number of researchers have essentially concluded that vaping causes COPD, and one researcher is telling the public that use of e-cigarettes increases one's risk of COPD just like cigarettes.

The paper, published in Drug and Alcohol Dependence, reports the results of a cross-sectional study based on the 2016 Behavioral Risk Factor Surveillance System (BRFSS) survey in Hawaii. The outcome variable was reporting ever having been told that one has COPD. The main predictor variable was ever having used an e-cigarette. The key finding of the study was that: "there was a significant association of e-cigarette use with COPD among nonsmokers (AOR = 2.98, CI 1.51–5.88, p <  .01), but the association was not significant among smokers (AOR = 1.29, CI 0.94–1.77, ns.)."

The paper concludes that: "The fact that findings for respiratory symptoms occurred primarily for nonsmokers argues against several alternative interpretations of the results." In other words, the paper is essentially arguing that this is most likely a causal effect (i.e., vaping causes COPD).

The Rest of the Story

There is absolutely no way one can conclude, or even speculate, based on the results of this cross-sectional study, that vaping is a cause of chronic obstructive lung disease. Remember, we are talking here about emphysema and chronic bronchitis (that's what is meant by COPD).

To see how ridiculous such a conclusion, or even such speculation is, one needs only to look at the sample size of never smokers in the 2016 Hawaii BRFSS who were current e-cigarette users and reported having COPD. It's 13 (based on the CDC's BRFSS online analysis tool). According to the article itself, the total sample of never smokers who were current vapers was only 45. A simple bivariate online analysis of the relationship between ever use of e-cigarettes and ever diagnosis of COPD among the never smokers in the 2016 Hawaii BRFSS reveals no significant association.

If you do the same analysis using the entire 2016 BRFSS (including all states), the proportion of never smokers who report having been diagnosed with COPD is actually higher among non-vapers (2.9%) than ever vapers (2.4%).

It's not just that there are dangers with drawing causal conclusions like this from a cross-sectional study. In this case, the sample size upon which the conclusion is being drawn is so low that the analysis is not at all reliable to begin with.

The paper ignores (and does not cite a single article from) a body of literature showing that smokers with COPD who switch to electronic cigarettes experience an improvement in their symptoms.

However, the worst problem with these conclusions (and even with the speculation) is that it is biologically implausible that vaping for a few years can cause emphysema or chronic bronchitis. Since vaping did not become widely popular until about 2011, the average number of years that the vapers in the 2016 Hawaii BRFSS used e-cigarettes could not be more than about five years.

There is simply no way that you can develop COPD from vaping for five years. Even among heavy chain smokers, it takes several decades before they develop COPD. I'm not aware of more than a handful of smokers who were diagnosed with COPD (caused by smoking) before they reached the age of 40. Population-level data show that the observed increase in COPD incidence among smokers does not begin until about age 45.

Even assuming that someone did not start smoking until they reached 20, it still takes a minimum of two decades of smoking to do enough damage to the lungs that a person develops and is diagnosed with COPD. So how can you get COPD from vaping (which is even less frequent than smoking) for just a few years?

People are just not thinking. The idea that there are a substantial number of never smokers in Hawaii who have developed COPD after just a few years of vaping is absurd on its face.

This leads me to believe that there is a strong, subconscious bias among many researchers who are so determined to find an association between vaping and chronic disease that they are forgetting basic pathology.

Moreover, there have not even been anecdotal reports of nonsmokers developing COPD after a few years of vaping. And clinical studies have failed to detect any decline in lung function, as measured by spirometry, among vapers.

Furthermore, if vaping was causing COPD, we would expect to see an increase in the prevalence of COPD over the past few years, especially since vaping rates started to increase exponentially starting in about 2011. Instead, we see little if any change in COPD prevalence since 2011.

The reason this is all so disturbing to me is not simply that it shows how scientific rigor in tobacco control literature has deteriorated. It is disturbing because disseminating these scientifically unsupported claims is going to discourage many smokers from trying to quit using e-cigarettes and may even cause many former smokers to return to smoking. After all, if you can get COPD from vaping, then why not go back to the real thing?

The unsupported, sweeping, hysterical conclusions being drawn from these studies are not just scientifically poor, they are causing harm to the public's health as well.

Sunday, February 03, 2019

Having Health Insurance Increases Your Risk of a Heart Attack, and Other Cross-Sectional Study Foibles

Later this week, a research study will be presented at the International Stroke Conference in Hawaii that purports to show that vaping increases the risk of heart attacks. In a recent post, I showed that this research is fatally flawed because it violates the basic principle in epidemiology that correlation does not equal causation. The study found a correlation between using e-cigarettes and ever having had a heart attack. The authors conclude that vaping must therefore increase heart attack risk. However, the more likely explanation is the opposite: smokers who experience a heart attack are more likely to try to quit smoking and therefore more likely to use e-cigarettes.

As an exercise, I used the same data (the 2016 Behavioral Risk Factor Surveillance Survey) to show that by the same reasoning, making a quit attempt increases your risk of a heart attack.

Here are some other factors that increase your risk for a heart attack, based on the 2016 BRFSS:
  • Having health care insurance (67% increase in heart attack risk)
  • Having a health care provider (174% increase)
  • Going to the doctor annually for a routine physical exam (150% increase in risk)
  • Having ever received the pneumonia vaccine (253% increase in risk)
  • Ever having had a mammogram (52% increase in risk)
So according to anti-vaping researcher logic, obtaining health care insurance, obtaining a health care provider, going to the doctor for routine exams, getting vaccinated for pneumonia, and having a mammogram all increase your risk of a heart attack.

By the way, the same analysis reveals that compared to vaping only occasionally, you reduce your risk of a heart attack substantially if you vape every single day.

In fact, daily vapers are at lower risk of having reported a heart attack than people who never vaped!

Junk Science Exposed: New Study Purports to Show that E-Cigarettes Increase Heart Attack Risk

According to the headline of a UPI news story from last week, vaping has been linked to an increased risk of having a heart attack. This research finding was reported worldwide, including a scary headline in London's Sunday Express reading: "New research claims vaping raises risk of deadly heart attacks and strokes."

This finding is profoundly important because if e-cigarette use does indeed increase heart attack risk, then the role of vaping in harm reduction comes into serious question.

The news headline stems from a paper that is being presented this week at the American Stroke Association’s International Stroke Conference in Hawaii.

According to the news coverage, the researchers used cross-sectional data from the 2016 Behavioral Risk Factor Surveillance Survey (BRFSS) and found that ever use of e-cigarettes increased the risk of reporting ever having had a heart attack, while controlling for age, gender, body mass index, history of diabetes, and smoking status. The same was true for the risk of reporting ever had a stroke.

While the abstract itself does not appear to be publicly available, the news articles report that the study found a 59% increase in heart attack risk associated with the use of e-cigarettes. According to one article: "The American Heart Association has subsequently cautioned the public against using e-cigarettes."

The Rest of the Story

It is irresponsible to use the results of this cross-sectional study to conclude (or even suggest) that e-cigarette use increases heart attack or stroke risk. Why? Because the study only assessed the relationship between "ever" having used e-cigarettes and "ever" having had a heart attack. The study has no information on which came first. In other words, it is entirely possible (and in fact quite likely) that the majority of respondents who reported having used e-cigarettes and having had a heart attack actually suffered the heart attack first and then subsequently started using electronic cigarettes because they were desperate to quit smoking after experiencing this life-threatening event.

A similar study (this one using cross-sectional data from the National Health Interview Survey) was published in the American Journal of Preventive Medicine last year and is subject to the same fatal flaw: it is highly likely that people who experienced a heart attack began using e-cigarettes in an attempt to quit smoking.

Trying to Quit Smoking Increases Your Risk of Having a Heart Attack

Using the same methodology as these studies, I examined the relationship between trying to quit smoking and heart attack risk. I used the 2016 BRFSS and modeled the risk of having had a heart attack as a function of having tried to quit smoking (and succeeding for at least one day). I controlled for age, gender, body mass index, diabetes, and smoking status.

The results:

Making a serious quit attempt is associated with a significant increase in heart attack risk. It actually increases your heart attack risk by 41%.


Obviously, what is going on here is not that quitting smoking increases your risk of having a heart attack. Instead, what is happening is that smokers who experience a heart attack are more likely to try to quit smoking.

But the same reasoning used by researchers to conclude that vaping increases heart attack risk supports the conclusion that trying to quit smoking increases heart attack risk.

For that matter, one could show that use of asthma inhalers is associated with an increased risk of having asthma, that use of insulin is associated with an increased risk of diabetes, or that the consumption of gluten-free food increases your risk for Celiac disease (caused by gluten allergy).

For those who are curious, trying to quit smoking is associated with a 38% increase in the risk of stroke.

Clearly, physicians should warn their smoking patients not to try to quit, as quitting appears to be associated with an increased risk of heart disease and stroke.

Sadly, we don't have to recommend that physicians counsel smokers not to try to quit -- the American Lung Association is already doing that.

Saturday, February 02, 2019

Does the American Lung Association Really Hate Smokers So Much that They Discourage Quit Attempts Using E-Cigarettes Despite New Clinical Trial Evidence of their Superiority to NRT?

On Wednesday, the New England Journal of Medicine published a new study that reported the results of a one-year randomized, clinical trial in which e-cigarettes were compared to nicotine replacement therapy (NRT) to aid smoking cessation. The study was conducted in the UK, and both treatments were accompanied by behavioral counseling. The result: "The 1-year abstinence rate was 18.0% in the e-cigarette group, as compared with 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence interval [CI], 1.30 to 2.58)."

This is the most definitive study yet on the effectiveness of electronic cigarettes for smoking cessation. It found that one-year smoking cessation rates with e-cigarettes were nearly twice those obtained using NRT. Although one must exercise caution in generalizing the results to the U.S., this evidence pretty much blows out of the water the claim being made by some anti-nicotine advocates that vaping actually inhibits smoking cessation.

A previous clinical trial conducted in New Zealand had found that e-cigarettes were as effective as NRT for smoking cessation, but that trial used first-generation e-cigarettes that are not thought to be as effective as products currently on the market.

This is great news for smokers, as it suggests that switching to vaping is another smoking cessation option that can be added to those already available. Certainly, for smokers who try to quit but fail with other therapies--like NRT--trying e-cigarettes is a strong and viable option. It may also be appropriate at this point for physicians to encourage smokers who want to quit and are open to trying e-cigarettes to make an attempt to switch to vaping even if they have not failed with other cessation approaches.

The Rest of the Story

So here is what the American Lung Association had to say in response to the study:

"The US Food and Drug Administration has not found any e-cigarette to be safe and effective in helping smokers quit. We only support methods that are FDA approved and regulated. Switching to e-cigarettes does not mean quitting. Quitting means truly ending the addiction to nicotine, which is very difficult."

In other words, the American Lung Association is saying that despite this clinical trial demonstrating that e-cigarettes are probably much more effective than NRT for smoking cessation, they would rather smokers continue smoking than make a quit attempt using electronic cigarettes.

The American Lung Association is stating that it does not "support" the use of e-cigarettes by smokers. This means that if a smoker is not willing to try NRT or a pill, then the American Lung Association would not recommend that they try quitting with e-cigarettes as an alternative.

Not only that, but according to this statement, the American Lung Association will never support the use of e-cigarettes because it will only do so once the FDA approves vaping as a cessation method, which will not and cannot happen. The FDA cannot approve e-cigarettes for smoking cessation because they are recreational products and not drugs. No manufacturer has ever applied to the FDA for approval of a vaping product as a smoking cessation method, and it is unlikely that will happen any time soon.

What could possibly explain why a public health organization that is supposed to be committed to improving lung health would actually discourage smokers from trying to quit using e-cigarettes, especially in the light of strong clinical trial evidence of their efficacy?

The only way I can reconcile this is to question whether subconsciously, the American Lung Association has so much hatred for smoking and smokers that they would actually prefer that a smoker continue to smoke and get sick from that smoking if they are not willing to use an FDA-approved pharmaceutical product. This is, after all, exactly what the organization is expressing. And although the reasoning behind this position is clearly not conscious, the only reasoning that could possibly explain it is some sort of underlying hatred of smokers and a desire to punish them if they don't try to quit "the right way" -- the "right way", of course, being defined by the American Lung Association.

It is important to note that the American Lung Association had a number of alternatives to its recommendation that smokers refrain from using e-cigarettes to quit. They could have recommended that NRT or pharmacotherapy remain a first-line approach, but that those smokers who fail to quit using NRT or pharmacotherapy may want to consider trying electronic cigarettes. They could have recommended that smokers switch to e-cigarettes and then try to wean themselves off the nicotine. Instead, the American Lung Association chose to make a blanket statement urging smokers not to try to quit using e-cigarettes.

I had thought that the tobacco control movement had reached its lowest point, but I never could have imagined that it would come to this: a national tobacco control organization has told smokers that they are better off continuing to smoke than trying to quit using an electronic cigarette. I don't think we can get any lower than this.

Thursday, December 27, 2018

"Truth" Campaign to Kids: Better to Smoke 19 Cigarettes than to Vape One Juul Pod

And this "Truth" Campaign "Fact" Isn't Even True

One of the oft-repeated "facts" being disseminated by the "truth" campaign is that one Juul pod is equal to 20 cigarettes worth of nicotine.

More specifically, the "truth" campaign claims, as its #1 most important fact about Juul that: "The amount of nicotine in one JUUL cartridge is roughly equal to the amount of nicotine in a pack of cigarettes."

Joining the "truth" campaign in spreading this factual information is the Centers for Disease Control and Prevention (CDC), whose web site currently states that: "a single JUUL pod contains as much nicotine as a pack of 20 regular cigarettes."

This "fact" has spread like wildfire. Just as one example, a parenting article in a news magazine writes: "Each JUUL pod contains the approximate equivalent to 1 pack of cigarettes, or 200 puffs. So, if a user goes through one JUUL pod a day, that is the nicotine equivalent of smoking a pack of cigarettes a day."

Similarly, the appropriately named "Scary Mommy" web site warns that: "one Juul “pod” contains 20 cigarettes worth of nicotine (that’s a pack of regular cigarettes)."

It's not just scary mommy blogs that are disseminating this "critical fact" about Juul. The high tech-site "Inc." has this to say about Juul: "The secret is its uniquely potent formula--a single pod contains roughly as much nicotine as a pack of smokes."

I could go on and on with examples. The Chicago Daily Herald reports that: "Most of Juul's single pods contain the same amount of nicotine as a pack of cigarettes." Collegiate Times tells readers that "Engineered to be much more convenient than a cigarette, JUULs are arguably more addictive as one pod is the equivalent of 20 cigarettes (or a typical pack of smokes)...". Vogue magazine reported that even "Dan from Poison Control" apparently informed one concerned caller that the amount of nicotine in a Juul  pod is exactly the same as the total amount of nicotine in an entire pack of cigarettes: "Dan from Poison Control called me back to say that a fresh Juul pod has the same amount of nicotine as 20 cigarettes."

One respiratory therapist warned that because a single Juul pod contains as much nicotine as a pack of cigarettes, a youth who vapes is in danger of dying from nicotine poisoning: "Juul, which is one of the most popular brands on the market, contains the equivalent of 20 cigarettes. Many times, a bottle of e-liquid can contain the same amount of nicotine as a pack of cigarettes. That means kids, who might like the flavor and puff, puff, puff and go through the entire container, are taking in 20 cigarettes worth of nicotine. This sudden increase in nicotine can lead to nicotine poisoning, a potentially fatal condition."

The Rest of the Story

There are two severe problems with this claim by the "truth" campaign.

First, the message that it is sending to kids is that you are better off smoking 19 cigarettes than vaping one Juul pod. This comparison certainly makes it sound like Juuling is a lot worse than smoking. And if that's the case, then the clear message is that you are better off smoking than Juuling.

That's clearly the message that the "truth" campaign and other anti-tobacco organizations and health agencies are sending to public health practitioners. For example, the National Center for Health Research informed its readers that vaping is no safer than smoking. A magazine devoted to asthma and allergies told its readers that e-cigarettes are no safer than cigarettes for kids with asthma.

This message is a potentially damaging one from a public health perspective. It undermines the public's appreciation of the severe hazards of smoking and obviously, if any kids end up smoking instead of Juuling because of this information, it could have disastrous consequences.

Apparently, I'm not the only one who sees the problem with this message. A number of young people took to Twitter with the same message:

"This JUUL thing is so Dumb I wanna smoke 19 Cigarettes."

"Hey guys.. time to smoke 19 cigarettes instead of a juul pod cause it’s better for you!!!!"

"Okay I’ll just smoke 19 cigarettes instead of my Juul now, thank you for the advice!"

 "yeah f__k the juul go smoke 19 cigarettes instead."

But there's a second, possibly more subtle problem with the claim:

It's not true.

It doesn't take an advanced math degree to fact-check this claim. We just need two pieces of information:

1. The most highly concentrated Juul pod (there are two concentrations) contains 40 mg of nicotine.

2. An average cigarette contains about 12 mg of nicotine.

Thus, a Juul pod contains the amount of nicotine equivalent to that in about 3 cigarettes (not 20 cigarettes).

Moreover, there is nothing terribly unique about the Juul in terms of nicotine content. There are hundreds of varieties of e-liquids on the market that contain 24 mg of nicotine per cartridge, with a cartridge delivering about 200 puffs, similar to a Juul pod. So in reality, the Juul contains less than twice the amount of nicotine present in many other electronic cigarettes.

Focusing on the nicotine content obscures a more important factor, one which does actually separate out Juul from most other vaping products. That factor is the rate of absorption of nicotine into the bloodstream. Because of the nicotine formulation used in Juul (i.e., a nicotine salt), it is absorbed rapidly into the bloodstream and the pattern of nicotine levels in the blood over time mimics that of cigarette smoking. This is unlike the pattern for almost every other type of electronic cigarette on the market, which uniformly deliver nicotine quite ineffectively and therefore have a low addiction potential. By focusing on the nicotine content, rather than the formulation, the "truth" campaign and CDC are obscuring the most important information that people need to understand.

This commentary is not to minimize the addictive potential of Juul, the fact that there is a high level of nicotine absorption from Juul (much higher than from almost all other e-cigarettes), or that the pattern of nicotine in the bloodstream over time produced by the Juul does mimic that of cigarette smoking. It is just to highlight that there are a lot of exaggerated claims out there and in addition to just being incorrect, some of these claims could actually do public health harm.


Note: This post is dedicated to Kimberly Manor, the owner of Moose Jooce vape shops in Michigan: "Kim Shilling Manor smoked 2 1/2 packs of Marlboro reds a day. She smoked even after her husband died of lung cancer and her mother developed lung cancer. Kim quit smoking the FIRST time she tried vaping! It was life changing for her and she opened Moose Jooce so people could see just how easy it was to live smoke free!" It is because of Kimberly, and the literally 2 million other former smokers out there with similar stories, that I continue to try to reveal the "rest of the story."

Tuesday, November 20, 2018

Will Marijuana Become the Next Juul?

Yesterday, the first recreational marijuana facility opened in Massachusetts. Out of curiosity, I decided to check out its menu of offerings. Although I thought that this ballot initiative was all about allowing adults to use marijuana for recreational purposes, I was surprised to find a menu that is certain to appeal to youth.

The Rest of the Story

Here are some menu items - tell me that they are not going to be appealing to teenagers:

  • Strawberry-flavored chewy bites
  • Large, citrus gummy bears
  • Delectable Belgian dark chocolate bars
  • Assorted fruit-flavored chews
  • Assorted fruit-flavored cubes
  • Raspberry flavored confection
  • Raspberry flavored lozenges
  • Chewy, cocoa caramel bite-sized treats
  • Raspberry & watermelon flavored lozenges
  • Chocolate-chip brownies.”
My point here is that we are in complete hysteria because youth are using flavored e-cigarettes and health agencies want to ban e-cigarettes because they attract youth with gummy bear and cotton candy flavors, yet we are practically encouraging youth to enjoy kid-friendly flavors and varieties of marijuana, doing nothing to address the access of youth to real cigarettes in retail stores, and allowing the unfettered sale and marketing of flavored alcohol products which are used by more high school students than use the Juul and other e-cigarettes combined.

I can drive to a store within 10 miles and get flavored alcoholic beverages, menthol cigarettes, and chewy, cocoa caramel marijuana, but I can't buy a Juul flavor multi-pack to help me quit smoking?

This is public health in 2018?

Tuesday, November 13, 2018

FDA to Announce Ban on Sale of Most Cigarettes in Convenience Stores Due to Addiction of Hundreds of Thousands of Youth to Cigarettes

Tomorrow, the FDA is expected to announce the strictest regulation of cigarettes sales in decades. Spurred by the data showing that nearly 8% of high school students are current cigarette smokers, the FDA will announce that from now on, with just a few exceptions, cigarettes may not be sold in any convenience store or gas station. Online sales of cigarettes will still be allowed, but it will be subject to advanced age verification procedures. The only stores that will be allowed to sell cigarettes without restriction will be those which are only open to adults (or which establish an area that is only open to adults).

The FDA said it was forced to take this drastic action because it has evidence that: "a new generation is being addicted to nicotine, and we can’t tolerate that."

The tobacco companies intentionally make cigarettes more addictive by adding ammonia to the product, which enhances nicotine absorption. Cigarettes are the most effective known product to deliver nicotine in a pattern that is capable of quickly initiating and then sustaining addiction.

According to the CDC, every day more than 3,200 youth smoke their first cigarette. It has been estimated that it only takes four to five cigarettes for a youth to become addicted to smoking. One out of every two long-term addicted smokers will die prematurely, primarily from lung cancer, lung disease, heart disease, stroke, or other cancers. 

The Rest of the Story

Actually, I got it wrong.

The FDA is not banning the sale of most cigarettes at convenience stores; it is banning the sale of most fake (electronic) cigarettes at convenience stores.

Convenience stores and gas stations can continue to sell real cigarettes - which, despite lower smoking rates, continue to addict a new generation to nicotine - but they will no longer be able to sell electronic cigarettes (with only minor exceptions).

Somehow, we have completely lost all sense of public health perspective. Every argument that the FDA is making in justifying a ban on the sale of electronic cigarettes in convenience stores and gas stations applies even more strongly for real tobacco cigarettes: you know, the ones that kill hundreds of thousands of Americans each year. Something is terribly wrong with our sense of perspective when we take the fake cigarettes off the shelf but allow the real ones to remain.

So let me attempt to correct this skewed perspective.

First, we need to recognize that the problem of youth addiction to electronic cigarettes is not a broad problem of youth becoming addicted to e-cigarettes; it is a very specific and narrow problem of youth becoming addicted to Juul. It is one specific product that is causing the problem.

Other than Juul, all other closed system electronic cigarettes do not have high addiction potential because they are actually quite poor at delivering nicotine. Specifically, there is no nicotine spike in the blood, and the nicotine level drops off quite slowly. In contrast, the Juul uses a specially formulated nicotine salt that is absorbed much more rapidly into the bloodstream, and the pattern of blood nicotine levels from Juuling mimics that of a real cigarette. Youth are becoming addicted to nicotine not because they are vaping generally, but because there is an epidemic of Juul use occurring in middle schools and high schools across the nation.

However, just four days ago, Juul announced that it would voluntarily stop selling flavored Juul products in all convenience stores and gas stations. In fact, Juul has agreed to stop selling flavored Juul products in any brick-and-mortar establishment. These products will only be available online and with age verification procedures.

So this sweeping action by the FDA is not necessary. It will not result in the elimination of flavored Juul sales from convenience stores because that is already occurring.

So the rest of the story is that what the FDA's action is doing is to make it much more difficult for adults who have quit smoking to continue to stay smoke-free using their favorite brands of electronic cigarettes, which will be taken off the shelves. Youth will not be able to purchase flavored Juul products from stores, but that was going to happen anyway. The other e-cigarettes that are being sold at these stores (i.e., products other than Juul) have low nicotine addiction potential. It makes no sense to take them off the shelves but to allow real cigarettes, which have extremely high addiction potential, to remain available for sale and distribution to the 3,200 youth who try these products every day.

I believe this action will have a net negative impact on the public's health because it will almost certainly result in many ex-smokers returning to smoking as their products disappear from convenience store shelves.

What the FDA should have done is to deal directly with Juul and demand that they voluntarily remove their flavored products from the shelf and bolster their age verification procedures for online purchases. But since Juul has already agreed to this, there is no need for this drastic regulation, especially because cigarette sales are being left unencumbered.

One might argue that the reason that Juul agreed to remove their flavored products from the shelf is that they anticipated this FDA regulation. If that is the case, then perhaps the threat of regulation was successful in achieving this result. But now that Juul has agreed to take most of their products off the shelves, the FDA should not proceed with the regulation. Unless it is sincerely concerned about youth becoming addicted to nicotine, in which case it should ban all cigarette sales in brick-and-mortar establishments that are not restricted to adults.

Monday, June 18, 2018

USC Ended Partnership with Anheuser-Busch InBev in April; Ohio State and San Diego State Should Follow Suit

I have been informed by the USC Suzanne Dworak-Peck School of Social Work that the School and its research team that had been involved in the Smart Drinking Goals project terminated its involvement with the project in April 2018 and that they are no longer associated in any way with the project.

The USC team had prepared toolkits summarizing the best current scientific thinking regarding environmental strategies for alcohol prevention. Although the team's involvement was apparently slated to last at least through 2018, they terminated their involvement in April and have completely disassociated themselves from the Smart Drinking Goals project.

I applaud USC and this research team for dissociating from the project.

The Rest of the Story

To the best of my knowledge, the Ohio State University is still involved with the Smart Drinking Goals program, and in addition, since yesterday I have learned that San Diego State University also seems to be involved with the program. Both of these institutions should immediately follow the lead and example set by USC and terminate their involvement with this project and their partnership with Anheuser-Busch InBev.

While public-private partnerships are sometimes tenable, in this case, you cannot have a credible partnership when the private corporation is bullying and disrespecting the autonomy of governments to implement their own public health measures to prevent excessive alcohol use and its associated harms. I cannot fathom an academic institution partnering with a company that went so far as to threaten a lawsuit against the city of Rostov in order to force it to allow the sale of beer at the World Cup soccer matches in Rostov Arena. Obviously, this completely undermines the supposed "smart drinking goals" initiative and exposes it for what it really is: a public relations hoax.

I have since learned that San Diego State University has apparently also partnered with Anheuser-Busch InBev to aid this public relations initiative. According to the university, it accepted a $200,000 grant from the alcohol corporation to be a part of the "implementation planning" for the Smart Drinking Goals project.

This grant completely exposes the hypocrisy of the alcohol company and demonstrates why this whole project is a hoax. Ironically, part of the San Diego State University project is to develop programs to reduce excessive alcohol consumption in sports arenas! Now you can see why this is a complete joke. At the same time that the company is, out of one side of its mouth, proclaiming that it cares about reducing alcohol consumption at sports arenas, from the other side of its mouth it is threatening to sue cities in order to force them to sell alcohol and facilitate excessive alcohol consumption in their sports arenas!

This hypocrisy boggles the mind, and it demonstrates that the Smart Drinking Goals program is not a sincere effort to address public health concerns but instead, a public relations hoax.

Hopefully, Ohio State and San Diego State will follow the example set by USC and immediately terminate their partnerships with Anheuser-Busch InBev.

Sunday, June 17, 2018

Anheuser-Busch InBev Proves that Its Smart Drinking Goals Program is a Complete Hoax: Ohio State and USC Have Fallen Prey

Two years ago, I explained why I think Anheuser-Busch InBev's Smart Drinking Goals program is a complete farce. Last year, I criticized the NIAAA for endorsing the alcohol industry's Smart Drinking Goals program. Today, I will show how Anheuser-Busch itself has proven that its Smart Drinking Goals program is a huge hoax, designed solely as a public relations ploy and devoid of any sincere intent to reduce alcohol consumption.

For brief background, senior employees of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) appeared in an Anheuser-Busch InBev promotional video that was designed primarily to serve the company's public relations interests. The video was brought to light in an article by Miriam Shuchman at Wired. In the video, Anheuser-Busch InBev boasts to the public about its "Smart Drinking Goals" program, which is purportedly designed to reduce "hazardous" drinking. Several Anheuser-Busch executives-- including its CEO, Chief "Health" Officer, and Chief Legal and Financial Officer--appear in the video, boasting about how wonderful this program is and implying how great a company Anheuser-Busch is for funding this program and how much it cares about the public's health.

But the Anheuser-Busch executives aren't the only ones who appear in this promotional, public relations video. Shockingly, this Anheuser-Busch PR effort (i.e., public relations effort) is also endorsed and promoted by senior officials of the Executive Branch of the United States government. And even worse, those senior officials are the Director and the Director of Global Alcohol Research of the NIAAA!

The Director of Global Alcohol Research at NIAAA provides a glowing endorsement of the program, describing it as "wonderful" (see 0:27-0:34 in the video). The Director of NIAAA also endorses the program, asserting that it will "go far in moving the field forward" (see 3:17-3:26).

However, the true purpose of the video is revealed at 3:42, when an Anheuser-Busch Global Advisory Council reveals the company's aspiration: "We're no longer a neighborhood's beer or a country's beer. We're in fact a corporation representing the world."

The video is clearly marketing Budweiser and other beers produced by Anheuser-Busch. As the company acknowledges, they are running this international program because they don't just want to be a neighborhood's beer or a country's beer; they want to be the world's beer.

The Rest of the Story

According to a Mother Jones article published last Friday, in 2005, Russia took a major public health step by banning the sale of alcohol in sports stadiums. When Russia bid to host this year's soccer World Cup, FIFA insisted that the country repeal its ban on alcohol consumption in stadiums as a condition of hosting the World Cup. Russia complied by creating an exemption from the law. However, earlier this year the city of Rostov (home to one of the stadiums being used for World Cup competition) passed its own law that prohibited the sale of alcohol at Rostov Arena (it did this by declaring the stadium a place of "mass gathering," thus removing the exemption from the national ban.

The city of Rostov thus exercised its right as a sovereign local government to protect the health and safety of its citizens by preventing alcohol sales at Rostov Arena, which could fuel violence, especially in the setting of international soccer competition. The policy was evidence-based, as there have been numerous episodes of violence fueled by the sale of alcohol at such matches.

Rather than respecting the autonomy of the Rostov government, Anheuser-Busch InBev threatened to sue Rostov city authorities. There is obviously no legitimate legal grounds for such a lawsuit. Rostov certainly has the legal authority to enact reasonable measures to protect the health, safety, and security of the public. Nevertheless, Anheuser-Busch InBev threatened the lawsuit in order to try to intimidate Rostov. It worked. The city backed down.

These actions of Anheuser-Busch InBev are not those of a company that has any interest in protecting the public's health. They are the actions of a bully corporation that puts the sale and consumption of its products above the public health, public safety, and even the autonomy of local government bodies.

In light of this action, the Smart Drinking Goals program cannot be taken seriously. It is purely a public relations ploy. While I don't blame the company for designing this clever marketing scheme because it's job is to sell alcohol, I do blame the NIAAA for endorsing the scheme, and I also blame the universities that have agreed to participate in the scheme by serving as partners.

Specifically, I denounce the Ohio State University, the University of Southern California, and investigators at both institutions for accepting what appears to be more than $1 million to partner with Anheuser-Busch and help serve as implementation planning and technical assistance sites for the Smart Drinking Goals program.

By doing this, Ohio State and USC are participating in a marketing ploy of the company. Essentially, Ohio State and USC are helping Anheuser-Busch to market beer and achieve its goal of becoming the world's beer. These universities are acting as essentially a marketing branch for Anheuser-Busch. With the promotion of Anheuser-Busch's interests that Ohio State and USC are providing, the company hardly needs its own marketing division. It can simply call Ohio State and USC its de facto Marketing and Public Relations Department.

It appears that Anheuser-Busch InBev's implementation partnerships are with the College of Social Work at the Ohio State University and School of Social Work at USC. The grant appears to be primarily with Ohio State University; however, since the principal investigator recently moved from Ohio State to USC, both institutions are now involved. The co-principal investigator of the project, who is at Ohio State, reports Anheuser-Busch funding in the amount of $946,517. The amount of funding to the principal investigator, who is at USC, is not clear.

I can see how researchers can be easily deceived by the clever scheme of this leading international alcohol corporation. Offers of money, especially for academic researchers like me, can easily distort our judgment. As the tobacco industry has proven, researchers and universities can essentially be bought out. The tobacco industry used this strategy to its great advantage.

But in some ways, this is worse than universities accepting tobacco money for research. Here, the universities are accepting money to actually be a part of the implementation of this alcohol company initiative. By doing so, they become co-conspirators. This is why I refer to them as participating in this public relations ploy.

If Anheuser-Busch InBev was sincere about wanting people to reduce their alcohol consumption, it would not bully city authorities like those in Rostov and essentially force them to allow the sale of alcohol at mass public events where there is a legitimate concern for public safety. It would not disrespect the autonomy of a local government to implement its own public health and safety laws.

The rest of the story is that this is not a company that public health (and social work) researchers and institutions should be collaborating with. Believe me, Anheuser-Busch is successful enough in its marketing and public relations on its own. It doesn't need help from respected academic institutions that are supposed to be in the business of saving lives and improving health, not marketing a dangerous product.

What business does a school of social work have partnering with a company that insists upon destroying the autonomy of communities and forcing them to serve alcohol at an event for which the sale of alcohol creates a substantial safety and security risk? Is this the type of company that Ohio State's and USC's social work schools want to be teaming up with?

Just as the NIAAA renounced its funding by the alcohol companies for research after the issue was brought to public attention, I hope that Ohio State and USC will also cancel their funding from Anheuser-Busch InBev and avoid the negative publicity that is sure to follow from any continued association with an industry that is preying upon communities and their leaders in order to force them to sell beer in a situation that creates a great risk of violence to their citizens.

UPDATE (June 18, 2018 - 7:50 am): I have been informed by the USC Suzanne Dworak-Peck School of Social Work that the School and its research team that had been involved in the Smart Drinking Goals project terminated its involvement with the project in April 2018 and that they are no longer associated in any way with the project.

The USC team had prepared toolkits summarizing the best current scientific thinking regarding environmental strategies for alcohol prevention. Although the team's involvement was apparently slated to last at least through 2018, they terminated their involvement in April and have completely disassociated themselves from the Smart Drinking Goals project.

I applaud USC and this research team for dissociating from the project.

Saturday, June 16, 2018

NIH Disbands Alcohol Clinical Trial Because of Scientific and Ethical Breaches

In a decision that I applaud, NIH Director Dr. Francis Collins announced yesterday that based on the recommendation of his Advisory Committee after an extensive investigation, he is discontinuing the MACH15 (Moderate Alcohol and Cardiovascular Health) clinical trial of moderate alcohol consumption (see original news reports here and here).

In its report, the NIH Advisory Committee to the Director concluded as follows:

"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. Independent review of the trial plan raised concerns that there are insufficient patients and not enough follow-up time to allow for meaningful assessment of cancer endpoints. The composite primary endpoint does not include heart failure. Thus, the trial could show benefits while missing harms."

As a result, the Committee recommended that:
  • "The MACH trial be terminated."
  • "The NIH should examine additional measures to prevent NIH staff from soliciting external funding to support programs."
  • "NIH Institutes, Centers, and Offices (ICOs) should ensure that program staff do not inappropriately provide non-public information, or engage in deliberations that either give the appearance of, or provide, an advantage to any single, or subset of, investigator(s)."
The Rest of the Story

I want to thank all the individuals and organizations who helped bring this to the attention of the NIH director and the DHHS Inspector General and who have been working to maintain a high level of scientific and ethical integrity at the NIAAA, especially my colleagues Dr. David Jernigan, Dr. Rich Saitz, Dr. Tim Naimi, Dr. Ziming Xuan, and Dr. David Rosenbloom here at the Boston University School of Public Health; Dr. Tom Babor at UCONN Health; Dr. Jim Sargent at Dartmouth's Geisel School of Medicine; Dr. Michael Carome and Public Citizen; Bruce Livingston and Carson Benowitz-Fredericks and Alcohol Justice; Diane Riibe and the Alcohol Policy Alliance; Dr. Thomas Hilton, former NIH science officer; Dr. Josh Sharfstein at the Johns Hopkins Bloomberg School of Public Health; Jennifer Grodsky at BU Federal Relations; Senator Edward Markey and his outstanding staff; the minority staff of the House Energy & Commerce Subcommittee on Oversight and Investigations; and Representative Lucille Roybal-Allard and her amazing staff.

And also, my sincere thanks and appreciation to the investigative reporters who helped shed sunlight (the best disinfectant, according to Justice Louis Brandeis) on what was going on behind the scenes, especially Roni Caryn Rabin at the New York Times who blew open the most important aspect of the story -- the secret meetings between NIAAA officials and alcohol industry executives in which the future principal investigator and NIAAA solicited funding from the alcohol industry. This was the revelation that led to the NIH director's investigation that ultimately led to the termination of the study.

Thanks also to Sharon Begley at STAT News; Stephanie Mencimer at Mother Jones, Miriam Shuchman (who wrote an excellent story at Wired); Ed Cara at Gizmodo; Liz Borkowski at The Pump Handle and the George Washington University School of Public Health and Health Services; Beth Mole at Ars Technica; and Shawna Williams at The Scientist.

It takes a village -- it certainly did to bring down this scientifically fraudulent and unethical research.

Sunday, June 10, 2018

Alcohol Clinical Trial Continues to Crumble: Anheuser-Busch Pulls Its Funding

In another setback for the NIAAA's and alcohol industry's study of the "health benefits" of encouraging people to drink, Anheuser-Busch has pulled its funding from the clinical trial because recent controversy over how the research funding was solicited has undermined the study's credibility.

According to an article by Roni Caryn Rabin in the New York Times:

"Brewing giant Anheuser-Busch InBev, one of five alcohol companies underwriting a $100 million federal trial on the health benefits of a daily drink, is pulling its funding from the project, saying controversy about the sponsorship threatens to undermine the study’s credibility, the company announced Friday. ... Anheuser-Busch InBev had committed $15.4 million to support the trial, representing nearly one-quarter of the $66 million in funds pledged by beer and liquor companies to date."

Last month, the NIH halted the trial while it investigates potential violations of NIH policy committed by the NIAAA in soliciting funding from alcohol companies to conduct the research. Two NIH committees are expected to report on the results of their investigations later this month.

The Rest of the Story

This demonstrates why accepting alcohol industry funding for this research was so inappropriate. Clearly, the alcohol companies are not in it for the science. They are in it for its public relations value. As soon as they perceived that the public relations value for the research deteriorated, they abandoned the research - they couldn't have gotten out of town more quickly.

This is why it was wrong to accept alcohol industry funding for this study in the first place. It was tainted from the start. Not only was the scientific objectivity compromised, but the ethical integrity was compromised as well. Essentially, the NIAAA - as well as investigators from Harvard School of Public Health, Johns Hopkins, and Wake Forest University - had agreed to accept money to do the public relations work for these companies. It was never about the science. It was about trying to help the companies sell beer, wine, and liquor.

In addition to its double violation of NIH policy (the solicitation of funding from alcohol companies by NIAAA officials and the acceptance of corporate money for a study that would not otherwise have been conducted), its violation of ethical standards (the principal investigator apparently lying about having had contact with the alcohol companies prior to initiating the research), and its violation of scientific integrity (the principal investigator promising the industry positive results and pitching it to the companies based on the public relations value for these companies), the trial had multiple other problems, including a possible violation of federal law, as it is not clear to me that the sponsor had obtained an IND (investigational new drug application) prior to recruiting patients.

And I haven't even yet revealed what is perhaps the greatest ethical violation of the study - its failure to adequately inform human subjects of the potential risks of participation in the study. For example, the study recruitment site, in listing the risks of participation in the research, fails to even mention that alcohol consumption increases the risk of cancer, especially breast cancer among women. The study fails to meet the requirements for human subjects protection because it fails to justify exposing women to an increased risk of breast cancer and it fails to demonstrate that the potential benefits outweigh these risks.

The study also fails to inform the public (and presumably human subjects as well) that alcohol consumption at the levels required in the study has been associated with an increased overall mortality risk in a recent study.

I will be delving into the human subjects protection failures of the research in future commentaries.

For now, the most important point is this:

The rest of the story is that the NIAAA, Harvard, and the other participating institutions allowed the alcohol companies to use them as part of their public relations and marketing plan to increase the sales of beer, wine, and liquor. The motivation behind their funding of the research was never a purely academic one, and it is this - above all - that rendered the money tainted. Now that the public relations value of the study has been compromised, Anheuser Busch has dropped it as fast as a wide receiver with greased palms. It's going to take a long time for the NIAAA and the participating academic institutions to de-grease themselves from this fiasco.

Johns Hopkins Public Health Researchers Claim that Smoking May Be No More Hazardous than Vaping

In an article published in the Summer 2018 issue of the Hopkins Bloomberg Public Health Magazine, two researchers at the Johns Hopkins Bloomberg School of Public Health are denying that smoking is known to be any more hazardous than vaping.

According to the article, Dr. Ana Maria Rule, an assistant professor in the the Department of Environmental Health and Engineering, argued that: "Even if vaping proves safer than smoking, that's still a long way from a gold stamp for their safety." This of course implies that we don't currently know that vaping is any safer than smoking. In turn, this means the professor's claim is that we don't currently know that smoking is any more harmful than vaping.

In the same article, Dr. Joanna Cohen, a professor and director of the Institute for Global Tobacco Control, is quoted as stating: "They are likely safer than continuing to smoke combustible cigarettes, but without the long-term studies, we just don’t know." Thus, Dr. Cohen is claiming that we just don't know whether smoking is any more hazardous than vaping.

The Rest of the Story

This type of denialism is something you might expect from the tobacco industry, not from public health researchers. But ironically, even the tobacco industry hasn't sunk to the level of claiming that their combustible cigarettes, which kill more than 400,000 Americans each year and more than 6 million people worldwide, may be no more hazardous than devices which contain no tobacco and involve no combustion.

In fact, all the major tobacco companies have in fact admitted that combustible tobacco products are far more dangerous than non-combusted products that don't even contain any tobacco. And even Dr. Stan Glantz, who is about as opposed to e-cigarettes as one can be, acknowledges that e-cigarettes are safer than real ones. Perhaps more objectively, the National Academy of Sciences stated that there is "conclusive evidence" that vaping is safer than smoking.

What almost nobody in tobacco control is acknowledging is that most of the major brands of electronic cigarettes that are sold at retail stores in the U.S. and which account for well over half of the market share have been tested and no detectable levels of any dangerous chemicals have been identified in the aerosol. This includes the major cigarette company brands, such as Mark Ten and Vuse, as well as Juul and several other leading brands made by the largest independent vape manufacturers. With these brands, even the potential health effects we are talking about are mild, acute respiratory and cardiovascular irritation. There is no evidence that vapers are exposed continuously enough for these acute changes to result in chronic lung or heart disease, but even if the risk is slightly increased, there is no way that it could equate to the risks of active smoking.

The problem with this denialism is not merely that it is spreading misinformation. The problem is that this is exactly the kind of false propaganda that is deterring many smokers from trying to quit smoking using vaping products and is causing some ex-smokers to return to smoking. If we aren't sure that vaping is any safer than smoking, then why bother quitting smoking using e-cigarettes? You might as well just keep on smoking. And if you've already quit using e-cigarettes, then what's the point of staying on e-cigarettes? Why not just go back to smoking, since we're not sure that it's any more dangerous than vaping?

If a physician were to give the same advice to a patient, it would be grounds for malpractice. Can you imagine doctors discouraging their smoking patients from switching to e-cigarettes because they are not sure it is any safer? Can you imagine doctors telling ex-smoking patients that they might as well resume smoking because they're not sure that their vaping is any better for their health than smoking?

Whether they realize it or not, this is precisely the effect statements like those being made by these Johns Hopkins researchers are having on the public. In fact, several national surveys have demonstrated that the public is largely misinformed about the relative hazards of smoking vs. vaping.  And it is this misperception that has stunted what otherwise could have been a much more substantial shift from smoking to vaping in this country. In other words, this isn't just a question of misleading the public. It's a question of saving lives, or failing to do so.

Hopefully, these researchers will publish a correction or retraction of these claims so that we can begin the process of restoring some semblance of a science base in the field of tobacco control.

Tuesday, May 08, 2018

E-Cigarette Opponents Still Making Up False "Facts" to Demonize Vaping

We're well into 2018 and there is now substantial research on the health effects of vaping as well as a decade of experience with large numbers of vapers, yet e-cigarette opponents are still making up false claims to buttress their demonization of vaping.

In an article by Jia Tolentino published yesterday in the New Yorker, a Harvard professor was quoted as claiming that: "vaping can cause something called bronchiolitis obliterans, or popcorn lung."

He also stated that Juul is "a massive public-health disaster," likened e-cigarettes to “bioterrorism,” and "predicted that, eventually, a state’s attorney general would sue Juul 'for willfully designing and pushing a product that will cause harm to the children of the United States.'"

The Rest of the Story

While he may be able to fool the public, this professor was no match for the likes of Jia Tolentino, who did extensive background research and therefore pointed out that: "Popcorn lung has been linked to diacetyl, an organic compound that some companies use in their e-liquid, and that has been detected as a by-product of e-cigarette vapor. But diacetyl has also been detected in cigarette smoke, at a level hundreds of times greater, and no feasible amount of smoking has been found to cause popcorn lung."

Moreover, there has not been a single reported case of bronchiolitis obliterans linked to vaping in the United States, despite millions of users and a decade worth of experience with heavy use of the product.

Claiming that vaping causes popcorn lung is irresponsible, as there is no evidence to back up the claim. If you're going to tell the public that vaping causes a serious and often deadly progressive respiratory disease, you ought to have at least one -- just one -- case to back it up.

The truth is that there is no evidence that vaping causes bronchiolitis obliterans and despite having levels of diacetyl that are hundreds of times higher, smoking itself has not been linked to bronchiolitis obliterans.

As I've said before, there's plenty of room for differing perspectives on the net public health benefits of electronic cigarettes, but making up false information is not acceptable, nor is it consistent with the ethical principles of public health practice.

The comparison to "bioterrorism" is also irresponsible and inappropriate. Vaping companies are doing a tremendous service to millions of smokers throughout the U.S. who have been unable to quit using pharmaceuticals, but have succeeded in quitting thanks to electronic cigarettes. To call these companies bioterrorists is despicable.

It is also inappropriate to call Juul a massive public health disaster. True, Juul is a major problem because it is leading to widespread youth use with a significant potential for addiction. But Juul is also helping millions of adults quit smoking. Its market share is up to close to 60%, so it appears to be the most commonly used strategy for quitting smoking in the United States. That's hardly a public health disaster.

Finally, it is irresponsible and inappropriate to accuse Juul of "willfully designing and pushing a product that will cause harm to the children of the United States." First of all, Juul did not design the product with the intention of causing harm to children. The product was designed to help adult smokers quit smoking. That is a laudable goal, not an evil one. In fact, the Juul represents a major advance in the effort to promote smoking cessation because it is the first electronic cigarette to deliver nicotine in a manner that is similar to real cigarettes and therefore is acceptable to a larger number of smokers who reject traditional e-cigarettes because they fail to deliver a nicotine hit.

Second of all, if you're going to sue Juul, you ought to also sue every single alcohol company as well. Their products are also causing harm to the children of the United States. And what about the tobacco companies themselves? Their products are causing far more harm to the children of the United States than all e-cigarettes combined. Why would we even think about suing Juul but not file suit against the cigarette companies as well?

Sadly, the scientific evidence doesn't matter any more in tobacco control. Our pre-determined conclusion that vaping is terrible, based on an almost puritanical ideology, is now running the show. Worse still, the actual truth about the harm being caused by products like Juul is not enough. We have to make up false and alarming information to support our pre-determined conclusions.

Let's be clear. There are at least 2 million ex-smokers in the U.S. who have quit smoking because of electronic cigarettes. To call this a public health disaster is to throw these 2 million former smokers under the bus and to essentially conclude that their lives don't matter.

I, too, have been outspoken about the risks posed by the widespread adoption of Juuling. But you have to have a sense of perspective. Yes, this is a serious concern. Yes, action needs to be taken to try to stem the tide of Juuling. But the Juul isn't causing substantial health damage. There is no evidence that even long-term Juuling increases the risk for disease. And Juul is helping hundreds of thousands of smokers to quit and perhaps save their lives.

The rest of the story is that this Harvard professor has now misled the entire nation into thinking that vaping causes a serious, often fatal, progressive respiratory disease, without a shred of evidence that this is the case and with overwhelming evidence that it simply is not true. Whatever you think about vaping and Juuling, lying to the public is not what we do in public health.

Thursday, April 12, 2018

NIH Director Grilled at Appropriations Hearing About NIAAA Collusion with Alcohol Industry

At the House Appropriations Committee hearing on the NIH Budget, NIH director Dr. Francis Collins was grilled about the collusion between the NIAAA and the alcohol industry in planning a clinical trial to study the health benefits of alcohol use. Congresswomen Lucille Roybal-Allard (D-CA) expressed concern about the fact that NIAAA violated NIH policy by soliciting funding from the alcohol companies and asked Dr. Collins who authorized the solicitation of funding. While Dr. Collins did not answer the question, he did say that his office is conducting an investigation and will provide the Inspector General with any uncovered materials that are of concern.

The questioning begins at 51:30 of the video.

Sunday, April 08, 2018

Principal Investigator of Alcohol Clinical Trial is Hiding its Industry Funding from the Public and Potential Research Subjects

I have already explained why I think the Moderate Alcohol and Cardiovascular Health (MACH15) clinical trial should be immediately halted because of both scientific and ethical breaches in the way the research was planned. Today, I reveal what I believe is misconduct in the actual conduct of the trial: namely, in the communication of the research sponsors to the public.

I believe that the public -- and especially research subjects -- have the right to know who is funding a clinical trial that is seeking their participation. In fact, there are rules requiring the sponsors of such studies to be revealed to the public. However, I believe the MACH15 study is violating these principles by hiding its true sponsors from the public.

The Rest of the Story

On the study web site, the study sponsor is reported as being the "National Institute on Alcohol Abuse and Alcoholism (NIAAA)." However, nowhere on the site does it disclose that the real sponsor behind the research are alcohol companies, which have ponied up to cover two-thirds of the cost of the entire research project. The alcohol money is being funneled through a "middle man" (the NIH Foundation) on its way to NIAAA, but the source of the money is clear: this is an alcohol industry-funded study. In violation of ethical principles for the conduct of research, this critical information is not being disclosed to the public on the project web site.

Therefore, I am calling both the Department of Health and Human Services (through the Inspector General) and Congressional oversight committees to require the study researchers to disclose to the public and potential participants that this study is being funded by the alcohol industry.

This is too reminiscent of the unethical behavior of tobacco-funded researchers in the past who failed to disclose the industry funding of their research. In fact, it was this behavior that contributed heavily to the implementation of conflict of interest disclosure rules.

The rest of the story is that the principal investigator of the MACH15 trial is hiding from the public the fact that this is an industry-funded study. I believe the trial should be halted, but if it is allowed to continue, the researchers should be forced to disclose the industry funding to the public and to any potential research participants.

Sunday, April 01, 2018

Alcohol Clinical Trial Should be Halted Because It Was Designed to Promote Drinking, Not to Answer a Research Question

Digging Deeper into the Harvard/NIAAA Solicitation of Alcohol Company Funding

In a previous post, I noted that I had reviewed materials obtained by the New York Times and shared with me for the article revealing that the NIAAA solicited funding from alcohol companies for the clinical trial of potential benefits of alcohol. A deeper examination of those materials allows me to now reveal that the real purpose of the clinical trial is not to conduct research to answer a question, but to help the alcohol industry sell beer, wine, and liquor by producing newspaper headlines to get doctors to start recommending moderate drinking to their patients.

The document I reviewed is a slide presentation and accompanying summary information apparently intended for a sales pitch to alcohol companies to fund this clinical trial. According to the New York Times: "two prominent scientists and a senior federal health official pitched the project during a presentation at the luxurious Breakers Hotel in Palm Beach, Fla., in 2014." The lead scientist on the "presentation team" was Dr. Kenneth Mukamal, who is now the Principal Investigator of the clinical trial. The senior federal health official on the "presentation team" was Dr. Lorraine Gunzerath, the Senior Advisor to the Director of the NIAAA.

Importantly, according to the New York Times, Dr. Gunzerath stated that this research would not have been conducted without the support of the alcohol companies because "We were supposed to be preventing alcoholism, so to spend that kind of money on research for a possible good use of alcohol was something that would never fly."

Also, according to a previous 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.”"
 
Based on this information, it appears that we already have three areas of misconduct in this research study before the trial itself has even been initiated:

1. The NIAAA violated NIH policy by soliciting funding from the alcohol industry. The NIH policy does not allow institutes to solicit funding. (NIH Policy Manual 1135 [Gifts Administration] - "NIH policy prohibits employees, either directly or through another party, from requesting or suggesting donations to the NIH or to any of its components, of funds or other resources intended to support activities.")

2. The NIAAA also violated NIH policy by accepting funding for a study that would not have been conducted were it not for the alcohol company money. Institutes of the NIH may accept a contribution, but only to conduct research that is either already underway or that would have been conducted even in the absence of that contribution. (NIH Policy Manual 1135 [Gifts Administration] - "the NIH may accept a gift to support a mission-related priority if it is already conducting the activity or is prepared to conduct the activity even without the gift. However, the NIH is precluded from accepting a gift to support an activity that would not be conducted but for the gift and thereby reorders the programmatic priorities of the agency and diverts the use of appropriated dollars from activities with higher priorities.")

3. The trial's principal investigator appears to have lied about not knowing that alcohol companies were supporting the trial and "literally" not having had any contact with alcohol companies.

The Rest of the Story

These facts alone are sufficient to warrant an immediate halt to the clinical trial. But today, I am revealing that the story gets even worse.

The stated purpose of the clinical trial, according to the presentation materials, was not to conduct an impartial investigation into the health effects of moderate drinking, but to produce newspaper headlines that would get doctors to recommend that their patients start drinking. Here is how the primary aim of the research was described:

"The proposed clinical trial is designed to provide doctors with the scientific/medical justification to incorporate a moderate drinking recommendation into their advice to patients."

To execute the sales pitch, the presentation includes a slide entitled "The Ultimate Goal." What is the ultimate goal? The slide shows three newspaper headlines touting the health benefits of an olive oil diet and a Mediterranean diet. Apparently, the ultimate goal is to generate news headlines reporting that moderate drinking is part of a health diet.

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..."

Yet another slide emphasizes that "What's missing" is "the type of convincing evidence that will show that moderate drinking is: 1) Safe 2) Part of a healthy diet to lower risk of common, important health problems. How do we do that?"

The rest of the story is that beyond even the violation of NIH policies and the ethical breaches committed in the planning of the study, the trial is scientifically compromised from the start because the researchers have essentially promised positive results to the alcohol industry, have demonstrated a substantial bias that undermines the objectivity of the study, and have stated that its purpose is not to answer a research question objectively but to provide the opportunity for newspaper headlines in order to convince doctors to start recommending moderate drinking to their patients.

That's a great sales pitch, and it's no surprise that it worked. If I were running an alcohol company, I would have been in on this marketing investment all the way. That the federal government -- and the nation's leading alcohol research agency to boot -- is offering this marketing opportunity is disillusioning.

Sunday, March 25, 2018

Congressional Investigation Needed into Scientific and Ethical Corruption at NIAAA

I used to think of the National Institutes of Alcohol Abuse and Alcoholism (NIAAA) as a highly-reputed, objective, science-based agency whose primary goal was to reduce alcohol consumption to improve the public’s health. The scientific integrity of the NIAAA is critical, as it describes itself as “the largest funder of alcohol research in the world.” The agency is funded by taxpayers to the tune of $480 million a year.

But then one day, all of that changed. On January 16, 2015, I was called into the office of the Director of NIAAA and was essentially reprimanded for conducting NIAAA-funded research that was detrimental to the alcohol industry. My NIAAA grant was focused on studying alcohol marketing and its possible link to underage youth drinking behavior. We identified the brands of alcohol that underage youth are consuming and found that their brand choices were related to their brand-specific advertising exposure. At the meeting, I was told that I would never again be funded to conduct research on alcohol marketing, regardless of how highly my research proposal was scored by the scientific review panel.

I later found out that the NIAAA director had extensive contact with the alcohol industry and that he promised the Distilled Spirits Council that this type of research would never be funded again: “For the record. This will NOT happen again. … I will NOT be funding this type of work under my tenure.”

Not only had the NIAAA director privately told an alcohol lobbying group that his agency would never fund research on alcohol marketing, but he then went on to participate in the industry’s marketing activities himself by appearing in a promotional video (at 3:17) for Anheuser-Busch InBev, creating the impression that the NIAAA is endorsing the alcohol company and its programs, which is a violation of NIH policy. The true purpose of the video is revealed at 3:42, when an Anheuser-Busch Global Advisory Council reveals the company's aspiration: "We're no longer a neighborhood's beer or a country's beer. We're in fact a corporation representing the world."

Finally, the truth about the relationship between the NIAAA and the alcohol industry has come out. In a New York Times article published last Saturday, Roni Caryn Rabin revealed that the NIAAA actually solicited funding from alcohol companies to conduct a study to demonstrate the “benefits” of alcohol consumption and industry officials were essentially promised positive results.

The Times reported having obtained slides from a presentation by a Harvard researcher to alcohol executives in which he makes a pitch for funding to study the health benefits of alcohol. The NIAAA apparently facilitated the meeting, at which a senior agency official was present. In the slides, the researcher suggests that the study could result in newspaper headlines reporting that alcohol is now part of a healthy diet. Promising positive results before even initiating a study and pitching the study based on its potential economic benefits to the industry violate standards of scientific integrity.

The NIAAA’s solicitation of donations for this research from the alcohol industry was a clear violation of NIH policy, not only because NIH officials are not allowed to solicit donations, but also because they are not allowed to accept funding for a study unless the agency would conduct the research even without the donation. However, a former NIAAA official apparently admitted to telling alcohol industry executives that “the research could not be done without their support.”

The story gets worse. The principal investigator of the study apparently lied about having met with the alcohol industry. In a July 2017 New York Times article, he was quoted as stating: “We have had literally no contact with anyone in the alcohol industry in the planning of this.” However, his name is on a presentation delivered directly to alcohol companies to convince them that they had “a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases.”

Apparently, the director of NIAAA was also dishonest, as he appears to have told the New York Times that the NIAAA did not solicit alcohol industry funds. This conflicts with the testimony of at least two high-level NIAAA officials—one of whom was the former director—who admitted that the meetings between NIAAA and the alcohol companies were “to determine if they had interest in taking part” as funders.

In fact, the advisor to the former NIAAA director apparently recognized that studying the benefits of alcohol was not even within the scope of legitimate NIAAA research: “We were supposed to be preventing alcoholism, so to spend that kind of money on research for a possible good use of alcohol was something that would never fly.” This is why it was so essential for the agency to convince the alcohol industry to fund the clinical trial.

The solicitation was successful. The NIAAA is now funding a $100 million clinical trial—largely funded by alcohol companies— designed to demonstrate the health benefits of alcohol, and the principal investigator is the researcher who gave the presentation.

Even if the study were a legitimate use of agency funds, it would still be inappropriate because many of its primary investigators have substantial financial conflicts of interest with the alcohol industry. At my institution, such researchers would not even be allowed to be involved in a clinical trial in which they have a significant conflict of interest. Our general policy is that an investigator with a significant conflict of interest cannot conduct a clinical trial on a product made by the relevant company. We do allow conflicted investigators to conduct pre-clinical studies, such as laboratory research; however, the line is drawn definitively at the level of a clinical trial. Thus, the NIAAA also appears to be violating the NIH conflict of interest policy.

Finally, the study itself is misguided and a waste of money. Even if it were to find that moderate drinking can reduce heart disease risk, it would still not be clear that recommending that people who don’t drink start to drink is warranted. Alcohol is a known carcinogen that causes breast cancer even when consumed in extreme moderation. Recommending that people consume a known carcinogen is not something that we do in public health.

In short, the NIAAA is assisting the alcohol industry in a marketing ploy to increase the sales of its products. The research has no scientific integrity and is tainted from the start. Its principal investigator solicited money from the industry and boasted of a positive outcome before the research was even started. Multiple NIH policies have been violated in the planning of the research alone.

That the NIAAA was involved in this corruption is inexcusable. This behavior risks damaging not only the reputation of the alcohol institute, but of the entire NIH. Congress should initiate an investigation immediately to protect the scientific integrity of federal health research. Further, it is imperative that this clinical trial be immediately halted on both scientific and ethical grounds.

Disclosure: I was a recipient of a grant from the NIAAA for a project to study the effects of brand-specific alcohol advertising on youth alcohol brand consumption (R01 020309 – September 20, 2011 through June 30, 2015).