Parents of a Florida teenager who became addicted to Juul have sued Juul, Altria, and Philip Morris USA based on a number of claims, including fraud, negligence, and violation of the RICO statute (the compliant is here). Dr. Stan Glantz and Lauren Lempert provide a nice summary of the reasoning behind the lawsuit and the specific claims being made. The case was filed on Monday in the federal district court for the middle district of Florida.
The Rest of the Story
Although the main complaint is that the company fraudulently provided misinformation about the product, its health risks, and its addictiveness, the complaint itself provides a huge amount of misinformation and distortion of the scientific facts related to vaping and Juul. Here is a sampling of the false or completely unsupported information that is claimed in the complaint:
1. Vaping causes chronic obstructive pulmonary disease (COPD): The lawsuit claims that "just like traditional cigarette smoke," vaping causes COPD because it "introduces foreign substances into the lung." There is absolutely no evidence to support this claim. Despite at least 12 years of use and prolonged vaping by millions of Americans, I'm not aware of a single case of COPD that has been documented to be caused by vaping. While vaping does cause acute respiratory irritation, there is no evidence at this point that prolonged exposure to e-cigarette aerosol is extensive enough to cause permanent lung obstruction.
2. Nicotine is a carcinogen: The lawsuit claims that "nicotine itself is a carcinogen." The leading, objective, international body that studies carcinogens (the International Agency for Research on Cancer [IARC]) has not declared nicotine to be a carcinogen.
3. Juul delivers carcinogens to users: The lawsuit claims that Juul "delivers toxins and carcinogens to users." However, the complaint does not specify exactly what toxins or carcinogens Juul delivers to users. Studies of the aerosol produced by Juuling, to the best of my knowledge, have not demonstrated the presence of detectable levels of carcinogens.
4. Juul is designed to transition users to cigarette smoking: The lawsuit claims that Juul is designed to make it "easier for e-cigarette users to transition to conventional cigarettes." The truth is the exact opposite. Juul was designed specifically to transition conventional cigarette smokers to vaping. Juul Labs would be stupid if they designed the product such that its users would transition back to smoking. The company makes no money if its users go back to smoking. In fact, the economic incentive for Juul is to eliminate smoking altogether. The more smokers who switch from conventional cigarettes to Juul, the more money the company makes. There is abundant evidence that Juul has succeeded in transitioning hundreds of thousands of smokers away from conventional cigarette use, but no evidence that Juul has transitioned anyone to cigarette smoking.
5. Juul is defectively designed: The lawsuit claims that the Juul e-cigarette is "defectively designed" because it delivers nicotine so effectively. The truth is that this is actually an incredibly effective design because it provides the greatest chance that a smoker will successfully quit smoking by switching to vaping. The problem with most other e-cigarettes is precisely that they do not deliver nicotine effectively. Juul corrected this problem and as a result, it has become the most effective smoking cessation product currently on the market. This is demonstrated by the tremendous market share that Juul holds among adult smokers trying to quit.
6. Juul aggravates nicotine addiction in cigarette smokers: The lawsuit claims that the company knew that Juul "posed a risk of aggravating nicotine addiction in those already addicted to cigarettes." There is no evidence to support this claim and the truth is likely the opposite. While smokers who switch to Juul are obviously still addicted to nicotine, they are no longer addicted to smoking. The behavior of smoking is a huge component of the addiction to nicotine that is observed in cigarette smokers. By eliminating that aspect of the addiction, the overall addiction is almost certainly lessened.
7. Juul fails to inform users that its product has not been found to be safe: The lawsuit claims that the company "fails to inform users that its products have not been found to be safe." The truth is that Juul says right on its web site that: "No tobacco-based or nicotine e-liquid product should be considered safe." In addition, Juul informs customers that: "Inhalation of e-vapor from JUUL may aggravate pre-existing respiratory
or heart conditions. Additionally, ingestion of nicotine, at any level,
may cause other conditions (such as an increase in your heart rate and
blood pressure, may cause dizziness, nausea, and stomach pain)." The company also warns users about ingesting the e-liquid, informing them that the product: "Contains nicotine, which is an addictive chemical and can be poisonous. Avoid contact with skin and eyes. Do not drink."
8. Juul falsely claimed that it is not affiliated with Big Tobacco: It is true that Juul claimed that it had no affiliation with Big Tobacco. But that was prior to its partial acquisition by Altria. You can hardly blame the company for making a true statement, as long as they no longer make that claim. A Google search revealed that, ironically, the only current internet source of the claim that "Juul Labs is not Big Tobacco" is the lawsuit itself.
9. Juul and Altria plan to use Juul as an entry point for youth to start smoking Marlboro cigarettes: Not only is there no evidence to back up this claim, but it is patently ridiculous. You don't get kids addicted to Marlboro by marketing Juul. You get kids addicted to Juul by marketing Juul. Data from the PATH study demonstrate that becoming a regular vaper is a path away from smoking, not towards smoking. In fact, the only kids who currently progress to smoking are those who do not become regular vapers. Why would a company think that by addicting kids to a mango-flavored product, they would suddenly develop a desire for the harsh taste of Marlboro? Altria may have a history of being sinister, but they are not stupid.
None of this is to deny the fact that Juul use among youth has become a serious public health problem that needs to be addressed urgently. None of this is to deny that Juul carries some responsibility for having created the problem. However, it doesn't seem fair to file a lawsuit against the company for making false claims by putting false claims into the complaint.
Ultimately, I go far beyond nearly all of my colleagues in public health because I believe that the use of nicotine salts is simply not a viable long-term option for a harm reduction strategy that is based on trying to get smokers to switch to vaping. Nevertheless, I don't think it is appropriate to sue the company based on alleged facts that are either completely undocumented or simply untrue.
Wednesday, April 17, 2019
Tuesday, April 09, 2019
New Study Finds Vaping is Not Associated with Cardiovascular Disease among Never Smokers; But Tobacco Control Researcher Dismisses Findings
A new study published online ahead of print in the American Journal of Medicine reports that there is no association between vaping and cardiovascular disease among never smokers.
Like previous studies of its kind, this was a cross-sectional study that examined the association between current vaping/smoking status and ever having been told that one has cardiovascular disease (including heart attack, coronary artery disease, or stroke). Previous studies used data from the National Health Interview Survey (NHIS) or the Population Assessment of Tobacco and Health (PATH) study; this paper used data from the Behavioral Risk Factor Surveillance Survey (BRFSS).
The authors reported no association between current vaping and self-reported cardiovascular disease among never smokers. However, they found that among current dual users there was an increased odds of having ever been told that one has cardiovascular disease.
In response to the study, one prominent tobacco control researcher concluded that dual use is causally associated with cardiovascular disease, while dismissing the negative finding that e-cigarette use was not associated with vaping among never smokers. He wrote: "The fact that the authors did not find an effect of e-cigarettes alone may be because they stratified the sample on e-cig and cigarette use, which reduces the sample size for each comparison, and so the power to detect an effect."
The Rest of the Story
This reminds me of what the tobacco industry used to do. If they saw a finding that they liked, they would emphasize that finding, but if they saw a finding that they didn't like, they would just dismiss it. This is sometimes called "cherrypicking." I've never picked cherries, but I assume that when doing so, one only picks the cherries that you like and disregards the ones that you don't.
As objective scientists, we can't cherrypick. It allows one to have a pre-conceived conclusion and then to simply publicize findings that support the conclusion while dismissing those that do not. It appears that this is what is going on here.
Cherrypicking is becoming more and more common among tobacco control researchers and advocacy groups. Recently I spoke at a conference on vaping, and one of the other speakers on the panel told the audience that there was no evidence vaping can help people quit smoking. The basis of that conclusion was that "there is no clinical trial that shows vaping to be effective ... we need a clinical trial." When I then pointed out that a randomized, clinical trial published last month in the prestigious New England Journal of Medicine found that vaping was twice as effective as nicotine replacement therapy for smoking cessation, they simply dismissed it, saying: "Well I still don't think it's effective." (The same person also did not think there is enough evidence to conclude that vaping is any safer than smoking.)
The reality is that many tobacco control researchers and advocates will not be convinced by any amount of data. You could have two clinical trials, both finding that vaping is effective for some smokers, and they would still dismiss the findings. (In fact, we do have two clinical trials -- it's amazing to see how many tobacco control advocates continue to insist that there have not been any clinical trials on the use of vaping for smoking cessation.)
Here, a positive finding is accepted and touted, while a negative finding is just dismissed. The reasoning given -- that the study didn't have the power to detect an effect -- doesn't hold water because the sample size of never smoking vapers in the study (15,863) exceeded the number of dual users (12,908).
But even the conclusion that dual use is causally associated with cardiovascular disease is unsupported by the evidence presented in the paper. This is a cross-sectional study, so it is entirely possible that the onset of cardiovascular disease preceded the vaping. In fact, this is almost certainly the case for most of the study subjects because e-cigarettes have been popular for only about eight years, and it takes decades for cardiovascular disease to develop.
It may actually be that the cardiovascular disease "caused" the vaping because having a heart attack or stroke is a strong stimulus for a smoker to try to quit, and many smokers try to quit by using e-cigarettes.
Moreover, dual users are almost certainly a different population from exclusive vapers and one systematic difference between the groups is likely that dual users have a heavier or more intense smoking history, making it more difficult for them to get off of e-cigarettes. If this were the case, it would explain the observed finding that dual use was associated with a higher risk of reporting cardiovascular disease.
The bottom line is that we can't draw causal conclusions from a cross-sectional study like this one, especially one in which it is impossible to determine which came first: the heart attack or the vaping. So to tout the association between dual use and heart disease as a causal finding is bad enough. But cherrypicking findings that support a pre-determined conclusion, while dismissing those which do not support that conclusion, is sinking to the level of the tobacco industry which we once criticized for doing the very same thing.
Like previous studies of its kind, this was a cross-sectional study that examined the association between current vaping/smoking status and ever having been told that one has cardiovascular disease (including heart attack, coronary artery disease, or stroke). Previous studies used data from the National Health Interview Survey (NHIS) or the Population Assessment of Tobacco and Health (PATH) study; this paper used data from the Behavioral Risk Factor Surveillance Survey (BRFSS).
The authors reported no association between current vaping and self-reported cardiovascular disease among never smokers. However, they found that among current dual users there was an increased odds of having ever been told that one has cardiovascular disease.
In response to the study, one prominent tobacco control researcher concluded that dual use is causally associated with cardiovascular disease, while dismissing the negative finding that e-cigarette use was not associated with vaping among never smokers. He wrote: "The fact that the authors did not find an effect of e-cigarettes alone may be because they stratified the sample on e-cig and cigarette use, which reduces the sample size for each comparison, and so the power to detect an effect."
The Rest of the Story
This reminds me of what the tobacco industry used to do. If they saw a finding that they liked, they would emphasize that finding, but if they saw a finding that they didn't like, they would just dismiss it. This is sometimes called "cherrypicking." I've never picked cherries, but I assume that when doing so, one only picks the cherries that you like and disregards the ones that you don't.
As objective scientists, we can't cherrypick. It allows one to have a pre-conceived conclusion and then to simply publicize findings that support the conclusion while dismissing those that do not. It appears that this is what is going on here.
Cherrypicking is becoming more and more common among tobacco control researchers and advocacy groups. Recently I spoke at a conference on vaping, and one of the other speakers on the panel told the audience that there was no evidence vaping can help people quit smoking. The basis of that conclusion was that "there is no clinical trial that shows vaping to be effective ... we need a clinical trial." When I then pointed out that a randomized, clinical trial published last month in the prestigious New England Journal of Medicine found that vaping was twice as effective as nicotine replacement therapy for smoking cessation, they simply dismissed it, saying: "Well I still don't think it's effective." (The same person also did not think there is enough evidence to conclude that vaping is any safer than smoking.)
The reality is that many tobacco control researchers and advocates will not be convinced by any amount of data. You could have two clinical trials, both finding that vaping is effective for some smokers, and they would still dismiss the findings. (In fact, we do have two clinical trials -- it's amazing to see how many tobacco control advocates continue to insist that there have not been any clinical trials on the use of vaping for smoking cessation.)
Here, a positive finding is accepted and touted, while a negative finding is just dismissed. The reasoning given -- that the study didn't have the power to detect an effect -- doesn't hold water because the sample size of never smoking vapers in the study (15,863) exceeded the number of dual users (12,908).
But even the conclusion that dual use is causally associated with cardiovascular disease is unsupported by the evidence presented in the paper. This is a cross-sectional study, so it is entirely possible that the onset of cardiovascular disease preceded the vaping. In fact, this is almost certainly the case for most of the study subjects because e-cigarettes have been popular for only about eight years, and it takes decades for cardiovascular disease to develop.
It may actually be that the cardiovascular disease "caused" the vaping because having a heart attack or stroke is a strong stimulus for a smoker to try to quit, and many smokers try to quit by using e-cigarettes.
Moreover, dual users are almost certainly a different population from exclusive vapers and one systematic difference between the groups is likely that dual users have a heavier or more intense smoking history, making it more difficult for them to get off of e-cigarettes. If this were the case, it would explain the observed finding that dual use was associated with a higher risk of reporting cardiovascular disease.
The bottom line is that we can't draw causal conclusions from a cross-sectional study like this one, especially one in which it is impossible to determine which came first: the heart attack or the vaping. So to tout the association between dual use and heart disease as a causal finding is bad enough. But cherrypicking findings that support a pre-determined conclusion, while dismissing those which do not support that conclusion, is sinking to the level of the tobacco industry which we once criticized for doing the very same thing.
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