Wednesday, November 30, 2016

Senator Johnson Calls on FDA to Halt Implementation of E-Cigarette Deeming Regulations Pending the New Administration

In a letter written last week to the FDA, Senator Ron Johnson (R-WI) called on the FDA to halt implementation of the e-cigarette deeming regulations pending the change in administration coming this January.

Senator Johnson wrote: "The incoming administration and the 115th Congress will likely re-examine and unwind burdensome regulations imposed by the Obama Administration. The U.S. Food and Drug Administration's (FDA) deeming regulations of e-cigarettes is a primary example of a rule that could eliminate an entire nascent industry. Accordingly, given the substantial likelihood that this burdensome rule will be undone, I urge the FDA to cease implementation of its deeming regulation to spare the growing e-cigarette industry unnecessary and avoidable compliance costs that it currently faces."

The Rest of the Story

I do not generally agree with Republican calls for a loosening of public health regulations, but in this case, I wholeheartedly agree with Senator Johnson. The FDA e-cigarette deeming regulations are unduly burdensome and will result in the decimation of the e-cigarette industry, putting thousands of small vape shops and companies out of business and protecting cigarettes from competition from a much safer product. Moreover, the deeming regulations violate the free speech rights of e-cigarette companies, prohibit the companies from taking steps to improve the safety of their product, and force companies to lie to consumers about the primary benefits of their products. This is a public health mess, and it does need to be unraveled.

The good news is that it appears that the new administration, or at least the new Congress, are planning to conduct a serious re-examination of the regulation of electronic cigarettes. Therefore, it is possible that we may be able to come out of this with more than just the Bishop-Cole "emergency" measure that would salvage the industry. Instead, it is possible that we can achieve a more sensible regulatory framework for e-cigarettes, one that treats these products completely differently from tobacco cigarettes, allows smoking cessation and modified risk claims to be made, eliminates the burdensome pre-market applications, and instead, sets safety standards for these products to ensure uniform safety and quality control, thus maximizing the benefits of vaping products while minimizing the risks.

This presents an important opportunity for vapers to make their voices heard. While CDC director Dr. Thomas Frieden views vapers only as "anecdotes," their collective experiences truly represent data that can help inform policy. Vapers need to share their experiences with members of Congress, especially members of the Senate Homeland Security and Government Affairs Committee, so that they will be able to separate out the fact of their experiences from the fiction that so many anti-smoking groups and health agencies have been spreading.

Tuesday, November 29, 2016

New Study Shows the Blatant Bias in Modern-Day Tobacco Control Research and Demonstrates Why You Need to Look at the Actual Data

A new study published online ahead of print in the journal Tobacco Control purports to demonstrate that a smoke-free bar and restaurant law implemented in São Paulo, Brazil in August 2009 resulted in a 11.9% decline in the heart attack death rate for the first 17 months after the law was in effect (through December 2010).

The paper used a time-series analysis to compare the monthly rate of heart attack deaths prior to the smoking ban to the rate after the ban was implemented. The baseline period was January 2005 through July 2009. The implementation period was August 2009 through December 2010. Thus, the researchers had data for approximately 5 1/2 years before the ban and for 17 months after the ban.

The paper concluded: "In this study, a monthly decrease of almost 12% was observed in mortality rate for myocardial infarction in the first 17 months after the enactment of the comprehensive smoking ban law in São Paulo city."

The methods used in the study are quite complex and are summarized as follows: "We performed a time-series study of monthly rates of mortality and hospital admissions for acute myocardial infarction from January 2005 to December 2010. The data were derived from DATASUS, the primary public health information system available in Brazil and from Mortality Information System (SIM). Adjustments and analyses were performed using the Autoregressive Integrated Moving Average with exogenous variables (ARIMAX) method modelled by environmental variables and atmospheric pollutants to evaluate the effect of smoking ban law in mortality and hospital admission rate. We also used Interrupted Time Series Analysis (ITSA) to make a comparison between the period pre and post smoking ban law."

In simple terms, the investigators compared the trend in heart attack deaths in São Paulo before the smoking ban to the trend in heart attack deaths in São Paulo after the smoking ban. They concluded that there was an 11.7% drop in the heart attack death rate in the 17 months following the implementation of the smoking ban.

The investigators attributed the observed decline in heart attack deaths to a reduction in secondhand smoke exposure, citing evidence that just 30 minutes of exposure to secondhand smoke can cause a heart attack.

The Rest of the Story

To demonstrate the blatant bias in the reporting of the study results, simply take a look yourself at the actual data from the study. Below, I have plotted the data from Table 2 (Monthly number of deaths for myocardial infarction, city of São Paulo, Brazil, January 2005 to December 2010), but I have added the monthly numbers to yield annual figures, which smooths the data making it much easier to inspect visually.

The smoking ban went into effect in August 2009. You can easily see from the figure that in 2010, there was a striking increase in the number of heart attack deaths, which reached an all-time high for the study period.

Somehow, it appears that all this fancy modeling yielded a completely spurious result. This is why I teach my students to always start out by looking at the actual data. When you put the data into a fancy statistical model, strange things can happen. You always need to make sure that the results of a statistical model are consistent with what you are observing visually when you look at the data. If there is a major inconsistency, as in this case, then you must suspect that something is wrong: namely, that the statistical technique is for some reason not modeling the data correctly. It is also possible that the data are wrong. But clearly, something is wrong here.

Here, an examination of the actual data reveals that there is absolutely no basis to conclude that the smoking ban resulted in an 11.7% decline in heart attack deaths.

But why did nobody see this? It's difficult to believe that the authors didn't see it, the reviewers didn't see it, and the journal editorial team didn't see it. This should in fact be the first thing that everybody looks at. Even if you just look at the data in Table 2 without plotting it out, it is immediately apparent that there was a striking increase in heart attack deaths in 2010, wiping out the possibility that the smoking ban led to a large and sustained decline in heart attack deaths through 2010.

It appears that either nobody looked at the actual data or that they looked but ignored it. Either way, this demonstrates a severe bias on the part of the investigators, reviewers, and editorial team. Had the study found no effect of a smoking ban, you can rest assured that everyone would have scoured over the paper for hours, trying to find some explanation for why the results came out "wrong." But here, since the results were "right" (that is, favorable), it appears that there was no desire to sincerely "review" the paper.

Finally, it is critical to mention that even if the paper had found a decline in heart attack deaths in 2010, this would not justify the conclusion that the smoking ban caused a decrease in heart attacks. The critical and fatal methodological flaw of this paper is that there is no comparison group. It is very possible that heart attack death rates were declining during the study period anyway, even in the absence of smoking bans. We actually know this to be the case from abundant international data. To conclude that the smoking ban had an effect on heart attacks, one would need to first control for secular trends in heart attack mortality that were occurring anyway, independent of the smoking ban. The paper could easily have done this by including some comparison group -- such as a nearby city, the county, the state, or the country. But there needs to be some control for secular trends.

Thus, even if this paper had convincingly demonstrated that there was a decline in heart attacks in São Paulo after the smoking ban, it would not have been valid to conclude that this was a causal effect. Without a comparison group, this study is as good as worthless.

When the tobacco industry used to put out studies like this to show that smoking bans cause massive losses of revenue for restaurants, we attacked them for conducting time series analyses without using an appropriate control group. Now it appears that we are doing the same thing ourselves. This certainly has the appearance of a severe bias: results that are "favorable" are correct and the methodology is automatically valid and those which are "unfavorable" are incorrect and the methodology must be attacked.

Perhaps one of my great frustrations of 2016 is the way in which science has largely disappeared from the public policy agenda. Decisions are being made almost completely on political grounds. It is a bad enough state of affairs that we in public health don't need to contribute to it. Even though we are working for worthwhile causes, we cannot let loose our insistence on rigorous science. Once we do that, then we're really sinking to the level of our opponents.

Finally, I should make it clear that any failure of this study to detect an immediate decline in heart attack deaths does not affect my support for smoke-free bar and restaurant laws. It's just that in promoting such laws, I believe we need to rely upon solid scientific data, not hocus pocus that comes out of some complex statistical model that no one really understands and which ends up completely misrepresenting the actual data -- data that one can see with one's own eyes.

Monday, November 28, 2016

Dishonesty of Vaping Opponents (Health Agencies) is Out of Control; Urgent Action is Needed

The misleading information being spread to the public by vaping opponents, including prominent health agencies like federal, state, and local health departments, has become out of control. It threatens to do immense public health damage by protecting cigarette sales at the expense of a much safer alternative - electronic cigarettes - and at the same time it also threatens the reputation of public health agencies.

Today, I highlight four examples of misinformation about electronic cigarettes from vaping opponents, representing four levels of health groups: international, national, state, and local.


World Health Organization: 

Vaping does not help people stop smoking

The World Health Organization (WHO) is waging an all-out war on electronic cigarettes, which is ironically helping to protect real cigarettes from what otherwise could have been immense competition from a much safer product. The WHO could hardly be doing the cigarette companies around the world any greater favor. Recently, a WHO report prepared for the Conference of the Parties (COP-7) meeting concluded that vaping does not help people stop smoking. Furthermore, the head of the convention secretariat made clear her opinion that electronic cigarettes "should not be promoted widely."

According to an article in The Guardian, Anna Gilmore, professor of public health at the University of Bath and the UK Centre for Tobacco Control Studies, stated: "The tobacco industry uses e-cigarettes to claim it is committed to harm reduction, but meanwhile it continues to engage in harm maximisation by spending millions to promote tobacco and oppose any policy that would reduce its use."

How ironic that Professor Gilmore is attacking the tobacco industry for opposing "any policy that would reduce" tobacco use, while at the very same time (and in the same sentence) she is vigorously opposing one of the most promising strategies ever for reducing tobacco use (vaping). In the same sentence, she condemns the tobacco industry for not being "committed to harm reduction," yet expresses her own opposition to harm reduction.

The rest of the story is that it is not the tobacco industry that is holding up the use of harm reduction as a widespread tobacco control strategy. In fact, the tobacco companies are largely supporting a harm reduction approach, and they are vigorously promoting vaping products. On the other hand, it is the tobacco control community and health agencies like the WHO that truly are holding up harm reduction through their opposition to promoting vaping as a much safer alternative to smoking.


Centers for Disease Control and Prevention: 

Reductions in the amount of cigarettes smoked daily by smokers represent great progress, but not among vapers
The director of CDC - Dr. Tom Frieden - was quoted recently as stating: "The pack-a-day smoker has become more and more rare. What we've seen is a shift from heavier smokers to lighter smokers. We're seeing really good progress."

What Dr. Frieden failed to reveal was that one major reason for recent declines in cigarette consumption is that millions of smokers are switching - in whole or in part - to vaping. And even those who switch only in part (so-called "dual users") are greatly improving their health if they cut down substantially on the amount they smoke. They are also reducing their level of smoking addiction which makes it easier for them to quit in the future. There is no question that the widespread use of electronic cigarettes, while strongly opposed by Dr. Frieden and the CDC - is contributing to declines in the amount smoked daily by smokers. Thus, the CDC is hindering the very "progress" that it claims to support.


The Ohio State University Comprehensive Cancer Center

We have no idea whether vaping is any safer than smoking

According to a statement from the deputy director of the Ohio State University Comprehensive Cancer Center, we have no idea whether vaping is any safer than smoking: "There is minimal data available regarding the direct health effects of e-cig use or vaping, but these products have gained rapid popularity among existing smokers and non-smokers alike, including young adults. We are concerned that people assume these products have fewer negative health effects as compared with cigarettes and other tobacco products. The reality is that they are still a tobacco product and people are still inhaling potentially harmful chemicals. They should not be considered a 'safer' option until science has the opportunity to catch up with the consumer market."

To further emphasize his statement that we have no idea whether smoking is any more hazardous than vaping, the deputy director said: "We have no idea where in the spectrum these are, in terms of safety. Are they like cigarettes, or nothing like cigarettes?"

It is disturbing to me that a comprehensive cancer center that every day sees the devastation to people's health and lives caused by smoking is unable to conclude that smoking is any more hazardous than vaping, despite scores of studies demonstrating the relative safety of vaping compared to smoking. Are you serious? Anyone who takes an even cursory look at the scientific evidence will tell you that there is no question that vaping is much safer than smoking. Even Stan Glantz - a vaping opponent - acknowledges that there is no question vaping is safer than smoking.


Knox County Health Department (Knoxville, Tennessee)

Vaping is not healthier than smoking

According to a "fact sheet" from the Knox County Health Department: "Vaping devices are often marketed as the “smarter” or “healthier” alternative to smoking. The literature has yet to prove this claim. ... There is no proof that they are “safer” or “healthier” than smoking, or if they pose different or additional risk."

A public health department should not be telling the public in 2016 that there is no proof that smoking is any more hazardous than vaping. Even the tobacco companies themselves aren't saying this. In fact, the tobacco companies are telling the truth and acknowledging that vaping is a safer alternative to smoking. It seems only to be health agencies that are still denying the science on vaping and smoking.

The Rest of the Story

For years we attacked the tobacco companies for misleading the public about the health effects of smoking. Now we are doing exactly the same thing. But I don't believe that it is unacceptable for the tobacco industry to mislead people while it's acceptable for us to do it. We need to be beyond reproach in our dissemination of information, and especially recommendations, to the public. A fear that vaping might spread does not justify deception of the public. Honesty is the best policy. In a political climate that is full of dishonesty, I think the last place we need more of it is in public health.

Monday, November 21, 2016

CDC-Funded Pasadena Health Department Campaign Calls Vapers "Stupid Sheep"; Rest of the Story Calls for a Public Apology

Federal taxpayer money is being used in a campaign that calls vapers "stupid sheep," according to an article in the Pasadena Independent. The article reports that a major print advertisement in the campaign contains a headline that reads: "Don't follow the herd. Vaping effects are unknown, stupid sheep."

An article in the San Gabriel Valley Tribune also reports that: "The advertisements compare e-cigarette users to 'stupid sheep.'"

The campaign is being funded by the Centers for Disease Control and Prevention (CDC).

The Rest of the Story

There really is no place for a campaign like this in public health. We should never call people stupid. Even if people are making poor health choices, it does not mean they are stupid. And we have no business calling them stupid. This gives public health a bad name and harms our reputation. It also undermines the public's appreciation of what public health is really about.

In this case, there are some very good reasons why many people choose to vape. I don't consider any of these to be "stupid." Which of the following does the Pasadena Health Department consider stupid?
  • The desire to save one's life by quitting smoking using e-cigarettes.
  • The desire to reduce one's risk of debilitating disease by switching from smoking to vaping.
  • The desire to protect people around you by switching to vaping.
  • The desire to improve symptoms of asthma by getting off cigarettes using vaping products.
The rest of the story is that it is actually the Pasadena Health Department which is "pulling the wool" over people's eyes (if there is any sheep-like behavior going on) by equating vaping with smoking.

In public health, we view the public as our "clients," in a sense. They are not our enemies. We do not attack them or insult them. So we don't ever call them stupid.

I call on the Pasadena Health Department to discontinue these advertisements and to apologize to all vapers. In addition, the CDC should make it clear to all grantees that it will not fund any health campaigns that call members of the public "stupid."

New Study on E-Cigarettes and Bronchitis: An Example of Scientific Dishonesty and Deception

A new study published online ahead of print in the American Journal of Respiratory and Critical Care Medicine along with a press release issued by the American Thoracic Society (publisher of the journal) conclude that youth use of electronic cigarettes contributes to "the burden of chronic respiratory symptoms in youth." Specifically, the research concludes that there appears to be a causal relationship between e-cigarette use and "chronic bronchitic symptoms (chronic cough, phlegm or bronchitis)" among youth.

According to the press release: "E-cigarette use among teenagers is growing dramatically, and public health experts are concerned that these devices may be a gateway to smoking. Now, new research indicates that even if these young e-cigarette users do not become tobacco smokers, e-cigarettes may harm their health."

One of the study authors was quoted in the press release as stating: "The Food and Drug Administration recently banned the sale of e-cigarettes to children under 18 years of age, and California just prohibited sale to young adults under 21. Our results suggest that these regulations and an environment that discourages the initiation of any tobacco product may reduce the burden of chronic respiratory symptoms in youth."

While the paper considers the possibility that the relationship between e-cigarette use and chronic bronchitic symptoms may not be causal, it essentially concludes that there is most likely a causal relationship: "It is, therefore, more likely that the observed (2014) relationship of bronchitic symptoms with e-cigarette use was causal, because the e-cigarette effect estimates were unchanged after adjustment for 2010 symptoms and after restriction to adolescents with no bronchitic symptoms in 2010."

The study involved a cross-sectional examination of the relationship between e-cigarette use and a past-year history of bronchitis symptoms and asthma symptoms (wheezing). The sample consisted of 2,086 southern California 11th and 12th graders, interviewed in 2014. Students were asked to report whether they had never used e-cigarettes, used e-cigarettes but not in the past month, or used e-cigarettes in the past month. Based on this question, they were categorized, respectively, as never users, past users, or current users of e-cigarettes. Current users were further classified into infrequent or frequent users based on whether they reported using e-cigarettes more than twice in the past month.

In the analysis, the investigators examined the relationship between the presence in the past 12 months of bronchitis or asthma symptoms and e-cigarette use. These relationships were then examined after controlling for two critical, potential confounding variables: (1) individual cigarette use; and (2) secondhand smoke exposure in the home.

The paper's abstract (a summary of the most important findings) reports a total of five findings:

1. There was a significant positive relationship between past e-cigarette use and bronchitis symptoms (not controlling for smoking or secondhand smoke exposure).

2. There was a significant positive relationship between current e-cigarette use and bronchitis symptoms (not controlling for smoking or secondhand smoke exposure).

3. The relationship between current e-cigarette use and bronchitis symptoms was significant for both infrequent and frequent users and was stronger for frequent users than infrequent users (not controlling for smoking or secondhand smoke exposure).

4. After controlling for smoking and secondhand smoke exposure or restricting the analysis to never smokers, there was still a significant positive relationship between past e-cigarette use and bronchitis symptoms.

5. After controlling for smoking and secondhand smoke exposure, there was no significant relationship between e-cigarette use (past or current) and asthma symptoms.

The abstract also notes that the relationship between current e-cigarette use and bronchitis symptoms was "attenuated" after controlling for smoking and secondhand smoke exposure.

The Rest of the Story

What the abstract does not tell you is that there were several other important findings of the paper:

1. After controlling for individual smoking and secondhand smoke exposure, there was no significant relationship between current e-cigarette use and bronchitis symptoms.

2. Among never smokers, there was no significant relationship between current e-cigarette use and bronchitis symptoms.

3. After controlling for individual smoking and secondhand smoke exposure, there was no significant relationship between either infrequent or frequent current e-cigarette use and bronchitis symptoms, and there was no significant trend.

Why weren't these critical results reported in the abstract? It certainly creates the appearance that the paper is trying to hide these important findings.

Moreover, it is deceptive to state that the relationship between current e-cigarette use and bronchitis symptoms was "attenuated" after controlling for individual smoking and secondhand smoke exposure. Actually, the relationship was no longer statistically significant. In fact, in none of the many analyses conducted was there a significant relationship between current e-cigarette use and any adverse respiratory symptoms - bronchitic or asthmatic - after controlling for individual smoking and secondhand smoke exposure.

In lieu of reporting these important "negative" findings, the paper instead uses the abstract to articulate the unadjusted study findings (results that do not control for smoking or secondhand smoke exposure), which are essentially meaningless because without controlling for these variables, one would actually expect to see an increase in respiratory symptoms in e-cigarette users (since we know e-cigarette use is highly correlated with smoking). So we can basically throw out the first 3 of the 5 reported results in the abstract.

What we are left with then, is that there was no association detected between e-cigarette use and asthma symptoms and that there was a positive association between past e-cigarette use and bronchitis symptoms, but not between current e-cigarette use and bronchitis symptoms. Taken as a whole, these findings do not support the conclusion that e-cigarette use has any adverse respiratory effects.

If there is no significant effect of current e-cigarette use on respiratory symptoms, then how can the study conclude that there is such an effect? The paper seems to gloss over the fact that the paper fails to find a dose-response relationship and in fact finds the opposite. Youth who use e-cigarettes frequently (at least once a month) are no more likely than never users to experience respiratory symptoms. The increase in respiratory symptoms was found only in youth who almost never use e-cigarettes!

While this study does not prove that e-cigarettes have no respiratory effects among youth, neither does it provide evidence that there is such an effect.

In fact, the headline of the paper - and its primary conclusion - should have been that there was no observed adverse effect of current e-cigarette use (including frequent e-cigarette use) on either bronchitic or asthmatic symptoms in youth vapers. Thus, there is no basis for the conclusion that electronic cigarette use contributes to "the burden of chronic respiratory symptoms in youth."

What concerns me even more than the fact that the study conclusion appears to be severely biased is the fact that the paper and the press release are both very deceptive. The paper abstract is hiding important findings. The same thing is true of the press release. In fact, nowhere in the press release does it even mention that there was no significant relationship found between current vaping and respiratory symptoms of any kind.

The press release also emphasizes the unadjusted findings, which is going to greatly confuse reporters and lead to inaccurate reporting of the findings of the study.

The rest of the story is that essentially what we have here is an example of scientific dishonesty and apparently intentional deception of the journal readers and the public. For a movement that has devoted so much attention to attacking the tobacco industry for its deception and scientific dishonesty, I believe that we need to adhere to the highest standards of honesty and transparency in our scientific reporting. This is not happening in our reporting of the health effects of vaping, and it is certainly not happening in this study and the dissemination of its results.

Sunday, November 13, 2016

E-Cigarette Companies: FDA Wants Smokers to Continue Smoking, But We Do Not; On the FDA's Decimation of the Vaping Industry

Totally Wicked - a Florida-based e-cigarette and e-liquid company that established the first brick shop in the U.S. - has announced that because of the FDA regulations, they have been forced to go out of business in 2018, once the pre-market tobacco application (PMTA) grace period ends. They will join what will certainly be thousands of other e-cigarette businesses and vape shops which simply cannot afford the capital costs associated with completing PMTA's.

In announcing the closing of its doors in 2018, Totally Wicked explained - in the most succinct and prescient manner I have heard - the absurdity and the irony of the FDA's approach to e-cigarette regulation:

"The FDA may want Americans to continue smoking; we do not."

As Totally Wicked explains:

"As a business we operate in both the EU and the USA, have a loyal customer base, offer a wide and dynamic range of hardware and e-liquids and try always to deliver the best possible service in an open and ethical way. However, this is clearly not enough for the FDA as they actively shut down this vibrant industry. With the stroke of a pen, the FDA is demanding fantastically unrealistic pre-market tobacco authorizations for a product that contains no tobacco, at a cost that is prohibitive to all but the tobacco giants, and bears no relations to the products’ risk or indeed, its remarkable potential when compared to the raging tobacco epidemic. It is designed quite simply to destroy the industry. By the end of 2018, there will be no independent vaping industry left within the USA - unless Congress decides to look deeper into this, or indeed the legal system is willing and able to hold the FDA to account for its fallacious representation of the risk impact that it has used to justify this regulatory abomination." ...

"This government and its federal bodies charged to defend and protect its citizens have failed the American smokers. While the majority of the rest of the world is moving towards an enlightened position on the transformational potential of consumer vaping products, the USA will retrench itself with a ‘year zero’ firestorm that is already alight in the USA and will consume all independent vape businesses like ours in Summer 2018."

The Rest of the Story

This is a perfect rendition of exactly what the FDA is doing with its misguided regulatory approach to electronic cigarettes. By treating vaping products exactly the same as deadly cigarettes (in fact, by regulating them more stringently than cigarettes), the FDA is essentially making it clear that it wants smokers to continue smoking rather than switch to a much safer alternative that could potentially save millions of lives. After all, the impact of the regulations - especially the PMTA requirement and the modified risk provisions - will be the decimation of the vaping industry and the creation of a huge impediment to the transformation of the nicotine market from the most toxic to the safest available products.

If the FDA truly wanted smokers to quit, then it would certainly craft regulations that promote smoking cessation, rather than regulations that block or impede smoking cessation by denying smokers the availability of a wide range of much safer alternative products. And it would certainly not create a regulatory infrastructure that gives a huge competitive advantage to real cigarettes over the fake ones.

It is very true: the FDA (and the federal government as a whole) has failed the American smokers. Rather than increasing the available options to quit smoking, the FDA has greatly limited those options. And instead of encouraging smokers to quit, the FDA has permanently stymied smoking cessation efforts.

But there is one ray of hope. As Totally Wicked suggests, the above scenario will occur: "unless Congress decides to look deeper into this." Fortunately, there are a number of federal lawmakers who have decided to look deeper into this. We will work with these members of Congress to try to prevent the FDA from carrying through with its destructive policies by enacting an alternative approach by which vaping products are regulating under a mechanism distinct from that which is used for products which actually contain tobacco.

As Totally Wicked says, it is sheer lunacy to regulate as tobacco products these devices that contain no tobacco.

Thursday, November 10, 2016

Is There a Silver Lining in a Dark Cloud?

From a public health perspective, there are many reasons to be concerned about the outcome of Tuesday’s election. However, there is one reason to potentially be encouraged. With a Trump presidency, and with Republican control of the Senate, we ironically have a tremendous opportunity to once and for all craft a sensible regulatory strategy for electronic cigarettes and vaping products.

The Rest of the Story

Although the issue was not directly addressed during the campaign, I would expect President-elect Trump to be supportive of vaping products and especially of the thousands of small businesses that are likely going to be forced out of business under the FDA’s current nicotine regulatory policy. In addition, we know that there are several Republican senators (whose party will now control the Senate) who are sympathetic to the public health damage being done by current policy. Moreover, several senators have specifically considered holding hearings on the issue and are amenable to the introduction of legislation to chart a different course than the FDA is currently taking.

I believe that this is actually a historic opportunity, due to a strange but true alignment of the stars. We must take advantage of this opportunity to undo the damage that the FDA’s vaping products policy has done and is slated to do moving forward.

However, it is important that we not settle for a quick-fix. We can do better than that. I don’t think we need to settle for a Cole-Bishop type amendment that merely changes the grandfather date for vaping products. Instead, I think there is an opportunity to put on the table a proposal for a new, comprehensive regulatory strategy for vaping products that treats these products completely differently from tobacco cigarettes and tobacco products. I believe that we need to create a separate and distinct regulatory framework specifically for vaping products, one that is not based on the Family Smoking Prevention and Tobacco Control Act.

Such a policy must take into consideration the relative risk profile of e-cigarettes compared to real cigarettes and must regulate these products accordingly. While Mitch Zeller has publicly stated the need to do this, the agency’s actual deeming regulations do just the opposite: they throw e-cigarettes into the exact same box as cigarettes and in fact give preference to tobacco-full, rather than tobacco-free cigarettes.

I don’t even think that the FDA is necessarily the appropriate agency to regulate vaping products. Perhaps it would be more appropriate to give regulatory jurisdiction to the Consumer Products Safety Council or a similar agency with experience regulating the safety of consumer products, rather than an agency whose sole experience is with regulating drugs and devices, where the regulatory standard is “safety” and “effectiveness.” Vaping products are not designed to be either safe or effective. They are designed as an alternative to deadly cigarettes. And they need to be regulated as such.

The basis of a regulatory policy for vaping products should be the promulgation of a set of safety standards that will maximize the benefits of these products, while minimizing their potential harm. Regulation of battery safety, heating temperature (and therefore, levels of adverse chemicals such as formaldehyde), flavoring ingredients, quality control, and marketing should be a priority. The pre-market approval process should be completely abandoned. The modified risk provisions should not be applied to vaping products. And finally, the statute should clearly state that smoking cessation claims will not be considered to be drug claims and that therefore, vaping products will not be regulated as drugs unless they specifically make claims about treatment of nicotine dependence or withdrawal. Claims related to smoking cessation should be explicitly allowed, subject of course to accuracy and validity of the claims.

The Senate has been understandably hesitant to tackle this issue during the election season. However, with a new administration the time will be ripe to take this issue on.

One might argue that it is unlikely that an administration would completely repeal an agency regulation that is already in force. However, President-elect Trump does not seem timid about threatening to completely repeal other health statutes and regulations so I don’t see any reason why he would be reluctant to do that with the FDA’s ill-advised e-cigarette regulations.

Last Chance to Register for Regulations for E-Cigarettes Conference

An exciting conference - Regulations for E-Cigarettes - will be held December 6-7 in Alexandria, VA. This is the inaugural Regulations for E-Cigarettes event, and it will focus on the complex regulations facing the electronic cigarette and vaping industries. It is of particular interest to those in the e-cigarette, testing, research, public health, and public policy fields. I will be speaking on the FDA's e-cigarette deeming regulations. I urge everyone to consider attending. The agenda and registration information are available here.

Monday, November 07, 2016

Investigators Botch Interpretation of New E-Cigarette Study Results; American Academy of Pediatrics Misrepresents the Findings

A new study published online this morning in the journal Pediatrics purports to show that flavored e-cigarettes serve as a gateway to youth smoking by increasing nonsmoking youths' intentions to smoke and decreasing smoking youths' intentions to quit.

The study reports results from the 2014 National Youth Tobacco Survey. In a cross-sectional analysis, the investigators examined the relationship between flavored e-cigarette use and (1) intentions to smoke among nonsmokers; (2) intentions to quit among smokers; and (3) perceptions of the danger of tobacco products among both smokers and nonsmokers.

The study concludes that the use of flavored e-cigarettes by youth is a gateway to future smoking: "Consistent with previous findings about e-cigarette use, our findings suggest that youth use of flavored e-cigarettes might serve as a gateway for future cigarette use."

A press release from the American Academy of Pediatrics (the publisher of Pediatrics) reports the conclusion of the study as follows: "Flavored E-Cigarette Use May Increase Teens' Taste for Smoking."

According to this press release: "New research shows the use of electronic cigarettes with flavors such as gummy bear and bubble gum among U.S. middle- and high-school students may serve as a gateway for future smoking." The press release also states that: "The study ... suggests use of these products increases young people's intentions to begin smoking... ."

The Rest of the Story

This study makes one of the cardinal mistakes of causal inference: assuming that correlation in a cross-sectional study equals causation. The fact that there is an association between the use of flavored e-cigarettes and higher susceptibility to smoking does not demonstrate that the use of e-cigarettes increases susceptibility to smoking. Because the data are cross-sectional, it could alternatively be the case that higher susceptibility to smoking causes youth to experiment with e-cigarettes.

In other words, the direction of this relationship could go either way: from e-cigarettes to an intention to smoke or from an intention to smoke to use of e-cigarettes.

Despite the fact that the relationship could be in either direction and despite the fact that the paper acknowledges that "the data are cross-sectional; thus, we were unable to establish causal inferences," the paper nevertheless concludes that e-cigarettes may be a gateway to smoking. Moreover, the press release clearly presents the findings as suggesting that e-cigarettes cause smoking initiation among youth.

This is a great example of the widespread bias against e-cigarettes that has taken hold in the tobacco control movement. Instead of presenting the study as showing equivocal results, the investigators and the American Academy of Pediatrics have both "chosen sides." This is not science; it is biased interpretation and presentation of science.

Why should we even be spending money on conducting this research if investigators and organizations are going to draw pre-determined conclusions regardless of whether those conclusions are supported by the data? Why not just save the time and money and jump right to the conclusion that e-cigarettes are a gateway to smoking without the need for actual scientific evidence? After all, we're drawing that conclusion without the presence of scientific evidence anyway.