Monday, November 30, 2015

Op-Ed in The Hill Argues for a Change in the Predicate Date for E-Cigarettes; Supports Appropriations Rider that Would Accomplish This

Today, Scott Ballin and I published an op-ed article in The Hill which argues that the predicate date for electronic cigarettes should be changed from February 15, 2007 - as proposed by the FDA - to at least the effective date of the final deeming regulations. We therefore support a House Appropriations rider that would accomplish precisely this. Discussion on that rider begins today. We hope that this piece will help inform that debate.

Sunday, November 29, 2015

New Study Suggests Very Little Risk Associated with Passive Vaping, At Least with MarkTen E-Cigarettes

A new study published online last week in the Journal of Occupational and Environmental Hygiene provides strong new evidence that passive vaping poses very little health risk, at least for MarkTen e-cigarettes, the brand used in the study.

(See: Maloney JC, et al. Insights from two industrial hygiene pilot e-cigarette passive vaping studies. Journal of Occupational and Environmental Hygiene, November 17, 2015, doi: 10.1080/15459624.2015.1116693.)

In the study, a series of six 1-hour vaping sessions were held over the course of a 12-hour day in a 137 cubic meter room designed to simulate a conference room setting. MarkTen e-cigarettes were used. The room air exchange rate was approximately 1.5 per hour. Active air sampling was employed, both under background and vaping conditions. Air samples were analyzed for propylene glycol, glycerine, nicotine, menthol, particulate matter, and formaldehyde.

The major study results were as follows: "Results of the active samples were below the limit of quantitation of the analytic methods. Near real-time data were below the lowest concentration on the established calibration curves. Data from this study indicate that the majority of chemical constituents [all but formaldehyde] were below quantifiable levels. Formaldehyde was detected at consistent levels during all sampling periods [the levels were no different during vaping compared to background]."

The study concludes: "These two studies found that indoor vaping of MarkTen prototype e-cigarette does not produce chemical constituents at quantifiable levels or background levels using standard industrial hygiene collection techniques and analytical methods."

The study was conducted and reported by scientists at Altria Client Services.

The Rest of the Story

In summary, this study showed that under realistic conditions of vaping in a public place, MarkTen e-cigarettes did not produce ambient levels of propylene glycol, glycerine, nicotine, menthol, or particulate matter above detectable levels, and that while formaldehyde was detected, it was present at background levels measured without vaping occurring.

The results of the study suggest that there is minimal risk associated with passive vaping under realistic conditions, at least with the use of MarkTen e-cigarettes. Of course, one cannot determine from this study whether risks associated with the vaping of other brands of e-cigarettes would be similar. Thus, it is important for similar studies to be conducted with all brands of e-cigarettes.

Importantly, however, the study demonstrates that it is possible to produce an electronic cigarette that produces very low risk of adverse health effects upon bystanders. In this study, exposure of bystanders to nicotine, propylene glycol, menthol, particulates, and formaldehyde was not a problem.

Based on the overall evidence to date, any conclusion that passive vaping poses a substantial public health risk is not justified. Therefore, I would argue that there is not a sufficient scientific basis to support bans on vaping in all public places, as there is with secondhand smoke.

It should also be recognized that an additional benefit of electronic cigarettes is that they may be effective in reducing or eliminating secondhand smoke exposure for many nonsmokers in the population, especially for children living in homes with smokers who were previously smoking in the home but who are able to switch to vaping. This is an additional benefit of electronic cigarettes that has not adequately been considered in previous cost-benefit analyses.

Tuesday, November 24, 2015

Thanks to Invalid NEJM Formaldehyde Study, Public is Being Told that Cancer Risk from Vaping is 15 Times Higher than from Smoking

According to an article published yesterday at, the cancer risk from vaping is 5 to 15 times higher than the cancer risk from smoking.

The article states: "A look at the dangers of inhaling formaldehyde published in the New England Journal of Medicine earlier this year included two studies that showed that the risk of developing cancer from long-term vaping is five times as high as that of smoking a pack of regular cigarettes a day. The second study suggested the risk was 15 times higher."

This alarming statistic was echoed by a physician who was interviewed for the story. Dr. John Mendelsohn, an emergency room physician and toxicology expert at Falmouth Hospital, was quoted as stating: "Formaldehyde is present in cigarettes as well, but it’s felt that the exposure of formaldehyde in the e-cigarette compared to a regular cigarette has probably a five times greater risk of toxicity."

Indeed, the article from the New England Journal of Medicine did conclude that: "Among persons with a body weight of 70 kg, the incremental lifetime cancer risk associated with long-term cigarette smoking at 1 pack per day may then be estimated at 9×10−4. If we assume that inhaling formaldehyde-releasing agents carries the same risk per unit of formaldehyde as the risk associated with inhaling gaseous formaldehyde, then long-term vaping is associated with an incremental lifetime cancer risk of 4.2×10−3. This risk is 5 times as high (as compared with the risk based on the calculation of Miyake and Shibamoto shown in Figure 1), or even 15 times as high (as compared with the risk based on the calculation of Counts et al. shown in Figure 1) as the risk associated with long-term smoking."

My colleagues and I have already pointed out that the formaldehyde in the NEJM study was only detected during high voltage conditions and was not a problem at the low voltages typically used by electronic cigarette users. Moreover, the high voltage condition produced a phenomenon known as the "dry puff," which creates a terrible taste that would not be tolerated by the vaper. As I have previously argued: "the researchers actually argued that vaping might be 15 times worse than smoking in terms of cancer risk! Yet it turns out that their conclusion was invalid and that while e-cigarettes can produce formaldehyde under normal conditions, the levels appear to be minimal and certainly do not produce a risk that compares to that of smoking."

The Rest of the Story

This story demonstrates just how misinformation about the relative risks of smoking vs. vaping are spreading widely to the public and policy makers.

It all starts with a misrepresentation in a scientific article: in this case, the article claimed that the long-term cancer risk associated with vaping is 5 to 15 times higher than that associated with smoking one pack per day.

Then, that misinformation spreads to the media, which widely disseminate it to the public.

Next, physicians reading this misinformation incorporate it into their own beliefs on the health risks of electronic cigarettes.

They then feed back the misinformation to the media, which further disseminates the scary but inaccurate information to the public and policy makers.

It becomes a self-perpetuating, vicious cycle.

We now know that the campaign of deception being waged by anti-nicotine researchers and groups is working. The public is widely confused about the relative risks of smoking and vaping. In fact, over time, the public has become more likely to falsely believe that smoking is no more hazardous than vaping.

As Jacob Sullum has noted: "misinformation about e-cigarettes, including sensational press coverage of weak or overinterpreted studies, is warping public perceptions of the risks posed by vaping, possibly deterring smokers from making a switch that could save their lives. British surveys indicate that misperceptions have increased in recent years. A survey of adults sponsored by the British group Action on Smoking and Health—which, unlike the American group of the same name, supports e-cigarettes as an aid to quitting—found that the share of respondents who incorrectly described e-cigarettes as “more harmful” than tobacco cigarettes or “equally harmful” rose from about 8 percent in 2012 to 20 percent in 2014."

Sullum is absolutely correct that this misinformation is problematic not only because it is unethical to lie, but because the "warped" public perceptions of the risks posed by vaping compared to smoking may actually deter smokers from trying to quit using e-cigarettes and potentially save their lives. The misinformation may also cause former smokers who quit using e-cigarettes to return to smoking, since if vaping is no safer than smoking, what's the point of giving up real cigarettes?

It is high time for another "truth" campaign. This campaign, however, is necessary not to correct damage done by the historical lies of the tobacco companies, but to correct the damage done by the current lies of the tobacco control movement.

Monday, November 23, 2015

Why are Altria and Reynolds American Supporting Increased Competition Against Cigarettes While Health Groups are Protecting Cigarette Profits?

Altria and Reynolds American are Supporting Policies that are Not in Their Best Economic Interest but which Protect the Public's Health

Anti-Smoking Groups are Protecting Economic Interests of Cigarette Companies at the Expense of the Public's Health

In an ironic twist that boggles the mind, both Altria and Reynolds American have taken a public policy position that protects public health despite being a threat to their cigarette profits, while the major anti-smoking groups are urging the FDA to stifle competition against cigarettes and thus protect the stream of profits for cigarette companies.

The irony concerns the positions of the two major domestic tobacco companies (Altria and Reynolds American) and the leading national anti-tobacco advocacy organization (the Campaign for Tobacco-Free Kids) on the issue of the predicate date that should determine whether or not electronic cigarettes need to file pre-market tobacco applications (PMTAs) in order to remain on the market.

The Background

The deeming regulations which FDA sent to the Office of Management and Budget for approval declare February 15, 2007 as the predicate or "grandfather" date for electronic cigarettes. Any existing e-cigarette or vaping product which was not on the market as of that date -- which is essentially every e-cigarette and vaping product currently on the market -- will have to submit a PMTA, which is an extremely burdensome, expensive, and nearly impossible to complete process.

In contrast, since virtually all tobacco cigarette brands currently on the market were already on the market in 2007, every cigarette brand is automatically "grandfathered in," meaning that it can continue on the market without having to submit any application or meet any safety standards.

In other words, the FDA wants to force electronic cigarette companies to submit burdensome applications just to stay on the market, while real cigarettes get a free ride and don't need to do anything (other than to simply note that they were on the market in 2007).

This is an insane position because it essentially means that the FDA views electronic cigarettes as a much greater threat to the public's health than real cigarettes, which kill more than 400,000 Americans each year.

Moreover, this policy would result in the decimation of the electronic cigarette industry, removing at least 99% of current e-cigarette and vaping products from the market. Most of these products are made by small manufacturers or vape shops which simply don't have the resources or expertise to put together the scientifically complex and unduly expensive applications that will be required for their products to stay on the market. The result of the removal of so many of these products from the market would be a public health disaster: many smokers who quit using e-cigarettes would be forced to return to cigarette smoking, and many smokers who would otherwise have quit using e-cigarettes will instead continue to smoke.

The FDA's decision to establish a predicate date of February 15, 2007 for electronic cigarettes would have the effect of stifling competition against tobacco cigarettes by removing from the market hundreds of brands of much safer alternative products. These vaping products are presently providing vigorous market competition against cigarettes. But the FDA would effectively remove this competition and allow cigarettes to continue their market dominance, along with an unfettered profit stream.

Financial analysts had predicted that based on volume growth during the period 2011-2014, e-cigarettes could literally transform the nicotine market, decreasing cigarette sales by as much as 50% over the next decade. The FDA deeming regulations will almost certainly ensure that such a public health miracle does not occur.

However, there is one chance to save the situation: A rider has been added to a House appropriations bill that would establish a predicate date for electronic cigarettes, by statute, of the effective date of the final e-cigarette deeming regulations. This would allow all e-cigarette and vaping products currently on the market to remain on the market without having to file PMTAs. These products would, of course, still be subject to any safety standards or other regulations promulgated by the FDA, including marketing, labeling, manufacturing, and flavoring restrictions.

The Campaign for Tobacco-Free Kids' Position

Shockingly, the Campaign for Tobacco-Free Kids has come out in opposition to the House legislation. The Campaign insists that the predicate date of February 15, 2007 not be changed, so that every e-cigarette product has to submit onerous and expensive applications to stay on the market. The main argument the Campaign provides is that changing the predicate date would prevent the FDA from ensuring the safety of the electronic cigarettes on the market and would tie the agency's hands in addressing the targeting of children with candy-like flavorings such as "cotton candy" and "gummy bear."

However, the Campaign for Tobacco-Free Kids is lying. It is simply not true that the FDA would be prevented from ensuring the safety of electronic cigarettes or that its hands would be tied in terms of addressing candy flavorings. In fact, the truth is quite the opposite. Regardless of the predicate date, the FDA is free to set any safety standards, including flavoring and marketing restrictions, that it wishes to set. And it can propose such standards at any time, including tomorrow morning if it wanted to.

Moreover, without being overburdened by the imposing requirement to review literally tens of thousands of pre-market tobacco applications, the agency could put its full attention and resources to simply promulgating safety standards for electronic cigarettes and vaping products. Rather than having to wait years to address problems such as battery safety and toxic flavorings, the agency could address these problems tomorrow morning. Changing the predicate date would free the agency to focus on setting safety standards immediately. This would put a quick end to the exploding batteries and other quality control issues that are impacting the safety profile of these alternative nicotine products.

But rather than pushing for effective regulation, the Campaign instead is favoring what essentially amounts to a prohibition-like approach. This approach offers the best protection for cigarette profits that money could buy: the removal of serious competition from the market.

The Altria and Reynolds American Positions

The two major U.S. tobacco companies, unlike the major anti-smoking groups, are supporting policies that make it easier, not more difficult, for alternative nicotine-containing products to compete with combustible products.

Altria has come out strongly in support of the House legislation that would change the predicate date from February 15, 2007 to the effective date of the final regulation. This is a striking position because it is not in the best economic interests of the company. The onerous, burdensome, and expensive PMTAs that the FDA wants to require for every e-cigarette product would help Altria to corner the market in e-cigarettes because it is the company best positioned to be able to carry out the Herculean task of successfully completing a PMTA. The predicate date of 2007 would put most e-cigarette companies out of business, allowing Altria to gain a huge share of the market. So it is worth noting that Altria's position is sacrificing its own interest in gaining market share for Mark Ten, and instead, demonstrates a sincere interest in saving and preserving a thriving e-cigarette and vaping market. Despite the economic ramifications for domestic cigarette sales, Altria seems committed to opening up the nicotine market to alternative products, beyond cigarettes.

Lorillard, which is now a part of Reynolds American (after being acquired by Reynolds American earlier this year), has also come out strongly in favor of changing the predicate date from 2007 to the effective date of the final regulation. And RAI Services Company (a wholly owned subsidiary of Reynolds American) has argued that either the predicate date should be changed to the effective date of the regulations, or that a clear pathway needs to be created to ease pre-market authorization for electronic cigarettes (which the FDA has clearly not done in its final deeming regulations). Thus, also against its own economic interests, Reynolds American is supportive of a change in the predicate date, demonstrating its own commitment to promoting a transformation of the domestic nicotine market.

And with the recent announcement that it is pursuing vapor-like technology for its VUSE e-cigarette product, it is clear that Reynolds American is now committed to the expansion of both the traditional e-cigarette and the newer vaping device market (notwithstanding its earlier reservations about open system vapor devices).

The Rest of the Story

So the dramatic irony is now clear. While the two largest cigarette companies are committed to a transformation of the nicotine market that would allow much safer electronic cigarettes and vaping products to compete with traditional, combustible tobacco cigarettes, the major anti-smoking groups are committed to halting this transformation and maintaining the status quo: the continued death of more than 400,000 Americans each year because they are forced to continue smoking the most highly toxic nicotine-delivery product, rather than any of a wide range of much safer alternatives that could save their lives.

It is baffling why the anti-smoking groups are so much more devoted, at this point in time, to halting e-cigarette use than to putting a huge dent in smoking. They appear to be devastatingly afraid of any increase in the number of Americans who are "addicted" to nicotine, regardless of whether that increase comes at the "expense" of saving thousands of lives. And to make matters worse, the best current scientific evidence suggests that the benefits of e-cigarettes will likely accrue without any significant increase in the number of "nicotine addicts." There is no evidence that e-cigarettes are resulting in any substantial proportion of non-smoking youth who are becoming addicted to nicotine, and the same is true for adult nonsmokers.

The battle against smoking-related morbidity and mortality -- which is the battle I joined in 1985 as a junior at Brown University -- has now been completely transformed into a battle against nicotine itself. The battle against death and disease has been transformed into a battle against addiction itself. The goal is no longer to make smoking history, but to put up a brick wall against the idea that someone, somewhere, might be actually deriving some measure of satisfaction or relief from a psychoactive substance called nicotine.

The tobacco control movement has now become reminiscent of the social movement which declared "war" on drugs, but then went on to promote ineffective and racist policies that sent minor marijuana offenders to prison as felons, while at the same time having little problem with (mostly white, upper-class) people having a few too many martinis at a business cocktail party and then killing someone on the way home. The black marijuana user ends up in prison, while the white drunk driver gets a slap on the wrist and perhaps a three-month license suspension but never sees what the inside of a prison looks like. But worst of all, the policies don't work. What has been lost is the goal: is it to punish people for their particular method of dealing with life stress or is it to find the most effective way to promote the overall health and well-being of the public?

For the tobacco control movement, it has ceased to be about finding the most effective way to promote the overall health and well-being of the public. The movement is now dead set on punishing people for having a particular method of dealing with life stress: the use of nicotine. And we now know that, in the mind of the tobacco control movement, even if that use of nicotine is literally saving a person's life, there is no good that comes out of saving that life at the expense of continued dependence on that particular chemical substance.

The rest of the story is that over the course of the past 30 years (and mostly during the last five), the tobacco control movement has lost its bearings. And the loss of that perspective is evidenced today by the most unexpected, shocking, and ironic turn of events: the tobacco companies have a vision of a transformed and much safer nicotine market, while the anti-tobacco groups are doing everything they can to preserve the current status of the market, where the most toxic consumer product known to mankind -- tobacco cigarettes -- continues to reign supreme.

Friday, November 20, 2015

My Public Comment to OIRA on FDA Deeming Regulations

This morning, I met with several staff of the Office on Information and Regulatory Affairs (OIRA) of the Office of Management and Budget (OMB) of the White House Executive Office to provide feedback on the proposed FDA deeming regulations for electronic cigarettes (RIN#0910-AG38). I am grateful for having had the opportunity to share my analysis of the regulations as pertaining to the provisions of Executive Order 12866, which outlines the criteria a regulation must meet in order to be approved by OIRA.

The OIRA staff was very interested in my analysis and appreciative of the insights I was able to provide, especially as they related to the specific provisions of Executive Order 12866 which I believe the deeming regulations violate.

The Rest of the Story

Here is a link to my public comment. It may be helpful to others as it articulates the specific provisions of Executive Order 12866 which I believe the FDA deeming regulations violate.

Please note that OIRA cannot disapprove the regulation and return it simply because it disagrees with the approach. There are specific criteria that the OIRA must follow in its review, and these are outlined in the Executive Order.

In particular, I believe that the deeming regulations are in violation of the following sections of Executive Order 12866:
  • 1(b)(5) 
  • 1(b)(6)
  • 1(b)(8)
  • 1(b)(11)
  • 1(b)(12)
In my public comment, I explain each of these violations in detail, based on my scientific analysis of the deeming regulations.

Wednesday, November 18, 2015

Nominee for New FDA Commissioner Derived Salary from Six Pharmaceutical Companies LAST YEAR

In President Obama's first inauguration speech, he promised to restore science to its proper place in government by shielding the regulatory process from corporate influence. One of his specific proposals to carry out this promise was to prevent anyone with a severe corporate conflict of interest from serving in the executive branch until at least one full year had gone by without the conflict in place. Thus, if you received salary from a pharmaceutical company in 2014, you would not be permitted to serve as the FDA Commissioner at least until 2016.

Unfortunately, as we have repeatedly seen campaign promises wither, this one too seems to have died a quiet death. For it was revealed yesterday by the Washington Post that President Obama's nominee for the Commissioner of the FDA - Dr. Robert Califf - received salary support from not one, not two, not three, not four, not five, but six pharmaceutical companies last year (2014). In addition, Dr. Califf was paid by eight pharmaceutical companies for consulting services and had personal equity in two pharmaceutical companies. In all, in 2014, Dr. Califf had significant financial interests in 14 different pharmaceutical companies!

To make matters worse, according to the FDA itself, a clinical trial led by Dr. Califf was sharply criticized by Public Citizen's Health Research Group for failing to quickly anti-coagulate patients treated with an experimental anti-coagulant drug who were then taken off that drug, resulting in an excess of 16 strokes among these patients. According to the FDA report: "The Division received comments from Public Citizen’s Health Research Group indicating concern that the applicant’s failure to “1) pre-specify criteria for transition to appropriate anticoagulation in the 30 days following study-drug discontinuation or 2) provide clear, standardized instructions to investigators on how to transition patients deemed eligible for further anticoagulation” exposed subjects to unnecessary harm and therefore was unethical. While it is obvious that the applicant can not have intended XARELTO subjects to have had a greater number of strokes while they were being followed because it worsens the apparent risk-benefit profile of XARELTO, it also true that lack of care in designing and conducting ROCKET could have resulted in some XARELTO subjects suffering unnecessary strokes." Recently, Project on Government Oversight (POGO) executive director Danielle Brian stated: "Dr. Califf’s handling of the Xarelto trial raises concerns about his judgment in overseeing the pharmaceutical industry."

The worst of the story, however, is that during his Senate confirmation hearings, Dr. Califf apparently defended his conflicts of interest with Big Pharma, demonstrated a misunderstanding of what conflict of interest is all about, and expressed no awareness of the severity of the problem of conflict of interest in making government regulatory decisions.

According to the Washington Post article: "President Obama’s nominee to lead the Food and Drug Administration defended his past ties to the pharmaceutical industry on Tuesday, saying that drug company dollars never influenced the outcome of his academic research and vowing to maintain the agency’s standards for ensuring that approved treatments are safe and effective. Robert Califf, a cardiologist and long-time Duke University researcher, acknowledged that pharmaceutical companies helped fund many of the clinical trials he oversaw. But the drug industry routinely funds such studies, he noted, and Duke’s contract requirements protected the independence of investigators to publish research outcomes, whatever the results."

This demonstrates a misunderstanding of the problem of conflict of interest. Conflicts of interest are a problem not because they lead to conscious manipulation of study findings by investigators, but because they could lead to subconscious bias in the conduct or reporting of the results of these studies. A conscious bias in reporting the results would represent academic misconduct, not merely conflict of interest. It is the subconscious bias produced by pharmaceutical company funding that is at issue here. That is what conflict of interest policies are designed to protect against - not the conscious manipulation of study findings, which is an ethical issue. Conflict of interest is not an issue about ethics as much as it is an issue about protecting the integrity of the research and regulatory process.

The Rest of the Story

It is difficult to understand how this nominee, who just last year had significant financial relationships with 14 different pharmaceutical companies, could - one year later - be confirmed as the head of the agency which regulates those 14 companies.

Clearly, Dr. Califf would have to recuse himself from any decisions regarding any of those 14 companies. However, since these represent some of the largest pharmaceutical companies in the nation (including Merck, Novartis, Roche, Eli Lilly, Bayer, Janssen, and Amgen, he would essentially have to recuse himself from all regulatory decisions made by the FDA. Therefore, it is apparent that because of his extensive financial conflicts of interest with Big Pharma, he is not qualified to serve as the FDA Commissioner.

Regardless of the integrity of his decision-making, the agency would always be under the public perception of a bias towards the pharmaceutical companies emanating from the Commissioner's conflicts of interest with these companies. This is simply not tolerable, and it is the precise reason why federal agencies have conflict of interest policies in the first place.

If Dr. Califf is appointed as the FDA Commissioner, I believe that he would be in violation of the Office of Government Ethics (OGE) regulations which state as follows: "a Federal employee may not personally and substantially participate in an official capacity in any particular matter which, to his knowledge, he or any other person (whose interests are imputed to the employee under 18 U.S.C. 208) has a financial interest if the particular matter will have a direct and predictable effect on that interest (5 CFR 2640.103(a))."

To avoid being in violation of this law, Dr. Califf would have to recuse himself from all FDA-related work.

Now, you might respond to this argument by pointing out that the prospective Commissioner is now divested of his financial interests and therefore, while he had financial interests in the past, he no longer holds them. So there is no violation of the government ethics regulations. Putting aside the point that this clearly violates the spirit of the law, though not the letter of the law, let's consider this further.

It is a good point. However, you are forgetting 5 CFR 2635.502(a), which clearly states that:

"Where an employee knows that a particular matter involving specific parties is likely to have a direct and predictable effect on the financial interest of a member of his household, or knows that a person with whom he has a covered relationship is or represents a party to such matter, and where the employee determines that the circumstances would cause a reasonable person with knowledge of the relevant facts to question his impartiality in the matter, the employee should not participate in the matter unless he has informed the agency designee of the appearance problem and received authorization from the agency designee in accordance with paragraph (d) of this section."

So what is the definition of a "covered relationship" with a "person?"

First, please note that according to the definition of "person": under 5 CFR 2635.102(k), a "person" includes a "corporation," "company," or "firm."

According to 5 CFR 2635.502(b)(1)(iv), a covered relationship includes: "Any person for whom the employee has, within the last year, served as officer, director, trustee, general partner, agent, attorney, consultant, contractor or employee."

Because it appears that Dr. Califf has, within the last year, served as a consultant and/or contractor for a number of pharmaceutical companies, it appears that his being appointed FDA commissioner at this time would violate 5 CFR 2635.502(a), unless he were specifically cleared for every activity he participates in by receiving authorization from the agency designee following a judgment that "the interest of the Government in the employee's participation outweighs the concern that a reasonable person may question the integrity of the agency's programs and operations." (see 5 CFR 2635.502(d)) He would have to receive such an authorization based on the above determination for each and every matter in which he participates. Obviously, this makes it clear that he is simply not in a position to be appointed as the FDA Commissioner given his extensive and recent history of Big Pharma conflicts of interest.

Finally, one might say: "Well, Dr. Siegel, I see your point but since it is almost 2016, it will be more than one year since the financial relationships so there is no problem and no technical violation of the law."

To which I would respond: "If that is the extent to which you have to go to defend this nomination and you still don't see a problem, then you are missing the forest for the trees."

The rest of the story is that the nominee for FDA Commissioner has such a severe, recent, and extensive history of financial interests with multiple pharmaceutical companies that it would violate all principles of scientific and regulatory integrity to appoint him to head the agency which regulates those very companies.

Monday, November 16, 2015

Anti-Smoking Groups are Admitting that They Can't Handle the Truth and Have No Interest in Sharing It

A revealing email from a state health department worker to Dr. Stan Glantz demonstrates the way in which anti-smoking groups are unable to handle scientific truth and the difficulty they have in telling the truth when it interferes with their underlying ideology.

Apparently, a state health department tobacco control practitioner attended a webinar in which Dr. Terry Pechacek from CDC explained that electronic cigarettes are much safer than tobacco cigarettes and that therefore, moving all current cigarette smokers to exclusive use of e-cigarettes would be a good thing. Similarly, Dr. Brian King of CDC noted that it would have positive public health benefits if all smokers switched to exclusive e-cigarette use. In addition, the practitioner has heard more and more information coming out which refers to e-cigarettes as being less harmful than cigarettes.

The email to Dr. Glantz stated as follows: "Throughout the last six months my colleagues and I have been hearing professionals refer to e-cigarettes as harm reduction. A few months ago I was attending a Youth Engagement Alliance webinar where Dr. Terry Pechacek was presenting. During his presentation, he made it sound like e-cigarettes are harm reduction and mentioned moving all current cigarette smokers to exclusive use of e-cigarettes. Then a few weeks ago after meeting with an individual who works at our state health department he stated that he had heard something similar at a conference he attended a few weeks ago by Dr. Brian King. Now we are seeing more and more information come out to the public referring to e-cigarettes as less harmful than cigarettes. How should public health advocates respond to statements like this from well-known individuals when a large amount of our work has been focused on educating on the harms of e-cigarettes?"

Apparently, this was just too much for the practitioner to handle as s/he perceived this as undermining his or her work in "educating on the harms of e-cigarettes." In other words, what s/he is saying is that "we have an underlying ideology, which is that e-cigarettes are terrible, and if anyone says anything potentially positive about e-cigarettes, it is damaging to our campaign which aims to demonize e-cigarettes. These scientific statements of the truth are becoming a pain in the ass because they conflict with our all-or-nothing, abstinence-only ideology. Is there any way I can back out of this, short of having to tell the truth, something I really don't want to do?"

The Rest of The Story

The rest of the story is that apparently, anti-smoking groups can't handle the truth. If the truth gets in the way of their pre-determined ideology, then it is the truth which must be suppressed, rather than the ideology which must be revised. In this situation, the practitioner is severely troubled because the things his or her state anti-tobacco campaign has been saying about e-cigarettes do not appear to be true. Rather than changing the campaign to tell the truth, he or she is looking for a way to get around the truth. This person is actually asking Dr. Glantz how to respond to statements of the truth from credible scientists!!! Apparently, when the truth interferes with your story in tobacco control, the option of changing your story to incorporate the truth is not an option that is even considered.

Thursday, November 12, 2015

First PMTA Approvals by FDA Demonstrate Why Treating E-Cigarettes Like Tobacco Products Makes No Sense and Will Decimate the Industry

This Tuesday, the FDA announced that for the first time, it had approved a set of new tobacco products for delivery into inter-state commerce under the PMTA (pre-market tobacco products application) pathway. This is the same pathway that the FDA will require all electronic cigarette products to follow. Unlike e-cigarettes, all smokeless tobacco products and cigarettes that were on the market as of 2007 were exempted from the requirement to file a PMTA. Thus, virtually the entire combustible cigarette market was grandfathered in and need not obtain any approval to continue marketing of these deadly products.

This week's PMTA approvals relate to a series of eight snus products produced by Swedish Match. With the FDA's approval, these products may now be marketed in the U.S.

The Rest of the Story

What the FDA did not readily reveal is that the Swedish Match application was incredibly complex, rigorous, burdensome, comprehensive, and extensive, weighing in at a total of more than 100,000 pages!

The FDA's decision summary is itself 67 pages long. The application had to be reviewed by the following disciplines:
  • Behavioral Pharmacology
  • Chemistry
  • Clinical Pharmacology
  • Engineering
  • Environmental Science
  • Epidemiology
  • Medical
  • Microbiology
  • Social Science
  • Statistics
  • Toxicology
In contrast, here are the disciplines that needed to review applications for the following much more toxic products to remain on the market:

  • Bupkes
  • Bupkes
  • Bupkes
  • Bupkes
Virginia Slims
  • Bupkes
  • Bupkes

The importance of this story is two-fold:

First, it demonstrates that successfully submitting a PMTA is a resource-intensive, complex, burdensome, and highly expensive project that can only be completed successfully by, if anyone, the absolutely largest e-cigarette companies (including the tobacco companies and the largest of the independent e-cigarette companies). This is simply not something that a vape shop owner, the owner of a small e-cigarette business, or the owner of a small e-liquid business is going to have the capability or resources to carry out. This backs up my point made yesterday that the FDA deeming regulations amount to a de facto prohibition of all or most electronic cigarettes currently on the market.

Second, it demonstrates the absurdity of the FDA's regulatory approach. While the most toxic consumer products on the market - combustible cigarettes - have to do absolutely nothing to stay on the market, much safer products such as snus and tobacco-free electronic cigarettes have to file burdensome and prohibitively expensive applications with little technical possibility of being approved under the guidance proposed by the agency.

This is an insane way to craft a regulatory strategy for the range of nicotine-containing products on the market. In fact, it is the exact opposite of the proper approach. The most toxic products - combustible cigarettes - are being given a free ride. The safest products on the market - electronic cigarettes - are being forced to complete complex, burdensome, expensive, and unruly applications for which in most cases it is technically impossible to make the demonstrations that are required by the deeming regulations.

Tuesday, November 10, 2015

IN MY VIEW: In Reality, FDA Deeming Regulations are Thinly Veiled Prohibition

Yesterday, based on my analysis of the FDA draft guidance that will accompany the electronic cigarette deeming regulations, I explained that the requirements for a pre-market tobacco product application (PMTA) are so cumbersome and expensive that only a few of the largest e-cigarette manufacturers would be able to keep their products on the market.

Today, I add a few clarifications and expansions on my commentary, which I didn't have time to discuss yesterday because I wanted to present a general overview of the regulations and their likely impact.

There are two additional points that come out of my analysis that deserve some discussion:

1. In reality, the requirements for a PMTA appear to be technically impossible to satisfy.

While I argued that most small businesses (e.g., vape shops) and e-cigarette companies will not be able to complete successful PMTAs because of the cost, resources, and lack of scientific expertise, it might be the case that not even the largest manufacturers - such as the tobacco companies - could be able to technically complete a successful application under the FDA deeming regulations and guidance. The studies necessary to demonstrate that the public health benefits of e-cigarettes outweigh the risks will take years. Required will be not only clinical trials of e-cigarettes to determine rates of smoking cessation, but also population-based studies to determine the rate of progression to tobacco cigarette smoking among youth who are exposed to electronic cigarettes as well as studies of the rate at which former smokers relapse to nicotine use with e-cigarettes and to cigarette smoking. Moreover, longitudinal studies will need to compare the rates of initiation or relapse with e-cigarettes with the rates that would have occurred in the absence of e-cigarettes. It's not clear to me that this can be done at all, but it certainly cannot be done within a period of 2 years (which is what the proposed deeming regulations suggested as a grace period). Even if the deeming regulations extend that grace period to 5 years, it will still not be enough time to answer all the questions that need to be addressed.

A second factor that makes the PMTA requirements technically impossible to satisfy is that a company must demonstrate the effect that marketing its particular product will have on the public's health, not merely the impact that the marketing of e-cigarettes as a category will  have on the public's health. But it is technically impossible to identify the impact that marketing a particular product will have on the public's health unless the marketing of all other products was temporarily suspended. In other words, the impact of one particular product on the public's health depends not only on the marketing of that product, but on the marketing, nature, health risks, and price of all other e-cigarette or vaping products on the market.

For example, imagine that a new very-low nicotine cigarette wanted to demonstrate that it would result in a positive public health benefit. The only way such a product would likely benefit the public's health is if all cigarettes on the market were required to be very low in nicotine. If there were alternative products on the market with higher nicotine, the low-nicotine product would be a bust, and therefore, despite any evidence of success in clinical trials, it would not improve the public's health. You simply can't demonstrate the public health impact of a single, specific product in the absence of knowing what all the products on the market are, their safety profiles, their appeal, their prices, and their effects on youth. In other words, what the companies are being asked to do in the PMTAs is technically impossible.

2. The deeming regulations represent a de facto prohibition of electronic cigarettes, rather than a regulatory approach to these products.

I have argued for several years that the appropriate approach for the FDA to take would have been to simply promulgate a set of regulations that establish uniform manufacturing, safety, and quality control standards for electronic cigarettes. These standards could address issues such as battery safety, voltage or temperature regulation, use of known harmful flavors such as diacetyl, use of pharmaceutical grade propylene glycol, etc. That is a true regulatory approach.

But what the FDA is doing instead is essentially making a decision to prohibit these products, or at very least, to prohibit 99% of these products. This is not a valid regulatory approach, especially when compared to the FDA's regulatory approach for real cigarettes, which is to do nothing!

Carl Phillips provides a much more detailed and thoughtful explanation of why the FDA deeming regulations are not truly a "regulatory" approach. He writes: "Any normal use of the word [regulation] in the context of products refers to rules for product characteristics, performance standards, manufacturing standards, labeling, and the like, such that a product in the category must meet the rules to be allowed on the market. FDA’s tobacco “regulation” includes almost none of that. There are some packaging and labeling rules, a ban on characteristic flavoring for cigarettes, and a prohibition against selling to minors (which is redundant with state laws). There is constant chatter about some day imposing some real regulations, like limiting quantities of particular chemicals that some believe to be independent sources of health risks, but there is nothing like that now. And there may never be, because the real effect of FDA “regulation” is simply to make it nearly impossible for manufacturers to introduce a new product or even make changes to existing products."

Monday, November 09, 2015

FDA is Out of Its Mind: Deeming Regulations Should Be Called "The Cigarette Protection Act of 2015"; Regs are an Embarrassment to Public Health and Will Decimate the Vaping Industry

OMB Should Be Called Upon to Disapprove the Regulations and to Require Changes to Protect the Public's Health

The Tobacco Vapor Electronic Cigarette Association (TVECA) has obtained a copy of the FDA electronic cigarette deeming regulations that were sent to the Office of Management and Budget (OMB) for final approval before promulgation, as well as a draft of the guidance that the agency intends to release in conjunction with the deeming regulations. The guidance relates to the recommended procedure for filing pre-market tobacco product applications (PMTA's). The TVECA has made the PMTA guidance publicly available on its web site, but did not make the deeming regulations available upon the request of the FDA.

The following commentary is based on my review of the PMTA draft guidance document. Although I have not yet reviewed the actual deeming regulations, it is possible, from analyzing the guidance, to infer the basic approach that the FDA has decided to take regarding the regulation of electronic cigarettes and vaping products. Once the deeming regulations are released, I will continue to analyze them and provide additional commentary, including any clarifications of the following commentary if they are necessary. However, the approach the FDA is taking appears clear from the draft guidance.

Caveat: This commentary is based solely on my review of the PMTA draft guidance. It is possible, although unlikely, that the actual deeming regulations include exemptions or modified provisions for certain small businesses. I had originally made a decision to postpone my commentary on the draft guidance document until the deeming regulations were released in their entirety, in order to avoid any error in case there are exemptions in the deeming regulations. However, I have made the decision to publish the commentary now because by the time the deeming regulations are released, it will be too late to change them. I believe that the risks associated with the possibility that the fine details of the deeming regulations render invalid my commentary below are far outweighed by the benefits of making this information available to the public so that interested parties can provide meaningful feedback to the OMB to inform a properly informed review of the regulations.

Now is the time when interested parties must understand the regulatory strategy that the FDA intends to take, and the implications of such a strategy, so that they can potentially provide comments to the Office on Management and Budget's Office of Information and Regulatory Affairs (OIRA), which has the authority to require changes in the regulations if it is unable to make "a reasoned determination that the benefits of a regulation justify the costs." In addition, as there are at least 34 scheduled meetings of interested parties with the OMB, I am publishing this commentary now to allow those groups to provide more informed advice and recommendations to the OMB, rather than having to guess about the approach that the FDA intends to take with respect to the regulation of electronic cigarettes.

According to the OIRA web site:

"Outside parties may provide written comments to the OIRA Administrator on a rule that is under review. If a rule is at OIRA for review, interested parties can provide comments by email at In the email please specify the name of the rule and the regulatory identification number (RIN) as specified in the docket for the rule on
Outside parties may also request a meeting with the Administrator, or his/her designee. If you would like to request a meeting to provide views on a rule being reviewed at OIRA, email: or call 202-395-6880 to schedule."

The regulatory identification number (RIN) for the deeming regulations is 0910-AG38.

Note: There are currently 34 scheduled meetings of interested parties with OIRA. The OIRA web site lists each of these meetings and who requested the meeting. After the meeting, the OIRA will list the meeting attendees and any public documents. A number of tobacco companies and electronic cigarette businesses or groups have already scheduled meetings, but so have several public health groups which have argued for stringent regulation of e-cigarettes, including the American Heart Association, American Academy of Pediatrics, American Thoracic Society, and Campaign for Tobacco-Free Kids.

Analysis of the FDA's Regulatory Approach

It is clear from the guidance that the approach the FDA is taking is as follows:

1. All electronic cigarette products that are sold directly to consumers (including e-liquids and vaping devices) will be required to submit a pre-market tobacco application which must be approved by the FDA in order for the product to stay on the market (it can remain on the market pending review of the application). The FDA has decided to use February 15, 2007 as the grandfather date for these regulations, and since no product currently on the market can be deemed "substantially equivalent" to products on the market eight years ago, all products will have to submit a PMTA. Products that are sold to wholesalers and retailers (i.e., not offered for sale directly to consumers) will not be required to submit a PMTA.

2. The PMTA must demonstrate that the product in question is beneficial to the public's health, taking into account not only the effects on smokers who use the product, but also the impact on nonsmokers - especially youth - who might initiate use of the product.

3. While a single PMTA may be submitted for multiple products, the demonstration in #2 must be made for every product individually. Different flavorings and different nicotine strengths constitute separate products. Thus, if a vape shop sells 100 flavors of e-liquids, and each is offered at four levels of nicotine, that shop will have to demonstrate for each of the 400 products that offering it for sale to the public will benefit the public's health. All of the requirements which I describe below apply to each separate e-liquid.

4. Vaping devices are also considered tobacco products. Thus, if a vaping shop offers for sale 20 different types of vaping devices, it will have to demonstrate for each device that offering it for sale will benefit the public's health. All of the requirements which I describe below apply to each separate device.

5. The PMTA should include the following information (this is just a partial list of the most cumbersome aspects of the application):

In general, for each product (meaning each flavoring/strength combination):
  • research findings on the health effects of the product;
  • research findings on the effect of the product on tobacco use among users of the product;
  • research findings on the effect of the product on tobacco use initiation among youth; and
  • research findings on the impact of the product on the population as a whole. 
Specifically, for each product:
  • a complete laboratory analysis of the constituents of the aerosol, with quantification of the concentrations of at least 29 specific chemicals;
  • the health risks of the product compared to never using a tobacco product;
  • the likelihood of youth initiating tobacco use with the new product;
  • the likelihood of former smokers re-initiating tobacco use with the new product;
  • the likelihood that consumers who initiate use of the product will later switch to more hazardous tobacco products;
  • the likelihood that consumers will use the product along with other tobacco products;
  • the likelihood of smokers switching to the product instead of quitting completely or trying to quit with an FDA-approved medication; and
  • a discussion explaining how the data above demonstrate that the introduction of the product into the market will contribute to the protection of the public's health.
And furthermore:
  • For the laboratory testing, at least 10 samples from three different batches need to be tested;
  • The testing must be done under a variety of conditions of use, such as varying voltages, and under conditions of intense and non-intense use;
  • If a vaping device is the product in question, it must be tested with a range of e-liquids;
  • If an e-liquid is the product in question, it must be tested with a range of vaping devices;
  • For e-liquids and vaping devices, the shelf life must be determined under varying conditions of temperature and moisture;
  • Changes in the aerosol flow rate and the constituents of the aerosol need to be tested over the life span of the e-liquid or vaping device;
  • All existing studies on the safety and use of the product must be submitted, including the results of all clinical and non-clinical investigations;
  • For any clinical studies of the product, the study sponsor must obtain an IND (investigational new drug) prior to initiating the research;
  • In general, non-clinical studies are not enough to support the conclusion that a product is appropriate for the protection of the public's health - clinical studies of each product are generally necessary;
  • For each product, genotoxicity and cytotoxicity studies are recommended;
  • A thorough literature review should be conducted;
  • The toxicological profile of each aerosol constituent should be provided - if no information is already available, toxicology studies need to be conducted;
  • For each constituent of the aerosol, the particle size in the aerosol should be determined, as well as the deposition of through inhalation;
  • For each constituent, the implications of the particle size and deposition during inhalation should be analyzed in terms of potential toxicity;
  • Animal testing may be necessary to determine potential toxicity;
  • For each aerosol constituent, the health effects of that chemical should be studied - both changes in physiological measurements and laboratory values (such as inflammatory markers) should be investigated;
  • If there are no existing data on the toxicity of a particular chemical component of the aerosol, then computation modeling studies should be conducted using surrogate (i.e., similar) chemical structures;
  • Consumer perception studies are highly recommended;
  • Studies of the potential use of the product by nonsmokers (including youth) and existing smokers is highly recommended. Such studies must be related to the product itself or a similar product. Thus, an open-system vaping device could not submit information on the results of a study involving a first-generation cig-a-like product, and vice versa; and
  • Puff topography studies should be included in the application.
6. In terms of the communications and marketing that will be allowed regarding electronic cigarettes and vaping products:
  • E-cigarette companies and businesses will not be allowed to market these products for smoking cessation; and
  • Therefore, no smoking cessation claims will be allowed for any of these products.

Implications of the FDA's Regulatory Approach

1. The most important implication of the FDA's regulatory approach for electronic cigarettes is that the FDA has apparently decided that electronic cigarettes pose a much greater threat to the health of the public than the extremely toxic tobacco cigarettes which are killing more than 400,000 Americans each year. This is evident by the fact that the agency is requiring an unduly expensive and burdensome process for every single electronic cigarette or vaping device and e-liquid to remain on the market, while the agency gave a free pass for all of the existing tobacco cigarette brands. Tobacco cigarettes can continue to kill hundreds of thousands of consumers each year with few additional restrictions or safety requirements, while the much, much safer electronic cigarettes must go through a nearly impossible, expensive, and burdensome application process.

2. The successful submission of a PMTA will be nearly impossible. Just look at it this way: In order to submit a successful application, one must demonstrate the overall benefits of your product outweigh any risks, including the possible initiation of nicotine use by nonsmokers or former smokers. One must identify the individual and population-level benefits and risks and have a mechanism to model these effects over time in order to determine and quantify the net effect on the population's long-term health. However, in the tobacco control community, there exists no consensus on any one aspect of the potential benefits and risks. For example, some tobacco control scientists have argued that e-cigarettes impede smoking cessation, while others (myself included) have argued that e-cigarettes aid smoking cessation. With this degree of disagreement within the public health community, how the hell is a manufacturer possibly expected to wade through the quagmire in order to provide a demonstration of net public health benefits or risks? If scientists with 30 or more years of experience in tobacco control cannot agree upon even the individual benefits of e-cigarettes, how can a vape shop owner possibly be expected to demonstrate the long-term health consequences of allowing his particular e-cigarette product onto the market?

Moreover, there is no existing model to weigh potential risks and benefits, even if they could be quantified. For example, suppose a product could demonstrate a 15% rate of smoking cessation using the product, but that comes at the expense of 3% of youth initiating nicotine use with that product, of which 32.6% of the youth progress to cigarette smoking. How do you calculate and then weigh the risks and benefits? Is this going to result in a positive or negative net long-term public health benefit? This is an exceedingly complex question. If researchers with 30 years of experience in modeling health risks associated with changes in smoking policies cannot provide an answer, how can we expect a vape shop owner to provide the answer?

3. Putting together a PMTA will be prohibitively expensive and resource-intensive for all but the largest companies. Suppose a vape shop sells 100 flavors of e-liquid, and each comes at three nicotine levels. That vape shop owner is going to have to submit 300 PMTAs, each one demonstrating the toxicological properties, vapor constituents, health effects, consumer use, vaping topography, risk of youth initiation, and overall risk benefit ratio for that product. The time alone required to assemble the application is itself prohibitive, but when you consider the cost of just doing the laboratory analyses, no vape shop in the country is going to be able to afford it.

4. The regulations will result in the decimation of the e-cigarette industry and put thousands of e-cigarette entrepreneurs and shops out of business. There will be a major contraction of the industry as only the tobacco companies and perhaps the largest of the independent e-cigarette companies will be able to survive the burdensome regulatory process. In the long-term, these regulations will cause e-cigarette sales to plateau, ending the possibility that vaping devices could transform the nicotine market by creating a major shift from combustible tobacco products to much safer forms of nicotine delivery. This will be destructive to the public's health, both in the short- and long-term.

5. The regulations will create a monstrous bureaucracy, tying up thousands of hours of FDA time that could be better used to confront the smoking epidemic, which actually would save lives. Moreover, the creation of this bureaucracy will not directly protect the public's health. Instead, the FDA should have simply promulgated a set of uniform safety standards and regulations that would have immediately protected the public's health, putting an immediate end to battery explosions and other problems. These standards should have included basic quality control requirements, battery safety, and temperature/voltage regulation to prevent the formation of hazardous degradation products such as formaldehyde.

6. The regulations will essentially force the e-cigarette companies and businesses to lie to their customers by hiding from them the fact that these products were originally designed to help people quit smoking and that thousands of consumers have successfully quit smoking with these products. E-cigarette companies and businesses will not be able to communicate the truth and instead will have to rely on other "benefits" of e-cigarette use in their marketing, such as their sexiness, use by celebrities, or coolness. This marketing is much more likely to appeal to kids than truthfully informing consumers that these products were devised for the express purpose of helping people get off toxic cigarettes by providing a much safer alternative form of nicotine.

The Rest of the Story

The rest of the story is that FDA must be out of its mind. These deeming regulations should really be called "The Cigarette Protection Act of 2015." The regulations are an embarrassment to public health. They create stringent requirements for electronic cigarettes, while allowing the much more toxic real cigarettes to remain on the market, unencumbered and unchallenged by competing products that are much safer and that could have otherwise transformed the nicotine market away from combustible tobacco products, thus saving thousands of lives.

The regulations will decimate the e-cigarette industry, forcing thousands of small vapor shops and e-cigarette sellers out of business. This will no doubt result in many vapers returning to cigarette smokers and many potential quitters from trying to quit using these products.

After acknowledging that there is a continuum of risk among nicotine-containing products, with e-cigarettes at the opposite end of the spectrum from tobacco cigarettes, the FDA has chosen to ignore the risk differences and instead, to treat e-cigarettes much more stringently than tobacco cigarettes. To stay on the market, Marlboro cigarettes had to do nothing at all. But to stay on the market, much safer Vuse e-cigarettes, which have been shown to have very low emissions with non-detectable levels of all the major chemicals of concern, will have to conduct extensive research, both clinical and non-clinical studies, spending millions of dollars, in order to stay on the market for the long-term.

The regulations will also force e-cigarette companies and businesses to lie about the primary purpose and benefit of their products (an aspect of the regulations that I believe violates the free speech rights of the companies and could be successfully challenged in court).

Finally, the regulations do nothing to directly address the known hazards of electronic cigarettes to users, such as lack of battery safety which has resulted in battery explosions, and the presence of carcinogens like formaldehyde in the vapor which could have been prevented by setting standards for proper regulation of voltage and/or temperature.

I can only hope that the OIRA will disapprove the regulations, requiring major changes in the regulatory approach that bring it in line with the concept of public health. Otherwise, thousands of innocent people are going to be harmed in the short-term, and perhaps millions in the long-term.

Thursday, November 05, 2015

American Lung Association and CVS Campaign Downplays the Importance of Smoking in Preventing Lung Cancer

Ad Looks Like Big Tobacco Ad from the 20th Century 

The American Lung Association (ALA), with primary financial support from CVS Health (CVS), has initiated a campaign called "Lung Force." The campaign features a video ad with the theme of "Anyone Can Get Lung Cancer." Although the ad cites the fact that lung cancer incidence among women has increased over the past decades and mentions radon and air pollution as causes, nowhere in the ad is smoking even mentioned.

I went to the Lung Force fact sheet on lung cancer and found that the #1 most important fact is as follows:

"1. Anyone can get lung cancer."

If you click on the link to get more information, it brings you to the video ad with the theme of "Anyone Can Get Lung Cancer" which doesn't mention smoking.

In a detailed sheet which summarizes the campaign, there is not a single mention of the importance of smoking as a cause of the increasing incidence of lung cancer among women, even though the sheet emphasizes how important it is to get out all the facts and educate women about the "basics" and even though the sheet mentions air pollution, radon, family history, and secondhand smoke as risk factors.

And in a detailed summary of the Lung Force campaign, it again fails to mention smoking. Instead, it de-emphasizes smoking by hiding the fact that smoking is overwhelming the chief cause of lung cancer among women. In fact, it appears that the main objective of the campaign is to downplay the role of smoking in causing lung cancer among women:

"We aim to change people’s minds about what it means to have lung cancer—so that everyone understands that anyone can get lung cancer."

In a long video about lung cancer featuring numerous lung cancer survivors, smoking is not mentioned a single time, other than in an attempt to suggest that smoking is not as important a risk factor for lung cancer as previously thought.

In fact, the campaign actively suppresses the sharing of the fact that smoking is overwhelmingly the leading cause of lung cancer. For example, in presenting Kellie Pickler's involvement in the campaign, sparked by the death of her grandmother from lung cancer, it fails to mention the important fact that her grandmother was a long-term smoker.

The Rest of the Story

I'm not sure that I can overstate my level of condemnation of this campaign. It is disturbing, and it is damaging. It undermines decades of education about the severe health hazards of smoking and about the role of smoking as the overwhelming most predominant cause of lung cancer. About 90% of the suffering that the campaign highlights could be prevented if we made smoking history. But instead, the campaign talks about air pollution, which only causes about 1% (at the most) of lung cancer.

The campaign's theme, and the video ad, look like a Big Tobacco campaign from the 20th century, downplaying the role of smoking in lung cancer by emphasizing that "anyone" can get lung cancer. I'm not sure the tobacco industry itself could have done a better job of downplaying the role of its products in the devastating lung cancer epidemic. 

Moreover, not only does the campaign fail to mention smoking as a leading cause of lung cancer and not only does it downplay the role of smoking, but it actively tries to confuse women about the role of smoking. By emphasizing that most lung cancer is diagnosed in nonsmokers and omitting the important fact that most of these women are former smokers, it appears to be intentionally trying to get women to think that smoking is not the predominant cause of lung cancer. Furthermore, it does not once mention the role that the tobacco industry played in the epidemic of lung cancer among women.

The tobacco industry should really send a thank-you note to the Lung Force campaign for running a public awareness campaign that downplays the role of smoking in a way that even Big Tobacco would not do, and is not doing, in the 21st century.

Wednesday, November 04, 2015

New Population-Based Study Shows that Adult E-Cigarette Use Has an Overall Benefit for the Public's Health

A new study published in the journal Nicotine & Tobacco Research is the first population-based study to comprehensively examine the pattern of electronic cigarette use among U.S. adults and demonstrates that the use of these products is having a strong net benefit for the public's health.

(See: Delnevo CD, et al. Patterns of electronic cigarette use among adults in the United States. Nicotine & Tobacco Research, 2015, 1-5; doi: 10.1093/ntr/ntv237.)

The study reports data from the 2014 National Health Interview Survey (NHIS), a nationally representative survey of the non-institutionalized, civilian population. This was the first time that the NHIS inquired about electronic cigarette use. The paper reports the breakdown of adults in the population on the basis of smoking status (current smoker, former smoker, and never-smoker) and for each category, the percentage of persons who reported using e-cigarettes ever, some days, and every day.

The former smokers are further broken down into recent quitters (those who quit within the past year), former smokers who quit 2 to 3 years ago, and former smokers who quit 4 or more years ago.

Using these data, I was able to estimate the overall proportion of daily electronic cigarette users in each of the smoking status groups. The public health implications of electronic cigarette users in each of the groups is as follows:

Daily and some day smokers (current smokers): POSITIVE - The more smokers can switch to electronic cigarettes, the better. While some anti-tobacco advocates have claimed that e-cigarettes impede smoking cessation, the scientific evidence support the opposite conclusion. Moreover, smokers who use e-cigarettes are not likely to have quit in the absence of e-cigarettes.

Recent quitters (quit within past year): POSITIVE - These are most likely former smokers who were able to quit by using electronic cigarettes.

Former smokers, quit 2 to 3 years ago: NEUTRAL - It is not clear whether these represent smokers who quit because of e-cigarettes or former smokers who started vaping.

Former smokers, quit 4 or more years ago: NEGATIVE - These likely represent former smokers who started vaping. However, it should be noted that the public health implications of this group are not necessarily negative, as it is possible that in the absence of e-cigarettes, these former smokers would have relapsed to smoking.

Never-smokers: NEGATIVE - Obviously, it is not beneficial for never-smokers to initiate nicotine use.

The Rest of the Story

Based on the reported NHIS data, the proportion of electronic cigarette smokers in each of the smoking status categories is as follows:

Current smokers: 49.9% (POSITIVE)
Recent quitters: 32.4% (POSITIVE)
Former smokers, quit 2 to 3 years ago: 9.5% (NEUTRAL)
Former smokers, quit 4 or more years ago: 3.0% (NEGATIVE)
Never-smokers: 5.2% (NEGATIVE)

Based on this analysis, of all adults who are every day vapers, 82.3% are using these products with a health benefit, 8.2% are using them with a health risk, and for 9.5% we don't have enough information to determine whether they are benefiting or being harmed. It seems quite clear that overall, the use of electronic cigarettes among the adult population is having a strong net public health benefit. Moreover, the proportion of daily vapers who appear to be former smokers who quit by using e-cigarettes is substantial, representing nearly one-third of all daily vapers.

In future surveys, it would be helpful to add questions inquiring whether former smokers had quit using e-cigarettes or whether they had relapsed back to nicotine use.

Tuesday, November 03, 2015

Alaska State Health Director Lies About Risks of Smoking, Surpassing the Modern-Day Tobacco Industry in Dishonesty

One of the major changes in the tobacco industry in the past decade and a half is that it is no longer undermining the public's appreciation of the hazards of smoking by downplaying the health risks. If anything, the tobacco companies have been relentlessly emphasizing that its combustible tobacco products (i.e., cigarettes) are substantially more hazardous than the non-tobacco-containing electronic cigarettes that they manufacture.

Unfortunately, the gains we have seen in tobacco industry honesty are being offset by lies about the risks of smoking coming from ... of all places ... health agencies. These agencies continue to lie about the risk of smoking by claiming that smoking is no more harmful than using a product that contains no tobacco and involves no combustion, despite both laboratory and clinical evidence that electronic cigarettes are much safer.

But things have become even worse. Last week, the Alaska state health department publicly claimed not merely that smoking is no worse than vaping, but that smoking may actually be safer than vaping.

According to an article in the Alaska Dispatch News, the commissioner of the Alaska Department of Health and Social Services was quoted as stating:

"If we know that kids think e-cigarettes are not smoking and e-cigarettes are OK and they’re a better alternative to smoking, we need to let them know that they are just as harmful, and perhaps more harmful, than smoking cigarettes and chewing tobacco."

The health director also suggested that e-cigarettes contain tobacco, stating:

"We all have known for a long time the dangers of tobacco use and the dangers of nicotine use, but for some kids they don’t think of e-cigarettes as necessarily being cigarettes or being tobacco, but they are."

As if two lies are not enough, the Alaska health department has also insinuated that vaping causes brain damage.

On top of that, the health department attacked Big Tobacco for claiming that e-cigarettes emit only vapor (rather than smoke), which is actually true.

And the department also put out a television advertisement claiming that vaping causes brain damage.

Furthermore, they put out an ad insinuating that e-cigarettes contain embalming fluid and nail polish remover.

The Rest of the Story

I honestly thought that I had seen it all. Lies about vaping being just as hazardous as smoking were being spewed all over the media by anti-smoking groups and health agencies. But the Alaska Department of Health and Social Services has surpassed all of these previous fallacious claims. They actually told the public that smoking may be safer than vaping. In addition, they also lied by telling the public that e-cigarettes do not contain tobacco, that they contain embalming fluid and nail polish remover, and that they cause brain damage because of high lead content.

I am literally hitting my head against the wall and pulling my hair out because it is so frustrating to be a part of an anti-smoking movement that is blatantly lying to the public and completely downplaying the severe risks of smoking. It is not e-cigarettes that threaten to offset years of progress in reducing smoking; it is the lying by these anti-smoking groups which do.

I had thought that as more and more scientific evidence accumulates to demonstrate that vaping is orders of magnitude safer than smoking, we would start to see a decline in the lies being disseminated by health agencies. But instead, the lies are accelerating and becoming even more ridiculous.

That the tobacco companies are being more honest about the hazards of smoking than the Alaska Department of Health is a pitiful statement about the state health department. What the hell are they doing, and what gives them the authority to tell blatant lies about the risks of smoking to the public without repercussions?

If I were an Alaska taxpayer, I would be quite angry that my tax dollars were going to a state effort to downplay the hazards of smoking. Even the tobacco companies aren't doing that anymore. That a state health department would take over that task is mind-boggling.

Monday, November 02, 2015

CDC Irresponsibly Lies to Public: Tells 1/4-Pack Per Day Smokers that They Might as Well Smoke 2 Packs Per Day

The Centers for Disease Control and Prevention (CDC) yesterday told 1/4 pack per day smokers that they might as well smoke 2 packs per day. Specifically, the CDC informed smokers that smoking 5 cigarettes per day offers no health advantages compared to smoking 40 cigarettes per day.

As quoted in an article in the Deseret News, a CDC spokesperson stated: "Just reducing the number [of cigarettes smoked per day] doesn't reduce health risks. You have to quit completely."

So according to the CDC, reducing the number of cigarettes smoked per day doesn't reduce health risks. That indeed implies that smoking 2 packs of cigarettes per day is no more harmful than smoking 1/4 pack per day and that reducing consumption from 40 cigarettes per day to just 5 cigarettes per day offers no health benefits.

The Rest of the Story

There's only one minor thing wrong with the CDC's statement ...

... It's not true.

Anyone who, like myself, has treated smokers with respiratory disease and listened to what they had to say can tell you that most (if not all) heavy smokers who drastically reduce their cigarette consumption experience substantial improvement in their respiratory symptoms. Moreover, such smokers experience objective improvement in lung function, as measured by spirometry.

In fact, Dr. Riccardo Polosa and colleagues demonstrated this finding specifically among smokers who cut their cigarette consumption by switching partially to e-cigarettes. Even among dual users (of both cigarettes and e-cigarettes), there was a substantial improvement in both respiratory symptoms and clinically measured lung function.

While it is true that reducing the amount one smokes does not decrease the risk of heart disease (because the atherosclerotic effects of tobacco smoke are saturated at a very low dose), the same is not true for respiratory disease. Basically, in someone with reduced lung function, every cigarette smoked contributes to further impairment. Smoking 40 cigarettes per day is going to cause a lot more impairment than smoking 5 cigarettes per day. And if a smoker is able to cut down from 40 cigarettes per day to 5 cigarettes per day, it clearly does offer health benefits over continuing to smoke 2 packs per day.

Is it better to quit smoking completely than to become a dual user of e-cigarettes and tobacco cigarettes? Of course! Should we encourage smokers to stop smoking completely instead of using both e-cigarettes and tobacco cigarettes? Of course! But this doesn't mean that it is acceptable to lie to people and tell them that substantially decreasing their cigarette consumption offers no health benefits over continuing to smoke heavily.

There is an additional health benefit of substantially cutting down on the amount smoked, beyond the improvement in respiratory symptoms. Drastically reducing cigarette consumption decreases the level of addiction to smoking and has been shown to make it easier to eventually quit smoking completely. Therefore, the claim that CDC is making to smokers is not only false, but it is irresponsible as well.

This public statement could very well cause many smokers who are thinking of substantially cutting down on the amount they smoke not to do so because they figure that there is no point in reducing consumption if it offers no health benefits. To the many thousands of dual users out there who have made great progress by sharply reducing their cigarette consumption, this false information could actually deter them from vaping and result in their returning to full-time smoking. After all, what is the point of vaping most of the time instead of smoking if you are just as healthy smoking all of the time?

There are many vapers who are in fact dual users, but they only smoke about 2-3 cigarettes per day. Would it not be a shame if these vapers, who have obviously made great progress towards quitting and have experienced great improvement in their respiratory symptoms return to full-time cigarette smoking because the CDC told them that cutting down to 2 cigarettes per day offers no health benefits over smoking 40 cigarettes a day?

Let me close by pointing out one thing that is apparently not clear to the CDC:

It is not OK to lie to the public!