Wednesday, July 31, 2013

New Study Reports Amazing 40% Success Rate at Two Years for Electronic Cigarettes Among Smokers with No Interest in Quitting at Baseline

A new study published online ahead of print in the journal Internal and Emergency Medicine reports that among a sample of 40 patients with no desire to quit smoking who were offered electronic cigarettes, 16 of them (40%) were either completely smoke-free or had cut down on their cigarette consumption by more than one-half at two-year follow-up.

(See: Polosa R, Morjaria JB, Caponnetto P, et al. Effectiveness and tolerability of electronic cigarette in real-life: a 24-month prospective observational study. Internal and Emergency Medicine. Published online July 2013. DOI: 10.1007/s11739-013-0977-z.)

The study involved 40 smokers in Catania, Italy who were not interested in quitting smoking at the time of recruitment into the study. Subjects were offered electronic cigarettes and provided with up to a six-month supply if they were initially and continued to be interested. They were followed up for a total period of two years. The main outcome variable - success - was defined as either quitting smoking completely or cutting down by more than one half on the number of cigarettes smoked per day.

The chief study result was that, using an intent-to-treat analysis, 40% of the smokers with no initial desire to quit smoking had successfully either quit or cut down by more than half. Specifically, 12.5% of the smokers quit completely and 27.5% cut their consumption by more than half. In this latter group, median cigarette consumption dropped from 24 cigarettes per day at the beginning of the study to only 4 cigarettes per day at the 24-month mark.

The study concludes: "In conclusion, persistent long-term modifications in the smoking habit of smokers not intending to quit can be attained by using e-cigarettes. This behaviour could be sustained over a prolonged period of time by advancing to newer more efficient models, which were well tolerated by users. Although not formally regulated, the e-cigarette can help smokers unable or unwilling to quit to remain abstinent or reduce their cigarette consumption and currently may represent the ultimate tobacco cigarettes substitute."

The Rest of the Story

What is remarkable about these results, despite the small sample size, is that the 40% success rate was obtained among a sample of smokers who did not intend to quit and in the absence of any other intervention. There was no counseling, medication, or telephonic support. Nevertheless, a quit rate of 12.5% - based on intent-to-treat analysis - was obtained at 24 months and a greater than 50% reduction in cigarette consumption was achieved in 27.5% of the smokers.

Of course, with this small sample of 40 smokers, one has to interpret the results with caution. Nevertheless, these results are impressive and suggest that e-cigarettes may have great promise, especially for smokers who cannot or do not quit successfully with traditional therapies or who are not particularly motivated to quit smoking.

The rest of the story is that it is becoming more and more difficult for anti-smoking advocates to argue that there is no evidence that electronic cigarettes can help smokers quit. While these advocates continue to complain about smoking cessation claims made by some e-cigarette companies, it appears that these claims are actually true. 

Tuesday, July 30, 2013

American Cancer Society and Alere Wellbeing are Now Apparently Knowingly Making a Fraudulent Claim about their Quit for Life Program

Back in May of this year, I revealed that the American Cancer Society (ACS) and Alere Wellbeing were making a fraudulent claim about their Quit for Life smoking cessation program. On their web site, these groups claimed that the Quit for Life program had an amazing 47% success rate.

At that time, I wrote: "If this blog were a PolitiFact fact checker, Alere Wellbeing's claim would get a rating of ... FALSE. Or more properly, a rating of: "Liar, Liar, Pants on Fire." It is not clear on what scientific basis Alere Wellbeing makes its claim, but presumably it comes from a study in which its own study team reported about a 41% quit rate for the program. However, this is based on the assumption that every smoker who was not successfully followed up was a quitter. Obviously, this is an unreasonable assumption. In an intent-to-treat analysis (which is the appropriate one to use), the quit rate was only 20.5%. It it were being honest, Alere Wellbeing would advertise a quit rate of 21%, instead of 47%. ... If one cherry picks from the literature, the highest quit rate I can find - based on an intent to treat analysis - is 33% from this study. In more realistic settings, such as this study of the Quit for Life program in actual routine use in Florida, the quit rate was only 16% (and that was only for three months). Importantly, the web site does not indicate that the 47% figure is from a responder analysis, rather than an intent-to-treat analysis. This is highly misleading, and in my mind, fraudulent."

The Rest of the Story

Today, I report that the ACS and Alere Wellbeing have apparently responded to my commentary by updating their web page with a tiny footnote, which acknowledges, in the smallest font imaginable, that: "Quit rates are based on program enrollees who respond to the 6-month outcome survey." (Note: font size is theirs, not mine.)

Even with my $400 progressive lenses, it is a stretch to be able to read that fine print. It seems clear that the ACS and Alere Wellbeing have something to hide: there is something that they apparently don't really want the reader to know.

But even more problematically, the fact that they have apparently added this footnote suggests that they are knowingly defrauding the public, because they are apparently fully aware that they are using an invalid claim - the effectiveness rate based solely on responders - rather than a more accurate claim, which would be the intent-to-treat analysis. At very least, if they were going to be honest in their advertising, they would have to reveal and report the intent-to-treat results in addition to the responder analysis results.

I don't believe that the lay public is going to really understand the difference, so this tiny disclaimer hardly improves the honesty of the site. In fact, it may make it worse because it now knowingly appears to be attempting to deceive consumers.

I think that to be honest, it is the intent-to-treat analysis results that must be reported here. That is certainly the standard that has been adopted in all of the Cochrane reviews that summarize the results of the effectiveness of various smoking cessation treatments.

The rest of the story is that the American Cancer Society and Alere Wellbeing now acknowledge that the 47% quit rate they boast about on their web site is based on the responder quit rate. But they do not provide the intention-to-treat quit rate on that web page, nor do they inform the reader of the response rate to the evaluation survey. In my view, this is fraudulent marketing, because it the company is knowingly providing a quit rate that is invalid -- essentially by definition the true quit rate is substantially lower than that which is being advertised.

Actually, to report the full extent of the rest of the story, the American Cancer Society and Alere Wellbeing are not fully acknowledging that their reported quit rate for Quit for Life is based on a shady responder analysis. On this web page, they continue to hide this fact from the public.

I find it interesting that the FDA is going to great lengths to take electronic cigarette companies to task for suggesting that these devices can help smokers quit (when there is abundant evidence that numerous vapers have found the product to be effective for smoking cessation), yet the FDA is silent in the face of this fraudulent marketing for medication- and counseling-based smoking cessation.

Monday, July 29, 2013

U.S. Thumbs Nose at World; Public Citizen Defends Ban on Clove Cigarettes

July 24th was the deadline for the U.S. to comply with a World Trade Organization (WTO) ruling which found that the federal ban on flavored cigarettes - with its exemption for menthol cigarettes - is a discriminatory trade practice because it protects domestic cigarettes with no rational public health justification.

The U.S. could have complied either by rescinding the ban on clove cigarettes or extending the ban to cover menthol cigarettes. However, so far the federal government has done neither. Since the deadline has passed without U.S. action, Indonesia may now appeal to the WTO to have trade sanctions implemented against us.

Public Citizen's Global Trade Watch argues that Indonesia and the WTO are misguided and that the flavored cigarette ban was a valid action to "keep tobacco companies away from our children."

According to its press release: "As the World Trade Organization (WTO) deadline passes today for the United States to comply with a WTO ruling against a U.S. ban on sweet-flavored cigarettes targeting youth, the spotlight shifts back to the WTO, which could now authorize trade sanctions if requested by Indonesia, the country that won the WTO challenge. “We now have to wait and see whether the World Trade Organization will slam us with trade sanctions because the United States wants to maintain a policy to keep tobacco companies away from our children,” said Lori Wallach, director of Public Citizen’s Global Trade Watch."

"“After last year’s rulings against U.S. dolphin protections and popular consumer labels letting Americans know where their food comes, will the WTO depart from its anti-consumer legacy or choose to punish the United States for a common sense public health law?” Yesterday, the Food and Drug Administration (FDA) requested public comment on an issue related to the WTO ruling: the health implications of menthol cigarettes. The Obama administration stated that FDA’s action constitutes compliance with a 2012 World Trade Organization order to alter a key component of the Obama administration’s landmark Family Smoking Prevention and Tobacco Control Act of 2009 (FSPTCA)."

"That law bans sweet-flavored cigarettes that entice youth to smoke. It shut down the sales of chocolate, strawberry and other sweet-flavored cigarettes sold only by U.S. firms as well as the sale of clove-flavored cigarettes that both U.S. and foreign tobacco companies were marketing. The WTO’s April 2012 final ruling against the FSPTCA concluded that the United States could only ban sweet-flavored cigarettes marketed to youth if it banned all flavored cigarettes, including menthols." ...

"It remains to be seen whether Indonesia will accept the FDA announcement or appeal to the WTO to enact trade sanctions against the United States. Indonesia convinced the WTO that the ban on its U.S. sale of clove-flavored cigarettes violated WTO anti-discrimination rules. U.S. consumer and health groups were outraged by the ruling, which effectively forbade incremental policies designed to target anti-smoking efforts at key populations – in this case, children."

The Rest of the Story

Please don't take this as a criticism of Public Citizen because I think most highly of the organization; however, on this issue, I think Public Citizen has it wrong. Public Citizen is giving Congress credit for taking an action to protect the health of children when in fact, the action was exactly the opposite.

The cigarette flavoring ban was not, as Public Citizen suggests, a policy to "keep tobacco companies away from our children." If the intent of Congress was to keep tobacco companies away from our children, then it certainly would have included menthol cigarettes in the ban, since about half of our children who smoke choose menthol cigarettes and at least three-fourths of African American youth smokers choose menthol-flavored cigarettes.

Instead, Congress decided to exempt the one flavor that actually is enticing youth to smoke and to ban flavors that haven't been used in cigarettes for years. In contrast to Public Citizen's statement, the Tobacco Act did not shut down the sales of "chocolate, strawberry, and other sweet-flavored cigarettes sold only by U.S. firms." There were no such cigarettes on the market at the time of the law's enactment. In fact, not a single major tobacco company had a chocolate, strawberry, or other sweet-flavored cigarette on the market at the time of the Tobacco Act.

The truth is that the only flavored cigarette actually smoked by more than a few youths in the country that was taken off the market was clove cigarettes. Essentially, the Tobacco Act's flavoring ban was a selective ban on clove cigarettes, with no other cigarette brands affected.

So Indonesia actually had more than a legitimate argument: it had a strong and compelling argument. The effect of the Tobacco Act's flavorings ban was to remove clove cigarettes from the market and nothing else. It was in no way intended to protect the health of children because the flavored cigarettes that youth actually smoke - menthol ones - were exempt from the law. The clear intent of Congress was to make it look like it was doing something to protect children but without actually endangering domestic cigarette sales.

In other words, the Tobacco Act was an intentional effort to discriminate against foreign-made cigarettes under the guise of being a legitimate public health policy.

Public Citizen is wrong when it suggests that the flavoring ban was "designed to target anti-smoking efforts at ... children." The rest of the story is that the ban was designed to create the appearance that Congress cares about children's health while actually being designed to protect cigarette sales at children's expense. In other words, it was designed as the exact opposite of what Public Citizen implies.

This can hardly be called a "common sense public health law." 

Moreover, Public Citizen is incorrect in asserting that the WTO's ruling precludes the United States from protecting the health of children. If the U.S. were really interested in doing that, it could simply ban flavored cigarettes, which was supposedly its intent in the first place.

The rest of the story is that it was never the intent of Congress, or of the anti-smoking groups who supported the Tobacco Act, to protect the health of children by preventing the tobacco companies from marketing flavored cigarettes to them. It was the intent of Congress and the anti-smoking groups to make themselves look good politically while actually protecting cigarette companies' ability to market the most youth-prevalent flavored brands: menthol cigarettes.

Friday, July 26, 2013

Disappointed that Many Anti-Smoking Researchers Seem Not to Care About the Truth

To me, scientific research is all about the search for the truth. You may have hypotheses to start, but you let the results take you where they may. Some of the most important discoveries have come from findings that were surprising, or even shocking, and which shattered the a priori hypotheses. For example, our understanding that the universe is expanding at an ever-increasing rate (the concept of inflation) came as a shock to astrophysicists. No one, even Einstein, had imagined that.

It is no different in public health. The truth is what you are after because you cannot find ways to reduce morbidity and mortality unless you accurately identify the underlying causes. And you cannot take the actions that are most likely to reduce morbidity and mortality unless you have an accurate understanding of what works and what does not.

Thus, it came as both a surprise and a disappointment to me when I came to realize that for many anti-smoking researchers, uncovering the truth no longer appears to be the ultimate aim. The latest episode, with Dr. Glantz comparing exposure of one day's worth of electronic cigarette use with 1/16th of a day's worth of nicotine inhaler use, is just the latest demonstration of this sad realization.

If one were after the truth, then it seems to me that one would want to compare daily carcinogen exposure from electronic cigarettes and nicotine inhaler use. But what appears to have happened is that Dr. Glantz was so intent on demonstrating his pre-determined conclusion that electronic cigarettes are toxic and inappropriate that he failed to try to determine what an appropriate comparison would be. He appears to have taken the data as they were reported because the findings were "favorable" to his pre-determined cause.

But it takes only a quick internet search to discover that no one uses just one nicotine inhaler cartridge per day. The absolute minimum recommended number of cartridges for the Nicorette inhaler is 6 per day. Not everyone has to use the same assumptions I did in my analysis, but if you are sincerely interested in the truth, rather than just making a point, then you need to make some attempt to compare apples and apples.

Why is this realization so difficult for me? Because sadly, it reduces much of the idealism that I brought into the field of scientific research in public health.

But the saddest part of the story for me is the way that this is affecting people's lives. Because of the biased conclusions that many anti-smoking groups have drawn about electronic cigarettes, thousands of vapers who had quit smoking successfully using e-cigarettes have been discouraged from continuing to use these products and a number of them have returned to cigarette smoking as a result. Many more have decided not to quit smoking because of unfounded fears regarding the alleged dangers of vaping. And on a grand scale, electronic cigarette companies have been forced to uniformly lie to their customers about the real purpose of their products.

This in no way serves the public's health. It harms the public's health. And that's the saddest part of the story.

Thursday, July 25, 2013

Anti-Smoking Researcher Misleads Public with Invalid Comparison of E-Cigs and Nicotine Inhaler: Correct Analysis Shows that Nicotine Inhalers Have Higher Amounts of Six Carcinogens

On his tobacco blog last week, Dr. Stan Glantz argued that nicotine inhalers are safer than electronic cigarettes as a harm reduction product based on a comparison he made between the amounts of several carcinogens in e-cigarette cartridges and nicotine inhaler cartridges. Actually, the comparison was between levels of these chemicals in the vapor produced from these cartridges. The data were taken from a paper by Goniewicz et al. that reported levels of various constituents of e-cigarette vapor and used a nicotine inhaler as a reference product.

Here is the analysis that Dr. Glantz reports:

"The unsigned comment is quoting the abstract of the paper by Goniewicz, et al. that I used to get compounds to compare with the Proposition 65 list.  Their paper also compared the levels of these compounds with a nicotine inhaler (the "reference" product" they refer to in the abstract, but did not fully develop that comparison.

Here are the results computed from Table 3 in their paper:

                                   ecig   inhaler   ratio
Formaldehyde        28.2      2.0         14
Acetaldehyde            7.4       1.1          7
Acrolein                    11.5      ND          --
o-methylbenzyne      3.9       0.7         6
Toluene                      0.8       ND         --
p,m-xylene                 0.1       ND         --
NNN                            1.5       ND         --
NNK                             6.6      ND         --
Cadmium                  0.09    0.03        3
Nickel                         0.19    0.19        1
Lead                           0.09    0.04        2
ND=not detected

Looked at this way, an e-cig delivers 14 times as much formaldehyde, 7 times as much actaldehyde, 6 times as much o-methylbenzene, 3 times as much cadmium and twice as much lead as a nicotine inhaler, as well as acrolein, toulene, p,m-xylene, NNN and NNK, which were not detected in the "reference device."

Based on these comparisons, one could use the data in this paper to conclude that nicotine inhalers would be a safer approach to delivering nicotine in a harm reduction strategy than e-cigarettes."

The Rest of the Story

The only problem with this analysis is that it is wrong.

The analysis is essentially comparing the amount of these chemicals produced by one cartridge of an electronic cigarette versus one cartridge of a nicotine inhaler.

Sound like a fair comparison? Comparing apples to apples?

Well, no.

While 150 puffs is the approximate dose of vapor that an electronic cigarette user inhales per day (about one cartridge - depending on the brand), a typical nicotine inhaler user will go through about 16 cartridges per day. Obviously, these figures vary depending on the individual, but it is not unreasonable to assume that a typical vaper would take 150 puffs per day, while a nicotine inhaler user might use 16 cartridges per day.

Since what we are interested in is the difference in toxicant exposure, we must take the number of cartridges used per day into our analysis. What we want to estimate and compare is the total daily exposure to these various chemicals.

So here is Dr. Glantz's table reproduced correctly to represent a comparison of daily carcinogen intake rather than intake from one cartridge:

                                   ecig   inhaler   ratio
Formaldehyde        28.2      32.0         0.9
Acetaldehyde            7.4       17.6          0.4
Acrolein                    11.5      ND          --
o-methylbenzyne      3.9       11.2         0.3
Toluene                      0.8       ND         --
p,m-xylene                 0.1       ND         --
NNN                            1.5       ND         --
NNK                             6.6      ND         --
Cadmium                  0.09    0.48        0.2
Nickel                         0.19    3.0        0.1
Lead                           0.09    0.64        0.1
ND=not detected

You can see that in contrast to what Dr. Glantz reported, the estimated daily exposure to six carcinogens is substantially higher for use of a nicotine inhaler compared to use of electronic cigarettes, based on the very same data that he believes is valid. As you can see, this changes the conclusion quite a bit.

To put it another way, here is the same table showing the ratio of daily exposure to chemicals from inhalers compared to e-cigarettes:

                               inhaler   ecig   ratio
Formaldehyde        32.0      28.2         1.1
Acetaldehyde            17.6       7.4          2.4
Acrolein                    ND      11.5          --
o-methylbenzyne      11.2       3.9         2.9
Toluene                      ND       0.8         --
p,m-xylene                 ND       0.1         --
NNN                            ND       1.5         --
NNK                             ND      6.6         --
Cadmium                  0.48    0.09        5.3
Nickel                         3.0    0.19        15.8
Lead                           0.64    0.09       7.1
ND=not detected
The rest of the story, then, is that use of a nicotine inhaler actually exposes users to higher levels of six different carcinogens than electronic cigarettes. Exposure to nickel is nearly 16 times higher. Exposure to lead is seven times higher. Exposure to cadmium is five times higher. And exposure to o-methylbenzene is three times higher.

Now unlike Dr. Glantz, I don't believe that these data are anywhere near sufficient to draw any conclusion about whether e-cigarettes would be safer or more appropriate as a harm reduction tool than nicotine inhalers. The point of this analysis is simply to show that when one is biased against a particular product, one loses the scientific objectivity and broader view that is necessary to provide a valid analysis.

So to be clear, I do not conclude from this analysis that e-cigarettes are safer than nicotine inhalers or more appropriate as a harm reduction tool. However, I do conclude that Dr. Glantz's analysis is invalid and misleading, and that based on the available data, it appears that electronic cigarettes are in the same relative vicinity as nicotine replacement products in terms of carcinogenic risk. In other words, they appear to be in the same ballpark.

In terms of likely cancer risk, then, we are not talking about the difference between Yankee Stadium and Fenway Park. We are talking about the difference between Fenway Park in the daytime and Fenway Park in the evening. (The Sox are 19-11 in day games and 42-30 in night games so I think I'm on solid ground, although I don't have the home/away splits.)

Four important things to note:

First, the analysis is obviously dependent on the assumptions regarding the number of puffs a vaper takes a day and the number of cartridges a nicotine inhaler user goes through per day. The point of this analysis is not to produce a precise estimate of exposure differences. It is merely intended to show that the original analysis is not tenable because the assumptions are grossly off. Nevertheless, my assumptions appear to be reasonable. For a medium smoker, 150 puffs a day is not unreasonable. And it is well-documented that many nicotine inhaler users go through as many as 20 cartridges per day.

Second, most people do not use nicotine inhalers for long periods of time (usually, only for a period of months). The duration of use is of course important in determining risk. However, since Dr. Glantz was comparing the two products for use in "harm reduction," we might as well go ahead and make that comparison.

Third, the relative safety difference between the two products is only a small part of the analysis of which would be more appropriate for harm reduction. The effectiveness of the products are also an important consideration. Nicotine inhalers are quite ineffective. The promise of electronic cigarettes is that they address not only the pharmacological aspects of the smoking addiction, but also the behavioral, psychological, and social aspects.

Finally, readers should not make too much out of the finding that e-cigarette cartridges had an average of 8.1 micrograms of tobacco-specific nitrosamines (NNN and NNK), while the nicotine inhaler did not have detectable levels. Why? Because it is well-documented that two other forms of NRT - nicotine patches and gum - do have detectable levels of NNN and NNK and these levels are comparable to those in electronic cigarettes. For example, one study found tobacco-specific nitrosamine levels of 8.0 ng in the nicotine patch compared to 8.2 ng/g in electronic cigarettes.

To conclude, I think there is much room for debate and discussion regarding the appropriate role for electronic cigarettes in tobacco control. Dissenting opinions from my own are valuable and necessary to ensure that the proper consideration is given to both the advantages and potential disadvantages of these products. However, we dearly need balanced and science-based perspectives that are as unbiased as possible. Pre-determined conclusions that lead researchers to misrepresent the science is not valuable to the process of formulating the policy that will best advance the interests of the public's health.

Remember, we're trying to save the lives of smokers, not of anti-smoking groups.

Wednesday, July 24, 2013

FDA Tells Us What We Already Knew About Menthol: No New Implications for Policy

Yesterday, the FDA released a long-awaited report summarizing the scientific evidence regarding menthol cigarettes. The report follows a similar report on menthol from the Tobacco Products Scientific Advisory Committee. The FDA is now asking for comments on the report as well as any recommendations for potential regulation. It is possible, but not definite, that the FDA could respond after the comment period by proposing a regulation.

Here are the major conclusions of the report:
  1. the weight of evidence supports the conclusion that, from a nonclinical toxicity standpoint, menthol in cigarettes is not associated with increased or decreased smoke toxicity;
  2. the weight of evidence supports the conclusion that menthol in cigarettes is likely associated with altered physiological responses to tobacco smoke;
  3. the weight of evidence supports the conclusion that menthol in cigarettes is likely not associated with increased or decreased levels of biomarkers of exposure;
  4. the weight of evidence supports the conclusion that menthol in cigarettes is associated with particular patterns of smoking;
  5. the weight of evidence is not sufficient to support a conclusion that consumer perceptions are associated with the use of menthol cigarettes;
  6. the weight of evidence supports the conclusion that menthol in cigarettes is likely associated with increased initiation and progression to regular of cigarette smoking;
  7. the weight of evidence supports the conclusion that menthol in cigarettes is likely associated with increased dependence; 
  8. the weight of evidence supports the conclusion that menthol in cigarettes is likely associated with reduced success in smoking cessation, especially among African American menthol smokers; and
  9. the weight of evidence supports the conclusion that menthol in cigarettes is not associated with an increase in disease risk to the user compared to non-menthol cigarette smokers.
The final conclusion of the report is as follows: "While there is little evidence to suggest that menthol cigarettes are more or less toxic or contribute to more disease risk to the user than nonmenthol cigarettes, adequate data suggest that menthol use is likely associated with increased smoking initiation by youth and young adults. Further, the data indicate that menthol in cigarettes is likely associated with greater addiction. Menthol smokers show greater signs of nicotine dependence and are less likely to successfully quit smoking. These findings, combined with the evidence indicating that menthol’s cooling and anesthetic properties can reduce the harshness of cigarette smoke and the evidence indicating that menthol cigarettes are marketed as a smoother alternative to nonmenthol cigarettes, make it likely that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes."

The Rest of the Story

The FDA's report adds very little beyond what we already knew and very little beyond what the Tobacco Products Scientific Advisory Committee (TPSAC) already concluded. In fact, you could summarize the findings of the FDA report as follows:

"FDA Concludes that Menthol Cigarettes are No More Hazardous, But That They Enhance Smoking Initiation By Masking Harshness of Tobacco."

Incidentally, the title of my March 2, 2011 post was:

"FDA Advisory Committee Concludes that Menthol Cigarettes are No More Hazardous, But That They Enhance Smoking Initiation By Masking Harshness of Tobacco."

So we are in no different a place scientifically as we were 17 months ago. The only thing that has happened is that the FDA has delayed any decision or action on menthol for 17 months. Although some might view this as a benefit to tobacco companies, I think they (Lorillard especially) would appreciate having some inclination of what FDA plans to do about menthol cigarettes. This would help immensely in planning purposes and potential preparation if there are going to be regulatory changes.

Readers should also recognize that this report has no new implications for policy and offers no hint as to what action the FDA might or might not take. All options, including doing nothing, are still on the table. The report doesn't provide any hints about what FDA might do because the decision is essentially a political and policy decision, not a scientific one.

Tuesday, July 23, 2013

Anti-Smoking Advocates Admit the Real Reason They Oppose Ban on Sale of Electronic Cigarettes to Minors: They Want Them Taxed Like Cigarettes

As anti-smoking groups' opposition to legislation that would have banned the sale of electronic cigarettes to minors in Rhode Island and Ohio has unfolded, it has become clear that their main concern is not protecting the health of children, but making sure that electronic cigarettes will be taxed at the same rate as cigarettes.

Within two days, Rhode Island's governor and anti-smoking advocates in Ohio have admitted that their primary concern is not protecting the health of children, but protecting cigarette sales from competition from much healthier e-cigs, which presently enjoy the advantage of avoiding tobacco excise taxes.

The real issue for these anti-smoking groups is apparently the desire to make sure that e-cigarettes do not enjoy any competitive advantage over tobacco cigarettes. They especially want to make sure that theses  products are taxed at comparable rates.

Here's what Governor Chafee had to say in his message vetoing legislation that would have banned the sale of e-cigs to minors: "The sale of electronic cigarettes to children should be prohibited, but it is counter-productive to prohibit sales to children while simultaneously exempting electronic cigarettes from laws concerning regulation, enforcement, licensing or taxation. As a matter of public policy, electronic cigarette laws should mirror tobacco product laws, not circumvent them."

Almost simultaneously, an anti-smoking advocacy group in Ohio (the American Cancer Society) admitted their the main reason for their opposition to a proposed ban on the sale of e-cigarettes to minors is that they want these products taxed similarly to cigarettes.

According to an article in the Columbus Dispatch: "Anti-smoking advocates say that below the surface of House Bill 144 is a tobacco-industry-crafted “Trojan horse” designed to ensure that the emerging electronic-cigarette market and other alternative nicotine products remain taxed at a lower rate than traditional cigarettes and stay outside the state’s indoor smoking ban."

The Rest of the Story

So what is the problem with these bills, in the eyes of the anti-smoking groups? The problem is that in banning the sale of e-cigarettes to minors, these bills define e-cigarettes as vaping products rather than tobacco products. This disturbs the anti-smoking groups because they want e-cigarettes to be defined as tobacco products so that they are taxed at the same rate and treated the same way. The bottom line: they don't want e-cigarettes to have a competitive marketing advantage.

This is completely ironic because what the anti-smoking groups are doing is protecting cigarette sales from potential competition. The irony is that the tobacco companies are the ones who are pushing for this legislation.

So the rest of the story is that we have an irony of epic proportions: the tobacco companies are lobbying to sacrifice cigarette sales at the expense of the much safer electronic cigarettes, while the anti-smoking groups are lobbying to protect cigarette sales by making sure that it is not too easy for smokers to quit smoking and switch to electronic cigarettes. These groups want to remove the competitive economic advantage that e-cigs currently have and institute economic reforms that would stimulate cigarette sales at the expense of a competitive product designed to get smokers off of cigarettes.

This has to be one of the most perverse episodes in tobacco control that I have ever witnessed.

The most telling part of the story is that defining e-cigarettes as tobacco products is not necessary to tax them. The legislature could simply impose a tax on electronic cigarettes.And the anti-smoking advocates understand this!

From the Columbus Dispatch article: "a recent legal opinion from the non-partisan Legislative Service Commission ... argues that the bill does not change the current tax status of e-cigarettes, and that nothing would stop advocates from pushing for a higher tax rate in the future. Cathy Callaway, associate director of state and local campaigns for the American Cancer Society’s Cancer Action Network, agrees, but she said the bill sets the stage for treating e-cigarettes differently from other tobacco products."

Aha. So the legislation is not a Trojan horse after all. It is a legitimate ban on the sale of e-cigs to minors. The problem is that anti-smoking advocates are worried that by defining e-cigs as a different product from cigarettes, it will set the stage for regulating them differently. That's what this really comes down to.

And you know what? It would be ludicrous, from a public health standpoint, to regulate e-cigs the same was as the real deadly ones. They must be regulated differently, and in a way that encourages smokers to quit smoking, rather than to continue smoking.

Ironically, the anti-groups are committed to preserving the competitive advantage that tobacco cigarettes enjoy and making sure they do not face competition from what otherwise would be a much cheaper (and much healthier) alternative. And at the same time, the cigarette companies are actually willing to see e-cigs be given a competitive advantage in the marketplace.

Sadly, I truly believe that cigarette companies sincerely want to create a market niche for electronic cigarettes as an alternative to smoking, while anti-smoking groups want to maintain the market in the direction of the real, irredeemably toxic tobacco cigarettes.

This is a story that is going to be very difficult and challenging to teach to my public health students this fall. I guarantee that they are not going to understand or believe this, and that it is going to shake their idealism about public health.

Monday, July 22, 2013

American Legacy Foundation Still Failing to Disclose Conflict of Interest in Commenting on Electronic Cigarettes

In a June 26 press release, the American Legacy Foundation downplayed the results of a new clinical trial showing that electronic cigarettes can surprisingly enhance smoking cessation among smokers with little motivation to quit.

According to the press release: "The researchers reported that e-cigarettes decreased some smokers’ cigarette consumption and that 8.7% quit smoking 40 weeks after the intervention ended. Unfortunately, they also found that smokers quit rates were not statistically different whether given e-cigarettes with or without nicotine –thereby causing a placebo effect. ... We cannot conclude from this study that e-cigarettes promote cessation. While the study showed that some smokers quit, it does not show that the product itself had any role in the behavior change. In fact, the results merely show that sucking on an empty cigarette holder (a placebo) would likely accomplish the same thing."

This press release misses the whole point. And in doing so, it ends up misleading the public.

There is no true "placebo" effect involved with electronic cigarettes because the mimicking of smoking with the use of a cigarette-like device is the main point of the product. We do not want research to control for this effect. We want research to measure this effect.

Unfortunately, the misinterpretation and misrepresentation of this scientific evidence by the American Legacy Foundation appears not to be simply a mistake, but it has the appearance of being a result of a financial conflict of interest that Legacy once again fails to disclose.

The Rest of the Story

The rest of the story is that the American Legacy Foundation has taken money from Big Pharma. In 2009-2011, it acknowledges having accepted donations from the following pharmaceutical companies, many of which manufacture smoking cessation products:

  • GlaxoSmithKline
  • Pfizer
  • Novartis
  • Schering-Plough  
The receipt of this money represents a conflict of interest that I believe must be disclosed in any statement in which Legacy is making recommendations for national policy regarding electronic cigarettes. However, I cannot find any financial disclosure in the press release which informs the public that Legacy has received significant funding from the pharmaceutical industry.

This funding is highly relevant because electronic cigarettes represent a major potential threat to pharmaceutical company profits. If electronic cigarettes prove to be effective and continue to increase in popularity, they could put a huge dent in pharmaceutical smoking cessation drug sales, causing billion dollar losses for the pharmaceutical companies. This could threaten Legacy's future funding. Thus, by accepting this funding, Legacy has a vested financial interest in the stability of these pharmaceutical companies, and therefore, in the continued high rates of sale of their smoking cessation drugs. Electronic cigarettes threaten those high rates of sale, especially because preliminary evidence suggests that they may actually be far more effective than traditional pharmaceutical approaches to smoking cessation.

I believe that the American Legacy Foundation should have disclosed its financial conflict of interest.

The rest of the story is that not only is Legacy misrepresenting the scientific evidence on electronic cigarettes, but this misrepresentation has the appearance of being influenced by the foundation's financial conflict of interest with Big Pharma.

Friday, July 19, 2013

Many Anti-Smoking Advocates Would Apparently Rather You Stay in a Sinking Ship than Use an Untested Lifeboat

I need to start by acknowledging that I am borrowing an analogy that was crafted by Jacob Sullum, senior editor at Reason Magazine. But the analogy is just perfect. Smokers are arguably in a sinking ship. Electronic cigarettes are a potential lifeboat. No, they have not been tested and approved by the FDA. But if you were in a sinking ship, would you remain in the ship because the lifeboats had not been FDA-tested and approved?

Apparently, many anti-smoking advocates and groups would give precisely that advice: stay in the sinking ship because the lifeboats are untested!

According to an article in the Ocala Star Banner, a health education specialist with the Florida Department of Health gave just this advice.

According to the article: "Evelyn James, health education specialist with the Florida Department of Health in Marion County (once called the Marion County Health Department), said e-cigarettes have not been studied. James urged potential users not to “replace one product that has been proven to be bad for you” for another that has not even been tested."

The Rest of the Story

Apparently, this anti-smoking advocate would rather that people continue to smoke, thus assuming known risks, than switch to electronic cigarettes which she states are an untested product.

Even if electronic cigarettes had not been "tested," this would be irresponsible and absurd advice.

But the rest of the story is that electronic cigarettes have been extensively tested and the ingredients in the e-liquids have been well-characterized.

Here is where our "another day, another anti-smoking lie about e-cigs" enters the picture.

According to the same article: 

"Erika Sward, American Lung Association's vice president of national advocacy, said e-cigs have not been thoroughly studied and no one really knows the chemical content in the e-juice."

The assertion that "no one really knows the chemical content in the e-juice" is a lie. As I explained yesterday, the contents of the e-juice have been extensively studied. In Zachary Cahn and my review of electronic cigarettes, we reported the results of at least 18 different studies which examined these ingredients. We know the chemical content of e-juice far better than we know the chemical content of cigarette smoke.

Once again, lies and distortion are necessary for anti-smoking advocates to discourage e-cigarette use because the truth simply doesn't comport with their blind ideology.

Thursday, July 18, 2013

Another Anti-Smoking Advocate Lies About Electronic Cigarettes

It seems that not a day goes by on which another anti-smoking advocate who opposes electronic cigarettes tells a public lie about these products in order to discourage their use.

Today's story comes from the tobacco dependence treatment specialist at Einstein Medical Center in Philadelphia, who was quoted as telling the public that electronic cigarettes contain an ingredient in anti-freeze. She claimed that propylene glycol, a central component of most electronic cigarette liquids, is found in antifreeze.

According to the article from the Philadelphia CBS affiliate: "There’s no standard formula for an e-cigarette.   But one of the things found in them is propylene glycol.  It’s a substance not to be trifled with, according to Tracy Kane, tobacco dependence treatment specialist at Einstein Medical Center in Philadelphia. “It’s something you would find in antifreeze, and it is what’s in e-cigarettes,” she explains.  “That’s why I encourage people to use the FDA-approved nicotine replacement therapies instead of the e-cigarettes — because we know what’s in the FDA-approved ones.”"

The Rest of the Story

The rest of the story is that unlike the main ingredients in anti-freeze - ethylene glycol and diethylene glycol - the chemical found in electronic cigarettes, propylene glycol, is generally regarded as safe. As we all know, anti-freeze is toxic and the reason for this is that both ethylene glycol and diethylene glycol are highly toxic.

In contrast to ethylene glycol and diethylene glycol, propylene glycol is not toxic. In fact, it is a common ingredient of household medical products such as cough medicines and it was once used commonly in asthma inhalers.

The truth is that the main ingredients in most anti-freeze are ethylene glycol and diethylene glycol. This is why anti-freeze is toxic. For example, the ingredients in Prestone anti-freeze are:
1. Ethylene glycol; and
2. Diethylene glycol

Ethylene glycol is the main ingredient used in most major brands of anti-freeze.

This tobacco dependence specialist needs a refresher course in chemistry.

The chemical structure of ethylene glycol is: OH-CH2-CH2-OH.
Ethylene is basically two ethylene glcyol molecules bonded together:

Propylene glycol is difficult to draw in one dimension, but it contains an asymmetric carbon atom, and thus is totally different from the toxic glycols found in anti-freeze. Its structure is:
OH-CH2-C-OH-CH2 (the last carbon atom is bound to both the OH and the CH2).

The tobacco dependence specialist also asserted that we don't know what is in electronic cigarettes.This is also untrue. The ingredients in these products are well known and almost all major brands contain nicotine, propylene glycol and/or glycerin, and sometimes, flavorings. That's pretty much it. No more research needs to be done to find out what is in the juice. In fact, most electronic cigarette companies disclose the ingredients on their web sites.

The unfortunate part of this story is not simply that an anti-smoking advocate is disseminating false information. The most unfortunate aspect of the story is that because of this misinformation, many ex-smokers who have quit successfully using e-cigarettes may well switch back to cigarettes out of fear that they are inhaling toxic anti-freeze.

Does not this advice, which is based on false information, amount to public health malpractice?

It is sad to see the complete degeneration of the science base in tobacco control. Almost every day, another anti-smoking group or practitioner makes a completely false statement about electronic cigarettes. There is room for debate about the appropriate role of these products in smoking cessation, but there is no room for lying or spreading false information. Science should be our guide, not pure ideology.

Wednesday, July 17, 2013

Pfizer's "Don't Go Cold Turkey" Campaign Highlights Widespread Misunderstanding of the Scientific Evidence on Quitting

Pfizer - the maker of Chantix - is running a "Don't Go Cold Turkey" campaign which "aims to ensure smokers who want to quit are aware of the help available to them from their healthcare professional and understand how taking the right approach can significantly increase the chances of successfully breaking the cycle of nicotine dependence."

According to the press release: "Dr Sarah Jarvis, medical broadcaster and practising GP, says: “As a GP, my main aim is to get people to look at leading healthier lifestyles and one of the most important lifestyle change is stopping smoking. I’m aware that the vast majority of people who do smoke are either desperate to quit or have tried and failed in the past. I want those who are motivated to quit to consider that there is support available and that by speaking with their healthcare professional or local stop smoking service, they can increase their chances of success by up to four times, compared to going “cold turkey”."

The Rest of the Story

One of the greatest misconceptions in tobacco control is that the use of medication improves the chances of quitting compared to "cold turkey" quitting. This is also one of the greatest examples of the miscommunication of scientific data in tobacco control, and Pfizer demonstrates it perfectly here.

The scientific evidence shows clearly that spontaneous (unplanned) cold turkey quitting is more effective than planned, medication-assisted quitting. The evidence also shows that on a population basis, the overwhelmingly most successful method used to quit is cold turkey quitting.

So why do so many anti-smoking practitioners and drug companies make these misleading statements that medication increases the odds of quitting compared to a cold turkey approach?

The answer is a misinterpretation (or misrepresentation) of the scientific evidence. There are many clinical trials demonstrating that medications such as Chantix are more effective than placebo. But that doesn't mean it is more effective than cold turkey quitting. It merely means that when you take a group of people who want to try to quit using medication and then you give them a medication that turns out to be a sham, it doesn't work.

To make the statement that medication is more effective than cold turkey quitting, one would have to compare a group of smokers given medication to a similar group who are motivated to quit cold turkey. You cannot randomize people to quit cold turkey because it takes a sincere desire to do so and a high level of motivation.

Such a study has never been done; however, retrospective studies that compare true cold turkey quitting with medication-assisted quitting uniformly show that the cold turkey approach is more effective.

It is easy to understand why Pfizer would misrepresent the science. But why is there such a high prevalence of misrepresentation of the data among anti-smoking groups and practitioners?

At least part of the answer, I believe, is the tremendous amount of funding that anti-smoking researchers and groups have received from Big Pharma. When you have a research organization such as the Society for Research on Nicotine and Tobacco which takes huge amounts of money from Big Pharma, it should come as no surprise that there is so much misrepresentation of the scientific evidence in the anti-smoking movement.

(Thanks to Shadow Guest for the tip.)

Tuesday, July 16, 2013

World Health Organization Lies About E-Cigarettes, Protecting Tobacco and Pharma Sales

In a salvo of Twitter messages, the World Health Organization (WHO) has disseminated false and misleading information about electronic cigarettes.

First, WHO states that there is "no" scientific evidence supporting the contention that electronic cigarettes can help someone quit smoking.

Second, WHO states that there are no approved smoking cessation devices that deliver nicotine to the lungs in a similar way to electronic cigarettes.

The specific claims were as follows:

"E-cigarettes are often touted as tobacco replacements, smoking alternatives or smoking cessation aids, however no scientific evidence yet."

"None of the approved, regulated smoking cessation aids, e.g. nicotine patches, chewing-gum, delivers nicotine to the lungs like e-cigarettes."

The Rest of the Story

The first claim is false because there is substantial scientific evidence that electronic cigarettes can be effective as a cigarette replacement or smoking cessation aid. First, there are a multitude of anecdotal reports and testimonials. Second, there is abundant survey evidence. Third, there are now two clinical trials showing that these devices can aid smoking cessation even among smokers who have no interest in quitting.

So it is a lie to claim that there is "no" scientific evidence.

The second claim is false because the nicotine inhaler is an approved, regulated smoking cessation aid that delivers nicotine to the lungs in a similar manner as electronic cigarettes. Like electronic cigarettes, most of the nicotine is absorbed in the mouth and upper airway, but some of it is delivered to the lungs.

So it is a lie to claim that no approved smoking cessation device delivers nicotine to the lungs.

I can understand the reasons why electronic cigarettes are controversial. However, I cannot condone dishonesty as a strategy to promote one's position on this issue. The World Health Organization is entitled to its opinion about whether electronic cigarettes should be promoted as a smoking cessation strategy. However, it is not entitled to lie to the public to promote its position.

Sadly, what the WHO is encouraging - with lies - is the return of ex-smokers to smoking. The WHO is not only lying, but those lies are protecting the tobacco industry and the pharmaceutical industry.

Monday, July 15, 2013

Anti-Smoking Researchers Still Hiding Tobacco Industry Funding, Failing to Disclose Conflict of Interest

A new study published this month in the Journal of the American College of Cardiology reports that secondhand smoke causes coronary artery calcification (an early sign of atherosclerosis) in nonsmokers.

(See: Yankelevitz DF, Henschke CI, et al. Second-hand tobacco smoke in never smokers is a significant risk factor for coronary artery calcification. JACC 2013; 6:651-657.)

The story here isn't the research itself, but the conflict of interest statement. According to the conflict of interest statement, two of the co-authors (Dr. Narula and Dr. Hecht) disclose conflicts, but "all other authors have reported that they have no relationships relevant to the contents of this paper to disclose." This means that Dr. Yankelevitz and Dr. Henschke, the two lead authors, are not revealing any conflicts of interest.

The Rest of the Story

Let's suppose for a minute that Dr. James Enstrom were to publish the same paper: a study of the effect of secondhand smoke on coronary artery calcification. Let's further suppose that Dr. Enstrom's conflict of interest disclosure were to read: "The author reports that he has no relationships relevant to the contents of this paper to disclose."

There is little question that within minutes of publication of such article, the anti-smoking groups (myself included) would be in an outrage, criticizing Dr. Enstrom for failing to reveal his past funding by the tobacco industry. Such funding is directly relevant to the study because the tobacco industry is affected financially by the results of the study. Finding increased effects of secondhand smoke could affect the public's perception of the risks of smoking and secondhand smoke and could also affect the fate of tobacco litigation. Thus, it could have a direct effect on cigarette company profits.

In fact, the anti-smoking groups attacked Dr. Enstrom anyway, even though he did reveal his tobacco industry funding, when he published an article about the effects of secondhand smoke on cardiovascular disease.

So clearly, in an article of this nature, a history of tobacco industry funding is most relevant and needs to be disclosed in the conflict of interest statement.

Readers may therefore be surprised to hear that both Dr. Yankelevitz and Dr. Henschke have a history of tobacco industry funding that is not disclosed in this article.Yet anti-smoking groups are not attacking them or this article. Why? What's the difference between Enstrom's research and this research? The difference is the findings. While Enstrom found no significant effect of secondhand smoke, this study reports "positive" findings. Thus, the deception by the authors regarding their history of tobacco funding is apparently acceptable to anti-smoking groups. It is the "results" of the research that apparently matter to the anti-smoking movement, not the ethical principles involved. Apparently, tobacco money automatically gets "cleansed" or "purified" when it is put to use in reporting "positive" rather than "negative" results.

What is the rest of the story? In 2006, Drs. Henschke and Yankelevitz were lead authors on a study of CT screening for early detection of lung cancer. In this paper, published in the prestigious New England Journal of Medicine, they disclosed funding from the "Foundation for Lung Cancer: Early Detection, Prevention, and Treatment." No tobacco industry funding was disclosed.

However, it turns out that the authors were hiding the truth and deceiving both the journal editors and the public. The truth is that the "Foundation for Lung Cancer: Early Detection, Prevention, and Treatment" was essentially a front group that was almost entirely funded by a cigarette company (Liggett). As revealed here at the Rest of the Story, in the Cancer Letter, and in the New York Times, a review of tax records showed that the Foundation for Lung Cancer: Early Detection, Prevention, and Treatment was "underwritten almost entirely by $3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Even, Grand Prix, Quest, and Pyramid cigarette brands."

The editors of both JAMA and the New England Journal of Medicine both stated that they had been deceived by the failed disclosure and would never have published the article had they known about the tobacco funding. (As expected, there was little criticism from anti-smoking groups, since the findings of the study were "favorable.")

According to these sources, as well as to an article at Source Watch, the front group - Foundation for Lung Cancer: Early Detection, Prevention and Treatment - was a research foundation set up by Dr. Henschke and Dr. Yankelevitz and underwritten by $3.6 million in grants from the Vector Group, parent company to Liggett. Apparently, Dr. Henschke was the president of the "foundation" and Dr. Yankelevitz was its treasurer.

Dr. Henschke was forced to publish a "correction" in the New England Journal of Medicine, in which she revealed that: "For full transparency we wish to inform you that $3.6 million (virtually all of the Foundation's funding) was contributed in 2000 through 2003 as an unrestricted gift by the Vector Group, the parent company of Liggett Tobacco, which manufactures cigarettes."

As if this weren't enough, it also turns out that Dr. Henschke and Dr. Yankelevitz hid another conflict of interest: both received royalties on patents licensed to General Electric relating to imaging techniques to detect lung cancer. Of course, the authors therefore had a financial interest in demonstrating the value of these techniques in the early detection of lung cancer.

They were forced to publish a second "correction" in the New England Journal of Medicine revealing that: "Drs. Henschke and Yankelevitz report receiving royalties from Cornell Research Foundation as inventors of methods to assess tumor growth and regression on imaging tests for which pending patents are held by Cornell Research Foundation and licensed to General Electric."

The authors, as well as Cornell Weill Medical College, denied that they were attempting to hide their tobacco company funding, although it seems quite obvious that they were indeed hiding this funding. They certainly deceived the editors of two major medical journals, who were both appalled when they found out the truth.

The rest of the story, sadly, is that rather than learn from their mistakes, these researchers (Dr. Henschke and Dr. Yankelevitz) are continuing to deceive the public by hiding their history of funding from the tobacco industry. If this funding was relevant in the New England Journal of Medicine article, then it is every bit as relevant in the JACC article. In fact, it is probably more relevant with the present article because with the earlier article, there was no clear direction that the tobacco industry conflict would bias the findings, but with the present study, there is. I have already explained why the fact that the funding occurred in the past is not a valid reason why it should not be disclosed.

I can certainly understand how researchers could make a mistake. We all make mistakes. But it is essential to learn from the mistakes and not to repeat them. The sad part of this story is that these researchers have apparently not learned from their mistakes, as they are repeating them. Once again, they have failed to disclose their tobacco industry funding (albeit in the past), which is a relevant financial conflict of interest that should have been disclosed in this article.

Even worse, it appears that this deception is not just a single episode, but it occurred in at least three other articles as well. A 2013 paper in the Annals of Internal Medicine about early detection of lung cancer using CT screening contains a disclosure in which Dr. Henschke fails to list her previous funding from Liggett as a conflict of interest. In addition, she deceives readers about her lung cancer research foundation by hiding the fact that the Foundation, or one similar to it, was essentially established from tobacco funding. Instead, she points out that the Foundation does not (currently) accept tobacco funds. But a reader could easily be deceived (and I think would be deceived) into thinking that the Foundation never took tobacco funding or that there was never a similar foundation that did take tobacco money. And I think someone reading this disclosure statement would be shocked to find out that the Foundation or one similar to it was established with tobacco industry funding.

The statement reads: "I am the President and serve on the board of the Early Diagnosis and Treatment Research Foundation.  I receive no compensation from the Foundation.  The Foundation is established to provide grants for projects, conferences, and public databases for research on early diagnosis and treatment of diseases.  Recipients include, I-ELCAP, among others.  The funding comes from a variety of sources including philanthropic donations, grants and contracts with agencies (federal and non-federal), imaging and pharmaceutical companies relating to image processing assessments.  The various sources of funding exclude any funding from tobacco companies or tobacco-related sources."

With this much detail given, including an emphasis about the lack of tobacco funding, but nothing about her tobacco funding in the past, it seems that this is an attempt to hide the truth from readers.

Dr. Yankelevich's disclosure for the same article also fails to mention anything about his history of tobacco industry funding. It fails to disclose his prior role as secretary of a foundation that was underwritten by a tobacco company.

Another example: this 2012 article about CT screening for lung cancer, which includes Drs. Henschke and Yankelevitz as co-authors, fails to provide any disclosure of these authors' development of a tobacco-funded research foundation or their history of tobacco funding.

And a third episode: this 2012 article, in which Drs. Henschke and Yankelevitz are co-authors, fails to disclose their history of tobacco industry funding.

Here are even more examples of articles in which this conflict of interest is not disclosed:

Article 1

Article 2

Article 3

Article 4

The original failures to disclose the tobacco industry funding of their research and the existence of significant financial conflicts of interest were bad enough. But their continuation to hide this conflict of interest is perhaps an even worse offense.

Friday, July 12, 2013

Blind Ideology of Anti-Smoking is Revealed

According to an article in the Berkeley Independent (South Carolina), some anti-smoking advocates in the state are opposed to electronic cigarette use for smoking cessation because users may quit smoking and improve their health, but they are still going through motions that look like smoking.

According to the article: "Lowcountry resident Ron Sena saw his first electronic cigarette while on a cruise with his wife. A smoker for 40 years, ... Sena’s interest in e-cigarettes was sparked. ... Sena said that since quitting traditional smoking and picking up the electronic version, his lung function and senses of taste and smell have improved dramatically. He felt so strongly about the health benefits of the products that he started his own business making refill cartridges for the devices. Many people feel the way Sena does about the health benefits of e-cigarettes, claiming they can notice the difference in their personal health. However, e-cigarettes face critics."

"Melissa Watson, a Columbia health counselor, has witnessed different results when others pick up e-cigarettes. Watson, who works with smoking cessation courses at Palmetto Health Baptist, has dedicated a good portion of her career to helping people quit smoking. In her opinion, e-cigarettes might not be as helpful in the quitting process as some claim. “Quitting isn’t the hard part,” she said.  “The hard part is staying quit.” Watson believes e-cigarettes, while potentially helpful from solely a harm reduction standpoint, are not useful in actually kicking the habit. She said the problem with e-cigarettes is they are designed to simulate smoking, while the commonly used nicotine gums and patches are not. “What’s the end goal?” she asked.  If the patient intends to fully quit tobacco use, she said, e-cigarettes are not the way to go."

"Dr. Scott Strayer of the University of South Carolina Medical School, shares a similar opinion. He noted that no studies yet prove that e-cigarettes are healthier or helpful in quitting. A former smoker of 15 years, Strayer said quitting is about “behavior change.” This can be difficult to achieve when still reliant on smoking something, even if it is electronic."

The Rest of the Story

It certainly appears that when Watson says that e-cigarettes are helpful from a harm reduction standpoint but not helpful in "kicking the habit," the habit she is talking about is not smoking cigarettes, but the behavior of holding a device and putting it to your mouth and inhaling from it. After all, she apparently does not consider someone who has switched from smoking to e-cigarettes as having "kicked the habit."

It also is apparent that she doesn't consider someone who has switched from tobacco cigarettes to e-cigarettes as having "fully" quit tobacco use. Apparently, if you are vaping, even though you are not using tobacco, you have not "fully" quit tobacco use because it "looks like" you are still smoking.

Dr. Strayer offers a similar viewpoint. Apparently, switching from smoking to electronic cigarettes doesn't qualify as "behavior change." It is not the behavior of smoking that he is talking about. It is the behavior of "looking like" you are smoking.

Today's story is a fine revelation of the blind ideology of the anti-smoking movement that I have been discussing for the past several months.

These advocates view nicotine as the problem, not disease and death. It is the addiction to nicotine that seems to bother these health officials, rather than the actual health effects of smoking. If research subsequently showed that nicotine has no serious long-term health effects, these advocates would still consider electronic cigarette use to be an evil and to consider it to simply be a "smoking behavior" because it involves nicotine use.

And it's possible that they would also consider vaping to be "smoking" or "partial" tobacco use even if a vaper was using a zero nicotine cartridge. Because when it really comes down to it, it is the act of going through the motions that look like smoking which is the problem, not the inhalation of toxic chemicals that cause disease and death.

How ludicrous for a health practitioner to argue that if a smoker quits smoking using e-cigarettes, that ex-smoker is still "engaging in smoking behaviors." No the person is not. What the person is doing is saving his or her life.

Thursday, July 11, 2013

Rhode Island Anti-Smoking Groups Lobbying Against Ban on Electronic Cigarette Sales to Minors

Normally, public health groups support policies that protect the public's health. But in today's Rest of the Story, I reveal that one public health coalition is pushing a policy that would harm children by potentially allowing them easy access to electronic cigarettes.

A coalition of anti-smoking groups in Rhode Island, including the American Lung Association, American Cancer Society, and American Heart Association, is urging Governor Chafee to veto legislation passed by the Rhode Island House and Senate which would ban the sale of electronic cigarettes to minors.

According to an article in the Providence Journal:

"Banning the use of e-cigarettes by minors should be the sort of legislation antismoking groups support. Instead they are calling for a veto."

"On July 1, two days before the General Assembly ended its 2013 session, state lawmakers passed a bill prohibiting persons under the age of 18 from using or purchasing e-cigarettes and other “vapor products” that heat liquid nicotine into a smokable vapor. But a coalition that includes some of Rhode Island’s largest health advocacy groups calls the bill a “stalking horse” for tobacco and e-cigarette companies that want to exempt the growing industry from the regulations and taxes imposed on traditional tobacco-based products."

The Rest of the Story

Why would any public health group want to work to ensure that youth have free access to electronic cigarettes?

There is no legitimate public health justification for such a position.

However, there is a possible political explanation. These anti-smoking groups, which have an ideological opposition to electronic cigarettes because they look like cigarettes, don't want the electronic cigarette companies to be painted as responsible companies that have supported actions to prevent youth access to their product. Instead, they would prefer that youth do have access because if large numbers of youths do start using these products, then they can successfully argue for a ban on electronic cigarettes. If youth continue to avoid these products (as they are now), it will be difficult for these organizations to convince policy makers that they should ban the products or put severe obstacles in their way (such as high taxes or stifling regulation of their sales or marketing).

In other words, these groups are using the health of children as a political pawn in their lobbying efforts to protect tobacco products and Big Pharma products from competition from electronic cigarettes.

In my opinion, public health groups shouldn't play games like this.

Wednesday, July 10, 2013

WGBH Boston Public Radio Segment on Electronic Cigarettes

It was a pleasure and honor to appear on Boston Public Radio as a guest of Jim Braude and Margery Eagan on their segment regarding electronic cigarettes. You can listen to the segment here. I believe it is the third story, following immigration reform and Cape Cod traffic.

Tuesday, July 09, 2013

Addiction Expert Calls Countries that have Banned Electronic Cigarettes "Nuts"

In a BBC News article, world-renowned addiction expert - Professor Robert West of University College London - called countries that have banned electronic cigarettes "nuts."

According to the article:

"It's clear that some children have tried electronic cigarettes, but Prof Robert West, director of Tobacco Studies at University College London, says there is no sign they are becoming popular in the UK - the only country he knows where the uptake is monitored closely. He adds that if and when young people do start smoking e-cigarettes, public health experts will have to study the causes carefully. "If those young people are people who would have smoked but instead they're using e-cigarettes, then that's a huge public health gain. If they're people who would never have smoked but they've taken up e-cigarettes, frankly in public health terms it's not really an issue - it's like drinking coffee or something, there's no real risk associated with it. "The real risk is if they start using e-cigarettes and this acts as a gateway into smoking. Now which of those things happens none of us knows at the moment."

"As for the idea that e-cigarettes undo the work to de-glamorise tobacco smoking, West, who has done consultancy work for nicotine cessation medication, says the public health opportunity provided by e-cigarettes lies in their remaining trendy. "The opportunity here is for something that's seen in a different light," he says. "We never got communities of people really enthusing about nicotine patches or nicotine gum. You didn't get a sort of nicotine gum users' group, in which they'd rave about the gum and sort of say: 'This sort of gum's so much better, and I make my own gum,' and stuff like that."

"Ninety per cent of e-cigarette users are also smoking, he says, indicating that the devices are being used as a quitting aid. Countries that have banned them are, in his view, "nuts"."

The Rest of the Story

It is an absolute breath of fresh air to read such enlightened comments on the issue of electronic cigarettes. I praise Dr. West for having the courage to take a position that is well-supported by science, even though it may go against the mainstream of the tobacco control movement.

Dr. West is something of a hero to me, as he has always demonstrated the courage to take what are sometimes unpopular, but always well-supported positions. One of the best examples is this article, in which Professor West criticizes the almost obsessive use of the transtheoretical model in the addiction field, despite the fact that it fails to accurately predict human behavior.

Following West, I recently concluded that: "In practice and as supported by a growing body of literature, there is little support for the Transtheoretical Model as a valid description of typical smoking cessation behavior. ... Smoking cessation programs and policies therefore need to lessen their reliance upon the Transtheoretical Model and become open to alternative models which allow for sudden, spontaneous, unplanned behavior that does not require a gradual progression through various stages of change."

I wish that tobacco practitioners and organizations in the U.S. were able to open their eyes and remove the ideological blinders that are obscuring their vision. As Dr. West points out, a tool such as this which makes it a social, acceptable, and trendy behavior to quit smoking will do exactly the opposite of what electronic cigarette opponents are scaring the public about. Instead of normalizing smoking, they will actually normalize quitting.

Monday, July 08, 2013

Another Day, Another E-Cigarette Opponent Fabricates Evidence to Deter Use; This Time, It's the World Health Organization

Hardly a day has gone by during the last week in which an electronic cigarette opponent has failed to fabricate evidence to deter the use of this product. First, it was a physician who stated that lung damage can occur due to temperatures of thousands of degrees, then it was a physician who stated that nicotine delivery is much higher in e-cigarettes than real ones.

Today, I report that the World Health Organization has fabricated a new piece of evidence that is completely false and has no basis in reality: that cigarettes are safer than e-cigarettes because unlike e-cigarettes they have a filter so the nicotine does not go directly to the lungs.

As first reported by Dr. Konstantinos Farsalinos on his electronic cigarette research blog: "In an unprecedented statement on Philippines national television, Dr Florante Trinidad, technical officer at “Tobacco-Free Initiative”-WHO Western Pacific Region, suggested that electronic cigarettes are more dangerous than tobacco. He [stated]: “The most dangerous thing about this product (e-cigarette) is that the nicotine goes directly to the lungs while regular cigarettes have a filter. With this delivery device the nicotine goes directly to the lungs.”"

Dr. Faraslinos goes on to argue that: "This is a previously-unheard statement. For the first time, a WHO official is publicly and directly suggesting to e-cigarette users (vapers) that it is safer to go back to tobacco cigarettes. Everyone who has seen this video got the same impression. The biggest issue is that this statement is scientifically false, misleading and dangerous for the health of e-cigarette users who may be intimidated and relapse to smoking."

In analyzing the validity of the WHO's statement, Dr. Farsalinos concludes that only one aspect of the statement is true: cigarettes do indeed have a filter. But everything else is fabricated: "in experienced consumers who were using advanced e-cigarette devices, nicotine levels in blood were elevated; still they were much lower than the levels found after smoking. In fact, scientists believe that nicotine delivery and absorption from e-cigarette should be increased so that they become more effective in smoking abstinence. The WHO official says the exact opposite. Is this because he prefers people to smoke rather than substitute tobacco with the much safer e-cigarettes?"

The Rest of the Story

The World Health Organization's fabrication is not only damaging because it is false, but because it could well lead to smokers deciding to continue using their deadly cigarettes instead of switching to far less harmful e-cigarettes. Or even worse, it could lead to ex-smokers who have quit via e-cigarettes returning to cigarette smoking. The statement is completely irresponsible and is tantamount to committing medical malpractice on a global scale.

Moreover, the WHO's statement is irresponsible because it suggests to the public that the filter in cigarettes conveys a degree of safety. If the cigarette companies were to say the same thing, they would find themselves in the courtroom the following day. Yet the World Health Organization can apparently commit scientific fraud with impunity.

This story, considered in light of the previous ones of the same nature, demonstrates the level to which electronic cigarette opponents have sunk. The arguments against a device that is helping millions of smokers to quit or to substantially cut down and to possibly save their lives are so weak that these opponents can only argue against the devices by fabricating evidence.

Friday, July 05, 2013

Anti-Smoking Advocates Call FDA Action on Slightly Modified Cigarettes "Historic"; They are Correct, But Only for Historic Stupidity

According to FDA Commissioner Margaret Hamburg, the agency took a "historic" action last week that is going to reduce "preventable disease and death" due to tobacco.

Dr. Hamburg noted that the FDA is the only agency in the world that has these powers. And the Campaign for Tobacco-Free Kids also boasted of the historic nature of the FDA's action.


What was this historic action taken by the FDA which will prevent disease and death due to tobacco?

A. Implemented an anti-smoking media campaign in all 50 states at funding levels recommended by the CDC.

B. Banned the use of menthol flavoring in all cigarettes.

C. Mandated a reduction of nicotine levels in cigarettes to below a level capable of sustaining addiction.

D. Increased the age of sale for cigarettes to 21.

E. Restricted access to cigarettes to a prescription-only basis.

F. Required the reduction of formaldehyde, benzene, and nitrosamine levels to trace levels.

G. Made sure that a couple of cigarette brands that are essentially the same as existing brands and which confer essentially the same public health risk do not enter the market.

The Rest of the Story

Arguably, choices A-F are measures that truly would be historic and truly would prevent disease and death due to tobacco. On the other hand, measure G is the one action above that would be meaningless and do nothing to protect the public's health.

Sadly, if your answer was "G," you are correct.

We know that minor changes in cigarettes do not correspond to substantial differences in public health risk. In fact, whenever cigarette companies have suggested that this might be the case, they have been immediately accused of fraud and taken to the courtroom or ordered to stop making such inane and unsupported claims.

How things have changed! Now the FDA can make essentially the same claim - arguing that very minor changes in cigarettes can substantially alter the public health risk associated with these products - yet the agency gets away with the same fraud that the tobacco companies were not able to get away with.

I have to give Lorillard credit here because unlike the FDA or anti-smoking advocates, Lorillard refrained from making any insinuation that the company's compliance with this aspect of the FDA regulation is in any way protecting the public's health.

But not so for the anti-smoking groups, which proclaimed this to be a historic event that is going to save countless lives.

The Rest of the Story

In 2013, while the tobacco companies themselves acknowledge that all of their cigarettes are equally hazardous, the Campaign for Tobacco-Free Kids is telling the public that despite very slight differences in product design, brands of cigarettes that are not identical raise substantially different issues of public health. The Campaign is arguing that despite these very minor differences, cigarette brands that are not identical are substantially different in terms of the public health risk that they pose. Thus, the Campaign argues that minor changes in cigarettes can make these products substantially safer.

This is the opposite of the position that the Campaign and other anti-smoking groups have traditionally taken. Previously, when faced with drastic differences in product design (Winston had no additives; Accord involved no combustion), the anti-smoking groups argued that despite these drastic differences, the products were substantially equivalent with regards to the public's health.

Now, all of the sudden, even minor differences render cigarettes substantially different in terms of public health risk.

How did it come to be that major differences in cigarette design used to be of no substantial public health consequence, while today, even minor differences are of substantial public health consequence?

Quite simply, the difference is that in 2009, the Campaign for Tobacco-Free Kids and other anti-smoking groups were successful in convincing Congress to enact the Tobacco Act, and so those groups are now under pressure to make it seem like the Act is going to accomplish something in terms of public health protection. So those groups are trying to convince the public that by strictly regulating very minor changes in cigarettes, the FDA is providing enormous protection to the public's health.

In other words, the Campaign for Tobacco-Free Kids and other anti-smoking groups have reversed their public positions because it is now politically advantageous to make the opposite argument that they made previously.

One final point. Many seem to be proclaiming that by acting on these six applications, the FDA has broken the logjam. That's just not apparent to me. Acting on six out of more than 3,000 applications that have been pending for many months does not break the logjam. In my view, the FDA should simply approve the majority of these applications in the next few weeks and make it clear that minor changes in cigarettes do not render these cigarettes substantially different in terms of public health risk.

And then the agency should move on and actually do something to protect the public's health.

Wednesday, July 03, 2013

Another Electronic Cigarette Opponent Fabricates the Science to Deter E-Cigarette Use

No sooner did I express my hope yesterday that "moving forward, tobacco control advocates and scientists will be able to engage in a discussion of this issue that is based on science, rather than ideology" then yet another electronic cigarette opponent - again a physician - fabricated information to deter smokers from using these products.

According to an article on the KJRH (Tulsa, OK) news site, a physician at the Palm Beach Cancer Institute was quoted as saying that electronic cigarettes may actually be more dangerous than real cigarettes and that the inhaled nicotine doses may be more than with real cigarettes.

According to the article, entitled "Doctors caution users of e-cigarettes, say vaping is worse than smoking the real thing":

"Touted as a safer alternative to traditional smoking, electronic cigarettes are supposed to give smokers their nicotine fix without the cancer-causing side effects of tobacco. But some have serious concerns that the battery-operated vaping devices may actually pose more dangers to users. ... Dr. Robert Greene treats lung cancer patients at the Palm Beach Cancer Institute and said the product is potentially a health hazard. “There really is no information about whether they're safe or not, and that's part of the problem," said Greene. He says with no real data on e-cigarettes, the three-year-old tobacco alternative may actually be more harmful that traditional cigarettes. "The doses of nicotine that you get could conceivably be higher than what you would get in a typical cigarette," said Greene."

The Rest of the Story

It is a fabrication of the scientific evidence to suggest that electronic cigarettes deliver higher doses of nicotine than real cigarettes. There have been multiple studies which all agree that electronic cigarettes deliver much lower levels of nicotine than real cigarettes. You simply cannot improve upon real cigarettes as a nicotine delivery device.

It is also a fabrication to suggest that electronic cigarette use is more hazardous than tobacco cigarettes. The physician is not directly quoted with this statement, but the reporter certainly seems to have gained the impression that this was the doctor's assertion.

Thus, it appears that this physician is actually stating is that regular cigarettes are probably no more harmful than electronic ones. Such an assertion is beyond belief. It is completely inconsistent with everything we know about toxicology and pathology and there is no scientific basis for such a statement. It conflicts directly with the available scientific evidence, which documents that the levels of hazardous components in electronic cigarettes are much lower than in traditional cigarettes. By what law of chemistry or medicine does this physician assert that the presence of much higher levels of many more toxins and carcinogens fail to make cigarettes more hazardous than these electronic devices?

I believe that this conclusion is not only unsupported by scientific evidence or common sense, but it is also irresponsible. Because it is telling physicians to inform their patients of something which is almost certainly untrue: that smoking cigarettes is no more hazardous than inhaling vaporized nicotine from a tobacco-free device that delivers primarily nicotine and propylene glycol and which for at least some major brands have been found not to contain any detectable levels of tested carcinogens.

Sadly, I have to repeat what I stated the other day: "This is yet another example of the depths to which electronic cigarette opponents are sinking to try to sink the electronic cigarette ship. Apparently, they realize themselves that they have such a weak case that they need to make up facts in order to make their case."