Tuesday, May 31, 2011

150 Additional Suicides Associated with Chantix Use; Breakdown in Surveillance Leads to Underestimate of Drug’s Potentially Severe Adverse Effects

According to an article at MSNBC.com, a “breakdown” in surveillance of the adverse effects of Chantix has led to an underestimate of the potential harm caused by the drug, with an additional 150 Chantix-associated suicides having not been reported to the FDA.

According to the article: “Hundreds of reports of suicides, psychotic reactions and other serious problems tied to the popular stop-smoking drug Chantix were left out of a crucial government safety review because Pfizer Inc., the drug’s manufacturer, submitted years of data through ‘improper channels.’ Some 150 suicides — more than doubling those previously known — were among 589 delayed reports of severe issues turned up in a new analysis by the non-profit Institute for Safe Medication Practices.”

“’We’ve had a major breakdown in safety surveillance,’ said Thomas J. Moore, the ISMP senior scientist who analyzed the data. The serious problems — including reports of completed suicides, suicide attempts, aggression and hostility and depression — had been mixed among some 26,000 records of non-serious side effects such as nausea and rashes, with some dating back to 2006, the year Chantix, or varenicline, was approved. They echo previous claims that the drug can induce extreme reactions in people trying to quit cigarettes, including vivid nightmares, crippling depression and sudden, violent outbursts. ‘It’s really chilling,’ said Moore, who analyzed 26 Chantix reactions in a paper published in the September 2010 issue of the Journal of Pharmacotherapy. ‘This seems to unleash something in people. It can be violence to anything around.’" …

“Moore, who has served as an expert witness in court regarding Chantix, said it's the riskiest drug among those analyzed from the FDA's adverse event reports. In the third quarter of 2010, it ranked first in reported deaths, with twice as many fatalities logged as any other drug, he said. … 'To us, it raises questions about whether this drug is safe for widespread clinical use,' Moore said. 'Does this tip the balance?'"

According to the article, there have now been a total of 272 suicides associated with Chantix use. Pfizer continues to deny that there is a causal link between the drug and these suicides.

The Rest of the Story

The most interesting aspect of this story is why anti-smoking groups that have called for a ban on electronic cigarettes, for which there have been adverse reports of zero suicides or deaths, are not calling for the removal of Chantix from the market, in light of the 272 suicides that are potentially linked to almost immediate neuropsychiatric effects of the drug.

The argument in favor of keeping Chantix on the market is that the benefit of its use in smoking cessation outweighs these potential side effects. That’s fine, but why doesn’t the same reasoning hold for electronic cigarettes. Given that e-cigarettes are helping thousands of people to quit smoking or cut down substantially on the amount that they smoke, shouldn’t they remain on the market? Don’t these benefits outweigh the risks, especially when there are no known risks, as not a single severe adverse event has been reported despite more than four years of widespread use?

The answer appears to be two-fold. First, the anti-smoking groups advancing this inconsistent policy on smoking cessation aids are all funded by Big Pharma. Most, if not all of them, have received money from Pfizer itself.

Second, there is an ideological block in the tobacco control movement which does not allow these groups to possibly view as favorable a product which simulates smoking behavior, even if it may save lives.

I believe that some form of relatively safe nicotine delivery in the form of a cigarette-like device is going to be the most important intervention of our time to reduce smoking-attributable morbidity and mortality. Just last week, Philip Morris International purchased rights to a product which delivers nicotine vapor through a device similar to an electronic cigarette, except that there is no electricity or heat involved. Instead, a chemical reaction takes place which results in the release of nicotine vapor, which is inhaled by the user.

Ironically, it is the anti-smoking groups which stand as the main roadblock between these interventions and their use in preventing smoking-related disease. You see, it’s not acceptable to quit smoking unless you quit smoking in the way we tell you to quit smoking. Doing so in a manner that simulates smoking is not OK. You must use the least effective of approaches: pharmaceutical agents that only address the pharmacologic aspects of smoking addiction, not the critical physical, behavioral, and social aspects of the addiction.

It might be the least effective method, but at least the financial relationship between the anti-smoking groups and pharmaceutical companies are not threatened. I have demonstrated how much money influences the anti-smoking groups, and nowhere is that money talking more than in the area of approaches to smoking cessation.

ADDENDUM (June 2, 2011 - 4:53 pm): I was just informed by Altria Client Services that it was Philip Morris International that acquired the rights to the technology described above, not Altria. I apologize for the error.

Friday, May 27, 2011

New England Journal of Medicine Commentary Suggests that NYC Outdoor Smoking Ban Goes Too Far

Echoing the sentiments I presented in my op-ed in the New York Times, a commentary appearing this week online ahead of print in the New England Journal of Medicine suggests that the outdoor smoking ban which went into effect in New York City this week goes too far (see: Colgrove J, Bayer R, Bachynski KE. Nowhere left to hide? The banishment of smoking from public places. New England Journal of Medicine 2011; 10.1056/nejmp1104637).

In the article, Colgrove et al., who are from the Mailman School of Public Health at Columbia University, argue that the New York City outdoor smoking ban goes beyond the need to protect nonsmokers from the health hazards associated with exposure to secondhand smoke. They cite testimony indicating that the purpose of the ordinance was, in part, to protect nonsmokers from having to see smokers in public.

In support of this point, the researchers cited a statement made by the NYC Health Commissioner in support of the ordinance: "Farley emphasized the importance of protecting children from exposure to adult smokers who would serve as negative role models. “Families,” he said, “should be able to bring their children to parks and beaches knowing 0that they won’t see others smoking.”"

The authors point out that: "air-monitoring studies have shown that health risks to people exposed to secondhand smoke outdoors drop off dramatically when the source of the smoke is more than 2 m away. The editor of the journal Tobacco Control dismissed as “flimsy” the evidence that secondhand smoke poses a threat to the health of nonsmokers in most outdoor settings. Nevertheless, smoking opponents continue to press their case using a variety of claims, including public health rationales as well as “public nuisance” arguments such as litter abatement."

The article concludes: "In the absence of direct health risks to others, bans on smoking in parks and beaches raise questions about the acceptable limits for government to impose on conduct."

The Rest of the Story

This is an interesting article because it shows how many public health practitioners who are outside of the tobacco control movement view the issue of these widespread outdoor smoking bans. This type of opinion would never be tolerated inside the tobacco control movement, as I demonstrated last week when I revealed that members of the Globalink list-serve attacked me for sharing my similar opinion publicly, rather than keeping it confined within the tobacco control movement.

Thursday, May 26, 2011

Why Fallacious Assertions About Low TSNA Cigarettes are Scientifically Worse than Fraudulent Statements About Low-Tar Cigarettes by Big Tobacco

I reported yesterday that anti-smoking researchers have attacked the U.S. tobacco companies for failing to produce lower TSNA (tobacco-specific nitrosamine) cigarettes. The attack occurs in a research article published in the journal Tobacco Control. The attack on the cigarette companies is based on the research finding, reported in the article, that TSNA levels in current cigarettes produced by Philip Morris, Reynolds American, and Lorillard are not significantly lower than they were three decades ago. The researchers further assert that cigarettes with lower TSNA levels reduce cancer risk. Thus, they argue that the tobacco companies have been neglectful by failing to reduce the TSNA levels in their products.

Yesterday, I explained why the assertion by the researchers in this article is a fallacious one: there is no evidence that cigarettes with lower TSNA levels are safer than other cigarettes because there are more than 60 carcinogens in tobacco smoke and the processes by which TSNA levels are reduced (which represent only 2 of the 60+ carcinogens) might actually increase levels of other carcinogens.

Today, I explain why the assertion that "TSNA-light" cigarettes are safer than "full-TSNA" cigarettes is even more fallacious than the tobacco companies' historical assertion that light (low-tar) cigarettes are safer.

Reason #1: The researchers knew that there are more than 60 carcinogens in tobacco smoke, yet they were willing to draw a conclusion about cancer risk based on lowered levels of two of them, with no knowledge of the levels of the other 58+ carcinogens. In contrast, low-tar delivery at least is indicative of a lowering in levels of all constituents, across the board.

I am not in any way justifying the claim that low-tar cigarettes are safer than high-tar cigarettes. However, it is at least the case that low-tar yields are indicative, to at least some degree, of a lowering of many types of carcinogenic substances in tobacco smoke, across the board. Lower tar yields presumably (if they translated into actual lowering of human exposure) indicate a lower amount of carcinogens and toxins across the spectrum.

In contrast, reduced levels of TSNAs in cigarettes indicates a reduction of only two of more than 60 known carcinogens. Not only is there the problem of the machine yields not adequately representing human exposure, but even if the exposure estimate was accurate, it would indicate a lowering of exposure to only two carcinogens. With low-tar cigarettes, if the machine yields were accurate, they would at least be indicative of a more across-the-board reduction in carcinogen exposure.

In fact, there is some evidence that cigarette filters have conveyed a small degree of health protection by slightly lowering lung cancer risk because of substantial tar reduction, the benefits of which are not undermined (or not completely undermined) by smoker compensation.

For example, Armadans-Gil et al. reported a 60% reduction in lung cancer risk associated with long-term use of filter-tip versus non-filter cigarettes.

In addition, there is some evidence that very high tar cigarettes (greater than 21 mg) do confer an increased risk of lung cancer. For example, Harris et al. found a quite robust and consistent relationship between very high tar cigarettes and higher cancer risk compared to medium, low, and very low tar cigarettes. Presumably, these findings are explained by a modest degree of protection conferred by the cigarette filter -- an effect that is not completely undermined by smoker compensation.

Moreover, the researchers knew - or at least should have known - that the evidence presented in the Department of Justice lawsuit against the tobacco companies made it clear that lower nitrosamine cigarettes do indeed have a higher yield of other carcinogens. The primary process by which TSNA levels are reduced - substituting flue-cured tobacco for burley tobacco - has the adverse side effect of increasing levels of other hazardous smoke constituents, including carcinogens.

In fact, lower TSNA cigarettes were found in tobacco company laboratory experiments to produce higher tar yields, as well as to increase hydrogen cyanide, carbon monoxide, and aldehyde deliveries.

In her final decision in the DOJ tobacco lawsuit, Judge Kessler found as follows: "This process allowed substitution of air-cured Bright tobacco for burley tobacco, and thus represented a potential advance in reducing the delivery of harmful TSNAs to smokers. ... When the air-cured bright tobacco was substituted for burley tobacco in the control cigarettes, as described in the experiments discussed in the patent, there were instances in which carbon monoxide (“CO”), hydrogen cyanide (“HCN”), FTC tar, and aldehyde (“RCHO”), deliveries were increased."

In light of this evidence, it seems to me to be quite disingenuous to assert that a low TSNA cigarette is safer than, and less carcinogenic than other cigarettes, especially when you know that the tar delivery may well be higher.

Moreover, it seems hypocritical to attack cigarette companies for failing to lower the TSNA levels using these methods, since such an approach would probably have led to higher overall carcinogen delivery and the anti-smoking groups would then have made toast of the companies in the courtroom.

Thus, while the fallacy of the tobacco companies "lights" assertion is primarily that machine yields do not accurately reflect human exposure, there are two fallacies with the researchers' "TSNA lights" assertion. First is the machine yield fallacy. Second is the fallacy that lowering levels of two specific carcinogens will reduce cancer risk when the levels of many other carcinogens are likely being increased.

Reason #2: The government required cigarette companies to disclose machine-measured tar yields to consumers and therefore implied that low-tar cigarettes convey some degree of health protection.

Again, I'm not excusing the tobacco companies, but the government was complicit in the fraud perpetrated upon American consumers by requiring what they knew was fallacious health-related information. The "light" labels largely corresponded to government-mandated product testing and the companies were accurately conveying the results of that testing.

In contrast, the government is not in any way suggesting that lower TSNA cigarettes are safer and has - at least up until now - rejected the idea of requiring TSNA level reporting to consumers. In fact, the FDA clearly stated, just yesterday, that low-TSNA cigarettes are not any safer.

Thus, while the tobacco companies were making assertions that were in line with official government policy, the Tobacco Control article is making an assertion that directly contradicts the official policy of the leading federal agency that regulates tobacco products.

The Rest of the Story

I think it is important to close this commentary by repeating a set of important findings from the scientific literature. In their article on levels of tobacco-specific nitrosamines in different types of tobacco, Ding et al. concluded as follows:

1. "The pyrosynthesis of benzo[a]pyrene (BaP) in cigarettes made exclusively with flue-cured or sun-cured tobaccos produces higher BaP levels in the smoke than in cigarettes made with burley tobacco."

2. "In cigarette brands containing different types of tobacco that delivered low TSNA levels in smoke, PAH levels increased as TSNA levels decreased. ... King et al. further illustrated the inverse relation between BaP and NNK emissions (nicotine-adjusted) in Australian and Canadian cigarettes (16). Such findings are important because smokers concerned about their health risk may switch to a brand that delivers lower levels of a particularly worrisome chemical but may not actually reduce risk because of their overall exposure to other harmful chemicals."

Fortunately, one of the authors of this article was Dr. David Ashley, and so I don't think he is going to fall for the anti-smoking researchers' claim that lowering TSNA levels in cigarettes reduces carcinogenic risk and that the FDA should therefore require cigarette companies to lower the TSNA levels, as recommended in the Tobacco Control article.

The rest of the story is that there is an abundance of existing literature (I've only cited a few select articles) which indicates that the methods used to produce low-TSNA cigarettes result in products that have higher levels of other toxins and carcinogens, including polycyclic aromatic hydrocarbons, hydrogen cyanide, and benzo(a)pyrene.

So the truth is that the researchers who have blasted the cigarette companies for failing to reduce TSNA levels have also attacked the companies for keeping down the levels of polycyclic aromatic hydrocarbons, hydrogen cyanide, and benzo(a)pyrene.

In other words, the current thinking, research, and policy recommendations in tobacco control are really no more science-based than the original deception of consumers by the tobacco companies, for which those companies were found guilty of RICO statute violations.

Wednesday, May 25, 2011

Anti-Smoking Researchers Tell Public that Marlboro Virginia Blend Cigarettes are Safer than Regular Marlboros, Camels, Kools, Winstons, and Dorals

Fraudulent Statements for Which Tobacco Companies Were Found Guilty Under RICO Statute are Now Being Made by Tobacco Control Researchers

In a shocking development, anti-tobacco researchers - including a member of the FDA Tobacco Products Scientific Advisory Committee (TPSAC) - are today telling the public that a particular brand of Marlboro cigarettes (Marlboro Virginia blend) is safer than many other brands of cigarettes on the market, including regular Marlboros, Marlboro special blend, Marlboro blend No.27, Marlboro blend No. 54, Marlboro smooth menthol, Basic, Camel, Winston, Kool, Pall Mall, Newport, and Doral.

Specifically, these tobacco control researchers are asserting that Marlboro Virginia blend cigarettes are safer than many other cigarette brands because they contain lower levels of tobacco-specific nitrosamines (TSNAs), which reduces the risk of cancer among smokers of this cigarette brand.

The researchers report that the overall level of TSNAs in Marlboro Virginia blend cigarettes is only 76 ng/cigarette, compared to 398 in Marlboro full flavor, 353 in Marlboro special blend, 371 in Marlboro blend No. 27, 572 in Marlboro blend No. 54, 386 in Marlboro smooth menthol, 514 in Basic, 301 in Camel full flavor, 424 in Winston full flavor, 327 in Kool filter kings, 279 in Pall Mall full flavor, 467 in Doral, and 340 in Newport.

Furthermore, the researchers assert that "higher levels of TSNA in cigarette smoke are associated with a higher risk of cancer in smokers."

Thus, these researchers are asserting that the lower levels of TSNA present in Marlboro Viriginia blend cigarettes are associated with a lower risk of cancer, and therefore, a safer cigarette compared to all the other brands tested in their study.

The researchers blast Philip Morris, Reynolds American, and Lorillard for failing to reduce the levels of TSNAs in their cigarettes over the past three decades, calling this failure a "remarkable neglect" by the tobacco industry.

In contrast, the researchers congratulate the Canadian cigarette manufacturers for lowering TSNA levels in their cigarettes. The researchers call on the FDA to require a reduction in TSNA levels in American-made cigarettes.

Source: Stepanov I, Knezevich A, Zhang L, Watson CH, Hatsukami DK, Hecht SS. Carcinogenic tobacco-specific N-nitrosamines in U.S. cigarettes: Three decades of remarkable neglect by the tobacco industry. Tobacco Control 2011. Published online ahead of print. doi 10.1136/tc.2010.042192.

The Rest of the Story

If Philip Morris were to make the exact same assertion as these tobacco control researchers, it would take all of about five minutes before the company would be attacked by anti-smoking groups for continuing its decades of fraud and deception of the public about the claim that some brands of cigarettes are safer by virtue of lower delivery of certain toxic constituents.

In fact, the major tobacco companies were found guilty of fraudulent activity under the RICO statute for making very much the same claim that these anti-tobacco researchers make today in their article: that certain brands of cigarettes are safer based on their lower delivery of specific carcinogens.

In my opinion, the assertion by these researchers, if appearing in any forum other than a research article, would be fraudulent. It would be little different from the deception of which we in tobacco control have attacked the tobacco companies.

Let's face the facts. If I were, today, to make a statement on my blog that Marlboro Virginia blend cigarettes are safer than Camel cigarettes, I would be essentially guilty of fraud. Certainly, I would be guilty of making a fraudulent claim. The claim would also be damaging, because it could mislead some smokers to believe that the cigarettes they are smoking are safer. I can assure my readers that I would not make such a claim unless I had very solid evidence to back it up.

But this is precisely the claim that these researchers are making today!

They are asserting that Marlboro Virginia blend cigarettes are safer than Camel cigarettes and a host of other brands because they deliver much lower levels of TSNAs and therefore reduce cancer risk. They are asserting that Marlboro Virginia blend cigarettes are less carcinogenic than other brands of cigarettes. They are also asserting that Canadian cigarettes are generally safer than U.S. cigarettes.

This is a first, as far as I am aware. I have never before witnessed anti-smoking researchers or advocates claim that one brand of tobacco cigarettes on the market is any safer than another brand.

Ironically, Philip Morris has had the restraint to refrain from honestly and accurately telling consumers of its Marlboro Virginia blend cigarettes that: "In the opinion of some anti-smoking researchers, this is a safer cigarette because it reduces your risk of cancer."

The glaring flaw in the reasoning of this study is that TSNAs are only one of the many (more than 60) carcinogens in tobacco smoke, and it is not necessarily the case that reducing TSNAs will reduce overall cancer risk. For example, it is entirely possible that the process of reducing TSNAs results in an increase in the level of some other carcinogens.

In fact, there is strong evidence that this in indeed the case. One of the prime strategies for reducing TSNAs is shifting from burley to flue-cured tobacco. While this does result in lower TSNA levels, it also appears to increase levels of benzo(a)pyrene and tar. Since tar and benzo(a)pyrene are also implicated in cancer risk, it is entirely possible that reduced TSNA cigarettes could increase cancer risk. We simply do not know.

Moreover, the cigarette smoke TSNA yields were studied using a smoking machine, not a real person. It is an unwise extrapolation to assume that the yields derived by a machine are going to be the same as those produced by an actual smoker, who may increase smoking intensity (puff volume and amount smoked) in response to decreases in certain constituents in the cigarette.

Just as it would be irresponsible, fraudulent, and illegal for Philip Morris to claim that its Marlboro Virginia blend cigarettes are safer than many other cigarette brands, I believe it is also irresponsible and inaccurate for those of us in tobacco control to assert that Marlboro Virginia blend cigarettes are less carcinogenic than other brands.

The FDA would be well-advised not to follow the researchers' recommendations here because such an action would essentially amount to a shift of the fraudulent tobacco industry claim of the past that cigarettes which deliver lower amounts of some constituent are safer than other brands from Big Tobacco over to the federal government. There is simply no scientific support for such an assertion. Thus, there is no scientific support for such a regulation. I hope this type of reasoning does not make its way over to the TPSAC.

What a tragedy it would be if the FDA did require the lowering of TSNA levels, forcing tobacco companies to abandon burley tobacco and switch to other blends which - although producing lower TSNA cigarettes - also produced cigarettes with higher yields of benzo(a)pyrene and other carcinogens, resulting in an overall increase in cancer risk among the population.

Of note, the researchers in this study did not measure any other carcinogens (other than TSNAs). Thus, I don't see how they can assert that Marlboro Virginia blend cigarettes are safer.

Not only are these researchers asserting that Marlboro Virginia blend cigarettes are safer than other brands, but they are also asserting that one can compare the carcinogenicity of any two brands of cigarettes simply by examining their TSNA content. Thus, for example, they are asserting that although not as safe as Marlboro Virginia blend cigarettes, Camel No. 9 menthols are less carcinogenic than Marlboro full flavor cigarettes.

Can you imagine R.J. Reynolds displaying ads in retail stores notifying the public that: "In the opinion of anti-tobacco researchers, Camel No. 9 menthol cigarettes produce a lower cancer risk than Marlboro full flavor cigarettes. As a tobacco company, we make no such assertion. We remind the public that they should be guided by the opinions of public health professionals. We defer to the opinions expressed by these professionals."

It is surprising that the tobacco companies aren't already having a field day with these assertions in this published article.

I should add that this deception - now being practiced by tobacco control practitioners rather than by tobacco companies - is not just taking place in the U.S. It is occurring internationally, as the implementing bodies for the Framework Convention on Tobacco Control are also proposing regulations on the TSNA content of cigarettes, which could potentially lead to an increase in overall cancer risk, but at best would be a guinea pig experiment on the world population accompanied by an implied fraudulent assertion of relative safety compared to older cigarettes.

I cannot help but close this piece by speculating as to the reasons why these study authors would make such an unfounded assertion, one that if made by tobacco companies instead of anti-smoking advocates would immediately bring vicious attacks and most certainly, a rash of lawsuits.

My only speculation is that anti-smoking advocates often have so much zeal and determination to attack the tobacco companies that this zeal can obscure scientific judgment. Apparently, the underlying "purpose" of this study was to show that TSNA levels have not decreased over time and therefore, that the tobacco companies have committed some sort of irresponsible, negligent act. If you read the entire paper, you'll see that this is indeed the underlying premise of the paper.

So if you begin from a position of wanting to attack the tobacco companies, I suppose that when you indeed find that TSNA levels have not declined, your first thought is to attack the tobacco companies and accuse them of "neglect," rather than to realize that if the tobacco companies had taken your recommended action and advertised their products as safer because of lower TSNA yields, those very same companies would have been attacked by anti-smoking advocates for misleading the American people and likely, would have faced a multitude of lawsuits for fraudulent deception of consumers.

The rest of the story, then, is that in their apparent zeal to attack the tobacco companies, anti-smoking researchers have made inaccurate and unsupported scientific assertions that are damaging to the public's appreciation of the hazards of smoking and of the lack of existence of any demonstrably safer brand of tobacco cigarettes in the current market.

What is even more shocking to me, however, is that although anti-smoking researchers are apparently readily willing to assert that some cigarette brands are safer than others, they are not willing to entertain even the possibility that some non-combusted, non-tobacco products (such as electronic cigarettes) are safer than combusted tobacco products such as the ones that were investigated in this study.

ADDENDUM (May 25, 2010 - 3:30 pm): Just moments ago, the FDA released warning letters to a number of tobacco retailers, declaring them guilty of health fraud for implying that their products are safer than other tobacco products on the market. The FDA asserted that: "To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products."

In light of this clear statement by the FDA, perhaps they should also send a warning letter to the authors of this research article, since the assertions in this article represent "health fraud"
according to the FDA.

Tuesday, May 24, 2011

Anti-Smoking Groups are Still Wildly Misinformed About Electronic Cigarettes

Although they have now been on the market for more than three years, many anti-smoking groups continue to be misinformed about these non-tobacco alternatives to cigarettes that have helped many smokers to quit.

Perhaps the best example of the misinformation that some of these groups are disseminating is the SmokeFree Vegas web site, which informs readers that electronic cigarettes are yet another Big Tobacco product designed to enable smokers to smoke in the presence of smoking bans.

According to the site: "Being that Big Tobacco is always finding loopholes to allow their products to stay on shelves, in the midst of the court’s decision there may already be a way for E-cigs to continue selling without FDA involvement. The grand majority of E-cigs are marketed as smoking alternatives – that is, products designed to be used where and when traditional cigarettes cannot; meaning that they serve the same purpose as a normal cigarette would."

The article then goes on to inform the public that if electronic cigarettes are marketing with a therapeutic claim, they will not be subject to any regulation:

"The potential loophole for E-cigs could apply to the companies that market their product as a therapeutic item rather than a recreational one. ... While recreational E-cig companies will now be required to adhere to FDA regulations and provide the government with lists of all chemicals and ingredients in their products, therapeutic E-cig makers wont have to abide by the same rules. Since all E-cigs function the same way (essentially), the only method by which the FDA will determine which products are therapeutic and which aren’t is by assessing their advertising. You can rest assured that this leaves plenty of room for legal ‘gray areas’ that most E-cig makers will try to use to convince the FDA that their product is, and always has been, therapeutic."

The Rest of the Story

This article couldn't be further from the truth. It is reporting the exact opposite of the facts.

First, electronic cigarettes are not a Big Tobacco ploy. They aren't manufactured, marketed, or distributed by tobacco companies at all. They are distributed by electronic cigarette companies, which are independent of the tobacco industry.

Second, marketing electronic cigarettes with a therapeutic claim is not a loophole that would allow an electronic cigarette company to avoid FDA regulation. Quite the opposite. Making a therapeutic claim would place electronic cigarettes squarely within the FDA's jurisdiction of the product as a drug-device combination under the Food, Drug, and Cosmetic Act, and therefore, would require the removal of the product from the market until the distributor conducts clinical trials to get the product approved as a safe and effective drug/device.

Most electronic cigarette companies are likely to avoid making therapeutic claims so that their products can be regulated under the less stringent Tobacco Act, rather than under the Food, Drug, and Cosmetic Act. Moreover, regulation of the product under FDCA would technically require the immediate removal of the product from the market, since if a company makes therapeutic claims, its product is an unapproved drug device combination and that company is subject to severe legal penalties in addition to withdrawal of its product from the market.

It's not difficult to get a story wrong, but it does seem unusual that so many anti-smoking groups are getting this one wrong. This suggests to me that it is more than just a multitude of innocent mistakes. Rather, I believe that these groups are ingrained with an underlying ideology that simply does not allow for the endorsement of a device that simulates smoking, no matter how many lives that device might save. Thus, their immediate impulse is to attack these devices, attack the tobacco industry for marketing these devices, and mix up the story as necessary to paint a picture that these devices are made by evil companies that are trying to pull one over on the public.

Ironically, the only deception of the public that is occurring or will occur from electronic cigarette companies is:

1) that they cannot tell the public the truth about the relative safety of these products compared to cigarettes because if they do so, the products are modified risk tobacco products and need pre-approval by the FDA; and

2) that they cannot market the products as helping smokers to quit - even though that is the precise purpose of the product - because doing so could be interpreted as a therapeutic claim and therefore place the product under FDA jurisdiction as a drug device combination under FDCA.

Monday, May 23, 2011

Chantix Implicated in Suicide; How Many Will It Take Before Anti-Smoking Groups that Demand E-Cigs Be Pulled From Market Also Call for Chantix Ban?

Chantix has been implicated in yet another suicide. This time, it is a tragic murder-suicide. The fathers of the two people killed have filed a lawsuit against Pfizer blaming Chantix for the deaths of their loved ones.

According to an article on the WTAE (Pittsburgh) web site: "The lawsuit contends New York-based Pfizer didn't sufficiently warn consumers until after the murder-suicide, even though those side effects were allegedly revealed during clinical trials. 'They clearly knew about it before this event. In fact, within a few weeks of Sean and Natalie's deaths, Pfizer was required to post a black box warning on the product,' said Pribanic [the attorney representing the plaintffs]. The lawsuit claims Chantix causes an "increased risk of death, including depression, agitation, hostility, rage and suicide." 'It makes some people, for reasons yet to be demonstrated, people who would otherwise never entertain such an idea, want to kill other people or themselves or both,' said Pribanic."

"Pfizer told Channel 4 Action News that 'We have not yet reviewed the circumstances of this case, but no causal relationship has been found between the medicine and neuropsychiatric events such as those alleged here.' The drug company said it received "post-marketing reports" of such symptoms that don't scientifically "establish a cause and effect relationship" between the medicine and such behavior. Pfizer said it warns users and their doctors to monitor "neuropsychiatric symptoms," and that patients who become hostile, aggressive or suicidal should immediately stop using the drug."

"In 2008, the Institute for Safe Medication Practices or ISMP issued a report that blamed Chantix for 1,001 serious incidents involving users of the medication in the first quarter of that year. At the time, the ISMP said that's more adverse events than reported for any other prescription drug...Pfizer issued a statement at the time that said the ISMP's "report was based solely on a tally of post marketing adverse events.... Such reports are often unverifiable and lack sufficient medical information to draw any conclusions."

The Rest of the Story

In light of the thousands of serious adverse events involving users of Chantix and the apparent fact that Pfizer is undermining its own warnings by denying any causal association between Chantix and the reported events, why is it that the anti-smoking groups which have called for electronic cigarettes to be pulled from the market are not calling for Chantix to also be pulled?

While Chantix has been associated with thousands of serious incidents and more than 100 deaths, electronic cigarettes have not been implicated in any. While there is abundant evidence that Chantix can cause severe psychiatric symptoms shortly after the drug is initiated, there is no evidence that electronic cigarettes cause any serious adverse effects.

The anti-smoking groups which have called for e-cigs to be banned have argued that electronic cigarettes must be proven safe before being allowed on the market. Why does the same not hold for Chantix? Why should this drug continue to be marketed even though it has clearly not been shown to be safe? Since both are products already on the market, why should a different standard apply to electronic cigarettes than to Chantix?

In my opinion, there are two answers.

1. Money

Every one of the anti-smoking groups which have called for a ban on electronic cigarettes has received funding from pharmaceutical companies that manufacture smoking cessation drugs, including Pfizer itself.

For example, the American Legacy Foundation is a recipient of Pfizer money.

The American Cancer Society and Action on Smoking and Health are recipients of Pfizer funding for tobacco control programs.

The American Cancer Society also has this financial relationship with Pfizer.

Pfizer reports a large number of grants in 2010 to the American Cancer Society, American Heart Association, American Lung Association, American Academy of Pediatrics, and Campaign for Tobacco-Free Kids here.

Additionally, Pfizer reports grants in 2009 to the American Legacy Foundation, along with the American Cancer Society, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Action on Smoking and Health, and American Academy of Pediatrics here.

Clearly, Pfizer's donations are being well-spent, because they are deflecting attention from Chantix and its dangers and leading to silence from the anti-smoking groups regarding the risks of Chantix, even though the very same groups demanded that electronic cigarettes be pulled from the market in the absence of any reported serious adverse effects.

In making their pronouncements against electronic cigarettes, these groups have not even disclosed their financial conflicts of interest, thus violating basic ethical principles on top of displaying inconsistency in their actions.

2. Ideology

The ideology is simply this: nothing that looks like cigarette smoking can possibly be a good thing, even if it saves lives. People need to quit smoking the way we say they should quit smoking. There is a right way and a wrong way to quit smoking. The right way is our way and the wrong way is any other way. If it looks like smoking, it's still smoking, even if there are no adverse health effects and the individual has achieved smoking cessation.

These anti-smoking groups can simply not tolerate the fact that a product which simulates smoking could possibly be a good thing and that they cannot possibly endorse such a product, even though the product is already saving lives and could potentially save millions of lives if broadly promoted among the population of current smokers.

If anti-smoking groups want to argue that any smoking cessation product on the market has to first be unequivocally proven safe, then fine. They can argue that e-cigarettes should be removed from the market but they must also call for Chantix to be pulled from the market for the same reason.

Alternatively, if they believe that the burden of proof is on others to demonstrate that Chantix is unsafe before pulling it from the market, then that's fine too. But then they must apply the same reasoning to electronic cigarettes and ask that these products remain on the market until such time as they are demonstrated to be unreasonably unsafe.

The glaring inconsistency in the policies being espoused by the anti-smoking groups is a glaring revelation of the influence of pharmaceutical money combined with the stifling effects of wearing ideological blinders.

Friday, May 20, 2011

A Strange Day: Tobacco Executive Tells Public that Smoking is Addictive: Prominent Anti-Smoking Advocate Tells Public that Smoking is Not Addictive

This is a day I thought would never come. Very strange indeed.

Today, a tobacco company executive is telling the public that smoking is addictive.

On the very same day, a prominent anti-smoking advocate is telling the public that smoking is not addictive.

In an ironic twist - as you would expect the exact opposite - the tobacco companies are now telling the public the truth about the addictive nature of smoking while at least some anti-smoking advocates are deceiving the public about smoking's addictive nature.

In a press release, anti-smoking advocate Professor John Banzhaf of the George Washington University School of Law tells the public that smoking is a choice, not an addiction, as smokers can easily switch to non-tobacco nicotine replacement products: "although there is evidence that for many people smoking involves addiction, that addiction is to the drug nicotine, not to the act of smoking itself, which is a behavior. Because those who desire to quit smoking (e.g., for a medical procedure) can ingest nicotine from nicotine gum, nicotine patches, nicotine spray, nicotine inhalers, and e-cigarettes, their decision to ingest it by smoking rather than by using nicotine replacement products is a choice. Since it is a choice rather than an addiction, disease, or health status, it seems more legally justified to restrict access to medical care to smokers than to the obese."

In contrast, Michael E. Szymanczyk, Altria's chairman and chief executive officer, yesterday told the public that smoking is indeed addictive. According to an article in the Richmond Times-Dispatch: "The top executive of tobacco giant Altria Group Inc. told shareholders Thursday that smoking is addictive and can be very difficult to quit."

The Rest of the Story

It is difficult to believe, but this is a true story. I'm not making this stuff up. You're not reading The Onion. You're reading the Rest of the Story.

And the rest of the story is that while the CEO of Altria acknowledged that smoking is an addiction and can be very difficult to quit, the former head of Action on Smoking and Health told the American people the exact opposite: that smoking is not an addiction, but is a choice, and that smokers can easily quit by switching to a nicotine-containing alternative, since it is only the nicotine that is addictive, not smoking.

Adding to the irony, Professor Banzhaf is one of the key architects of litigation against the tobacco companies in the first place - litigation that relies upon the argument that smokers are not responsible for their injuries from smoking because they were addicted to smoking and could not easily quit or use an alternative, safer nicotine-containing product.

The anti-smoking advocates seem to change the science on whether smoking is a choice or an addiction based on the issue of the day. If the issue is a lawsuit, then smoking is an addiction. If the issue is refusing to hire smokers, then smoking is a choice. If the issue is the FDA regulating nicotine, then smoking is an addiction. If the issue is denying medical care to smokers, then smoking suddenly becomes a choice again.

Thursday, May 19, 2011

Former ASH Director Calls Smoking a Choice, Not an Addiction; Destroys Basis for Thousands of Legal Claims by Smokers Against Tobacco Industry

With apparent zeal for trying to further the "cause" of preventing medical care for smokers, former director of Action on Smoking and Health - Professor John Banzhaf - is publicly claiming that smoking is a choice, not an addiction, thus destroying the critical legal basis for thousands of pending lawsuits against the tobacco industry.

In a press release issued yesterday, Professor Banzhaf argues that: "although there is evidence that for many people smoking involves addiction, that addiction is to the drug nicotine, not to the act of smoking itself, which is a behavior. Because those who desire to quit smoking (e.g., for a medical procedure) can ingest nicotine from nicotine gum, nicotine patches, nicotine spray, nicotine inhalers, and e-cigarettes, their decision to ingest it by smoking rather than by using nicotine replacement products is a choice. Since it is a choice rather than an addiction, disease, or health status, it seems more legally justified to restrict access to medical care to smokers than to the obese."

The Rest of the Story

Professor Banzhaf's statement destroys the most critical aspect of the legal argument in thousands of pending lawsuits by smokers against the tobacco industry: that the smoker was addicted and could not easily have made a choice to quit smoking. Ironically, this is precisely the major defense argument presented by the tobacco industry in every one of these cases.

The tobacco companies should retain Professor Banzhaf as an expert witness in future cases, as his testimony would be devastating to the plaintiffs in these cases. Of course he would not testify in that capacity, but his public statement can certainly be used by tobacco attorneys as evidence that at least some tobacco control experts view smoking as a choice and not an addiction.

It is also ironic that Banzhaf is in many ways the architect behind litigation behind the tobacco companies, as he played a major role in crafting and promoting these cases. It is therefore ironic that he is now, in a single stroke, destroying the major legal basis for this entire field of litigation. Apparently, the zeal to try to prevent medical care for smokers is overwhelming.

The truth is that Professor Banzhaf is wrong on the science. Smoking is an addiction and it is not simply an addiction to nicotine. If it were merely an addiction to nicotine, then nicotine replacement therapy would have a far greater success rate than it does. Addiction to smoking involves both pharmacologic factors (i.e., nicotine) and behavioral factors (e.g., physical stimuli associated with smoking). In fact, one of the reasons why electronic cigarettes are helping many smokers quit who have failed on NRT is that it addresses both the behavioral and pharmacologic aspects of the smoking addiction.

This statement is a bonanza for tobacco companies, as they can use it as a defense in every lawsuit to help convince the jury that the smoker was responsible for his or her own demise.

As far as the effort to deny medical care to smokers goes in the first place, I condemn it. There is no place for this type of bigotry in medical practice. Where smoking is a contraindication to a medical procedure, then of course you would not operate unless the person quits smoking. But it any other case, it is a violation of basic ethical principles of medicine to deny care to an individual because of a personal health behavior decision.

Wednesday, May 18, 2011

Anti-Smoking Advocates Spreading Misleading Information While Encouraging Some Ex-Smokers to Return to Smoking

In two separate op-ed articles published during the past week, anti-smoking advocates are misleading the public about the scientific evidence regarding the safety of electronic cigarettes, while at the same time encouraging many ex-smokers to return to cigarette smoking.

In an op-ed in the Tacoma News Tribune, Tacoma-Pierce County health director Dr. Anthony Chen advises smokers not to use electronic cigarettes because "FDA analysis of e-cigarettes found their vapor contains nicotine and other harmful chemicals known to be toxic and cancer-causing." He writes that "it is bad policy to allow the public to be exposed to harmful chemicals such as nicotine and nitrosamines."

In an op-ed in the Lexington Herald-Leader, professors Ellen Hahn and Carol Riker also advise smokers not to use electronic cigarettes to quit smoking, asserting that electronic cigarette companies "oppose smoke-free policies" and accusing them of "attacking public-health professionals." Moreover, the authors argue that electronic cigarettes "emit secondhand vapor that includes nicotine and may include other potentially harmful chemicals." They also argue that electronic cigarette use "is an uncontrolled experiment conducted by those whose primary interest is to profit from addiction, which causes early, painful death."

The Rest of the Story

Both op-eds are grossly distorting the actual scientific evidence and misleading the public.

Chen asserts that the FDA analysis of electronic cigarettes found that their vapor contains cancer-causing chemicals (i.e., tobacco specific nitrosamines). However, what he doesn't reveal is that only trace levels were found, that these levels are comparable to those in the nicotine patch or nicotine gum, and that these levels are orders of magnitude lower than those found in cigarettes. Thus, what the FDA analysis actually shows is that in terms of carcinogenicity, electronic cigarettes are much safer than tobacco cigarettes.

Chen also asserts that it is bad public policy to allow the public to be exposed to nicotine and nitrosamines. What he is conveniently hiding from the public, however, is that his health department allows the public to be exposed to nicotine and nitrosamines every day. By allowing the sale of nicotine patches and nicotine gum, Chen is allowing perhaps thousands of Tacoma-Pierce County residents to be exposed to nicotine and nitrosamines. It is well-established that NRT products contain nicotine and nitrosamines. In fact, nitrosamines are easily detectable in the saliva of nicotine gum users. By not mentioning this, Chen is further misleading the public.

Hahn and Riker assert, first, that the electronic cigarette companies oppose smoke-free policies. This is untrue. The electronic cigarette companies have never opposed smoke-free policies. They have merely asked that their products, which do not produce tobacco smoke, not be included in such policies.

Hahn and Riker assert, second, that the electronic cigarette companies are attacking public health professionals. I am not aware of any such attacks, although these companies are correcting misinformation being disseminated by public health professionals, like Hahn and Riker.

Hahn and Riker assert, third, that electronic cigarettes emit vapor that contains nicotine and possibly other toxic chemicals. However, there is no evidence to support this claim. No studies have documented that the emitted vapor from the electronic cigarette contains any appreciable quantity of nicotine and no studies have documented that the emitted vapor contains any other toxic chemical in appreciable amounts. Because nicotine is effectively absorbed in the mouth and lungs, it is highly unlikely that the emitted vapor from electronic cigarettes contains anything other than trace amounts of nicotine.

Finally, Hahn and Riker assert that e-cigarette makers' primary motive is to profit from addiction and that this addiction to nicotine causes a slow, painful death. If the e-cigarette makers' primary motive was to profit from addiction, then why are they making and marketing zero-nicotine cartridges and why are they encouraging their customers to gradually wean themselves down from 16 mg to 12 mg to 8 mg to 4 mg to zero nicotine? The truth is that many of the electronic cigarette companies have a sincere interest in helping to save lives but providing an alternative to the dismal NRT products currently on the market, which fail in the overwhelming majority of smokers who try them.

That nicotine addiction alone causes a slow and painful death is not clear. There is no evidence, for example, that the use of NRT for a prolonged period of time increases the risk of cancer or heart disease. In contrast, there is massive evidence that the continued use of cigarettes increases the risk of cancer, heart disease, and lung disease. Rather than causing death, electronic cigarettes are preventing a the long, painful death of which Hahn and Riker speak by helping smokers to get off the tobacco cigarettes.

By encouraging ex-smokers who have successfully quit smoking by using e-cigarettes to stop using these products - which is invariably going to lead them to return to cigarette smoking - these anti-smoking advocates are doing a disservice to the public, I believe. The companies that truly benefit from this advice are the tobacco companies, because they are the ones who stand to gain from public health practitioners' efforts to discourage the use of electronic cigarettes. Doing so will only increase sales of the real ones.

Tuesday, May 17, 2011

New Study Concludes that Thirdhand Smoke Causes Lung Damage to the Fetus; Declares Changing Bedsheets a Problem of Global Proportions

An article published online ahead of print in the American Journal of Physiology has concluded that changing bedsheets is a problem of global proportions, given evidence it reports that direct application of tobacco-specific nitrosamines to fetal lung extracts induces lung damage (see: Rehan VK, Sakurai R, Torday JS. Thirdhand smoke: A new dimension to the effects of cigarette smoke on the developing lung. American Journal of Physiology: Lung Cellular and Molecular Physiology 2011; can have as serious or an even more negative impact on an infants' lung development as postnatal or childhood exposure to smoke."

They also conclude that "exposure to the constituents of thirdhand smoke is as damaging and, in some cases, more damaging than secondhand smoke or firsthand smoke."

Furthermore, they conclude that "prenatal disruption of lung development [by thirdhand smoke] can lead to asthma and other respiratory ailments that can last a lifetime."

Finally, the study concludes that "THS [thirdhand smoke] is a hidden toxin present in the households of smokers where pregnant women and small children live without realizing that they are being exposed to such dangerous toxicants. The same risk exists for adult workers who clean and change bed sheets in hotel rooms where cigarette smoking is allowed the world over, especially in China and other countries in Africa, Asia, South America and North America – a problem of global proportions!"

Based on the press release, international news headlines warned that "'Thirdhand' smoke hurts infant lungs" and "Thirdhand smoke dangerous to unborn babies' lungs."

The Rest of the Story

The conclusions of this study are grossly exaggerated and have almost no relationship to the actual findings of the study.

The study did not actually examine the effects of thirdhand smoke exposure at all. It merely examined, in a laboratory setting, the effects of directly treating fetal lung extracts with tobacco-specific nitrosamines.

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Monday, May 16, 2011

Health Groups Acknowledge that Park Smoking Ban is Not About Critical Health Protection for Nonsmokers

In response to my op-ed in the New York Times suggesting that banning smoking in every outdoor park in New York City might be going too far, two health groups - the American Cancer Society and the NYC Department of Health - published letters to the editor defending this policy.

The American Cancer Society acknowledges that in a large park, such as Central Park, nonsmokers can easily avoid exposure to secondhand smoke, but asks the question: "is it really fair...?" The ACS argument is that a nonsmoker should never have to be exposed to even a whiff of secondhand smoke because "there is no safe level of exposure" and that government should pass laws to ensure that this is the case.

The Department of Health makes two arguments. First, the ban is not just about health, but about "enjoyment" of parks. It argues simply that "smoking doesn't belong there."

Second, the Department of Health argues that the ban is necessary to prevent children from having to see people smoke: "Children in parks or on beaches should be learning how to play baseball, bike or swim, not how to smoke."

The Rest of the Story

The first problem with both the ACS and the Commissioner of Health's arguments is that by their reasoning, smoking should be banned everywhere outdoors in the city.

If government must ensure that citizens never have to endure even a single whiff of secondhand smoke because there is "no safe level of exposure," then why are the ACS and Health Commissioner not calling for a complete ban on outdoor smoking? Why should nonsmokers have to be exposed to people smoking on sidewalks, for example? In fact, it is a heck of a lot easier to avoid exposure to secondhand smoke in a wide-open park than it is to avoid exposure to smoke on a sidewalk.

If the ACS and Health Department's arguments held any teeth, then it would be justified to simply ban smoking everywhere outdoors - and especially in the most crowded places, like sidewalks.

The Health Commissioner also argues that smoking "doesn't belong" in parks. Well, is he saying that smoking does belong on every sidewalk in New York City? Is there a proper place to be exposed to secondhand smoke, and an improper place to experience such exposure? It's not a matter of smoking "belonging" or not belonging, it's a question of whether there is a substantial public health hazard.

Finally, the Department of Health argues that the smoking ban is justified because children should not have to see smokers in public. Well if that's the case, then how is it justified to allow children to have to see smokers in any other outdoor place? Once again, if you want to protect children from having to see a smoker, then you pretty much have to ban smoking everywhere. In fact, if a smoking ban in an outdoor park is justified on the basis of protecting children from having to see a smoker, then so is a complete ban on any outdoor smoking, period.

The second problem with these arguments is that they argue for banning smoking based on concerns unrelated to critical protection of nonsmokers from substantial health hazards attributable to secondhand smoke exposure. One thing that is clear from these letters is that for the anti-smoking groups, this truly isn't about health protection from significant hazards of secondhand smoke, it is about never having to even see a smoker in public.

The Health Commissioner and ACS director, for example, defend the need for the smoking ban on the basis that it is necessary for people to be able to "enjoy" themselves outdoors. That this is about "enjoyment" and not "health" is a problem, I think. The same justification for banning smoking would also apply to banning the use of perfume. To be sure, that can also affect someone's "enjoyment" of being on a park bench.

Even more troublesome is the stated justification of protecting children from having to ever see a smoker. If that justifies smoking bans, then why not simply ban smoking everywhere outdoors? And why not ban smoking indoors when there is a child present?

These letters demonstrate the main point in my column: that our arguments in support of these widespread outdoor smoking bans risk our undermining the entire basis for smoke-free policies that are truly needed to protect people's lives: bans in places where people simply can't escape substantial exposure.

By framing smoking bans in terms of "enjoyment," rather than "health," I believe we are hurting our overall cause of protecting the public from the severe hazards of chronic exposure to secondhand smoke in the workplace.

By framing smoking bans in terms of "smoking not belonging" in a particular place, we are undermining our case for banning smoking in places like bars and restaurants, where our opponents defend smoking by arguing that it does belong.

And by framing smoking bans in terms of preventing children from having to ever see a smoker, we turn smoking from a health issue into a moral concern, which seriously undermines our case for workplace smoking bans.

Based on the stated arguments in support of the NYC park smoking ban, I have to say that the movement to protect nonsmokers from substantial health threats from secondhand smoke exposure is not a "symbolic victory," it is not a victory at all. In fact, it may just be moving us in the wrong direction, not the right one.

Thursday, May 12, 2011

Anti-Smoking Advocate Attacks Me for Expressing My Opinions About Outdoor Smoking Bans Publicly

Writing on the Globalink international list-serve of tobacco control advocates, a Globalink member attacked me for expressing my disagreement with widespread outdoor smoking bans publicly, rather than keeping it private among the Globalink membership.

The advocate wrote: "It's certainly acceptable to disagree with other advocates on a Globalink forum, but to do so in a public forum, a national daily no less, is counterproductive at best."

The advocate also compared my opinion to that of a former R.J. Reynolds executive, writing about my op-ed: "The article also reminded me of the quote from R.J. Reynolds Chairman, Charles Harper: "If children don't like to be in a smoky room, they'll leave." When asked by a shareholder about infants, who can't leave a smoky room, Harper stated, "At some point, they begin to crawl." --Carrig, David, "RJR Wins Fight", USA Today: B1, April 18, 1996 The same could be said of outdoor public places such as parks and beaches, especially when there is hardly a breeze blowing."

The Rest of the Story

This story is important because it demonstrates the mentality within the anti-smoking movement these days. It is not acceptable to express disagreement with any aspect of the agenda of the movement publicly. If you do so, you will be attacked by your colleagues. All dissent must be kept internal.

It sounds more like a religion, than a science-based public health movement. In fact, it was a desire not to let criticism go public that spurred some leaders within the Catholic Church to cover up or ignore sexual assaults that had been perpetrated by some priests. Disallowing dissent is something that is done by religious movements; it should not be a part of public health movements.

It is interesting and instructive that rather than deal with the substance of my arguments, the writer has instead chosen to attack me personally and to criticize the fact that I expressed my opinion, rather than the substance of my opinion or the science and reasoning I used to back it up.

It is also interesting to see how when an anti-smoking advocate criticizes any aspect of the agenda, he is immediately equated with being a tobacco industry spokesperson. Comparing me to the former chief executive of R.J. Reynolds in terms of my position on secondhand smoke is like comparing granola bars to Vienna Fingers.

The purpose of such comments is clear. It is an attempt to quell any possible dissent by attacking the dissenter. This is an effective tactic (although not in my case) for silencing dissent. It works extremely well in religious movements, and it is working extremely well in tobacco control.

I should also note that the advocate's call for me to express my opinions on Globalink - where he or she says it would be appropriate to do so - is quite ironic, given that I was expelled from Globalink specifically for expressing dissenting opinions about issues like this one.

Wednesday, May 11, 2011

Coca-Cola Company and PepsiCo Opposing Measure to Curb Obesity; Will American Dietetic Association & Other Health Groups Continue to Take Their Money?

Public health advocates in Massachusetts have submitted legislation that would help curb obesity in the Commonwealth by significantly reducing soda consumption. The bill would eliminate soda's exemption from state sales tax -- an exemption which was originally intended to keep down prices of essential consumer products: namely, food.

However, according to an article in today's Boston Globe, the measure is being vigorously opposed by the American Dietetic Association's, American Cancer Society's, American Academy of Pediatrics', and American Academy of Family Physicians' corporate partner(s) - Coca-Cola and PepsiCo.

According to the article, the Coca-Cola Company and PepsiCo - working through the American Beverage Association (which they heavily fund) - is working to oppose not only this but every other measure throughout the nation which would reduce soda consumption and thus help curb the obesity epidemic.

According to the article: "The American Beverage Association has been aggressively fighting taxes on soda, as cities and states across the country look for new tools to counter an obesity epidemic and raise revenue amid squeezed budgets. It has spent millions fighting initiatives that impose product-specific excise taxes on sugar-sweetened beverages and has been successful in nearly every attempt."

The Rest of the Story

Sadly, whether they intend to or not, the American Dietetic Association, American Cancer Society, American Academy of Pediatrics, and American Academy of Family Physicians are helping to defeat this important public health legislation by promoting the image of Coca-Cola and PepsiCo as leaders in the fight against obesity.

By partnering with these companies, taking their money, promoting the companies on their web sites, giving these companies immense public relations benefits, and helping to legitimize the biased science put out by these corporations, the ADA and the other health groups are aiding these companies' efforts to kill not only this but every other piece of public health legislation throughout the nation that would help curb obesity by reducing soft drink consumption.

Moreover, these health organizations are violating their own stated principles in accepting money from these opponents of efforts to curb obesity in the United States.

For example, the American Cancer Society misleads the public by stating that it will not partner with any company whose products contribute to obesity. Clearly, it is violating its own stated criteria here. The ACS claims: "If a product contributes to obesity, a major contributor of cancer, it's out."

Yet, the truth is that the ACS accepts money from the Coca-Cola Company, which indisputably manufactures products that contribute to obesity.

The American Cancer Society is compromising its honesty and integrity. It is lying to the public, and all for the sake of receiving money from Coca-Cola. Another way to view this of course is to see that the ACS has been bought off by Coca-Cola and that they have to resort to lying to the public to feebly defend their lack of integrity.

Another example of how these health groups are compromising their integrity is the American Academy of Pediatrics, which publicly states that Coca-Cola is a leader in the movement to improve the health of children worldwide.

Exactly how does opposing every piece of public health legislation that would reduce obesity by lowering soda consumption constitute being a leader in the movement to improve the health of children worldwide?

The rest of the story is that with "enemies" like these health groups, the Coca-Cola Corporation and PepsiCo do not need friends. These health groups are doing more than these soft drink companies could ever dream of to aid them in their efforts to oppose public health measures that would decrease the sale of their most lucrative products.

To be clear, I'm not arguing that Coca-Cola and PepsiCo should be supporting soda taxes. The fact that they oppose these taxes is strong evidence that these measures are effective ones that would actually hurt their bottom lines, and therefore would have an effect on obesity. They logically oppose these taxes because it would harm the sales of their products -the very mechanism by which these policies help promote the public's health.

My criticism here is directed at the health groups which are aiding these corporations in their efforts to undermine measures that are critical in the movement to address the obesity problem in the United States. I find it very sad that these organizations are more interested in monetary donations than in working with the rest of us in public health to try to put a dent in obesity and the devastating effects it has on the lives of individuals and families.

Tuesday, May 10, 2011

Argentina Bans Electronic Cigarettes, But Keeps the Real Ones

Argentina yesterday banned electronic cigarettes, apparently because of concerns over the safety of the product and concerns about whether these devices actually can help smokers to quit.

According to an article from the AFP: "Argentina on Monday banned the import, sale and promotion of electronic cigarettes, saying there is no proof they help smokers kick the tobacco habit. ... Manufacturers say the cigarettes are not harmful to the smoker or people around them -- a claim health experts reject. Experts also said the devices, which are meant to simulate the experience of puffing on a cigarette, are ineffective in helping smokers end their habit."There is no scientific evidence that validates these products as auxiliary measures to stop smoking, nor their safety," said Roberto Lede, a senior official in Argentina's state regulatory office said.The statement mentioned a World Health Organization (WHO) recommendation stating that the level of safety and the degree of nicotine absorption by these products has not been established. Eduardo Bianco, a leading Uruguayan anti-tobacco expert, said at a WHO health conference in Uruguay in November that electronic cigarettes "sabotaged smoking prevention efforts" designed to encourage people to quit."

The Rest of the Story

This is great news for the tobacco companies in Argentina, as it ensures that their profits will not be threatened and that a viable method for smokers to quit using their products will remain unavailable. The country could not have done anything more significant to protect the profits of its tobacco companies.

The health authorities' claim that there is no evidence that electronic cigarettes can help smokers quit is fallacious. There is abundant evidence that thousands of smokers have been able to quit smoking, or at least cut down substantially, with the help of electronic cigarettes. It has also been established that electronic cigarettes are much safer than tobacco cigarettes. Furthermore, there is no evidence that these products pose any dangers to bystanders.

Argentina's action represents a huge victory for the transnational tobacco companies and a huge defeat for the public's health.

Monday, May 09, 2011

New Zealand Ministry of Health Declares that Electronic Cigarettes are Safer than Tobacco Cigarettes

For the first time ever, a national public health department has declared that electronic cigarettes are safer than regular tobacco cigarettes.

According to an article in the New Zealand Herald: "The [New Zealand] Ministry of Health has stated that electronic cigarettes are "far safer" than smoking tobacco."

This may be the first time that any public health agency has made such a declaration. In the United States, the FDA has warned the public about the dangers of electronic cigarettes, tried to discourage the public from using these products, and attempted (unsuccessfully) to take electronic cigarettes off the market. Local health departments have also discouraged smokers from using these products. Anti-smoking groups have also tried to get electronic cigarettes taken off the market.

According to the article, the New Zealand Ministry of Health concluded that: "As the e-cigarette delivers only nicotine ... without the 4000 or so other chemicals in tobacco smoke, it is far safer than smoking. The risks to smokers of pure nicotine, delivered in doses seen with the e-cigarette and nicotine replacement therapy products, are extremely low."

Nevertheless, the Ministry of Health stopped short of encouraging smokers to use these products to quit smoking. In fact, the article states that: "The ministry considers them an unapproved medicine and says their distribution would be an offence."

The Rest of the Story

I congratulate the New Zealand Ministry of Health for being the first public health agency to draw the solid, evidence-based conclusion that electronic cigarettes are far safer than tobacco cigarettes. My review of the scientific evidence (published in the Journal of Public Health Policy) came to the same conclusion.

However, it is still baffling that after concluding that electronic cigarettes are far safer than tobacco cigarettes, the Ministry of Health would then declare that the distribution of these products would be an "offence." An offence to what? The profits of tobacco companies? The sale of chemotherapy drugs to treat cancer? The profits of hospitals that treat chronic obstructive pulmonary disease?

This schizophrenic action of the New Zealand health ministry demonstrates the resistance in the tobacco control movement to the concept of harm reduction. Here, the Ministry of Health has concluded, unequivocally, that electronic cigarettes are far safer than tobacco cigarettes because they deliver nicotine without the tens of thousands of toxic and carcinogenic chemicals in tobacco smoke. However, the ministry does not want smokers to use this much safer product. It would still prefer that smokers use the real cigarettes. And it would still prefer that ex-smokers who have successfully quit by virtue of electronic cigarettes return to smoking the real, toxic ones.

This mentality makes no sense. It is the product of an ideology in tobacco control that simply does not allow the concept of harm reduction to enter the picture.

But at least there is one victory here: the first ever acknowledgment by a public health agency that electronic cigarettes are far safer than the analogues.

Friday, May 06, 2011

New York Times Op-Ed Suggests that NYC Outdoor Smoking Ban Goes Too Far

My op-ed in today's New York Times argues that New York City's ban on smoking in all parks and beaches, which will go into effect on May 23, goes too far because it is not necessary in order to protect the public from any significant public health hazard.

In the piece, I argue that in outdoor places where nonsmokers can move freely about, the duration of secondhand smoke exposure is so short that it does not represent any substantial threat to the public's health. Instead, policy makers have enacted this law on the basis that government intervention is justified to prevent even fleeting exposure to tobacco smoke.

I also point out that because policy makers supporting these policies have realized that the scientific evidence does not support their position, anti-smoking groups have recently begun to manufacture evidence that even fleeting exposure to tobacco smoke can cause heart disease and lung cancer. I highlight the Surgeon General's recent statement that even brief exposure to tobacco smoke causes heart disease and cancer, and explain why that assertion is unfounded and inaccurate.

Finally, I argue that the zeal to extend smoking bans to places where nonsmokers can easily avoid exposure is going to harm the tobacco control movement in the long run. By trying to convince the public that even a brief exposure to tobacco smoke causes heart disease and cancer, we are going to risk losing our public credibility. Moreover, we are going to risk losing what really matters at this point: extending the protection from the real hazards of secondhand smoke in the workplace - especially in bars, restaurants, and casinos - to the millions of workers who currently do not enjoy such protections.

By casting ourselves as zealots whose real goal is simply to eliminate smoking everywhere that a nonsmoker might even have to see someone smoking, we are sacrificing the validity of our arguments in favor of workplace smoking bans. In the long run, that is going to harm our cause more than the trivial gains to be realized from banning smoking in every remote outdoors location in New York City.

Thursday, May 05, 2011

Article in New England Journal of Medicine Criticizes TPSAC for Failing to Recommend Menthol Ban

My perspective article, published yesterday in the New England Journal of Medicine, criticizes the FDA Tobacco Products Scientific Advisory Committee (TPSAC) for failing to recommend a ban on menthol cigarettes, arguing that this was a lost opportunity for public health.

I write: "Although some public health groups hailed as a public health victory the release of a report on menthol cigarettes by the Tobacco Products Scientific Advisory Committee (TPSAC) of the Food and Drug Administration (FDA), close examination of the report and its recommendations reveals that it actually represents a huge victory for Lorillard, the manufacturer of the leading brand of menthol cigarettes (Newport) — and a disappointing setback for the health of black Americans."

The article then points out that "the TPSAC did not recommend a ban on menthol cigarettes. Instead, the report simply stated, “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.” Thus, the committee’s basic “recommendation” is not a recommendation at all, but a conclusion that doesn’t suggest any particular action to the FDA."

I argue that "it is specifically because Congress knew that a menthol ban would substantially benefit the public’s health (by decreasing tobacco sales) that politicians chose to exempt menthol from the Tobacco Act in the first place. It is because a menthol ban would actually reduce tobacco sales that an advocacy group called the Campaign for Tobacco-Free Kids and other health groups supporting the tobacco-regulation legislation ensured that such a ban was not included in it — since it would have risked the loss of Philip Morris’s support for the law and the crumbling of the deal that had been forged with the country’s largest tobacco company. The mandate for the TPSAC to study the menthol issue was actually a compromise forged to appease the Black Congressional Caucus, which vigorously denounced the exclusion of menthol from the bill’s flavoring ban. The Campaign for Tobacco-Free Kids, for its part, opposed an amendment that would have eliminated the menthol exemption, defending that opposition by warning that if menthol were banned, a black market in contraband cigarettes was likely to be created — an argument that had been made vigorously by Lorillard."

Two members of the TPSAC - Dr. Samet and Dr. Benowitz - wrote a corresponding perspective article about the TPSAC menthol report. In it, they argue that: "The TPSAC, a scientific advisory committee, was not charged with addressing regulatory options and did not have the time or expertise to analyze regulatory scenarios, including any involving inadvertently opening a door for the introduction of contraband menthol cigarettes into the U.S. market."

The Rest of the Story

Drs. Samet and Benowitz argue that the TPSAC is a scientific body and is therefore not charged with addressing regulatory options. If every FDA scientific panel made the same argument, there would be no drugs on the market. After all, every FDA scientific panel is charged not simply with examining the science, but with making a recommendation to the agency with respect to policy: namely, whether to approve or disapprove a pharmaceutical company's application for a drug to be placed on the market.

Can you imagine if an FDA scientific advisory panel came back to the agency with a recommendation stating: “This drug treats hypertension and would therefore improve the public’s health, but there are some serious potential side effects that need to be studied.” That gives the agency no guidance in terms of what action to take. The entire point of the advisory panel is to recommend a policy action to the FDA.

Moreover, the argument that TPSAC was not charged with addressing regulatory options flies in the face of its legislative mandate. The Family Smoking Prevention and Tobacco Control Act mandated that the TPSAC issue not only a scientific report, but also a "recommendation" to the FDA regarding the regulation of menthol cigarettes.

Moreover, the Act mandated that TPSAC examine not only the public health impact of menthol cigarettes, but also the potential black market and contraband concerns. The Committee was to weigh these factors in making its recommendation to the Agency.

Here is the text of the Congressionally-mandated charge to TPSAC, in section 907(e) of the Tobacco Control Act:

‘‘(1) REFERRAL; CONSIDERATIONS.—Immediately upon the establishment of the Tobacco Products Scientific Advisory Committee under section 917(a), the Secretary shall refer to the
Committee for report and recommendation, under section 917(c)(4), the issue of the impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities. In its review, the Tobacco Products Scientific Advisory Committee shall address the considerations listed in subsections (a)(3)(B)(i) and (b).
‘‘(2) REPORT AND RECOMMENDATION.—Not later than 1 year after its establishment, the Tobacco Product Scientific Advisory Committee shall submit to the Secretary the report and recommendations required pursuant to paragraph (1).

It should be immediately apparent to readers that TPSAC failed to complete its mandate because it did not issue any "recommendations" to the Agency regarding the regulation of menthol cigarettes. Clearly, the legislation asks the TPSAC to make recommendations to the Agency. If it had required only a scientific report, it would have stated that the Committee issue "a report," not a "report and recommendations." The TPSAC did the former, but not the latter.

What may not be so apparent is that TPSAC was charged not only with examining the public health impact of menthol, but also the black market/contraband concerns. According to the law, TPSAC "shall address" the considerations in subsections (a)(3)(B)(i) and (b). What exactly are these considerations?

The consideration in subsection (a)(3)(B)(i) is simple. It's the public health impact of menthol cigarettes. Specifically: "(i) CONSIDERATIONS.—In making a finding described in subparagraph (A), the Secretary shall consider scientific evidence concerning— (I) the risks and benefits to the population as a whole, including users and nonusers of tobacco products, of the proposed standard; (II) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (III) the increased or decreased likelihood that those who do not use tobacco products will start using such products."

In other words, TPSAC was mandated to consider the effects of a menthol ban on disease risk, smoking initiation and smoking cessation. It did carry out that mandate.

However, TPSAC was also charged with addressing the considerations in section 907(b):

"The Secretary shall consider all other information submitted in connection with a proposed standard, including information concerning the countervailing effects of the tobacco product standard on the health of adolescent tobacco users, adult tobacco users, or nontobacco users, such as the creation of a significant demand for contraband or other tobacco products that do not meet the requirements of this chapter and the significance of such demand."

Thus, the law specifically mandates that TPSAC must consider the potential concerns regarding a black market or contraband in developing its report and recommendations. TPSAC did not carry out this mandate. Instead, it simply punted the issue back to FDA, urging the FDA to conduct the analysis that TPSAC was supposed to conduct.

More importantly, the clear intent of the legislative mandate was that TPSAC weigh the public health benefits of a menthol ban against the black market/contraband concerns and come up with an overall recommendation taking both into account. This is what would have been helpful to the FDA and this is what the law called for.

The rest of the story, then, is that not only did the TPSAC do the public a disservice by wasting all this time studying the issue but failing to make a recommendation. In addition, the TPSAC failed to carry out or fulfill its Congressional mandate.

This is a shame not only because the Committee wasted time and resources. It is a shame because the Committee wasted what could have been an opportunity to promote the one action that the FDA could have taken that would actually have improved the public's health. The Committee, however, was too weak-willed for that. It would have required actually standing up to Big Tobacco.

As I conclude in the article: "At the end of the day, it is difficult to understand the rationale for a policy that bans every other type of cigarette flavoring — including chocolate, strawberry, banana, pineapple, cherry, and kiwi — yet exempts the one flavoring that is actually used extensively by tobacco companies to recruit and maintain smokers, a finding that has been documented extensively by the TPSAC itself. Ironically, it is because removing menthol would actually improve the public’s health by reducing the consumption of cigarettes that we are not going to see such an action from the federal government. There is no political risk in banning chocolate and strawberry cigarettes, since no companies are currently selling such products and they play no role in smoking initiation. Menthol, however, is a major contributor to smoking initiation and continued addiction, and for this reason, it will continue to enjoy the protection of a federal government that seems afraid to alienate any corporation, whether it’s part of Big Pharma, Big Insurance, or Big Tobacco."