Tuesday, July 31, 2012

Kentucky Center for Smoke-free Policy Continues to Make Misleading Claims About Electronic Cigarettes and to Disseminate Irresponsible Advice to Smokers

In what now seems almost like a crusade, the Kentucky Center for Smoke-free Policy is out to get electronic cigarettes and to protect smoking cessation drugs from any possible competition from these new products. In the most recent salvo, a representative of the Center appeared on television to discourage smokers from using electronic cigarettes in an attempt to quit smoking.

In the television interview, Dr. Ellen Hahn spoke about the potential use of electronic cigarettes for smoking cessation: "You do hear people claim that they have success [but] ... the bottom line is, though, that the electronic cigarette is not really a quit aid. ... There's a lot of myth and misperception and confusion about the product ... the industry is not allowed to make therapeutic [smoking cessation] claims but yet people are confused."

The Rest of the Story

Is it the "people" (i.e., smokers) who are really confused, or is it the Kentucky Center for Smoke-free Policy?

There is abundant evidence that literally thousands (if not tens of thousands) of electronic cigarette users have successfully used these products to either quit smoking or to cut down substantially on the amount that they smoke. A clinical trial has demonstrated that among smokers who were not motivated to quit, 54% were able to quit completely or to cut down by at least half on the amount they smoke.

Thus, it is quite misleading to state that the electronic cigarette is not a quit aid. For many smokers, it is indeed a quit aid.

The myth and misperception and confusion about the product to which Dr. Hahn refers is the perception that electronic cigarettes may be helpful in quitting or cutting down on smoking. The implication is that smokers are confused because many of them think that e-cigarettes could be helpful in quitting or cutting down.

But the reality is that it is the Kentucky Center for Smoke-free Policy which appears to be confused because the truth is that thousands of smokers have used electronic cigarettes successfully to quit completely or cut down substantially. More than half of unmotivated smokers were successful, so one would expect much higher rates of success among smokers who are actually motivated to pursue an alternative to their toxic cigarettes.

In light of the existing clinical trial evidence, how can one go on television and deceive the public by asserting that there is no evidence for the potential of electronic cigarettes in smoking cessation. To do so is to completely ignore the results of the clinical trial evidence, as well as to ignore the multitude of anecdotal evidence based on personal reports of ex-smokers. Ignoring the anecdotal evidence may not be all that troubling, but ignoring the clinical trial evidence is gravely problematic.

The advice from the Kentucky Center for Smoke-free Policy is irresponsible because it asserts that the many electronic cigarette users who have quit successfully using these devices should discontinue their use and take their chances with NRT or Chantix. But because a large proportion of these ex-smokers are vaping specifically because they tried NRT or Chantix and failed, this advice is tantamount to urging these ex-smokers to return to cigarette smoking. It is difficult to imagine more irresponsible medical advice.

In fact, many vapers have reported dramatic improvement in their health, such as increases in lung function and physical stamina. Discontinuing electronic cigarette use and returning to smoking is the last thing in the world these individuals should be encouraged to do. Returning to smoking will undoubtedly harm the health of these individuals and perhaps even ruin what would have been a great opportunity to keep them off cigarettes permanently.

In the second part of the salvo of scientific misrepresentation, Dr. Hahn published an op-ed in the Lexington Herald-Leader in which she asserted: "Although some people report they were able to quit smoking by using e-cigs, there is no scientific evidence that this works."

Apparently, Dr. Hahn either has not read or is ignoring the Polosa study, which provides exactly the kind of scientific evidence that she claims does not exist. In that study, electronic cigarettes were found to be useful in smoking reduction or smoking cessation in a majority of smokers who were not even motivated or attempting to quit. 

In the third part of the salvo, Dr. Hahn wrote a letter to a hotel at which a vapers convention is being held this weekend. She urges the hotel not to allow vaping inside the building because of its supposed carcinogenic effects. However, in providing the evidence for those carcinogenic effects, she deceives the hotel management by failing to provide the whole story.

Hahn only notes that the FDA lab testing "found the vapor to contain several cancer causing agents." She fails to report the levels of the carcinogens detected. The rest of the story is that only trace levels of tobacco-specific nitrosamines were detected and these are a result of the fact that nicotine is derived from tobacco. The same trace amounts of tobacco-specific nitrosamines are present in nicotine gum and the nicotine patch.

I have no problem with public health advocates intervening with a hotel to try to make sure that hotel guests are appropriately protected from health hazards. However, I think it is the responsibility of those advocates to provide an unbiased picture of the scientific information, not a misleading assessment that leaves out critical information.

Finally, it appears that Dr. Hahn may have a financial conflict of interest, as a disclosure was apparently made that she has either served on a speaker's bureau or received honoraria from Pfizer (the maker of Chantix), a company which stands to lose severely if electronic cigarettes continue to rise in popularity. If accurate, then this conflict should have been disclosed in the op-ed as well as the letter.

To be sure, more research needs to be conducted on electronic cigarettes to more clearly define their effectiveness in smoking cessation and to more fully understand their precise health effects. However, notwithstanding the need for more research:

(1) It is incorrect to state that there is no evidence that these devices are useful in smoking cessation or reduction. Clinical trial evidence suggests that these products could be very useful, even among smokers with little motivation to quit.

(2) It is misleading to assert that electronic cigarettes are not a smoking cessation aid. They are for many people. What remains to be seen is exactly what proportion of smokers will be successful in quitting or cutting down substantially.

(3) It is deceptive to scare people by asserting that electronic cigarettes deliver carcinogens, without noting the level of those carcinogens and the fact that the same carcinogens are also present in nicotine replacement products.

(4) It is imperative that researchers giving national advice on electronic cigarettes disclose significant financial conflicts of interest, so that the public has the ability to take this into consideration when evaluating the validity of that advice.

Read more here: http://www.kentucky.com/2012/07/22/2266540/e-cigs-not-as-harmless-as-claimed.html#storylink=cpy

Monday, July 30, 2012

American Legacy Foundation Takes More Money from Pfizer; Still Fails to Disclose Conflict of Interest on Electronic Cigarette Recommendations Disseminated to the Public

The American Legacy Foundation took money from Pfizer as recently as last year; this money was used to support a national survey of more than 3000 American smokers about smoking cessation.

The 2011 funding is in addition to additional funding that Legacy received from Pfizer in 2009, and further confirms that Legacy has financial ties to the pharmaceutical industry, which stands to lose severely if electronic cigarettes continue to become more and more popular.

At the same time that it accepts funding from Pfizer, Legacy continues to fail to disclose this significant conflict of interest on its web page which disseminates to the public recommendations about electronic cigarettes. Specifically, the web page recommends that the FDA take electronic cigarettes off the market until they are proven to be safe and effective: "The FDA should take electronic cigarettes off the market until it is satisfied that they are safe and effective."

According to the web page, Legacy's recommendation is as follows: "While we remain open to promising products that can help smokers quit smoking, a consideration of all of the available evidence combined with important unanswered questions strongly supports our call on the FDA to prohibit the marketing and sale of e-cigarettes unless and until the FDA is satisfied that they are safe and effective."

Importantly, nowhere on the web page does Legacy disclose that it has received funding from a pharmaceutical company which manufactures a smoking cessation product, and thus that the Foundation has a conflict of interest by virtue of this pharmaceutical company funding. The public is therefore not able to take this conflict of interest into consideration when evaluating Legacy's presentation of the scientific evidence and formulation of its recommendation.

The Rest of the Story

It is interesting that the American Legacy Foundation chooses to continue pointing readers to this recommendation to ban electronic cigarettes, even though the District Court for the District of Columbia has ruled that the FDA does not have the authority to remove electronic cigarettes from the market in the absence of therapeutic claims by manufacturers because they must be regulated under the Tobacco Act rather than under the Food, Drug, and Cosmetic Act.

It is unfortunate that the American Legacy Foundation misrepresents the findings of a 2009 FDA laboratory study on electronic cigarettes, and fails to even mention numerous studies conducting since that time which point to the relative safety of electronic cigarettes over regular cigarettes. Legacy highlights the finding that electronic cigarettes were found to contain tobacco-specific nitrosamines, without notifying readers that the levels of these TSNA's were extremely low, that these levels are comparable to those in nicotine gum and patches, and that the TSNA's are present at trace levels simply because the nicotine is derived from tobacco.

All nicotine products derived from tobacco are going to have trace levels of tobacco-specific nitrosamines so this finding is essentially meaningless. It does not indicate that electronic cigarettes are carcinogenic. Instead, it demonstrates that electronic cigarettes pose a much lower level of carcinogenic risk that tobacco cigarettes, because the levels of TSNA's in these devices are orders of magnitude lower than in regular cigarettes.

Why is the American Legacy Foundation misrepresenting the health risks of electronic cigarettes to the public?

Well, one potential explanation - only apparent to those who might somehow discover the Foundation's financial ties to Big Pharma from sources other than the recommendations themselves - is that the financial conflict of interest is contributing to this bias in the reporting of the scientific evidence.

A second factor could be the reluctance to admit that a behavior which looks like smoking might actually be significantly safer than cigarette smoking and therefore might be something which a public health organization might actually recommend as a strategy for smoking cessation. Of course, this would take sales away from pharmaceutical companies, including Pfizer, and so it also plays into the bias caused by the conflict of interest.

The failure to disclose a significant conflict of interest is unfortunate because it deprives the public the information it needs to appropriately evaluate the validity of the Foundation's presentation of the scientific facts and recommendations about electronic cigarettes. In this case, a blatant misrepresentation of the scientific evidence occurs, but readers have no way of knowing that Legacy has a financial interest in promoting the sales of smoking cessation drugs over electronic cigarettes.

Another public communication from Legacy which has the appearance of a bias potentially resulting from a conflict of interest is the Foundation's 2008 press release praising Pfizer for "proactively and voluntarily giving more prominence to its consumer warning messages specific to their popular smoking medication, Chantix." Unfortunately, and quite inexplicably, the press release fails to mention just what the adverse side effects of Chantix might be that are the subject of these warning messages.

Ironically, the press release closes by emphasizing that: "smokers therefore need to be armed with all the available information to make the best, most informed choices about the smoking cessation medications available to them." But Legacy fails to provide the very information that smokers need most: that Chantix was associated with severe psychiatric side effects - including suicide.

In the press release, Legacy appears to be intentionally hiding from the public the fact that Chantix was associated with adverse side effects as severe as death. Given the funding from Pfizer, what else are we to think, other than that this biased reporting of the science is being influenced by this financial conflict of interest, which - incidentally - is not even disclosed in the press release.

Friday, July 27, 2012

WebMD Article Highlights Debate Over Electronic Cigarettes

A WebMD article published yesterday highlights the debate over electronic cigarettes.

On one side of the debate are public health practitioners who argue that there is no evidence that these products are safer than regular cigarettes and that they may be leading to smoking among youth and former smokers.

The article highlights this side of the debate as follows: "This is an unproven device and we know very little about its long-term health effects,'' says researcher Jennifer Pearson, PhD, MPH. She is a investigator at Legacy, an antismoking group in Washington, D.C. "E-cigarettes are probably less harmful than combustible cigarettes, [but] we don't have data to say that and can't talk about long-term effect.' There are many unknowns and unanswered questions, she says. For example, have they encouraged former smokers to reignite their nicotine addiction? Are current smokers using them to quit or to circumvent smoke-free indoor air laws? And how are they affecting people who have never smoked. 'Are they acting as gateway products?"

Pearson and colleagues have called for the removal of electronic cigarettes from the market until the FDA regulates them.

On the other side of the debate are public health practitioners like myself who argue that if one actually takes the time to review the available evidence, one will readily see that there is strong evidence that electronic cigarettes are much safer than regular cigarettes, that youth are not taking up vaping in any significant numbers, and that the primary use of these products is among smokers who are trying to quit or cut down on the amount of the harmful cigarettes they are smoking. In fact, a clinical trial demonstrated that 54% of smokers who were not motivated to quit were able to cut down by at least half on their smoking with the help of electronic cigarettes.

According to the article: "Michael Siegel, MD, disagrees. He is the associate chairman of community health sciences at the Boston University School of Public Health. They do have an important role to play in getting people to quit smoking, he says. "Taking them off of the market would be a disaster because essentially all of these smokers would be forced to go back to cigarette smoking," he predicts. They feel like a cigarette, look like a cigarette, and you smoke it like a cigarette and see vapor when you exhale,'' he says. This is appealing to a smoker who is often as addicted to the nicotine as the actual act of smoking a cigarette. They are not attracting new smokers, he says. Very few never-smokers are using these products, so all the concerns that kids and nonsmokers are going to use them seem unfounded,' Siegel says."

"Gilbert Ross, MD, agrees. He is the executive director and medical director of the American Council on Science and Health, a New York City-based consumer education/public health organization. 'E-cigs contain only water vapor, safe [diluents] such as glycerin, and nicotine, in a cigarette-like delivery device, and [are] highly likely to be much less harmful than inhaling combusted tobacco smoke.'"

The Rest of the Story

The current evidence suggests that, far from causing former smokers to "re-ignite their nicotine addiction," electronic cigarettes are helping nicotine-addicted smokers to become former smokers, or at least to cut down substantially on the amount they smoke.

There is also abundant evidence vaping is far less hazardous than smoking. I fail to understand how in July 2012, public health practitioners who have thoroughly reviewed the existence evidence can tell the public that "we don't have evidence to say that" vaping is less hazardous than smoking.

Particularly problematic is the fact that the American Legacy Foundation investigators fail to disclose a significant conflict of interest, which is that Legacy has been a recipient of Pfizer money, and therefore has financial ties to the pharmaceutical industry, which stands to lose severely if electronic cigarettes continue to become more and more popular.

The American Legacy Foundation continues to argue that "the FDA should take electronic cigarettes off the market until it is satisfied that they are safe and effective." This would be a devastating blow to the public's health because it would force many ex-smokers who are currently staying smoke-free with the help of e-cigarettes to return to cigarette smoking. It would also take away a viable alternative to cigarettes for about 1.8 million people, undeniably resulting in an increase in cigarette consumption, and therefore, in disease and death.

I absolutely cannot understand such a recommendation, especially in July 2012 when we now have clinical trial evidence of the effectiveness of these products in helping even unmotivated smokers to cut down substantially on the amount that they smoke.

Thursday, July 26, 2012

Lynn Health Officials Propose to Reduce Youth Access to Cigarettes by Capping Number of Stores that Sell Tobacco at 180 and Prohibiting Pharmacies from Selling Cigarettes

According to an article in the Daily Item (Lynn, MA), health officials in Lynn have proposed two regulations designed to limit youth access to tobacco. First, the number of tobacco retailers would be capped. Second, tobacco sales would not be allowed in pharmacies. These proposed regulations were inspired by the finding that Lynn has the highest ratio of tobacco outlets to population in the state.

According to the article: "Local teenagers have more opportunities to buy cigarettes and other tobacco products in local stores than their peers in many other Massachusetts cities, said city Health Director MaryAnn O’Connor and an anti-smoking advocate working with the city. Citing state Public Health statistics, O’Connor and Joyce Redford said Lynn has almost three local stores selling tobacco products for every 1,000 people age 18 and older living in the city. ... O’Connor said the Board of Health is reviewing several measures aimed at keeping cigarettes and other tobacco products out of teenagers’ hands, such as capping the number of tobacco retailers in the city and banning tobacco sales at pharmacies." ...

"O’Connor said a ban on pharmacy sales of tobacco would immediately drop the ratio by banning sales in chain-operated drug stores as well as independently owned pharmacies like Crown Drug on Lewis Street. ... Girl’s Inc. substance abuse prevention coordinator Cassie Haughton said the number of licensed tobacco retailers in Lynn exceeds the state average by 60 percent. She said that statistic translates into opportunities for teens or people they can convince to buy for them to obtain cigarettes. “We’re hoping the city can put a cap on the number of tobacco licenses they allow in the city,” Haughton said." ...

"O’Connor said placing a cap on the number of local retailers at, say 180 licenses, would allow new stores or ones that have not had licenses to acquire them when other license holders close."

The Rest of the Story

This is just the latest example of how tobacco control has gone awry. Here, health officials are proposing to limit youth access to cigarettes by making sure that there are no more than 180 places in Lynn for kids to buy cigarettes and by making sure that they cannot buy cigarettes at pharmacies.

I am quite confident that youth in Lynn would have just as easy a time obtaining cigarettes if there were 180 places to buy cigarettes in Lynn than if there were 250 places to buy cigarettes. Capping the number of tobacco retail outlets at 180, or even half that number, is not going to have any effect whatsoever on youth access to cigarettes.

First of all, less than half of youths obtain their cigarettes by purchasing them in the first place. Second, limiting the number of stores that sell cigarettes will simply send kids to the stores that do sell cigarettes.

In other words, the effect of the proposed regulations will be nothing other than re-distributing the market share for the sale of cigarettes to youth to a lower number of stores, as well as shifting tobacco sales to youth from pharmacies to gas stations and convenience stores.

As I have argued previously, prohibiting sales of tobacco in pharmacies will have no effect on youth access to cigarettes. If the Lynn health officials really wanted to limit youth access to cigarettes, then they should ban the sale of tobacco in all places other than pharmacies. Pharmacies are the least likely place for youth to purchase cigarettes. They are much more likely to buy cigarettes in gas stations and convenience stores, retailers that are left untouched by the proposal.

The proposed regulations are also terribly inconsistent and hypocritical. If cigarettes are so bad that they should not be sold in pharmacies, then why aren't cigarettes so bad that they shouldn't be sold at gas stations or convenience stores? Obviously, this measure isn't about public health protection, it's about being political cowards and trying to achieve political gain without having to actually take a principled stand.

The proposal to limit the number of cigarette retailers is also hypocritical. Officials are telling us that cigarettes are so bad and their sale exposes children and promotes tobacco use. So what are we going to do about it? Get rid of the sale of cigarettes in Lynn stores? No, of course not. Instead, we're going to set an arbitrary limit of 180 stores that can sell tobacco.

What the crafters of this proposal are basically saying is: "It's only a problem if more than 180 stores in Lynn sell cigarettes. As long as we limit the number of stores that sell cigarettes to 180 or less, then everything is fine. There's no need to protect the kids that live around those 180 stores from the sale of cigarettes, just the kids who would live around the 181st store."

This is absurdity. It makes no sense. If there is a public health justification for banning the sale of tobacco products in Lynn, then ban it. If not, then don't. But to pretend that arbitrarily setting the number of tobacco outlets at 180 is some sort of public health measure is insane. It does nothing to prevent the sale of cigarettes, which will certainly remain readily available with 180 outlets in the city.

Do you mean to tell me that if there 181 stores that sell cigarettes in Lynn, there is a major public health problem, but if we get that number down to 180, we have addressed that problem?

I just don't understand this type of reasoning. What are these folks thinking?

The rest of the story is that limiting the number of stores in Lynn that sell cigarettes is not going to have any impact on smoking and the policy therefore does not protect the public's health. As such, it represents an unjustified intrusion on private business and is therefore an arbitrary and inappropriate public policy. If advocates want to work in their communities and try to limit the sale of tobacco, that is fine. It serves an educational purpose and allows the community to mobilize around the issue. But a legislated mandate on the number of stores of a given type is not justified unless there is evidence that it would serve a substantial government interest, like protecting the public's health. Cutting the number of tobacco-selling stores down to 180 and preventing tobacco sales in pharmacies is not going to have any impact on smoking in Lynn. Cigarettes will remain readily accessible.

This is a waste of time. Advocates in Lynn should instead be focusing on how to prevent youth from wanting to buy cigarettes in the first place. Interventions that reduce the demand for cigarettes are the tried and true, evidence-based approaches to youth smoking prevention.

Wednesday, July 25, 2012

Portland City Council Inducted as Sixth Member of Colonel Benjamin Church Hypocrisy Hall of Shame

Colonel Benjamin Church Hypocrisy Hall of Shame Award

Awarded to: Portland City Council       Diamond Rank

Awarded for: Banning smoking in all outdoor public parks, but allowing smoking in indoor private clubs."

Other Hall of Shame Members:

Attorney General of Florida  SILVER RANK

National Anti-smoking Organization  GOLD RANK

Mayor of New York City        BLUE RANK

U.S. Senator, New Jersey   BRONZE RANK

New York State Senator         DIAMOND RANK

Today, I am announcing the induction of the 6th member of the the Colonel Benjamin Church Hypocrisy Hall of Shame.

Today's award goes to the Portland (Maine) City Council, which last Thursday voted to ban smoking in all outdoor public parks, but to continue to allow smoking indoors in private clubs.

According to an article in the Portland Press-Herald: "A City Council committee voted Thursday to recommend that the council ban smoking in all public parks but declined to pursue a ban for private clubs. Banning smoking in all city-owned and maintained parks would "basically complete" Portland's restrictions on smoking near playgrounds, athletic fields and beaches, said Councilor Edward Suslovic, chairman of the Public Safety, Health and Human Services Committee." ...

"Despite their unanimous support for the smoking ban in parks, committee members decided against pursuing a proposal to prohibit smoking in private/fraternal clubs such as the American Legion, Eagles and Elks." 

City Councilor John Coyne explained his reason for voting against a ban on smoking in private clubs:
"I look at this as government getting into something we don't need to. I just don't think the city really has a role in it."

"Suslovic (another City Council member) said he also prefers to see clubs deal with the issue privately, but urged them to reconsider permitting smoking."

The Rest of the Story

If banning smoking in private establishments, such as the American Legion, is something that we don't need "government getting into," then why should the city ban smoking in all other private establishments, such as bars, restaurants, and the buildings of private organizations?

If banning smoking in private clubs is something that the city does not "have a role in," then why should the city have a role in banning smoking in private restaurants and bars?

If clubs should deal with the issue privately, then why shouldn't bars also deal with the issue privately.

In advancing these arguments, the Portland City Council has destroyed its own arguments for banning smoking in all private establishments in the city.

To be sure, the problem of secondhand smoke exposure is far worse in indoor private clubs than it is in outdoor public parks. If you were going to justify exempting one of the two from a smoking ban, you would certainly be more justified in exempting outdoor parks than in exempting indoor workplaces, albeit they are located within "private" clubs.

This is first-rate hypocrisy and worthy of induction into the Colonel Benjamin Church Hypocrisy Hall of Shame at the Diamond Level.

Tuesday, July 24, 2012

New Article Calls for Removal of Electronic Cigarettes from Market With No Data to Substantiate Benefits of their Removal and Without Disclosure of Conflict of Interest of Study Author

A new article published online ahead of print in the American Journal of Public Health reviews the results of an American Legacy Foundation survey related to awareness and use of electronic cigarettes.

The study reports the survey results as follows: "In the online survey, 40.2% (95% confidence interval [CI] = 37.3, 43.1) had heard of e-cigarettes, with awareness highest among current smokers. Utilization was higher among current smokers (11.4%; 95% CI = 9.3, 14.0) than in the total population (3.4%; 95% CI = 2.6, 4.2), with 2.0% (95% CI = 1.0, 3.8) of former smokers and 0.5% (95% CI = 0.16, 1.4) of never-smokers ever using e-cigarettes. In both surveys, non-Hispanic Whites, current smokers, young adults, and those with at least a high-school diploma were most likely to perceive e-cigarettes as less harmful than regular cigarettes."

Based on these findings, the article makes the following recommendation:

"Given the widespread availability, awareness, and use of ENDS by millions of consumers,
ENDS should not be marketed until adequately tested and regulated by the FDA."

In a press release accompanying the article, David Abrams, PhD, Executive Director of the Schroeder Institute at Legacy and senior author of the paper, encouraged smokers to use all kinds of pharmaceutical products other than electronic cigarettes, stating: "Until adequate research and regulation is in place, smokers should be wary of using e-cigarettes, and smokers who want to quit should, instead, pursue research-proven effective cessation tools, such as nicotine replacement products, telephone quit lines and Web-based cessation services, as well as non-nicotine pharmacotherapies like bupropion and varenicline."

The Rest of the Story

There are three major findings of this new paper:

1. Many smokers are now very aware of the existence of electronic cigarettes as an alternative to smoking tobacco cigarettes and a substantial proportion of smokers (11%) has used electronic cigarettes. Approximately 4.1% of current smokers are currently using electronic cigarettes, which translates into about 1.8 million smokers using the product.

2. Very few neversmokers appear to be using the product.

3. Smokers who use the product appear to have a greater interest in quitting smoking.

This study therefore confirms the findings of previous research which has found that electronic cigarettes are a growing phenomenon among smokers, that use is very low among nonsmokers, and that smokers are largely using the product as a safer alternative to smoking tobacco cigarettes and as a means to cut down on the amount they smoke or to attempt to quit altogether.

Based on the findings of the study, the paper concludes that ENDS should not be marketed until adequately tested and regulated by the FDA. Since these products have not been regulated by the FDA (and any regulations could not possibly be put in place before about 2 years), the paper is thus calling for the discontinuation of e-cigarette marketing, which is essentially a call for a ban on the sale of electronic cigarettes.

Strikingly, this conclusion has nothing to do with any data presented in the paper. In fact, if anything, the data actually presented in the paper point to the promise of electronic cigarettes as a harm reduction strategy in tobacco control. The popularity of the product speaks to its likely usefulness to smokers in keeping away from tobacco cigarettes. If the product were not useful, its popularity would not be growing as it is. The study also confirms previous findings that e-cigarettes are primarily being used by smokers as either a safer alternative to tobacco cigarettes or as a strategy for reducing or eliminating tobacco cigarettes.

All of these findings, taken together, suggest that electronic cigarettes have great promise as a harm reduction and smoking reduction/cessation strategy. Of course, FDA regulations are necessary and would help to ensure that these products are as safe as possible and that quality control standards and other safety measures are adhered to, as well as that youth cannot access these products.

However, there is nothing in the findings of the paper that speaks to the need to take the product off the market because of safety concerns or demonstrated hazards.

It may therefore strike some readers as curious that the paper draws this striking conclusion. The conclusion is striking, by the way, not only because it has nothing to do with the study findings, but because it runs afoul of the law. The District Court for D.C. has already ruled (and the FDA has accepted its decision) that the FDA cannot regulate electronic cigarettes as drug-delivery devices in the absence of therapeutic claims. Thus, this paper is calling on the FDA to do something (halt the marketing of electronic cigarettes) which it has no legal authority to do.

Equally striking is the recommendation of the paper's senior author that smokers trying to quit not use electronic cigarettes but try every drug under the sun (nicotine replacement therapy, buproprion, Chantix, etc.). This is an odd recommendation because these drug products have dismal success rates: less than 8% long-term.

Even odder is the implied recommendation that smokers who have successfully quit  using electronic cigarettes stop using their e-cigarettes and make an attempt to stay quit using NRT or drugs, something which is very unlikely to be successful. Most electronic cigarette users acknowledge that taking these products off the market would most likely lead to their returning to cigarette smoking, not to their maintaining themselves smoke-free using NRT or other drugs.

Despite the striking lack of connection between the study conclusion and its actual findings, and despite the strange recommendation - coming from public health practitioners - that ex-smokers who are successfully staying off cigarettes by virtue of e-cigarettes should discontinue their e-cigarette use and risk returning to smoking, a presumably hidden fact which is not disclosed in the article may help explain the study conclusion and recommendations.

Specifically, the senior author of the paper has a significant financial conflict of interest by virtue of his previous grant funding from a number of pharmaceutical companies. Dr. Abrams has received grant funding from multiple pharmaceutical companies that have investigated or manufactured smoking cessation drugs, including Eli Lilly, Dupont Merck, Glaxo-Wellcome, SmithKline Beecham, Sano Corporation, Bristol-Myers Squibb, Knoll Pharmaceuticals, and Pfizer. Dr. Abrams also reports having served as a senior scientific advisor for Johnson & Johnson. It is difficult to find a pharmaceutical company involved in smoking cessation drugs that Dr. Abrams has not had an association with over the years.

This is not to criticize him; the research has made important contributions. It is simply to make note of the financial conflicts of interest that are present with respect to his views on electronic cigarettes, a major threat to the profits of these very same pharmaceutical companies. I believe that these conflicts of interest should be readily disclosed in the paper.

The rest of the story is that:

1) the article draws a major conclusion which lacks supportive evidence and which has no relation to the findings actually reported in the paper;

2) the paper advances a piece of medical advice which is ill-chosen and could be harmful to many people; and

3) that both of these problems appear in the setting of substantial financial conflicts of interest which are not readily disclosed.

Friday, July 20, 2012

Ethical Breach in Sleep Bruxism Study also Destroyed its Scientific Credibility

Yesterday, I discussed a new study published in the July issue of Tobacco Control which reports the results of a randomized controlled trial designed to study the relationship between secondhand smoke exposure and sleep bruxism in children. I argued that the study violated ethical principles of research conduct because parents in the control group were instructed to continue smoking in the presence of their children (while parents in the intervention group were instructed to stop smoking in the presence of their children).

Today, I comment further on why the study was unethical and I explain why this serious ethical breach also destroyed the study's scientific credibility.

The Ethical Breach

As I noted yesterday, the Helsinki declaration emphasizes that an effective intervention (or treatment) cannot be denied to human research subjects unless it is associated with only a small increase over minimal risk. Clearly, the withholding of any treatment for the control group in this study represented a large increase over minimal risk. Even the study authors acknowledge this critical point. Thus, the study violated the Helsinki declaration.

But it gets even worse. What was the intervention delivered to research subjects that according to the study, resulted in the removal of secondhand smoke exposure for children in that group? It was simply instructing the parents not to smoke around their children. If reducing secondhand smoke exposure is as simple as instructing parents not to smoke around their children, then it becomes even more of an ethical breach to withhold this very simple intervention from the control group.

The Rest of the Story

The breach was more than just an ethical one. It also resulted in the destruction of the scientific integrity of the study. Let me explain why.

Recall that the authors of the study defended the protocol by noting that after randomization, 27 families refused to participate in the study. Many families randomized to the intervention group withdrew from the study because they did not feel they would be able to refrain from smoking in the presence of their children. And many families randomized to the control group withdrew from the study because they were concerned about the risks of secondhand smoke and did not want to continue to expose their children to these risks.

Therefore, what remained in the control group were parents who were not particularly concerned about the risks of secondhand smoke exposure and who had no interest in reducing or eliminating their children's exposure. The investigators themselves acknowledge that every parent remaining in the control group met this "criterion": "All the parents of group 2 remaining in the trial were those who reported not being able to reduce children's exposure to SHS." 

Given that there were only 107 families in the study, the withdrawal of 27 families who recognized that the study was unethical represents a huge proportion of the eligible sample.

What this means is that the randomization was destroyed. This was not a randomized study, as the paper claims. Instead, it was essentially a self-selecting study where two very different groups of families were obtained. In fact, they couldn't have been more different. One group was very concerned about the health of their children and wanted to reduce their children's exposure to secondhand smoke. The other group was apparently not that concerned about the health of their children had no desire to reduce their children's exposure.

In other words, in purporting to examine the effect of secondhand smoke on the elimination of sleep bruxism in children, what the study actually investigated was the role that parental concern over child health plays in eliminating sleep bruxism.

It may well be that the higher rate of reduction of sleep bruxism in the intervention group was not due to reduction of secondhand smoke exposure, but to the fact that these parents were more concerned about their children's health and may have intervened in other ways to try to help their children overcome the problem of sleep bruxism. Parents in the control group likely did much less to work with their children to eliminate bruxism.

Given this plausible alternative explanation for the observed study findings, I believe that the study conclusions are invalid.

The rest of the story is that this study should not have been published, not only because the research violates basic ethical principles of research conduct but because the study has no scientific validity.

Thursday, July 19, 2012

New Study Violates Ethical Principles by Asking Parents to Expose their Children to Secondhand Smoke; Study Should Not Have Been Approved or Published

A new study published in the July issue of Tobacco Control reports the results of a randomized controlled trial designed to study the relationship between secondhand smoke exposure and sleep bruxism in children. Sleep bruxism is a condition in which individuals grind or clench their teeth during sleep, which can lead to jaw muscle fatigue, pain, and tooth wear. The objective of the study was to determine whether secondhand smoke exposure is a cause of sleep bruxism in children.

The study subjects were 498 white children, recruited from schools in Naples, Italy. Children were examined for sleep bruxism and parents were asked to report how often they smoked in the presence of the child. Children who exhibited sleep bruxism and were exposed to secondhand smoke were then randomized into two groups.

According to the study:

"The smoking members of the families in group 1 were asked not to smoke in the presence of the child for a period of 6 months, while those in group 2 were asked not to change their smoking habits."

After 6 months, 38% of the children in group 1 exhibited sleep bruxism, while 90% of the children in group 2 still exhibited sleep bruxism. Based on these results, the paper concludes that secondhand smoke exposure is a cause of sleep bruxism in children.

According to the article, the study was approved by the Ethics Committee of the Second University of Naples.

The Rest of the Story

This study violates basic ethical principles of research conduct because it exposes children to unreasonable and unnecessary risks, intentionally encourages parents to put their children at risk, and fails to incorporate alternative methods that would reduce these risks.

According to the Helsinki declaration: " In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests."

Furthermore, the Helsinki declaration states that:

"The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances:
  • The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or
  • Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option."
In the present study, children in group 1 were provided with an intervention to reduce their exposure to secondhand smoke: parents were asked not to smoke in the presence of their children. Children in group 2 were not provided with any treatment. According to the Helsinki declaration, this would have been acceptable only if: (1) there was no treatment available; or (2) children receiving no treatment would not be subject to any risk of serious harm. Neither of these conditions are met.

Furthermore, this study goes beyond simply providing no treatment to the children in group 2. Instead of simply observing these children over time, the study protocol called for "asking" the parents not to change their smoking habits.

In other words, the investigators knowingly and intentionally placed the children in group 2 at significant risk of health damage. The paper itself acknowledges that: "Exposure to secondhand smoke (SHS) represents a serious public health threat, remaining a preventable cause of morbidity among children. Adverse health effects have been found in children exposed to SHS, including increased risk of pneumonia, bronchitis, respiratory illness, wheezing, middle ear effusions, otitis media and cardiovascular damage."

Thus, the children in group 2 were intentionally and knowingly put at increased risk of pneumonia, bronchitis, respiratory illness, wheezing, middle ear effusions, otitis media and cardiovascular damage for the purpose of having a group in which secondhand smoke exposure was persistent for six months, to allow the investigators to compare the effects of removing secondhand smoke exposure with the effects of continuing that exposure.

In other words, the children in group 2 were placed at significant risk. This is not acceptable.

In the United States, the federal regulations on the protection of human subjects (section 46.406a) would have allowed this research to be conducted on minors only if: "The risk represents a minor increase over minimal risk." This condition is clearly not met, as the risks of pneumonia, bronchitis, respiratory illness, and cardiovascular damage are a major increase over minimal risk.

Moreover, there was an alternative procedure available that would have provided the same scientific knowledge without putting children at substantially more than minimal risk. The investigators could have encouraged all parents not to smoke around their children and then followed all the children over time as a single group. Then, they could have assessed changes in secondhand smoke exposure and related those changes (or lack of changes) to the persistence or disappearance of sleep bruxism.

It is important for me to emphasize that there is no justification for the investigators asking parents to continue to smoke in the presence of their children. 

Because this research violates the Helsinki declaration and because it also violates the U.S. federal regulations on the protection of human subjects, I do not believe that the journal should have published the paper. The journal, as a policy, will only publish research that conforms with the Helsinki declaration. This policy appears to have been violated in this case.

A commentary published simultaneously in the July issue of Tobacco Control expresses similar concerns about this study's violation of ethical principles, arguing that the study "contravenes the Helsinki declaration."

In the commentary, Barrientos-Gutierrez et al. state that: "Preventing family members from stopping smoking and actively seeking children to be exposed to a dangerous pollutant is reckless, as the benefits of knowing if SHS is a risk factor for bruxism cannot overcome the dangers of exposing children to SHS or the benefits of quitting."

They conclude: "Considering children's high vulnerability and inherent risks from SHS, we cannot think of a single research question that could justify actively seeking exposing children to SHS or preventing parents from stopping smoking to provide a healthier environment for themselves and their families."

In the same issue, the authors of the study respond to this commentary. Rather than acknowledge that they made a mistake, they instead defend the study. But in defending the study, they deliver a definitive knock-out blow to their argument that the study was ethical. They point out that after being randomized to group 2, a number of the families dropped out of the study, refusing to participate because: "aware of the risks of SHS, [they] decided to reduce it and therefore did not participate."

If the subjects themselves realized that they were being put at undue risk by agreeing to participate in the study, then it is quite clear that this research was unethical. In fact, after a number of families refused to participate because of the risks to which they were being asked to be exposed, the IRB should have been informed and the study should have been halted.

The authors go on to justify their research by noting that "all of the parents of group 2 remaining in the trial were those who reported not being able to reduce children's exposure to SHS." This is an unacceptable argument. A feeling that one is not able to take a particular action is no justification for investigators putting the children of those subjects at risk and failing to deliver any intervention to encourage those parents to quit, reduce their smoking, or not smoke in the presence of their children.

Let me provide an analogy to show how unacceptable these arguments are. Suppose researchers wanted to determine whether crack cocaine use during pregnancy causes infant health effects. The investigators recruit a group of pregnant crack cocaine users and randomize half of them to stop using crack cocaine. The other half of the subjects are randomized to a group that is instructed not to stop using crack cocaine.

A concerned physician at the hospital writes to the investigators asking how this study can be allowed to proceed. The investigators respond by arguing, first, that there is no ethical problem because after being randomized to the continued use of crack group, subjects are free to withdraw from the study if they don't want to put their fetuses at risk of harmful health effects.

This argument is ridiculous, because we don't protect human subjects by giving them the option of withdrawing from a study if they don't want to assume health risks that are unreasonable.

Second, the researchers argue that the subjects in the group randomized to continue crack cocaine use were not confident about their ability to stop using. This argument fails because the lack of self-efficacy in a human subject should not be used as an excuse to put that individual at risk. In fact, these subjects are a particularly vulnerable group that needs most to be protected from risk.

While I was disappointed to see that the authors defended their research, the most disappointing part of the story was that the journal stood by its decision to publish the paper. Apparently, the journal felt it was doing a service by publishing commentaries about the ethics of the study and a response from the study authors. But that is not sufficient. If the study was unethical and violated basic ethical principles of ethical conduct, then it should not have been published. Publishing a study in which pregnant women were encouraged to continue smoking crack cocaine would not be justified by the journal publishing commentaries about the ethics of the study in the same issue.

Wednesday, July 18, 2012

New York Times Reports that FDA Spied on Agency Scientists Who Disagreed with Established Positions and Tried to Quell Collaboration Between Dissenters

According to a July 14 article in the New York Times, the Food and Drug Administration (FDA) spied on a number of agency scientists who expressed disagreement with established agency positions by secretly capturing their emails, analyzing them, tracking their computer keystrokes in real-time, and creating directories of communications organized by the names of sympathetic public officials with whom they were communicating.

According to the article: "A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and even President Obama, previously undisclosed records show. ... What began as a narrow investigation into the possible leaking of confidential agency information by five scientists quickly grew in mid-2010 into a much broader campaign to counter outside critics of the agency’s medical review process, according to the cache of more than 80,000 pages of computer documents generated by the surveillance effort. Moving to quell what one memorandum called the “collaboration” of the F.D.A.’s opponents, the surveillance operation identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and “defamatory” information about the agency." ...

"The agency, using so-called spy software designed to help employers monitor workers, captured screen images from the government laptops of the five scientists as they were being used at work or at home. The software tracked their keystrokes, intercepted their personal e-mails, copied the documents on their personal thumb drives and even followed their messages line by line as they were being drafted, the documents show.
The extraordinary surveillance effort grew out of a bitter dispute lasting years between the scientists and their bosses at the F.D.A. over the scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation. A confidential government review in May by the Office of Special Counsel, which deals with the grievances of government workers, found that the scientists’ medical claims were valid enough to warrant a full investigation into what it termed “a substantial and specific danger to public safety.”" ...

"While federal agencies have broad discretion to monitor their employees’ computer use, the F.D.A. program may have crossed legal lines by grabbing and analyzing confidential information that is specifically protected under the law, including attorney-client communications, whistle-blower complaints to Congress and workplace grievances filed with the government." 

The Rest of the Story

While the FDA claims that these efforts were intended only to prevent the release of confidential, proprietary information, it seems quite clear that the scope of the agency's spying efforts goes way beyond that narrow aim. The number of scientists who were monitored, the nature of the spy effort (including intercepting emails and tracking keystrokes in real-time), and the analysis of information that is protected under whistle-blower  laws all indicate that the agency far exceeded its discretionary authority.

The most concerning aspect of the story is that it exposes an attempt on the part of the FDA to quell dissent by intimidating scientists from expressing disagreement with agency decisions that they felt put the safety of public at risk. In fact, an independent review confirmed that the concerns of these scientists about the approval of devices that exposed patients to dangerous levels of radiation were warranted: these devices represented “a substantial and specific danger to public safety.”

The integrity of science depends on the ability of scientists to express disagreement. In fact, most of the great scientific advances have come from scientists who have been willing to challenge conventional thinking. Quelling dissent destroys the integrity of the scientific process and ensures that agency decisions will be made on political, rather than scientific grounds.

Tuesday, July 17, 2012

States May Default on Tobacco Bonds if Cigarette Consumption Continues to Fall; Master Settlement Agreement is Working As Intended to Protect Tobacco Profits

The Attorneys General of 46 states which signed the Master Settlement Agreement ought to be congratulated for their efforts to protect tobacco profits. By permanently tying the solvency of state budgets to continued high levels of cigarette sales, the state AGs have done more to protect cigarette profits than anyone could imagine of public officials.

This reliance of state fiscal solvency on tobacco sales is illustrated beautifully by a San Francisco Chronicle article from last Thursday, which reports that a number of states may default on their tobacco bonds if cigarette consumption continues to decline. At very least, these states may need to draw on reserve funds, which pushes them into a tighter budget situation.

According to the article: "The declining number of U.S. smokers is proving hazardous to the health of municipal bonds backed by payments from cigarette companies under a 1998 settlement with 46 U.S. states, Moody’s Investors Service said. The rating company projected that almost three-quarters of the $20.4 billion in tobacco bonds it grades will default if cigarette consumption declines 3 percent to 4 percent annually. ... Payments by Altria Group Inc.’s Philip Morris unit, Reynolds American Inc. and Lorillard Inc. to states under the settlement back $101.5 billion of bonds, according to data compiled by Bloomberg. ... Cigarette use fell 9.2 percent in 2009 and 6.4 percent in 2010, according to Janney Montgomery Scott LLC, a Philadelphia- based brokerage. ... Virginia, California and Nassau County, New York, may use reserve funds to pay debt service on three tobacco-bond issues from 2006 and 2007, Mesirow said in May. ... Moody’s projected that 33 percent of the tobacco bonds it rates can’t withstand annual consumption declines of 2 percent to 3 percent, while 41 percent of the debt couldn’t handle declines of 3 percent to 4 percent."

The Rest of the Story

Out of their greed for political and economic gain, the Attorneys General have done a tremendous service for the tobacco companies. They have created a financial partnership between their states and Big Tobacco, by which the fiscal solvency of the states depends on continued high levels of cigarette consumption. They have destroyed the incentive for states to take any action that might substantially reduce cigarette use.

This explains why so few states are running effective tobacco control programs, why so few states are allocating their MSA money to anti-tobacco programs, and why Congress (aiming to protect the states they represent) crafted tobacco legislation that does very little to actually make a dent in cigarette consumption, contrary to what the FDA Commissioner touted in her op-ed last week.

Not only is the Tobacco Act working perfectly, as I reported yesterday, to protect cigarette consumption, but the Master Settlement Agreement is also working - as intended - to protect cigarette sales.

Not only do these state and federal actions protect cigarette sales, but they discourage the promotion of safer alternatives to cigarettes, such as electronic cigarettes, which could potentially put a dent in cigarette sales. Thus, it is perhaps no surprise that policy makers have been so reluctant to embrace this potentially life-saving technology.

Monday, July 16, 2012

FDA Commissioner Says Tobacco Act is Working to Reduce Youth Smoking; However, Not a Single Measure Cited is Effective

Last Thursday, FDA Commissioner Margaret Hamburg published a self-congratulatory op-ed which argued that the Tobacco Act is working and that the FDA's actions to date under the Act have been effective in helping to prevent youth smoking.

In this Reuter's op-ed column, Hamburg wrote: "Three years ago, President Obama signed the Family Smoking Prevention and Tobacco Control Act into law. ... Today, I am pleased to report that the law is working. In passing the Tobacco Control Act, Congress recognized that the linchpin of any successful strategy to reduce adult tobacco use must be to prevent young people from ever starting. ... Reversing this trend requires aggressive action on two fronts: reducing the attractiveness of tobacco products to children and ending their access to them. That's exactly what the FDA is doing."

Hamburg cites seven FDA actions that she claims have been effective.

"During our first 12 months of regulating tobacco, the FDA pulled candy and certain other flavored cigarettes off the market; issued tough new regulations to halt sales of cigarettes, cigarette tobacco, and smokeless tobacco to young people; banned brand-name sponsorship of sporting events and concerts; and implemented requirements for new warning labels for smokeless tobacco products. The FDA also has begun funding state authorities to assure vigorous enforcement of these new actions to protect our children. ... the FDA is enforcing the prohibition on misleading labeling and advertising claims, and ... tobacco companies are required to report the quantities of harmful or potentially harmful chemicals in the products they make. The FDA also is requiring graphic health warnings on cigarette packages and ads."

The op-ed concludes: "Much has been done since that day three years ago when the Tobacco Control Act was signed into law by the president in the White House Rose Garden. To the FDA, these achievements represent a solid foundation to build on."

The Rest of the Story

Let's analyze each of the seven actions that the FDA claims has been effective in reducing youth smoking or otherwise protecting the public's health. For each action, I'll grade it (on a scale of A-F) in terms of its effectiveness in protecting the public's health by either reducing youth smoking, promoting smoking cessation, or reducing the toxicity of cigarettes:

1. Pulling candy and certain other flavored cigarettes off the market.

What the FDA Commissioner did not tell us is that the so-called flavored cigarettes taken off the market represented only about 0.1% of the market, that almost no youth were smoking these types of cigarettes, and that not a single Big Tobacco brand was taken off the market as a result of the law. In fact, there is no evidence that the candy-flavored cigarette ban prevented a single youth from starting to smoke.

In contrast, the FDA's "action" spared menthol cigarettes, which are the one flavoring that actually is being smoked by youth. In fact, more than half of youths smoke menthol cigarettes. And although it has been more than a year since the expert panel issued its report to FDA concluding that a menthol ban would benefit the public's health, the FDA has taken no action.

This action has had no appreciable effect on youth smoking.

Grade: F

2. Issuing tough new regulations to halt sales of tobacco products to young people.

The scientific literature shows that youth access regulations have no effect on youth smoking. In fact, fewer than half of youth smokers obtain their cigarettes by purchasing them. So even if sales to minors were reduced to zero, it still would not prevent youth from smoking, as there are multiple other sources of cigarettes.

This action has had no appreciable effect on youth smoking.

Grade: F

3. Banning brand-name sponsorship of sporting events and concerts.

While this is a laudable action, the Master Settlement Agreement had already put substantial restrictions on sponsorships of sporting events and concerts. Thus, this restriction has had minimal effects on youth smoking.

Grade: C-

4. Funding state authorities to assure vigorous enforcement of youth access laws.

As above, the scientific literature shows that youth access regulations have no effect on youth smoking. In fact, fewer than half of youth smokers obtain their cigarettes by purchasing them. So even if sales to minors were reduced to zero, it still would not prevent youth from smoking, as there are multiple other sources of cigarettes.

This action has had no appreciable effect on youth smoking.

Grade: F

5. Enforcing the prohibition on misleading labeling and advertising claims.

The Department of Justice lawsuit had already resulted in a prohibition on misleading labeling and advertising claims. The FDA's actions add an enforcement component; however, only a handful of very small companies have violated this prohibition, so the effects of this action are minimal.

Grade: D

6. Requiring tobacco companies to report the quantities of harmful or potentially harmful chemicals in their products.

As I have argued previously, this requirement is a complete waste of time and does nothing to protect the public's health.

It must be remembered that there are between 10,000 and 100,000 chemicals in tobacco smoke, most of which have not yet been identified. Most likely, the majority of hazardous chemical constituents of tobacco smoke have not yet been identified. It is naive to think that by controlling levels of certain of these 20 selected chemicals, one can control the level of risk posed by different brands of cigarettes.

The entire strategy makes no scientific sense, is not founded in any scientific evidence base, is misleading and deceptive at the core, and represents a tremendous waste of time and resources. This is regulation for regulation's sake, and there is no public health benefit of these regulations. If anything, it is a huge distraction from the types of public health efforts that are actually needed to effectively address the problem of tobacco-related morbidity and mortality.

So in my view, the Secretary of Health and Human Services is deceiving the American public when she states that: "Today’s actions [the issuing of guidances on modified risk tobacco products and harmful constituents] represent critical steps forward on providing Americans with the facts about the dangers of tobacco use and to stop children from smoking."

Neither of these actions will do anything to help provide Americans with the facts about the dangers of tobacco use, nor will they do anything to stop children from smoking.

That the Department of Health and Human Services and the FDA see these actions as representing "significant" actions to "address the tobacco epidemic" is gravely worrisome.

Grade: F

7. Requiring graphic health warnings on tobacco product packages and ads.

I have written extensively on why graphic warning labels will have only a minimal impact on smoking. There is a substantial body of evidence to suggest that these warnings will not be effective in deterring either youth or adults from smoking. Moreover, the FDA's proposed warnings likely violate the First Amendment by compelling manufacturers to urge their customers not to purchase their products. This goes beyond a factual warning and thus requires a higher level of scrutiny under the commercial free speech rulings of the Supreme Court, which this regulation cannot withstand.

Grade: D


Overall, not a single one of these actions has had, or will have any substantial effect on improving the public's health by either preventing youth smoking, promoting adult smoking cessation, or reducing the health risks of cigarettes. This is hardly a "solid foundation" to build on.

The rest of the story is that after three years, the Tobacco Act has accomplished nothing.

I do agree with the Commissioner on one point: The Tobacco Act is working. It is working as intended. And that intention was to make it look like the law would protect the public's health without actually taking any of the difficult actions necessary to really put a dent in cigarette sales. The law was intended to allow public health groups and politicians to be able to score political and financial points from their constituents by telling them that they were standing up to Big Tobacco, when in fact, they were actually standing shoulder-to-shoulder with Big Tobacco in crafting a law that would only have the appearance of protecting the public's health.

So after three years, the law is working precisely as intended.

Thursday, July 12, 2012

British Medical Association Suspends Membership of Physician for Questioning the Validity of a Secondhand Smoke Claim -- A Claim Which the BMA Itself Admits Was Incorrect

Yes, you read that headline correctly. The British Medical Association (BMA) has suspended the membership of a physician who, on a radio talk show, criticized the BMA for disseminating to the public what he believed was inaccurate data on the danger of secondhand smoke exposure in cars. And the BMA acknowledges that the physician was indeed correct and that the BMA's claim was a false one.

According to an article in The Pulse: "A retired GP has been suspended from the BMA Welsh Council until 2014 after he questioned the evidence behind the BMA's campaign to ban smoking in vehicles on BBC Radio. Dr Brendan O'Reilly, a retired GP, has also had his BMA membership suspended until he provides ‘an acceptable written apology' to four named BMA members, including Dr Vivienne Nathanson, head of the BMA science and ethics committee. In a hearing held yesterday a BMA Council panel said they considered Dr O'Reilly's language when describing his opposition to the BMA's use of statistics on the risks of passive smoking in cars as ‘unacceptable'. But Dr O'Reilly said he was being ‘harangued' by the BMA for simply expressing a difference of opinion." ...

"Among figures questioned by Dr O'Reilly was a statistic that children in cars are exposed to 23 times more toxins than people in a smoky bar. In its determination, the BMA admitted it did, at a later stage, have to publicly revise some of the data in its briefing paper Smoking in Vehicles. But it said Dr O'Reilly's use of the term manipulation was ‘detrimental to the honour and interest of the BMA'. The panel also said it found ‘unacceptable' a comparison made by Dr O'Reilly between ‘the statement of Dr Vivienne Nathanson and the dossier that allegedly led to the Iraq War'. The panel said in identifying himself as a member of BMA Wales Council he should have ‘conducted himself in accordance with the duties expected of a member'." ...

"'BMA members should be able to debate differences in opinion without being threatened or harangued for doing so,' he [O'Reilly] added. ‘There is a massive issue here about free speech.'"

The Rest of the Story

The false statistic that was included in a BMA briefing paper - the claim that level of secondhand smoke in cars are 23 times higher than in a smoky bar - was the subject of an in-depth exploration in an article published in the Canadian Medical Association Journal by two tobacco control scientists. In that article, the authors found no substantiation for the claim. While still supporting the policy of banning smoking in cars, they wrote: "We traced the evolution of this “myth turned fact” to emphasize that only credible evidence should be presented to advance policy. Solid evidence has been the foundation of the progress made in tobacco control in recent decades. The biggest danger of inaccurately interpreting research on smoking in cars for the sake of a snappy media sound bite is to lose favour with an overwhelmingly supportive public and to provide ammunition for opponents of tobacco control."

After the error was revealed, the BMA acknowledged the mistake and issued a retraction:

"Please note, there is an error in the BMA briefing paper: Smoking in vehicles. On page 4, in the 3rdparagraph, the following sentence is incorrect: “Further studies demonstrate that the concentration of toxins in a smoke-filled vehicle is 23 times greater than that of a smoky bar, even under realistic ventilation conditions”. THIS SENTENCE HAS BEEN REPLACED WITH: "Further studies demonstrate that the concentration of toxins in a smoke-filled vehicle could be up to 11 times greater than that of a smoky bar”. We apologise for this error."

On the radio show, Dr. O'Reilly apparently criticized the BMA for exaggerating the exposure levels to secondhand smoke in cars and compared the dissemination of inaccurate information to support its position with President George Bush's false claims that Iraq harbored weapons of mass destruction in order to engender public support for an invasion of that country. Dr. O'Reilly apparently did note that he was a member of the BMA, but did not claim to be representing the organization in his comments.

While the BMA might have valid grounds for suspending Dr. O'Reilly if he misrepresented himself as speaking in the name of the BMA, that does not appear to be the case. Instead, it appears that he simply noted that he was a BMA member. If that is indeed the case, then the BMA's action is quite troublesome because it means that they have essentially kicked him out of the organization for expressing an opinion with which they disagree.

Actually, they don't even disagree with the crux of the opinion - that the organization had disseminated false scientific information. But they apparently did not like the way he conveyed that information - comparing it to George Bush's false claims about the status of weapons of mass destruction in Iraq.

While I don't believe there was any need to make or validity to, a comparison of the "23 times greater" mistake with the lies about weapons of mass destruction in Iraq that led to a war which killed thousands, I don't see how a medical association can expel a member simply for expressing his opinion, even if that opinion represents dissent from the official views of the organization.

This does appear to represent a violation of free speech and an attempt to quell dissent through a form of censorship.

Readers of the Rest of the Story will recognize that Dr. O'Reilly's experience in being expelled from the BMA is similar to my own experience. I was expelled from a number of tobacco control list-serves for expressing dissenting opinions. Interestingly, the opinions which most directly led to my expulsions were also criticisms of exaggerated facts about secondhand smoke.

It appears that secondhand smoke claims are a sacred sacrament in the tobacco control movement and that you absolutely can't criticize them. Doing so represents heresy and you must be ex-communicated from the movement on the spot.

Wednesday, July 11, 2012

Appeals Court Invalidates NYC Graphic Anti-Smoking Poster Law; Shows Why Campaign for Tobacco-Free Kids Negotiation of Tobacco Act Was a Travesty

Yesterday, the U.S. Court of Appeals for the Second Circuit upheld a federal district court's ruling that invalidated New York City's requirement that graphic, anti-smoking posters be displayed at the point-of-sale in all retail cigarette outlets.

So how does that demonstrate why the Campaign for Tobacco-Free Kids negotiating the Tobacco Act was a travesty? To understand that, I need to present some background.


In 2010, a federal judge invalidated New York City's ordinance which would have required the display of graphic, anti-smoking posters anywhere cigarettes are sold. The law was struck down because it violates the preemption clause in the Federal Cigarette Labeling and Advertising Act (FCLAA), which preempts state and local regulation of the advertising and promotion of cigarettes.

The Campaign for Tobacco-Free Kids responded with a press release arguing that the federal judge is "wrong on the law" because the proposed law regulates the sale of cigarettes, not their advertising or promotion.

According to the press release, entitled "Federal Court Is Wrong on the Law in Striking Down New York City's Requirement for Tobacco Health Warning Signs in Stores": "We believe that a federal judge was wrong on the law in striking down New York City's requirement that all businesses selling tobacco products post tobacco health warning signs. New York City acted lawfully to more effectively inform consumers about the health risks of tobacco use, and we urge the City to appeal. The judge ruled today that New York City's requirement is preempted by the Federal Cigarette Labeling and Advertising Act, which restricts the authority of states to regulate tobacco advertising and promotion. However, this ruling fails to recognize that New York City established the signage requirement as part of its regulation of the sale — not the advertising or promotion — of tobacco products, which is permitted by federal law. The new federal law enacted in June 2009 that grants the U.S. Food and Drug Administration authority over tobacco products explicitly protects the rights of states and localities to regulate the terms and conditions of tobacco sales. Contrary to today's ruling, New York City's regulation does not restrict the advertising or promotion of tobacco products."

This is an important statement, because it demonstrates that the effect of the Tobacco Act depends heavily upon whether the Campaign for Tobacco-Free Kids correctly understood and interpreted the law with regards to federal preemption of local tobacco regulation. The Campaign took it upon itself to negotiate the Act with Philip Morris, without involvement of the rest of the tobacco control community. In these secret, back-room negotiations, the Campaign made all of the decisions and took the future of local tobacco control regulation into its own hands.

Critically, any mistakes in understanding and interpretation of the law by the Campaign could result in devastating consequences for the future of tobacco regulation in the United States. 

The Rest of the Story

On January 27, 2011, I responded to the Campaign for Tobacco-Free Kids' argument with the following counter-argument:

The Federal Cigarette Labeling and Advertising Act (FCLAA) states that: "No requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of this chapter." (15 U.S.C. §1334)

The key phrase here that needs to be interpreted in light of New York City's proposed law is "with respect to."

The Campaign for Tobacco-Free Kids would have us construe "with respect to" in the most narrow possible way. The Campaign is arguing that the requirement for graphic anti-smoking posters is merely a restriction on the sale of cigarettes and does not affect the promotion of cigarettes in any substantial way that would invoke the preemption clause. The judge, however, found that such a construction of the term "with respect to" is too narrow.

Let me explain why I think the Campaign for Tobacco-Free Kids is the one who is wrong on the law and why I think that any restriction which substantially impacts the promotion of cigarettes, even if primarily intended as a restriction on cigarette sales, runs afoul of the "with respect to" meaning and therefore must be viewed as being preempted by federal law.

The clear intention of the graphic, anti-smoking posters is not simply the provision of scientific information or facts. One look at the intended images will convince anyone that the purpose of these posters is to discourage the purchase of cigarettes. In other words, this is all about requiring an anti-promotional display. It is intended to counter the promotion of cigarettes, or more accurately, to require cigarette retailers to counter their own promotion of cigarettes. There is no question that these required posters undermine the promotion of cigarettes by the store.

Thus, at its core, this regulation is not about regulating the sale of cigarettes. It is about regulating the promotion of cigarettes to the public.

Suppose that a city decided to require the display, at point of sale of cigarettes, of a six-foot poster with the text of the Surgeon General's warnings. Based on the Campaign's interpretation of the law, such a requirement would not be preempted because it is regulating the sale of cigarettes, not the advertising or labeling of these products. But such a provision would clearly be preempted by FCLAA because it is essentially requiring huge warning labels to be displayed at the point of sale. Only the federal government has the authority to regulate cigarette warning labels.

My point is that the mere fact that a regulation is intended to control the conditions under which cigarettes can be sold does not mean that the regulation is not being imposed with respect to the advertising and promotion of cigarettes. One must look more broadly at the overall impact of the restriction. If that restriction has a substantial and direct effect on the promotion of cigarettes, then it runs afoul of the preemption provision and is not permitted under federal law.

In this case, the proposed law clearly imposes a requirement regarding the promotion of cigarettes in retail stores. The law must therefore be interpreted as imposing a regulation with respect to the promotion of cigarettes. Such a regulation is preempted by FCLAA.

The city of New York has appealed the District Court judge's decision. Based on my analysis, I do not expect that appeal to ultimately be successful.

The Appeals Court Decision

In upholding the District Court's ruling, the Appeals court wrote: "Plaintiffs argue that it is a requirement with
respect to promotion; defendants argue that it is only a requirement with respect to sale. (Appellees' Br. at 20-21; Appellants' Br. at 24-25). We agree with plaintiffs that the Resolution is a requirement with respect to the promotion of cigarettes. ... By its terms, it affects the display of cigarettes, which is a type of promotion. Specifically, a display is a form of publicity that can further the sale of merchandise. ... Placing a graphic warning adjacent to a product display necessarily affects -- or "treads on," Vango Media, 34 F.3d at 74 -- the content of the image projected and the message conveyed to the consumer by that display. ... requiring a warning sign in close proximity to a cigarette display has practically the same effect as requiring a warning on the display itself, thereby directly affecting the content of the promotional message conveyed to consumers at the point of The display is therefore a form of promotion. Indeed, by the City's own admission, one of the reasons it chose to regulate the point of sale was to "deliver a different message" from that delivered by the cigarette manufacturers and to "counteract tobacco advertising." (Id. at 27; Proposal at 9). Requiring that the manufacturers' message be countered at the point of purchase is surely a form of regulating promotion."

The Consequences of the Co-optation of the Tobacco Control Movement by CTFK

The Campaign for Tobacco-Free Kids has demonstrated that it has a poor understanding of the law. I am not a lawyer, but it was clear to me based on a careful analysis of the facts of the case that the New York City law was preempted by FCLAA because it represented a regulation with respect to the promotion of cigarettes. Had the Campaign allowed the input of other groups and consulted with tobacco control experts throughout the country, it would have been informed of the invalidity of its interpretation of the law, and the Tobacco Act's preemption of local regulations like those attempted in New York City could have been avoided.

The Bigger Picture

When I started my career in tobacco control, it was truly a grassroots social movement. The individuals involved in the movement were largely unpaid volunteers and they were involved because of a deep personal conviction in the cause, motivated by nothing other than a sincere desire to reduce tobacco-related morbidity and mortality. Similarly, the organizations involved seemed to be motivated solely by a desire to reduce tobacco-related disease.

But there was one thing which we didn’t have in the movement: money. Both individuals and organizations worked either as volunteers or on a shoestring budget. Even many of the researchers in the field did their tobacco research on no budget or on a very low budget. There were no multi-million dollar grants for anti-smoking research or interventions.

At the time, many of us (myself included) felt that if only we had money, if only we could establish a huge infrastructure for tobacco control, then we could really have an impact. If only there were a number of well-funded, national organizations devoted to tobacco control. If only there were well-funded national grant-making organizations that could fund research and intervention at the local level. And if only these national organizations would have the money necessary to be able to access the media: that would give us tremendous political power.

Money, we believed, could extend and enhance the grassroots social movement of tobacco control, bringing it to all communities throughout the country.

I will be the first to admit that I was wrong.

Unfortunately, money has resulted in the appearance of one prominent anti-smoking organization – the Campaign for Tobacco-Free Kids – that in my opinion has essentially taken over the entire movement. There simply is no other organization with the level of resources available and thus there is no competition or opposition to anything the Campaign decides to do or to support.

While there could be no single, dominant organization when no one had money, the fact that one group has huge amounts of money and others have little has created a harmful monopoly in the tobacco control infrastructure.

But what makes the situation even worse is that the Campaign has co-opted the grassroots social movement of tobacco control by taking it upon itself to play the role of “official” representative of the tobacco control movement in all major federal policy matters. It was the Campaign that was at the negotiating table during the global tobacco settlement talks, which ultimately resulted in the Master Settlement Agreement. And it was the Campaign that was at the negotiating table during the talks that ultimately resulted in the federal FDA tobacco legislation.

In my opinion, the Master Settlement Agreement is the worst public health blunder of my lifetime. It will be surpassed as the worst blunder as the ill effects of the Tobacco Act are realized in future years. 

Unfortunately, policy makers in Washington seem to have the impression that somehow the Campaign for Tobacco-Free Kids is the representative of the anti-smoking movement. So anything the Campaign approves seems to be viewed – inaccurately -- as representing the endorsement of the public health establishment. It is the Campaign’s self-annointment as the representative for the movement that has enabled two of the worst federal tobacco control policies ever to gain acceptance.

Sadly, the infusion of money into the tobacco control movement has led to the end of the grassroots nature of the movement. Instead, it has resulted in its institutionalization as a money-driven bureaucracy that has little interest in what the grassroots actually think. I simply do not see groups like the Campaign for Tobacco-Free Kids or even the voluntary health agencies really taking the time to listen to their constituencies. They tell their constituencies what to think and what to support. There is no room for dissension or opposition and no interest in engaging the grassroots in the decision-making process.

So rather than being a movement that is driven by the community, through its individual grassroots advocates, the tobacco control movement has become one that is driven by one or two national organizations, without grassroots participation in the decision-making process.

Perhaps most importantly, I think that the “monopolization” of the tobacco control movement has pushed aside or perhaps even undermined the work of true grassroots organizations as well as individuals, working at the community level, leaving them essentially powerless. How can a local advocate or advocacy group play any kind of leadership role when the leadership has been usurped away by one or two national organizations?

So I have to say that I was wrong. The availability of money at the national level has not helped the tobacco control movement. It has hurt it.

While the national money has certainly resulted in some “accomplishments,” in the long run, I think it has resulted in, and will continue to result in greater harm to the tobacco control movement. What I see is the degradation of the movement due to its co-optation by one or two well-funded national organizations, with the loss of integrity and character of the movement and its major organizations, the emergence of a regulation for regulation’s sake mentality, and most importantly, the destruction of the grassroots social movement that achieved tremendous success in the effort to reduce the toll that tobacco takes on the health and lives of Americans.