Thursday, November 29, 2012

New England Journal of Medicine Commentary Argues Against Cigarette Tax Increase Because It Would Save So Many Lives that Payments for Social Security Would Increase

A commentary published yesterday in the New England Journal of Medicine argues against a federal cigarette tax increase because it would save so many lives that tens of thousands of people would live longer, resulting in increased Social Security and Medicare payments years later.

(See: Baumgardner JR, Bilheimer LT, Booth MB, Carrington WJ, Duchovny NJ, Werble EC. Cigarette taxes and the federal budget -- report from the CBO. New England Journal of Medicine 2012; 367:2068-2070.)

The authors, from the Congressional Budget Office (CBO), estimate the effects of a 50 cent per pack increase in the federal cigarette tax on the federal budget over a 70-year period. They find that while health care spending would substantially decrease, this effect would eventually be offset by increases in Social Security and Medicare spending because tens of thousands of people would live longer and thus be eligible for these programs.

The authors conclude that: "By 2035, some 63,000 additional adults would be alive because of the higher cigarette tax. And by 2085 (the final year of the analysis), more than 3 million adults would be nonsmokers because of the policy, including about 200,000 who would otherwise have died earlier."

However, they also find that: "The reduction in federal outlays would total $730 million over the period between 2013 and 2021. During the second decade, however, the effects on longevity would begin to dominate and federal spending would be higher than it would have been otherwise — an effect that would continue through 2085. The two principal drivers of that increase in spending would be Social Security and Medicare. Improvements in longevity from a reduction in smoking tend to have their greatest effect on the size of the elderly population and thus tend to boost spending on programs aimed at that population."

The Rest of the Story

This is one of the most perverse policy analyses that I have ever seen, and it is certainly the most perverse one that I have ever seen published in a medical journal. The authors are actually putting forward the argument that a major consideration in public health policy should be the fact that by saving tens of thousands of lives, a policy may result in increased spending for Social Security and Medicare because people will live longer.

Can you imagine the same argument being put forward regarding an analysis of whether the federal government should require health insurance companies to cover mammography? Would anyone in their right mind advance the argument that we should not require coverage for mammography screening because it would save the lives of thousands of younger women, therefore increasing Social Security spending because they will now live to be 65, rather than dying in their 40s or 50s and thus not becoming a drain on the system?

Should we consider that by requiring insurance companies to cover costly treatments for acute leukemia in children, the federal deficit could be affected because large numbers of children who otherwise would have died will now live long enough to enjoy their senior years and having children and grandchildren of their own?

Should policy makers consider that by instituting flu clinics for senior citizens they may be saving tens of thousands of lives per year, and therefore increasing Social Security and Medicare costs from what they would have been if these seniors contracted the flu and pneumonia and died off?

The fiscal effects of prolonged life on future Social Security and Medicare payments is simply not an appropriate criterion upon which to evaluate public health policies. Decisions about funding Social Security and Medicare must be kept separate from decisions about interventions to improve the public's health. If a public health program results in saving lives and people living longer, than it is the government's responsibility to find methods to raise the revenue necessary to provide Social Security and Medicare payments when these people reach age 65. The decisions must be kept separate.

Interestingly, one does not see the CBO or other groups advancing this same argument for other issues, such as mammography. The argument is almost always reserved for tobacco policies. In fact, the argument was developed by the tobacco industry, which in 2001, advanced the argument that smoking in the Czech Republic had net economic benefits for the economy because smokers die earlier. The report was attacked internationally, forcing Philip Morris to disavow the report and apologize.

The rest of the story is that it is despicable that the Congressional Budget Office believes that it is appropriate to evaluate a public health policy based on whether it might save lives and therefore increase Social Security and Medicare spending. In doing so, the CBO is borrowing a page right out of the tobacco industry's playbook. This type of analysis would never be done for an issue such as mammography, because anyone who advanced such an argument would be raked over the coals.

Like Philip Morris, the CBO should disavow its report and apologize for the argument it advances.

Finally, while it is shameful that the CBO has advanced this argument, it is also shameful that the journal agreed to publish this argument, thus giving it legitimacy. Both the CBO and the journal owe readers and the public an apology.

Wednesday, November 28, 2012

New Study Concludes that Banning Smoking in Cars with Children Would Substantially Reduce Secondhand-Smoke Related Illness

A new study published online ahead of print in the journal Tobacco Control reports measurements of particulate and nicotine levels in cars with smoking occurring. Based on these measurements, the study concludes that secondhand smoke exposure in cars makes up as much as 30% of tobacco smoke exposure for children and that banning smoking in cars with children would dramatically reduce illness.

(See: Northcross AL, Trinh M, Kim J, et al. Particulate mass and polycyclic aromatic hydrocarbons exposure from secondhand smoke in the back seat of a vehicle. Tobacco Control 2012; doi: 10.1136/tobaccocontrol-2012-050531.)

The methods of the study were as followed: "SHS exposures in stationary vehicles with two different window configurations were monitored. A volunteer smoked three cigarettes in a one-hour period for twenty-two experiments. PM2.5, CO, nicotine and PAH where measured in the backseat of the vehicle."

The results were as follows: "We estimate that a child spending only ten minutes in the car with a smoker at the mean PM2.5 concentration measured in the first window configuration −1697 mg/m3 – will cause a 30% increase to the daily mean PM2.5 personal average of a child."

The study concludes: "Reducing SHS exposures in a vehicle would substantially reduce personal exposure for both children and adults. Particularly in the case of children, measures to reduce or eliminate SHS exposure in vehicles could have a  major impact in reducing the risks of SHS-related illness.

The Rest of the Story

There is a significant flaw in the article which renders its conclusion questionable.

The article makes an assumption that is not explicitly stated. The assumption is that smokers who smoke in cars in the presence of their children do not smoke in the home. This is not only a questionable assumption, but it is most likely incorrect.

A parent who smokes in the enclosed environment of a car with his or her child present is most likely not going to refrain from smoking in his or her own home. Chances are that the child is exposed to secondhand smoke not only in the car, but in the home as well.

Since the study assumed that no smoking takes place in the home (it used measurements taken from smoke-free homes in estimating the increased exposure attributable to tobacco smoke exposure in the car), it has grossly overestimated the true fraction of tobacco smoke exposure due to the car compared to the home.

In fact, if one uses the same levels of particulate matter and nicotine as were found in cars in this study and estimates the proportion of overall tobacco smoke exposure for children who live in a home with a smoker, one realizes that the percentage of exposure from the car is only about 2% to 10% of the child's total secondhand smoke exposure.

Although the concentration of secondhand smoke in cars is very high, the duration of exposure in the car is much lower than in the home. Dose is equal to concentration multiplied by duration. Because the duration of exposure in the home is so much greater than in the car, the dose received in the home dwarfs that from the car.

The rest of the story is that for a child exposed to tobacco smoke in a car, that exposure probably accounts for only 2% to 10% of his or her overall tobacco smoke exposure. Between 90% and 98% of that child's exposure to tobacco smoke occurs in the home. For this reason, banning smoking in cars is going to slightly reduce the child's secondhand smoke exposure, but it is unlikely to cause a major reduction in health effects because the child is still heavily exposed to tobacco smoke in the home. A reduction of 2% to 10% is unlikely to substantially reduce the risk of illness due to secondhand smoke.

If anti-smoking advocates want to protect children from the health effects of secondhand smoke, and they feel that banning smoking in private cars is justified, then why are they not also calling on laws to ban smoking in homes with smokers?

Tuesday, November 27, 2012

Campaign for Tobacco-Free Kids Boasts that Master Settlement Agreement Held Tobacco Industry Accountable for Its Deadly Products and Deceptive Actions

In a statement congratulating Senator-elect Heidi Heitkamp (North Dakota) on her election, the Campaign for Tobacco-Free Kids praised her for "protecting her state's kids and health from the tobacco industry" by being a leader in achieving the 1998 Master Settlement Agreement (MSA) between 46 states and the four major tobacco companies.

According to the statement: "In electing Heidi Heitkamp as their next U.S. senator, the voters of North Dakota have chosen a true champion in protecting her state's kids and health from the tobacco industry. The Campaign for Tobacco-Free Kids congratulates Senator-elect Heitkamp on her victory and looks forward to working with her to win the fight against tobacco use, the nation's number one cause of preventable death. As North Dakota's attorney general, Senator-elect Heitkamp was a leader in achieving the 1998 state tobacco settlement, which held the tobacco industry accountable for its deadly products and deceptive actions and restricted some of the industry's most harmful marketing practices."

The Rest of the Story

Far from protecting her state's kids and health from the tobacco industry and holding the tobacco industry accountable for its deadly products and deceptive actions, former Attorney General Heitkamp actually protected the profits of Big Tobacco and released the companies from accountability by leading the efforts to immunize the companies from further lawsuits in return for a hefty monetary payoff.

From the perspective of the tobacco companies, the Master Settlement Agreement was brilliant. The states are now fiscally dependent on a steady stream of cigarette revenues. Any substantial drop in cigarette smoking threatens the state's fiscal situation. Thus, there is no incentive to take any action that will substantially reduce cigarette sales. Perhaps this is why we haven't seen many major anti-tobacco initiatives at the state level since the Master Settlement Agreement was signed. We've seen mostly minor initiatives that dilly dally around the margins, but very few which actually aim to put a major dent in cigarette sales.

Big Tobacco could not have scripted a happier (more favorable) ending to the Master Settlement Agreement saga. If they had sat down and tried to figure out a way to institutionalize tobacco consumption and to find a way to make the states become dependent upon tobacco sales for their economic survival, they could not have come up with a better scheme than this.

Out of their greed for political and economic gain - and under the leadership of Heitkamp - the Attorneys General did a tremendous service for the tobacco companies. They 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

The bottom line is that the tobacco companies have the states coming and going. The MSA scheme was brilliantly concocted by the companies: no matter what the states do, their financial well-being is inextricably tied to that of the major cigarette companies. The partnership between the two is strong and irrevocable, and the risk of states taking any major action to threaten tobacco profits is nil.

This is the ultimate reason why I think that the MSA was such a disaster from a public health perspective. Contrary to what the Attorneys General have boasted, the MSA was about money, not public health. It is a public health disaster by virtue of it providing the states with 100% security - security against the states having any incentive to enact tobacco policies that would threaten their profits.

The MSA is a huge security contract for the tobacco companies. By paying off the politically and economically greedy Attorneys General, the major tobacco companies have succeeded in achieving not only protection of their profits from competition from smaller manufacturers, but also strong partners in protecting their profits from any other threats - including litigation (a.k.a. the Price and Engle bond payments) and substantially declining cigarette consumption.

The major cigarette companies deserve this protection - they earned it by outsmarting the Attorneys General and enticing them by dangling $206 billion in front of them. They are effectively protecting the best interests of their shareholders.

But the American people deserve far better from their elected officials. The Attorneys General are not protecting the best interests of their citizens; far from it - they have sacrificed the public's interest for political and financial gain.

In direct contrast to what the Attorneys General predicted, the Marlboro Man isn't riding into the sunset on Joe Camel. Instead, they're both having a beer and a good laugh together as they enjoy their trip to the bank. And that trip to the bank is possible due to the efforts of former Attorney General Heitkamp.

Monday, November 26, 2012

Despite Best Efforts of Anti-Smoking Groups, Electronic Cigarettes are Here to Stay

The Food and Drug Administration along with at least seven national anti-smoking groups made a valiant effort to remove electronic cigarettes from the market. In 2009, the FDA exerted what it purported was its jurisdiction over electronic cigarettes under the Food, Drug, and Cosmetic Act and effectively banned these products. At the same time, seven national anti-smoking groups promoted the removal of electronic cigarettes from the market. These seven groups, along with the amount of money they received from Pfizer and GlaxoSmithKline between 2009 and 2012, are as follows:

Pfizer

American Academy of Pediatrics: $720,800
American Cancer Society: $252,750
American Heart Association: $136,000
American Lung Association: $190,250
Campaign for Tobacco-Free Kids: $100,000
American Medical Association: $857,500
American Legacy Foundation: $300,000
Action on Smoking and Health: $200,000

GlaxoSmithKline

American Cancer Society: $602,010
American Lung Association: $143,461
Association for the Treatment of Tobacco Use and Dependence: $5,000
Campaign for Tobacco-Free Kids: $400,000
American Heart Association: $115,000
American Medical Association: $15,000
American Academy of Pediatrics: $65,075
American Legacy Foundation: $10,000

The Rest of the Story

Today, I am happy to opine that despite the best efforts of these anti-smoking organizations, electronic cigarettes are here to stay. The FDA failed in its efforts because the courts ruled that its jurisdiction over these products falls under the Tobacco Act, not the Food, Drug, and Cosmetic Act (in the absence of therapeutic or drug claims made by electronic cigarette companies). The anti-smoking organizations failed in their efforts because the state legislatures which considered bans on electronic cigarettes were swayed by an outpouring of protest from vapers who testified that they would most likely return to cigarette smoking if these devices were taken off the market.

Today, because of a number of subsequent developments in the electronic cigarette market, I can assert that these products are here to stay and that they will form the basis of a competitive and expanding market in the years to come.

Among the important developments (in addition to the D.C. District Court's decision on the FDA's regulatory authority) is the entrance of the major cigarette companies into the electronic cigarette market. I have already discussed the acquition of Blu cigs by Lorillard. Today, I report the efforts of Reynolds American to enter the electronic cigarette market.

According to an article in the Business Journal, Reynolds American has formed a subsidiary called the R.J. Reynolds Vapor Company which is test-marketing what it calls a "digital" cigarette, which is similar to but more advanced technologically than most electronic cigarettes on the market.

According to the article: "Reynolds American President and CEO Dan Delen said during Investors Day presentations Monday morning that the company is focusing over the long-term on emerging smoke-free products such as snus and its new electronic cigarette Vuse that offer larger margins and greater potential for growth. "Everything we're working on from an innovation standpoint has a higher margin than cigarettes," Delen said. "I think we're very well positioned in an evolving market." ... In the growing electronic cigarette category, which offers users a nicotine-infused vapor to inhale, Delen said RAI subsidiary R.J. Reynolds Vapor Co. is preparing to make a "big splash" after a limited launch of its Vuse product earlier this year. Delen said Vuse is more of a "digital cigarette" than merely an electronic one given its use of computer chips that Delen said help offer an experience closer to that of actually smoking. Delen said Vuse is also set apart by being produced domestically, while most electronic cigarettes are produced abroad. "We're not looking to make a little splash in the category," Delen said. "We're looking to make a big splash in the category." ... Delen said ... Reynolds American is focusing on markets centered around emerging products."

Philip Morris has also entered the "non-tobacco" cigarette market, after having purchased the patent to a new nicotine aerosol technology, although it is not clear how closely this new nicotine aerosol system resembles a cigarette rather than an inhaler.

British American Tobacco has also entered the electronic cigarette market. Its Nicoventures division is working on a nicotine inhaler to be launched within the next two years and it is supporting the development of what is apparently some type of non-tobacco, electronic cigarette. According to this same Financial Times article, Imperial Tobacco and Japan Tobacco are also preparing to enter the electronic cigarette market.

All of these tobacco companies realize something that the major anti-smoking groups fail to realize: It is no longer 1954 and the cigarette companies have not just issued their Frank Statement. Nor is it the 1960s, 1970s, 1980s, or 1990s. It is 2012, and the major cigarette companies have - unlike the major anti-smoking groups - begun to embrace the concept of harm reduction in the form of non-tobacco cigarette alternatives that deliver nicotine without the tar, toxins, and carcinogens and which therefore promote smoking cessation with an approach that may be more effective than traditional pharmacological methods.

A second major development is the increasingly effective voice of the vaping community. Vapers are letting their voices be heard, and after hearing the truth from vapers, policy makers are just not able to take the anti-smoking groups' advice and remove these products from the market. The electronic cigarette consumer advocacy and trade groups, internet forums, and vapers themselves have changed the dynamics of the playing field. The voices of the anti-smoking groups and pharmaceutical companies are not the only ones being heard. The true stories being shared by vapers who have successfully quit smoking or greatly reduced the amount they smoke thanks to electronic cigarettes, and who have experienced dramatic improvements in their health, are outweighing the financially conflicted and ideologically-driven voices of the anti-smoking movement. This is not to say that the battle is over, but I do believe that in the U.S. at least, the battle is now going to be over the nature of regulation, not the presence or absence of electronic cigarettes on the market.

An article published yesterday in the Financial reports that the electronic cigarette industry is currently a $2 billion global market. According to the article:

"after an initial fad period where the product was available exclusively on-line, e-cigs are now gaining acceptance as repeat usage products available through a variety of popular distribution channels, including convenience stores and supermarkets (for example, Tesco in the UK has signed a deal to stock E-Vapes) and the product is now no longer the preserve of specialists. ... Little wonder then that Tobacco and Pharma players have begun to sit up and take notice. In the world’s biggest e-cigarette market, the US, two leading tobacco players have entered the e-cig market by either buying an established e-cig brand (as in the case of Lorillard buying Blu for US$135mn in April 2012) or by launching their own e-cigarette brands on the market (eg Swisher’s eponymous e-cigarettes and e-cigars, also in 2012). Larger tobacco companies with more sizeable financial outlay have decided to develop their own alternative cigarette-mimicking nicotine delivery devices, such as global no.2 tobacco player, BAT, which in 2011 set up a company called Nicoventures to develop modified risk and nicotine delivery products. According to its product developer, Kind Consumer, its lead product will be a "pharmaceutically regulated substitute cigarette”. ... Globally, the NRT retail market is worth US$2.4bn (excluding prescription sales), and enjoying stable overall growth, but how long before it is eclipsed by the already US$2bn-strong e-cigarettes market?"

Euromonitor International recently projected that by the year 2050, the non-tobacco cigarette market (which is dominated by electronic cigarettes) will account for 4% of the entire tobacco market.

Sadly, if electronic cigarettes do take off as a more effective tool for getting smokers off their cigarettes and helping to save their lives, it will not be thanks to the efforts of the national anti-smoking groups. It will be despite their best efforts.

Wednesday, November 21, 2012

UAB Health System Admits It is Setting a Bad Example and Encouraging Obesity By Continuing to Hire Overweight People

According to an article in the Birmingham News, the University of Alabama Birmingham (UAB) Health System is defending its new tobacco-free hiring policy by arguing that hospitals must set a good example and that hiring smokers encourages smoking.

UAB's hospital and medical system will institute a tobacco-free hiring policy beginning in July 2013. The health system will refuse to hire anyone who uses tobacco, including not only smokers but users of smokeless tobacco products as well. Because the policy is enforced using a cotinine test, it will presumably also apply to users of electronic cigarettes and nicotine replacement therapy.

According to the article: "Ferniany [CEO of the UAB Health System] said it is important to set an example in the medical community. 'Smoking hurts health,' he said. 'It causes illness, and hospitals should not encourage that in any way.'"

The Rest of the Story

The UAB Health System is defending its policy on the grounds that hiring smokers sets a bad example in the medical community and that it encourages smoking. But by the same logic, hiring overweight people also sets a bad example in the medical community and it encourages obesity. However, UAB isn't planning to discriminate in hiring against overweight individuals. It is only going to discriminate against smokers.

Thus, by its own argument, the UAB Health System is admitting that it is setting a bad example in the medical community and is encouraging obesity.

Shame on UAB Hospital for setting a bad example and promoting obesity. A hospital should be helping to prevent disease and death, not cause it.

Tuesday, November 20, 2012

DHHS Hides from Public the Fact that Chantix Has Been Associated with Hundreds of Suicides; Recommends Drug that Has Caused Many Deaths over Product that Has No Known Serious Adverse Effects

The Department of Health and Human Services (DHHS), on its new web site devoted to smoking, is hiding from the public the fact that Chantix (varenicline) has been associated with hundreds of suicides. It is also recommending Chantix - a drug that has caused hundreds of deaths - over electronic cigarettes, which have no known serious adverse side effects, because of its concern over potential unknown risks of electronic cigarettes.

On its web site, DHHS advises smokers trying to quit not to use electronic cigarettes, but does recommend that they use Chantix. However, while this page warns about potential unknown risks associated with electronic cigarettes, it does not mention the well-documented, known, serious side effects of Chantix and it fails to provide its own mandated black box warning.

On its smoking cessation medication page, DHHS deceives the public by failing to mention that Chantix has been associated with hundreds of suicides. Instead, it suggests only that Chantix has been linked to rare cases of "suicidal ideation." The DHHS states only that: "There have been rare reports of mood swings, depression and suicidal thoughts." The DHHS also fails to inform the public that Chantix has been banned for pilots, air traffic controllers, and commercial drivers.

Even on its detailed fact sheet regarding Chantix, DHHS hides from the public the fact that there have been hundreds of reports of suicide among patients taking Chantix. It merely states that: "There have been rare reports of mood swings, depression, and suicidal thoughts."

The Rest of the Story

I don't understand the logic behind recommending a product associated with hundreds of deaths over a product that has no known serious adverse effects simply because we don't fully understand all the potential effects of that product. It can't be worse than Chantix.

The DHHS itself acknowledges that it is better to use a product that is known to be reasonably safe but whose effects have not been completely characterized over a product that is known to cause deaths. It acknowledges that "The effect of NRT on the body is not fully known," but still recommends NRT because "NRT products are safer than cigarettes."

But there is a problem here that is far worse than the inappropriate medical advice to smokers. That problem is a lack of honesty and therefore, I violation of public health ethics in my opinion.

I believe it is dishonest to inform the public that Chantix is associated with rare reports of mood swings, depression, and suicidal ideation, without informing the public that Chantix has also been associated with reports of actual suicides. The DHHS is apparently intentionally hiding this information from the public. If Pfizer did the very same thing, it would be guilty of fraud and DHHS itself would likely be prosecuting Pfizer for failure to mention that there were reports of actual suicides or attempted suicides.

The black box warning on Chantix informs the public that the drug has been associated with reports of not only suicidal thoughts but suicidal behavior (suicide and attempted suicide). It is clear to me that DHHS is intentionally hiding the "rest of the story" from the public.

I view this as a violation of the code of public health ethics because honesty and transparency are two of the principles upon which the ethical practice of public health are based. 

The result of this deception is substantial. A reader is likely to come away with the impression that varenicline can cause some suicidal thoughts, but that this side effect is not serious enough that one has to be concerned about actually attempting suicide.

There are at least 200 lawsuits that have been filed by the families of plaintiffs who allege that their loved ones committed suicide as a result of taking the smoking cessation drug Chantix (varenicline) or by plaintiffs who attempted suicide after starting Chantix. These cases were filed by a single law firm, which is investigating another 1,200 cases. Another firm is investigating 175 similar cases.

Obviously, the problems that have been alleged to be caused by Chantix go beyond suicidal "thoughts."

The rest of the story is that not only is DHHS giving inappropriate medical advice to smokers, it is also being dishonest with the public by hiding factual information about the potential risks associated with varenicline.

Monday, November 19, 2012

Department of Health and Human Services Warns Smokers Wishing to Try Quitting Using Electronic Cigarettes to Stick With Regular Cigarettes Because They Don't Know How Much Nicotine They'll Get; Department Spreading False Information About the Scientific Evidence

On a new web site devoted to tobacco and smoking cessation, the Department of Health and Human Services (DHHS) warns smokers wishing to try quitting using electronic cigarettes not to do so because they will not know how much nicotine they are getting in each puff. In effect, this amounts to a recommendation that these smokers stick to their regular cigarettes, since many of them have tried unsuccessfully to quit using the other products recommended by DHHS: nicotine replacement products and smoking cessation drugs.

There is a large population of smokers who have tried to quit using traditional NRT or smoking cessation drugs and failed. Having heard from ex-smokers about their success with electronic cigarettes, many of these smokers wish to try quitting using these innovative products, which vaporize nicotine from a glycerin or propylene glycol base and involve no tobacco. The Department of Health and Human Services' official advice to these smokers: don't use electronic cigarettes because there is no evidence that they can help you quit and you don't know how much nicotine you're getting in each puff.

According to the DHHS information page on electronic cigarettes: "Because clinical studies about the safety of e-cigarettes have not been submitted to the U.S. Food and Drug Administration (FDA), you have no way of knowing:
  • If they are safe
  • Which chemicals they contain
  • How much nicotine you are inhaling
Nicotine is a highly addictive substance. Additionally, these products may be attractive to kids. Using e-cigarettes may lead kids to try other tobacco products—including conventional cigarettes—which are known to cause disease and lead to premature death.

Although e-cigarettes may be marketed as a tool to help smokers quit, they have not been submitted for FDA evaluation or approval and there is no evidence to support those claims. There are, however, a number of FDA-approved quit-aids available to smokers, including:
  • Nicotine gum
  • Nicotine skin patches
  • Nicotine lozenges
  • Nicotine oral inhaled products
  • Nicotine nasal spray
  • Zyban
  • Chantix"
On another of its information pages on electronic cigarettes, DHHS warns that: "When FDA conducted limited laboratory studies of certain samples, FDA found significant quality issues that indicate that quality control processes used to manufacture these products are substandard or non-existent. FDA found that cartridges labeled as containing no nicotine contained nicotine and that three different electronic cigarette cartridges with the same label emitted a markedly different amount of nicotine with each puff. Experts have also raised concerns that the marketing of products such as e-cigarettes can increase nicotine addiction among young people and may lead kids to try other tobacco products."

The Rest of the Story

The recommendation by DHHS that the many smokers who have failed to quit using NRT or smoking cessation drugs should not try electronic cigarettes in an attempt to quit smoking is tantamount to a recommendation that these smokers continue to smoke rather than risk possibly using a product that delivers markedly different amounts of nicotine in each puff.

What DHHS is actually saying is: "Rather than using electronic cigarettes, a much safer product but one which delivers unknown quantities of nicotine and widely varying amounts of nicotine in each puff, you are better off using regular cigarettes, which are finely tuned - due to years of experience and strict quality control procedures - to deliver precisely the same amount of nicotine in each puff."

I find this to be irresponsible advice and in a sense, a form of public health malpractice. Any physician who advised a patient unwilling to try NRT or a drug (because they failed in the past) to stay on cigarettes rather than switch to electronic cigarettes would perhaps be subject to a malpractice claim. Is not delivering such advice on a mass level an example of public health malpractice?

The Department's concern that electronic cigarettes do not deliver known or consistent quantities of nicotine is hardly something that makes the use of these products risky. In fact, it makes them less addictive than regular cigarettes because the consistent delivery of nicotine is one of the factors that makes cigarette smoking so addictive. Ineffective delivery of nicotine actually reduces the addictive potential of electronic cigarettes (which may explain why 2/3 of ex-smokers in my survey of electronic cigarette customers who had quit smoking six months after using these products reported having stopped using electronic cigarettes as well).

If anything, the inconsistent delivery of nicotine is a concern for the effectiveness, not the safety of these products. If electronic cigarette companies can find technology to better regulate the nicotine delivery, they be be more effective for smoking cessation.

Furthermore, consistency of nicotine delivery is not a particular concern of most electronic cigarette companies at the present time because their products are not being marketed with therapeutic claims. They are not being marketed as devices to treat nicotine dependence. Instead, they are being marketed as alternatives to cigarette smoking for smokers concerned about the health damage that is being caused by their smoking.

The Department's concern that these products may serve as a gateway for youth smoking is a purely hypothetical one, and there is no evidence to support this theory. There is, in fact, no evidence that electronic cigarettes have become popular among youth and there is no evidence that youth are initiating nicotine use with these devices and then progressing to cigarette smoking.

Finally, and perhaps most importantly, DHHS is lying to the public when it asserts that "there is no evidence to support" the claim that electronic cigarettes can help smokers quit. In fact, there is abundant evidence. We know for a fact that there are thousands of ex-smokers who have quit smoking using these devices. Moreover, we know from the first clinical trial of electronic cigarettes that 54% of smokers who were unmotivated to quit at baseline were nevertheless successful in either quitting or cutting down by more than half the amount that they smoke.

So the DHHS' assertion that there is no evidence that electronic cigarettes can help smokers quit is simply not true.

The rest of the story is that through its dissemination of false and misleading information about electronic cigarettes, the DHHS is not only violating basic principles of truth and honesty, but it is also giving inappropriate medical advice and helping to protect the cigarette companies from what might otherwise be a serious threat to their continued profits from the sale of cigarettes.

Thursday, November 15, 2012

New Study on Graphic Warning Labels Provides Further Evidence that They are Unconstitutional

A new study on the effectiveness of cigarette graphic warning labels published in the current issue of the American Journal of Preventive Medicine inadvertently provides evidence that the FDA's requirement that tobacco companies place these "warnings" on their cigarette packs is unconstitutional, as it compels speech that is not purely factual.

(See: Trasher JF, et al. Cigarette Warning Label Policy Alternatives and Smoking-Related Health Disparities. American Journal of Preventive Medicine 2012; 2012;43(6):590–600.)

The study was intended to test the effectiveness of graphic warning labels in deterring smoking among adult smokers. A sample of 1000 adult smokers was divided into experimental and control groups. The control group was shown the current text-only warnings while the experimental groups were shown a series of graphic pictorial warnings. Subjects were asked to rate the warnings in terms of credibility, relevance, and perceived effectiveness.

The study found that pictorial warnings were rated as more effective and concludes that such warnings are effective in encourage smoking cessation: "A cost-effective means of intervention, pictorial labels and specifically graphic imagery have the potential to significantly influence adult smokers to understand the range and magnitude of smoking-related risks, while encouraging them to quit."

The Rest of the Story

It is a huge stretch to conclude from this study that pictorial cigarette warnings are effective in promoting smoking cessation among adult smokers. The study merely tested the perceived effectiveness of the labels following a single exposure occurring in a laboratory setting and did not measure any actual change in behavior. There is strong evidence that there is a rapid wear-out effect whereby smokers get used to the warnings quickly and they fail to motivate quitting after this wear-out occurs.

This type of evidence is simply not going to withstand scientific scrutiny by the courts. The D.C. Court of Appeals has already let it be known that it is not going to be swayed by this type of experimental evidence. There are no convincing studies that demonstrate an actual effect of graphic warning labels on smoking behavior and the FDA admitted as much.

But the more interesting aspect of the rest of the story is that this study inadvertently provides evidence for the tobacco companies to bolster their argument that the graphic warning labels are unconstitutional. The key issue is whether the labels are merely presenting factual information or whether they are attempting to promote smoking cessation by stirring emotions and going beyond merely providing facts to warn users about the health effects.

According to this study: "The tobacco industry has argued that the FDA’s proposed imagery is not real and involves emotional appeals instead of the simple transmission of risk information. However, smokers in the present study rated the graphic imagery as more credible, personally relevant, and effective than either textual content or alternative imagery that could be used in its place."

And how, exactly, did the study measure the effectiveness of the warning labels? One of the questions used to assess effectiveness was whether: “The health warning label makes you think about quitting.” Only after this question was asked were respondents asked to rate the overall effectiveness of the warning labels. Thus, it was clear to respondents that the effectiveness of the warning labels was to be assessed in terms of the degree to which they encouraged smoking cessation.

Clearly, then, the intended purpose of the warning labels in the eyes of tobacco control practitioners is not merely to provide health information but to effectively encourage smoking cessation. This is precisely the tobacco industry's argument and this paper helps to confirm that argument. These labels are not merely thought of in the tobacco control movement as a mechanism to effectively inform smokers about the health consequences of smoking. They are thought of and intended as a mechanism to persuade smokers to quit.

In other words, the FDA is forcing the tobacco companies to use their cigarette packages as a sort of anti-smoking billboard in which they must encourage consumers not to use that product. This goes beyond the provision of factual information and therefore makes the warning labels subject to a higher level of scrutiny. The labels do not pass that higher level of scrutiny because there is not sufficient evidence to demonstrate that they will be effective for their intended purpose and it cannot be argued that the intervention is the least intrusive one available for this purpose.

Wednesday, November 14, 2012

On What Passes for Science in Tobacco Control: New Study Purports to Show Effect of College Tobacco Ban on Smoking Rates, But Fails to Consider Age Differences Between Pre- and Post-Ban Samples

A study published in the journal Preventive Medicine in 2011 purported to demonstrate that a tobacco-free campus policy led to a decrease in smoking among students at Indiana University.

(See: Seo D-C, Macy JT, Torabi MR, Middlestadt SE. The effect of a smoke-free campus policy on college students' smoking behaviors and attitudes. Preventive Medicine 2011; 53:347-352.)

The study was a quasi-experiment, using a repeated cross-section design with a comparison group. Indiana University instituted a campus-wide tobacco ban in 2008. Cross-sectional surveys were conducted in 2007 - prior to the ban - and in 2009. Similar surveys were conducted during the same years at Purdue University, which did not institute a campus-wide tobacco ban.

The methods were as follows: "In fall 2007, 84 Indiana University instructors and 67 Purdue University instructors were asked for permission to administer a survey in their classes. Among those contacted, 73 Indiana instructors and 55 Purdue instructors agreed. A total of 3492 students (2057 from Indiana and 1435 from Purdue) were invited to complete a group administered paper-and-pencil survey, and 3266 students (1930 [93.8%] from Indiana and 1336 [93.1%] from Purdue) participated. In fall 2009, 77 out of 87 Indiana instructors and 54 out of 65 Purdue instructors agreed to have the survey administered in their classes. A total of 3455 students (2215 from Indiana and 1240 from Purdue) were invited to participate, and 3207 students (2042 [92.2%] from Indiana and 1165 [94.0%] from Purdue) completed the survey."

The study found that current smoking prevalence at Indiana University dropped from 16.5% to 12.8%, but at Purdue University, it increased from 9.5% to 10.1%. Based on this finding, the study concludes that the tobacco ban led to a decrease in smoking among Indiana University students.

The Rest of the Story

What the study fails to point out to readers is that the pre- and post-ban student samples were not at all comparable. The key to the validity of this study is that the pre- and post-ban samples need to be comparable, so that accurate comparisons can be made of smoking rates. However, the sampling procedure failed to yield comparable samples. In fact, the differences between the samples were striking and furthermore, would systematically lead to an underestimation of true smoking prevalence at Indiana University in 2009.

Table 1 reveals the differences in the two samples. The differences are striking. In 2007, the proportion of males in the Indiana University sample was 42.4%. In 2009, it was 37.6%. In 2007, the percentage of freshman in the sample was 19.5%. In 2009, the percentage of freshman was 26.9%. The percentage of students living in residence halls increased from 26.8% to 33.8%.

Anyone looking at these differences can easily see that the study conclusions are invalid. The same reasoning that led to the conclusion that the smoking rate dropped would lead to the conclusion that the percentage of males dropped and that the percentage of freshman dropped and that the percentage of students living in residence halls dropped as a result of the tobacco-free policy.

But it is obviously not true that the tobacco ban led to a decline in the percentage of male students at Indiana University or that it led to fewer freshmen or fewer students living in residence halls. In order to draw such conclusions, one would need comparable samples. The study failed to achieve that.

In fact, the differences in the samples would - in each case - lead to an underestimation of smoking prevalence at Indiana University in 2009 compared to 2007. In general, the post-ban sample was a younger one, with more freshmen and fewer upperclassmen. We know that smoking prevalence increases with age. Thus, just based on the differences in the sample, one would expect smoking rates to have dropped from 2007 to 2009.

But it gets worse. At Purdue University, the opposite occurred. The sample in 2009 was an older sample. The percentage of freshman in the sample decreased from 27.3% to 17.5%. Thus, sampling alone would lead to an overestimation of the smoking prevalence in 2009 compared to 2007.

The gender differences in the sample would also lead to an underestimation of smoking prevalence in 2009 at Indiana University. We know that smoking rates are substantially lower among college-aged females than males. So the much lower percentage of males in the 2009 sample at Indiana University would lead to an artificially low estimate of the percentage of smokers.

Shockingly, the study makes no attempt to control for these age and gender differences. Its conclusion is based solely on the observed difference in overall smoking prevalence in the two samples.

This is yet another example of the kind of shoddy research that passes for science in the tobacco control movement today. My impression is that researchers are so anxious to find significant effects of tobacco control policies that they subconsciously are trying to find such effects, rather than allowing the data to drive the conclusions.

Incidentally, the authors acknowledged that "the campus-wide smoke-free air policy was not actively enforced and people can be seen smoking on a regular basis." Perhaps this is why there is a need to distort the science to find an effect. The policy must be justified and based on the impossibility of enforcing such a policy, one would be hard pressed to defend it. But if one can cook up evidence showing that it reduced smoking rates, then one can justify the policy. It appears that this study succeeded in doing so.

Tuesday, November 13, 2012

Department of Health and Human Services is Promoting Complete Outdoor Tobacco Use Bans on College Campuses, Despite Lack of Scientific Evidence to Support Need for These Policies

Earlier this fall, the Department of Health and Human Services announced a new initiative to promote outdoor tobacco use bans on every college campus in the United States. These bans are intended not to protect the public from secondhand smoke exposure, but to make it difficult for tobacco users on campus so that they decide to quit using tobacco.

According to an article in the Daily Caller: "the Tobacco-Free College Campus Initiative, reportedly part of Health and Human Services’ national Tobacco Control Strategic Action Plan, which will push ... institutions of higher learning to adopt tobacco-free policies. “Twenty million students, about a third of all young adults in this country, are enrolled in higher education,” added University of Michigan Tobacco Research Network executive director and Koh advisor Clifford Douglas. “Through their campus policies, colleges and universities have a unique opportunity to influence a student’s daily life.”"

According to DHHS, a campus tobacco-free policy is one where "no employee or member of the public may use any tobacco product anywhere on facility grounds." Thus, these policies prohibit:
  • the father of a student from using Camel snus in his car parked in a university parking lot;
  • a member of the public visiting a campus library from using Ariva (a dissolvable tobacco) while sitting in her car in the library parking lot;
  • a faculty member from smoking in a remote area of an unoccupied lot at 11:00 at night with no one around.

The Rest of the Story

While the father of the student is prohibited from using Camel snus in his car parked in the university parking lot, his son is allowed to drink alcohol on campus to the point of intoxication.

While the member of the public visiting a campus library may not use Ariva, students may proceed from the library to university parties where alcohol is served in abundance.

While the faculty member may not smoke in a remote area of an unoccupied lot, the students who that faculty member teaches are within university rules to consume alcohol at university parties and become intoxicated.

Might I suggest that when we are devoting national government resources to banishing tobacco use from every remote area of college campuses, yet allowing rampant alcohol use, intoxication, and alcohol-related violence, sexual assault, and other consequences to continue due to the address alcohol use on college campuses, something is wrong with our priorities and our perspective.

Why is it necessary for DHHS to promote tobacco-free campuses policies? Would it not be enough for DHHS to engage in a campaign to promote smoking bans in indoor areas of all college campuses and in outdoor areas where nonsmokers congregate, such as building entrances or public events? What would be lost by engaging in a vigorous campaign to ensure that no nonsmoker on a campus need be exposed to secondhand smoke? Why the need to ban not only all smoking anywhere on campus, but also all tobacco use anywhere on campus?

A major problem with the policy is that it is paternalistic. It aims not to protect nonsmokers from secondhand smoke exposure, but to protect smokers from themselves. The same reasoning, for example, would justify policies to ban the consumption of unhealthy foods or soft drinks on college campuses.

Another major problem is that there is no evidence that these policies will achieve their desired goal. I am aware of no studies which demonstrate that campus tobacco-free policies lead to a decline in tobacco use among university-affiliated individuals or among the public. In fact, my own research failed to find any effect of 100% bar and restaurant smoking bans on adult smoking rates. It is not clear that these policies actually encourage smokers to quit. Instead, they most likely shift the places where smokers smoke. Smokers will go off campus to smoke, finding areas that are not on campus grounds. But it's not clear that these policies result in them quitting.

These policies are also hypocritical, because they tell students that it is not acceptable to use tobacco, but that you can drink as much alcohol as you want. To be sure, alcohol use is a much more serious problem in terms of causing actual death and destruction on college campuses. Hundreds of students die from alcohol-related consequences, but I am not aware of any deaths among college students from tobacco use. What these policies do is look the other way towards the problem of alcohol use, while making it look like the colleges are really concerned about student health and welfare. No wonder colleges love these policies.

And no wonder the alcohol industry loves these policies as well. They divert attention from the death and destruction caused by alcohol and take the alcohol companies off the hood. One of the partners working with DHHS on the campus tobacco-free initiative is the BACCHUS network, which is funded largely by the alcohol industry.

It is unfortunate that the DHHS is essentially partnering with the alcohol industry in helping to divert attention from the alcohol problem by focusing resources on the need to ban tobacco in every remote area of campus, while alcohol use continues to remain rampant throughout the campus.

Moreover, the DHHS is diverting attention away from areas where there is a real need to protect people from secondhand smoke: the 24 states that still do not offer protection for workers in bars, restaurants, and casinos. If DHHS really wants to do something to save lives, it should spend its resources on a vigorous initiative to spread bar/restaurant and casino smoking bans to these 24 states, instead of worrying about whether someone might be chewing a tobacco orb in a parked car.

Monday, November 12, 2012

Americans for Nonsmokers' Rights Accuses the Rest of the Story Author of Being Unprofessional for Sharing his Opinion About Smoking Ban/Heart Attack Studies; Attempt to Quell Dissenting Opinion is Unsuccessful

In an apparent attempt to quell dissent on the issue of whether smoking bans lead to immediate, dramatic reductions in heart attacks, Americans for Nonsmokers' Rights (ANR) has accused me of acting unprofessionally by sharing my opinion about the lack of scientific evidence to support the group's conclusion that smoking bans have such effects.

On Friday, I criticized an ANR document which purports to share with the public a list of the U.S. studies examining the short-term effects of smoking bans on heart attack rates. Under the category of "United States," ANR lists just one study - a study by Lippert and Gustat which concluded that smoking bans do lead to immediate reductions in heart attacks. I note in my commentary that ANR omitted from its list the two largest studies conducted in the U.S., both of which failed to find a short-term effect of smoking bans on heart attacks.

In response to my commentary, ANR wrote me and accused me of acting unprofessionally by sharing these opinions on my blog. ANR wrote: "Your approach to 'discussing' these sorts of issues continues to be exceedingly unconstructive and unprofessional."

The Rest of the Story

To translate ANR's message to me: "It is unprofessional of you to share your dissenting opinion publicly on your blog. You are free to disagree, but not to express your disagreement with others. That is unprofessional behavior."

This is a strange interpretation of academic freedom, free speech, and scientific integrity.

By the way, I don't begrudge ANR's disagreement, as it may exist, with my opinions regarding the scientific evidence related to the short-term effects of smoking bans on heart attacks. I would have been happy to discuss with ANR the scientific evidence and its strength, as well as the analytic and statistical issues involved with the scientific interpretation of these studies.

However, ANR's note was not simply a statement of scientific disagreement. It was an accusation of unprofessional behavior on my part. In other words, it was an attack on my personal character and integrity.

As I have noted before, this is a common tactic in the anti-smoking movement for dealing with dissent. Rather than deal substantively with the scientific issues, you attack the dissenter, trying to discredit him personally. This is also a tactic that I observed tobacco companies using in years past.

This is mildly ironic, as it was my disagreement with and discomfort with this very tactic that led to my resigning from the ANR Board of Directors in the first place. I now see that they haven't come very far since that time.

This story simply reinforces (and demonstrates) the argument I made in my commentary: "This is not science, it is politics. ANR has ceased being a science- or policy-based organization and has entered the political realm. ... It's sad for me to see the deterioration of the scientific integrity of the tobacco control movement, and it is particularly disheartening to see our organizations adopting many of the same tactics that we attacked the tobacco companies for using in years past."

While it would not be surprising to see ANR using this tactic against its "opponents" (and I have documented how ANR indeed uses this tactic against opposing groups), it is unfortunate that the organization has to resort to using this tactic against its own colleagues in the tobacco control movement.

ANR's response also demonstrates how it is cherry-picking the studies which have favorable results and intentionally excluding studies that don't have favorable results. The response argued that the Shetty et al. study should not included because of several methodological weaknesses, including the fact that it defined all smoking restrictions as "smoking bans" even if they were only partial bans. That's fine, but if one is going to restrict studies that have methodological weaknesses, then one has to do that with all studies, not just with the ones that have unfavorable findings.

In fact, the Lippert and Gustat study - which ANR cites as its only U.S.-based multi-state study, is the weakest of all studies on smoking bans and heart attacks. As I have pointed out previously, there are two major flaws of this study which render its conclusion invalid.

1. There is no control group.

The study simply compares changes in self-reported prevalence of heart attacks in states with smoking bans from approximately 2006 to 2009. The study finds that in some states, there was a significant decline during this three-year period. However, without knowing what happened in states without a smoking ban, it is impossible to attribute this change in heart attack prevalence to the smoking ban. One needs to know what was the change in heart attack prevalence from 2006 to 2009 in states that did not enact smoking bans.

The study does not report this information. However, from the Health Care Utilization Project (HCUP) data, we can obtain the changes in hospital discharges with a primary diagnosis of heart attack (i.e., incident heart attacks) in states without smoking bans between the years 2006 and 2009. Here are the data for all states without smoking bans in the HCUP database for which there are data for these years (the last column shows the percentage change from 2006 to 2009):

State 2006 2009
SC 9825 8890 -9.5
OK 8687 8030 -7.6
AR 7192 6837 -4.9
KY 12839 12444 -3.1
MO 15198 14310 -5.8
TN 17229 16493 -4.3
WV 6645 5891 -11.3
TOTAL 77615 72895 -6.1

From this table, one can see that in every state without a smoking ban for which HCUP data are available during the study period, there was a substantial decline in heart attacks, ranging from a decline of 3.1% in Kentucky to a decline of 11.3% in West Virginia. Overall, the decline in heart attacks in these 7 states without smoking bans was 6.1% from 2006 to 2009.

Therefore, how can this study conclude that the decline in self-reported heart attacks in the 17 smoking ban states from 2006 to 2009 was different than what would have been observed in the absence of these bans? Clearly, there is a secular trend of declining incident heart attacks in the United States that is independent of statewide smoking bans.

Given this baseline secular trend, the study cannot conclude that the observed declines in self-reported heart attacks observed in the 17 study states were attributable to the smoking bans in those states, as opposed to simply reflecting underlying secular trends, which are readily observable in states without such smoking bans.

2. The study conducts the wrong statistical analysis.

The study's conclusion that the smoking bans led to a significant reduction in heart attacks is based on the observation that in 10 of the 17 states, the prevalence of heart attacks declined. Of course, another way to look at this is to say that in 7 of the 17 states, the prevalence of heart attacks increased. The real question is this: if there were no true change in heart attacks, what percentage of the time would 10 out of 17 states show a decrease in heart attacks by chance alone?

Think of it this way. Suppose you flip a coin 17 times and come up with 10 heads. Can you conclude that this is not a fair coin, and that it must be weighted more heavily towards heads?

Well one can calculate the probability of obtaining 10 or more heads out of 17 coin tosses with a fair coin. Using the binomial distribution, one can determine that if one flips a fair coin 17 times, the chances of getting at least 10 heads is 31.5%.

Thus, by chance alone, if one were to examine changes in heart attack prevalence in 17 states, one would find that heart attacks decreased in 10 of those 17 states 31.5% of the time (if there were actually no true change in heart attacks). This is far beyond any reasonable level of statistical significance (which is usually set at about 5%).

If one is going to exclude any study because of methodological weaknesses, it would have to be the Lippert and Gustat study.

My impression remains that ANR is not objectively analyzing the methodology of these studies and excluding those whose methods are not scientifically solid. Instead, ANR is finding reasons to exclude the unfavorable studies while not applying the same standards to studies with favorable results.

The rest of the story is that this adds to the evidence that ANR's omission of all studies with unfavorable findings is an intentional action on the part of ANR to deceive the public about the scientific evidence by hiding negative studies and only sharing studies that support the organization's pre-determined conclusions.

Friday, November 09, 2012

Anti-Smoking Group Cherry-Picking Studies to Mislead Pubic About the Science: Americans for Nonsmokers' Rights is Hiding Information from the Public

As a former Board member of Americans for Nonsmokers' Rights (ANR), I can attest to the fact that as an organization, we used to attack the tobacco companies for cherry-picking studies that supported their claims, hiding key information from the public to make it appear that there was no evidence to show that secondhand smoke is harmful.

For example, the tobacco companies would point to one study which failed to find a connection between secondhand smoke and heart disease, while ignoring all the rest of the studies. Of course, we criticized the industry, arguing that all studies need to be considered and that failure to do so is misleading the public by hiding key scientific information.

Today, I report that Americans for Nonsmokers' Rights is itself engaging in cherry-picking by only sharing one side of the scientific evidence on the relationship between smoking bans and immediate reductions in heart disease.

In this document, ANR purports to share with the public a list of the U.S. studies examining the short-term effects of smoking bans on heart attack rates. Under the category of "United States," ANR lists just one study - a study which concluded that smoking bans do lead to immediate reductions in heart attacks.

The Rest of the Story

Curiously, ANR omitted from its list, the two largest studies conducted in the U.S., both of which failed to find a short-term effect of smoking bans on heart attacks.

What ANR could have, and should have added to the list are these studies:

1. Shetty KD, DeLeire T, White C, Bhattacharya J. Changes in U.S. hospitalization and mortality rates following smoking bans. Journal of Policy Analysis and Management 2011; 30(1):6-28.

This study by researchers from the RAND Corporation, Center for Studying Health System Change, University of Wisconsin, and Stanford University is the first to examine the relationship between smoking bans and heart attack admissions and mortality trends in the entire nation, using national data. All previous U.S. studies only examined one particular city. In contrast, this study examined data from the Nationwide Inpatient Survey (NIS), which is nationally representative and includes 20% of all non-federal hospital discharges in the United States.

The study found no significant effect of any smoking restrictions (including bar and restaurant smoking bans) on either heart attack admissions or mortality. The paper concludes: "We find no evidence that legislated U.S. smoking bans were associated with shortterm reductions in hospital admissions for acute myocardial infarction or other diseases in the elderly, children, or working-age adults."

2. Rodu B, Peiper N, Cole P. Acute myocardial infarction mortality before and after state-wide smoking bans. J Community Health 2011.

This study systematically examined changes in heart attack mortality trends within the first year of implementation of smoking bans in the six states which adopted such bans during the period 1995-2003. The results were that in four of the six states (California, Utah, Delaware, and South Dakota), the smoking bans were not associated with any significant short-term decline in heart attack mortality. In one of these states - South Dakota - there was an 8.9% increase in heart attack mortality during the first year of the smoking ban which was significantly different from the expected decline of 7.2%. The paper concludes: "The major finding of this study is that state-wide smoke-free laws resulted in little or no measurable immediate effect on AMI [acute myocardial infarction] death rates."

What's Going On Here?

Unfortunately, I no longer believe that the omission of these studies is just a curious, inadvertent omission of these key studies. Instead, I now believe that this is an intentional action on the part of ANR to deceive the public about the scientific evidence by hiding negative studies and only sharing studies that support the organization's pre-determined conclusions.

This is not science, it is politics. ANR has ceased being a science- or policy-based organization and has entered the political realm. This, of course, is the reason why I stepped down from the ANR Board when I first saw the organization start eschewing scientific integrity in favor of using these political tactics (a fact that incidentally - ANR acknowledged).

It's sad for me to see the deterioration of the scientific integrity of the tobacco control movement, and it is particularly disheartening to see our organizations adopting many of the same tactics that we attacked the tobacco companies for using in years past.

Thursday, November 08, 2012

Researcher Says We Should Accept Smoking Ban/Heart Attack Link as Fact, Even Though His Own Study Fails to Demonstrate Such an Effect

Last week, I discussed a new study published online ahead of print in the journal Archives of Internal Medicine which concluded that smoke-free restaurant and bar ordinances in Olmsted County, Minnesota produced a 34% decline in heart attacks and a 17% decline in sudden cardiac deaths. I pointed out that there was no comparison group, so that one cannot determine whether the observed declines in Olmsted County differ from secular declines that may have occurred elsewhere in Minnesota during the same time period. However, I presented data from the Health Care Utilization Project database which showed that in Minnesota as a whole, there was a 26% decline in heart attacks during the identical time period. This calls into question the validity of the study's conclusion that the decline in heart attacks was due to the smoking ban. I also provided data on heart attack mortality in Olmsted County which demonstrated a deceleration in the rate of decline of heart attack deaths in Olmsted County associated with the smoking ban.

Despite the failure of these data to support the conclusion made in the paper, one of the study authors has publicly asserted that: "We should now accept this as fact."

According to an NPR story: "'We should now accept this as fact,' says Richard Hurt, a professor of medicine at the Mayo Clinic who led one of the studies. Tobacco industry arguments that secondhand smoke isn't a major risk factor for heart disease, he says, are 'just nonsense,' because the only risk factor that changed in those 18 months was secondhand smoke. People's cholesterol and blood pressure stayed the same, and obesity rates increased."

The Rest of the Story

It's amazing to me how weak the evidence can be that apparently is now considered "fact" in the anti-smoking movement in 2012.

The researcher's own study does not support this alleged "fact," because it fails to show any significant difference in heart attack trends in Olmsted County and the rest of Minnesota during the study period and because there was actually a deceleration in the decline of heart attack deaths in Olmsted County associated with the smoking ban.

Furthermore, the authors conclusion that the Olmsted County smoking bans led to a 17% decline in sudden cardiac death is based on their finding that from 2001 to 2009, the rate of sudden cardiac death dropped by 17%; however, they acknowledge that the observed 17% decline was not statistically significant and that they cannot conclude from the analysis that the point estimate is significantly different from zero.

Nevertheless, the authors ignore the lack of statistical significance, writing it off by arguing that had there been a higher sample size, the result would have been statistically significant. They write: "We observed a statistically non-significant decline in the incidence of SCD [sudden cardiac death], which may reflect the relatively smaller number of events in the SCD group. These findings suggest that SHS [secondhand smoke] exposure could be a risk factor for SCD."

It turns out that the authors also found, but hide from the readers, that there was a 17% increase in sudden cardiac death rates associated with the implementation of the smoke-free restaurant law in Olmsted County. From 18 months prior to the smoke-free restaurant law to 18 months after the law, the rate of sudden cardiac death (as reported in Table 2) increased by 17% (the identical amount by which sudden cardiac deaths decreased over the entire study period).

This finding, like the 17% decline in sudden cardiac deaths, was not statistically significant. Curiously, however, the authors do not similarly argue that we can ignore the lack of statistical significance of this finding because of a small sample size.

It appears that statistical significance only matters when the finding in question is an "unfavorable" one. But when the finding is a "favorable" one, then statistical significance can be ignored. In other words, it is quite clear that the investigators were "hoping" to find an effect of the smoke-free laws on sudden cardiac death and that - although I believe subconsciously - they slanted their interpretation of the data in order to favor such a finding.

Despite this sleight of hand, the assertion that the smoking ban led to an immediate and dramatic decline in sudden cardiac deaths in Olmsted County is not merely a study conclusion, but is now a "fact." In other words, no further research needs to be done and the question is permanently settled. Furthermore, anyone who challenges this conclusion (like me) is out of touch with reality because they are challenging an established fact. There is no room for dissent. Anyone challenging this conclusion must be simply echoing a tobacco industry argument.

Actually, the tobacco industry no longer argues that secondhand smoke is not a risk factor for heart disease. And to my knowledge, the tobacco companies aren't even challenging the contention that studies like Dr. Hurt's are invalid because they contain no comparison group. In fact, that the tobacco companies have decided to stop publicly challenging these conclusions is precisely the reason why I believe the science in the anti-smoking movement is deteriorating. We are losing the rigor of our science because we can now get away with it.

In my opinion, the primary reason for this deterioration is that the tobacco companies have relinquished their role as watchdogs over the anti-smoking movement and its scientific claims.

To the best that I can pinpoint it, this shift occurred some time around 2000. Coincident with the tobacco companies' acknowledgment of the health hazards of cigarette smoking, it appears to me that they also changed their strategy with regards to challenging the scientific pronouncements of anti-smoking groups. Prior to that time, the tobacco companies would vigorously challenge the results of anti-smoking advocates' published studies. They would issue press releases, make public comments in newspaper articles, even take out advertisements challenging these conclusions.

But for about the last 12 years, the tobacco industry has -- presumably as part of a concerted, strategic decision -- laid low and allowed the anti-smoking advocates' and groups' scientific claims to remain unchallenged. They have remained relatively quiet and are basically allowing the anti-smoking scientific claims to remain unchallenged in the public eye.

I'll tell you why I think this is the critical factor that has led to the deterioration of the quality of tobacco control science.

Back in the 1990's, any time anti-smoking researchers or groups would publish scientific papers, they would be very worried about the potential reaction of the tobacco companies. Prior to submitting any paper, researchers would consider the questions "What will the tobacco companies say?" and "How can we make sure we can defend these conclusions against potential tobacco industry criticism?" The same was true of conclusions disseminated by anti-smoking groups.

In fact, much of my role in the movement was to serve as a source for assessment of the strength of conclusions being made by anti-smoking groups before they went public with them. Every day, I would get calls from anti-smoking groups asking me to review their fact sheets to make sure they were solid and that the claims would be defensible against any potential tobacco industry attacks.

There was a pervasive sense of fear among all of us in tobacco control that if we slipped in the slightest, the tobacco companies would be there to attack us and publicly shoot down our statements.

Thus, we were extremely careful in drawing conclusions. There was a much higher burden of evidence required before causal conclusions were drawn. A single cross-sectional study would almost never be relied upon to draw a causal conclusion, for example.

Without the tobacco companies playing their watchdog role, however, there is no longer this sense of fear. There is no longer a concern about results being attacked or conclusions being challenged. It has become essentially a free-for-all, where anything goes and no one has to worry about their conclusions being challenged. In fact, the movement has evolved into one where challenging its conclusions is tantamount to working for the tobacco industry. Anyone who does challenge the conclusions of the movement is attacked and accused of being a tobacco industry mole or sympathizer. Thus, there is little threat that conclusions of anti-smoking researchers or groups will be challenged in the first place or that if challenged, the individual criticizing the conclusions will be taken seriously.

Ironically, the Rest of the Story is one of the only watchdogs there is to monitor the quality of science in tobacco control.

In the long run, I believe the tobacco companies made a wise decision. First, they help shed their public image as corporations that are undermining the scientific conclusions of the health community. Second, by letting the anti-smoking groups run rampant, they probably realize that these groups will eventually destroy their own credibility by making more and more outlandish statements, until finally, the public loses faith in the scientific integrity of these anti-smoking groups.

Ironically, the tobacco companies actually have a lot more legitimate criticisms of the validity of anti-smoking groups' scientific claims now than they did during the time when the companies were actually challenging these claims.

Tuesday, November 06, 2012

Obsession with Nicotine as Sole Component of Smoking Addiction is Evident in Current Journal Issue; Ties with Big Pharma are Blinding Our Eyes

This month's issue of the journal Nicotine and Tobacco Research is devoted to articles on the study of nicotine receptors in mice and rats.

The articles in the issue include:
  • Nicotinic ACh Receptors in the Hippocampus: Role in Excitability and Plasticity
  • Preclinical Evidence That Activation of Mesolimbic Alpha 6 Subunit Containing Nicotinic Acetylcholine Receptors Supports Nicotine Addiction Phenotype 
  • Nicotinic Regulation of Energy Homeostasis 
  • From Men to Mice: CHRNA5/CHRNA3, Smoking Behavior and Disease Impact of Tobacco Regulation on Animal Research: New Perspectives and Opportunities 
  • Pharmacological Differences Between Rat Frontal Cortex and Hippocampus in the Nicotinic Modulation of Noradrenaline Release Implicate Distinct Receptor Subtypes 
  • Mice Lacking the β4 Subunit of the Nicotinic Acetylcholine Receptor Show Memory Deficits, Altered Anxiety- and Depression-Like Behavior, and Diminished Nicotine-Induced Analgesia
  • Bupropion and its Main Metabolite Reverse Nicotine Chronic Tolerance in the Mouse 
The issue also includes a summary review article of the significance of this research for the development of new smoking cessation drugs, which features as its example of the implications of this line of research the development of the nicotine vaccine.

The Rest of the Story

This issue of the journal Nicotine and Tobacco Research is a fine demonstration of the tobacco control  movement's preoccupation with nicotine as the sole component of smoking addiction and its obsession with treating smoking cessation at the molecular and cellular level.

However, smoking is a complex behavior that occurs not at the molecular level, but at the level of individual and the environment. Smoking addiction is far more than simply an addiction to nicotine. The behavioral, physical, and social stimuli associated with the smoking behavior play an important role. There is a body of research which demonstrates that the smoking behavior itself - even with nicotine - is self-reinforcing to some extent. De-nicotinized cigarettes have been shown to reduce symptoms of nicotine withdrawal.

The tobacco control movement's obsession with nicotine as the sole factor in smoking addiction has contributed to its missing a golden opportunity to save lives: the development of electronic cigarettes. These devices address not only the pharmacologic aspect of nicotine addiction, but the behavioral, physical, and social aspects as well. This is why preliminary clinical trials have shown that electronic cigarettes have great promise in helping smokers to reduce the amount they smoke or quit smoking altogether.

The tobacco control movement's pre-occupation with smoking cessation drugs that target nicotine receptors is not a coincidence. The movement is heavily funded by Big Pharma and has followed the money, rather than the best interests of the nation's smokers in finding ways to help them.

The Society for Research on Nicotine and Tobacco (SRNT), the producer of the journal Nicotine and Tobacco Research, is a prime example. The SRNT is funded by Big Pharma, and specifically, by pharmaceutical companies that manufacture smoking cessation drugs. For example, two of the major sponsors of the 2012 SRNT conference, which apparently provide financial support for SRNT that helps fund the annual conference, are Pfizer and GlaxoSmithKline. Pfizer, of course, is the manufacturer of varenicline (Chantix) and GlaxoSmithKline makes Zyban. Both of these are smoking cessation drugs.

The 2011 annual meeting of the Society for Research on Nicotine and Tobacco was supported by three different pharmaceutical companies: GlaxoSmithKline, Johnson & Johnson, and Pfizer.

On its web site, the Society for Research on Nicotine and Tobacco acknowledges financial support from three different pharmaceutical companies: GlaxoSmithKline, Johnson & Johnson, and Pfizer.

These pharmaceutical sponsorships create an unavoidable bias that precludes a truly objective consideration of any scientific issue that may have significant implications for the profitability of smoking cessation drugs, and therefore, for their manufacturers, who are SRNT sponsors. Thus, it is small surprise that SRNT's journal has devoted an issue to nicotine receptors in mice and rats.

Monday, November 05, 2012

Study Concludes that Thirdhand Smoke Could Cause Lung Damage in Hotel Housekeepers

A study published last year in the American Journal of Physiology warns that exposure to thirdhand smoke could cause lung damage in hotel housekeepers who change the bed sheets in rooms of smokers, even when no smoking is occurring at the time the housekeeper is cleaning the room. The study concludes that thirdhand smoke is a substantial hazard that puts anyone exposed at risk of lung damage. Thirdhand smoke is exposure to tobacco smoke that off-gasses from surfaces on which it has deposited during active smoking, although the exposure occurs when smoking is not present.

(See: Rehan VK, Sakurai R, Torday JS. Thirdhand smoke: a new dimension to the effects of cigarette smoke on the developing lung. Am J Physiol Lung Cell Mol Physiol 301:L1-L8, 2011.)

According to one of the study authors quoted in a KABC-TV article about the study, the results of the study showed that: "exposure to thirdhand smoke is as damaging, and in some cases, more damaging than secondhand or firsthand smoke." This was not an aberrant quotation, as a press release issued by the research institute where the authors work made the same claim.

The study itself 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, all over the world: a problem of global proportions!"

The Rest of the Story

What is the actual scientific evidence uncovered in this study of thirdhand smoke that demonstrates it is a problem of global proportions, threatening hotel workers throughout the world?

The evidence is as follows: "Fetal rat lung explants were exposed to nicotine, 1-(N-methyl-N-nitrosamino)-1-(3-pyridinyl)-4-butanal (NNA), or 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), the two main tobacco-specific N-nitrosamine constituents of THS, for 24 h. We then determined key markers for alveolar paracrine signaling [epithelial differentiation markers surfactant phospholipid and protein synthesis; mesenchymal differentiation markers peroxisome proliferator-activated receptor (PPAR- ), fibronectin and calponin], the BCL-2-to-Bax ratio (BCL-2/Bax), a marker of apoptosis and the involvement of nicotinic acetylcholine receptors (nAChR)- 3 and - 7 in mediating NNA’s and NNK’s effects on the developing lung. Similar to the effects of nicotine, exposure of the developing lung to either NNK or NNA resulted in disrupted homeostatic signaling, indicated by the downregulation of PPAR- , upregulation of fibronectin and calponin protein levels, decreased BCL-2/Bax, and the accompanying compensatory stimulation of surfactant phospholipid and protein synthesis. Furthermore, nAChR- 3 and - 7 had differential complex roles in mediating these effects. NNK and NNA exposure resulted in breakdown of alveolar epithelial-mesenchymal cross-talk, reflecting lipofibroblast-to-myofibroblast transdifferentiation, suggesting THS constituents as possible novel contributors to in utero smoke exposure-induced pulmonary damage."

To translate this into plain English:

"We chopped up fetal rat lungs into cubes and marinated the cubes in a solution containing nicotine, NNK, or NNA [which are tobacco-specific nitrosamines present in tobacco smoke that have been demonstrated to cause lung cancer and lung damage]. We found that exposure to these chemicals caused damage to the fetal rat lung tissue."

That's interesting, but how do you get from that to the conclusion that touching a bed sheet in a room where someone smoked is a problem of global proportions and may be even more hazardous than active smoking?

This is about as fallacious an extrapolation as I've ever seen in a scientific paper.

In fact, the paper did not study thirdhand smoke exposure and it did not study the effects of this exposure on humans under conditions of realistic exposure. It does suggest that if you splatter tobacco-specific carcinogens and toxins directly onto the lungs of children, you will cause damage, but it provides no evidence whatsoever regarding the actual effects of exposure to the residue left on surfaces after active smoking has concluded. And it certainly doesn't provide evidence that thirdhand smoke exposure is as harmful as or more harmful than active smoking.

The authors themselves acknowledge that: "We must state that a comprehensive assessment of the risks of THS on the developing lung, the molecular pathways, the specific cell-types involved, and the levels of different THS constituents required in mediating these risks requires further extensive characterization of levels of THS constituents in the environment, and the realistic exposure of the developing fetus and growing child to these constituents."

In other words, the authors acknowledge in the paper that in order to draw a conclusion about the actual risks associated with thirdhand smoke, one would need to examine and identify the "levels of different THS constituents required" to cause lung damage. But this study made no attempt to measure the levels of exposure to THS constituents under realistic conditions (or even under unrealistic conditions - it simply did not measure exposure to thirdhand smoke).

Unfortunately, this limitation did not stop the authors from concluding that thirdhand smoke is a health threat of global proportions that is as dangerous as, or perhaps even more dangerous than active smoking.

If readers were not convinced of the deterioration of the science within the anti-smoking movement last week when I revealed the poor quality and blatant bias of two recent studies purporting to show that smoking bans cause an immediate and dramatic reduction in heart attacks, they should hopefully be convinced by the rest of this story.

This is yet another example of a study conclusion that has no relation to the actual scientific investigation. The authors could have made the same conclusion without presenting any data. In fact, it has the appearance of investigators who had a pre-determined conclusion that they wanted to disseminate this conclusion and simply needed to have some data on hand to give them an excuse to spread their conclusion across the world.

It actually fits into the unscientific framework set up by the California research program which funded this work, as that program itself drew pre-determined conclusions about the effects of thirdhand smoke.


(Thanks to Michael McFadden for the tip.)

Friday, November 02, 2012

Meta-Analysis of Smoking Ban and Heart Attack Studies Seems to Have Cherry-Picked Its Data, Excluding the Second Largest Study Because It Failed to Find an Effect

As I reported here yesterday, in the largest meta-analysis to date of studies examining the effect of smoking bans on heart attack admissions, a paper published this week in the journal Circulation concludes that smoking bans lead to an immediate 15% decline in heart attack admissions or deaths. I noted that the authors excluded from the analysis a study which found no effect of smoking bans on heart disease deaths in six states. After further examination of the reasons provided by the authors for the exclusion of that study, I have concluded that there was no valid reason for the study's exclusion and it appears to be motivated by a desire to exclude the negative findings than by a valid scientific justification.

To remind you, in that study (Rodu B, Peiper N, Cole P. Acute myocardial infarction mortality before and after state-wide smoking bans. J Community Health 2011), the authors examined age-adjusted rates of heart attack mortality during the 3 years before implementation of the smoking ban and during the first year after the smoking ban was implemented in the eight states that implemented smoking bans between 1995 and 2003. These trends were also compared with those in the 44 other states without smoking bans.

The results were that in four of the six states (California, Utah, Delaware, and South Dakota), the smoking bans were not associated with any significant short-term decline in heart attack mortality. In one of these states - South Dakota - there was an 8.9% increase in heart attack mortality during the first year of the smoking ban which was significantly different from the expected decline of 7.2%. These results certainly seem to refute the assertion that smoking bans lead to a dramatic, immediate decline in heart attacks.

The authors of the meta-analysis give two major reasons for excluding the Rodu study:

1. The study "did not report or present data that permitted estimating relative risk and confidence intervals."

2. "In addition, the analysis was based on a very small number of data points...".

The Rest of the Story

Let's examine each of these supposed justifications for excluding the Rodu study.

1. The study "did not report or present data that permitted estimating relative risk and confidence intervals."

The raw data to calculate these relative risks and confidence intervals would gladly have been provided by Dr. Rodu had the meta-analysis authors simply asked him for the data. The authors acknowledge that they contacted the authors of another study (the "Malta" study) to provide additional information, but they apparently made no attempt to contact Dr. Rodu. Given the large size and importance of the Rodu study, its exclusion is not scientifically justified on these grounds, especially since the data were only one email away.

2. "In addition, the analysis was based on a very small number of data points...".

This is untrue. The Rodu study was actually the second largest study ever conducted. It examined heart attack death rates in six different states. Most of the other studies examined heart attacks in only one community, and many of those communities were small. Dr. Glantz' own study, in which he concluded that a smoking ban in Helena, Montana reduced heart attack admissions, was based on a decrease of only 16 cases.

A number of the studies included in the meta-analysis had very small sample sizes. As Rodu et al. point out in their paper: "In Helena there were 40 and 24 admissions for AMI before and after the smoke-free ordinance; in Pueblo the corresponding numbers were 399 and 291; in Bowling Green, 36 and 22; and in Monroe County, 17 and 5." In contrast, the Rodu study was based on a total of nearly 40,000 heart attack deaths.

In my view, there is no justification for excluding such an important study: the study with the second largest sample size of all. Moreover, if one is going to exclude studies based on low sample size, then you need to be consistent. If the authors wanted to exclude studies with low sample size, then they should have set a threshold and excluded all studies below that threshold. Of course, if the threshold was set above the sample size of the Rodu study, that would have resulted in throwing out most of the studies they reviewed.

It is therefore my opinion that underneath the surface, the real reason for the exclusion of the Rodu study was that it showed negative results among a systematic sample of large populations. The study is fatal to the notion that smoking bans produce dramatic, immediate, and measurable reductions in heart attacks.

Most worrisome about the cherry-picking that is evident in this meta-analysis is that this is precisely what the authors of the meta-analysis have attacked the tobacco companies for doing in their own analyses in the past.

The rest of the story is that the scientific quality of research in the area of smoking bans and heart attacks has deteriorated to such a level that we are now using techniques that we attacked tobacco companies for using in the past: failing to include comparison groups in our analyses, being inconsistent in our criteria for including studies, and employing a systematic bias in our interpretation of the results so as to produce favorable findings.