Why Requirement That All Smokers Be Prescribed Medication is Inappropriate: It Violates Basic Medical Principles for Benefit of Pharmaceutical Profits

Yesterday, I revealed that the Joint Commission's new tobacco treatment accreditation standard was created by a panel whose chair is financially conflicted by virtue of current and multiple past financial relationships with pharmaceutical companies that market or are developing smoking cessation drugs. As I noted, the standard requires hospitals to offer smoking cessation drugs to every smoking patient upon discharge.

The purpose of yesterday's post was not necessarily to criticize the requirement itself, but to criticize the fact that the standard was set by a severely conflicted panel: one whose chair has and has had financial conflicts of interest with Big Pharma.

Today, I explain why this requirement is inappropriate.

The Rest of the Story

Quite simply, the requirement is inappropriate because it requires hospitals to offer smoking cessation medication to every smoking patient, even if in the judgment of the treating physician, prescribing a smoking cessation drug is not the most appropriate and effective treatment for his or her patient.

There are many available treatments for smoking dependence and the most effective treatment plan should be individualized. As with most other aspects of medicine, there is no room for a one-size-fits-all, strictly prescribed treatment plan for every patient, regardless of individual circumstances.

Take the example of type II diabetes. One would not set a standard that requires every patient diagnosed with type II diabetes to be treated with an FDA-approved diabetes medication. In fact, 90% of cases of type II diabetes can be adequately treated with exercise and diet alone. To require every hospital to prescribe a diabetes medication to every type II diabetes patient upon discharge would be inappropriate. The appropriate treatment depends on the individual circumstances.

However, the Joint Commission panel's requirement ignores individual circumstances and undermines the judgment of the treating physician in favor of setting a one-size-fits-all mandate that every smoker be prescribed an FDA-approved smoking cessation drug. In many cases, this will not be the most appropriate choice of treatment. Yet hospitals may risk losing accreditation if they fail to follow the standard.

For example, consider a patient with the following history:

Patient X is admitted and treated for a kidney stone. She has a 25 year history of smoking. She has tried nicotine replacement therapy on six different occasions and failed to quit smoking on any of those occasions. She tried Chantix once but discontinued the drug because of severe side effects. Two years ago, she tried hypnotherapy which was very successful. She kept off cigarettes for nearly two years. However, she resumed smoking one month prior to admission due to the stress related to the loss of her job. She is now employed at a new position which she loves, but she hasn't tried to quit smoking since she resumed working.

In this case, the treating physician might legitimately and appropriately believe that the best treatment for the patient would be to try hypnotherapy again. She tried NRT six times and failed so prescribing NRT does not seem likely to be effective. Prescribing Chantix is probably not appropriate given the severe side effects the patient experienced. However, the patient has already been quite successful with hypnotherapy and her sustained period of cessation was interrupted only because of severe stress, which has now been relieved. It seems that a second trial of hypnotherapy might be the most effective and appropriate approach. At very least, it would be reasonable for a physician to so opine.

The Joint Commission panel's standard, however, would find this physician and this hospital in non-compliance. The patient must be offered an FDA-approved smoking cessation drug. Hypnosis doesn't cut it. Acupuncture doesn't cut it. Electronic cigarettes do not cut it. Even if the patient has previously had success with one of these approaches and no success with FDA-approved cessation drugs.

In many ways, this violates a basic principle of medicine: that each patient should be treated in that patient's best interests, without regard to the financial profits of corporations. In this case, the decision is being made not based on what is best for the patient, but what is best for the pharmaceutical companies.

That such a requirement was developed by a panel whose chair has a history of financial conflicts of interest with Big Pharma makes it completely unacceptable.

Chair of Panel Setting Joint Commission Standards on Smoking Cessation for Hospitals is Financially Conflicted

The Joint Commission is a body that sets standards for the accreditation of hospitals and health care facilities. Since most states require hospitals to be accredited to receive Medicaid reimbursement, following the standards set by the Joint Commission is quite important for most hospitals.

Recently, a panel of the Joint Commission developed standards regarding tobacco use screening and treatment. These standards go into effect in January 2012 and they therefore become a part of the accreditation assessment for hospitals.

While some aspects of the standards set by the panel are straightforward and non-controversial (e.g., all patients should be screened for tobacco use), one striking aspect of the standards is that every patient should be treated with smoking cessation drugs, unless there is a specific contraindication.

As stated by the panel, the smoking treatment standards are "consistent with the 2008 United States Public Health Service Guideline, Treating Tobacco Use and Dependence" and require "that all tobacco users be identified, that tobacco users be provided or offered both evidence-based counseling and medications during the hospitalization and upon discharge, and that tobacco use status be assessed post-discharge."

According to the panel's standards, not only must every patient be treated with smoking drugs during hospitalization (unless contraindicated), but every patient should be prescribed an FDA-approved smoking cessation drug upon discharge.

This recommendation is not exactly evidence-based, because there is a large body of research showing that FDA-approved smoking cessation drugs are highly ineffective, failing to work in the overwhelming majority of patients who are treated with them. Long-term success rates with these drugs are on the order of about 8%. Thus, they have about a 92% failure rate. This makes the recommendation that every patient be prescribed one of these drugs upon discharge quite curious.

The Rest of the Story

Perhaps the recommendation that every patient be prescribed one of the dismally effective FDA-approved smoking cessation drugs is not so mysterious when one learns that the chair of the Joint Commission panel that set this standard has a conflict of interest by virtue of his receiving grant funding from a pharmaceutical company that is in the late stages of developing what it hopes will soon be ...

... an FDA-approved smoking cessation drug.

Moreover, panel chair has a long history of financial conflicts of interest with pharmaceutical companies that manufacture FDA-approved smoking cessation drugs.

The panel chair is Dr. Michael Fiore, who is currently receiving grant funding from Nabi Pharmaceuticals, which has a smoking cessation drug in the late stages of development. The drug is a nicotine vaccine which has been given fast track status by the FDA "for use as a therapeutic for smoking cessation."

Clearly, it is to Nabi Pharmaceutical's great financial interest to have in place as it begins to market this drug a hospital standard requiring all smokers to be prescribed at discharge and FDA-approved smoking cessation drug.

We are talking about an enormous amount of money here. Nabi Pharmaceuticals estimates that the nicotine vaccine market will be $2.1 billion in sales: "The smoking cessation Rx market is young and growing. Datamonitor estimates that the market will grow at a compound annual growth rate of 11% and will reach approximately $3.8 billion by 2018. Datamonitor forecasts that nicotine vaccines will account for $2.1 billion of these sales."

Thus, NicVAX is projected to be the most prescribed smoking cessation medication and the drug to benefit most from the Joint Commission panel's recommendation that every smoking patient leave the hospital with a smoking cessation drug prescription in hand. In fact, giving patients the nicotine vaccine prior to discharge will become the easiest way for hospitals to meet the Joint Commission panel's standards.

On top of the current financial conflict of interest with Big Pharma, Dr. Fiore has a long history of similar conflicts: In 2008, Dr. Fiore "reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome."

In 2008, Dr. Fiore reported "that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."

According to Dr. Fiore's testimony in the Department of Justice tobacco lawsuit: "GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence. That donation by GlaxoSmithKline was to the University. Named chairs at the University of Wisconsin provide the person who sits in that chair to access to the revenue generated from the investment on the initial grant. So in this instance, I have access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities." Dr. Fiore recently gave up this endowed Chair position, but the past conflict is enormous and it appears that much of the panel's work occurred during a time when this conflict was still present.

In his 2005 testimony, Dr. Fiore also admits that he did "consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."

In 2000, Dr. Fiore reported that he "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome."

I have no problem with researchers receiving pharmaceutical funding to conduct clinical research. However, scientists with financial conflicts of interest should not be put in a position of making national recommendations regarding the use of those medications. And they absolutely should not be in the position of setting standards for hospital accreditation when those standards involve the use of medications made by companies with which they have financial conflicts of interest.

This is not an issue of small potatoes. We're talking about potentially $2.1 billion of sales for Nabi Pharmaceuticals. Having Dr. Fiore as chair of the technical advisory panel for the Joint Commission on smoking cessation treatment standards is like giving Big Pharma a seat at the table. Why not just allow the pharmaceutical companies to write the standards that dictate hospitals' prescribing patterns for smoking cessation drugs? Frankly, such a process would have resulted in precisely the same recommendation as this expert panel.

It's a shame that the Joint Commission allowed financially conflicted scientists to participate in the setting of standards for hospitals. It gives pharmaceutical company interests an undue influence - albeit indirectly - on drug prescription policy.

First Clinical Trial of Electronic Cigarettes Suggests They May Be More Effective Than Traditional NRT Products

The results of the first clinical trial of electronic cigarettes, reported yesterday in the journal BMC Public Health, suggest that these devices may be more effective than traditional NRT products for smoking cessation and may be particularly effective in smokers who are unmotivated to quit.

(see: Polosa R, et al. Effect of an Electronic Nicotine Delivery Device [e-Cigarette] on Smoking Reduction and Cessation: A Prospective 6-Month Pilot Study. BMC Public Health 2011; 11:786 doi:10.1186/1471-2458-11-786)

The subjects were 40 healthy, adult, regular smokers with no interest in quitting. They were provided with electronic cigarettes and minimal intervention (a baseline and four follow-up clinic visits). They were not instructed to try to quit smoking, but were simply allowed to use the electronic cigarettes however they wished.

The sustained smoking abstinence rate at six-month follow-up was 22.5%.

The proportion of subjects who experienced a sustained reduction in the amount smoked by at least 50% was 32.5%.

Thus, 55% of subjects either cut down their consumption by 50% or more or quit smoking altogether at six months follow-up.

No serious adverse events were reported in the study.

The authors conclude: "Although not formally regulated as a pharmaceutical product, the e-Cigarette can help smokers to remain abstinent or reduce their cigarette consumption. By replacing tobacco cigarettes, the e-cigarette can only save lives. Here we show for the first time that e-Cigarettes can substantially decrease cigarette consumption without causing significant side effects in smokers not intending to quit."

The Rest of the Story

Based on a Cochrane review of seven studies that measured smoking cessation using nicotine replacement therapy (NRT), the average 6-month point prevalence of smoking abstinence is only 17.8%, and the 6-month point prevalence of smoking abstinence in the pooled data from these studies is only 11.9%. However, these were generally studies of smokers who were motivated to quit. The fact that this trial found a 6-month abstinence rate of 22.5% among a sample of smokers who were not motivated to quit is quite encouraging.

Moreover, the NRT clinical trials generally involved substantial intervention and encouragement to quit smoking. This trial simulated a real-life experience, where no motivation or support was offered to subjects to quit smoking. In fact, smokers who expressed interest in cessation services were withdrawn from the study. The fact that 22.5% of smokers quit and an additional 32.5% reduced their cigarette consumption by at least half suggests that electronic cigarettes are a promising strategy for both harm reduction (reduction in cigarette consumption) and smoking cessation.

Further trials are necessary to confirm these results and especially, to try electronic cigarettes as a strategy for smoking cessation among smokers who are motivated to quit. Nevertheless, the results of this initial clinical trial are encouraging. Electronic cigarettes appear to be a promising strategy for smoking cessation. Use of these devices among smokers who are unable to quit with other available methods (such as NRT) should be encouraged by health professionals, anti-smoking groups, and the FDA.

If Anti-Smoking Groups Want Electronic Cigarettes Off the Market, Why Aren't They Calling for FDA to Remove Propylene Glycol from Cigarettes?

And Why is FDA Scaring Ex-Smokers About Use of Electronic Cigarettes But Failing to Remove Propylene Glycol from Regular Cigarettes?

Most electronic cigarettes involve the vaporization of a liquid containing nicotine dissolved in glycerin and/or propylene glycol. The major question regarding the long-term safety of these devices is whether or not long-term inhalation of propylene glycol may have adverse respiratory effects. Two initial studies, one conducted recently by Philip Morris, suggest that propylene glycol appears to be safe for long-term inhalation. Nevertheless, the chief health concern regarding e-cigarettes remains the long-term effects of inhalation of propylene glycol and any other chemicals resulting from the heating of propylene glycol.

Other than that (and the effects of nicotine exposure itself), there are really no outstanding health concerns regarding electronic cigarettes, since the issue of diethylene glycol seems to have been solved and the levels of carcinogens (tobacco-specific nitrosamines) in electronic cigarettes are only trace levels, comparable to those in nicotine patches and nicotine gum.

With this as background, consider that at least eight anti-smoking and health groups have called for the removal of electronic cigarettes from the market, because they do not feel that these products have been deemed safe for use. Presumably, these groups are concerned about the long-term effects of propylene glycol inhalation, and the inhalation of byproducts resulting from the heating of propylene glycol.

Similarly, the FDA has scared ex-smokers about the toxins in electronic cigarettes, encouraging them to return to cigarette smoking rather than remain smoke-free using e-cigarettes, presumably also because of concerns over the effects of the long-term inhalation of propylene glycol and any associated byproducts of the heating of propylene glycol.

The Rest of the Story

If the FDA and the anti-smoking and health groups are so concerned about the effects of long-term inhalation of propylene glycol and any byproducts that result from heating propylene glycol, then these very same groups ought to be immediately banning (or calling for a ban on) the use of propylene glycol in regular cigarettes.

After all, if the concerns about the safety of long-term inhalation of propylene glycol are serious enough that we need to discourage smokers from switching from regular cigarettes to electronic cigarettes, then certainly we must have enough concern about long-term inhalation of propylene glycol to require the elimination of this additive from all cigarettes.

And if we are concerned enough about the potential effects of byproducts that result from the simple heating of propylene glycol, then certainly we must be even more concerned about the health effects of combusted propylene glycol, as occurs in many cigarettes.

Since propylene glycol is an additive, the FDA could easily ban its use in regular cigarettes.

Why aren't the anti-smoking groups calling for a ban on propylene glycol in cigarettes? Why hasn't the FDA taken rule-making action to prohibit the use of propylene glycol in cigarettes?

The answer, I believe, is that the FDA's regulation of tobacco products is a sham. It is essentially a Congressional hoax -- a deal set up between politicians and Philip Morris -- to achieve the dual purposes of providing a political victory to the politicians (making it look like they were standing up to Big Tobacco) and an economic victory to Philip Morris (institutionalization of its dominant market share and the elimination of the most serious potential threats to cigarette regulation that could otherwise substantially put a dent in its profits).

Not only is the entire idea of FDA regulation of tobacco products a sham, but the way in which the agency is implemented the law is as well. The approach so far has been to give the most scrutiny to the safest of the spectrum of products on the market (a.k.a, the initial agency ban on electronic cigarettes, the focus on dissolvable tobacco products) and to let the most hazardous products continue to kill hundreds of thousands of Americans, unfettered by meaningful and significant regulation (a.k.a., no ban on menthol cigarettes, no ban on propylene glycol in cigarettes, no regulation of any other hazardous chemicals in cigarettes, no regulation of carcinogens in cigarettes, etc).

In other words, so far the FDA has done absolutely nothing to reduce cigarette use or to make cigarettes safer. It has, however, undermined successful smoking cessation for thousands of successful ex-smokers by urging them to return to regular cigarettes rather than use electronic cigarettes which are loaded with "toxins," "carcinogens," and "anti-freeze."

The anti-smoking groups, for their part, are playing right along with the scam. On the one hand, they are apparently concerned about the effects of long-term inhalation of propylene glycol, demanding that it be shown to be safe before being allowed to be used to help get smokers off of regular cigarettes. On the other hand, they are unwilling to step up and apply the same principle to the real cigarettes, as not a single one of them has called for the FDA to remove propylene glycol as an additive to regular cigarettes.

To be clear, I am not myself calling for a ban on propylene glycol in cigarettes. In fact, I disapprove of the entire idea of regulating the safety of this product by controlling the levels of individual constituents, when there are between 10,000 and 100,000 of those constituents in tobacco smoke. I think the entire process - the entire regulatory scheme - is absurd.

However, I do expect some consistency from anti-smoking groups and from the FDA. I do expect regulation and policy to be guided by science, rather than by politics and ideology. So far, science is taking a back seat. To be exact, the back row of seats in a long, stretch limousine.


NOTE: R.J. Reynolds has responsibly disclosed the ingredients and additives it uses in its products. It lists propylene glycol as an additive in numerous brands of cigarettes, including (but not limited to): Camel Crush, Camel Filters 99 Hard Pack, Camel Filters Hard Pack, Camel Filters Soft Pack, Camel Filters Menthol, Camel Menthol Silver Hard Pack, Camel Blues, Camel No. 9, Camel Turkish, Camel Wides, Kool (all sub-brands), Salem (all sub-brands), Doral (all sub-brands), Newport (all sub-brands), and Lucky Strike non-filter soft pack.

Rest of the Story Puts Odds of National Tobacco Conference Not Taking Big Pharma Money at 13:1

The 2012 National Conference on Tobacco or Health will be held next July in Kansas City.

Among the program areas to be discussed are:

1. Cessation: "Includes reimbursement and insurance issues; telephone quitline services; innovative methods; cessation programs in the workplace, health care, or other settings; cessation programs for youth and adults; cessation interventions for specific populations; and cessation training programs and certification."

2. Non-Cigarette Tobacco and Nicotine Products: "Includes smokeless tobacco prevention strategies of smokeless tobacco industry strategies; e.g. rodeo sponsorships; alternative nicotine delivery devices and related products; and smokeless tobacco and alternative products as harm reduction."

In my view, it is impossible for an objective discussion of smoking cessation treatment (e.g., the effectiveness of pharmaceuticals) and alternative nicotine delivery products (such as electronic cigarettes) to take place at a conference sponsored by pharmaceutical companies.

For example, imagine that the conference were being sponsored by an electronic cigarette company. Arguably, tobacco control advocates from across the country would vigorously protest, demanding that the sponsorship be rescinded because no objective consideration of the role of electronic cigarettes in tobacco control can take place at a conference where money is coming in from the electronic cigarette companies.

Well the same is true with pharmaceutical sponsorship. How can the role of smoking cessation drugs be objectively considered at a conference sponsored by the manufacturers of those very products?

The Rest of the Story

While the 2012 sponsors of the National Conference on Tobacco or Health have not yet been announced, I put the early odd of the conference not accepting Big Pharma sponsorship at 13:1. On its web site page seeking sponsors, the conference is highlighting its past sponsorship by pharmaceutical companies, including Pfizer and GlaxoSmithKline. This seems to indicate a willingness, if not a desire, to obtain pharmaceutical sponsorship again this year for the 2012 conference.

For the betters among you, I have the over-under at $20,000.

Boston Public Health Commission Considering Regulation to Ban Electronic Cigarette Use in the Workplace

The Boston Public Health Commission is considering a new regulation which would ban the use of electronic cigarettes in the workplace. The regulation would also restrict the sale of electronic cigarettes to minors and require a permit for selling these products.

The proposed regulation cites as a justification for the ban on electronic cigarette use (vaping) in the workplace: "the U.S. Food and Drug Administration has conducted laboratory tests that found e-cigarettes contain toxic chemicals and carcinogens; and the health effects of involuntary exposure to e-cigarette vapors containing these chemicals and carcinogens is unknown."

The Rest of the Story

The FDA scared the public and implied that electronic cigarettes present a substantial risk of cancer to users by reporting its laboratory finding that electronic cigarettes are dangerous because they contain carcinogens. The FDA failed to inform the public about the level of carcinogens they detected and how it compares to the level of tobacco-specific nitrosamines in regular cigarettes and in nicotine replacement products. The truth is that the FDA found only trace levels of carcinogens, comparable to those found in nicotine patches and nicotine gum, and orders of magnitude below the levels of these same carcinogens in regular cigarettes.

The rest of the story is that:

• The FDA found only trace levels of tobacco-specific nitrosamines in electronic cigarettes, comparable to those found in FDA-approved nicotine replacement products like nicotine patches and nicotine gum.
• The levels of carcinogens that have been detected in electronic cigarettes are orders of magnitude lower than in regular cigarettes, indicating that electronic cigarettes are likely much safer than regular cigarettes in terms of cancer risk.
• The minute levels of tobacco-specific nitrosamines in electronic cigarettes are a necessary result of the extraction of nicotine from tobacco. Overall, these devices deliver nicotine with only a few other chemicals, compared to the delivery of nicotine plus tens of thousands of chemicals and more than 60 proven carcinogens in regular cigarettes.
• There is no evidence, and little reason to believe, that there would be any significant exposure to carcinogens among bystanders in the proximity of electronic cigarette users.

As far as the presence of "toxic chemicals" goes, the FDA reported only one such chemical (diethylene glycol) and it was present in just one cartridge of one brand of electronic cigarettes. Subsequent to that investigation, multiple brands of electronic cigarettes have been tested for diethylene glycol and not a single brand has been found to contain this chemical. It appears that this was an anomaly caused by one company's use of a non-pharmaceutical grade of propylene glycol. The use of pharmaceutical grade propylene glycol should not result in the presence of diethylene glycol in the electronic cigarette, which appears to be the case with every other brand of electronic cigarettes that has been tested subsequently.

The public needs to understand that there is presently no more scientific justification for banning electronic cigarette use in the workplace than there is for banning the use of the nicotine inhaler, which many smokers are using in an attempt to quit smoking. Both contain similar levels of tobacco-specific nitrosamines, and there is no evidence that the use of these inhaled products results in any significant carcinogenic exposure among bystanders.

Moreover, the statement that we don't know what vapers are inhaling is a myth. Electronic cigarette emissions have been tested in numerous laboratory studies. Cahn and I reviewed these studies in our review article published in the Journal of Public Health Policy.

We concluded as follows:

"As ~5300 of the estimated 10 000–100 000 chemicals in cigarette smoke have ever been identified,[4] we already have more comprehensive knowledge of the chemical constituents of electronic cigarettes than tobacco ones. We were able to identify 16 studies[5–17] that have characterized, quite extensively, the components contained in electronic cigarette liquid and vapor using gas chromatography mass spectrometry (GC-MS) (Table 1). These studies demonstrate that the primary components of electronic cigarette cartridges are propylene glycol (PG), glycerin, and nicotine. Of the other chemicals identified, the FDA has focused on potential health hazards associated with two: tobacco-specific nitrosamines (TSNAs) and diethylene glycol (DEG).[5]

TSNAs have been detected in two studies at trace levels.[5,6] The maximum level of total TSNAs reported was 8.2 ng/g.[6] This compares with a similar level of 8.0 ng in a nicotine patch, and it is orders of magnitude lower than TSNA levels in regular cigarettes.[18] Table 2 shows that electronic cigarettes contain only 0.07–0.2 per cent of the TSNAs present in cigarettes, a 500-fold to 1400-fold reduction in concentration. The presence of DEG in one of the 18 cartridges studied by the US Food and Drug Administration (FDA) is worrisome, yet none of the other 15 studies found any DEG. The use of a non-pharmaceutical grade of PG may explain this
contamination.

Other than TSNAs and DEG, few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns. Although the existing research does not warrant a conclusion that electronic cigarettes are safe in absolute terms and further clinical studies are needed to comprehensively assess the safety of electronic cigarettes, a preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products."

In summary then, there is presently no evidence that electronic cigarettes pose any known health threat to bystanders. In other words, there is no evidence that secondhand vaping poses any health hazards.

Perhaps it would be helpful here for me to present my philosophy regarding the criterion that justifies government action to ban a personal behavior in order to protect the health of bystanders. The criterion I have always adhered to is that the burden of proof is on the government to demonstrate that the behavior in question endangers the health of others. There must be substantial evidence, in other words, that a health hazard exists. The mere possibility of a health hazard is not, in my opinion, sufficient to justify banning a widespread public behavior.

For example, when I have lobbied for laws and regulations to ban smoking in the workplace, my testimony has always been based on substantial evidence of the health hazards associated with secondhand smoke exposure. I never asked any city council or state legislative body to ban smoking in workplaces simply because of the "possibility" that secondhand smoke exposure might be harmful. I, and other anti-smoking advocates, did not demand government intervention until sufficient scientific evidence had accumulated to support the contention that secondhand smoke exposure in the workplace was a cause of health harm among exposed nonsmoking workers.

There are many exposures, which, from time to time, the media or the public associate with potential harm to the public. If government agencies banned these exposures every time there was mere speculation that the exposure might be harmful, it would prove to be an undue and overly burdensome level of intervention in the workplace.

For example, Action on Smoking and Health has argued that the breathe of smokers is itself toxic and has promoted the idea of banning smokers from the workplace simply because of speculation that exhaled toxins could threaten the health of nonsmokers. Would we not all agree that for the government to take such an intrusive action without actual evidence of harms to nonsmokers caused by exhaled chemicals from smoking employees would be inappropriate?

I have two other concerns about setting a precedent of the government banning behaviors in the absence of scientific evidence that those behaviors are causing health harm. First, might it undermine efforts to protect the public in situations where we really do have evidence of harm? In this case, I fear that basing a non-vaping regulation on no scientific evidence of harm could undermine efforts in other states - which do not yet have workplace smoking laws - to protect the public from the hazards of secondhand smoke in the workplace.

Second, banning electronic cigarette use in the workplace could place an undue burden on smokers who are trying to quit smoking using electronic cigarettes or ex-smokers who have successfully quit using e-cigarettes and who are trying to stay smoke-free.

Finally, I want to make it clear that I do not oppose the aspect of the proposed regulation regarding the sale of electronic cigarettes to minors. Certainly it is reasonable to make sure that electronic cigarettes cannot be easily purchased by minors. My comments relate solely to the portion of the proposed regulation that bans vaping in the workplace.

Baylor Health Care System Will Not Hire Smokers Trying to Quit or Ex-Smokers Who Remain Off Cigarettes Using Nicotine Replacement Therapy

The Baylor Health Care System has announced that it will no longer hire smokers. But the policy goes far beyond that. The hospital system will not consider for employment smokers who are trying to quit using nicotine replacement therapy or electronic cigarettes. Nor will it hire ex-smokers who are successfully keeping themselves off of cigarettes by using NRT products or electronic cigarettes.

The policy is not simply an anti-smoker policy. It is an anti-nicotine policy. It forbids the employment of anyone who uses nicotine in any form, even if the person is using a product like electronic cigarettes in order to successfully keep away from cigarette smoking.

The Rest of the Story

This policy is making a moral statement, not a public health statement. In fact, in some ways the policy deters the improvement of the public's health by casting a dark cloud on the millions of smokers who are making or have successfully made quit attempts using nicotine replacement therapy, whether in the form of nicotine patches, gum, inhalers, or electronic cigarettes.

Why would a health care system want to discourage people from quitting smoking using nicotine-containing products?

The Baylor Health Care System appears to have joined the abstinence-only movement which has proven so counterproductive in public health.

Hearing on Cigarette Warnings Reveals Key Issue: Are Proposed Labels Warnings or Advocacy Statements?

I have been writing for the past several weeks about what I see as a key issue in the lawsuit regarding the FDA's proposed cigarette warning labels: whether the proposed labels represent merely warnings about the health effects of smoking or whether they are really anti-smoking advertisements designed primarily to promote smoking cessation. According to an Associated Press article regarding last week's hearing before the District Court judge, this does appear to be a key issue in the case and Judge Richard Leon directly questioned the government attorney about this.

According to the article: "A federal judge peppered a government lawyer with questions Wednesday expressing doubts about whether the Food and Drug Administration can force tobacco companies to post graphic images on their cigarette packages showing the health effects of smoking. In a two-hour hearing, U.S. District Judge Richard Leon closely questioned Justice Department lawyer Mark Stern on whether the nine graphic images proposed by the FDA convey just the facts about the health risks of smoking or go beyond that into advocacy — a critical distinction in a case over free speech. ... Lawyers for the tobacco companies argued that the government is free to tell people how to live — through steps such as enacting smoking bans on teenagers and by requiring written, factual warnings on the sides of cigarette packages from the surgeon general about the effects of smoking. But what the government cannot do is "conscript" the companies "into an anti-smoking brigade," noted First Amendment lawyer Floyd Abrams told the judge. The judge questioned Stern about why the images did not amount to advocacy. "What do you say is the line" between advocacy and fact? he asked Stern. "This is not an ordinary product" and the images coupled with written warnings are designed to communicate the dangers to the public — including youngsters as well as adults, Stern replied."

The Rest of the Story

You can see why I argued yesterday that the amicus brief submitted by the Campaign for Tobacco-Free Kids and other anti-smoking groups hurts the government's case. In the hearing, government lawyer Mark Stern was very careful to insist that the purpose of the graphic warning labels is to "communicate the dangers to the public." He apparently argued that the graphic nature of the warnings is necessary in order to effectively communicate the dangers, as evidence shows that the current warnings are not effectively doing so.

In contrast, the amicus brief argues that the purpose of the graphic warnings is to send an anti-smoking message, encouraging smokers to quit by referring them to a telephonic counseling service, which the groups assert has proven effective in promoting smoking cessation.

Now, the FDA is in the awkward position of having to counter the amicus brief and convince the judge that the reasons for the graphic warning labels set forward in the brief by the anti-smoking groups are not the real reasons that the FDA has proposed these warnings.

While it is true that tobacco is not an ordinary product and that the type of warning that might be sufficient for a typical consumer product may not be effective for cigarettes, this would still not seem to explain why the 1-800-QUIT-NOW message needs to be included on the label. To me, the inclusion of that requirement is the chief legal problem with the proposed labels, as it appears difficult to assert that the inclusion of the smoking cessation number is intended and necessary to effectively convey a health warning, rather than intended to promote smoking cessation and help smokers quit by referring them for telephonic counseling.

According to the AP, Judge Leon indicated that he hopes to issue a ruling by the end of October.

Amicus Brief Submitted by Anti-Smoking Groups Undermines Case for Graphic Cigarette Warning Labels

A consortium of anti-smoking and health groups - including the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society, American Lung Association, American Medical Association, and the American Academy of Pediatrics - has submitted an amicus brief with the D.C. District Court to support the FDA's proposed graphic cigarette warning labels, which have been challenged by R.J. Reynolds, Lorillard, and several smaller tobacco companies.

The brief begins by making several strong points. First, it establishes that warning consumers about the health effects of smoking is a legitimate government interest. Second, it establishes that the current warning labels are insufficient for this purpose (there is abundant evidence to support this contention). Third, it provides evidence that the revised, graphic warning labels represent an improvement and that consumers are more likely to pay attention to them.

The Rest of the Story

At this point, however, the brief makes a surprising blunder. Rather than sticking to the argument that the revised warning labels will be more effective by virtue of more effectively delivering information about the adverse health effects of cigarette smoking, the brief essentially shows its hand of cards: it puts forward the argument that including the national quitline number on the cigarette pack will encourage individuals to quit smoking and help them quit by offering them assistance to do so about which they would not otherwise have known.

The brief argues: "Finally, there is also strong scientific evidence demonstrating the value of including the national quitline number, 1-800-QUIT-NOW, in the graphic warnings to inform consumers about the availability of assistance if they want to quit. As the Institute of Medicine found, quitlines have proven “effective … in helping individuals to stop smoking”—increasing smoking abstinence by as much as 30 to 50 percent. Id. at 237. Based on a careful review of the evidence, the U.S. Public Health Service similarly concluded that smokers who use telephone quitlines are significantly more successful at quitting than those who get little or no counseling. U.S. Pub. Health Serv., Clinical Practice Guidelines, Treating Tobacco Use and Dependence: 2008 Update 91-92 (2008).14 The Public Health Service’s guidelines accordingly recommend that “clinicians and health care delivery systems should both ensure patient access to quitlines and promote quitline use.” Id. at vii. These conclusions are consistent with well-established evidence confirming that by providing a direct and immediate cue for action, quitlines significantly increase the likelihood of changes in behavior. See, e.g., David B. Abrams, et al., Boosting Population Quits Through Evidence-Based Cessation Treatment and Policy, 38 Am J. Prev. Med. Supp. S351-363 (2010)."

This argument goes beyond the need to improve the warning message to make it more effective. First, it speaks to a desire not only to warn people about the health effects of smoking, but to encourage then to quit (beyond any desire to quit that might be associated with knowledge of health effects). Second, it demonstrates that the purpose of the revised warning labels is not merely to communicate health information more effectively, but to serve as an anti-smoking advertisement that promotes smoking cessation. Third, the argument acknowledges that an additional purpose of the warning label, beyond informing consumers about the health effects of the product, is to make them aware of a particular smoking cessation quitline service: in essence, to refer them for telephonic smoking cessation counseling. The brief essentially admits that a major purpose of the new warning labels is to "ensure patient access to quitlines and promote quitline use." The warning label is intended to serve as a "direct and immediate cue for action."

These purposes go far beyond the legitimate government interest in effectively communicating to the public a warning about the health effects of cigarette smoking. In the exact words of the interveners, a major purpose of the revised warning labels is to provide an anti-smoking advertisement that will promote smoking cessation by referring potential customers to a smoking cessation hotline number that will provide telephonic counseling as a direct and immediate intervention to try to get the customer to quit smoking.

It is not difficult to see that forcing a tobacco company to put an advertisement on its cigarette package which goes so far as referring a potential customer for a telephonic counseling intervention as a direct intervention to get the customer to discontinue the use of that product goes far beyond the permissible actions of the government under the First Amendment, even as accepted in Commonwealth Brands, Inc. v. United States (678 F. Supp. 2d 512, 528-32 [2010]). The district court in that case merely upheld the legitimacy of the government's interest in improving warnings in order to "convey relevant information in an effective way" (678 F. Supp. 2d at 530-31). However, provision of a referral for telephonic counseling to encourage discontinuation of the use of the product seems far beyond the conveying of "relevant information" to improve the effectiveness of the health warning.

This seems to be a rather strange situation where an intervener's amicus brief actually appears to help the other side. In this case, the anti-smoking groups' brief aids the plaintiffs by helping to establish that the purpose of the revised warning labels goes far beyond the desire to simply improve the effectiveness of the conveying of relevant health information to the consumer. If anything, the brief helps establish that the true underlying motive behind the revised warning labels is to achieve a large-scale, telephonic counseling intervention on cigarette purchasers by using the cigarette pack as a billboard to advertise, promote cessation, and refer the smoker for a telephonic counseling intervention.

To be clear, I am not in any way criticizing the intervention itself or the desire of these anti-smoking groups to aim to reduce smoking prevalence by using the cigarette pack as a form of an anti-smoking advertisement with a direct referral to the smoking cessation hotline. In fact, I applaud them for suggesting such an intervention. The problem, however, is that the intervention is almost certainly not constitutional, as it appears to violate the tobacco companies' free speech rights by compelling them to use their own cigarette packages as a referral system to initiate a process with each customer that is designed to ultimately lead to discontinuation of product use.

That is going to be a tall order for the FDA to defend. And ironically, I think this amicus brief actually makes it more likely that the judge will grant the plaintiff's request for a preliminary injunction.

Two Advertising Industry Groups Join Lawsuit Against FDA's Graphic Cigarette Warning Requirement

Two advertising industry groups have filed amicus briefs with the D.C. District Court, seeking to join the lawsuit by several tobacco companies, which seek an injunction against the FDA's proposal to require graphic warning labels on cigarette packages.

According to an article in the Richmond Times-Dispatch: "'The new cigarette warnings are expressly designed to be propagandistic rather than informative,' wrote the groups who represent hundreds of U.S. companies and thousands of advertising professionals. 'If the government can deputize tobacco companies through their product packaging and advertisements to deliver its message, there is no reason it could not do so for other things — and history shows it will not hesitate to do so.'"

The Rest of the Story

The advertising groups' comments mirror my own observations about the case. The central question is whether the "warning labels" are simply health warnings or whether they are actually advertisements that directly discourage product purchase. While the government has a legitimate interest in warning consumers about the health hazards of consumer products, it would be a violation of free speech rights to require those companies to go beyond warning labels and actively and directly discourage product purchase on the product labels.

The advertising groups raise this legitimate question: if the court rules that the FDA is justified in requiring anti-smoking advertisements on cigarette packages, then doesn't such a decision open the door to a floodgate of state actions to require all sorts of anti-product advertising on consumer product labels?

For example, could the New York City Health Department not then require that McDonalds display prominent anti-obesity posters at point of purchase of Big Macs, with gross pictures of fat-laden arteries and a message urging consumers not to consume this fat-laden product?

Could the Boston Public Health Commission not require that coffee containers include a graphic picture of a person suffering a cardiac arrhythmia, with a warning discouraging consumers from drinking coffee out of fear of suffering such an arrhythmia?

Clearly, the court must preserve the demarcation between a legitimate health warning message designed to inform consumers of non-controversial, factual information and persuasive advertising that goes beyond a mere warning message and directly discourages purchase of the product.

I think the FDA is going to have a difficult time convincing the court that graphic ads which display a stop-smoking quitline number are merely health warning messages, and that they do not cross the line into being persuasive advertisements intended to directly discourage the use of the product by consumers.

Philadelphia Board of Health Considering Requiring Graphic Anti-Smoking Posters at Point of Tobacco Purchase

According to an article in the Philadelphia Inquirer, the Philadelphia Board of Health is considering an ordinance that would require retail tobacco stores to display graphic anti-smoking advertisements at the point of purchase.

According to the article, one aspect of the advertisements would be a smoking cessation hotline number.

The Rest of the Story

Quite simply, the rest of the story is that the proposed regulation is almost certainly unconstitutional because it violates the free speech rights of retail stores by compelling them to engage in speech with which they disagree and which is intended to directly harm their business by discouraging the purchase of the items in question.

Consider, for example, the requirement that McDonalds post, at the point of purchase, a graphic advertisement that shows a clogged artery with a message discouraging consumers from eating Big Macs. This would clearly be viewed as violating McDonalds' free speech rights.

Similarly, consider a requirement that a store selling light bulbs post an advertisement with a picture of environmental damage urging customers to purchase fluorescent bulbs in order to save energy and lessen the carbon blueprint. This, too, would clearly be unconstitutional.

The government does have a legitimate right to require health warning labels at point of purchase of products that may be hazardous. However, the proposed posters are not merely warning labels. They are advertisements that promote smoking cessation. In other words, they go beyond warning about health consequences and proceed to encourage smokers to quit. They discourage consumers from purchasing the very products that are being sold by the retail stores which are being required to display the posters.

A similar ordinance enacted by the New York City Council was struck down by a federal judge, although the ruling is under appeal.

New Study Finds No Significant Decline in Heart Attack Mortality Rates During the First Year in Six States with New Smoking Bans from 1995 to 2003

Jacob Sullum over at Reason.com's Hit & Run blog has alerted us to a new study, published online ahead of print late last month in the Journal of Community Health, which systematically examines 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.

(see: Rodu B, Peiper N, Cole P. Acute myocardial infarction mortality before and after state-wide smoking bans. J Community Health 2011; published online ahead of print on August 30, 2001. doi: 10.1007/s10900-011-9464-5)

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. 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%.

In two of the states - Florida and New York - there were declines in heart attack mortality during the first smoking ban year that were significantly greater than previous trends. However, these declines were not significantly different from the declines during the same year observed in the other 44 states. Specifically, the heart attack rate in Florida fell by 8.8% in 2004 and in New York it fell by 12% in 2004 (2004 was the year of the smoking ban implementation in both states). However, nationally, the heart attack mortality rate fell by 9.8% during 2004, a value not statistically different from what was observed in New York or Florida).

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."

"Smoke-free ordinances may serve public health objectives by providing non-smokers with indoor environments that are free from irritating and potentially harmful pollutants. However, this study does not provide evidence that these ordinances result in a measurable immediate reduction in AMI mortality of the magnitude claimed by reports based on very small incident numbers."

The Rest of the Story

This study adds to the growing body of literature suggesting that in large, systematic studies of multiple states or large population groups, no significant immediate effects of smoking bans on heart attacks can be detected. Jacob Sullum astutely points out that the studies which have reported dramatic effects of smoking bans on heart attacks have been in small communities, with small sample sizes. The larger studies - conducted on entire states or nations - and the systematic studies which have examined multiple communities or states - have generally failed to find any significant effect.

This phenomenon is a class demonstration of publication bias. When small studies are the ones which tend to report an effect and larger studies do not, one must be very suspicious of publication bias. The reason for this is that small studies which find a negative effect tend not to be published (or communities in which no dramatic decline in heart attacks is observed anecdotally tend not to be chosen for study).

I have argued that there is more than just publication bias occurring here, because even with the small positive studies, many have used inappropriate analyses or incorrectly analyzed or reported their findings. A great case in point is the Ohio Department of Health study released just last week, in which the actual data presented showed no evidence of an effect of the smoking ban on heart attacks, but the report concluded that there was a substantial effect. The discrepancy arose because the report essentially ignored the first six months of baseline data, in which there was a dramatic decline in heart attacks. Thus, the report gives the false impression that the baseline rate of change in heart attacks in Ohio was stable. In this light, the decline in heart attacks after the smoking ban is interpreted as demonstrating a huge effect of the ban. Instead, the truth is that the decline in heart attacks before the ban was actually greater than the decline after the ban.

Jacob Sullum nicely summarizes the phenomenon described above and also calls for a re-examination by the Institute of Medicine of the evidence on this issue: "While a few small jurisdictions, such as Helena, Montana, and Pueblo, Colorado, have seen big drops in AMI rates after implementing their smoking bans, studies that look at multiple jurisdictions and bigger populations (including analyses of nationwide data) find no such effect. Ban boosters focus on the few places that fit the story they want to tell, ignoring the broader picture. This blatant cherry picking has been blessed by the National Academy of Sciences, whose Institute of Medicine issued a 2009 report endorsing the biologically implausible notion that smoking bans have a noticeable impact on heart attack rates within a year or two. In light of the accumulating evidence to the contrary (much of which was available when the report was written), that embarrassing conclusion should be revisited."

Pasco County Considering Not Hiring Teachers Who Smoke

According to an article in the St. Petersburg Times, the Pasco County (Florida) school board is considering not hiring teachers who smoke. At present, the county refuses to hire school food service workers who smoke. The policy being discussed would extend that restriction to all school district employees.

According to the article, a major reason for the proposed policy is to prevent sending a mixed message about smoking to students. The article quotes a school board member as stating: "We are sending a mixed message when we tell students not to smoke then we allow smoking for teachers."

The policy would apply only to new hires, not to existing employees.

The Rest of the Story

If the school board member really believes that her argument justifies a ban on hiring smokers in the school system, then would she not also have to support a new policy that precludes the hiring of people who drink alcohol, use swear words, or have sex?

After all, students are sent a message that they should not smoke, use alcohol, or swear, and younger students are sent a message that they should not have sex. So to avoid sending a mixed message to students, would it not be important to preclude teachers who smoke, drink, swear, or have sex? You might as well convert the Pasco County public school system into a convent.

I would also point out that if the justification for this proposed policy is to prevent sending a mixed message, then shouldn't the policy apply both to current and new employees? How does a new employee smoking send a mixed message to students, while a current employee smoking does not?

It must be recognized that this policy would result in a substantial problem for many teachers in the County to find employment. It would affect a large number of individuals, as the school system is quite large. There are about 65,000 students, 13 high schools, 15 middle schools, and 45 elementary schools.

It is also important to point out that the policy would result in a decrease in the quality of the teaching staff at these schools. According to the article, 27% of district employees smoke. To reduce the pool of applicants by throwing out 27% of them right from the start is certainly going to result in the inability to hire the best candidates for the job.

Fortunately (and surprisingly), the tobacco prevention program at the Pasco County Health Department appears to have an enlightened and appropriate attitude about the proposed policy: "Lisa Sloan, a tobacco prevention specialist with the Pasco County Health Department, told the board that targeting the workplace rather than employee hiring would likely have more widespread results. It's also easier to regulate what people do at district locations rather than worry about what they do elsewhere, she added. She said that about 27 percent of district employees smoke, and that a new policy supported with health services could help reduce those numbers. Sloan recommended a go-slow approach, to win the widest backing possible.'Smokers are addicted. This is very uncomfortable,' she said. 'They don't like restrictions and they certainly don't like surprises.'"

I agree, and congratulate the Pasco County Health Department for dealing with the issue of employee smoking in the appropriate way. Employment discrimination is not justified, even if it would reduce health insurance costs or improve employee health.

The FDA's Harmful Constituents in Cigarettes List: A Bureaucratic Waste of Time

The FDA's Center for Tobacco Products, as part of its new authority under the Family Smoking Prevention and Tobacco Control Act, has decided to try to protect the public's health by compiling a list of harmful and potentially harmful constituents in cigarettes and cigarette smoke (as well as other tobacco products). The Agency is seeking public comment to help prepare this list of constituents which are inhaled and which cause direct or indirect harm to cigarette users.

The Rest of the Story

In my opinion, this exercise is a pointless waste of time and resources. It would be useful only if the FDA could do something meaningful with the list. But there really is nothing that the Agency can do with the list that is permissible under the law and that would protect the public's health by making cigarettes safer.

The public needs to understand that there are between 10,000 and 100,000 chemicals in cigarette smoke, and that only about 4,000 to 6,000 of these chemical constituents are known. The majority of the constituents in tobacco smoke are a mystery. Moreover, we do not know exactly which constituents, at what levels, and in what combination, are responsible for each of the disease caused by tobacco smoke exposure. Thus, the reduction or removal of specific constituents in tobacco smoke is essentially pointless, as it will not ensure any reduction in risk.

A great example of this is the Winston cigarette, which has removed all additives and consists only of "pure" tobacco. Given the elimination of all additives, one would think that the anti-smoking groups would have congratulated R.J. Reynolds for having produced a safer cigarette. Instead, the anti-smoking groups attacked Reynolds for advertising that Winston cigarettes are additive-free, and forced the company to put a disclaimer on its packages and advertisements for Winston declaring that "no additives does not mean a safer cigarette."

Clearly, the anti-smoking groups understand that even the removal of all additives from cigarettes does not in any way imply that the resulting product is safer.

Nevertheless, the anti-smoking groups, and apparently the FDA as well, would have us believe that by limiting certain constituents - like nitrosamines - in cigarettes, the product will be made safer. Some - like the Campaign for Tobacco-Free Kids - have stated to the public that cigarettes with lower nitrosamines would be safer.

To my mind, this is fraudulent deception. It's no different from what the tobacco companies did regarding low-tar cigarettes or no-additive cigarettes, and it is precisely what they were found guilty of in federal court when Judge Kessler issued her scathing opinion.

But in 2011, it is the anti-smoking groups and the government which are perpetuating the very myths that the DOJ lawsuit aimed to dispel. And most ironically, it is Philip Morris - a defendant in the DOJ lawsuit - which is the only group to tell it like it is and provide appropriate advice to the public: If you are concerned about your health, says Philip Morris, then quit smoking.

Not so, according to the anti-smoking groups. The implication of the Campaign for Tobacco-Free Kids' public statements is that it is only a matter of time before the FDA issues regulations that will mandate changes in cigarettes to make them safer. The Campaign's de facto advice to smokers: don't quit now, because if you wait a little bit, the FDA will be mandating a safer cigarette.

The rest of the story is that nitrosamines are only one of more than 40 recognized carcinogens in tobacco smoke. Thus, lowering levels of nitrosamines is not necessarily going to lower cancer risk. It also depends on what happens to the other 39. And it turns out that the most common methods used to reduce nitrosamines in cigarettes result in an increase in at least some of the other carcinogens in the cigarette. Moreover, we simply don't know which carcinogens, at what amounts, and in what combination, are responsible for the carcinogenic effects of cigarettes. Nor do we have biomarkers that accurately predict human risk. It would take a long-term epidemiologic study to determine whether mandating reduced TSNA levels in cigarettes would result in a safer product.

There is actually scientific plausibility behind the notion that mandating lower TSNA cigarettes could result in a more hazardous, not a less hazardous product. Such a mandate would almost certainly result in higher use of flue-cured, rather than burley tobacco in cigarettes because burley tobacco produces higher TSNA levels. Thus, such a mandate by the FDA would cause tobacco manufacturers to shift towards higher amounts of flue-cured tobacco.

However, there is scientific evidence that flue-cured tobacco yields higher levels of benzo[a]pyrene and tar than burley tobacco. Since tar and benzo[a]pyrene are associated with cancer risk, it is at least plausible that an FDA directive to reduce TSNA levels would increase the national burden of cancer.

For these reasons, compiling a list of the hazardous components in cigarette smoke is not only an exercise in futility that wastes time and resources, but it may also be providing a false sense of "security" to the public. Even if a large number of the known toxins in cigarette smoke were removed, there would be no guarantee that the resulting product would be any safer. But the FDA's regulation of cigarettes, and its emphasis on the "hazardous ingredient list" undermines the public's appreciation of the dangers of cigarette smoking and the complete lack of understanding of what is contained in cigarette smoke and how each of the tens of thousands of constituents relates to human health. It presents a false sense to the public that by virtue of FDA regulation, cigarettes are somehow going to be safer. This undermines decades of education about the harmful nature of cigarette smoking, and in my opinion, does more damage than good.

Canadian National Conference on Tobacco or Health Throws Scientific Integrity Out the Window; Accepts Major Sponsorship from Pfizer

The 7th annual National Conference on Tobacco or Health will be held this November in Toronto.

A leading sponsor of the conference is Pfizer, manufacturer of Chantix, a smoking cessation drug which has come under fire because of its association with suicide, violent behavior, and heart attacks.

One of the major topics of discussion at the conference will be methods for smoking cessation. For example, two of the sessions listed on the preliminary program are "Comprehensive Approaches to Tobacco Cessation and Support in Health Care and Community Settings" and "Cessation: Tried, Tested and Now."

The Rest of the Story

The National Conference on Tobacco or Health has sacrificed its scientific integrity for money. By accepting this sponsorship from Pfizer, the conference has assured that no objective and unconflicted discussion of the effective strategies for smoking cessation can take place.

For example, how can an objective discussion of the risks of Chantix use possibly occur at the conference? To be sure, the conference is not going to highlight or even accept any talks on the deaths caused by Chantix. Doing so would risk future sponsorship.

How can one expect that the conference would include in the program a talk on the hundreds of cases of violent and often fatal adverse effects that have been reported with Chantix when the drug's manufacturer is a major sponsor of the conference?

The pharmaceutical sponsorship creates, by its very existence, 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 conference sponsors. This bias does not necessarily have to be conscious. In fact, the most concerning bias is that which could arise subconsciously by virtue of the sponsorship of the conference by Big Pharma.

The rest of the story is that the funding by Pfizer creates a substantial conflict of interest that precludes the objective consideration of many important scientific issues; in particular, the role of smoking cessation drugs as part of national tobacco control strategies.

The International Society for the Prevention of Tobacco Induced Diseases (ISPTID) is one of the few national or international organizations that, despite past acceptance of sponsorships from Big Pharma, has changed and found other ways to support its annual meetings. I understand the difficulty of finding funding to support these large meetings. But it is possible to find alternative sources of funding. Failing to do so compromises the scientific integrity of these conferences.

World Trade Organization Rules U.S. Cigarette Flavoring Ban Discriminatory; Finds U.S. in Violation of Trade Agreements

The World Trade Organization (WTO) has found that the Family Smoking Prevention and Tobacco Control Act's prohibition of flavored cigarettes with an exemption for menthol violates international trade agreements because it arbitrarily (without a health basis) discriminates against imported cigarettes. In particular, the WTO found that the ban on clove cigarettes ("kreteks") unfairly discriminates against imported flavored cigarettes (largely from Indonesia, which filed the complaint) while allowing domestic flavored cigarettes (menthol cigarettes) to remain on the market.

According to an article in the Jakarta Globe: "The Indonesian government has welcomed the World Trade Organization’s ruling against a US ban on the importation of clove cigarettes, calling for shipments to resume. The global trade body ruled on Friday that the United States was imposing discriminatory trade rules in banning the sale of kretek — Indonesian clove cigarettes. Gusmardi Bustami, the director general of international trade at Indonesia’s Trade Ministry, said on Sunday that the ruling made it clear that the US had engaged in trade discrimination. “With this ruling, the US must admit that they were wrong for their discriminatory trade rules. I don’t see any reasons why we can’t resume selling kretek cigarettes to the US,” Gusmardi said."

"The US Food and Drug Administration in September 2009 banned cigarettes with fruit, confectionery or clove flavors, arguing they encouraged young people to smoke. That resulted in a ban of imports of kretek the following year. But menthol cigarettes were not banned, and the Indonesian government said the US was protecting domestic sales of menthol cigarettes and that it intended to keep kretek out of the market. “Our study concludes that clove and menthol are equally harmful to health, therefore, the ban was discriminatory,” Gusmardi said. In its ruling, the WTO panel found that clove and menthol-flavored cigarettes are “like products.” Gusmardi said that kretek is used by fewer than 1 percent of young smokers and accounts for less than 1 percent of total cigarette sales in the US. Meanwhile, menthol was consumed by 43 percent of young smokers and made up almost 25 percent of total cigarettes sold in the country."

The World Trade Organization has asked the U.S. to revise its law so that it comports with international trade policy. If the U.S. does not wish to comply, it still has 60 days to appeal the ruling.

While clove cigarettes are produced almost entirely outside the U.S., essentially all menthol cigarettes are produced domestically.

The Rest of the Story

This ruling confirms my judgment, expressed in a July 22, 2010 post, that the Tobacco Act's flavored cigarette ban violates international trade policy by arbitrarily (without a health basis) treating like products differently -- favoring domestic cigarettes over imported ones. As I wrote at that time: "the Family Smoking Prevention and Tobacco Control Act's ban on flavored cigarettes - including clove cigarettes - but with an exemption for menthol cigarettes does appear to violate international trade agreements. Specifically, it appears to violate Articles 2.1 and 2.2 of the Technical Barriers to Trade Agreement, Article 3.4 of the General Agreement on Tariffs and Trade, and Articles 5.4 and 5.5 of the Agreement on the Application of Sanitary and Phytosanitary Measures."

I summarized the basis for my opinion as follows: "As I have argued extensively, there is no public health or scientific justification for the menthol exemption. It was clearly a political compromise that served purely political purposes. In fact, a number of health groups and policy makers have readily acknowledged that the menthol exemption was inserted for political reasons. I have yet to hear any credible scientific or public health justification for such an exemption (which is perhaps the reason why the U.S. has failed to provide any justification to Indonesia)."

The WTO decision follows the reasoning that I outlined. Clove cigarettes and menthol cigarettes are "like products." They are both flavored cigarettes. However, there is no public health justification for banning clove cigarettes while exempting menthol cigarettes. Since clove cigarettes are almost exclusively imported and menthol cigarettes are almost exclusively produced domestically, the policy represents discrimination which maximizes trade effects.

This ruling exposes the hypocrisy of the national anti-smoking groups and politicians who crafted the Tobacco Act. It also exposes the fact that the Tobacco Act is largely a political show-piece, designed to make it look like anti-smoking groups and politicians are taking on Big Tobacco, when in fact they are protecting the domestic cigarette market.

The Ohio Miracle: How Statistics Can Be Used to Create an Effect that Isn't There

Yesterday, I commented on a new report out of the Ohio Department of Health which concludes that the statewide smoking ban implemented in May 2007 caused a significant decline in heart attacks during the period 2007-2009, based on an analysis of hospital discharge data for the diagnosis of myocardial infarction (heart attack). However, I explained that the actual data do not demonstrate any effect of the smoking ban on heart attacks: the baseline annual rate of decline in heart attacks in Ohio was 4.7%, and the average post-implementation annual rate of decline in heart attacks was 3.6%.

How, then, did the report manage to find "a significant change in age‐adjusted rates of AMI discharges within one month after the enactment of the Smoke‐Free Workplace Act"?

The Rest of the Story

The key to understanding this story is to appreciate the difference between an a priori hypothesis and a post-analysis hypothesis. An a priori hypothesis is a logic-based theory that is developed prior to the analysis and guides the analytic method based on a conceptual model of the expected pattern of the outcome variable over time, and in relation to the intervention being tested. A post-analysis hypothesis is one that develops after the data analysis has been initiated.

In the Ohio report, the study puts forward a clear a priori hypothesis: that the rate of decline in heart attacks accelerated after implementation of the smoking ban. Thus, a linear trend in heart attacks is assumed, which changes after the smoking ban. This is most directly modeled as two lines: one before the ban and one after the ban, with the inflection point (or change in slope) at the point of implementation.

Nowhere does the report hypothesize, based on a conceptual model, that the pattern of heart attacks would follow a polynomial curve, with a huge decline in heart attacks that levels off completely for a period of time and then resumes with another huge decline in heart attacks. There is absolutely no a priori reason to believe that this is the pattern that heart attack trends in Ohio would follow. None of the prior studies on smoking bans on heart attacks has used such a model or detected such a pattern.

Nevertheless, this is the structure that this study imposes on the data.

Now, if one were to simply model the changes in heart attacks in Ohio as two lines, one before and one after the intervention, one would find that the slope of the pre-intervention line exceeds that of the post-intervention line. In other words, heart attacks were declining slightly more rapidly prior to the smoking ban than after the smoking ban, at least during the study period 2005-2009, which are the years used in the Ohio analysis. There is no way to avoid this conclusion if one uses a linear model.

Now consider what happens if you model these same data by forcing a polynomial curve. Because of the shape of the curve, it is going to markedly exaggerate the slope of the declining heart attack trend before the inflection point because there is only one year's worth of data. Thus, the actual data points prior to the intervention are going to be too high and to correct for that, the dummy variable "finds" that the heart attack rates were higher in this pre-intervention period than after the intervention.

One can see this in Figure 1. There is no reason to believe, for example, that the decline in heart attacks from January 1, 2005 to January 1, 2006 was extremely sharp for the first half of the year and decelerated rapidly in the latter half of the year. There is no reason why a linear trend could not be hypothesized to have occurred, especially over such a short period of time when there is seasonal variation in rates. In order to correct for this, the cubic model needs to "artificially" increase the pre-intervention heart attack rate estimates.

This is best seen in Figure 2, where one can see that the observed heart attack rates from January 1, 2005 to June 1, 2005 are completely inconsistent with the model used. In fact, for some reason, the figure does now show the predicted heart attack values for January 1, 2005 to June 1, 2005.

By ignoring the actual sharp decline in heart attacks that occurred from January 1, 2005 to June 1, 2005, the model is able to make it appear that there wasn't much change in the heart attack rate just prior to the smoking ban. Obviously, this is nonsense. In fact, if one believes this modeling of the data, then there was a drastic decline in heart attacks in the early part of 2005 which leveled off in association with the smoking ban implementation.

Despite the precarious nature of the analysis, it doesn't stop the report from going on to estimate the actual number of heart attacks averted and to calculate the dollar savings from those averted heart attacks. This should certainly give the reader pause as to the true intentions and purpose of the report. Is it to find out the truth, or to provide post-hoc justification for the smoking ban?

The rest of the story is that the data tell one story and the report tells quite another. When a linear model doesn't provide the answer one wants, it is just too easy to use more complicated models, for which there is no conceptual basis. If you try enough manipulations, you are always going to be able to show the effect that you want. However, it is the truth that we should be after, not "favorable" evidence.

New Report from Ohio Health Department Concludes that Smoking Ban Reduced Heart Attack Admissions; However, Actual Data Show No Apparent Efffect

A new report out of the Ohio state Department of Health concludes that the statewide smoking ban implemented in May 2007 caused a significant decline in heart attacks during the period 2007-2009, based on an analysis of hospital discharge data for the diagnosis of myocardial infarction (heart attack).

The study compared hospital discharge data on patients with a primary diagnosis of acute myocardial infarction from before to after the state Smoke-Free Workplace Act went into effect. Data were obtained from all hospitals in Ohio for the years 2005 through 2009. Thus, the rate of change in heart attacks could be estimated for the year before the Act and for the first three years following implementation of the Act.

The report concludes: "The analysis determined a significant change in age‐adjusted rates of AMI discharges within one month after the enactment of the Smoke‐Free Workplace Act."

A press release accompanying the report also boasted that: "The analysis of discharge data from Ohio hospitals ... revealed a sharp decline in heart attack rates immediately following implementation of the law."

The conclusion that the smoking ban led to a significant decline in heart attacks was widely disseminated by the media (example 1; example 2; example 3).

The Rest of the Story

Unfortunately, the actual data presented by the report does not support the conclusion that the smoking ban led to an immediate and significant decline in heart attacks in Ohio.

The smoking ban went into effect in December 2006, although rules for implementation were not issued until May 2007. Thus, the ban was implemented starting in December 2006 but was in full effect by May 2007. Therefore, 2007 was the first year in which the ban was in effect. Any change in heart attacks from 2006 to 2007 could potentially be attributed to the smoking ban. The change in heart attacks from 2005 to 2006 represents the baseline trend in heart attacks in Ohio, prior to the smoking ban. The change in heart attacks from 2007 to 2008 and from 2008 to 2009 represents the 2nd and 3rd years of implementation of the ban.

So if the report's conclusion is correct, then the rate of decline in heart attack discharges in Ohio for the years 2006 to 2007, 2007 to 2008, and 2008-2009 should be substantially greater than the rate of decline in heart attacks from 2005 to 2006, prior to the ban. Let's look at the actual data:

The annual declines in the age-adjusted hospital discharge rates for acute myocardial infarction across hospitals in Ohio were as follows:

2006-2007 (baseline): -4.7%

2006-2007 (first year of implementation): -2.7%
2007-2008 (second year of implementation): -2.2%
2008-2009 (third year of implementation): -6.3%

Average annual decline post-implementation: -3.6%

Thus, what the data show is that the baseline annual rate of decline in heart attacks in Ohio was 4.7%, and the average post-implementation annual rate of decline in heart attacks was 3.6%.

In other words, the rate of decline in heart attack discharges in Ohio was greater prior to the smoking ban than it was in the first three years after the smoking ban.

This clearly does not support the conclusion that the smoking ban resulted in a large and immediate decline in heart attack discharges.

If one looks at the data graphically, one can see that there was little change in the heart attack trend in Ohio after the smoking ban. There was a gradual decline that clearly was present prior to the smoking ban went into effect. The rate of decline decreased slightly during the first two years of the ban and then accelerated slightly during the third year of the ban.


How, then, is the report able to come up with a conclusion that the smoking ban led to an immediate and significant decline in heart attacks?

The answer is simple: by using a cubic spline model rather than a simple linear model, which is what the report hypothesizes in its introduction section. The cubic model negates the large decline in heart attacks that was observed during 2005 (see Figure 1 of the report). It essentially "erases" the baseline trend of a substantial decline in heart attacks, zeroing it out so that any decline in heart attacks observed after the intervention will appear greater than prior to the intervention.

Had the report simply drawn two lines, one before and one after the intervention, it would have been forced to conclude that there was no significant change in the rate of decline in heart attacks (or if anything, the rate of decline decreased following the smoking ban).

The most accurate description of the trend in heart attacks in Ohio is that the rate was dropping rapidly prior to the smoking ban and that the rate of decline decelerated slightly during the first two years of smoking ban implementation and then accelerated during the third year. The presence or absence of the smoking ban appears to have nothing to do with the heart attack trend.

Another way in which the report makes it appear that the effect of the smoking ban is greater than actually observed is by plotting the data on a graph that fails to use 0 as the lower end of the y-axis (again, see Figure 1). This is a classic flaw in graph presentation that can deceive viewers into believing that an effect is present when it is not. Graphs should always have 0 as the lower end of the y-axis in order to avoid this problem.

Darrell Huff discusses this method of distorting data presentation in his classic book "How to Lie With Statistics." (see Chapter 5: The Gee-Whiz Graph)

Because the actual data show no significant increase in the rate of decline in heart attacks in Ohio after implementation of the smoking ban, I won't even get into the most important flaw of the analysis, which is the absence of any comparison or control group. Even if heart attacks did decline in Ohio during the past four years or so, one needs to know whether that is unique or whether heart attacks were also declining elsewhere during the past four years. Without any comparison group, it is impossible to make such a determination.

The rest of the story is that this report has manipulated the analysis in order to try to show an effect that is simply not present in the data. This doesn't do anti-smoking advocates any favors. While I agree with the ultimate conclusion of the health department director - that the smoking ban was a highly appropriate intervention that is having a positive health impact on Ohio residents - a large and immediate decline in heart attacks is not part of the reason. By placing such a large emphasis on the need to demonstrate an immediate decline in heart attacks (when it takes many years for secondhand smoke exposure to cause heart disease), and by distorting the science in order to try to show such effects, anti-smoking advocates are actually weakening, not strengthening the argument for workplace smoking bans.

In Embarrassment for National Anti-Smoking Groups and Politicians, Tobacco Companies Instruct Them on How to Properly Conduct Their Business

In a major embarrassment for the national anti-smoking groups and members of Congress who have painted themselves as wanting to reduce smoking rates, several of the nation's tobacco companies have provided a scathing, yet correct critique of their efforts and insightful recommendations of what they should be doing if they were seriously interested in reducing tobacco use.

When even the tobacco companies criticize you for not doing the right things to reduce tobacco use, it should wake you up, or at least give you pause to consider your actions.

The critique of current anti-smoking efforts comes in the form of the legal brief submitted by Reynolds American, Lorillard, Commonwealth Brands, and Santa Fe Tobacco Company seeking to overturn the graphic warning label requirement.

One of the points made in the brief is that the requirement for large graphic warning labels is not narrowly tailored as it is not the least restrictive policy that would advance the government's interest in warning consumers about the hazards of smoking. Moreover, the tobacco companies argue that there are far more effective ways to reduce smoking than showing smokers gory pictures.

In particular, the tobacco companies put forward two alternative ideas which, unlike the warning labels, are evidence-based and have been shown to substantially reduce smoking rates.

1. The tobacco companies point out that the federal government could require states to spend a significant amount of their Master Settlement Agreement proceeds on tobacco control programs. This requirement could be in the form of tying federal funding to states having allocated a certain proportion of MSA revenue to anti-smoking programs.

The companies write: "The MSA annually provides the States with billions of dollars intended for tobacco control programs. The federal Centers for Disease Control and Prevention (“CDC”) has found that requiring the States to increase the allocation of MSA funds to youth tobacco prevention—from the meager 3.5% recently employed to the still-modest CDC-recommended 15%—would be effective in reducing tobacco use. ... The Government therefore could use its power under the Spending Clause ... to condition receipt of federal funds on States’ allocation of MSA funds in accordance with CDC recommendations."

2. The tobacco companies also point out that the federal government could increase the cigarette tax, which would lead to a reduction in cigarette consumption.

The companies write: "The Government could also consider whether increased cigarette taxes, which have been shown to reduce cigarette consumption, would be at least as effective as the Rule."

The Rest of the Story

I believe that if the national anti-smoking groups and members of Congress who supposedly want to reduce smoking rates had implemented the tobacco companies' recommendations, rather than become obsessed with the inane idea of asking the FDA to regulate the "safety" of tobacco products and relying upon warnings on the cigarette packs to discourage smoking, the field of tobacco control would be in a drastically better place than it is today.

While raising the federal cigarette excise tax would itself reduce smoking rates, allocating those revenues towards state-of-the-art anti-smoking programs in all 50 states, combined with requiring states to allocate a minimum proportion of their MSA payments to such programs, would represent the most effective national strategy for tobacco control in history.

Imagine if all 50 states implemented tobacco control programs similar to that in California, the only state with a sustained, comprehensive tobacco control program for the past two decades. Imagine if those programs included a focus on reaching disadvantaged communities, including communities of color. Imagine, for example, if the money were available to provide Pathways to Freedom to every African American smoker who desired to quit smoking. Imagine if all states implemented anti-smoking television commercials like those used in the "truth" campaign.

This is where the anti-smoking groups and Congress should have directed their efforts over the past five years, rather than creating an untenable system by which the agency charged with protecting the nation's food and drug supply is charged with somehow ensuring that cigarettes are "safe," which is an impossible task that wastes precious resources.

I think it is embarrassing that at the end of the day, the tobacco companies - and not the national anti-smoking groups (i.e, Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, American Lung Association, etc.) - have put together an effective strategy for reducing tobacco use, while the national anti-smoking groups have instead created a purposeless federal bureaucracy that is going to spend millions of dollars but effect no substantial changes in either cigarette safety or cigarette smoking rates.

It is one thing for other tobacco control advocates to point out to these anti-smoking groups that perhaps the strategies they are pursuing are not the most effective. It is downright embarrassing, however, when the tobacco companies themselves point out that the strategies being promoted by those groups are the least effective ones available, and then they go ahead and lay out the strategies that would actually make a huge dent in cigarette sales.