Hospital that Refuses to Hire Smokers Lacks Understanding of What Employment Discrimination Is; Policy is Politically-Based, Not Health-Based

Michigan hospital which discriminates against smokers in employment does not even admit that it is discriminating, according to an article in the Detroit News.

According to the article: "Crittenton, which hires 200 to 250 new employees each year, feels confident its policy does not discriminate, Kapuscinski [Crittenton's director of marketing and communications] said. "Several courts have upheld there's no constitutional right to smoke," said Kapuscinski, who expects more Metro Detroit hospitals to follow Crittenton's lead. "We felt very comfortable that we were not discriminating."

Crittenton is one of three Michigan hospitals that not only refuse to hire smokers, but will also not hire any applicant who uses nicotine in any form, including nicotine replacement therapy and electronic cigarettes. The other two are ProMedica Hospital (two different locations).

ProMedica Hospital's policy states that its purpose is to "foster a healthier work force, as well as to demonstrate to our patients and the community our strong commitment to health and wellness. ProMedica is asking our employees to model — and benefit from — the same healthy behaviors we promote to our patients and the community. Employee applicants are asked about the use of tobacco and nicotine replacement, and are screened for nicotine before they are hired. Applicants who declare use or screen positive for nicotine may reapply for a position after they have been tobacco/nicotine-free for 90 days."

The Rest of the Story

It is one thing to discriminate against a group of people and to justify that discrimination on health or economic grounds. It is another thing to deny that you are even discriminating.

In this case, Crittenton Hospital is discriminating against smokers, but doesn't even admit that it is discriminating against them.

Clearly, Crittenton doesn't understand the definition of employment discrimination. This is quite unfortunate, and irresponsible, because every employer should understand what employment discrimination is.

Employment discrimination is defined as making hiring decisions based on the group to which an applicant belongs, when that group membership has no direct bearing on the applicant's bona fide qualifications for the job.

For example, if I refuse to hire people on the basis of their race or religion, it constitutes employment discrimination because I am systematically denying employment to applicants based on the group to which they belong, and that group membership has no bearing on their job qualifications. If I refuse to hire people who weigh more than 200 pounds, that is also employment discrimination, unless the individual's weight has a direct bearing on his or her job qualifications. If I refuse to hire people who use nicotine, that is also employment discrimination.

I would have a lot more respect for Crittenton if it at least admitted that it is engaged in employment discrimination, but that it is a legal form of discrimination. To argue that its policy does not discriminate against smokers demonstrates a lack of understanding of what discrimination is, and that is troubling.

It is true that employment discrimination against smokers is perfectly legal in 21 states. Fine, but if you are going to discriminate, at least have the understanding to call it discrimination.

That the policy of these hospitals is that not only are smokers denied employment, but also anyone who uses nicotine, including people who are trying to quit smoking, demonstrates that these policies are not health-based, but political statements. They are merely expressing an ideological (essentially a political) view against nicotine use as a vice. They are making a moral issue out of a health issue.

If the true interest were in promoting health, then the hospitals would certainly not refuse to hire people who are using nicotine replacement therapy or electronic cigarettes, as they are trying to quit smoking. Wouldn't the hospitals reward these people, rather than punish them?

If the true interest were in "asking our employees to model — and benefit from — the same healthy behaviors we promote to our patients and the community," then the hospital would also refuse to hire obese individuals, those with poor nutrition, those who don't exercise, those who don't wear seat belts, and those who practice unsafe sex, use tanning salons, or don't wear sunscreen.

These policies are not only employment discrimination but they are political statements and have nothing to do with health promotion. Thus, not only are they wrong because employment discrimination is inappropriate, they are not even justified by the very reasoning used to defend them.

FDA CTP's Farce “Action” on Star Scientific’s BDL Products: The Non-Smoking Gun – Guest Commentary by Mr. Sandy Hoff (Izof_texas on Yahoo)

The following is a guest commentary offered by Mr. Sandy Hoff. In it, he makes a strong argument that the FDA's Center for Tobacco Products erred in not defining Ariva-BDL and Stonewall-BDL as tobacco products under the Family Smoking Prevention and Tobacco Control Act. Mr. Huff provides strong evidence that the base Ariva product constitutes a tobacco product, as the FDA has clearly stated that it is a smokeless tobacco product. He then argues that since the BDL varieties are made of powdered, although then compressed tobacco, there is no reason they do not also constitute smokeless tobacco products under the law:

Star Scientific's Ariva product (the "non-BDL" form) has been on the market since 2001. Star has always been most forthcoming about the contents of this product. For example, from its 2009 Annual Report, on pages iii and 6 (and numerous other places therein), Star clearly states that the Ariva product is compressed powdered tobacco. This same claim can be found in every annual report since Ariva was introduced in 2001. Any doubt about the notice to the industry and public of this fact can be erased by a search on "Star powdered tobacco."

The BDL products are made in exactly the same way ... the only difference is that Star has fine-tuned it's (patented) process for curing tobacco for low TSNA content so that it can produce tobacco with levels of TSNA that are "undetectable" by current standard methods. In other words, the only difference between the proposed new BDL products and the previous ones is that the cured tobacco that is first powdered and then compressed is lower in TSNA. (The original Ariva product already contained a "low" level of TSNA ... an order of magnitude or more lower than Swedish snus, which has a stellar safety record regarding use and carcinogenic activity.)

It's like a snowball made from "yellow snow.” In Star's new "BDL snowball" the snow is so clean you just can't see the yellow any more.

So here is the "smoking gun" of incompetence for the FDA’s Center for Tobacco Products (FDACTP). The FDA in 2003 ruled that the Ariva product is indeed a "customarily marketed" smokeless tobacco product and therefore FDA could not, at that time, regulate the products because, then, it had no jurisdiction. See this letter from the FDA to the Campaign for Tobacco-Free Kids, declining its petition for FDA to regulate Ariva as a drug or adulterated food.

Quoting from the last page: “Based on the evidence submitted by the petitioners, FDA has determined that Ariva meets the definition of “smokeless tobacco” in the Comprehensive Smokeless Tobacco Health and Education Act because it is made of powdered tobacco “intended to be placed in the oral cavity.” Moreover, FDA believes that, based on the information available to it at this time, it is precluded from asserting jurisdiction over Ariva as currently marketed because it is a “customarily marketed” tobacco product within the meaning of Brown & Williamson.”

Because the BDL products in question are made from powdered, then compressed, tobacco, the FDA’s failure to define these products as “tobacco products” can only be seen as an administrative mistake of monumental proportions.

My feeling is that Star should: (1) sue FDA for a declaratory judgment on this matter; and (2) test market its BDL products in boxes that proclaim: "As safe and good as your mom's spaghetti" ... with pictures of happy, smiling, consuming children on the boxes. The test market should of course be Washington D.C.

Then see how long it takes FDA to figure out that these are indeed smokeless tobacco products.

As Part of Campaign for Tobacco-Free Kids Event, Florida Anti-Tobacco Group Lies to Public About Tobacco Industry

According to an anti-tobacco group - SWAT (Florida) - the tobacco companies are making candy-flavored cigarettes to try to entice youth to smoke. This claim means that the tobacco companies are violating federal law, which precludes them from marketing candy-flavored cigarettes.

The specific claim is as follows: "No joke. Big Tobacco is making candy-flavored tobacco to get you to smoke. Do they think you're stupid? Yes, they do. But you can do something about it. On March 23rd, join kids from all across the nation for Kick Butts Day and stand up against Big Tobacco."

The clear implication of this statement is that tobacco companies are making candy-flavored cigarettes. The assertion is not that Big Tobacco is making candy-flavored tobacco to get you to chew, or to snuff, but that the companies are using these products to get you to smoke. Thus, the implied claim is that the companies are producing candy-flavored cigarettes, not just flavored smokeless tobacco.

Since such products are banned by the Family Smoking Prevention and Tobacco Control Act, SWAT's claim amounts to an accusation that the tobacco companies are breaking the law. This is quite a serious accusation.

The Rest of the Story

There are two aspects to this story that are not at all surprising.

The first is that an anti-smoking group is lying. This seems to have become acceptable in the tobacco control movement.

The second is that the Campaign for Tobacco-Free Kids is, in a sense, behind this lie. It turns out that the SWAT group's campaign against flavored tobacco products which entice youth to smoke is part of an event called Kick Butts Day, which is organized and run by the Campaign for Tobacco-Free Kids. The false accusation against Big Tobacco by SWAT is part of this event.

The false accusation against Big Tobacco is not just found in a single poster for the event. It is also found on the web site of the SWAT organization. The site contains a document, entitled "Not for Sale: Big Tobacco's Sweet Tooth for Addiction," which states: "One of the tobacco industry’s most bold new tactics is the creation of candy flavored cigarettes...". It then lists as talking points the following:

• "RJ Reynolds, who formerly used cartoon character Joe Camel to market their products, have a new line of flavored Camel cigarettes with names like Twista’ Lime, and seasonal flavored cigarettes like Bayou Blast Mardi Gras Berry Blend."

• "Kool cigarettes now come in a special version called Smooth Fusion. The Smooth Fusions range in flavor from Caribbean Chill, Midnight Berry, Mintrigue and Mocha Taboo."

• "Several brands of seasonal Camel cigarettes are named to reflect alcohol flavors like Margarita Mixer and Beach Breezer."

These talking points are all lies. Reynolds American removed all its candy-flavored cigarettes from the market five years ago. There are no lime, berry, mint, mocha, or margarita cigarettes currently on the market.

While one cannot blame the Campaign for Tobacco-Free Kids directly for these lies, I think that the Campaign does bear some responsibility for them since this is its event. Apparently, the Campaign is not giving out accurate information to the youths who are involved in Kick Butts Day. They are apparently not informing the youths that the tobacco companies now comply with federal regulations against putting candy flavors in cigarettes -- a law that resulted in no public health benefit because no kids were smoking candy-flavored cigarettes.

The youths' confusion on this point is directly attributable to the Campaign for Tobacco-Free Kids. In the Kick Butts Day activity guide, it suggests holding an event to protest Big Tobacco's use of flavored tobacco products to addict kids, but nowhere does the guide inform youths that this applies only to smokeless tobacco. Nowhere does it tell the youths that candy-flavored cigarettes have been off the market for five years. Nowhere does it tell the youths that federal law prohibits candy-flavored cigarettes and that all tobacco companies are in compliance with that law.

No wonder the youths were confused about this. I can hardly blame them. It is the Campaign which really needs to bear responsibility for this.

Youth activism is a great thing, but not if youths are not properly educated about the facts. When youths are used as puppets by an organization - as the Campaign for Tobacco-Free Kids uses them - it is a disservice both to the youths and to the public.

On the other hand, these activities do seem to be succeeding in training the next generation to move on to work for the Campaign for Tobacco-Free Kids. After all, they apparently now know how to lie to and deceive the public for political gain.


UPDATE - Tuesday, March 29, 10:50 a.m: I have been informed by Jeff Stier, Senior Fellow at the National Center for Public Policy Research, that he has communicated with the SWAT group, which explained that its claim that Big Tobacco is marketing candy-flavored tobacco to entice youth to smoke is based on the contention that the marketing of candy-flavored snus will lead to youth use of snus which will in turn lead to kids starting to smoke cigarettes. I thank Jeff for this update and for the original tip that led to this post.

If this explanation is correct, then the web site statement is terribly misleading, because it implies that Big Tobacco is still marketing candy-flavored cigarettes, rather than this convoluted explanation of how candy-flavored snus is going to cause kids to start smoking. If this is what was meant, than the site should simply have stated so. Moreover, the site should have backed up the claim with evidence to support this contention. I am not aware of any such evidence but I'm sure if this group is making the claim, it must have some evidence to support it.

Unfortunately, I still have to stick with my argument that the group is lying to the public, because it continues to claim, in this document on its site, that:

• "RJ Reynolds, who formerly used cartoon character Joe Camel to market their products, have a new line of flavored Camel cigarettes with names like Twista’ Lime, and seasonal flavored cigarettes like Bayou Blast Mardi Gras Berry Blend."

• "Kool cigarettes now come in a special version called Smooth Fusion. The Smooth Fusions range in flavor from Caribbean Chill, Midnight Berry, Mintrigue and Mocha Taboo."

• "Several brands of seasonal Camel cigarettes are named to reflect alcohol flavors like Margarita Mixer and Beach Breezer."

Utah Department of Health Tells Public There is No Evidence that Electronic Cigarettes Help Smokers Cut Down on the Amount They Smoke

Despite widespread, published survey evidence that electronic cigarettes help many smokers to reduce the amount they smoke, the Utah Department of Health is asserting to the public that no such evidence exists.

According to an article on Salt Lake City's ABC-TV affiliate web site, the Utah Department of Health stated: "There is no legitimate scientific evidence that e-cigarettes will help smokers quit or reduce their use of any tobacco product."

The Rest of the Story

Note that there is a difference between stating that we cannot conclude from existing evidence that e-cigarettes help smokers cut down and that "there is no" evidence. Had the Health Department simply offered its own conclusion that when one examines the evidence, it is premature to conclude definitively that electronic cigarettes are effective for smoking cessation or smoking reduction, I would not have had a problem with that. However, the Department of Health instead apparently asserted that there simply is no evidence that electronic cigarette use can lead to a reduction in smoking. I believe this is false.

There is abundant evidence, not only anecdotal evidence but also published scientific survey evidence, that many vapers have been successful in reducing the number of cigarettes they smoke. In my own study, we found that two-thirds of electronic cigarette users reported cutting down on the number of cigarettes they smoked.

Given what we now know, I find it irresponsible (and inaccurate) for a health department to report to the public that there is no evidence that vaping can help smokers to cut down on the amount they smoke.

From this article, it appears that the Utah Department of Health would rather have smokers continue to smoke than succeed in quitting or cutting down on the amount they smoke using e-cigarettes. The Department recommends pharmaceutical therapy, but we know that these products have a dismal success rate, on the order of only about 8% long-term. Recommending that people use NRT products is tantamount to recommending that they not bother to try quitting. Especially for people who have tried unsuccessfully in the past with these products.

Unfortunately, it appears that public health groups are trying to punish people who are using electronic cigarettes. Nowhere is this more clear than in South Dakota, where the three largest health care providers in the state have banned the use of these products on hospital grounds. These providers do not appear to understand that people using electronic cigarettes are making quit attempts. They should be applauded, not punished. Furthermore, there is no evidence that electronic cigarette vapor poses any dangers to others. Moreover, these policies do not merely ban electronic cigarette use in the hospital. You cannot vape outside, anywhere on the premises.

Why punish people who are making such a strong effort to quit and who are not exposing others to secondhand smoke? Shouldn't we be applauding these individuals, rather than punishing them? Isn't this exactly what we want smokers to be doing, if possible?

Why is it that health care and public health groups are so determined to try to punish electronic cigarette users? I believe the answer is that these groups cannot tolerate any activity that merely looks like the act of smoking. It is the act of smoking, not the actual health risks, that appear to be motivating these groups.

FDA's Refusal to Define Ariva-BDL as a Tobacco Product Flies in the Face of the Clear Definition of Smokeless Tobacco in Tobacco Act

On Wednesday, tobacco manufacturer Star Scientific Inc. announced that the FDA responded to its application seeking "modified risk tobacco product" status for Ariva-BDL and Stonewall-BDL. Surprisingly, the Agency did not respond by either approving or denying Star Scientific's request. Instead, the FDA notified the company that these products are not subject to FDA jurisdiction because they are not "tobacco products" under the Family Smoking Prevention and Tobacco Control Act.

According to an Associated Press article by Michael Felberbaum: "Tobacco maker Star Scientific Inc. said Wednesday that the Food and Drug Administration has informed the company that two of its dissolvable tobacco lozenges aren't covered by the law regulating tobacco, clearing the way for them to be marketed and sold. The small Virginia company, which has sold tobacco products that dissolve in the user's mouth since 2001, said the FDA's Center for Tobacco Products says that its Ariva-BDL and Stonewall-BDL products aren't subject to regulation. ... Star Scientific had asked the FDA to certify the products as "modified risk" tobacco products under a 2009 law, making itself the test case for a big issue of whether the agency would allow certain products to be marketed as less harmful than cigarettes. The company says the lozenges contain "below detectable levels" of certain cancer-causing chemicals found in tobacco and its smoke. The tablets contain tobacco's addictive component, nicotine. Star Scientific has said its method of tobacco cultivation and preparation creates tobacco leaves with low levels of some carcinogens." ...

"But Star Scientific said the agency's notices from Dr. Lawrence Deyton, the center's director said, "At this time, only cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco are subject" to the law and that based on the company's submissions, the products are not currently subject to regulation."

The Rest of the Story

Ariva-BDL and Stonewall-BDL clearly are tobacco products under the Family Smoking Prevention and Tobacco Control Act. As it did with electronic cigarettes, the FDA's Center for Tobacco Products is misunderstanding the clear definition of "tobacco product" that was laid out for it by Congress.

The Center for Tobacco Products doesn't seem to understand that it can't simply regulate products the way it wants to. It has to follow its Congressional mandate, which was clearly laid out in the Tobacco Act.

And according to that act, these dissolvable products, which are derived from powdered tobacco and placed in the mouth, are undoubtedly tobacco products. Specifically, the law defines them as smokeless tobacco products.

Star Scientific didn't have a problem understanding this definition, as it appropriately applied to the FDA for designation of these products as modified risk tobacco products. It is unclear why the FDA's Center for Tobacco Products is the only one which cannot read and understand a clear and simple definition.

The Tobacco Act defines tobacco products as follows: "The term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)."

There is no question that Ariva-BDL and Stonewall-BDL are made or derived from tobacco and are intended for human consumption. Star Scientific acknowledges this in its own press release, stating that: "Ariva-BDL, a dissolvable tobacco lozenge with wintergreen flavoring, is made with flue-cured tobacco that contains levels of tobacco-specific nitrosamines (TSNAs) that are below detectable limits ("BDL") by most current standards of measure."

Furthermore, the Tobacco Act provides a specific definition for smokeless tobacco: "The term ‘smokeless tobacco’ means any tobacco product that consists of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity."

Star Scientific acknowledges that Ariva and Stonewall consist of powdered tobacco that are placed in the oral cavity. It states: "Both products are pieces of powdered and compressed StarCured tobacco that dissolve completely in the mouth and leave no residue." Thus, it seems quite clear that these products are smokeless tobacco products under the law. That the BDL varieties of these products are made from tobacco with lower nitrosamine levels does not alter the fundamental definition of these products as tobacco products. Neither does the apparent fact that these products consist of tobacco that is somehow compressed and may not actually consist of a powder.

The intent of Congress was clear: dissolvable tobacco products were to be regulated as smokeless tobacco. By taking this action, the FDA has created a loophole that is clearly inconsistent with the intent of the Congress.

The broader implication of this story is that the FDA is truly struggling with the task of regulating tobacco. As I argued long before the legislation was enacted, regulating a deadly product simply does not fit into the Agency's regulatory mission or experience. Putting tobacco under the FDA's jurisdiction was a bad idea from the beginning. Every day that unfolds we see yet another manifestation of the folly of this decision.

Chair of TPSAC Claims that Committee's Recommendation is Clear; Defense of Committee's Cop-Out is Uncompelling

The chair of the FDA's Tobacco Products Scientific Advisory Committee (TPSAC), in an article in the New York Times, defended the Committee's cop-out (its failure to issue a recommendation on whether the FDA should ban menthol cigarettes) by putting forward the weak and untenable argument that the Committee did in fact issue a recommendation that the FDA ban menthol cigarettes.

According to the article: "While the eight-member group led by Dr. Samet did not recommend a specific policy to phase out or ban menthol cigarettes, that was never its role, he said in the interview, emphasizing the word “scientific” in its formal title, Tobacco Products Scientific Advisory Committee. Further, Dr. Samet disagreed with statements by some stock analysts and public health advocates that the panel did not make a clear recommendation. It did, he said, in the conclusive statement in its 231-page report: “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.” “To me that speaks quite clearly to what our recommendation is,” Dr. Samet said. “I think the major issue is probably a failure to understand the role of this committee and what the F.D.A. does as a regulatory agency. I think the statement about removal is what the public health recommendation is, and I think how one achieves that outcome depends on the strategies available to the F.D.A. under the law.”"

The Rest of the Story

Sorry to have to break this news, but the statement "Removal of menthol cigarettes from the marketplace would benefit public health in the United States" is not a recommendation, but a scientific conclusion. A recommendation must suggest an action or provide advice. The TPSAC's "recommendation" does not do either of these.

To show how ridiculous it is to argue that the conclusion of the report is a recommendation, consider the following statement, which mirrors the conclusion of the TPSAC report. As you will see, this statement is not a recommendation, because it does not put forward, suggest, or advise a particular action. This conclusion is compatible with taking action or not taking action.

Example #1: Removal of all cigarettes from the marketplace would benefit the public's health.

This is a true statement. Invariably, if all cigarettes were removed from the marketplace, it would benefit the public's health. But making such a statement does not imply that one is offering a recommendation that cigarettes be prohibited. One could draw this conclusion, yet believe that prohibition of cigarettes would have disastrous social and economic consequences, and therefore one could actually advance the opposite recommendation: Congress should not ban cigarettes.

The conclusion is a scientific one. It does not imply a particular policy action. One could make the statement and also believe that Congress should ban cigarettes. One could make the statement and also believe that Congress should not ban cigarettes. Clearly, it is a conclusion and not a recommendation.

That this is a conclusion rather than a recommendation is also clear from investors' response to the report. If this were a recommendation for a menthol ban, Lorillard stocks would not have jumped up a whopping 14% in just two days after the report's release.

Ultimately, what concerns me most about the panel's failure to make a recommendation is simply that this was a huge cop-out. By failing to tell us what it really thinks, the Committee is doing a major disservice. You don't issue a report that doesn't make a recommendation, and then try to use media interviews to actually make a recommendation. If you have a recommendation, then just tell us. This is a cowardly action.

At this point, I would settle for any recommendation from the Committee. Ban menthol, don't ban menthol, lower menthol levels, phase out menthol, regulate menthol levels, do nothing. To simply punt the issue back to the FDA is not only a cop-out but an abrogation of the Committee's Congressionally-mediated responsibility.

While I don't know for sure why Dr. Connolly resigned from the Committee, my guess is that he was unhappy with the Committee's apparent unwillingness to recommend a ban on menthol cigarettes or a gradual phase-out of these products. I give him credit for getting off the committee before having to have his name tied to a cop-out report.

The FDA is not going to ban menthol cigarettes and any doubt about this was erased with the TPSAC report. Had the Committee come out with a strong and unequivocal recommendation that the FDA ban menthol cigarettes, it would have at least raised the possibility that the FDA could follow through with such an action. But this report gives the Agency the excuse it needs to refrain from making a politically dangerous move. The Agency is off the hook.

Just yesterday, a new research article came out which concludes that menthol cigarettes are actually less harmful than non-menthol cigarettes, because they pose a lower risk of lung cancer. The study also found that menthol smokers smoke less than non-menthol smokers. Combined with the TPSAC's weak-willed action, this pretty much puts a death knell in the chances for a ban on menthol cigarettes.

FDA Shadow Panel Issues Statement on TPSAC Menthol Report

This morning, the FDA Shadow Panel issued the following statement on the TPSAC menthol report. The statement appears on the Shadow Panel web site, at: http://www.fdashadowpanel.com/Recommendations.html.

In summary, the Shadow Panel believes that while the report itself was strong and provided solid scientific evidence of the public health harms caused by menthol cigarettes, the committee itself was weak-willed, as it failed to actually make a recommendation based on its findings. Further, the Shadow Panel believes that this lack of action on the part of TPSAC is exactly what Philip Morris had in mind when it pushed for FDA regulation of tobacco under the Family Smoking Prevention and Tobacco Control Act. The Shadow Panel believes that this is a harbinger of things to come and indicates the ineffectiveness of this law in protecting the public’s health. The Panel urges Congress to consider repealing the Tobacco Act and designing a national tobacco control strategy that not only has some teeth, but which is based on evidence-based methods for reducing tobacco use – methods which will actually save lives.

Shadow Panel Statement on TPSAC Menthol Report Of Mice and Menthol A Strong Report, but a Weak-Willed Committee On June 22, 2009 President Obama signed into law the Family Smoking Prevention and Tobacco Control Act charging the Food and Drug Administration (FDA) with regulation of tobacco products. The Tobacco Control Act provided for creation of a Tobacco Products Scientific Advisory Committee (TPSAC) to advise the FDA. One of the express charges for the TPSAC was to create a "report and recommendation" on "the issue of the impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities." On June 8, 2010 a panel of experts shadowing the TPSAC (the FDA Tobacco Products Scientific Advisory Shadow Panel) issued a press release calling for "the elimination of the use of menthol in cigarettes." The Shadow Panel's recommendation was based on strong evidence that menthol acts as an anesthetic agent that makes cigarette smoking more appealing by masking the harshness of burning tobacco. Further, that menthol deceives smokers into thinking that cigarettes are less harsh and therefore safer, and that menthol brands are disproportionately targeted at African- Americans. On March 18, 2011 the TPSAC issued a report entitled, "Menthol Cigarettes and Public Health: Review of the Scientific Evidence and Recommendations.” What follows is the Shadow Panel's review and assessment of the TPSAC report: For a 231-page report that at first reads more like a legal document than a scientific one, clearly careful to keep every word within its "conceptual framework for cigarette smoking" authorized by Congress, the understated prose packs a wallop. There is surprisingly little arcane methodology or jargon. The notable exception is an appendix consisting of a lengthy series of unexplained complex equations entitled, "Results from a Population Dynamics Model of the Consequences of Menthol Cigarettes for Smoking Prevalence and Disease Risks," apparently calculated to the year 2050). The report painstakingly defines the parameters of the public health impact of menthol cigarettes its authors sought to ascertain. The committee sought to apply an innovative "systems science" approach, which it describes as consisting of "the factors that drive the tobacco epidemic and resultant disease burden" as well as an assessment of "the potential consequences of tobacco control measures." The result is that no stone has been left unturned, and it is doubtful that a single relevant study on the subject of menthol cigarettes was overlooked. Any attempt by the tobacco industry or pro-tobacco financial analysts to find fault either with the scientific analysis or the strength of the conclusions will be futile. If anything, the report bends over backwards to acknowledge the input of the tobacco industry and the "non-voting members of the committee," i.e., the representatives from the industry. The report even includes a quotation (page 70) from a submission by Newport maker Lorillard that the company's marketing expenditures have not been disproportionately weighted toward African-American smokers or any other ethnic group or gender. An etymologist might point out that this is technically true only by virtue of the fact that African-Americans are still a minority population. In other words, while the greater part of the advertising budget might not be specifically targeted at African-Americans, the company's spending on Newport is indeed proportionate to the high market share that brand has among African-Americans. The summary of the evidence for a causal relationship between advertising and promotion of cigarettes and an increase in tobacco use is meticulously presented. The report importantly notes the dramatic increase in retail marketing since the end of billboard and most print advertising under the Master Settlement Agreement, but it fails to put into perspective the relative impact of such point-of-sale expenditures compared to the past century's far more ubiquitous advertising. The report cites the 1964 Surgeon General's Report on Smoking and Health as the landmark scientific publication in the field of tobacco control. That achievement is all the more remarkable when one considers that the authors of the 1964 report completed the work of reviewing the 11,000 studies to that time on smoking and disease in less than one year, the same length of time it took to write the present report on this single aspect of smoking. But the present report suggests we have come a long way from the 1964 report (and many subsequent ones by the Surgeon General) that did not even mention cigarette brand names. The strongest and lengthiest part of the report, Chapter 5 on Marketing and Consumer Perception, covers the gamut of product and package design, as well as marketing tactics. A fascinating section on the role of branding and labeling in consumers' taste perception and sensory evaluation cites manufacturers' various uses of the color green and includes this sentence: "Menthol packaging reflects the tobacco industry's knowledge about how color, labeling and other elements of branding will improve the consumer experience of the product's characterizing flavor." Ultimately, the report's findings are a split decision. On the one hand, the committee did not find that menthol cigarettes increase the risk of disease. But on the other hand, it found that the availability of menthol cigarettes "has led to an increase in the number of smokers and that this increase does have adverse public health impact in the United States." The finding that menthol is associated with lower levels of cessation among African-Americans is compelling, as is the finding of a higher prevalence of menthol cigarette use by the youngest adolescents. Despite the strength of its conclusion that menthol cigarettes substantially harm the public’s health, the committee fails to recommend a ban on menthol cigarettes. The committee's "recommendation" is printed in boldface on page 208: "Removal of menthol cigarettes from the marketplace would benefit public health in the United States." This, unfortunately, is a conclusion, not a recommendation. The big mystery and disappointment is why the committee did not recommend the removal of menthol cigarettes from the marketplace. One answer lies in the concerns about a black market for menthol cigarettes and "after market mentholation" (i.e., do-it-yourself menthol kits with roll-your-own cigarettes) acknowledged in the final section of the report. But this is reasoning that puts the cart before the horse. In the end, the committee proved weak-willed. The devastating impact menthol cigarettes have had on the African-American community should necessitate a greater degree of input of that community in the ultimate decision by the FDA. Upon reading this report, African-American and all anti-tobacco organizations should demand nothing less than the addition of menthol to the list of far less common but already banned candy flavorings. The action of the TPSAC on menthol was also the first test of how effective the new FDA law will be. The Committee's failure to recommend a ban on menthol cigarettes calls into question the effectiveness of the new law and regulatory process. Not recommending the banning of menthol cigarettes means the current market of mentholated cigarettes continues unchecked. This stark reality stands in contrast to promises that FDA regulation of tobacco would be a panacea for the tobacco pandemic. Clearly, the first important test of this claim has been a failure. Congress and the FDA should revisit the viability of this law, including and up to consideration of repealing the law.

TPSAC Was Charged By Law to Weigh Public Health Benefits of Menthol Ban with Black Market Concerns; Panel Failed to Fulfill Its Mandate

As I discussed here yesterday, the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) punted on the menthol cigarette issue, refusing to make any recommendation to the FDA about whether or not to ban menthol cigarettes. Today, I reveal that by failing to make a recommendation, the TPSAC actually failed to fulfill its Congressional mandate under law.

The Rest of the Story

The Family Smoking Prevention and Tobacco Control Act mandated that the TPSAC issue not only a report, but also a recommendation to the FDA regarding the regulation of menthol cigarettes.

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

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

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

It should be immediately apparent to readers that TPSAC failed to complete its mandate because it did not issue any "recommendations" to the Agency regarding the regulation of menthol cigarettes.

What may not be so apparent is that TPSAC was charged not only with examining the public health impact of menthol, but also the black market/contraband concerns.

According to the law, TPSAC "shall address" the considerations in subsections (a)(3)(B)(i) and (b).

What exactly are these considerations?

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

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

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

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

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

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

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

TPSAC Recommendations are Waste of Time; Conclusions are Obvious, Report Adds Little, and Lack of Recommendations Simply Punts Issue Back to FDA

A year ago, when the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) began considering whether to recommend that the FDA ban menthol cigarettes, the FDA knew it had two basic choices:

1) To ban menthol cigarettes; and

2) Not to ban menthol cigarettes.

Now, after a year of time and the expenditure of a huge amount of money (taxpayer money, I might add), after substantial research and analysis, and after meeting after meeting evaluating the policy and scientific issues, the TPSAC final report does little other than to essentially tell the FDA that it has two basic choices:

1) To ban menthol cigarettes; and

2) Not to ban menthol cigarettes.

The report makes no recommendation and doesn't even offer a hint as to which of the two options would be better. It does not put forward a recommendation for either option #1 or option #2. Essentially, the entire report concludes by telling the FDA that it has these two options. But no recommendation is made in terms of which option the FDA should take.

Sorry to break the news to you, but the FDA knew it had these two options a year ago. What the Agency needed was an expert evaluation of the policy and scientific issues, leading to a recommendation of which of the two options it should take.

Can you imagine a similar "recommendation" coming out of an FDA advisory committee charged with evaluating whether the FDA should approve a new drug? Can you imagine such a committee coming out with the following recommendation:

"We recommend that the FDA consider whether to approve this new drug or not."

Thanks, but with advice like that we'd be better off saving the money and simply letting the FDA deliberate the issue itself from the beginning.

The TPSAC simply punted here, making no recommendation and simply pushing the issue back to the Agency. The FDA could not possibly have received anything less helpful than this advice: "You need to study the issue and decide what to do."

Gee, thank you. That really help clarify the situation for us.

The Rest of the Story

Both the conclusions and "recommendations" of the TPSAC report are no-brainers that were readily apparent one year ago without any expenditure of money on research or analysis. Let's break them down one by one and you'll see what I mean:

Conclusion #1: "Menthol cigarettes have an adverse impact on public health in the United States."

Of course menthol cigarettes have an adverse impact on public health in the United States. All cigarettes have an adverse impact on public health in the United States. Had TPSAC concluded that menthol cigarettes do not have an adverse impact on public health in the United States, I would have recommended that the panelists undergo a psychiatric examination. This conclusion is obvious and it didn't take a year of study to derive. We knew this a year ago. It's hard to believe that all of the Committee's research, analysis, and evaluation resulted in this obvious, self-evident conclusion. The taxpayers wasted their money if this was all they got out of the Committee's deliberations.

Conclusion #2: There are no public health benefits of menthol compared to non-menthol cigarettes."

Of course there are no public health benefits of menthol compared to non-menthol cigarettes. We already knew that. Not even the tobacco companies were alleging that menthol cigarettes provide some public health benefit. Once again, if the Committee had concluded that menthol cigarettes provide a public health benefit compared to non-menthol cigarettes, I would have recommended a psychiatric examination for the panelists before they returned home from Washington. Once again, it's hard to believe that all of the Committee's research, analysis, and evaluation resulted in this obvious, self-evident conclusion. The taxpayers wasted their money if this was all they got out of the Committee's deliberations.

"Recommendation" #1: "Removal of menthol cigarettes from the marketplace would benefit public health in the United States."

Apparently, TPSAC does not understand the difference between a recommendation and a conclusion. This is why I put the word "recommendation" in quotation marks.

TPSAC's basic "recommendation" is not a recommendation at all. It is, in fact, a conclusion. By definition, a recommendation is a suggestion or piece of advice. The TPSAC's basic "recommendation" is not a recommendation at all because it doesn't do either. It is a conclusion, devoid of any suggestion or advice.

Stating that the removal of menthol cigarettes would benefit public health doesn't suggest any particular action to the FDA. A recommendation would have looked something like this:

"We recommend that the FDA ban menthol cigarettes."

Or this:

"We recommend that the FDA not ban menthol cigarettes."

Moreover, even as a conclusion, the statement is self-evident and obvious. Of course banning menthol cigarettes would have a public health benefit. We knew this a year ago. If it didn't have a public health benefit, then why was Lorillard so worried about such a potential decision? Was there ever a doubt that in the face of a ban on menthol cigarettes, some smokers would choose to quit smoking? Of course not. Lorillard certainly knew that. I knew that. And I think the FDA knew that.

In fact, it is specifically because Congress knew that a menthol ban was the one potential policy it might include in the Tobacco Act that would substantially benefit the public's health (a.k.a., decrease tobacco sales) that our politicians chose to exempt menthol in the first place.

We really didn't need a year of research and taxpayer expenditures to tell us what Lorillard told us over a year ago: Of course banning menthol will have a public health benefit. It will decrease cigarette sales because it will lead some smokers to quit. Not all smokers, of course, But some smokers. And it might deter some youth from smoking as well. Not all youth, but some youth. This conclusion was obvious from the start and in fact, it is because of a fear that a menthol ban would actually impact tobacco sales that the health groups (i.e., the Campaign for Tobacco-Free Kids and Friends) did not include such a ban in the legislation in the first place. God forbid the legislation might actually decrease cigarette sales. Then Philip Morris might not support it and the deal would crumble.

Recommendation #2: "TPSAC recommends that FDA consult with appropriate experts and carry out relevant analyses depending on the actions taken in response to this report from TPSAC."

In other words, what this is saying is: "We aren't making any recommendation here about what you should do about menthol, but in case you do decide on your own that you want to consider a menthol ban, then we recommend that you think about it carefully." Extremely helpful to the Agency. I don't think they would have thought about this had TPSAC not pointed it out.

I have to say that this is one of the most stupid processes I have observed in all my years following federal policy making and the result is as meaningless as anything I have witnessed. The report offers absolutely nothing. There is no guidance provided to the Agency. No recommendation is put forward.

The rest of the story is that TPSAC has simply punted the issue back to the FDA. They could have simply told the Agency a year ago: "We punt this back to you. We are not going to make any recommendation anyway, so we're not going to pretend to actually be carrying out a thoughtful analysis. We don't want to waste taxpayer money only to come back to you in a year and say that our conclusion is that you should consider the issues and make a decision on your own."

One of the skills I teach my students is how to write a policy memo. In such a memo, students analyze a public health policy, provide the policy options, evaluate each option, and close by making a recommendation. I have to say that if a student ever handed in a policy memo that looked like the TPSAC report, the student would fail my class. First of all, TPSAC doesn't appear to understand the difference between a conclusion and a recommendation. Second of all, the report doesn't make any recommendation. The whole point of the exercise was to offer some guidance, some suggestion for action. The report fails in that regard. In my class, that results in a failing grade. In the real-life classroom of federal public health policy making, that results in a waste of taxpayer dollars.

ADDENDUM (March 21, 2010 - 9:20 a.m.): It has been pointed out to me that the FDA's Center for Tobacco Products efforts (including expenditures on the TPSAC) are funded not by taxpayers, but by user fees assessed on cigarette companies. For this reason, it is not truly taxpayer money that I feel has been "wasted," but cigarette company user fees. This makes the issue of wasting taxpayer money a non-concern, although I still am troubled by the fact that such an intensive effort yielded, in the end, no actual recommendation for action (or non-action). Thanks to readers for pointing this out to me.

FDA Advisory Panel Does Not Recommend Menthol Ban and Warns of Potential Black Market: Huge Victory for Lorillard

In what is certainly a huge victory and sigh of relief for Lorillard, the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) today released its recommendations regarding menthol cigarettes and did not directly recommend that the FDA ban these products. Instead, the Committee merely noted that banning menthol cigarettes could benefit the public's health by inducing many smokers to quit, and recommended that the FDA merely consider the issue further. Moreover, the Committee explicitly warned about the potential black market consequences that could be associated with a menthol ban and urged the FDA to carefully study such potential effects before taking any such action.

After a one sentence recommendation that states: "Removal of menthol cigarettes from the marketplace would benefit public health in the United States," the report emphasizes that it "has no specific suggestions for follow-up by FDA to this recommendation."

The report emphasizes that "TPSAC is not proposing specific policy actions that should be taken by FDA... ."

After the one sentence "recommendation," the report then provides a full two and a half pages of details about the potential adverse effects of a menthol ban related to contraband cigarettes and a black market, and concludes that the FDA would need to carefully assess the potential for contraband menthol cigarettes.

The Rest of the Story

If I worked for Lorillard, I would be breathing a huge sigh of relief this afternoon. This is essentially a best-case scenario for Lorillard, as the the TSPAC took the least drastic action that could possibly have been expected given the make-up of the panel and the conclusions regarding the marketing and impact of menthol in its report.

Here is what TPSAC did not do:

Most importantly, the Committee did not recommend a ban on menthol cigarettes. This is a huge victory for Lorillard.

Second, the Committee did not recommend reductions in levels of menthol. Another victory for Lorillard

Third, the Committee did not recommend marketing restrictions on menthol cigarettes. Yet another victory for Lorillard.

And fourth, the Committee did not put any particular time frame or specific recommendation for action on the FDA. It merely noted that a menthol ban would benefit the public's health and leaves it at that.

Here is what TSPAC did do:

Most importantly, TPSAC gave the FDA a huge out by elaborating in detail all of the potential adverse consequences of a menthol cigarette ban.

Second, TPSAC gave the FDA the benefit of time by emphasizing the importance of further review of the possible ramifications of a menthol ban.

In essence, what the TPSAC did is what legislative committees do when they want to reject a measure without insulting its sponsors: they send it to committee for further review.

The FDA now has exactly what it needs to avoid having to take on a difficult political issue. I have made clear my opinion that the FDA is not going to ban menthol, regardless of the TPSAC recommendations, purely for political reasons. Taking on a menthol ban is the last thing in the world that the Administration needs right now, at a time when it is fighting with every last breath just to maintain the health care package that passed last year and to fend off political damage from attacks that big government has taken over health care.

The political prospects for a menthol ban were low to zero even before this report. But now, the FDA has all the justification and back-up it needs to save face even to the most staunch health advocates. The FDA can say that its expert panel warned about potential black market effects and emphasized that the Agency needs to study the issue further before taking any drastic actions.

It is important to note that all of the major conclusions of the report are things that we already knew. We didn't need a full year of research and taxpayer expenditures to find out that "Menthol cigarettes have an adverse impact on public health in the United States" (what cigarettes do not?) We also didn't need a full year of effort to conclude that "There are no public health benefits of menthol compared to non-menthol cigarettes" (what cigarettes do have benefits compared to others?).

We knew a year ago that banning menthol would have public health benefits (this is precisely why Lorillard was so worried about a potential ban).

What we didn't know a year ago was whether the TPSAC would recommend that the FDA ban menthol.

Now we know the answer. And it is a resounding NO. Although TPSAC made it clear that banning menthol would benefit the public's health, the Committee did not make such a recommendation. Instead, TPSAC swept the issue under the rug by giving the FDA an out, taking the pressure off the FDA by removing any time pressure, not calling for any specific FDA action, and emphasizing in the great detail all the potential adverse effects of a ban that the FDA must carefully study prior to implementing a ban.

The rest of the story is that TPSAC punted and Lorillard returns this punt for a touchdown.

TPSAC Menthol Report Answers the Scientific Questions, But Doesn't Tip Committee's Hand, Demonstrating this is About Policy and Politics, Not Science

Six draft chapters of the FDA Tobacco Products Scientific Advisory Committee (TPSAC) menthol report are now available. These chapters are the following:

• CHAPTER 1: OVERVIEW: WHAT THIS REPORT IS ABOUT and CHAPTER 2: TPSAC’S APPROACH TO ITS CHARGE
  
• CHAPTER 3: THE PHYSIOLOGICAL EFFECTS OF MENTHOL CIGARETTES
• CHAPTER 4: PATTERNS OF MENTHOL CIGARETTE SMOKING
  
• CHAPTER 5: MARKETING AND CONSUMER PERCEPTION
  
• CHAPTER 7: EFFECTS OF MENTHOL ON THE DISEASE RISKS OF SMOKING

These chapters answer all of the key scientific issues that the Committee was asked to consider. Briefly, the report concludes the following:

• There is no evidence that menthol cigarettes are any more hazardous than other cigarettes in terms of their health effects.
• Menthol does contribute to the smoking initiation process by masking the harsh taste of tobacco.
• Menthol cigarettes are disproportionately popular among African American smokers.
• Menthol cigarettes are marketed disproportionately to African Americans.
• The marketing messages convey that menthol cigarettes may be safer.
• Menthol cigarettes may increase the difficulty of quitting.
• The marketing of menthol cigarettes, in combination with its effects, make the product appealing, lead to a perception of relative safety compared to other cigarettes, and make the product more appealing, especially among the African American population.

Based on these findings, it is completely impossible to know what the Committee's recommendations will be. They could recommend a ban on menthol cigarettes, regulation of menthol levels, regulation of menthol cigarette marketing, or further study. Any of these options could be consistent with the scientific findings of the report.

The Rest of the Story

That one can read essentially the full report and have no idea what the Committee will recommend demonstrates a point I have been making for some time: that the menthol issue is not a scientific one, but purely a political and policy one. In other words, science cannot determine what the nation's approach to menthol cigarettes should be. Only policy criteria and politics can make that determination. Thus, the Committee has essentially wasted a year of time and a huge amount of resources. Nothing new came out of the report. This is all information we have known for some time. The Committee could have made its recommendations a year ago, as none of these scientific findings add anything new that was necessary to contribute to a policy decision.

Put in other words, the decision about whether or not to ban menthol cigarettes is not one that flows logically from any particular scientific finding regarding menthol. What it flows from is simply two things:

1. The policy criteria that one decides to use to judge whether a cigarette flavoring should be banned; and

2. Politics.

Essentially, there are two criteria that TPSAC could use to make a decision regarding menthol:

A. A cigarette flavoring should be banned if it increases the toxicity of the product.

B. A cigarette flavoring should be banned if it contributes to increased smoking initiation or decreased smoking cessation by making smoking more appealing.

Under criterion A, menthol should not be banned because there is no evidence that menthol cigarettes are any more toxic than other cigarettes. This is something we knew a year ago before the Committee began its research and deliberations.

Under criterion B, menthol should be banned because obviously it increases the appeal of the product. The cigarette companies would not use this additive if it didn't increase the appeal of the product. That is the case with every additive. This is something we knew a year ago before the Committee began its research and deliberations.

You see, nothing happened in the past year that contributed toward the Committee's decision. What it needs to do is figure out what is the appropriate criterion to use in making a policy decision regarding menthol. This is an issue of policy, not science. Nothing that is in the report contributes towards that decision. The decision is separate from the science. You have to decide what policy criteria to use, and that doesn't have any relationship to the scientific issues. It could have been done a year ago, and no report was necessary to come to such a decision.

This is very different from an issue where the science actually dictates the decision. For example, if the FDA were deciding whether or not to approve a new drug, we could read the advisory committee's report and we would immediately know whether the committee would recommend to approve or disapprove the drug. The answer to the question would flow logically out of the conclusions in the report.

The same thing is true of an FDA panel considering whether to take a particular drug off the market. The answer flows from the scientific analysis.

The menthol issue is completely different. No clear answer flows from this scientific analysis. At the end of the day, it comes down to: What criteria are you going to use to decide the appropriate regulatory approach to menthol as a cigarette flavoring or additive? The answer to that question in no way flows from scientific information. It flows from policy judgment. Or, at worst, from political considerations.

So I find myself in the absurd situation of having no better idea (literally zero percent improvement in confidence) of what TPSAC will recommend after having read six chapters of its report than before the committee even started considering the issue.

The Committee could still recommend a ban on menthol cigarettes, regulation of menthol levels, regulation of menthol cigarette marketing, or further study. None of these policy approaches flows directly from the report's analysis of the scientific issues. It is a completely separate and different decision.

Safeway Lawsuit Against San Francisco Highlights the Irrationality and Lack of Public Health Basis of Pharmacy Tobacco Sales Bans

Consider the following four facts about the city of San Francisco's law which prohibits cigarette sales in certain types of stores:

ONE

San Francisco's 7-Eleven stores sell the following medicines that are designed to improve human health by helping to treat illness:

• Aspirin (an analgesic and anti-pyretic)
• Tylenol (an anti-inflammatory drug)
• Advil (an anti-inflammatory drug)
• Claritin (an anti-histamine)
• DayQuil (a combination of analgesic, anti-pyretic, cough suppressant, and decongestant)
• NyQuil (a combination of analgesic, anti-pyretic, cough suppressant, and anti-histamine)
• Aleve (an anti-inflammatory drug)
• Motrin (an anti-inflammatory drug)
• Pepcid (a treatment for gastroesophageal reflux)

San Francisco's Walgreen's stores also sell the following medicines that are designed to improve human health by helping to treat illness:

• Aspirin (an analgesic and anti-pyretic)
• Tylenol (an anti-inflammatory drug)
• Advil (an anti-inflammatory drug)
• Claritin (an anti-histamine)
• DayQuil (a combination of analgesic, anti-pyretic, cough suppressant, and decongestant)
• NyQuil (a combination of analgesic, anti-pyretic, cough suppressant, and anti-histamine)
• Aleve (an anti-inflammatory drug)
• Motrin (an anti-inflammatory drug)
• Pepcid (a treatment for gastroesophageal reflux)

There's just one difference. According to city law, the first set of stores (7-Elevens) can sell cigarettes, but the second set of stores (Walgreen's) cannot.

This is because Walgreen's also contain a pharmacy and the city's law prohibits the sale of tobacco products in any store that contains a pharmacy.

TWO

There are 15 Safeway grocery stores in San Francisco. At 10 of these stores, cigarettes cannot be sold. At 5 of the stores, cigarettes can be sold. They are exactly the same store: Safeway. Yet 10 can sell cigarettes and 5 cannot. Clearly, the public doesn't see these stores as being different. They are all Safeways.

To be clear:
The Safeway at 1335 Webster Street cannot sell cigarettes, but the Safeway at 350 Bay Street can.
The Safeway at 2020 Market Street cannot sell cigarettes, but the Safeway at 145 Jackson Street can.
The Safeway at 2300 16th Street cannot sell cigarettes, but the Safeway at 3350 Mission Street can.
The Safeway at 298 King Street cannot sell cigarettes, but the Safeway at 5290 Diamond Heights Boulevard can.
The Safeway at 15 Marina Boulevard cannot sell cigarettes, but the Safeway at 625 Monterey Boulevard can.

There's just one difference. According to city law, the first set of stores (Safeways) cannot sell cigarettes, but the second set of stores (Safeways) can.

THREE

The Safeway store at 145 Jackson Street offers adult immunizations. However, it is allowed to sell cigarettes.

The Safeway at 298 King Street does not offer any immunizations. However, it is not permitted to sell cigarettes.

There's just one difference. According to city law, the first store (Safeway) can sell cigarettes, but the second store (Safeway) cannot.

FOUR

The Safeway store at 145 Jackson Street sells health-related items, including medicines. In addition to offering immunizations against seasonal influenza, pneumonia, and the H1N1 virus, it sells a host of medicines, including Allegra, which (for those of you in the Bay Area), is on sale this week for $17.99 (20-count; 12-hour relief).

This store - which offers all of these immunizations and sells all of these medicines - can, by law, sell cigarettes. And it does sell cigarettes, to go with its immunizations and medicines.

The Rest of the Story

The obvious irrationality of San Francisco's law banning cigarette sales at pharmacies is readily apparent when you examine the preposterous situation it has created.

Some stores that sell medicines to help people recover from illness can sell cigarettes, while others cannot.

Some Safeways can sell cigarettes, while others cannot.

A Safeway that offers immunizations and sells medicines can sell cigarettes, while another Safeway that does not offer immunizations cannot sell cigarettes.

The city argues that the law is intended to prevent stores that sell healthful items - medications to be exact - from also selling an unhealthful item: cigarettes. However, the Safeway store at 145 Jackson Street and does offer lots of medicines as well as immunizations is allowed to sell cigarettes by this law, while its counterpart at 298 King Street which does not offer immunizations cannot sell cigarettes.

The irrationality of this law is the basis of a lawsuit that Safeway has filed against the city. A Safeway spokeswoman pointed out: "Safeway is first and foremost a retail grocery store that happens to sell health and wellness products. There are many other stores in the city that provide these same products but without a pharmacy. Yet they are still allowed to sell tobacco."

While the lawsuit may not ultimately succeed because the courts generally give wide discretion to governments when applying the rational basis test (an ordinance may discriminate against certain types of stores as long as there is some rational basis for that discrimination), it is very clear that the ordinance lacks any rational public health basis.

The rest of the story is that there is no rational public health basis for this law.

IN MY VIEW: Society for Research on Nicotine and Tobacco (SRNT) Has Compromised Its Scientific Integrity by Accepting Pharmaceutical Money

According to its web site: "The Society for Research on Nicotine and Tobacco (SRNT) is the leading association focused on this special area of research. SRNT was founded in 1994 to coordinate and advance research on a broad array of topics ranging from the pharmacology of nicotine to the societal influences on use of tobacco.

"The mission of the Society is to stimulate the generation of new knowledge concerning nicotine in all its manifestations - from molecular to societal. The Society has three main aims:

1. To sponsor scientific meetings and publications fostering the exchange of information on nicotine and tobacco.
2. To encourage scientific research on public health efforts for the prevention and treatment of tobacco use.
3. To provide a means by which legislative, governmental, regulatory and other public agencies can obtain expert advice and consultation on nicotine and tobacco."

The Rest of the Story

Although its main purpose is presumably to foster objective scientific consideration of the issues regarding nicotine and tobacco control, what is not immediately apparent to web site viewers is that the Society is apparently heavily funded by the pharmaceutical industry. This funding, in my view, 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 or international tobacco control strategies.

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.

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

One way in which the conflict of interest created by these pharmaceutical sponsorships may play out is in the determination of the scientific agenda for the annual meeting. For example, while the annual meeting program highlights several talks about the benefits of Chantix (manufactured by conference sponsor Pfizer), I cannot find in the program any talk dedicated to discussing the many suicides and other serious adverse effects attributed to Chantix. I could find no paper, for example, which focuses on the reported effects of Chantix on suicidal ideation, completed suicide, or other violent behavior.

How can one expect that the Society 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?

There were numerous papers presented about the effects of smoking cessation drugs. How can these papers present a completely objective picture of the efficacy of these medications when the manufacturers of these drugs are the very sponsors of the conference?

This is in no way to fault the individual scientists who presented on these issues at the conference. Nor is it to suggest that any wrongdoing occurred. It is merely to point out that 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.

It is also important to point out that 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.

I should also note that SRNT is not unique in relying upon pharmaceutical company sponsorship. As I noted yesterday, the 14th World Conference on Tobacco OR Health, which was held in Mumbai, India in March 2009, was sponsored by two of the largest representatives of Big Pharma: GlaxoSmithKline and Pfizer. The 2007 National Conference on Tobacco or Health was sponsored by Pfizer, as was at least one event at the 2009 Conference. And the Sixth National Conference on Tobacco or Health in Canada in 2009 was also sponsored by Pfizer.

I should once again highlight the International Society for the Prevention of Tobacco Induced Diseases (ISPTID) as 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.

Setting an Example for the Integrity of Tobacco Control Science by Discontinuing Sponsorship by Pharmaceutical Companies: ISPTID Leads the Way

On its 2006 annual meeting web site, the International Society for the Prevention of Tobacco Induced Diseases (ISPTID) stated that it is "a not-for-profit, academic, scientific and humanitarian organization of health professionals and scientists, independent from any industrial, political, governmental, or ideological group."

The rest of the story, however, is that this very conference - the Fifth Annual Conference of ISPTID - was, according to the web site, sponsored by Pfizer, a pharmaceutical company.

According to an article in its journal - Tobacco Induced Diseases - the Sixth Annual Meeting of the International Society for the Prevention of Tobacco Induced Diseases, held in Little Rock in 2007, was also sponsored by Pfizer.

According to the article: "Many contributors and sponsors supported this meeting impartially for its intended cause. The meeting was supported by funds from National Institutes of Health which includes support from National Institutes of Drug Abuse and National Cancer Institute. In addition, the meeting was funded by International Society for the Study of Lung Cancer. The corporate funding was received from Pfizer, Inc ... . Without their help the hosting of this meeting at this site would not have been possible. The sponsorship support helped to bring many scientists, graduate students and non-scientists all across the globe."

ISPTID emphasized that Pfizer's sponsorship was critical to the conference and that the very hosting of the meeting in Little Rock "would not have been possible" without Pfizer's support.

The sponsorship by Pfizer is particularly concerning because it creates a possible financial conflict of interest that might be viewed as interfering with the objective discussion of tobacco science issues that involve the assessment of the role of smoking cessation drugs in tobacco control. Discussions at the conference regarding the appropriate role of smoking cessation drugs in tobacco control could potentially have the appearance of being biased by the sponsorship of the conference by Pfizer. More importantly, the Pfizer sponsorship appears to have belied the claim that ISPTID was an organization fully independent of industry groups.

The Rest of the Story

Unlike many other organizations in tobacco control which apparently have not come to understand the fact that pharmaceutical industry sponsorship is problematic because it could potentially interfere with scientific integrity by creating a perceived (or real) financial conflict of interest, the International Society for the Prevention of Tobacco Induced Disease has now rejected the idea of pharmaceutical sponsorship.

Under the leadership of its new president, Dr. Taru Kinnunen, ISPTID did not take any pharmaceutical sponsorships and its most recent conferences - including the 8th annual meeting in Boston last September - have not been sponsored in any way by pharmaceutical companies.

At a time when finding funds to pay for conferences like this is getting more difficult, ISPTID - and particularly Dr. Kinnunen - are to be congratulated for taking the principled stand of not relying on pharmaceutical funding.

As I have discussed in earlier columns, in contrast to recent meetings of the ISPTID, both the World Conference on Tobacco and Health and the National Tobacco Control Conference apparently are still accepting pharmaceutical company sponsorships. The 14th World Conference on Tobacco OR Health, which was held in Mumbai, India in March 2009, was sponsored by two of the largest representatives of Big Pharma: GlaxoSmithKline and Pfizer. The 2007 National Conference on Tobacco or Health was sponsored by Pfizer, as was at least one event at the 2009 Conference. The Sixth National Conference on Tobacco or Health in Canada in 2009 was also sponsored by Pfizer.

The Society for Research on Nicotine and Tobacco (SRNT) is heavily conflicted because of its pharmaceutical sponsorship, and it continues to rely on that sponsorship. It currently acknowledges support from three different pharmaceutical companies: GlaxoSmithKline, Pfizer, and Johnson & Johnson.

Why is ISPTID 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 can only attribute that, at least in part, to the integrity and character of its leadership, including past president Dr. Taru Kinnunen, who I admire deeply for her commitment, integrity, and passion for improving the public's health, but without sacrificing scientific integrity in the process. I can only hope that more tobacco control groups will follow ISPTID’s lead.

My Op-Ed on Pharmacy Tobacco Sales Ban Highlights How Politics, Not Public Health, is Driving Many in Tobacco Control

Those of you who read my blog post on Thursday about the Fall River (Massachusetts) City Council's initial approval of an ordinance that bans tobacco sales in stores that have pharmacies (but not in the stores from which youth are most likely to buy cigarettes) will recognize my opinion piece published yesterday by the Fall River Herald-News, to which I offered a slightly modified version of my blog commentary.

In the piece, I note - sarcastically - that the Fall River City Council is to be congratulated for sending the clear message to youth that "they want people to die of lung cancer from cigarettes purchased at gas stations and convenience stores like Honey Farms and Cumberland Farms, rather than at large chain pharmacy stores like CVS, Rite-Aid, and Walgreens. ... It is truly a tragedy when someone dies of a smoking-related illness and it turns out that their cigarettes were purchased in a pharmacy."

This action by the Fall River City Council frames smoking in exactly the wrong way. It is not a problem because cigarettes are being sold in the same store as medications. It is a problem because cigarettes are killing hundreds of thousands of Americans each year.

Moreover, the action by the Fall River City Council will have no effect on youth smoking. Kids will still be able to purchase cigarettes at numerous other stores in the city, including gas stations and convenience stores where they are already more likely to be buying their cigarettes in the first place.

This is largely a feel-good measure: a law enacted to make it look like the City Council is tackling the smoking problem, but without the policy makers having to actually take a politically difficult action that would truly make a difference in lowering Fall River's very high smoking rates. In other words, the action is essentially a political one, not a public health-based measure. The political rhetoric of the City Council members may be advanced because of the initiative, but the rate of smoking among Fall River's youth will not decline one iota because of it.

The Rest of the Story

This op-ed piece highlights a much broader issue in tobacco control, beyond merely the merit of laws that ban the sale of tobacco products in pharmacies. The piece highlights the growing trend of what one might call "political correctness" in tobacco control. By that, I mean taking actions purely for political gain, not for tangible public health benefit.

I think the term "political correctness" is widely overused. Often opponents of an action use the term to attack any policy they oppose. As I see it, political correctness is the enactment of a policy purely for political gain (i.e., public approval), devoid of any true public health or public welfare justification.

Attacking policy makers who support workplace smoking bans on the grounds that they are acting out of "political correctness" is baseless in my view, because smoking bans have tangible and substantial public health benefits. However, enacting an ordinance that makes it appear that you are addressing a problem without actually advancing the public's health - such as banning tobacco sales only in pharmacies - is an example of what might rightly be called political correctness. The policy is achieving little other than political benefit for the policy makers. There is no tangible and substantial public health benefit, as there will be no effect on overall tobacco sales. The ordinance will merely shift sales from one type of store to another.

That shifting of tobacco sales affects the profitability of various businesses, but it does not affect the public's health. Advances to the political image of policy makers is coming at the expense of a loss of business by some stores. This re-distribution of tobacco sales profits is not justified by any public health gains. The public does not benefit. The politicians who enacted the law do benefit, by virtue of improving their public image: making it look like they are taking a tough stand for the protection of the public's health.

In recent months, I have commented on a range of similar policies which share this characteristic: they are feel-good policies which allow politicians to make it look to the public like they are taking a principled stand for the public's health, but which in fact have no significant public health benefits.

Examples include the following:

• New York City's law requiring graphic warning posters at cigarette point-of-sale
• San Francisco's law banning Happy Meals (toy giveaways with certain foods marketed to children)
• New York City's ban on flavored tobacco products
• The Family Smoking Prevention and Tobacco Control Act
• The Framework Convention on Tobacco Control's proposed cigarette ingredient regulations
• The Framework Convention's proposed approach to regulating cigarette additives
• Washington state tobacco control groups' support for a law banning menthol cigarillos
• The FDA's ban on flavored cigarettes
• The American Lung Association's call for initiatives to reduce the burden of lung cancer among African Americans

The list could go on, but these examples I think demonstrate my point.

The rest of the story is that there has been a disappointing and unfortunate shift in tobacco control activities: away from measures that may be less politically popular but which are evidence-based and actually make a difference in reducing smoking rates and towards measures that are politically popular but do little or nothing to reduce the burden of tobacco-related morbidity and mortality.

Dishonest Disclosures? Six Articles on Health Effects of Hookah Use Fail to Mention that Research Sponsor Was Directed by a Tobacco Industry Executive

Six different papers on hookah (also called waterpipe, shisha, or narghile) use, published between 2008 and 2010 and funded by the International Development Research Centre, failed to report any conflicts of interest. The papers, their funding sources, and their conflict of interest statements, are as follows:

1. Al Rashidi M, Shihadeh A, Saliba NA. Volatile aldehydes in the mainstream smoke of the narghile waterpipe. Food and Chemical Toxicology. 2008 Nov;46(11):3546-9.

Funding source: International Development Research Centre and National Cancer Institute

Conflict of interest statement: "The authors declare that there are no conflicts of interest."

2. Monzer B, Sepetdjian E, Saliba N, Shihadeh A. Charcoal emissions as a source of CO and carcinogenic PAH in mainstream narghile waterpipe smoke. Food and Chemical Toxicology. 2008 Sep;46(9):2991-5.

Funding source: International Development Research Centre and University Research Board at the American University of Beirut

Conflict of interest statement: "The authors declare that there are no conflicts of interest."

3. Saleh R, Shihadeh A. Elevated toxicant yields with narghile waterpipes smoked using a plastic hose. Food and Chemical Toxicology. 2008 May;46(5):1461-6.

Funding source: International Development Research Centre and University Research Board at the American University of Beirut

Conflict of interest statement: "We have no conflict of interest in connection with the
research reported in this manuscript."

4. Sepetdjian E, Shihadeh A, Saliba NA. Measurement of 16 polycyclic aromatic hydrocarbons in narghile waterpipe tobacco smoke. Food and Chemical Toxicology. 2008 May;46(5):1582-90.

Funding source: International Development Research Centre and University Research Board at the American University of Beirut

Conflict of interest statement: "Nothing to declare."

5. Daher N, Saleh R, Jaroudi E, Sheheitli H, Badr T, Sepetdjian E, Al-Rashidi M, Saliba N, Shihadeh A. Comparison of carcinogen, carbon monoxide, and ultrafine particle emissions from narghile waterpipe and cigarette smoking: Sidestream smoke measurements and assessment of second-hand smoke emission factors. Atmospheric Environment 2010; 44(1): 8-14.

Funding source: International Development Research Centre and U.S. Public Health Service.

Conflict of interest statement: None.

6. Khalil J, Heath RL, Nakkash RT, Afifi RA. The tobacco health nexus? Health messages in narghile advertisements. Tobacco Control. 2009 Oct;18(5):420-1.

Funding source: International Development Research Centre

Conflict of interest statement: "None."

The Rest of the Story

What none of these papers disclose is that there is a significant conflict of interest:

The work was funded by an organization that is directed by a Chair who, at the time of the research and publications, was a tobacco industry executive.

The Chair of the International Development Research Centre is Barbara McDougall. Mrs. McDougall joined the Board in January 2007 and since December 2007 has directed the organization, serving as its Chairman.

Although her biography on the IDRC web site does not mention it, McDougall was, until last March, a tobacco industry executive.

From October 2004 to March 2010, McDougall was on the Board of Directors of Imperial Tobacco Company, which is owned by British American Tobacco. She served as the Chair of the Imperial Tobacco Canada Corporate Social Responsibility Committee, whose job it was to make it look like Imperial Tobacco is a socially responsible company, when in fact the company is the leading cause of cancer and heart disease in Canada.

Her 2006-2007 report starts by pretending that: "Being a socially responsible company is a top priority at Imperial Tobacco Canada." Obviously, that's a big lie, as Imperial continued to sell deadly tobacco products which serve as the leading cause of preventable deaths in all of Canada. In many respects, I view the insincere and fake efforts to make Imperial Tobacco to look socially responsible to be even more reprehensible than the actual production of cigarettes.

At any rate, the rest of the story is that despite the lack of any disclosed conflicts of interest, all of the above research was funded by an organization directed by a tobacco industry executive.

I therefore view these disclosures as being inaccurate and untruthful. Wouldn't it be important for the public to know that an article which compares the risks of hookah use with the use of cigarettes and other tobacco products was funded by an organization run by a tobacco industry executive? And not just any tobacco executive, but someone on the Board of Directors of the leading tobacco company in all of Canada.

I think it is shameful not to have such an important piece of information disclosed in these research articles. This is especially true since the conflict of interest could easily be perceived as affecting the conduct and reporting of the research findings. After all, hookah use is a potential competitor to the use of cigarettes and other tobacco products and Imperial Tobacco has a direct financial interest in the results of this research on the relative health effects of hookah use compared to the products which Imperial produces, markets, sells, and relies upon for its profits.

To not let readers of these articles know that the research sponsor was (at the time) run by a tobacco industry executive is irresponsible and undermines the purpose of conflict of interest disclosures.

Apparently, some or all of the researchers were not aware of this conflict of interest at the time they submitted their papers to the journals. A more recent article published by many of the same authors does disclose that the International Development Research Centre was chaired by a tobacco industry executive: "Revelations regarding IDRC Chairperson Barbara McDougall’s unfortunate ties to the tobacco industry were not known to the authors of this study at the time it was funded and executed". Strangely, however, the papers still state: "All other authors declare that they have no conflicts of interest."

I don't understand how they can make this statement. It can't be both ways. If the research sponsor was directed by a tobacco industry executive, then the researchers are conflicted, and that conflict needs to be disclosed. The fact that they did not know who the Chair of the Board was does not remove the conflict. Nor does the conflict mean that the researchers were biased. But the bias may come in at a higher level. For example, in the very decisions about what research to fund in the first place, having a tobacco industry executive as the Chair of the Board may influence those decisions. Studying hookah use seems to be a wise decision for a tobacco company Chair because it would help deflect attention of her products and put them onto hookah, a potential competitor.

Many researchers do not understand that a financial conflict of interest is not assessed by whether the researcher is biased or not. A researcher can be biased without any conflict of interest and a researcher could be unbiased with a serious conflict of interest. The presence of a conflict is assessed objectively by the financial relationships of the researcher and research sponsor. In this case, it is clear that there is an important conflict of interest. It doesn't mean the investigators were biased. It simply means that there is a financial conflict of interest which is relevant, and ethical considerations require that the conflict be disclosed to readers.

I want to make two other important points. First, although the investigators cannot be blamed, in some sense, for not disclosing the conflict because they apparently did not know about it, I would argue that there is some responsibility on their part because they should have known about it. I believe that when a researcher accepts funding from an organization, it is incumbent upon the researcher to understand who he or she is taking money from.

Second, these failed disclosures are not all in the past. While the PDF versions of the article can perhaps not be changed, the HTML versions of these articles certainly can be changed, and the conflict of interest statements could easily be updated, revised, or replaced. An erratum statement could easily be published noting the new information and the presence of a conflict. In other words, this is not just a mistake that happened in the past. It is, in a sense, an ongoing one.

It is important to point out that conflicts of interest are important not only in research that denies the health effects of tobacco products. Conflicts of interest are important in all research, even if it is reporting that tobacco use is harmful.

Finally, I should make it absolutely clear that I am making no statement about the merits of the findings of these articles. In no way should this commentary be construed as defending or supporting hookah use. In fact, this commentary is not about hookah use, it is about conflict of interest and the revelation of what appears to be a widespread failure on the part of six articles to disclose an important conflict in the research.