American Dietetic Association Partners with Coke and Pepsi to Help Market Soda to Public; ADA is Helping Promote Obesity and Undermining Public Health

On its web site, the American Dietetic Association (ADA) claims to be "your source for trustworthy, science-based food and nutrition information." The ADA also claims that it "is committed to improving the nation's health and advancing the profession of dietetics through research, education and advocacy."

One aspect of the ADA's web site is its corporate sponsorship program where it welcomes select groups (which provide it with donations) to the "health community."

The American Dietetic Association acknowledges that its corporate sponsorship program allows corporate sponsors to "Reinforce and elevate your position as a leader in health and wellness."

The Rest of the Story

Two of the ADA's corporate sponsors -- companies which the ADA is therefore promoting as being leaders in health and wellness -- are the Coca-Cola Company (manufacturer of Coke) and Pepsico (maker of Pepsi) .

So much for the ADA's ability to deliver "trustworthy" and "science-based" food and nutrition information. You simply can't do that when you're receiving funding from companies that are marketing some of the most unhealthy snacks and beverages imaginable. Even if acting only subconsciously, these sponsorships are going to temper the information that the ADA provides about the unhealthiness of drinking Coke and Pepsi. Moreover, the sponsorship gives these corporations the opportunity to make it look like they are committed to the nation's health, thus obscuring attention from the contributions their products are making to the obesity epidemic.

The ADA honored the Coca-Cola corporation with this press release announcing their partnership. In the release, the ADA readily acknowledges that one of the purposes of the sponsorship is to give Coca-Cola "prominent access to key influencers, thought leaders and decision makers in the food and nutrition marketplace."

In this press release, the American Dietetic Association allows Coca-Cola to tell the public that its sugar-laden soft drinks are designed to "meet their hydration needs." The ADA also describes Coca-Cola as being committed to: "product innovation and nutrition education, helping to meet changing consumer wellness needs through beverages and serving as a resource for health professionals and others interested in the science of beverages and their role in healthful living."

Thus, on its own web site, the ADA is promoting Coke - a sugar-laden soft drink - as being valuable for meeting people's "hydration needs."

Coca-Cola and Pepsico are certainly getting their monies worth from their sponsorship of the ADA.

For example, the ADA has published a lengthy document about improving nutritional standards in schools, but nowhere in the document does it recommend banning soda vending machines. The document goes into unproven, marginal strategies such as garden-based education, but it ignores evidence-based strategies such as soda taxation or removal of soda from schools.

Moreover, nowhere on the ADA's web site does it recommend the taxation of soda and junk food, restrictions on soda marketing in schools, or removal of soda and junk food vending machines as strategies to improve school and childhood nutrition. Taxation of soft drinks is an evidence-based strategy to address obesity that is widely supported by public health groups.

To add insult to injury, the ADA's healthy eating tip sheet does not recommend that people moderate their soda intake.

According to a post over at the Healthy Eating Politics blog: "In her book, Food Politics, Marion Nestle, a Professor of Nutrition, Food Studies, and Public Health at New York University, wrote:"

"The ADA's stance on dietary advice is firmly pro-industry; one of its basic tenets is that there is no such thing as a good or a bad food. The Association is apparently willing to enter into partnerships with any food company or trade organization, regardless of the nutritional quality of its products."

On the ADA's own web site, the Coca-Cola Company boasts about its sponsorship of the American Dietetic Association and how Coca-Cola is committed to promoting the public's health by helping people to meet their "hydration" needs: "We are proud to partner with the American Dietetic Association, one of the country's leading authorities in health and nutrition education. Our partnership with the American Dietetic Association is central to our efforts to continually provide consumers with innovative options that meet their hydration needs and ever-changing tastes and information that allows them to make informed decisions about their personal wellbeing. Like ADA, Coca-Cola understands that a healthy lifestyle involves balancing many different elements — staying physically active, consuming a balanced diet, getting enough rest — and even keeping a positive attitude."

Thanks to the ADA, the Coca-Cola Company is getting a huge public relations benefit and a rare and unique opportunity to improve its public image and obscure attention away from the contribution of its products to poor nutrition and obesity.

In its annual sustainability report for 2009-2010, the Coca-Cola Company uses its sponsorship of the American Dietetic Association to enhance its own public image as a socially responsible company that is committed to improving the public's health. Coca-Cola writes: "We continue to build public-private partnerships to promote the importance of energy balance that includes physical activity and sensible, balanced diets. In the United States, we currently reach millions of consumers annually through our work with the American Dietetic Association... ."

Pepsico, too, uses its sponsorship of the American Dietetic Association to enhance its image as a socially responsible company that is working to improve the public's health. In its 2008 annual sustainability report, it writes: "In the U.S., we’re working with the American Dietetic Association, the nation’s largest organization of food and nutrition professionals, to develop educational programs and engage in frequent dialogues that will make a positive difference in public health through improved product choices and adoption of active lifestyles."

For Coca-Cola and Pepsico, corporate sponsorship is actually part of their marketing mix. Sponsorship is an aspect of public relations, which is one of the four elements of corporate marketing: advertising, sales promotion, public relations, and direct marketing.

As Rosenberg and I wrote in an article in the journal Tobacco Control in 2001: "Corporate sponsorship of events and organisations is a well recognised marketing tool. In the marketing literature, sponsorship is noted to enhance a corporation’s image, to associate the name of a sponsoring company with causes that are important to a particular target group, to offer effective product exposure, to target specific populations including groups that are difficult to reach through more traditional forms of advertising, and to provide publicity for a company through highly visible activities. Corporate sponsorship of, and donations to, social causes has been termed “cause related marketing” and its purposes, according to Kotler, are to “enhance corporate image, thwart negative publicity, pacify consumer groups, launch a new product or brand, broaden their customer base, and generate incremental sales” (page 29)."

As we noted, the purpose of corporate sponsorships is "to promote brand and company awareness, to develop brand and company associations with attractive images, to create co-marketing opportunities by allowing them to combine advertising with sponsorship in promotion of a product image, and to enhance their public image by achieving recognition as good corporate citizens. Each of these functions is well recognised in the marketing literature as a major objective of corporate sponsorship."

Thus, by accepting corporate sponsorships from companies like Coca-Cola and Pepsico, the American Dietetic Association is not only compromising its own scientific and public health integrity, it is also serving as a pawn in the marketing plans of these companies, allowing them to further promote the very products which are in part responsible for the obesity epidemic.

The American Dietetic Association, therefore, is actually helping to market soda and other unhealthy products, undermining its entire public health goal.

The rest of the story is that the American Dietetic Association has prostituted itself, its scientific integrity, and its commitment to the public's health by accepting corporate sponsorships from the Coca-Cola Company and Pepsico and allowing itself to be used to help market products which are contributing substantially to the very problem that the ADA purports to be confronting.

To make matters even worse, the ADA has accepted corporate sponsorships from a host of other corporations which are also marketing unhealthy foods - such as candy and junk food - which are contributing to the nation's obesity epidemic. These companies include Con-Agra, which markets Wesson vegetable oil for use in frying foods, Slim Jim Beef & Cheese "snacks," and Kid Cuisine All American Fried Chicken.

Just how much of a contribution is Con-Agra making to the health of our nation's children by marketing Kid Cuisine All American Fried Chicken, and how much of a contribution is the ADA making by helping Con-Agra to market this product?

Well, let's look at the nutritional information for a single serving of Kid Cuisine: it contains 540 calories, a whopping 24 grams of fat, 210 fat calories, 1 gram of trans-fat, and 750 mg of sodium. Is this really the kind of product behind which the ADA wants to ally itself? Is this really the type of product that the ADA wants to help market to the nation's children?

A single serving of Slim Jim Beef & Cheese "snack" delivers a whopping 630 mg of sodium, along with 100 fat calories and a half gram of trans-fat. Is this really a product that the ADA wants to help market as nutritious snack food?

Whether it intends to or not, through its Pepsico sponsorship, the ADA is actually helping the company market its Captain Crunch cereal to America's children, which in just a 3/4 cup serving delivers 11.8 grams of sugar. Is this the ADA's idea of a healthy breakfast for a child?

Also through its Pepsico sponsorship, the ADA is helping Pepsico to market its 2-ounce Flamin' Hot Cheetos snack, which delivers 340 calories and 22 grams of fat to a child in a single serving.

And this is just the beginning. The ADA is running a virtual brothel of corporate sponsorships, in which it is completely prostituting its scientific and public health integrity by enabling the marketing efforts of many of the companies making the very products which are least nutritious.

Take its Mars Company sponsorship. Does the ADA really want to help market the Snickers bar as a nutritious snack, when a single bar delivers to a child 280 calories, 14 grams of fat, and a whopping 5 grams of saturated fat?

And what about its sponsorship by Cargill? Just how nutritious is Cargill's Sterling Silver chuck beef burger, which delivers 230 calories, 16 grams of fat, and a full gram of trans-fat in a single patty?

The American Dietetic Association has lost its ability to provide unbiased and trustworthy nutrition information and recommendations to the public. It has also lost its credibility in making recommendations for public health policy. Worst of all, it is actually contributing to, rather than confronting, the nation's obesity epidemic by serving as a marketing tool for the very corporations whose products are most responsible for poor nutrition and obesity, especially among our nation's children.


NOTE (April 12, 2010 - 1:00 pm): The ADA's sponsorship by Con-Agra is acknowledged here. The funding is for the 2011 Food & Nutrition Conference & Expo in San Diego in September. The conference would more aptly be named: "The 2011 ADA Slim Jim Beef & Cheese Conference."

Arkansas Bans Smoking in Cars With Children Under 14, Claiming It Will Spare Them From Secondhand Smoke Exposure

In 90 days, smoking in cars with children under 14 years old will be illegal in Arkansas, thanks to legislation enacted by the state legislature last week. It is already illegal to smoke in cars with infants and children under age 6; the legislation extends the ban to include smoking in cars with children up to age 13.

According to an article on the KSPR (Springfield, Missouri ABC affiliate) web site: "90 days from now your vehicle will not longer be your castle, if you will. Arkansans already can't smoke in the car if a child in a car seat is a passenger; Arkansas legislators say tweaking that law will spare more than 270,000 children from exposure to secondhand smoke."

According to another article, the director of the Arkansas Department of Health supported the law, stating: "Perhaps some of the worst exposure is in an automobile."

The legislation was widely supported by anti-smoking groups, including the American Cancer Society, which advocates state laws banning smoking in cars with children under age 18.

The Rest of the Story

The truth is that this law will not spare 270,000 children from secondhand smoke exposure. It may spare them from exposure during the minutes they are in a car, but it will not spare them exposure during the hours upon hours that they are in the home.

If these groups are sincere about standing up to protect the health of children, and if they are willing to interfere with parental autonomy in private vehicles by banning smoking in those vehicles, then why are these groups not proposing or supporting bans on smoking in the home? After all, the home - not the car - is the greatest source of secondhand smoke exposure for children who live with smokers.

The state health department director is mistaken in arguing that the worst exposure is in the car. He is confusing concentration of exposure with dose. The dose of exposure is equal to the concentration of exposure multiplied by the duration of exposure:

Dose = Concentration x Duration

While the concentration of secondhand smoke in cars can be very high, the duration of this exposure is short compared to the duration of exposure in the home. And you can bet that if parents are smoking in cars with children, they are most likely also smoking in the home.

By not supporting a ban on smoking in homes with young children, I believe that these politicians, policy makers, and anti-smoking groups are actually being hypocritical and displaying a lack of sincerity, as well as a subordination of public health protection to politics.

My own position is that although smoking in cars with children is unfortunate, the government should not interfere with parental autonomy to make decisions about their children's health risks unless those risks are immediately life-threatening (such as not wearing a seat belt or car seat) or if the behavior causes harm to the child (e.g., abuse or neglect). I do not support smoking bans in the home for this reason. However, I also do not support bans on smoking in cars for the same reason. It would be hypocritical of me to argue for smoking bans in cars with children, but to oppose such policies in homes with children.

Sometimes the most difficult decisions in public health are ones in which we must accept the fact that many parents put their children at risk of health problems. We can still intervene to try to prevent this from happening with educational and persuasion campaigns, but coercive measures that interfere with parental autonomy when the child is not in a situation of direct, life-threatening risk or actual harm are not justified.

While the policy makers and health groups supporting the smoking ban in cars with children are well-intentioned, I believe they are also being insincere in their stated intention of protecting the health of these children. They want to protect them from high, but short-term exposure in cars, but they are perfectly willing to subject those kids to long-term exposure to secondhand smoke in the home.

The problem is that once you regulate the smoking behavior of parents in the presence of their children, you have asserted jurisdiction over the issue. If you fail to ban smoking in the presence of children in the home, you now share responsibility for subjecting children to this exposure. Why? Because you could have acted to prevent such exposure, but you failed to do so.

Chantix: Why the Black Box Warning is Not Enough and Drug Should Be Removed from the Market

Yesterday, I called for the removal of Chantix from the market, arguing that the black box warning was not adequate to protect the public from the severe adverse side effects that have been observed with the drug. Today, I explain why it is that the black box warning is not sufficient to protect consumers.

The black box warning for Chantix notes the following:

"All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide, have been reported in some patients attempting to quit smoking while taking CHANTIX in the postmarketing experience. ... Advise patients and caregivers that the patient should stop taking CHANTIX and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior."

The black box warning, then, advises physicians to observe patients being put on Chantix for "suicide-related events," including "suicide."

This simple question comes to mind: What use is it to observe patients for suicide? In what way does that protect the consumer? If a side effect of the medication is committing suicide within days of initiating therapy, how is monitoring the patient for suicide going to help?

The FDA itself has reported a typical case of Chantix-associated suicidal ideation as follows: "A 30 year-old female reported that she was taking varenicline 0.5 mg/day to help her quit smoking. She indicated that she had taken the pill for 5 days as directed. In her report, she stated, 'I became very depressed for no apparent reason and started having suicidal thoughts. I worried that I was going to hurt myself or someone else. I was also in a state of panic and unable to eat. I thought that I might go crazy and felt completely out of sorts. I quit taking the pill. About 36 hours later, I felt like myself again.'"

Fortunately, this woman stopped taking the medication. However, the story could easily have been different. Instead of stopping the medication, she could have instead attempted or committed suicide in response to her suicidal ideation. Monitoring patients like this for suicide attempts makes no sense. The purpose of monitoring is to prevent these adverse consequences -especially death - from occurring.

There are three situations in which a black box warning can be effective in protecting consumers. I will describe each of these situations and show why Chantix does not meet any of these criteria:

1. Early Detection of Side Effects Can Prevent Serious Adverse Consequences

One situation in which a black box warning may be appropriate is when monitoring of early side effects can prevent serious consequences. For example, if a side effect of a medication is liver damage, then monitoring a patient's liver enzymes for evidence of early liver injury can prevent serious disease by alerting the physician to this side effect so that the medication can be discontinued before it causes actual liver damage.

Chantix does not meet this criterion because its most worrisome side effect - sudden suicide - often occurs without warning, often in a matter of days following initiation of therapy. Relying on patients who become depressed to call their physician to report the symptoms is ineffective because one of the symptoms of depression is the inability to do just that. That the most worrisome side effect is not just depression but frank suicidality makes the black box warning ineffective in this regard.

2. Restricted Use of the Drug May Prevent Side Effects

A second situation in which a black box warning may be appropriate is when the severe side effects of the drug tend to occur only in certain patients. In this situation, warning physicians not to prescribe the drug to those patients can prevent the serious side effects. For example, if a drug causes blood clots only in people who are obese, then warning physicians not to prescribe the drug to patients who are obese will be effective in preventing this side effect.

This is not the situation with Chantix because its potentially lethal side effects have been observed to occur among all patients, not only those with existing psychiatric disease. In fact, FDA's review of Chantix side effects revealed that of cases of Chantix-related suicidal behavior in which psychiatric history was known, 44% of victims had no prior history of psychiatric disease.

3. The Benefits of the Drug Far Outweigh the Costs and Despite the Severe Side Effects, Physicians Should Use the Drug if Benefits Outweigh Risks for a Specific Patient

The third situation in which a black box warning may be appropriate is if the benefits of the drug far outweigh the costs on a societal level and the warning will ensure that physicians weigh the costs and benefits of the drug for the specific patient. For example, a drug that is used to treat cancer might have a severe adverse side effect but its benefits might still outweigh this cost if there are no other treatments available and so this is the only choice that patients have. This criterion will generally not be met if there are lots of other drugs on the market that are equally effective.

In my view, this criterion is not met for Chantix because this drug is not uniquely effective. There are many other treatments on the market (including a variety of nicotine replacement medications) that are equally effective. Moreover, the overall success rate with Chantix is still exceedingly low, and in the overwhelming majority of cases, the use of Chantix will not succeed in getting the patient to quit.

Under these circumstances, I simply do not see how the benefits of keeping Chantix on the market outweigh the many deaths that it has caused. It is not like this is some sort of wonder drug that is very effective in helping people quit smoking, nor is it like this drug is so much more effective than other smoking cessation drugs on the market.

Since none of these three criteria is met, I do not believe that the black box warning is appropriate and I reiterate my call for the removal of Chantix from the market.

Rest of the Story Calls for Removal of Chantix from the Market: FDA, Pfizer, and Anti-Smoking Groups Have Done Enough Damage to People's Lives

Today, I am calling for the FDA to remove Chantix from the market and for anti-smoking groups and researchers to demand that the FDA take such action.

It has become clear to me that the current black box warning is simply insufficient to protect the public from the significant and severe adverse side effects of Chantix.

The FDA responded to the more than 100 reports of suicides, more than 400 reports of violence, and more than 11,000 other cases of severe side effects associated with Chantix by requiring Pfizer to place a "black box" warning label on the medication. The label warns physicians to monitor their patients for adverse psychiatric effects, such as severe depression, violent behavior, and suicidality.

However, it has become clear to me that this black box warning is simply not sufficient. The severe and often deadly effects of Chantix can occur quickly and without warning. Many of the individuals who have died as a result of Chantix use committed suicide suddenly, without warning, and within just days after initiating therapy with this medication. Clearly, the black box warning was not sufficient. With a drug that can have such severe adverse effects in such a short time, it is simply impossible to appropriately monitor and prevent these effects from becoming lethal through physician monitoring. The effects appear too quickly and medical practice is not set up to conduct psychological testing every day for a one- to two-week period following initiation of medical therapy for smoking cessation.

Evidence published in January demonstrates that Chantix is most definitely not a safe drug. A study published in PLoS One reported that Chantix is the worst drug offender in terms of being associated with suicidal behavior and violence towards others. According to the research, Chantix has been associated with more than 400 cases of violence and more than 11,000 serious adverse effects. Chantix was associated with 18 times the number of violence cases as one would have expected by chance.

The study controlled for the possible increased tendency towards aggression among the population being treated with Chantix and the relationship between varenicline use and violence was still enormous. Thus, these effects seem to be a real side effect of Chantix use.

The article concludes: "Acts of violence towards others are a genuine and serious adverse drug event associated with a relatively small group of drugs. Varenicline, which increases the availability of dopamine, and antidepressants with serotonergic effects were the most strongly and consistently implicated drugs."

This research has led some to conclude that: "the message is clear that while Chantix can prove to be an effective weapon for chronic quitters (smokers who try various magic bullets to kick the habit, only to fail…), the costs to some in terms of Chantix aggression and other Chantix side effects can be potentially devastating."

According to a news article published in the March 2009 issue of the Journal of the American Medical Association (JAMA), evidence was already mounting at that time supporting the conclusion that use of the smoking cessation drug varenicline (Chantix) is associated with suicidal ideation and behavior in a substantial number of treated patients (see: Kuehn BM. Studies linking smoking-cessation drug with suicide risk spark concern. JAMA 2009;301(10):1007-1008).

According to the article: "A new analysis by the US Food and Drug Administration (FDA) adds to evidence that varenicline might be associated with an increased risk of suicidal thoughts and behavior, including among patients with no psychiatric history. The results, which were published in January, follow warnings from the agency that such a link is likely, as well as label changes noting a possible risk. ... An analysis of adverse event reports submitted to the FDA between May 2006 (when varenicline was approved) and November 2007 found 116 cases of suicidal ideation and 37 cases of suicidal behavior, more than half resulting in death. Half of the patients reporting either suicide ideation or suicidal behavior had a history of psychiatric problems, 26% had no such history, and 24% had an unknown psychiatric history."

Because there are many other treatments available for smoking cessation with similar effectiveness, I believe that the cost-benefit ratio for Chantix is now clearly on the side of the costs to society - even with the black box warning - and the drug should therefore be pulled from the market.

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

The plaintiff's attorney was quoted in the article as describing the cases as follows: ""Tragically, almost without explanation, these people commit suicide, often without any prior diagnosis of family or individual history of depression, psychosis or any other type of psychological conditions."

According to the article: "On Feb. 1, 2008, the Food and Drug Administration issued an alert that 'serious neuropsychiatric symptoms have occurred in patients taking Chantix.' The symptoms include 'changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicides.' 'It appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms,' the FDA stated. ..."

"A study in May 2008 by the Institute for Safe Medication Practices, a prescription drug watchdog group based near Philadelphia, reported that in the fourth quarter of 2007, varenicline accounted for 988 serious injuries reported to the FDA, more than any other single drug. ... The Federal Aviation Administration has banned pilots and air traffic controllers from using Chantix; the drug has also been banned for use by commercial drivers." ...

"On Feb. 1, 2008, Pfizer strengthened its Chantix labeling to include stronger warnings about neuropsychiatric symptoms. In May 2008, it revised the warning again, advising physicians to discontinue Chantix immediately if patients become agitated, depressed or suicidal."

However, discontinuing Chantix as a result of patients becoming suicidal is ineffective. If patients are suicidal and they commit suicide, it is too late to withdraw the medication. No physician's office is equipped to conduct the kind of day-to-day, intensive psychological monitoring that would be needed to make Pfizer's recommendation effective in preventing these severe adverse side effects.

The FDA cannot allow this black box warning to remain the only protection for patients, as it is woefully inadequate. The time has come to pull Chantix from the market.

The Rest of the Story

How ironic it is that the FDA is spending more time trying to ban electronic cigarettes - which have not caused a single reported death or severe adverse effect in the U.S. - but is sitting on its hands with regards to Chantix, which continues to kill people due to its effects on violence, aggression, depression, and suicidality.

And ironically, while five anti-smoking groups have called for the removal of electronic cigarettes from the market, none have called for the removal of Chantix, although the latter drug is actually killing people while the former is not.

For this reason, I argue that both the FDA and the anti-smoking groups bear major responsibility in the tragedy of Chantix-related suicide.

Also bearing responsibility, I believe, are the anti-smoking researchers who have been recommending the use of Chantix as part of a national smoking cessation strategy, but who had or have severe conflicts of interest by virtue of their receiving money from pharmaceutical companies that manufacture smoking cessation drugs, in particular - from Pfizer, the manufacturer of Chantix.

The Chantix experience serves as a poignant (and tragic) reminder of exactly why it is that financial conflicts of interest are not to be tolerated in the formation of national clinical treatment policy. The presence of financial conflicts of interest produces a bias (even if subconscious) that is unacceptable when recommendations are being made that affect people's lives (i.e., clinical practice).

The bias in the Clinical Practice Guideline panel's analysis is apparent when one considers the research documenting that the overwhelming majority of successful quit attempts are unplanned. The planning of quit attempts by patients with medication provided by their physicians is, on a population basis, one of the least effective methods of smoking cessation.
Planned quit attempts are actually less successful than attempts that are unplanned. National smoking cessation policy and treatment of patients should therefore be based on efforts to motivate patients sufficiently to quit cold turkey, rather than to plan quit attempts for them.

The bias created by financial conflicts of interest with Big Pharma in tobacco control continues and can be seen in numerous research articles. For example, in response to the article documenting that unplanned quit attempts are the most successful, a researcher from the University of Vermont challenges the conclusions of that study. What is not disclosed is the fact that in 2006, the same researcher "accepted honoraria, fees or travel expenses from Academy for Educational Development, Atrium Healthcare, Cambridge Hospital, Celtic Pharmaceuticals/Xenova, Concepts in Medicine, Cowen and Companies, Cygnus, Edelman Bioscience, Exchange Supplies Ltd., Fagerstrom Consulting, Free and Clear, Health Learning Systems, Healthwise, JSR, Insyght, LEK Consulting, Maine Medical Center, Nabi Pharmaceuticals, New York Association of Substance Abuse Providers, Nabi Biopharmaceuticals, National Institutes on Health; Pfizer/U.S., Pfizer Canada, Pinney Associates, Sanofi-Aventis, Shire Health London, Temple University of Health Sciences, University of Wisconsin and ZS Associates."

What at first glance might appear to be an unbiased assessment of the state of the research turns out instead to be written by someone who has received money from a large number of pharmaceutical companies, including several that have a direct financial stake in consumers making planned rather than unplanned quit attempts.

Not long ago, an NIH expert panel released a 2008 update of the clinical practice guideline regarding the treatment of tobacco use and dependence (see: Fiore MC, Jaén CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. May 2008).

The guideline recommends that every patient who wishes to quit be treated with pharmaceuticals, unless medically contraindicated. The guideline also recommends the use of Chantix, despite concerns about its potential suicide risk.

Far from being an objective review and assessment of the best possible strategy to enhance smoking cessation among smokers in the United States, the guideline is a heavily biased analysis that is plagued by the presence of severe financial conflicts of interests among the panel's chair and at least 8 of its other members.

Nine of the panel members have received, or are currently receiving, funding from pharmaceutical companies. Most of the involved companies stand to gain from the clinical practice guideline's recommendations, because these companies manufacture drugs recommended by the panel.

Here is the long list of financial conflicts of interest among this supposedly objective panel of expert scientists:

Michael C. Fiore (panel chair): "reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome."

William C. Bailey: "reported significant financial interests in the form of compensation from three different pharmaceutical companies in 2006 and two in 2007 for speaking engagements."

Timothy B. Baker: "reported that he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."

Neal L. Benowitz: "reported significant financial interest in the form of compensation from one pharmaceutical company for each of the years 2005-2007, as well as stock ownership in one pharmaceutical company."

Michael G. Goldstein: "reported that his employer received support from Bayer Pharmaceutical prior to 2005 and that he was employed by Bayer Pharmaceutical Corporation prior to January 1, 2005. His organization received payments for his professional services from two pharmaceutical companies and one commercial Internet smoking cessation site during the period 2005-2007."

Harry A. Lando: "reported serving on an advisory panel for a new tobacco use cessation medication and attending 2-day meetings in 2005 and 2006 as a member of this panel."

C. Tracy Orleans: "reported significant financial interests in the form of a dependent child who owns pharmaceutical stock... ."

Maxine L. Stitzer: "reported participation on a pharmaceutical scientific advisory panel for a new tobacco use cessation medication."

Sally Faith Dorfman: "reported her employment by Ferring Pharmaceuticals, Inc., a company whose business does not relate to treating tobacco dependence."

GlaxoWellcome, which apparently endowed the Chair position that the chair of the panel enjoys, is the manufacturer of Wellbutrin, Commit lozenge, Committed Quitters, NiQuitin/Nicoderm, Nicabate, and Nicorette. The use of all of these drugs is recommended by the panel.

What this means is that we basically have a group of experts who are largely financially linked with pharmaceutical companies, and who stand to gain personally if they recommend the use of pharmaceuticals as part of their smoking cessation guidelines. The more use of pharmaceuticals they recommend, the more they stand to gain.

While I find it objectionable that these agencies would allow experts with these type of financial conflicts of interest to serve on the panel, I find it equally troubling that such individuals would agree to serve. I believe that based on these conflicts, these experts should have recused themselves from service on the panel.

This is a conflict of interest in the ugliest way that I can imagine. It is precisely the type of thing that needs to be stopped.

Perhaps the most troubling conflict of all is that of the expert panel's chair - Dr. Michael Fiore. Dr. Fiore has reported "that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis." Pfizer is the company that markets Chantix.

That this panel made a national recommendation that all physicians use Chantix (and other drugs) to treat every smoker without specific contraindications and that this recommendation was made by a panel whose Chair had received money from Pfizer, is inexcusable. It is even more troubling that the panel has not issued any kind of update or warning to modify its recommendation that Chantix be used as a smoking cessation drug in light of the many reports of the deadly side effects that this medication has had.

The rest of the story is that the many Chantix-associated suicides are truly a tragedy, and they are even more tragic because the deaths that have been caused by Chantix would possibly have been prevented had the national panel not consisted of members with such severe financial conflicts of interest. Any kind of objective review of the data, in my opinion, would have precluded a national panel from recommending the use of this drug, given the many alternatives available that have similar effectiveness. At very least, an objective panel would have returned to this issue after - at the latest - the January 2011 report and issued a modification of the Clinical Practice Guideline retracting the recommendation that patients be treated with Chantix.

The central tenet of medicine and public health is "to do no harm." Sadly, this is a story in which physicians and public health practitioners have caused harm. While mistakes occur, and are excusable because people are only human and cannot predict the future, clouding scientific and policy issues by financial conflicts of interest that result in poor national recommendations is not acceptable. We owe the public a greater degree of scientific, medical, and public health integrity.

Opinion Column in Emory University Student Newspaper Elegantly and Cogently Presents Argument Against Complete Campus Smoking Bans

This piece by Simon Mettler at Emory University is a must-read, as it cogently and persuasively outlines the argument against campus-wide smoking bans (policies that ban smoking everywhere on a campus - even in all outdoor areas, parking lots, etc.). I couldn't have stated the argument myself. I would be very curious to hear how anti-smoking groups respond to this argument.

Worcester City Council Poised to Tell Pharmacies: You Can Sell Soda, Junk Food, and Hazardous Chemical Products, But Not Tobacco

According to an article in the Worcester Telegram & Gazette, the Worcester City Council is considering an ordinance that would ban the sale of tobacco in pharmacies.

According to the article: "Given the flak it has received in some quarters, it will be interesting to see if the City Council proceeds with efforts to have Worcester join a handful of communities across the state in banning the sale of cigarettes and other tobacco products by local health care providers, including chain pharmacies and other drugstores, and colleges. While advocates of the proposal consider it an important public health initiative, others strongly feel the council is overreaching big time with it and just another example of the “nanny state” mentality prevalent in Massachusetts. They contend it is nothing more than a feel-good ordinance that will do little, if anything, to cut down on the number of Worcester residents who smoke, while imposing yet another financial hardship on a sector of the local business community. Heck, if people aren’t going to be able buy cigarettes in a pharmacy, they will simply go to a nearby convenience store or elsewhere to buy their smokes. So, what’s the point of such a targeted ban?"

The Rest of the Story

That's a fair question. What is the point of a city government banning the sale of tobacco products in pharmacies?

The point is that the city is making sure that its own perception of the appropriate mission of these retail stores is consistent with the types of products that it offers for sale. In other words, the justification for this law is that is it necessary to ensure that the perceived mission of retail stores is consistent with the products that they sell to the public.

This is hardly an adequate justification for the use of the state's police powers to intervene in the private decisions of business owners as to what legal products to offer for sale to the public.

Moreover, if the government's true interest is in making sure that the perceived health-promotion mission of a pharmacy is not undermined by the sale of products that are harmful to health, then why allow pharmacies to continue to sell soda and junk food, which are unhealthy and are contributing towards the nation's obesity epidemic?

If the concern of the Council is in reducing smoking, then it should actually take quite the opposite action: it should ban the sale of cigarettes in corner convenience stores and gas stations, where kids are most likely to be obtaining those cigarettes, and ensure that the only sale of tobacco products that can take place is in large chain stores which have strong training programs to reduce the sale of cigarettes to minors.

Which do think are responsible for a greater amount of cigarette sales to minors in Worcester? Its ten CVS stores or the combination of its ten 7-Eleven, Store 24, Madison Shell Food Mart, Cow Farm Mini Mart, DJ's Convenience Store, Chandler Street Gas & Food, Yankee Food Mart, and Honey Farms stores?

This law will simply shift sales of cigarettes from pharmacies over to convenience stores and gas stations. It will not result in any decrease in the sale of tobacco to minors, nor in youth cigarette use.

How can this type of government intrusion be justified when the only tangible result is a loss of profit by some stores and a gain in profit by other stores? Is it really a legitimate government interest to regulate who profits from the sale of tobacco products and who does not?

But most importantly, what possible consolation is it for our society to know that the lung cancer and heart disease deaths of its citizens are being caused by cigarettes sold at gas stations and convenience stores, rather than by cigarettes sold at pharmacies?

I'm afraid we've lost sight of the proper way to frame this issue. Are cigarettes a problem because they kill people? Or are they a problem because they are sold in certain types of stores? If only cigarette sales were restricted to gas stations and convenience stores, then we could all breathe a lot easier, knowing that somehow we have tackled this issue head on. Or maybe, instead, we've diverted attention away from the evidence-based measures which have been proven to reduce cigarette use.

You don't see any tobacco companies fighting against these proposals. Perhaps it's because they know their profits are safe: cigarette sales are not going to decline.

Is it not sad that it is the tobacco companies, but not many public health advocates, who are aware that these laws are not public health measures in the first place? They are feel-good measures that may bring the opportunity for political propaganda statements, but they do not save lives or protect the public's health.

Op-Ed Blasts TPSAC For Weak-Willed Failure to Make Menthol Cigarette Recommendation

An op-ed by Dr. Alan Blum, Director of the Center for the Study of Tobacco and Society at the University of Alabama, published yesterday in the Birmingham News, sharply criticizes the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) for its failure to make a recommendation regarding FDA action on menthol cigarettes. Instead of making such a recommendation, the Committee simply concluded that banning menthol cigarettes would benefit the public's health, but that there could also be black market consequences. The Committee thus gave no indication to the FDA of what policy action would be appropriate.

About the TPSAC's actions, Dr. Blum writes: "Unfortunately, the committee that produced this sobering report did not translate its conclusion into a recommendation that menthol be banned. Instead, the committee fretted about a potential black market for menthol cigarettes and the possible introduction of do-it-yourself menthol cigarette kits to circumvent such a ban. But this reasoning puts the cart before the horse. In the end, the committee proved weak-willed."...

"The horrific impact menthol cigarettes have had on the African-American community warrants that all health organizations and everyone concerned about the rising cost of health care urge the FDA and Congress to add menthol to the list of far less widely consumed but already banned candy flavorings."

Dr. Blum then notes that the menthol story simply illustrates the lack of effectiveness of the entire FDA tobacco regulatory scheme created by the Campaign for Tobacco-Free Kids and Philip Morris in Congressionally-mediated negotiations. He concludes: "The committee's failure to recommend an unequivocal ban on menthol cigarettes reveals the toothlessness of the new law and the lack of effectiveness of the regulatory process by the FDA."

Dr. Blum also explains the folly of putting cigarette safety regulation in the hands of the FDA in the first place: "The public entrusts the U.S. Food and Drug Administration with ensuring the safety and effectiveness of medications that improve health -- not substances that cause disease. Yet, two years ago, President Barack Obama signed into law a misguided bill supported by the American Cancer Society, the American Medical Association and most other health organizations that placed the nation's most lethal consumer product -- cigarettes -- under the control of the FDA. Incredibly, the Family Smoking Prevention and Tobacco Control Act directs the FDA to issue safety standards for a product that kills nearly half a million Americans a year. ...

"Small wonder, then, why Philip Morris, maker of Marlboro, the world's largest-selling cigarette, wholeheartedly supported the bill, even as the bill's proponents were claiming that it would be the death knell for Big Tobacco. The law only served to increase the skepticism of all too many smokers, who reason that if cigarettes were really so dangerous, then the government would ban them. Now Philip Morris can reassure its customers that it is complying with strict product-safety standards, in effect making and marketing government-approved cigarettes."

The Rest of the Story

Dr. Blum is one of the few in the tobacco control movement who has consistently argued that the very idea of the FDA tobacco legislation was flawed from the beginning. He is also one of the few who has publicly criticized the Campaign for Tobacco-Free Kids, American Medical Association, and other health groups for supporting the secretly negotiated bill that was crafted behind closed doors by the Campaign for Tobacco-Free Kids and Philip Morris.

Now, as Dr. Blum demonstrates, it is clear that the law lacks any teeth. It is a pure showpiece, allowing politicians, politically-motivated health groups, and Philip Morris make it appear to the public that they are doing something to protect the public's health, when the truth is that this law did and will do virtually nothing to reduce smoking and the now estimated to be a half million U.S. deaths per year that it causes.

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.