Lessons Learned in 2011: Reflections on the Year in Tobacco Control

After reflecting on the events of 2011, here are the major lessons I've learned and their implications for public health:

1. Some anti-smoking groups really are lying to the public.

Previously, I was able to hold out hope that false statements being made by anti-smoking groups to the public were merely mistakes or oversights. It is now clear, however, that some anti-smoking groups really are lying to the public and the apparent intention is to mislead the public in some way.

For example, the American Cancer Society (winner of the 2011 Liar, Liar, Pants on Fire Award) lied to its constituents in telling them that the FDA Tobacco Act banned all flavored tobacco products. The ACS clearly understood that the legislation exempts menthol cigarettes because it was one of the groups that supported the legislation and was briefed on the bill by the Campaign for Tobacco-Free Kids, which negotiated the terms of the legislation. The false statement made by the ACS is therefore difficult to explain as a simple oversight.

Instead, it seems clear to me that the ACS is afraid to tell the public the truth - that while the bill bans all the flavorings in cigarette brands which are rarely used by youths - it exempts menthol, which is the chief flavoring present in the brands favored by 80% of African American youth smokers and 50% of all youth smokers. Telling the public the truth - that the bill exempted menthol - would be an embarrassing admission for the ACS, because it would reveal that the Tobacco Act is a scam, which allows health groups and politicians to boast about how they are fighting Big Tobacco but which actually failed to ban any flavored cigarettes manufactured by Big Tobacco and exempted the one flavoring in cigarettes which is favored by half of the nation's youth smokers.

As a second example, Americans for Nonsmokers' Rights (runner up for the 2011 Liar, Liar, Pants on Fire Award) lied to the public by stating that there are virtually no health disparities between active and passive smoking. This is clearly false, as there are many health disparities between the two. The apparent purpose of this lie is to mislead the public into thinking that secondhand smoke is more hazardous than it actually is. But of course, the adverse side effect of this is that it also misleads the public into thinking that active smoking is not as hazardous as they have been led to believe. Moreover, I discussed the issue with a staff member of ANR, explaining why the information is incorrect. That the organization apparently decided to retain the false claim suggests that this was an intentional decision rather than a mere oversight. It certainly does create a more alarming health scare: if secondhand smoke's health effects are every bit as severe as those of active smoking, then secondhand smoke is much more hazardous than even the scientific evidence demonstrates!

The implication of these lies for public health are that the anti-smoking movement is going to lose its public credibility. Like the "global warming movement," which has lost credibility (undeservedly) because of a few exaggerations, I fear that the tobacco control movement will similarly lose credibility because of its willingness to lie to the public. Eventually this is going to catch up with us. I don't want to see the tobacco control movement go the way of the global warming movement. But we risk that happening if we continue to lie to the public in this way.

2. The smoke-free aspect of the tobacco control movement has largely become an attack on smokers, rather than a battle against tobacco smoke.

Two trends that have picked up steam in 2011 are policies which ban smokers from potential employment and policies which ban smoking in large, wide-open outdoor areas such as Central Park or entire areas of a downtown. Both of these policies have left the realm of protecting the public from secondhand smoke to punishing smokers for their poor health behavior decisions. Banning smoking in the entirety of Central Park is obviously not necessary to protect the public from exposure to secondhand smoke. And banning smokers, rather than just tobacco smoke, from the workplace, is obviously not necessary to prevent exposure to tobacco smoke in the workplace.

These policies are instead intended to punish smokers by either: (1) making it more difficult for them to smoke outdoors; or (2) making it more difficult for them to find employment. The latter effect can be quite significant in communities in which a single hospital system is the major employer. If that hospital system refuses to consider applications from smokers, it truly does make it much more difficult for smokers to find employment. This is especially true with the job shortages we are facing today.

The implications of this development for public health is that we are now using employment discrimination as a strategy for health promotion. I find this a troubling development. In addition, we are now viewing smoking as a moral, rather than a health issue, and trying to protect people not only from tobacco smoke exposure, but from having to even see a smoker in public.

3. At a national level, the tobacco control movement has waged a war on smokers, rather than on the tobacco industry and its most hazardous products. It is working to help entrench the most risky existing tobacco products, protect existing cigarette market shares, and fend off Big Pharma from competition, all at the expense of the health of smokers.

The implementation of the FDA Tobacco Act has turned into a disaster because it has resulted in the protection and institutionalization of the most hazardous existing tobacco products - cigarettes - and the stifling of much safer alternatives such as electronic cigarettes, which could otherwise be helping many smokers who would not otherwise quit smoking to successfully discontinue smoking.

Rather than embrace products such as electronic cigarettes, which are being used successfully by thousands of ex-smokers to keep them off cigarettes, anti-smoking groups are making it difficult, if not impossible, for these products to compete with tobacco cigarettes. The recommendations of the Institute of Medicine committee reinforce this view. In fact, it is the very purpose of the FDA Tobacco Act.

The implication of this development for public health is that cigarettes now have the FDA seal of approval, while safer products - such as electronic cigarettes - have an almost insurmountable barrier in front of them if they want to promote themselves effectively in the marketplace (i.e., as safer alternatives to tobacco cigarettes).

The Rest of the Story

If this were a state-of-the-tobacco-control-movement address, I would be forced to give a quite negative report. The thrust of national tobacco control efforts is the exact opposite of what public health would call for: protection of the most hazardous products and the imposition of insurmountable barriers to much safer products that have the potential to save thousands of lives. At the local level, the goal of protecting the public from the hazards of secondhand smoke are being supplanted by policies designed to punish smokers. And for some reason, lying to the public has become an acceptable tactic that is supposedly justified based on the good ends which these lies are serving.

My hope is that 2012 will bring a re-examination of the public health practice of tobacco control and a return to the basic public health objectives that the movement is supposed to serve.

Winner of 2011 Liar, Liar, Pants on Fire Award: American Cancer Society

Today I announce the first place winner in my annual Liar, Liar, Pants on Fire Award for the worst public lie in the tobacco control field in 2011 (the Liar, Liar, Pants on Fire Award name is borrowed from PolitiFact, which uses the term in its truth-o-meter).

First Place - 2011 Liar, Liar, Pants on Fire Award: American Cancer Society

In a communication sent to the American Cancer Society's (ACS) network of advocates throughout the nation (including myself) and posted on the Society's web site, the ACS lied about the effects of the FDA tobacco legislation passed by Congress in 2009. Although this lie first appeared in print in 2009, the ACS has continued to mislead the public about this issue, and in 2011, lobbied for state legislation in New York that would have plugged the flavored cigar loophole, but failed to address the menthol cigarette exemption. The ACS incorrectly and deceptively referred to this legislation as a ban on flavored "tobacco products," when in fact, it merely banned flavored cigars and smokeless tobacco and left menthol cigarette untouched.

According to the American Cancer Society's statement: "Our nation's children – potential first-time smokers – will no longer be seduced by flavored tobacco products, including candy- and fruit-flavored cigarettes, which will be banned."

The American Cancer Society thus claimed that the FDA tobacco legislation banned all flavored tobacco products.

The Rest of the Story

If the American Cancer Society had read the actual text of the legislation or read any of hundreds of newspaper articles about the bill, it would have easily found out that the bill did not ban all flavored tobacco cigarettes that seduce young smokers. The bill specifically exempted menthol from its ban on cigarette flavorings.

The key section of the bill about which the ACS lied is section 907(a)(1)(A), which reads: "Beginning 3 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke."

The American Cancer Society is well aware that menthol is a cigarette flavoring whose primary purpose is to help addict youths by making cigarette smoke less harsh. The ACS itself, in a special report on the topic, stated that cigarette companies use menthol flavoring to: "Numb throat so the smoker does not feel as much throat irritation."

In support of this assertion, the ACS cites a tobacco industry document which argues that a flavoring (such as menthol) which makes cigarette smoke less harsh will help entice youth smokers. According to the ACS report: "The Teague document details a number of product features that make smoking more tolerable for beginning and learning smokers. For example, it discusses methods of reducing harshness, making the flavor bland since new smokers don’t like the taste of the smoke, and improving the “mouth feel” by reducing negatives like hotness and dryness."

In fact, the ACS report goes into tremendous detail about how the tobacco companies are using menthol to entice young African Americans to smoke (whether you agree with this conclusion or not, my point is that the ACS has certainly concluded and argued to the public that menthol is used to entice young smokers):

"The tobacco companies’ success in using menthol cigarettes to target African American kids is exemplified by the disproportionate number of young blacks who smoke menthol cigarettes. Not only does menthol numb the throat to allow deeper inhaling, the companies know menthol is attractive to their African American targets: “Young blacks have found their thing, and it’s menthol in general and Kool in particular.” It is hardly surprising then that 80 percent of 12- to 17-year-old black smokers choose Newport, the leading menthol brand, compared to just 16 percent of young white smokers. Again, these product design decisions can have a terrible impact on health. Menthol cigarettes have higher carbon monoxide concentrations than non-menthol cigarettes and may be associated with a greater absorption of nicotine. Moreover, research indicates that mentholated cigarettes may increase the risk of both lung and bronchial cancer by promoting lung permeability and diffusability of smoke particles. African Americans are more likely to develop and die from cancer than persons of any other racial or ethnic group. Lung cancer is the second most common cancer in both African American men and women and it kills more African Americans than any other type of cancer."

So the ACS is aware that the bill exempts menthol and has also argued previously that menthol flavoring is used in order to entice young smokers by making the smoke less harsh and in particular, by enticing African American youths who are attracted by the menthol flavor.

Therefore, I am saddened but forced to conclude that the American Cancer Society lied to its constituents and the public in its communication stating that the FDA legislation banned all cigarette flavorings and thus ends the enticement of youths by these flavorings.

I should say that I am a long-time American Cancer Society supporter, volunteer, donor, and fund raiser and thus it greatly saddens me to see the ACS lie to the public like this.

But the reason for this lie is also clear. If the ACS were honest with the public, it would have to admit that the bill is a public scam which does little to protect children from addiction to cigarettes but lots to protect cigarette sales. Most notably, the bill bans all the flavorings that are not used very often (or at all), such as banana, pineapple, cherry, chocolate, and cherry, but exempts the one flavoring (menthol) which the ACS itself admits is used to entice huge numbers of young smokers, including a disproportionate number of African Americans. The ACS itself tells us that Newport - a menthol-flavored brand - is smoked by 80% of African American teenagers.

It's interesting that when it was trying to get this bill passed, the ACS had no problem featuring the problems of tobacco use in the African American community, but now that the legislation has been enacted, the ACS is pretending that the African American community doesn't exist and that the enticement and seduction of African American youth smokers by menthol-flavored brands is not a problem.

Clearly, the ACS is afraid to tell the public the truth - that while the bill bans all the flavorings in cigarette brands which are rarely used by youths - it exempts menthol, which is the chief flavoring present in the brands favored by 80% of African American youths. Moreover, menthol is the chief flavoring in the brands favored by about 50% of all youth smokers!

Telling the public the truth - that the bill exempted menthol - would be an embarrassing admission for the ACS, because it would reveal that the Tobacco Act is a scam, which allows health groups and politicians to boast about how they are fighting Big Tobacco but which actually failed to ban any flavored cigarettes manufactured by Big Tobacco and exempted the one flavoring in cigarettes which is favored by half of the nation's youth smokers.

Given that the American Cancer Society has focused so much effort on criticizing the tobacco industry for lying to the public, it seems hypocritical for the ACS to now engage in the same tactics, even though the Society might argue the lie is for a good purpose. I would argue that the lie is not only a lie, but it is for a bad purpose: protecting the menthol cigarette market to ensure that the Tobacco Act had no actual impact on cigarette sales and tobacco company profits.

The American Cancer Society is well-deserving of recognition as the first place finisher in the Rest of the Story's 2011 Liar, Liar, Pants on Fire Award competition.

Runner-Up for 2011 Liar, Liar, Pants on Fire Award: Americans for Nonsmokers' Rights

Today I announce the 2nd place finisher in my annual Liar, Liar, Pants on Fire Award for the worst public lie in the tobacco control field in 2011 (the Liar, Liar, Pants on Fire Award name is borrowed from PolitiFact, which uses the term in its truth-o-meter). The winner will be announced later this week.

Second Place - 2011 Liar, Liar, Pants on Fire Award: Americans for Nonsmokers' Rights

According to Americans for Nonsmokers' Rights (ANR) - a leading national smoke-free air advocacy group - active smoking is no worse than secondhand smoke exposure.

In a fact sheet entitled "Secondhand Smoke: The Science," the group claims that the health effects of secondhand smoke are virtually the same as those of active smoking. According to the fact sheet, "there are virtually no health disparities between active and passive smoking."

The fact sheet also states that active smoking only causes the same amount of heart damage as 30 minutes of exposure to secondhand smoke.

The precise statements made by ANR are as follows:

1. "A June 2004 study published in the British Medical Journal reaffirmed that there are virtually no health disparities between active and passive smoking. The risks of heart disease associated with secondhand smoke are twice what were previously thought and are virtually indistinguishable from those associated with active smoking."

2. "Just thirty minutes of exposure to secondhand smoke can cause heart damage similar to that of habitual smokers."

The Rest of the Story

These false claims are damaging because they undermine decades of public education about the hazards of active smoking. They represent a lie that is every bit as false as anything the tobacco industry has fraudulently asserted in the historical annals of tobacco industry lies and deception.

The claims are particularly damaging because if believed by the public, they remove any incentive for smokers to quit. If smoking is only as bad as secondhand smoke exposure, then the hazards of active smoking are no where near as great as previously thought. Moreover, if smokers are going to be around people who smoke anyway, then there is no incentive for them to quit.

The health effects of active smoking are quite distinguishable from those of passive smoking. While passive smoking only increases the risk of lung cancer by a factor of about 1.3, active smoking increases lung cancer risk by a factor of about 17. That's more than an order of magnitude of difference in risk.

Similarly, the risk of COPD associated with active smoking is much greater than the risk associated with passive smoking.

While it is true that for heart disease, the risk associated with very heavy passive smoking approaches that associated with very light active smoking, it is simply not true to assert that the overall effects of secondhand smoke and active smoking are virtually indistinguishable and that "there are no health disparities between active and passive smoking."

Moreover, it is untrue that 30 minutes of secondhand smoke causes heart damage, much less the same degree of heart damage as observed in a chronic, active smoker. While it is true that 30 minutes of secondhand smoke exposure causes endothelial dysfunction, this is not equivalent to "heart damage." Heart damage implies damage to the heart muscle, such as observed in a myocardial infarction, or heart attack. Thus, a mere 30 minutes of secondhand smoke exposure does not cause heart damage. Clearly, it is false to assert that 30 minutes of secondhand smoke exposure causes "heart damage similar to that of habitual smokers."

The problem with these statements is not simply that they are untrue. They may be damaging to the public's appreciation of the hazards of active smoking. If the public believes that active smoking is only as dangerous as a mere 30 minutes of secondhand smoke exposure, then the public may believe that smoking is not as dangerous as they have been told. This is why this type of false propaganda can undermine years of public education about the hazards of smoking.

While the fact sheet was originally posted in 2006, it remains eligible for the 2011 Liar, Liar, Pants on Fire Award because it remains on the web site today, unchanged. This is despite my conversation with staff at ANR, explaining why these claims are false.

While lying to the public would be bad enough, lying in a way that is likely to undermine the public's appreciation of the hazards of smoking is particularly egregious. That makes this lie deserving of recognition as the second place finisher in the Rest of the Story's 2011 Liar, Liar, Pants on Fire Award competition.

Third Place Finisher of Liar, Liar, Pants on Fire Award: World Medical Association

Today I announce the 3rd place finisher in my annual Liar, Liar, Pants on Fire Award for the worst public lie in the tobacco control field in 2011 (the Liar, Liar, Pants on Fire Award name is borrowed from PolitiFact, which uses the term in its truth-o-meter). The runner-up and winner will be announced in subsequent days.

Third Place - 2011 Liar, Liar, Pants on Fire Award: The World Medical Association

On October 4, 2011, the World Medical Association issued a press release in which it claimed that the tobacco industry was promoting electronic cigarettes in shops and on the internet in an effort to recruit young people.

According to the press release: "The World Medical Association will step up its fight against smoking with proposals to ban the production, distribution and sale of candy products that depict or resemble tobacco products. At their three-day Council meeting in Sydney, Australia, (April 7-9) WMA delegates agreed to recommend to their annual Assembly in October plans to strengthen the organisation's anti tobacco policy to combat moves by the tobacco industry to make their products more appealing to young people. Delegates argued that the WMA should extend its policy to include restrictions on smokeless tobacco and tobacco-derived products, including prohibiting all government subsidies for tobacco-derived products. Dr. Ardis Hoven, chair of the Board of the American Medical Association, said the tobacco industry was now involved in aggressively promoting new forms of cigarettes, such as smokeless tobacco and electronic cigarettes in shops and on the internet to attract and appeal to young people, and the WMA needed to respond strongly."

The Rest of the Story

The claim that the tobacco industry is promoting electronic cigarettes is a lie.

Tobacco companies have nothing to do with electronic cigarettes. They neither produce nor market these products.

The rest of the story, then, is that the Medical Association is lying. The problem is, it's not clear exactly which Medical Association is lying.

Either the American Medical Association is lying, or the World Medical Association is lying.

The Western Medical Association claims that the American Medical Association chair told the audience that tobacco companies are aggressively marketing electronic cigarettes. So there are two possibilities:

1. The American Medical Association is lying about tobacco companies marketing electronic cigarettes. This is the case if the AMA chair did actually make this claim.

2. The Western Medical Association is lying about tobacco companies marketing electronic cigarettes. This is the case if the AMA chair did not actually make this claim.

Either way, a physician's organization is lying to the public in order to cast electronic cigarettes in a negative light, and thus encourage smokers to stick with regular cigarettes and ex-smokers who have quit by virtue of e-cigs to return to tobacco cigarettes.

Moreover, it appears that both the World Medical Association and the American Medical Association are trying to eliminate the safer alternatives to cigarette smoking, while protecting existing cigarettes from any serious competition and ensuring that the hundreds of thousands of people who are using electronic cigarettes to help quit smoking will be forced to return to their Marlboros, Camels, Newports, Kools, and Salems.

Why are these physician organizations acting to protect the profits of cigarette companies at the expense of the public's health?

And why are they lying to the public in order to achieve that result?

While blatantly lying to the public would be bad enough, lying in a way that is going to encourage people to use a far more harmful product than a safer one is particularly egregious. That makes this lie deserving of recognition as the third place finisher in the Rest of the Story's 2011 Liar, Liar, Pants on Fire Award competition.

Campaign for Tobacco-Free Kids Exempts Cigars from Sports Sponsorship Ban, Then Complains that Cigar Company is Sponsoring Orange Bowl; More Hypocrisy

The Campaign for Tobacco-Free Kids has joined Senator Dick Durbin in condemning the Orange Bowl for accepting sponsorship from a cigar company and urging the NCAA to prohibit such sponsorship. In a letter to the Orange Bowl and the NCAA, the Campaign writes: "As public health groups that combat the use of tobacco and its devastating toll on American families every day, we urge the Orange Bowl Committee and the NCAA to cancel a cigar company sponsorship of the Discover Orange Bowl. Tobacco has no place in sports, and the promotion of cigars at such a prestigious sporting event entices youth and young adults, putting them at risk of developing a deadly addiction."

The Rest of the Story

If it is the case that tobacco has no place in sports and promotion of cigars at sporting events entices youths to smoke, then why didn't the Campaign for Tobacco-Free Kids make sure to include a ban on cigar company sponsorship of sporting events when it helped craft the Family Smoking Prevention and Tobacco Control Act?

As the leading health group at the negotiating table with Philip Morris when this legislation was crafted, the Campaign for Tobacco-Free Kids could easily have demanded that the exemption of cigars from the sports sponsorship ban be eliminated. It would have taken just one additional sentence in the legislation to include cigars in the sports sponsorship ban. But the Campaign for Tobacco-Free Kids failed to act.

Instead of turning all of our criticism to the Orange Bowl and the NCAA, perhaps the public should direct its primary criticism at the Campaign for Tobacco-Free Kids for creating the loophole in the law which allowed this cigar sponsorship to take place in the first place.

Does it not seem mildly hypocritical for the Campaign to complain about the cigar sponsorship when it is responsible for allowing this sponsorship in the first place?

The Campaign for Tobacco-Free Kids now joins Senator Durbin as co-recipients of the Hypocrisy of the Year Award for 2011.

Senator Durbin Solidifies His Position As Hypocrisy of Year Winner

Senator Dick Durbin yesterday called on the NCAA and the Orange Bowl to rescind sponsorship of the Bowl by Camacho Cigars.

Durbin and several other Senators wrote: "Tobacco has no place in sports, and the promotion of cigars at the Orange Bowl sends the wrong message to young fans. A tobacco company’s sponsorship of the Orange Bowl undermines a premier collegiate sporting event and promotes tobacco use to young fans, putting them at risk of developing an addictive and dangerous habit. Furthermore, Camacho Cigars’ sponsorship is at odds with the NCAA rules prohibiting tobacco use by student athletes and all game personnel in any form at practice and in competitions."

The letter to the Orange Bowl noted that: "The Family Smoking Prevention and Tobacco Control Act of 2009 bans sponsorship of sporting and entertainment events by cigarette and smokeless tobacco brands."

It then argued that: "Cigars contain the same toxic and cancer-causing chemicals found in cigarettes, and public health experts have warned that cigars are not a safe alternative to cigarettes."

The Rest of the Story

The rest of the story is that Senator Durbin has no one to blame but himself.

It was he who championed the legislation which exempted cigars from the sports sponsorship ban. If Senator Durbin felt so strongly that "tobacco has no place in sports," and that "cigars contain the same toxic and cancer-causing chemicals found in cigarettes," then why didn't he include a ban on cigar sponsorship of sporting events in the Family Smoking Prevention and Tobacco Control Act which he championed?

The same criticism that Durbin is leveling at the NCAA and the Orange Bowl could be leveled at Durbin himself for his failure to include cigars in the tobacco sports sponsorship ban. Why did he not heed his own warning that "cigars are not a safe alternative to cigarettes?"

The situation might be different if Senator Durbin had nothing to do with the tobacco legislation. If he were trying to clear up a loophole that others had inserted into the legislation, it would be one thing. But Durbin championed the legislation. He was certainly in a position to suggest that it be amended to include a ban on cigar sponsorship of sporting events. The loophole he is lambasting now is the very loophole he created!

This solidifies Senator Durbin's hold on the Rest of the Story's 2011 Hypocrisy of the Year Award.

2011 Hypocrisy of the Year Award

As the holidays approach, The Rest of the Story will be posting a number of end-of-the-year features, including the eagerly-awaited annual Hypocrisy of the Year awards and the highly-anticipated Liar, Liar, Pants on Fire awards.

We kick off these end-of-year features, which are meant to provide a moment of reflection on the practice of tobacco control during the past year, with the announcement of the 2011 Hypocrisy of the Year Award.

The 2011 Hypocrisy of the Year Award

This year's award is presented to ...

... Senator Dick Durbin (D-IL), who closed out his 2011 political year by calling on the FDA to ban all flavored cigars. In a letter to the FDA Commissioner from Durbin and three other Senators, they wrote: "Cigars with candy-like flavorings such as strawberry, watermelon, vanilla and chocolate attract kids to smoking and help hook them on this addictive habit. Congress helped protect young people from the harmful effects of tobacco by banning flavored cigarettes. ... We urge FDA to immediately close the current regulatory loopholes and prohibit flavored cigars in the interest of public health."

Apparently, Senator Durbin is aware that flavorings in tobacco products may attract youth and believes that regulatory loopholes that allow tobacco companies to entice youth to smoke with the use of product flavorings should be banned. He also boasts about the fact that he voted for legislation that banned all flavored cigarettes.

Shall we congratulate the Senator for his principled stand in support of the nation's youth and his standing up to Big Tobacco to protect the health of our children?

The Rest of the Story

Not so much.

At the same time that Senator Durbin decries the loophole that allows flavored cigars to remain on the market, he remains silent about the loophole - for which he was partly responsible - that allows tobacco companies to continue to entice youth smokers by adding a flavoring to their cigarettes: menthol.

Senator Durbin is not telling the truth when he asserts that all flavored cigarettes have been banned. Not so. All flavored cigarettes with the exception of menthol cigarettes have been banned. And while the banned flavorings were found in no more than about 0.1% of the youth market (and in not a single brand manufactured by Big Tobacco), menthol cigarettes represent about half of the cigarettes smoked by our nation's youth.

Why did Senator Durbin agree to support legislation that contained a menthol exemption which put Big Tobacco profits ahead of the health of the nation's children? Because Philip Morris, the largest producer of menthol cigarettes, demanded that the menthol exemption remain in the bill. Thus, the rest of the story is that Senator Durbin caved in to the financial interests of Philip Morris, selling out the health of the nation's children, and especially the nation's African American children (of whom about 80% of smokers smoke menthol cigarette brands).

Senator Durbin supported the menthol exemption even though the National African American Tobacco Prevention Network (NAATPN) made its opposition to this exemption very clear:

"'It is a national disgrace and a tragedy that these lethal menthol products have been allowed to be marketed so disproportionately to African-American youth – or to any youth for that matter,' said John Payton, president of the NAACP Legal Defense and Educational Fund. 'The FDA should help millions of Americans avoid tobacco-related death and disease by banning menthol flavoring in cigarettes.' 'NAATPN raised the issue of menthol as a tobacco additive nearly three years ago, as the legislation was being developed to give authority to the FDA to regulate tobacco for the first time,' said William S. Robinson, NAATPN's executive director. 'We thought then, and still do now, that the exemption of menthol as a banned flavoring is wrong, discriminatory in its impact, and is a major factor in continuing the health-related disparities that currently exist.'"

When the Tobacco Act passed, Senator Durbin was quoted as saying: "This is a bill that will protect children and will protect America. Every day that we don't act, 3,500 American kids - children - will light up for the first time."

Certainly, Senator Durbin couldn't have been suggesting that by getting rid of cigarette flavorings that appeal to 0.1% of youth, we are going to be protecting 3500 children from lighting up for the first time. But the truth is that the legislation Durbin championed made it a point to prevent putting any serious dent in youth smoking by exempting the menthol flavorings which are enjoyed by a full 50% of youth. What Durbin did was ban the flavorings that no kids were using, and exempt the one flavoring which one in two were hooked on.

Today, how can Senator Durbin have the gall to stand in front of the American people and talk about the need to close legislative loopholes when he created a loophole that tobacco companies can drive a menthol cigarette-filled Mack truck through? And even if he now regrets including the menthol exemption, why is he now only calling on the FDA to ban flavored cigars? Where is his letter urging the FDA to close the menthol cigarette loophole that he created to appease Philip Morris?

For the starkness and boldness of this hypocrisy, The Rest of the Story presents the 2011 Hypocrisy of the Year Award to Senator Dick Durbin.

IN MY VIEW: IOM Report Essentially Recommends that Tobacco Research Funds Be Laundered Through Corporate-Influenced Third Parties

In the last two days, I have commented on two aspects of the IOM report on modified risk tobacco products. First, I argued that the report recommends such stringent scientific standards for the approval of reduced risk products that it puts a nearly insurmountable obstacle in the path of these products and thus helps protect the most highly toxic existing tobacco products. Second, I argued that the report recommends another insurmountable obstacle in the path of reduced risk products: the need to conduct clinical trials with existing cigarettes as a control, which would be unethical.

Today, in the third in a three-part series on the IOM report, I address the IOM committee's suggestion that tobacco companies not be permitted to conduct their own studies in support of modified risk tobacco product applications, but that instead, they should provide funding to an "independent," "third-party" institution to conduct the research.

The reason for this requirement, according to the report, is that: "The history of public distrust and the absence of governance in the tobacco industry have created an isolated industry that lacks not only the expertise to produce the necessary range of credible and reliable data, but it also lacks the trustworthiness to acquire external expertise and avenues to disseminate acquired data."

The solution, according to the report, is: "To improve the credibility of the studies in support of an MRTP application under Section 911, tobacco product sponsors and the CTP should consider facilitating the creation of a third party or third parties for the conduct and oversight of these studies."

What might such a third party entity look like? The report suggests that a "possibility for an organizational model lies in the Reagan-Udall Foundation (RUF), which advises the FDA on modernizing regulatory science. It conducts and oversees studies on regulatory science, particularly in the emerging fields of pharmacogenomics and genomic-based prediction of drug response and adverse event risk."

The Rest of the Story

The IOM report is simplistic and naive in believing that by laundering money through a third-party, research funded by the tobacco industry magically becomes equivalent to research not funded by the industry or to research conducted independently of the industry. The research is still being funded by the tobacco companies and any influence of tobacco funding is not going to suddenly disappear. Instead, what the structure does is create the appearance that research is independent of the industry when in fact, that research is being funded directly by the industry.

In fact, what this could end up doing is reducing scrutiny of such research. Whereas work funded by the tobacco industry would undergo strict scrutiny, by laundering the money through an independent organization, the connection to the tobacco industry would no longer be apparent. The work would take on an automatic assumption of impartiality when such an assumption is not warranted.

An excellent example of this effect is a study conducted by Dr. Claudia Henschke of the use of CT scanning for the early detection of lung cancer.

In an October 26, 2006 article in the New England Journal of Medicine, Dr. Claudia Henschke of Weill Cornell Medical College and a group of other investigators reported the results of a study of the use of low-dose spiral CT scans as a screening tool to detect lung cancer among asymptomatic individuals. The article reported that 85% of patients with lung cancer detected had stage I cancer and the estimated 10-year survival among these patients was 88%. The study concluded that: "Annual spiral CT screening can detect lung cancer that is curable" and that "such screening could prevent some 80% of deaths from lung cancer."

The paper listed its funding sources at the end, one of which was the Foundation for Lung Cancer: Early Detection, Prevention & Treatment.

The New England Journal of Medicine has a policy of not publishing any paper supported with funds from the tobacco industry. Not seeing any disclosure of funding from the industry, the Journal published the paper.

The rest of the story is that the Foundation for Lung Cancer: Early Detection, Prevention, & Treatment was, according to a New York Times article, "underwritten almost entirely by $3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Eve, Grand Prix, Quest and Pyramid cigarette brands. The foundation got four grants from the Vector Group, Liggett's parent, from 2000 to 2003."

According to the New York Times article and a concurrent article in The Cancer Letter, the Journal of the American Medical Association was also deceived by the absence of disclosure of Dr. Henschke's tobacco funding and would never have published her paper had they known that Henschke received tobacco industry money for her CT screening research.

Had the study been directly funded by Liggett, the article would have had to disclose this. Instead, the article was able to hide behind the Foundation sponsor's name, which sounded independent. Two major medical journals were deceived about the nature of the study's funding and the article did not receive the scrutiny that it would have if it were known that industry funding were behind the study.

The IOM report clearly views tobacco money as being tainted. But the committee is deceiving themselves if they believe that the money is magically cleansed just by passing hands from the tobacco industry to a third party.

Let's now look specifically at the entity which the IOM report puts forward as being an example of what an independent, third-party institution might look like: the Reagan-Udall Foundation.

Far from being an independent entity, the Reagan-Udall Foundation is heavily funded by and partly controlled by industry. On the Board of the Foundation are:

• the President and CEO of the Grocery Manufacturers Association;
• the President and CEO of GE Healthcare;
• a senior adviser to the Genzyme Corporation; and
• a group president of Johnson & Johnson.

Thus, the Reagan-Udall Foundation is partially controlled by Big Food, Big Pharma, and Big Biotechnology.

And by statute, the Foundation's Board must include "four representatives from the general pharmaceutical, device, food, cosmetic, and biotechnology industries."

Far from being an independent third-party scientific foundation, the Reagan-Udall Foundation serves as an institutionalized strategy to ensure that industry has a continuing influence on health policy, in spite of the science.

Moreover, it ensures that conflicts of interest abound and that scientific decisions are not made independently from corporate interests.

The Reagan-Udall Foundation has been criticized because it goes a long way toward turning the FDA into a drug company. It has been further criticized because of undue influence by corporate interests. As a Health Care Renewal article by Dr. Roy Poses pointed out, several of the Foundation's Board members who do not directly represent Big Food, Big Pharma, or Big Biotechnology have previously worked for those industries and/or have financial conflicts of interest with those industries. In fact, Dr. Poses notes that a majority (7 of 13) of the original Reagan-Udall Foundation Board members had "ties to the pharmaceutical, biotechnology, and medical device industries." The Health Care Renewal article concludes that: "There is reason for concern that this foundation, despite its relationship to the FDA, is apt to put the interests of these industries ahead of those of the general public."

The article concludes: "The pharmaceutical, biotechnology, and medical device industries already have astounding resources to market their wares and shape public opinion. They don’t need a government sponsored foundation to help them innovate or develop products. The public does deserve a government agency that protect its health and safety by making sure that drugs and devices are safe and effective, and that operates free of the influence of those with vested interests, especially in the drugs and devices the bureau is supposed to evaluate."

An article at 24-7 News summarizes the problem:

"Drug company executives are allowed to serve on a new Food and Drug Administration (FDA)-related board called the Reagan-Udall Foundation. ... The foundation is supposed to help improve the drug approval process, but with so many scandals involving defective drugs in recent years, is it wise to give the pharmaceutical industry so much say on the Reagan-Udall board? Does this just shriek conflict of interest? Well, this new food and drug research foundation, which is affiliated with FDA, brings private companies into a curiously close relationship with regulators like the FDA. Serving as chairman of the Reagan-Udall board is former FDA Commissioner Mark McClellan; executives from drug makers Johnson & Johnson and Genzyme, medical device maker General Electric Company, and the Grocery Manufacturers Association, which includes Hormel Food Corporation and Kellogg Company, were among those picked to lead the Foundation. ... consumer advocates and some lawmakers have criticized the relaxed partnership, stating that allowing companies to fund government-sanctioned research could increase the FDA’s vulnerability to industry clout. They also question how the FDA will be able to objectively review products that incorporate its own research and if this new collaboration will open potential for pressure on the FDA."

Byron Richards describes the Reagan-Udall Foundation in even more alarming terms: "Kennedy and Enzi are claiming that the Reagan-Udall Foundation for the FDA is nothing but a friendly non-governmental research foundation. I will fully document in a subsequent article that this is not the case. It is actually the tool by which Big Pharma and Big Biotech will lock in their profits for the next 50 years, as FDA joins them in the drug development and marketing business. This is one of the greatest safety threats in the history of America."

Representative Rose DeLauro (D-CT) criticized the legislation that created the Reagan-Udall Foundation, calling on the FDA "to cease all activities related to its creation." DeLauro argued that: "the Reagan-Udall Foundation will compromise FDA’s independence and favor the drug industry that will be funding it. Even FDA officials have acknowledged that the donors to the Foundation will have the primary say over how the funds are used."

The IOM committee is deceiving themselves if they think that a so-called "independent" third-party like the Reagan-Udall Foundation is going to use tobacco industry funding to produce unbiased scientific research.

The IOM report wants to have it both ways. It wants to view tobacco industry money as tainted and any tobacco-funded research as non-credible. But then it wants to make tobacco industry funding of research the basis for modified risk product applications. The only difference is that rather than conducting the research itself, the tobacco funding will be laundered through a third party. It just doesn't work. A horse of a different color is still a horse.

The bottom line is that if you are going to regulate the tobacco industry and require the industry to submit scientific research to support its applications for certain classifications of products, you cannot then tell the industry that it cannot conduct research and use that research in its applications.

The rest of the story is that the IOM report play along with the continuing hoax that is the Family Smoking Prevention and Tobacco Control Act. The Act was designed to protect today's highly toxic, existing cigarettes by putting huge obstacles in the way of the introduction of potentially safer products. The anti-smoking groups and politicians who supported the legislation want it to look like they are reforming the tobacco space and forever changing the landscape to favor the protection of the public's health. But the opposite is true. The Act institutionalizes the existing tobacco market and makes true reform almost impossible.

The IOM committee can hide behind the charade of having us believe that research funded by industry automatically becomes objective and unbiased when the money changes hands to a third-party. But the truth isn't all that difficult to see. It's not only the tobacco companies that have been deceptive. It's the anti-smoking movement as well.

IOM Recommendations Place Insurmountable Obstacle in the Way of New Reduced Risk Products By Requiring Research that Cannot Ethically Be Conducted

Yesterday, I provided my evaluation of the IOM report on modified risk tobacco products, opining that the rigorous scientific standards recommended by the report to support a modified risk product application place a nearly insurmountable obstacle in the way of the development of truly reduced risk products, and therefore serve as a death knell for harm reduction as a viable strategy to reduce the disease and death caused by cigarettes in the United States. I noted that the report is consistent with the clear intentions of the politicians and anti-smoking groups which supported the Tobacco Act, which I believe was intended to protect the existing high-risk cigarette market.

Today, I reveal an additional reason why the IOM report recommendations place an insurmountable obstacle on the development and approval of new reduced risk tobacco products. This one is not a logistic or economic obstacle, but an ethical one.

The Rest of the Story

The IOM report recommends that a new tobacco product that wishes to be marketed as a reduced risk product must be tested in a clinical trial in comparison to a regular (existing) product. Specifically: "Any clinical trial should include at least two control conditions—usual brand use and cessation—to allow examination of the relative effects of the MRTP on biomarkers of exposure or risk."

Suppose that a company wishes to demonstrate that a new cigarette - Brand X - reduces individual risk. The IOM recommendations require it to conduct a clinical trial comparing Brand X to an existing cigarette brand. Thus, one group of subjects would be randomized to switch to brand X, and another group of subjects would be randomized to continue to smoke their usual brand.

In my view, this is an unethical research protocol, and I would hope that no IRB in the country would approve such a protocol. Because of the known severe risks of cigarette smoking, it is not ethical to randomize subjects to a condition characterized by smoking cigarettes as usual. No IRB would or should approve such a protocol.

In fact, the only condition in which a randomized clinical trial involving cigarettes is ethically appropriate is when the study is designed to assess smoking cessation (or at least reduction in smoking). For example, one could test a new product designed to help smokers quit by randomizing smokers to receive either the new product or usual cessation care (i.e., nicotine replacement therapy). But you can't include a control group which is instructed to continue to smoke their regular cigarettes.

You can easily see how the IOM report's basic strategy of requiring clinical trials to demonstrate reduced risk of tobacco products is fundamentally flawed. In order to compare a new product with an existing product in a randomized clinical trial, you need to randomize subjects to either smoke the new cigarette or their usual cigarette. But it is unethical to instruct subjects to continue to smoke regular cigarettes.

If the subjects don't continue to smoke their regular cigarettes, then the clinical trial falls apart because you need a large sample of subjects who continue to smoke their usual brand in order to maintain an adequately sized control group. That smokers quitting would harm the scientific value of the study is a serious ethical breach that cannot be tolerated.

Imagine a randomized clinical trial of electronic cigarettes compared to regular cigarettes. Such a study, according to the standards recommended by the IOM report, would be required. No IRB in its right mind would approve a trial in which subjects were randomized to either use electronic cigarettes or to smoke Marlboros. Clearly, such a study cannot be done. The IOM recommendations amount to a catch-22 by which companies can never produce the scientific evidence that is required to achieve reduced risk product status.

The rest of the story, then, is that the IOM report is recommending that in order to obtain approval of a tobacco product as a modified risk product, a company must conduct randomized clinical trials that are unethical. Elsewhere, of course, the report emphasizes that all scientific studies must meet basic ethical standards. Thus, the result is a recommendation which places an insurmountable obstacle before companies wishing to develop reduced risk products.

The IOM report proposes a system of scientific study of reduced risk cigarettes by which these products would be studied using the typical pharmaceutical drug model. Companies would have to apply for an IND (Investigational New Drug) application and after preclinical studies, conduct phase II and phase III clinical trials, which - as I noted above - would be unethical. Not only is this a catch-22, but this regulatory model makes a travesty of the FDA's regulation of pharmaceuticals by placing cigarettes in the same category as drugs.

The IOM report states: "In the case of a truly new product (where nothing similar is sold elsewhere) an Investigational New Drug application model could be the most appropriate approach. In such cases, then, the FDA could require that preclinical laboratory testing be completed before moving to animal or human studies (e.g., phase I), which would have to be justified by significant findings in the laboratory work. If preclinical findings pointed to potential reduced exposure, then the FDA could authorize phase II or III trials to explore the experience of reduced exposure in larger human populations under controlled conditions (e.g., RCTs)."

This proposal, in my view, would undermine the entire FDA system of drug regulation. Tobacco products are not drugs and they should not be treated as such, even if they are potentially lower risk compared to traditional cigarettes. The IND/randomized clinical trial approach is appropriate for pharmaceutical products that are going to be regulated under the federal Food, Drug, and Cosmetic Act (FDCA). But it is not appropriate for tobacco products, which are recreational products not intended to prevent or treat any disease. Putting them into that category does not make any sense.

It should seem pretty clear at this point that what the IOM report is doing is trying to fit a square peg into a round hole. The regulatory scheme created by the FDA Act for tobacco products simply doesn't fit these products. The scheme would be appropriate for pharmaceutical drugs, but it just doesn't fit for recreational (and inherently hazardous) tobacco products.

Now, I am convinced more than ever that the Tobacco Act must be amended by Congress if there is to be any meaningful and effective national harm reduction strategy to reduce the disease and death caused by cigarettes and other tobacco products.

IOM Report on Modified Risk Tobacco Products Interprets Tobacco Act as Putting Insurmountable Barriers in the Way of Reduced Risk Tobacco Products

The Institute of Medicine last week released its long-awaited report on the scientific evidence required to support designation of tobacco products as modified risk products under the Family Smoking Prevention and Tobacco Control Act [the Tobacco Act].

The report recommends that extensive scientific evidence, including findings from randomized controlled trials and longitudinal cohort studies, be required to show that potential reduced risk products will reduce individual health risks and improve the public's health on a population basis.

The report summarizes the rigorous nature of the scientific evidence required as follows: "The evaluation of the effect of MRTPs on public health will require a wide range of evidence and therefore will require many different types of study designs, including studies of the composition of MRTPs and studies of human exposure, human health effects, the likelihood of addiction and abuse, and the perception and understanding of the product by the public. Furthermore, the evidence must be able to reliably support predictions about the effect of marketing the product on public health, and therefore these studies must be properly designed and rigorously conducted. Study designs will need to include all relevant populations including populations at a high risk for tobacco use. Study designs must be able to not only support inferences about the mechanisms of the products effects, but they must also be able to support predictions about the products’ effects in the real world."

The report makes it clear that demonstration of reduced risk cannot be made based simply on laboratory or pre-clinical studies, but requires the conduct of clinical trials and long-term longitudinal cohort studies.

As the report states: "there is no proof that any individual constituent or group of constituents is responsible for a given disease. For a biomarker of exposure to be accepted as a biomarker of risk or a surrogate endpoint of disease, there should be a strong biological rational as well as compelling data from clinical and epidemiologic studies. Experimental designs, in particular randomized controlled trials (RCTs), provide data that can support the strong inferences about the effect of an MRTP on human health relative to conventional tobacco products. The use of appropriately designed clinical trials will be important to establish whether the use of the MRTP reduces exposure to toxicants or induces positive changes in surrogate markers as claimed by the manufacturer. An RCT is an effective means of examining acceptability and use of the MRTP, the ability of the MRTP to increase cessation in users of conventional tobacco products, and the likelihood that availability of the MRTP will lead to dual use. RCT methods can also produce evidence on whether and how much individuals use an MRTP after they have used it to help them quit conventional products, changes in perception of the MRTP with its continued use, and the MRTP’s ability to suppress tobacco withdrawal symptoms. It is important to recognize that no single RCT can address all of these areas, and each study should have a focused objective with a primary endpoint."

"Long, intensive, and robust observational studies of actual health outcomes may be required to fully evaluate the net effects of MRTPs relative to conventional tobacco products. Prospective cohort studies are obvious candidates for the evaluation of MRTPs, and will also be an essential tool to validating anticipated or claimed effects of marketed MRTPs on both individuals and on the public’s health."

"It is clear that no single class of evidence (e.g., preclinical, RCTs, consumer perception, epidemiologic) in itself will be sufficient to support an MRTP application."

Thus, not only must the applicant demonstrate an improvement in individual and population health through randomized controlled trials and long-term longitudinal studies, but multiple clinical trials are required.

Moreover, the report recommends that tobacco companies not be allowed to submit their own research findings: "the committee concluded that the tobacco industry currently lacks not only the trustworthiness, but also lacks the expertise, infrastructure, and other resources needed to independently produce the scientific evidence necessary to meet the public health standards set by the law."

Instead, the report insists that tobacco companies must contract with independent third parties to conduct the required research.

The Rest of the Story

The scientific requirements recommended by the IOM report are so rigorous that I believe the implementation of such standards would place an insurmountable, or virtually insurmountable, obstacle in the way of the development and marketing of truly reduced risk tobacco products. I believe that these standards would be a de facto death knell for the strategy of harm reduction as a tool for controlling tobacco-related disease in the United States.

The requirements for conducting long-term epidemiologic studies and randomized clinical trials to demonstrate reduced individual and population risk are so burdensome that they remove most of the incentive to develop such products, especially since there is no guarantee that long-term studies will support the approval of such products. In addition, the length of time required to conduct these studies is prohibitive in most cases.

Consider the need to demonstrate a reduction in cancer risk. Cancer takes many years to develop so one cannot simply conduct a two-year cohort study to determine whether a new type of cigarette will reduce cancer risk. It would take a minimum of perhaps ten years to know whether the product reduces cancer risk. Very few companies are going to want to expend the amount of money required to carry out such long-term studies, with no guarantee of success.

Moreover, the requirements for randomized clinical trials that include a control group of regular cigarette users cannot be followed while still conducting ethical research. You cannot ethically randomize human subjects to smoke regular cigarettes. I will write more about this in a separate post tomorrow.

The Two Pathways for Modified Risk Products

There are two possible pathways for modified risk tobacco products: the reduced risk pathway and the reduced exposure pathway. Reduced risk products are those for which the manufacturer wishes to claim that the product is safer than other products on the market. Reduced exposure products are those for which the manufacturer will not make any explicit health claim, but will merely inform consumers that it contains less of a certain constituent, or is free of a particular constituent.

For the reduced risk pathway, the IOM report makes it clear that the manufacturer must show that the product will reduce health risks to individual users and to the population as a whole. This is a very high scientific standard, one that can only be met through long-term epidemiologic studies with thousands of product users in order to establish the long-term relative risks of using these products.

However, this produces a catch-22 situation: A manufacturer cannot market a product until it demonstrates that it reduces individual risk. But a manufacturer cannot demonstrate that the product reduces individual risk unless it first markets the product. Receiving special FDA permission to test market the product in a small population will not allow the large sample size necessary to examine the effects of these products on cancer risk. Such studies require perhaps hundreds of thousands of users in order to have enough power to detect differences in cancer risk.

Thus, it is virtually, if not literally impossible for any reduced risk product ever to be approved by the FDA under these scientific standards.

For the reduced exposure pathway, the manufacturer need only show that the product does indeed decrease exposure to a particular constituent or constituents and that a corresponding reduction in health risk is "reasonably likely." This is possible to do with laboratory studies, so it is feasible to make the necessary demonstrations to the Agency.

However, there is a third requirement: the manufacturer must show that as it plans to package and market the product, consumers will not believe that the product reduces their risk. In other words, even though consumers know that the product reduces exposure, they must not believe that it reduces risk.

This, again, creates a nearly impossible task. If consumers are aware that a product reduces exposure to one or more harmful substances, they are naturally going to believe that it reduces their risk of disease. The only way to avoid this perception would be not to tell consumers that the product reduces exposure. But in that case, the new product is no longer a reduced exposure product and so it cannot be approved for marketing in the United States.

Thus, the FDA Tobacco Act creates another catch-22: A manufacturer cannot market a product as reduced exposure unless it can show that consumers will not perceive it to be less harmful. But consumers will only perceive that the product is not any less harmful if it is not marketed as reduced exposure.

This provision, in other words, makes it virtually, if not literally impossible to market a reduced exposure product. One would have to make very limited claims that do not result in consumers believing the product is any safer. But if consumers don't believe the product is any safer, then why would they want to switch to that product? It would not be cost-effective to market the product, because it surely would not compete with existing products on the market in the absence of any consumer belief that the new product is safer.

Consistency of the IOM Report Recommendations with the Tobacco Act

I need to make it clear that I am not criticizing the IOM report for an overly stringent interpretation of the Tobacco Act. It is my opinion, which I expressed before the Tobacco Act was even enacted, that the above implications of the modified risk tobacco product provisions of the Tobacco Act were exactly what Congress and the anti-smoking groups which supported the legislation desired.

So I believe that the IOM report is accurately outlining the rigorous scientific evidence that the statute requires. I believe that a major purpose of the FDA Tobacco Act was specifically to put a huge barrier in the way of modified risk products, which have long been despised by the anti-smoking groups (and usually with good reason). But the climate has changed (e.g., consider the development of electronic cigarettes, which contain no tobacco) and the law needs to change with the climate. Unfortunately, the Tobacco Act employs an old picture of the tobacco product space and inhibits a true harm reduction approach in favor of preventing deceptive marketing that characterized the previous century, when there was no federal regulation of tobacco products. The times have changed, but the Act's view of the times has not. As a result, the Act essentially nixes harm reduction as a viable tobacco control strategy in favor of protecting the existing high-risk cigarette market. Even the tobacco companies recognize that this is an antiquated view; they desire to bring reduced risk products into their portfolios.

The rest of the story, then, is that the Tobacco Act's modified risk provisions simply make no sense. It is essentially a hoax, designed to make it look like the policy makers and health groups are interested in protecting the health of smokers, but instead, if you actually read the fine print, you'll find that the law sacrifices the health of smokers by making it impossible for tobacco companies or public health groups to pursue a harm reduction strategy. The Act preserves the existing market of the highest risk tobacco products and stifles competition from alternative products that might truly reduce health risks. The IOM report's interpretation of the Act is perfectly consistent with the statute.

This is not science-based policy. It is protectionism. Protection of the status quo. Protection of the existing tobacco market. The anti-smoking groups are not interested in actually protecting the health of smokers by encouraging them to use potentially less harmful alternatives. Instead, they are protecting the highest risk products and making sure that smokers continue smoking these high-risk products and that they do not switch to products that could potentially save their lives, or at least greatly reduce their risk of disease.

My Analysis of IOM Report on Modified Risk Tobacco Products Will Be Posted Monday and Tuesday

I am not posting today, as I am busy digesting the very long IOM report on Modified Risk Tobacco Products. My commentaries on that report will be posted on Monday and Tuesday. If anyone has read the report and would like to comment, feel free to use this comment section to do so. In the mean time, I will be at work reading and analyzing the report.

2009 National Conference on Tobacco or Health Sacrifices Scientific Integrity By Accepting Sponsorship from Big Pharma

The 2009 National Conference on Tobacco or Health, held in Phoenix from June 10-12, included two major program areas related to smoking cessation and the strategies used to promote cessation:

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

2. "Nicotine and the Science of Addiction (N&SCI)—Includes: research related to addiction; scientific rationale for tobacco control policies; current research in nicotine and other components of tobacco; and current research in addiction."

The Rest of the Story

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

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

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

The pharmaceutical sponsorship creates, by its very existence, an unavoidable bias that precludes a truly objective consideration of any scientific issue that may have significant implications for the profitability of smoking cessation drugs, and therefore, for their manufacturers who are conference sponsors. This bias does not necessarily have to be conscious. In fact, the most concerning bias is that which could arise subconsciously by virtue of the sponsorship of the conference by Big Pharma.

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

This is in no way to fault the individual scientists who presented on these issues at the conference. Nor is it to suggest that any wrongdoing occurred. It is merely to point out that the pharmaceutical sponsorship creates, by its very existence, an unavoidable bias that precludes a truly objective consideration of any scientific issue that may have significant implications for the profitability of smoking cessation drugs, and therefore, for their manufacturers who are conference sponsors.

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

Will the 2012 National Conference on Tobacco or Health accept pharmaceutical company sponsorship? I have put the odds of the Conference not accepting Big Pharma funding at 13:1, with the early over/under at $20,000. Readers are invited to place their bets on either the accept/not accept or over/under betting lines. Unlike wealthy political candidates, bets as large as $10,000 are not accepted. We'll stick with friendly bets for now.

Greek Health Ministry Will Reportedly Help Improve Cigarette Sales by Banning Electronic Cigarettes

According to an article at ekathimerini.com, the Greek Health Ministry is in the process of banning the sale of electronic cigarettes because they contain nicotine and may pose a health risk. According to the article: "As electronic cigarettes are embraced by smokers trying to kick the habit or to abide by a ban on smoking in public places, the Health Ministry is reportedly planning to forbid the trade and use of the electrical device, noting that it contains nicotine and remains a health risk."

The Rest of the Story

Because electronic cigarettes are embraced by smokers trying to kick the habit, banning these products makes no public health sense. What the Greek Health Ministry is apparently saying is that they would rather smokers continue to smoke the well-proven to be deadly tobacco cigarettes rather than to quit smoking by using a product that is free of tobacco and produces no smoke.

This action will harm both smokers and nonsmokers. Smokers who have successfully quit or cut down significantly using electronic cigarettes will essentially be forced to return to smoking tobacco cigarettes full-time. Nonsmokers who were protected from secondhand smoke because the people they live with switched to electronic cigarettes will again be exposed to secondhand smoke. This is a lose-lose proposition.

There are two entities whose profits will increase as a result of the Greek government's action. First, the tobacco industry will regain sales from smokers who had switched over, in whole or in part, to electronic cigarettes. Second, the pharmaceutical industry will regain sales from smokers who used electronic cigarettes, rather than pharmaceutical products, in their efforts to quit smoking.

The fact that electronic cigarettes contain nicotine is no reason to ban the product. What sense is there in allowing nicotine to be sold when accompanied by over 10,000 other chemicals, including more than 60 carcinogens, but not allowing nicotine to be sold with only a few other chemicals, none of which have been demonstrated to be hazardous at the levels that occur in the vapor produced by electronic cigarettes?

As far as health risks beyond the nicotine, none of yet been identified. Tobacco-specific nitrosamines were found to be present only at trace levels, comparable to the levels in nicotine gum and nicotine patches, and at 1400 times lower a level than present in some cigarettes. Diethylene glycol has so far been identified in only one brand of electronic cigarettes, which I believe is no longer sold. Long-term inhalation of propylene glycol has been hypothesized to be potentially toxic, but preliminary studies have not substantiated this concern. Other than these three specific concerns, there are no other specific health risks that have been identified.

According to Action on Smoking and Health, other countries in which electronic cigarettes have been banned include Brazil, Australia, Canada, Israel, Mexico, and New Zealand.

Ironically, it is the health authorities in these countries which are protecting the profits of tobacco companies at the expense of the public's health.

Department of Health and Human Services Shows It is Driven by Politics, Not Science; Sibelius Overrules FDA and Bans Over-the-Counter Plan B Access

In an unprecedented move, the Secretary of Health and Human Services - Kathleen Sibelius - overruled an FDA decision that would have removed the age restriction on over-the-counter sales of the morning after pill (also called plan B or emergency contraception), allowing access to the pill for girls below age 17 (the lower limit for sale would have been age 11).

It is thought that this is the first time that the Secretary of Health and Human Services has overruled an FDA action.

There is strong evidence that the morning after pill is safe and effective for girls between the ages of 11-16. Research has shown specifically that 11-16 year-old girls are able to read and understand the directions, use the product safely and effectively, and do both of these without physician consultation. The only significant side effect is nausea, which lasts a few hours (nausea associated with pregnancy can last months). There is no risk of overdose. Moreover, there is strong evidence that availability of the medication does not lead to increased unprotected sex among adolescents or young girls.

In other words, as the American Council on Science and Health emphasized in its Facts and Fears column last Thursday, there is no medical or scientific reason to overrule the FDA's decision.

What was Secretary Sebelius' reason for overturning the FDA's decision? According to several newspaper articles, the Secretary argued that young girls are unable to "understand the instructions." Sebelius noted that: "there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age."

The Rest of the Story

Secretary Sibelius argued that the cognitive differences between older and younger adolescent girls renders the younger girls incapable of understanding and following the instructions for the use of the morning after pill.

Let's examine, then, the instructions to see how hard it might be for an 11- or 12-year-old girl to follow them.

The instructions are as follows: "Take one white pill."

Now I can see where Dr. Sibelius is coming from. The instructions entail taking one pill. That seems far too difficult for an 11-year old to comprehend. Clearly, the girl would need to consult with her physician to understand what she is supposed to do.

For one thing, she may not understand the number one. Her doctor can review her numbers with her and explain what is meant by the number one.

For a second thing, she may not know her colors. The physician can explain to her what "white" means by giving examples of things that are white.

It's hard to fathom how an 11-year-old would be able to comprehend instructions as complicated as "take one white pill."

President Obama supported the Secretary's decision, arguing that the younger girls may not be able to use the pill properly.

I see the President's point here. A 14-year-old might mistakenly think that the pill is designed to be placed into the ear, rather than swallowed. Or she might think that, like snus, the pill is supposed to be placed in the nasal cavity. There are innumerable ways in which girls could use the pill improperly.

Clearly, the arguments being put forward by both Secretary Sibelius and President Obama are a smokescreen. They make no sense. It is quite evident that the real reason for their opposition to the pill are political. They are afraid that the decision to make the pill available could be used against the President in the 2012 presidential election campaign, especially since his opponent is certainly going to be a strong conservative candidate.

This is an egregious example of politics, rather than science, guiding federal public health policy. It is also the reason why I am not optimistic about the federal government - including the current administration - taking any major action that would actually put a dent in cigarette sales. When it comes down to it, politics will outweigh science and we're not going to see any major policy action that would substantially reduce the government's cigarette tax revenues. This is just one reason why I don't think a menthol cigarette ban will see the light of day, and certainly not before the 2012 election.

The rest of the story is that despite the promises when President Obama took office, politics - and not science - is still dictating federal public health policy. This is hardly what I imagine President Obama had in mind when in his inaugural address he called for "science to be restored to its rightful place."

Medical Scientists to Smokers: Keep Smoking, Don't Quit Using Electronic Cigarettes

In their print and radio column entitled "Medical Discovery News," two biomedical scientists have urged smokers not to use electronic cigarettes to quit smoking, even though thousands of ex-smokers have successfully quit using these devices and many have experienced remarkable improvement in their health.

The scientists express four major concerns about electronic cigarettes:
1. Nicotine delivery is variable.
2. The products contain nitrosamines.
3. The products contain other toxic chemicals.
4. Youth may find the product appealing.

The authors write: "For scientists, those are enough reasons to not try an e-cigarette. At the very least, wait until science shows what is in them before smoking one, or better yet, choose not to smoke at all."

The Rest of the Story

Let's examine each of the four concerns:

1. Nicotine delivery is variable.

So what? In what way does this create harm to users? The effect of having variable nicotine delivery is simply that the product may be less effective in smoking cessation. But there is no harm to users. In fact, variable nicotine delivery would make the product less addictive than regular cigarettes.

2. The products contain nitrosamines.

The authors don't tell you the rest of the story, which is that the level of tobacco-specific nitrosamines in electronic cigarettes are orders of magnitude lower than in regular cigarettes (about 1400 times lower than in Marlboros). Moreover, the level of tobacco-specific nitrosamines are comparable to what is found in nicotine patches and nicotine gum. But the authors do not recommend that smokers refrain from using those products. If anything, the FDA laboratory finding of only trace levels of tobacco-specific nitrosamines in electronic cigarettes shows that these products are much safer than cigarettes in terms of their carcinogenic potential.

3. The products contain other toxic chemicals.

OK. What are they? And where is the evidence that they are harmful to users? And what health effects do they cause? The components of electronic cigarettes have been studied extensively, and so far no one has suggested a particular chemical delivered by these products that has been shown to be harmful. What we do know is that while there are only a handful of chemicals in electronic cigarettes, there are more than 10,000 in regular cigarettes, including more than 60 carcinogens. Which product do you think is likely to be safer?

4. Youth may find the product appealing.

This is a valid concern. However, to date there is no evidence that youth are actually using the product. This is certainly something that needs to monitored, and youth access to electronic cigarettes certainly has to be regulated, but this is not a reason to recommend that smokers not use electronic cigarettes to get off regular ones.

Unfortunately, what these scientists are recommending is essentially that smokers should keep smoking rather than switch to electronic cigarettes. I find this to be irresponsible medical advice. There's no question that smokers are much better off quitting smoking and switching to electronic cigarettes than continuing to smoke. There is strong evidence that electronic cigarettes are much safer and there is strong anecdotal evidence that there is an immediate health improvement among smokers who switch to electronic cigarettes.

The reality is that NRT and other smoking cessation drugs are ineffective, with failure rates of greater than 90% over the long-term. In that light, it seems irresponsible to tell smokers - most of whom have tried to quit and failed with NRT - that they should continue to try using this ineffective method that has already failed them. Essentially, that is tantamount to telling them to continue smoking. I find that to be really bad medical advice.

Menthol Cigarette Use Among Youths Soars While Anti-Smoking Groups and Policy Makers Congratulate Themselves for Getting Rid of Flavored Cigarettes

According to an article on the Minnesota Public Radio web site, the Minnesota Department of Health reported this week that no progress has been made in recent years in reducing smoking among youth. According to the article: "Public health officials are disappointed with new findings that show there has been no significant change in tobacco usage among teenagers during the past few years. The Minnesota Department of Health survey shows that among high schoolers tobacco use remains stagnant, at around 26 percent."

Perhaps the most striking finding of the survey is that "the use of menthol cigarettes has more than doubled among teenage smokers in the past decade."

According to the Minnesota Department of Health's press release, in 2000, menthol cigarette use among high school students in Minnesota was 19.9%. In 2011, the prevalence of menthol cigarette use rose to 47.3%. There was a substantial increase in menthol cigarette use in the past three years, from 39.1% in 2008 to 47.3% in 2011.

The Rest of the Story

These findings stand in stark contrast to the proclamations of anti-smoking groups and policy makers that the Tobacco Act put an end to flavored cigarettes and eliminated the tobacco industry's ability to addict kids with flavored cigarettes.

For example, in a communication sent to the American Cancer Society's (ACS) network of advocates throughout the nation in June 2009, the American Cancer Society stated: "Our nation's children – potential first-time smokers – will no longer be seduced by flavored tobacco products, including candy- and fruit-flavored cigarettes, which will be banned." Thus, the American Cancer Society claimed that the Tobacco Act bans all flavored tobacco products that might seduce children.

In a press release issued by the FDA in 2009, the U.S. Department of Health and Human Services Assistant Secretary for Health stated that: "Flavored cigarettes attract and allure kids into lifetime addiction. FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily." Thus, the Department was claiming that all flavored cigarettes were now banned and that this policy would have a major impact on reducing the use of flavored cigarettes among youth.

The truth is that the use of flavored cigarettes among youth has increased, not decreased since the implementation of the Tobacco Act.

The rest of the story is that while the national anti-smoking groups and policy makers congratulate themselves for having protected youths from addiction by flavored cigarettes, the proportion of youths smoking flavored cigarettes appear to be higher now than ever before.

CDC Seems to Know the Answer Before Starting the Research on Economic Effects of Smoke-Free Bars and Restaurants

The Centers for Disease Control and Prevention (CDC) recently announced that it was partnering with Pfizer to conduct a study on the economic impact of smoke-free bar and restaurant laws. On Monday, I questioned whether this partnership with a pharmaceutical company, about whose products the CDC makes national policy recommendations, taints the agency's scientific objectivity. Today, I question whether CDC has answered the research question before actually conducting the study and therefore, I suggest that the agency may be wasting Pfizer's money since the answer seems to already be known.

The Rest of the Story

In the press release announcing the study, CDC Director Thomas Frieden states: "Making worksites, restaurants, and bars smoke-free saves lives, increases productivity, reduces health care costs, and doesn’t hurt business."

If smoke-free laws do not hurt business, then haven't we already answered the question? This statement by CDC's director seems to imply that we have answered the question before having started the research. If that's the case, then what's the point of doing the research? Isn't this a waste of Pfizer's money?

What's most interesting to me is not that CDC appears to have answered the question before starting the research, but that no one even attempted to hide that fact. The CDC director comes right out and tells us the answer to the research question, before Pfizer's money is even put to work.

This also raises the question of how objective the research process can be if the agency conducting the study has already drawn a conclusion.


(Thanks to Pam Parker for the tip.)

CDC Partnership with Pfizer Puts Question Mark on Its Scientific Objectivity

According to a CDC Foundation press release, the CDC Foundation, the CDC, and Pfizer have formed a partnership, made possible by Pfizer funding, to conduct a study examining the economic impact of smoke-free bar and restaurant laws in nine states.

According to the press release: "As part of ongoing efforts to reduce disease and death caused by smoking and secondhand smoke exposure, the CDC Foundation and CDC have launched a new initiative to study the economic impact of smoke-free policies on restaurants and bars in nine states. ... This initiative, made possible by a partnership grant from Pfizer to the CDC Foundation, will assess the economic impact of local smoke-free laws on restaurants and bars by examining objective economic indicators." ...

"'We deeply appreciate our ongoing partnership with Pfizer to support CDC’s work to protect us all from dangerous and expensive health threats,' says Charles Stokes, president and CEO of the CDC Foundation. 'Each public-partnership forged through the CDC Foundation helps CDC put science into action to save lives. We believe this innovative partnership, which was made possible by Pfizer, could substantially improve health for many individuals and communities.'"

"'As part of Pfizer's commitment to addressing important public health needs, we are proud to partner with the CDC Foundation on this research initiative,' said Freda C. Lewis-Hall, M.D., FAPA, chief medical officer and executive vice president, Pfizer. 'Our goal is to help the CDC Foundation, working with CDC and other partners, provide state and local health groups with an independent, objective assessment of the economic impact of smoke-free policies on restaurants and bars. We hope that the results of this analysis will advance efforts to reduce secondhand smoke and the serious health risks it poses to nonsmokers.'"

The Rest of the Story

According to the CDC Foundation, it accepts partnerships only if they "present no conflict of interest for CDC or the CDC Foundation."

I do not understand how the CDC can argue that partnering with Pfizer is not a conflict of interest. If CDC conducted no work that related to the approval of disapproval of products manufactured by Pfizer, I would agree that the partnership does not represent a conflict of interest. But that is not the case. The CDC reviews and issues approval or disapproval to products manufactured by Pfizer and other pharmaceutical companies all the time.

For example, the CDC makes recommendations regarding the use of vaccines. One vaccine about which the CDC deliberated was Pfizer's Prevnar. The CDC Advisory Committee on Immunization Practices (ACIP) regularly makes recommendations regarding the use of vaccines.

Furthermore, CDC makes recommendations regarding a wide range of other drugs, related to the prevention and treatment of all sorts of infectious and chronic diseases.

Through its partnership with CDC and the CDC Foundation, Pfizer has the potential to gain an increased corporate image among CDC staff, and therefore, to influence decisions that the CDC makes about the approval or disapproval of Pfizer products. I am not arguing that the influence is a conscious one. I’m not saying that CDC will consciously say to itself: we received money from Pfizer so let’s be extra nice to them in our formulation of public recommendations. However, I do believe that the receipt of this funding from Pfizer, which the CDC Foundation praises heavily in its press release, will have the effect of improving the company’s image within the agency, and that it could potentially have a subconscious effect on the agency and therefore influence its actions. This is precisely how conflicts of interest work.

If this were an individual researcher rather than an agency, there is no question that the partnership with Pfizer and other pharmaceutical companies would represent a conflict of interest. I see no reason why it is not a conflict just because the CDC is an agency rather than an individual. The conflict of interest would be expected to work in exactly the same way.

The CDC Foundation has a large number of partnerships with Big Pharma companies, including GlaxoSmithKline, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Novartis, and Sanofi-Aventis. So the problem is not restricted to this one partnership with Pfizer.

The CDC Foundation also partners with the Coca-Cola Company. According to the CDC Foundation, partnerships are only accepted with "Corporations whose goals or philanthropic interests align with CDC’s work...".

In what way do Coca-Cola’s goals align with those of CDC? The CDC is in the business of trying to improve the public’s health. Coca-Cola is in the business of trying to market and sell sugar-laden soft drinks that contribute to the obesity epidemic. The CDC presumably favors school nutrition improvement. Coca-Cola has opposed virtually every piece of state legislation to improve school nutrition. The CDC presumably wants to decrease the consumption of sugar-laden soft drinks. Coca-Cola is working to sustain the sales of its sugar-laden soft drinks.

Don’t get me wrong. I’m not criticizing Coca-Cola. They are not in business to reduce obesity. They are in business to sell soft drinks and I wouldn’t argue that they should do otherwise. If anything, I commend Coca-Cola for being brilliant enough to use its money in a way that may soften the CDC’s stance on sugar-laden soft drinks.

The CDC Foundation also partners with Abbott Laboratories.

How could the CDC’s partnership with Abbott Laboratories not constitute a violation of its corporate partnership policy? Abbott Laboratories is one of the leading manufacturers of infant formula, which it is pushing to pregnant women through programs such as the giveaway of infant formula in hospitals. Presumably, the CDC has a vested interest in promoting increased breastfeeding and reduced use of infant formula. This certainly appears to represent a conflict of interest.

The CDC Foundation also partners with Georgia Pacific.

How could CDC’s partnership with Georgia Pacific not constitute a conflict of interest? Georgia Pacific is one of the nation's leading corporate polluters. In what way does that align with CDC's mission and goals?

The rest of the story is that through its corporate partnerships with companies which either produce products that are causing harm to the public or which are within the scope of CDC’s public recommendations, the CDC Foundation is creating significant conflict of interests that conflict with its stated policy of avoiding such conflicts. I believe that these partnerships taint the scientific objectivity of the agency, are inconsistent with the stated mission and policy of the CDC and CDC Foundation, and represent a disservice to the public’s interest.