Wednesday, January 31, 2007

More Anti-Smoking Groups Claiming that Secondhand Smoke is Worse than Active Smoking

Today, I reveal and discuss six more examples of anti-smoking groups claiming that secondhand smoke exposure is more dangerous than active smoking.

1. The headline of a March 2005 press release issued by Action on Smoking and Health (ASH) reads: "Secondhand Tobacco Smoke More Dangerous Than Smoking Itself."

This press release, which is still available on the internet (and has not been corrected), goes on to say that the California Environmental Protection Agency has concluded that secondhand smoke causes breast cancer in premenopausal women and that the risk from secondhand smoke is actually higher than the risk of breast cancer from active smoking. This is apparently the "evidence" for the proclamation that secondhand smoke is more dangerous than smoking itself.

2. According to ActNowBC: "Second-hand smoke can be more dangerous than smoking. Smokers inhale their chemical cocktail through a filter; second-hand smokers aren’t so lucky."

3. According to the Canadian Health Network:
"Why is second-hand smoke more harmful than what smokers inhale? Second-hand smoke has twice as much nicotine and tar as the smoke that smokers inhale directly from their cigarettes."

4. In a medical news article on from last April, the director of ASH is quoted as saying: "I know that the secondhand smoke is different from, and in many ways more dangerous than directly inhaled smoke. It's the difference between a well-ventilated fire in a fireplace and one where there is not enough ventilation to produce proper oxygenation."

5. According to a youth anti-smoking group: "Studies have found that secondhand smoke is even more dangerous than inhaled smoke because it burns hotter."

6. According to the British Columbia Ministry of Health: "Breathing second-hand smoke can be more dangerous than inhaling smoke through a filtered cigarette. It has twice as much nicotine and tar as the smoke that a person smoking inhales and has five times more carbon monoxide, a deadly gas that starves your body of oxygen."

The Rest of the Story

The rest of the story is that in their zeal to scare the public about the effects of secondhand smoke in order to promote smoking bans, anti-smoking groups have stretched and exaggerated the truth so much that they are now widely disseminating misleading and/or inaccurate information to the public.

Let's start with ASH's claim: "Secondhand Tobacco Smoke More Dangerous Than Smoking Itself."

This claim is simply false. Secondhand smoke is not more dangerous than active smoking. Active smoking is more dangerous than secondhand smoke exposure. A multitude of epidemiologic studies document this fact.

What ASH has done is to completely distort a scientific finding - that the relationship between the dose of secondhand smoke and the risk of breast cancer is not linear - and to twist it in such a way that it comes out stating that passive smoking is more dangerous than active smoking.

This is a gross distortion of the truth.

It would be interesting to know whether ASH actually believes this headline or not. If ASH recognizes that active smoking is more harmful than secondhand smoke, then it is lying in telling the public the opposite. On the other hand, if ASH does believe that active smoking is less hazardous than passive smoking, then I suggest that ASH has completely lost its scientific competence and credibility and has no business making any statements regarding the science of active or passive smoking to the public. And certainly, the public should not listen to anything that ASH has to say.

Perhaps there is a middle ground here, where what ASH is actually doing is making a statement that they know will be misleading to many people, but relying on a technical defense - that with respect to breast cancer, secondhand smoke may pose a greater risk than active smoking - to justify the statement. If that is the case, things are no better. In some ways they are worse. Because that would imply that ASH is intentionally distorting the scientific evidence - the truth - in order to make people believe something that isn't true.

This is exactly the kind of deception and distortion that we are constantly accusing the tobacco companies of doing.

So none of the options are good: either ASH is lying, completely incompetent, or no better than the tobacco companies in terms of deceiving the public. Not a pretty picture for one of the most prominent national anti-smoking organizations, and because of that, for the entire anti-smoking movement.

Some might ask the question: how can I say that the entire anti-smoking movement is tarnished by the actions of one group? First of all, it's clear that it is not just one group. But second of all, if no other anti-smoking group is willing to publicly state that what ASH has communicated in its headline is wrong, then we are all sort of accomplices to the deception and distortion, and I do think that it therefore reflects on the entire anti-smoking movement.

The claim made by ActNowBC is also extremely deceptive, although admittedly it is slightly less egregious than the claim made by ASH. "Second-hand smoke can be more dangerous than smoking" is not an accurate representation of the truth, I would submit. Active smoking is clearly and unequivocally worse than passive smoking, according to an overwhelming body of scientific literature. I would like to see ActNowBC's documentation of scientific evidence that secondhand smoke can be more dangerous than active smoking. My personal opinion is that this is not based on any scientific documentation, but is a gross distortion of the scientific truth.

The statements that secondhand smoke is more harmful or more dangerous than mainstream smoke are very misleading. These statements imply, I believe, that active smoking is therefore not as dangerous as passive smoking.

While it may be true that sidestream smoke contains higher concentrations of some constituents than mainstream smoke, it is not correct to imply that therefore, exposure to secondhand smoke is more dangerous than exposure to mainstream smoke. The reason is that while the smoker directly inhales the mainstream smoke, the nonsmoker inhales sidestream smoke that has been greatly diluted.

I suppose that if it were common practice for nonsmokers to go around and suck in on the smoke directly emanating from the burning cigarette tip of smokers around them, then it might be correct to state that secondhand smoke is more dangerous than mainstream smoke. But because nonsmokers invariably inhale smoke that has been greatly diluted (which is not the case for active smokers), this statement is thus very misleading.

The shame of all of this is that not only are anti-smoking groups making inaccurate and misleading statements to the public, but they are completely tarnishing the reputation and credibility of the movement. They are making us no better than the tobacco companies with respect to deceiving people about the truth. They are also undermining the public's appreciation of the hazards of active smoking. All in an effort to exaggerate the health effects of secondhand smoke, something which is completely unnecessary and uncalled for.

The tobacco companies are not the only ones who should be preparing corrective statements to disseminate to the public.

(Thanks to Mike Walsh for the tip.)

Tuesday, January 30, 2007

Car Smoking Ban Proponent Claims Secondhand Smoke is Worse than Firsthand Smoke

According to an article on the WTAE-TV web site (Channel 4, Pittsburgh), Pennsylvania state representative Peter J. Daley, who plans to introduce state legislation that would ban smoking in cars with children, is telling the public that secondhand smoke is worse than active smoking.

The article quoted Representative Daley as stating: "We know that secondhand smoke is worse than firsthand smoke. The studies are all in, and we really want to protect the health of our children."

According to the article, "Daley argued that smoking in a car with a child, even with the windows down, is like smoking in a closet with a child. And while he admits it would be hard to enforce, he believes law enforcement must try."

The Rest of the Story

It may not be the case that this legislator created this fictitious statement on his own. It may well be that he garnered the false information from communications put out by any of a number of anti-smoking groups, which have told the public that secondhand smoke exposure is as bad as active smoking.

Here are some examples of these communications:

1. Anti-Smoking Group Claims that 30 Seconds of Secondhand Smoke is As Bad As a Lifetime of Active Smoking in Terms of Coronary Artery Function (link)

According to an article in the St. Paul Pioneer Press, a Minnesota anti-smoking group has publicly claimed that 30 seconds of secondhand smoke is as bad as a lifetime of active smoking in terms of coronary artery function. The group - Association for Nonsmokers (Minnesota) - issued a press release which declared that a mere 30 seconds of secondhand smoke exposure results in coronary artery damage that is indistinguishable from the damage suffered by active smokers (many of whom have smoked for decades).

According to the article, the Association for Nonsmokers press release claimed that: "Just 30 seconds of exposure can make coronary artery function of nonsmokers indistinguishable from smokers."

The Rest of the Story obtained a copy of the press release, dated August 30, which indeed stated:

"Research studies have shown that even just thirty seconds of exposure to secondhand smoke can make coronary artery function of non-smokers indistinguishable from smokers."

2. At Least 18 Anti-Smoking Groups Claim that Secondhand Smoke Causes Heart Damage as Severe as that of Active Smoking (link)

No fewer than 18 anti-smoking groups are publicly claiming that just a half hour of exposure to secondhand smoke causes damage to the heart of nonsmokers similar to the heart damage caused by active smoking.

Smoke-Free Houston: "Even half an hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

Smoke Free Galveston: "Even half an hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

SmokeFree City: "Even half an hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

Americans for Nonsmokers' Rights
: "Even a half hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

University of Missouri Student Health Center: "Even half an hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers." "Even half an hour of ETS exposure causes heart damage similar to that of habitual smokers."

Kids Involuntarily Inhaling Secondhand Smoke: "Even half an hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

TriCounty Health Department: "A half hour of secondhand smoke exposure causes heart damage similar to that of a habitual smoker."

Virginians for a Healthy Future: "Even a half hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

Maryland Department of Health and Mental Hygiene (cached): "Even a half hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

Washington State Department of Health: "As little as half an hour of secondhand smoke exposure can cause heart damage similar to that caused by habitual smoking according to a study published in the Journal of the American Medical Association (JAMA. 2001;286:436-441)."

American Public Health Association: "Even a half hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

Illinois PIRG: "Just a half-hour of secondhand smoke exposure causes heart damage similar to that of a habitual smoker, according to the Journal of the American Medical Association."

Tobacco Technical Assistance Consortium: "Even a half hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

Coalition for a Tobacco-Free Hawaii: "even a half-hour of second-hand smoke exposure can cause heart damage similar to that of habitual smokers."

Bucks County Tobacco Control Project: "According to the Journal of the American Medical Association, even a half hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

Hendricks County Coalition for Tobacco Intervention and Prevention: "A half hour of secondhand smoke exposure causes heart damage similar to that of an habitual smoker."

Northwest Arkansas Radiation Institute: "Even half an hour of second hand smoke exposure causes heart damage similar to that of habitual smokers."

3. Anti-Smoking and Health Groups Claiming that Secondhand Smoke is as Hazardous as Active Smoking (link)

According to a number of anti-smoking and health groups, there is one thing that is as bad for your health as smoking - and that's breathing in secondhand smoke. The problem is that in comparing these health risks, these groups are claiming that secondhand smoke and active smoking are equally hazardous. They're not stating that secondhand smoke is dangerous, although not as bad as active smoking. They're telling the public that these hazards are nearly equivalent.

Here are the fallacious claims:

Baltimore Health Department, Tobacco Use Prevention and Smoking Cessation Program: "Second-hand smoke can be as harmful as smoking."

SmokeFree Australia: "New report warns passive smoke almost as harmful as smoking."

Louisiana Public Health Institute: "Comparing the effects of active smoking and secondhand smoke, researchers found that chronic exposure to secondhand smoke is about 80% as harmful as smoking a pack of cigarettes per day."

Hong Kong Tobacco Control Office: "Is secondhand smoke less harmful than active smoke? No!!"

Asante Health System: "Secondhand, or passive, smoking is almost as harmful as firsthand, active smoking."

University of Ottawa Health Services: "True or False, second hand smoke is not as bad than smoking? False. Second-hand smoke has up to 4000 chemicals in it; non-smokers are more susceptible to heart and vascular damage than smokers are, even though they absorb much smaller doses of the smoke toxins." (cached - not active link): "Smoking can have a negative impact on both male and female fertility. It is important to note that exposure to second hand smoke can be just as harmful as smoking itself."

Women's Health (cached - not active link): "Just breathing in the smoke from a smoker is almost as harmful as smoking the cigarette."

The rest of the story is that anti-smoking groups are widely disseminating to the public the message that secondhand smoke exposure is as bad as active smoking.

This is unfortunate for two reasons.

The first, of course, is that it is wrong and it is therefore irresponsible of these anti-smoking groups to be communicating this misleading and inaccurate information to the public.

The second is that these communications may actually work to undermine the public's appreciation of the health risks of active smoking. If active smoking is only as bad as secondhand smoke exposure, then it actually isn't as bad as the public has been led to believe. And why should a smoker quit smoking, if they will still be exposed to secondhand smoke and that exposure is as bad as their active smoking?

In an effort to protect people from secondhand smoke, anti-smoking groups are not only using unethical tactics; they are also undermining much of the work that public health practitioners have done over the past decades in educating smokers about the hazards of active smoking.

(Thanks to JustTheFacts for the tip.)

Monday, January 29, 2007

New York Times Op-Ed Exposes Misguided Response to Harvard Nicotine Report

My op-ed published in this Sunday's New York Times exposes a number of misleading aspects of the cigarette nicotine yield story that was prominently reported over the past week.

1. Marlboro nicotine yields have not steadily increased, as claimed in the report.

Contrary to claims made in the report, nicotine yields of Marlboro cigarettes have not steadily increased over the past nine years. Of the 16 Marlboro brands whose nicotine yields were consistently reported to the Massachusetts Department of Public Health for the entire period 1997-2006, the average nicotine yield was 1.81 mg in 1997 and 1.81 mg in 2006. Thus, there was certainly not a steady increase in these yields.

While the report concluded that there was a steady increase, it did so by using a simple linear model to explain the nicotine trends. The data, however, suggest a non-linear trend. It appears, instead, that nicotine yields increased slightly from 1997 to 2003, and then decreased, at a greater annual rate, from 2003 through 2006. The overall pattern is more consistent with a skewed "V," and this is more appropriately modeled with two lines - one increasing and one decreasing.

At any rate, it is quite clear that nicotine yields of Marlboro have not been increasing steadily and that they are, in fact, no higher at the present time than they were nine years ago.

While the discrepancy for this one particular cigarette brand may not seem important, it is critical for two reasons.

First, it is important because Philip Morris directly challenged the conclusion of the report regarding its brands - Marlboro in particular - and the Harvard report insisted that Philip Morris was wrong (even though Philip Morris demonstrated that there was no difference in average nicotine yields in Marlboro sub-brands from 1997 to 2006). This demonstrates that it is not always the case that anti-smoking researchers are correct and tobacco companies are wrong. It is important that information disseminated to the public, even if it comes from anti-smoking groups, be critically examined and given careful scrutiny.

Scrutiny is not something that anti-smoking groups seem to want, and it is clearly not something that they are willing to accept. This is one reason why I feel that The Rest of the Story is needed and that it performs a valuable service.

Second, it is important because Marlboro is not just an isolated brand - it comprises more than 40% of the cigarette market. If you include several other Philip Morris brands whose nicotine yields don't appear to be higher in 2006 than in 1997, it turns out that for more than half of the cigarette market, nicotine yields are not actually increasing steadily, as suggested by the report.

A sales-weighted average analysis of nicotine yields would most likely show that there has been little overall change in nicotine yields on a population level.

2. Even among brands for which nicotine yields have increased, it is not necessarily true that nicotine dosages among smokers have increased.

The report itself made clear that the results cannot be used to infer changes in actual exposure of real-life smokers. The results only demonstrate the outcome of a machine "smoking" a cigarette under experimental and rigidly controlled conditions, which do not mimic those which exist in real life. Smokers tend to compensate for differing nicotine yields by adjusting the intensity of their smoking (both the puff volume and the cigarette consumption) to maintain a relatively constant nicotine dosage.

This well-recognized compensation mechanism explains why "light" cigarettes are not safer. Smokers simply compensate by smoking more. These cigarettes may actually be more harmful by increasing the overall tar delivery, which would increase cancer and chronic lung disease rates.

3. Increasing nicotine yields is not necessarily bad from a public health perspective. We should not be criticizing the companies for increasing yields any more than we should praise them if they decreased the nicotine yields.

The entire framing of the report and the press releases issued by anti-smoking organizations in response implies that cigarette companies are doing something wrong if they increase nicotine yields, and that therefore, they would be doing something good if they decrease nicotine yields.

Unfortunately, it's not quite so simple, and I thought it was critical to inform the American public about this point.

In fact, lowering nicotine levels could be the last thing in the world that we want cigarette companies to do. It would give smokers a false impression that they are smoking safer cigarettes, it would lead to an increase in cigarette consumption, and therefore, it would increase tar delivery and the corresponding carcinogenic health consequences.

It seems as though anti-smoking groups are just seizing the opportunity to take a pot-shot at the tobacco companies. Unfortunately, this pot-shot is counter-productive, because it sends a misleading message to the public. The pot-shot is also devoid of strong public health-based reasoning.

What we desperately need is sound public health reasoning, not politically-motivated rhetoric. It appears that anti-smoking groups hailing the results of this report were engaging in the latter, not the former.

But hopefully now the public is aware of the truth.

4. Anti-smoking groups that have used the report to call for passage of long-stalled FDA tobacco legislation are full of crap.

OK - I didn't quite use that language in the op-ed piece. But this is my blog, so I can call a spade a spade.

Groups like the Campaign for Tobacco-Free Kids, which have claimed that the Harvard report indicates the need to pass the long-stalled FDA tobacco legislation, are misleading the American public, in my opinion. Because this legislation actually precludes the FDA from removing the nicotine from cigarettes. Yet removing the nicotine is the only way to address the problem that the Campaign is bemoaning - the use of nicotine by cigarette companies to addict kids.

Regulating the levels of nicotine to make sure that they don't increase would be absolutely useless. Forcing the levels to come down would be absolutely disastrous for the public's health. Frankly, there is no point in using the addictiveness of cigarettes to argue for the need for FDA regulation unless what you are calling for is granting the FDA the power to eventually eliminate the nicotine from cigarettes.

If the Campaign for Tobacco-Free Kids and other anti-smoking and public health groups were truly sincere in their public statements that we need to do something to protect kids from cigarette company attempts to addict them through the manipulation of nicotine in cigarettes, then the only viable option is to remove the nicotine. Nothing else would work - and in fact, merely lowering the levels of nicotine would actually harm the public's health.

So if these anti-smoking groups really were sincere, the last thing in the world they should be doing is supporting legislation that ties FDA's hands by specifically precluding it from removing the nicotine. But that's precisely what the Campaign for Tobacco-Free Kids and its coalition of anti-smoking and public health groups have done for the past two years.

I have, in fact, challenged the Campaign for Tobacco-Free Kids to demand the revision of the proposed FDA legislation to delete the provision which ties FDA's hands with regards to the regulation of nicotine in cigarettes. But so far as I can tell, they have not responded. From what I gather, they seem determined to sell out the public's health for the financial interests of tobacco companies and to grant the tobacco companies the most special protection one can imagine - in spite of all the Campaign's rhetoric about the FDA legislation being needed to eliminate special protections that the tobacco companies have enjoyed.

Now I recognize that eliminating nicotine in cigarettes may not be politically or socially feasible at this time. That's fine. An anti-smoking group can argue, if it wants, that granting FDA such authority would kill the bill. That's fine. But don't make such a compromise and then have the gall to get up in front of the public and tell them that the rising nicotine yields in cigarettes indicate the need for FDA regulation of tobacco products. Don't mislead the public by making them think that rising nicotine is a terrible thing and that you are going to fix the problem. Don't mislead the public by making them think that you are going to end special protections for the tobacco companies when you are really granting them the most special protection they could ever ask for. Don't mislead the public by making them think that you are supporting the regulation of tobacco products in much the same way as the FDA regulates food and drugs.

All of that is complete crap. What you are doing is making a purely political compromise and selling out the protection of the public's health to appease the financial interests of tobacco companies. Maybe that is the right thing to do (I don't think so, for reasons which I will articulate in the coming weeks). Again, this is all fine. But you just have to admit that this is all about politics and not about protecting our children from rising nicotine levels.

It is the hypocrisy, deceptiveness, lack of sincerity, complete lack of transparency and forthrightness, and lack of complete honesty that troubles me most about the support of the FDA tobacco legislation by many anti-smoking groups.

Finally, I should note that Senator Kennedy, who plans to re-introduce FDA tobacco legislation in the next few weeks, has apparently not finalized his bill. It is entirely possible that he could remove this provision from the legislation and introduce a bill that would allow FDA to have freedom in regulating nicotine levels in cigarettes.

Senator Kennedy responded to the release of the Harvard study by stating: “This study is … dramatic new proof that Big Tobacco is addicted to addicting millions of young smokers into lifetimes of illness and early death. Congress has been an accomplice in the travesty because of the success of the tobacco lobby in blocking real reform. Hopefully, the study will be a wake-up call to persuade Republicans and Democrats alike to enact long overdue legislation allowing the FDA to regulate cigarettes and deal with their enormous risks.”

If Senator Kennedy is serious that the addiction of millions of young smokers is a problem that the FDA must be given the authority to step in and solve, then he must remove the provision in the past years’ legislation that would prohibit the FDA from eliminating nicotine in cigarettes.

When the bill is introduced in the next few weeks, we’ll know right away whether Senator Kennedy and the anti-smoking groups supporting the previous legislation are serious about addressing what they say is a public health travesty, or whether they are just blowing smoke.

The Rest of the Story

Let me make it clear that I am not necessarily calling on the removal of nicotine from cigarettes. What I'm really doing is calling the anti-smoking groups' bluff. Are they really sincere in their public statements, or are they just blowing smoke?

I've put things right on the line. These groups -- in particular, the Campaign for Tobacco-Free Kids -- are now up against a wall. It's decision time. Are they going to follow through with their public statements and true to their word, make their words count by demanding that Senator Kennedy remove the provision that ties the FDA's hands in terms of regulating nicotine in cigarettes?

Or are they going to reveal a complete lack of integrity by continuing to support legislation that would not only preclude the FDA from fully regulating nicotine in cigarettes, but would permanently protect the FDA from any attempt to make cigarettes a product that does not addict our vulnerable children? A bill that would permanently institutionalize the nicotine-based addiction or millions of children to a deadly product?

The same dilemma now is faced by Senator Kennedy. It's all on the table now. He has publicly stated that Big Tobacco addicting children by increasing nicotine levels is a travesty, and that he is going to do something about it.

Will he do something about it -- by introducing legislation that removes the restriction on FDA's ability to remove nicotine from cigarettes -- or will he, like Tobacco-Free Kids (at least for the last two years), reveal a lack of sincerity by granting the tobacco companies special protection with his pen at the same time as his mouth is telling us that he will do the exact opposite?

Friday, January 26, 2007

Daily Free Press Highlights Misleading Nature of Anti-Smoking Groups' Coverage of Nicotine Yield Report

An article in yesterday's Boston University Daily Free Press highlights my commentary about the misleading nature of anti-smoking groups' public response to the nicotine yield report released by researchers at Harvard last week (see front page here).

The article, entitled "BU professor calls nicotine study misleading," states: "A Boston University professor is challenging a recent Harvard School of Public Health study that reported cigarette companies have been increasing nicotine levels in cigarettes since 1997. ... In questioning the results, BU School of Public Health professor Michael Siegel said the study is misleading to the public. Siegel, who has studied tobacco control for 21 years, said he does not challenge the study's findings, which were released Jan. 18, agreeing that nicotine levels have generally increased. However, he disagreed with the study's report that tobacco company [brand] Marlboro increased its cigarettes' nicotine levels."

"'I was intrigued by this topic because [Harvard] concluded that Marlboro was increasing their nicotine yield and Philip Morris released that the 2006 level was equal to the 1997 level,' he said. ... 'Why was there this direct contradiction? . . . The only way to resolve it was to look at the data myself.'"

"Siegel said he looked at the reports for the 16 sub-brands of Marlboro and extended the Harvard study through 2006 ... He found that the Marlboro nicotine counts at the beginning and end of the 10-year period were the same, which he said is important because '40 percent of the market is Marlboro.' 'I don't see how you could possibly conclude that it has gone up,' Siegel said. 'It's no higher now than it was nine years ago...'"

"Siegel said the issue was larger than a data discrepancy because the Harvard study was misleading, implying that raising nicotine levels is a bad practice, [and noted that] lowering nicotine levels would increase cancer rates because smokers would increase puffs to get more nicotine and 'get a higher tar delivery.'"

The Rest of the Story

I'm glad that the rest of the story is starting to be told. It is critical that the public have an accurate understanding of the scientific and policy considerations regarding nicotine in cigarettes. This will not, however, be the last article that exposes the misleading nature of the anti-smoking groups' communications on this issue. It is only the first.

Thursday, January 25, 2007

Financial Ties Between Head of Smoking Cessation Guideline Panels and Big Pharma Run Deep

When I wrote yesterday about the financial conflicts of interest inherent in the pharmaceutical industry connections of a number of panelists on the groups that developed the Public Health Service's clinical practice guideline on the treatment of tobacco use and dependence and the national smoking cessation action plan, I wasn't aware of just how deep those connections were.

Today, I reveal the extent of these financial ties with regards to the chair of these two panels and argue that it is unethical and irresponsible to have such an individual developing what is supposed to be independent, objective, and unbiased national guidelines to the clinical and public health approaches to addressing tobacco use cessation.

The Rest of the Story

According to his testimony in the Department of Justice tobacco lawsuit, the chair of the panels which put together the clinical practice guideline and the national smoking cessation plan runs a tobacco research center which receives or has received funding from GlaxoSmithKline, Pfizer, Sanofi, Ciba-Geigy, and Elan. The center had a budget of about $6 million in 2004, with about 16% coming from pharmaceutical companies. This means that the center received close to $1 million from Big Pharma in that year alone.

In addition, the panel chair does consulting work for pharmaceutical companies, for which his annual income is between $10,000 and $40,000.

To top it off, his position as chair for the treatment of tobacco dependence at his university was endowed by none other than GlaxoSmithKline, which produces a range of smoking cessation products, including Zyban, Commit, NicoDerm CQ, and Nicorette. It is unclear how much money GlaxoSmithKline provided for this endowed chair position, but the panel chair disclosed that he has "access to up to $50,000 per year" - which is the "revenue generated from the investment on the initial grant."

If the pharmaceutical companies - or any companies - endowed a position for me, giving me access to up to $50,000 per year, paid me between $10,000 and $40,000 per year in consulting fees, and provided research funding to the tune of up to $1 million per year to my institution, I would gladly develop national guidelines that called for the use of those companies' products.

If it were the pharmaceutical companies who were paying, I would gladly make pharmaceutical treatment of nicotine dependence the cornerstone of my national smoking cessation action plan and my clinical practice guidelines. I would happily throw the most successful quitting strategy - cold turkey - to the wind and call for "free FDA-approved pharmacotherapy" for all smokers who seek help from the national quitline and to opine that a "key feature of a quitline is having counselors who are trained to work with smokers to establish a detailed quitting plan, including the provision of specific advice on the types of medication that are most appropriate for the smoker in making the quit attempt."

That leaves no room for even considering the idea that quitting cold turkey might be the best approach for an individual smoker, and it also assures a continued stream of pharmaceutical funding to my institution by incentivizing the pharmaceutical companies to compete vigorously to be sure that their products are the ones recommended by the national quitline.

Yes - I do think it is unethical and irresponsible to have individuals with these kind of ties to the pharmaceutical companies sitting on, or worse - chairing - national panels of experts to make recommendations and develop guidelines for national policy on smoking cessation.

This really makes a farce of the whole process of providing a so-called independent and entirely science-based and objective review of the evidence and formulation of the most sound and appropriate recommendations. So I renew and strengthen my call for the retraction of both the clinical practice guideline and the national smoking cessation action plan. I think both need to be re-developed by panels whose members and chair do not have severe financial conflicts of interest.

I don't know if this type of thing goes on with other clinical and public health recommendations, but if it does, the problem needs to be addressed. Would we really want researchers with strong financial ties to Big Pharma making national decisions regarding the appropriate treatment for various medical problems? If someone is going to recommend that all patients in the country take a particular drug for a particular problem, I want that recommendation to be based on the most objective review of the science, not based on a financial conflict of interest because the panelists making the recommendation were receiving consulting fees from pharmaceutical companies.

Of course, the most basic element of protecting the public from the effects of these types of financial conflicts of interest is disclosure of the conflicts. Unfortunately, my review of the panel chair's center website suggests that the ties of the center to Big Pharma are not prominently disclosed. If this observation is correct, I think this failure is unethical.

Please correct me if I'm wrong, but it appears to me that the financial ties to the pharmaceutical companies are not disclosed on the main web site pages: you have to actually go and read the center's annual report(s) to find out that it receives major funding from pharmaceutical companies.

For example, the 2005 annual report does disclose that the center received $400,000 from Big Pharma in 2005. The 2004 annual report discloses $1 million of pharmaceutical company funding.

But on the main pages, and in particular, the About Us pages, this funding does not appear to be disclosed (see About Us 1; About Us 2; About Us 3; About Us 4; About Us 5). In fact, on the main About Us page, it states: "Through its federal and foundation grants and its clinical trials, the Center has brought more than $30.4 million into the state of Wisconsin from outside sources." Nothing is disclosed about pharmaceutical company funding - only federal and foundation grants are mentioned. It mentions the clinical trials but doesn't disclose that at least some of these are being funded by pharmaceutical companies.

I find this very problematic, especially since at least a part of the role of the website is to play some role in the potential recruitment of human subjects who may take part in a pharmaceutical company-sponsored clinical trial.

I could be wrong, and maybe I'm missing something (and let me know if I am), but I can't seem to find any prominent disclosure of the financial conflict of interest - the funding of the center, in part, by pharmaceutical companies. It is not the case that the center is completely failing to disclose the funding - it is openly acknowledged in the annual reports - but I question how many website readers are going to go to the trouble of opening the annual reports and reading the financial disclosures at the end.

The rest of the story is that the tobacco control movement appears to be plagued by a severe financial conflict of interest problem. I do not think that we as a movement have done enough to guard against financial conflicts caused by pharmaceutical company funding of tobacco control research, and more importantly - the development of tobacco control guidelines, recommendations, and strategies. I do not even think that we are doing what we should be doing in terms of the disclosure of these conflicts of interest.

This wouldn't necessarily be as much of a problem if it weren't a fact that we as a movement spend a lot of our time complaining about tobacco industry-related conflicts of interest and that we skewer any individual who so much as accepts a free lunch from the tobacco companies. If we want to retain credibility in attacking those with tobacco industry ties and the role of tobacco company funding of research and influence on policy, then we need to clean our own house first.

Wednesday, January 24, 2007

NIH Cancels Meeting Because of Researchers' Conflicts of Interest; Same Policy Should Apply to Smoking Cessation Panels

According to an article in Friday's Wall Street Journal, the National Institutes of Health has canceled a meeting of a panel of experts to discuss approaches to treating pregnant women and babies with herpes infection and to draft guidelines because of concerns of financial conflicts of interest among several of the panel members (see Armstrong D. NIH cancels meeting on herpes. The Wall Street Journal, January 19, 2007, section B, page 2).

It turns out that several of these physicians were paid consultants or speakers for GlaxoSmithKline, which manufactures a herpes drug - Valtrex. Treatment of pregnant women with Valtrex to prevent herpes infection of the newborn is a controversial issue.

Apparently, the concern was that the financial conflict of interest would preclude the panel experts from developing, in a purely scientific and unbiased way, recommendations for the most appropriate approach to prevent herpes infection in the newborn. These researchers potentially stand to benefit financially from the increased use of Valtrex, and this was apparently deemed to be inappropriate for their participation on this panel which would be developing guidelines to be followed by medical practitioners throughout the country.

The Rest of the Story

In 2000, the U.S. Public Health Service put out a clinical practice guideline for treating tobacco use and dependence (encouraging and promoting smoking cessation among smoking patients). According to the introduction of the guidelines: "The panel employed an explicit, science-based methodology and expert clinical judgment to develop recommendations on the treatment of tobacco use and dependence."

The guideline demonstrates an obsession with the use of pharmaceutical products to treat smoking cessation. In fact, it goes so far as to demand the use of nicotine replacement therapy or other pharmaceuticals with every patient who the physician is helping to quit smoking. The idea of quitting cold turkey, long the mainstay of successful smoking cessation, is completely dismissed.

At the end of the guideline, after the summary, the text, the references, and the glossary, is a biography of each of the panel members. Nowhere in these biographies is it mentioned that there is any financial conflict of interest for any of the panel members.

It is only if you read all the way to the 3rd appendix that you find out the following shocking revelations:
  • the chair of the panel which developed the guideline is a pharmaceutical collaborator, consultant, and grant recipient. Dr. Michael Fiore, the panel chair, collaborated with Glaxo Wellcome and received research funding from Glaxo at the time the CPG was released in 2000.
  • In addition, as of 2001, Dr. Fiore had "served as a consultant for, given lectures sponsored by, or ... conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, Pharmacia, and Glaxo Wellcome."
  • 11 of the 18 panel members who developed the guideline acknowledged financial relationships with one or more pharmaceutical companies (see page 173 and 174 of the guideline).
  • Three out of the five project consultants had financial relationships with Big Pharma.
  • To make matters even worse, one of the peer reviewers of the report was the head of Psychiatry Clinical Development at Glaxo Wellcome (see page 159).
In other words, the head of the panel that produced this clinical practice guideline as well as 10 of the other 17 members had an extensive financial interest in the pharmaceutical industry and between them, they had in fact a financial relationship with most, if not all, of the pharmaceutical companies that manufacture drugs whose use is recommended in the guideline.

Thus, the guideline is anything but an independent review of the evidence and an objective assessment of the most effective approaches to smoking cessation in the population. It is a strategy that was put together largely by individuals with a vested financial interest in promoting pharmacotherapeutic treatment (and not cold-turkey treatment) of smoking cessation.

In my view, this is irresponsible and unethical public policy. You simply cannot allow these kinds of financial conflicts of interest to enter into the promulgation of national medical and public health policy recommendations.

Just as the NIH has canceled the panel meeting of the herpes experts who have a financial conflict of interest because they receive or have received money from the manufacturer of a herpes treatment drug, the Public Health Service should have canceled the meeting of this panel of so-called independent experts who used nothing but so-called expert clinical judgment.

In fact, I would go so far as to say that the guideline itself should be retracted and a new panel, consisting of experts without a financial conflict of interest, should be assembled to consider the issue in an unbiased and impartial way.

And I think the same thing is true of the National Action Plan for Tobacco Cessation that was developed by a panel of experts in 2003. These recommendations are also guided by an obsessive focus on pharmaceutical treatment.

And it is no surprise. If you read beyond the text of the plan and go all the way past the references to the appendices at the end, you'll note the following conflicts of interest:

"Dr. Fiore [the Chair of the panel] has served as a consultant, given lectures sponsored by, or has conducted research sponsored by GlaxoSmithKline, Pharmacia, Pfizer, and Sanofi-Synthelabo. In 1998, the University of Wisconsin (UW) appointed Dr. Fiore to a named Chair, made possible by an unrestricted gift to UW from GlaxoWellcome."

"Dr. Richling has received honoraria for speaking engagements from Pfizer and Merck. On February 1, 2003, Dr. Richling joined the Midwest Business Group on Health as COO. The following organizations are members of this organization: Abbott Laboratories; AstraZeneca; Aventis; Bristol-Myers Squibb; Genentech; GlaxoSmithKline; Lilly; Pfizer; Pharmacia; Roche; and Schering-Plough."

In my opinion, these financial conflicts of interest are so egregious for panel members who are supposed to be objectively developing a national smoking cessation strategy that the entire recommendation is thrown into question. I think it should be retracted and a new, truly independent panel be convened to consider the issue.

The NIH is wise to cancel this meeting of experts, who were to develop national guidelines, in the presence of panel members with substantial financial conflicts of interest. But those of us in the tobacco control movement need to learn something from this. We need to follow suit. Smoking cessation treatment guidelines and national cessation strategy guidelines need to be developed by experts who are not conflicted because of financial relationships with Big Pharma. It's time to throw out the bath water completely and start over with a new baby.

Tuesday, January 23, 2007

Boston Globe Notes My Disagreement With Conclusion that Marlboro Nicotine Yields Have Steadily Increased Over the Past Nine Years

An article in today's Boston Globe notes the results of my analysis, which showed that contrary to widespread media reports and statements by a number of anti-smoking groups, nicotine yields of Marlboro cigarettes did not steadily increase from 1997 through 2006.

I'm glad that the Globe was willing to share my perspective, because I think it's important for the public to see the rest of the story.

IN MY VIEW: The Big Hoax - Rising Nicotine Levels as a Reason for the Proposed FDA Tobacco Legislation

It truly is one of the biggest hoaxes I've seen in a long time. Talk about pulling the wool over people's eyes.

The Campaign for Tobacco-Free Kids (TFK) is using the Harvard report that shows increases in the nicotine yields of cigarettes over the past 8 or 9 years as supporting documentation that Congress must enact the TFK-supported FDA tobacco legislation that stalled during the past two sessions, but which has been given new life with the change in Congressional leadership.

The Campaign argues that because tobacco companies are "secretly" and deliberately manipulating nicotine levels, Congress must enact legislation so that FDA can regulate the constituents of tobacco products. The implication is that if only the TFK-supported FDA legislation were enacted, the problem of nicotine addiction would be over. In fact, TFK states as much: "The proposed legislation would grant the FDA the authority and resources to stop harmful tobacco company practices that continue to addict children."

The Rest of the Story

The chief "tobacco company practice" that continues to addict children is the addition of nicotine to cigarettes (or more properly, the failure to refrain from adding back the nicotine after it is extracted). Clearly, the Campaign is implying that if the FDA legislation is enacted, the FDA will be able to get rid of the nicotine from cigarettes so that the companies can no longer continue to addict our children.

There's just one problem with this.

The legislation that TFK supported during the past two sessions of Congress would have specifically precluded the FDA from eliminating nicotine from cigarettes.

So this turns out to be yet another example of blowing smoke. It is talking out of one side of your mouth but acting out of the other side.

On the one hand, TFK gives the public this great sound bite about how terrible it is that cigarette companies are manipulating nicotine levels and how we need the FDA tobacco legislation to stop this manipulation and to stop the addiction of our kids.

On the other hand, TFK is supporting legislation and failing to disclose to the public that the legislation does not allow the FDA to do precisely what TFK implies is the problem for which FDA regulation is needed in the first place.

Now it is possible that TFK is demanding that Senator Kennedy remove the clause from the legislation which ties FDA's hands in terms of getting rid of the nicotine, but I highly doubt it. Why? Because doing so would result in the loss of Philip Morris' support for the legislation. And I believe that TFK is more interested in getting something enacted so that they can put a feather in their cap than in making sure that legislation that is enacted does not grant special protections to the tobacco industry - protections that are not granted to any other industry regulated by the FDA.

In calling for legislation that allows the FDA to regulate tobacco products in much the same way as FDA regulates food and drugs, anti-smoking groups are full of it. The proposed legislation does not give FDA authority that is at all similar to the authority it has over food or drugs. Neither of those product manufacturers are granted special protections that tie FDA's hands in terms of the actions that it can take.

I'm not arguing here that FDA should have the same authority over tobacco products that it has over food and drugs; I'm just saying that we should call a spade a spade and not deceive the public into thinking that this is the case.

I also want to point out that attacking the cigarette companies because they "manipulate" nicotine levels is a little ridiculous. There is no way that the cigarette companies can not manipulate nicotine levels. Whatever level of nicotine they choose to put in their cigarettes is in their control. By definition, they have to manipulate the level of nicotine.

So while attacking the cigarette companies for manipulating the nicotine levels in their cigarettes creates a good sound bite, it has little meaning. There is no way that can fail to manipulate the nicotine levels.

Finally, I have to admit that from a public health policy standpoint, I fail to see what all the fuss is that anti-smoking groups are making about this nicotine report. The nicotine levels in cigarette have increased slightly. So what?

I really mean that: So what?

I simply fail to see what the significance is of the rising nicotine yields in terms of public health policy.

The implication of attacking companies for increasing nicotine levels is that if nicotine levels were falling, it would be a good thing. But lowering nicotine levels would be a public health disaster. Because of the well-recognized phenomenon of compensation, where smokers adjust their inhalation and consumption to maintain consistent nicotine dosage, any major decline in nicotine levels will result in increased cigarette consumption. If tar levels remain the same, then tar delivery will increase, resulting in a rise in lung cancer, other cancers, and chronic debilitating lung disease.

We don't want nicotine levels to decline.

In some ways, rising nicotine levels is the next best thing to eliminating the nicotine, which so far no U.S. public health group has called for. Assuming that there is no similar increase in tar levels, higher nicotine yields could actually lower cigarette consumption, which would lower tar delivery.

I have to admit that all of the brouhaha that anti-smoking groups are creating over the rising nicotine yields has me a bit mystified. It is as if the groups are simply looking for anything to make news and any excuse to attack the cigarette companies. But it is coming at the expense of focusing the public's attention on an issue that has little meaning, and perhaps even has the opposite meaning of what people are being led to believe.

Ultimately, I find the framing of this issue by the anti-smoking groups to be not only very deceptive, but very damaging. It undermines the real public health policy issues that we need to consider. It suggests the opposite of what could be a solution, or at least an effective response, to the problem.

The saddest realization for me is the apparent lack of sincerity of the major anti-smoking groups. It baffles me how an organization that is supposed to be protecting the health of kids can come out and spout lots of propaganda about how rising nicotine levels are terrible and therefore we need to enact the FDA legislation, but in the back rooms, they have negotiated a bill that does exactly the opposite: precludes the FDA from actually dealing with the problem in a definitive way.

I feel that this is a case where the health of our nation's children have truly been sold out to protect the profits of the tobacco companies.

Don't get me wrong. I'm not necessarily arguing that we should eliminate nicotine from cigarettes. I don't know that it would be a viable solution at this time. But if we're not prepared to do that, then let's cut the crap about how we're going to give FDA the power to stop the terrible, secret manipulation of nicotine that is addicting our kids. That's not going to end any time soon. And it won't end any time at all if the Campaign for Tobacco-Free Kids has its way.

Monday, January 22, 2007

Analysis Shows No Increase in Nicotine Yields of Marlboro Cigarettes from 1997-2006; Widespread Media Reports Have Given a Misleading Picture

According to a new report released this Thursday by the Harvard School of Public Health, cigarette companies - including Philip Morris - steadily increased the nicotine yield of their cigarettes - including Marlboro - during the period 1997-2005. The report describes the increase as being a total of 11% over the seven-year period 1998-2005, or an average increase of 1.6% each year during that period.

According to the report, Marlboro brands "showed a significant increase in smoke nicotine yield." During the overall study period of 1997-2005, the report estimates the increase to be 0.019 mg per year. The report concludes that there has been a "statistically significant trend in increased smoke nicotine yield of 0.019 mg per cigarette (1.1%) per year from 1997-2005 as measured by a smoking machine under the MA method." This trend was said to hold for all market categories, and in particular, for the most popular cigarette brand - Marlboro: "The present analysis of the leading U.S. brand family, Marlboro, demonstrates a significant increase in smoke nicotine yield, contradicting the PM USA claims."

Philip Morris has taken issue with the study's conclusions, arguing that there was no increase in the nicotine yield of Marlboro cigarettes between 1997 and 2006 and that there are no consistent trends indicating an increase in these yields over time, although there are random fluctuations over the time period.

The report has received extensive media coverage, with headlines across the country informing the public that there has been a large, significant, and steady increase in nicotine yields over the recent eight-year time period.

For example, a New York Times article reported that: "A Harvard study concluding that cigarette makers have for years deliberately increased nicotine levels in cigarettes to make them more addictive led to renewed calls Thursday for greater federal oversight of the industry."

Major anti-smoking groups also hailed the study and told the public that it shows the need for FDA regulation of tobacco products. The Campaign for Tobacco-Free Kids (TFK) issued a press release stating that: "The Harvard study uses sophisticated methods of analysis and also includes data from 1997 and 2005, demonstrating conclusively that there is a clear upward trend in the levels of nicotine found in Marlboro."

TFK used the study results to call for passage of legislation that would grant the Food and Drug Administration (FDA) authority to regulate tobacco products: "A new study released today by the Harvard School of Public Health shows the critical need for Congress to enact legislation granting the U.S. Food and Drug Administration (FDA) authority over tobacco products. The Harvard study expands on and confirms an August 2006 study released by the Massachusetts Department of Public Health that found that tobacco companies have deliberately increased the levels of nicotine in cigarette smoke since 1998. The FDA legislation would require tobacco companies to disclose to the FDA changes in their products and provide FDA the authority to require them to reduce levels of constituents, like nicotine that make them more harmful or more addictive. ... The fact that the tobacco companies have been able to secretly increase nicotine levels in tobacco smoke occurred only because no federal or state agency currently has regulatory authority over cigarettes or what tobacco companies put in cigarettes. ... The proposed legislation would grant the FDA the authority and resources to stop harmful tobacco company practices that continue to addict children... ."

The American Legacy Foundation, one of the funders of the study, issued a press release stating that: "These data from Harvard University are an expanded study of findings first released in August of last year by the Massachusetts Department of Public Health. Both studies show that nicotine levels in seven brand families -- including Marlboro, Newport and Camel cigarettes -- have increased significantly between 1997 and 2005."

The Rest of the Story

The steady and significant increase in nicotine yields of Marlboro cigarettes over the past eight years or so sounds like a concerning finding. It sounds like Philip Morris is secretly and deceptively increasing the nicotine yields of its leading cigarette - Marlboro - and apparently, lying about it (since they deny the allegations of the report), all in an effort to increase the addictive potential of their cigarettes, and as a result of all of this, harming the public's health in a way that demands passage of the Campaign for Tobacco-Free Kids' FDA tobacco legislation that it has been promoting for the past two years.

At least this is what the major anti-smoking groups want the public to think.

There are, however, a number of major problems with this.

First, and most significant, is the fact that the major allegation of the report - that there has been a steady increase in nicotine yield of Marlboro cigarettes since 1997 and that Philip Morris is wrong to deny that - appears to be inaccurate.

Given the discrepancy between what the newspapers are all saying and what Philip Morris is claiming, I saw only one way for me to resolve the issue for myself: and that is to obtain the data and analyze it for myself.

Using the data on nicotine yields of Marlboro cigarettes provided by Philip Morris to the Massachusetts Department of Public Health (MDPH) for the years 1997 through 2006, I conducted my own analysis of the trends in Marlboro nicotine yields. During this time period, there were 16 Marlboro sub-brands whose nicotine yields were reported to MDPH each year. I assembled a complete panel of data that included the nicotine yields of each of these 16 Marlboro sub-brands for the period 1997-2006.

Before getting to the details of the analysis, take these two pieces of data and see what conclusion you would come to yourself:

Average nicotine yield of all 16 Marlboro sub-brands in 1997: 1.81 mg
Average nicotine yield of all 16 Marlboro sub-brands in 2006: 1.81 mg

To get right down to it, then, the rest of the story is that there was no change in the average nicotine yield of Marlboro cigarettes from 1997 to 2006.

Or to say it another way: the average nicotine yield of Marlboro cigarettes in 2006 was exactly the same as in 1997, nine years earlier (at least to two decimal points).

Even if one examines the average nicotine yield of Marlboro cigarettes in 2005, there still was very little change from 1997 to 2005: a slight increase from 1.81 mg to 1.85 mg. That represents an increase of just 2.2% over an eight-year period, which (if one assumes a steady linear increase) corresponds to an annual increase of just 0.3% per year, or 0.005 mg per year. This is about one-fourth of the increase that is described for Marlboro in the report.

If you examine the data in more detail, you can see that the assumption that there has been an increasing linear trend in Marlboro nicotine yields over the past 8 or 9 years appears to be unclear. Instead, it appears that there was a small increase from 1997 to 2003, and then a small decrease from 2003 to 2006 (the average nicotine yields by year, starting in 1997, are: 1.81 mg, 1.74, 1.83, 1.85, 1.84, 1.89, 1.93, 1.87, 1.85, 1.81).

If you model the Marlboro nicotine yield trend as a steady, linear increase, you do get a pattern of an overall increasing trend, with an increase of 0.008 mg per year. However, one can more accurately model the data as showing two lines: first, a line with increasing from 1997 to 2003; and second, a line with decreasing slope from 2003 to 2006. If one does this, there appears to be a 0.024 mg per year increase in nicotine yield between 1997 and 2003 and a 0.038 mg per year decrease between 2003 and 2006.

While it is not clear whether these trends reflect an actual intention to increase nicotine yields of Marlboro sub-brands from 1997 to 2003 and then decrease the yields in the past three years or whether this is random variation over time, what is clear is that there is no steady increase in the nicotine yields of Marlboro cigarettes as a group.

If one examines trends by Marlboro sub-brand, there are a total of only 4 sub-brands (out of the 16) which had higher nicotine yields in 2006 than 1997 (to one decimal point). There are 5 sub-brands which had lower nicotine yields in 2006 than 1997 (to one decimal point). The other 7 sub-brands had essentially no change between 1997 and 2006.

My analysis applies only to Marlboro cigarettes and thus I am not commenting on the conclusions regarding the trends in nicotine yields of other cigarette brands. But it does appear clear that with regard to Marlboro, there has certainly not been a steady, significant, and substantial increase in nicotine yields over the past 9 years.

Moreover, examining the data for one other Philip Morris brand - Basic - in a similar manner, one finds a very similar result: there was an increase in nicotine yields from 1998 to 2004, but a decrease from 2004 to 2006, such that over the entire period 1998 to 2006, the average nicotine yield actually fell slightly.

It appears that the Campaign for Tobacco-Free Kids was wrong in stating that the data demonstrate "conclusively that there is a clear upward trend in the levels of nicotine found in Marlboro." Going from 1.81 mg to 1.81 mg is hardly a clear upward trend.

The American Legacy Foundation was also apparently wrong in telling the public that nicotine levels in Marlboro "have increased significantly between 1997 and 2005."

Anti-smoking groups appear to have been too hasty in jumping upon the conclusions of the report and disseminating the findings to the media before all the conclusions were carefully evaluated and scrutinized, especially using the most recent data (from 2006) that are publicly and easily available.

In its haste to use these findings to support the need for FDA tobacco legislation, the Campaign for Tobacco-Free Kids has told us that it is the increase in nicotine levels that presents the critical need to pass this legislation. Now that it is clear that nicotine yields in Marlboro cigarettes are not on the rise, but are in fact decreasing, will the Campaign now agree that the legislation is no longer needed?

Beyond the fact that the data do not demonstrate an increase in nicotine yields for Marlboro, there are a number of other problems with the conclusions that anti-smoking groups are drawing and disseminating to the public regarding this issue.

For one, even if there had been an increase in nicotine yields in (Marlboro) cigarettes, this does not necessarily mean that the public's health is harmed. It is well documented that smokers compensate in response to changes in nicotine yields to maintain exposure to a relatively constant nicotine dose. This is why "light" cigarettes are not safer products. While the nicotine levels are lower, smokers compensate by simply smoking more; this negates the potential benefits of reduced nicotine and tar levels.

In a similar way, smokers might be expected to compensate by smoking slightly less if nicotine yields increase. This could actually have a marginally positive health benefit if it reduces overall cigarette consumption.

In fact, the report acknowledges this important point: "The increase in smoke nicotine yield does not necessarily signify any change in exposure within the population of smokers, particularly as human smoking behavior is compensatory and will adjust for differences in smoke yield."

If the increase in smoke nicotine yield (assuming it were a real and sustained increase over time) doesn't necessarily indicate any change in exposure among smokers, then what exactly is the significance of these findings? How do the findings indicate any net public health detriment from the changing nicotine yields?

If anything, the way this issue is being presented to the public by anti-smoking groups could actually harm efforts to protect the public's health. By focusing on increases in nicotine yields as if they are necessarily harmful to public health, anti-smoking groups are implying that decreases in nicotine yields would be a good thing. But the truth is that reduced nicotine yields could be harmful to public health because they would likely increase cigarette consumption (due to compensation), leading to increased tar delivery and higher rates of lung and other cancers as well as chronic lung disease.

Another problem with the way the information is being presented to the public by anti-smoking groups is the implication that the tobacco companies are doing something wrong if they are increasing nicotine yields (assuming, again, then this were true, which is no longer clear - it's clearly not true for Marlboro and Basic). This implies that if the companies were decreasing nicotine yields, they would be doing something good. But because of compensation, as discussed above, a decline in nicotine yields could be devastating to the public's health. It is just not accurate to present the issue in a way that equates nicotine yields with harm to the public's health.

Yet another problem I have with the reporting of this story by anti-smoking groups is the implication that tobacco companies should not be controlling the levels of nicotine in their cigarettes and that there is something illegal or wrong with them doing so.

There is nothing illegal about the nicotine in cigarettes, nor is there anything wrong with manipulating nicotine yields. What is wrong, if anything, is the fact that cigarettes are made to be an addictive product by the failure to remove the nicotine. Whether the average nicotine yields in cigarettes are 1.9 mg or 1.7 mg, cigarettes are still addictive. If we're going to allow the companies to market an addictive product, I frankly don't see any difference between a product that delivers an average of 1.9 mg of nicotine versus 1.7 mg. And if we're going to allow nicotine in cigarettes, then what is wrong with cigarette companies controlling the amount of nicotine in the product.

The companies are truly in a catch-22 situation. If they increase the nicotine levels, anti-smoking advocates lambast them for trying to addict people. If they decrease the nicotine levels, then we lambast them for misleading people about the public health benefit of the altered product and for causing cigarette consumption to increase. I guess the only way companies could avoid being lambasted is to maintain nicotine levels at exactly the same level - but then they'd be attacked for maintaining levels of addiction in the population.

The point is that if anti-smoking advocates are disturbed by the addictiveness of cigarettes, then there's only one thing that can be done - and that's to require the elimination of the nicotine. Short of that, there's nothing that can be done. At least not anything beneficial. Requiring reductions in nicotine levels would be the worst thing we could do, because cigarette consumption would rise due to compensation, causing increased tar delivery and increased disease and death.

This brings us to our final point. The Campaign for Tobacco-Free Kids is, in my view, full of crap in proclaiming how the supposedly increasing nicotine yields demand FDA tobacco legislation to be enacted. The truth is that the legislation that TFK has promoted during the last two legislative sessions would have specifically precluded the FDA from eliminating the nicotine in cigarettes. Any effort to make cigarettes a non-addictive product by removing the nicotine would have certainly been tied up by lawsuits claiming that this provision in the legislation precludes any such action (which I believe it does).

If the supposedly rising nicotine yields in cigarettes should cause TFK to do anything, it would be to force TFK to withdraw its support for the current form of the legislation, which specifically does not allow FDA to eliminate the nicotine from cigarettes.

I'm not necessarily calling for the elimination of nicotine from cigarettes here. What I am saying is that if anti-smoking groups are going to complain about the nicotine levels and lambast the tobacco companies for manipulating these levels, then they should be calling for the elimination of the nicotine. That's the only way to address the problem. If they are not willing to do that, then they should shut up already. Their support for legislation that precludes FDA from addressing the problem is appalling given the public statements that these groups are making about how awful it is that cigarettes are addictive and that cigarette companies control nicotine levels and that they have been (supposedly) increasing nicotine levels steadily over the past eight years.

Finally, TFK's assertion that tobacco companies have been able to "secretly" increase nicotine levels is absurd. Those (supposed) increases were headlines in the New York Times. They were reported publicly. How secret is that?

This story has a number of important lessons for the public. For one, it shows how careful one has to be in blindly accepting what is reported to you by the media. It shows the importance for careful scrutiny, review, and analysis of information before it is necessarily accepted as being accurate. It also demonstrates how biased the anti-smoking movement and its groups are: how they jump without haste into attacking tobacco companies for wrongdoing before there is an adequate basis upon which to do so.

The rest of the story is that at least for the leading cigarette brand in the United States, there has not been a steady increase in nicotine yields over the past 8 or 9 years as widely reported by anti-smoking groups to the media. As 1.81 mg is not higher than 1.81 mg, the conclusions that were widely disseminated by anti-smoking groups to the media concerning increases in nicotine yields for Marlboro cigarettes were incorrect.

Unfortunately for the anti-smoking movement, this is going to be an embarrassment, because it represents an instance in which Philip Morris was clearly correct, and the anti-smoking groups were wrong.

Sometimes when you are too hasty in attacking the enemy, it comes back to haunt you. My calls for being more careful in drawing our scientific and policy conclusions and attacking others in the tobacco control movement ought to be considered more seriously. If they are not, this is exactly the kind of unfortunate outcome that can occur.

Saturday, January 20, 2007

Newspaper Editorial Supports Smoking Bans in Homes; As Car Smoking Bans Spread, Concern Over Intrusion into the Home Should Jolt Anti-Smoking Groups

An editorial in yesterday's The Journal News (lower Hudson Valley, New York State) supports the idea of banning smoking in the home when children are present.

The editorial, written in response to the recent proliferation of laws banning smoking in cars with children present, supports those laws. But it goes further, stating that extending these bans into the home is also justified. Car smoking bans are seen as a good first step, but the ultimate step is clearly expressed as banning smoking in homes with children.

According to the editorial: "Starting today, residents of Bangor, Maine, can be stopped and ticketed for smoking in their vehicles if children are with them. Another case of a nanny state run amok? Not when the party gaining protection is kids - beneficiaries often unable to stick up for themselves.The Rockland County Board of Health wants the county to join the fledgling movement to ban smoking in motor vehicles when children under 18 are present. It seems a no-brainer to protect minors, for whom tobacco is off-limits anyway, from the damaging effects of second-hand smoke - especially as the kids sit in a car, often with little ventilation, as non-thinking adults puff away. In fact, it makes sense to protect all New York kids, not just Rockland's. ...

Second-hand smoke exposure precipitously raises kids' risk of diseases such as bronchitis, pneumonia and asthma. In children, these can kill - making second-hand smoke akin to child abuse. ...

While the home has always enjoyed special protection from government intrusion - police can't enter without a warrant or exigent circumstances - we see little justification for making the family room a sanctuary for those thoughtless enough to poison their kids with tobacco smoke. In any case, the family car is a fitting start."

A smoking ban in cars when children are present was enacted earlier this week in Bangor, Maine. Similar statewide bans are in place in Arkansas and Louisiana, and are currently under consideration in Connecticut, Maine, California, and New Jersey.

The Rest of the Story

The one good thing that can be said about this editorial is that at least it presents a consistent argument. Unlike the proponents of car smoking bans in Bangor and elsewhere, the editorial board is not just talking the talk about protecting children but failing to actually put its actions where its mouth is. The newspaper is taking a strong position in favor of protecting children from exposure to secondhand smoke, and that exposure does not start and end in the family car. The home is a more important source of exposure, as the duration of that exposure is much higher than in a car.

The problem is that the policy the newspaper is supporting represents an unwarranted intrusion into the private home. In an era when the government has apparently been wire-tapping private citizens, we need to draw a firm line to protect citizens from government intrusion into their homes -- particularly, when it comes to merely protecting citizens from an increased risk of disease.

Before going any further, I should make it clear that there are legitimate justifications for government intrusion into the private home. Specifically, there are two.

One is to protect people from immediate, severe, and direct harm. We do intrude into the private home to protect people from physical and sexual abuse. Children, in particular, need and deserve this protection.

But there is a difference between risk and harm, and it is critical for anti-smoking advocates to understand that distinction. Physical and sexual abuse results in direct, immediate, and severe harm to children. It is not merely a question of increasing the risk for some illness or disease. It is an issue of direct harm.

Once we start intruding into the private home to protect children from merely the increased risk of illness, we have crossed a line that should not be crossed. That would open the door to regulating all kinds of risks to which parents expose their children. That justification for intervening to protect kids from secondhand smoke would also justify laws that prohibit parents from taking their kids to fast food restaurants, serving them food with trans-fats, not forcing them to get sufficient physical activity, not putting sunscreen on their kids, allowing their kids to ride heelies, allowing their kids to drive, serving alcohol to their own kids, or using wood-burning stoves in the house when children are present.

The second justification for government intrusion into the home is to prevent the risk of immediate death from life-threatening emergencies, particularly fires. So we have requirements regarding fire safety -- such as requiring smoke detectors, electrical inspections, proper ventilation of wood-burning appliances, etc. These are deemed necessary because failure to take these precautions can lead to immediate death.

Such is not the case with secondhand smoke exposure.

What the Journal News does not appear to understand - and this is critical - is that secondhand smoke is not akin to child abuse because it usually does not involve harm; it merely involves increased risk of illness. Child abuse is behavior that immediately, directly, and severely harms children. Behaviors that merely put kids at increased risk of disease - such as feeding them fast food or exposing them to smoke from wood-burning stoves - do not represent child abuse.

These behaviors might be viewed as stupid, unfair, uncompassionate, and irresponsible, but they are not child abuse. I'm not saying that we should view them this way; I'm just pointing out that however anti-smoking advocates do view these behaviors, they are wrong in equating or comparing smoking around kids to abusing them.

It seems to me that there are two possibilities to explain the proliferation of proposals to ban smoking in cars with children, and both are equally troubling.

First, it could be that anti-smoking groups are just disturbed by the exposure of kids to smoke in cars (which they should be) and want to get rid of it, but they have no intention of promoting banning smoking in homes. If this is the case, then they are being inconsistent in their arguments. They are passing feel-good laws that do little to really protect kids from secondhand smoke exposure but allow them to think that (and say that) they are doing something for the kids. They are taking a troubling step by accepting that the government can interfere with parental autonomy and individual privacy by regulating parental behavior that merely puts their kids at increased risk of disease, but then failing to act to protect kids where the exposure actually causes disease: in the home. The sincerity of our desire to protect kids then really comes into question.

Second, it could be that anti-smoking groups are promoting smoking bans in cars merely as a stepping stone to home smoking bans. If that is the case, then the anti-smoking movement is at least consistent and sincere in its desire to protect kids, but it is willing to cross the line into regulating private behavior in the home to merely reduce the risk of illness. That is a dangerous concept. We don't want to go there.

(Thanks to JustTheFacts for the tip).

Friday, January 19, 2007

Bangor Car Smoking Ban Proponents Tout New Law As Placing Health of Kids Above Bad Habits of their Parents and Concerns for Civil Liberties

Proponents of Bangor's recently enacted ban on smoking in cars with children present are preparing to publicize the new law, and are touting its placement of the health of kids above the smoking habit of their parents and above concerns over erosion of civil liberties.

According to a Bangor Daily News article: "Thanks to an anonymously funded 10-day radio campaign that will begin this week, few area residents will be able to claim ignorance of a new citywide ban on smoking in vehicles when a child is present. ... According to Elinor Goldberg, executive director of the nonprofit Maine Children’s Alliance, an anonymous donor recently contributed $2,000 to pay for a radio campaign designed to alert people about the new ordinance. ... Goldberg acknowledged that many people object to the new ban as an erosion of civil liberties, but likened the initiative to measures that protect children against physical abuse at the hands of their parents. 'This isn’t about civil liberties at all,' she said. 'It’s about protecting children’s health.'"

"Larry Julius, market manager for Clear Channel Communications in Bangor, said two paid advertisements will start airing Friday, the day the smoking ban takes effect. ... 'I have been a supporter of this initiative from the beginning, and I am very proud to be part of a community where the health of its kids doesn’t take a back seat to the bad habits of their parents,' he said."

Supporters of a proposed car smoking ban in Rockland County, New York expressed similar arguments. According to an article in The Journal News: "Add automobiles to the growing list of places where smokers might soon be banned from lighting up.The Rockland County Board of Health adopted a resolution yesterday recommending that the county 'study the possibility of prohibiting smoking in automobiles when children under the age of 18 are present.' 'It makes a great deal of sense to prohibit smoking in cars,' said Dr. Jeffrey Oppenheim, a neurosurgeon and the member of the board who proposed the ban. 'Children don't have a choice when someone lights a cigarette in a car with closed windows.'"

The Campaign for Tobacco-Free Kids expressed support for the proposed measure, stating (according to the article): "The evidence that secondhand smoke is harmful to children is so overwhelming that it trumps all other arguments."

The Rest of the Story

As well-intentioned as the proponents of these smoking bans might be, I'm afraid that their arguments leave a lot to be desired.

A law that bans smoking in cars with children present but allows smoking in homes with children present does not place the health of children above the smoking habit of their parents, nor does it put children's health above the protection of civil liberties.

If the Maine Children's Alliance were correct that: "This isn’t about civil liberties at all. It’s about protecting children’s health," then the Bangor City Council would have (and should have) banned smoking in the presence of children - period. Banning smoking in the very limited time that children are traveling in a car, but allowing it for the hours upon hours that children are in the home makes no public health sense at all, and it certainly doesn't cast the issue as not being about civil liberties.

If Bangor were truly "a community where the health of its kids doesn’t take a back seat to the bad habits of their parents," then it would have (and should have) banned smoking in homes when children are present.

Bangor clearly did let "the health of its kids take a back seat to the bad habits of their parents."

If the evidence that secondhand smoke is harmful to children "trumps all other arguments," then why isn't the Campaign for Tobacco-Free Kids calling for legislation that bans smoking around children - in the home as well as in cars?

I hate to have to say this, but this is really crap. The evidence that secondhand smoke is harmful to children does not trump all other arguments. If it did, then we should simply ban all smoking in the presence of children. Any organization that truly believes that the evidence that secondhand smoke is harmful to kids trumps all other arguments but does not call on smoking bans in the home with children is talking out of both sides of its mouth (something that is not new for the Campaign for Tobacco-Free Kids).

Obviously, I am not arguing here that smoking should be banned in homes with children. It shouldn't. What I am pointing out is that the arguments being used to support car smoking bans to protect children's health are faulty. It is a lot of rhetoric, but very little substance.

I understand that there are anti-smoking groups which support car smoking bans in order to protect children from secondhand smoke exposure in cars. They are entitled to support such proposals. But don't give me all this crap about how such policies put the health of children above all other arguments. They don't. If you really want to talk that talk, then put up or shut up. Put up by calling on smoking bans in the home. Otherwise, cut out all the rhetoric about not letting the health of kids take a back seat to the habits of their parents.

Of course you're letting the health of kids take a back seat to the habits of their parents. Of course you're letting other arguments take precedence over the health effects of secondhand smoke on kids. Of course you're putting civil liberties above protection of children's health. You're doing all of these things because you apparently recognize that banning smoking in the home is not a justified intrusion into parental autonomy and individual freedom and privacy.

I, of course, would argue that the same concerns about intruding into parental autonomy and individual freedom and privacy hold for the car as well as the home. Others may somehow disagree and argue that there is a difference between a private car and a private home. I don't see the difference, but someone could advance the argument. But don't try to make people think that you are putting kids' health above all other concerns. You're not. In fact, you're ignoring the larger and more important concern - smoking in the home - and merely feeling good about yourselves by addressing a concern - smoking in cars - that creates merely transient exposure. The exposure in homes is far greater in duration and therefore far more significant than exposure in cars.

If you're not willing to walk the walk, then please don't talk the talk.