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?

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