Wednesday, February 14, 2007

IN MY VIEW: New Study Shows that FDA Tobacco Legislation Would Set Up System of Government-Sponsored Fraud

In her final opinion in the DOJ tobacco lawsuit against the tobacco companies, Judge Gladys Kessler ruled that the defendants had engaged in fraud by marketing cigarettes that rated lower yields via machine testing in a way that falsely led consumers to believe that these products offered a health benefit over higher machine-yield products.

A major part of the basis for this decision was a body of literature demonstrating that machine-yields of nicotine and other tobacco constituents have no direct relationship with actual human exposure, and thus with actual health risk, either on an individual or a population level. Machine yields, for example, do not adequately account for changes in human smoking behavior (e.g., compensation) which accompany any change in the yields of cigarettes.

A report released yesterday by the journal Tobacco Control and written by a group of tobacco control experts confirmed not only that machine-measured toxin yield information is virtually meaningless, but that newer advances in the way in which these yields are measured - which attempt to more closely simulate actual smoking behavior - are inadequate, and even these new methods do not yield information that is of any consumer value.

"Although each of the testing regimes will help to "characterise" how a product performs under a given set of smoking conditions, none of the smoking regimes "represent" human behaviour in terms of compensatory smoking and none is likely to produce emissions that will be markedly associated with human exposure or risk, either for individual smokers or for population-level differences between brands." ...

"After nearly 40 years—and after great cost to public health—the public health community is now coming around to the realisation that lower ISO emission cigarettes are not lower-risk products. Unfortunately, many regulators fail to understand the distinction between "product characterisation" and predicting human exposure. At the same time as they insist that cigarette emissions are not measures of risk, various regulators continue to use cigarette emissions in ways that assume a link between the machine emissions and human exposure. Many jurisdictions continue to require that quantitative levels of tar, nicotine and carbon monoxide appear on packages. These numbers continue to be misunderstood and misused by smokers, including smokers in the most affluent and highly educated countries in the world. To date, there is no evidence that quantitative emissions constitute effective consumer information, and several scientific bodies have rightly called for the removal of these emissions from packages. ... the tobacco industry should be prohibited from using machine emissions in any of its labelling, advertising or marketing directed at consumers, even if accompanied by "warnings" or disclaimers, such as those that currently appear in the US and Europe." ...

"patterns of use must be examined to understand the interaction between product design and smoking behaviour in humans, and to identify systematic differences across products. Products that deliver fewer toxins for a fixed volume of smoke and also promote greater smoke intake when used by consumers are not lower-risk products. Likewise, products that deliver higher amounts of toxins, but discourage repeated use might potentially be seen as harm reducing compared with conventional cigarettes."

At the same time as tobacco control experts were concluding that regulation of machine-measured cigarette constituent emissions was of no public health value and would actually be deceptive to the public, a prominent tobacco control group - the Campaign for Tobacco-Free Kids - was pushing for FDA legislation that would regulate cigarettes primarily by giving the FDA the authority to limit the machine-measured yields of certain of their constituents.

The Rest of the Story

This is the logic that underlies the thinking of the modern day tobacco control movement? Is this the best that we have to offer?

We know that measurements of the amounts of various constituents in cigarettes have no demonstrable relationship with actual human exposure or with actual human health risk, so we propose a system to regulate the safety of cigarettes that relies upon reducing the measured levels of various smoke constituents. What a brilliant idea!

We attack the tobacco companies for relying upon cigarette constituent measurements in making implied health claims, take them to court, get them convicted for fraud, and then proceed to go ahead and propose to set our own cigarette constituent level regulations, thereby making our own unsubstantiated implied health claims.

Unfortunately, the idea isn't just stupid. It's also damaging. The reason? Because like the machine-measured nicotine yields that we blasted the tobacco companies for relying upon in their communications, these FDA-sanctioned tobacco constituent levels will have no demonstrable relationship to the public's health, yet they will most certainly be interpreted by consumers as conveying an improved degree of safety.

There is no question that by virtue of cigarettes being placed under the regulatory jurisdiction of the FDA and by virtue of FDA promulgating "product safety standards," the public is going to assume that cigarettes have been made to be a safer product. However, those product safety standards are none other than specified reductions in a number of specifically chosen tobacco constituents, whose levels have not been shown to correlate directly with human health risk.

Essentially, what the proposed FDA legislation would do is simply change who is committing the fraud. Right now, it's the cigarette companies doing the dirty work, marketing reduced tar and reduced nicotine cigarettes in a way that deceives consumers into believing that these products are known to be safer. If the FDA legislation is enacted, then it will the government who is doing the dirty work, implying to the public that reduced X and Y cigarettes are known to be safer, when there is absolutely no evidence that such a product would, in fact, be safer.

No wonder why Philip Morris loves this legislation so much. It completely takes away the risk of litigation for fraud, yet allows the tobacco companies to tell consumers that they are complying with stringent product safety standards, assuring a safer product that is produced under the strict scrutiny of the Food and Drug Administration.

This whole thing is a huge hoax in the making.

It has the potential to institutionalize the fraud that the tobacco companies have committed, but to put it into the hands of our own government.

The Tobacco Control review article points out many reasons why regulation of tobacco smoke constituent levels would not necessarily produce a safer product: "not all constituents change to the same extent or even in the same direction under different testing regimes—for example, the NNK and benzo[a]pyrene:nicotine ratios decrease under more intense puffing conditions, whereas the nicotine ratio for carbon monoxide increases, as does the overall tar:nicotine ratio. It is unclear to what extent certain emissions can be reduced independently of others. Manufacturers have also shown their skill in substantially reducing machine emission levels through subtle design changes. Recent evidence from the UK suggests that tobacco manufacturers have adhered to the "10–1–10" limits on ISO emissions simply by increasing the level of filter ventilation so that brands provide deceptively low readings under machine conditions. Filter ventilation is the most prominent, but by no means the only design change available to manipulate yields. ... Emission limits will require considerable resources to implement and monitor, resources that may exceed the current capacity of regulators. There are also concerns that emission limits would exempt tobacco manufacturers from liability. Most important, it is uncertain how consumers will respond to emission regulation. Despite clear scientific statements to the contrary, consumers may interpret emission limits as an indication that cigarettes are less harmful—much in the same way that they have interpreted emission reductions in the past. In fact, future emission limits may be even more likely to undermine perceptions of risk than in the past: "new" emission reductions would be based on a "superior" machine method, would be more comprehensive in scope, and may have the formal endorsement of the [FDA]. ... one can also envision how manufacturers might shape consumer response through packaging and marketing. Overall, regulations that achieve modest reductions in smoke toxicity but result in fewer quitters or more initiators are not effective policy measures."

But the most important reason why the product safety standard approach taken in the proposed FDA legislation is a potential hoax is that there is simply no evidence that cigarettes can be made to be a safer product, in actual human practice, simply by mandating a reduction in levels of specified smoke constituents.

We simply do not know which constituents, at what levels, and in what combination, result in what degree of risk of what diseases that are caused by smoking.

Anyone who promises you that they are going to "save countless lives" via these product safety standards (precisely what the Campaign for Tobacco-Free Kids is telling its constituents) would probably also be effective in selling you a bridge in Brooklyn.

In one respect, the Campaign for Tobacco-Free Kids is precisely correct in stating that this legislation is going to save countless lives. It is so unclear that product safety standards will do anything to reduce overall health risks that it is impossible to count any lives that will be saved. Perhaps that's why the Campaign is having trouble counting them.

By the way, I'm not expecting that the Campaign or any other anti-smoking group would have all the answers to these issues. I don't expect them to be able to solve the problem. What is inexcusable, however, is pretending that they have a solution that is going to protect the public's health and save countless lives when in fact, we don't have a clue that we're going to be able to regulate the product in a way that makes it any safer.

Ultimately, there's only one way that I think even has the potential to be successful in developing safer cigarettes or other tobacco products. And that's to allow the free market system to work. Free market competition could, possibly, result in a race to see which company could come up with safer products. The proposed FDA legislation, however, destroys the possibility of this free market competition by making it impossible for any tobacco company to market a truly reduced risk product. I'll provide more details about this in a subsequent post, but for now, suffice it to say that the legislation would make it virtually impossible to market a reduced risk product. The scientific hurdle that the legislation sets up in the way of marketing a reduced risk product is, in my opinion, insurmountable.

What the bill does, on the other hand, is set up a competition to see who can market a reduced exposure product, which, just like reduced-nicotine or reduced-tar cigarettes, is likely to be just as effective in killing people, but which would most certainly be interpreted by the public as implying a reduced health risk.

Essentially, what the proposed legislation does is set up a system of government-administered public fraud in order to benefit the tobacco companies.

Ironically, but shamefully, if that happens, the groups that you'll have to thank the most are the major anti-smoking groups themselves. The Campaign for Tobacco-Free Kids and Friends are the ones who have joined Philip Morris in promoting the establishment of this system of government-sponsored fraud to once and for all get the tobacco companies off the hook.

Soon, it will be the government that is doing to smokers what the tobacco companies have been doing to them for so many years.

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