Friday, February 02, 2007

IN MY VIEW: Harvard Nicotine Report and Campaign for Tobacco-Free Kids' Response Undermine Government's Case Against Big Tobacco

One of the central contentions of the government's case against the tobacco companies in the RICO lawsuit, which is now under appeal, is that cigarette companies committed fraud by marketing "light" and "low-nicotine" cigarettes with the false implication that these products were somehow safer than full-flavor brands.

In its post-trial brief, the Campaign for Tobacco-Free Kids argues: "the Record also demonstrates that these descriptors [e.g., "lights" and "low-nicotine"] were fraudulent.
As the evidence adduced at trial overwhelmingly shows, the defendants knew and intended that “brand descriptors communicate a less hazardous cigarette than full-flavor brands,” ... the “data that have been used to justify the campaign for low nicotine cigarettes does nothing of the sort”. Therefore, tragically, smokers who switched to light and low tar mistakenly believed that doing so resulted in a real risk reduction of adverse health effects, when in fact, the perceived risk reduction was an “illusion.”"

Now, a new report from Harvard concludes that cigarette companies have been increasing the nicotine yields in cigarettes in order to increase their addiction potential and that this has increased these products' hazard to human health: "In conclusion, according to the HSPH researchers, the extended analysis of MDPH data has demonstrated its potential to reveal undisclosed hazards to human health." In other words, the increased nicotine cigarettes represent a hazard to human health.

The report concluded that "the total nicotine dosing capability, the speed with which nicotine can be delivered and the ease with which nicotine can be extracted are among the determinants of the addiction potential of a cigarette. Higher nicotine content in the tobacco rod increases the potential for smokers to extract more nicotine from the cigarette. Animal and human studies have demonstrated that the development and maintenance of a drug addiction can be facilitated by ease of achieving addictive levels of the drug."

In response to the report, the Campaign for Tobacco-Free Kids issued a press release which stated: "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."

"Manufacturers of food, drugs and even pet foods are required to disclose to the FDA and the public changes in their products in order to protect the public health. Only the tobacco industry is exempt from these basic public health protections. These studies demonstrate that what the tobacco industry knows and what consumers don’t, can kill us."

The clear implication of the Campaign for Tobacco-Free Kids' public statement is that higher nicotine yield cigarettes are more dangerous because they have higher addictive potential. According to the Campaign, reducing levels of constituents like nicotine will make cigarettes less "harmful" or less "addictive." Also, the increased nicotine levels in cigarettes "can kill us." In other words, a higher nicotine yield cigarette is more hazardous.

The Rest of the Story

There is a huge problem with the report and the Campaign for Tobacco-Free Kids' response to it.

If the report and the Campaign for Tobacco-Free Kids are correct in implying that higher machine-measured nicotine yields in cigarettes indicate a more hazardous product in some way, then is it not the case that lower machine-measured nicotine yields in cigarettes indicate a less hazardous product in some way? And if that is true, then is it not also the case that the cigarette companies were not committing fraud by implying to consumers that low-nicotine and "light" cigarettes were, in some way, less hazardous than full-flavor brands?

Unfortunately, the DOJ tobacco litigation is not over. The case is currently under appeal. If I were Philip Morris or other tobacco defendants, I would be using this new information from Harvard and from the Campaign for Tobacco-Free Kids to defend myself before the D.C. Court of Appeals.

I would argue that the report and these statements confirm that in the view of public health researchers and organizations, there is indeed reason to imply that low-nicotine and "light" cigarettes are in some way less hazardous. Therefore, our use of brand descriptors is not fraudulent. Public health researchers and groups themselves have told the public that higher machine-measured nicotine yield products confer an increased hazard to consumers. So how could it be fraudulent for us to make similar implications?

In one sense, it is a good thing that the report and the Campaign's statement did not come out before the trial had concluded. It would have provided strong evidence that the tobacco defendants could have used to support their argument that the use of descriptors like "light" and low-nicotine cigarettes are not fraudulent. After all, what public health researchers and groups are actually saying is that higher machine-measured nicotine yields indicate some degree of increased hazard to human health, whether that be through an increased addiction potential or otherwise.

Even if the only thing we are talking about is addiction potential, and not risk of disease, then the Harvard report and the Campaign's statement still provide enough evidence, I believe, to get the tobacco industry off the hook. Why? Because the addiction potential of cigarette products could reasonably be represented as indicating a measure of the degree of health hazard posed by the product. Is is not true that to some degree, the addictive potential of a cigarette brand indicates its level of safety and hazard to the public? After all, a cigarette with an extremely low addiction potential would clearly represent less potential health hazard to the public, especially to young people, than a cigarette with much higher addiction strength.

Could not the cigarette companies make a reasonable argument, based on the evidence presented by Harvard and the Campaign, that their use of "light" and low-nicotine brand descriptors did accurately imply the brands' levels of hazard to the public in terms of the addiction strength of these brands? After all, "the total nicotine dosing capability, the speed with which nicotine can be delivered and the ease with which nicotine can be extracted are among the determinants of the addiction potential of a cigarette. [Lower] nicotine content in the tobacco rod [decreases] the potential for smokers to extract more nicotine from the cigarette. Animal and human studies have demonstrated that the development and maintenance of a drug addiction can be [hampered] by [difficulty] of achieving addictive levels of the drug."

Sounds like a pretty strong argument to me.

The only way for the government to get out of this predicament would be for it to argue that machine-measured nicotine yields are not indicative of actual population dosage of nicotine among smokers, that machine-measured nicotine yields do not necessarily indicate the addiction potential of a cigarette in actual life (under actual smoking conditions), and that there is therefore no reason to imply that lower machine-measured nicotine yields confer any potential benefit to human health.

In other words, the DOJ would have to argue that the Harvard report is seriously flawed and that the Campaign for Tobacco-Free Kids is spewing forth propaganda that is devoid of any truth. Otherwise, one of the central government claims in the lawsuit falls by the wayside.

The rest of the story is that in apparent zeal to attack the cigarette companies for anything in order to generate publicity - and to promote passage of FDA tobacco legislation - we have shot ourselves in the foot. We have destroyed one of the key arguments upon which the landmark DOJ tobacco case, and its favorable decision, were based.

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