Friday, August 08, 2008

FDA Tobacco Legislation Would Be a Death Knell to Reduced Risk Products and Could Cost Countless Lives

According to an August 1 article in the Lexington Herald-Leader, health experts have concluded that the FDA tobacco legislation currently being considered by Congress would put an end to the prospect of the development of truly reduced risk tobacco products because it bans the introduction of such products unless a reduced population-based and individual-based risk can be demonstrated through long-term epidemiologic studies.

According to the article: “Legislation approved by the House on Wednesday to give the Food and Drug Administration regulatory control over tobacco products fails to address the massive market changes of the last decade, growers and others say. Cigarette makers no longer claim nicotine isn't addictive or that their products aren't harmful, and the bill doesn't take that into account. It also doesn't acknowledge scientific advances in the potential for "reduced-harm" products, an advocate said. Scott Ballin, health and tobacco consultant with the Alliance for Health, Economic and Agriculture Development, said lawmakers are ignoring these issues because they complicate the bill. ‘They want to see it in simple terms: Big Tobacco bad, FDA good,’ he said. The bill ‘raises the bar extremely high to ever allow lower-risk products onto the markets,’ Ballin said.”

“While the FDA could demand reduction or elimination of cancer-causing chemicals, manufacturers could not introduce or market lower-risk products without first proving such claims with decades-long population studies, according to a 2007 analysis by the Royal College of Physicians. That won't create much incentive to develop such products, Ballin said.”

The Rest of the Story

These are insightful and important observations about the likely impact of the proposed FDA tobacco legislation.

The key section of the bill is section 911, which sets out the criteria that need to be met before a reduced risk product can be introduced into the marketplace. According to this section:

"the Secretary shall approve an application for a modified risk tobacco product filed under this section only if the Secretary determines that the applicant has demonstrated that such product, as it is actually used by consumers, will--`(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and `(B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

Section 911(g)(1)(A), the (A) clause above places an insurmountable obstacle in the path of approval of modified risk products, at least for a 10-20 year period (which is enough to remove any incentive for companies to pursue such products). In order to demonstrate that the product, as actually used by consumers, will significantly reduce the risk of tobacco-related disease to individual users, large-scale, long-term epidemiologic studies are necessary. Even ignoring the requirement under 911(g)(1)(B), the (B) clause above (which itself appears to introduce an insurmountable obstacle), the bill as currently written precludes any harm reduction approach to tobacco control both by making it impossible for such products to meet the conditions for approval and by eliminating any incentive (especially economic) to develop such products. Thus, the bill may have the exact opposite effect that many believe it should have. It protects the existing high-risk products on the market.

Section 911 creates a literal catch-22 for reduced risk products. In order to introduce such a product into the market, you need to demonstrate that on an individual basis, it will reduce the risk of tobacco-related disease. However, in order to make such a demonstration, one would need to introduce the product into the market and follow a large sample of smokers for a long period of time – at least 10 years, if not longer. Thus, there is realistically no way to get a reduced risk product onto the market.

This legislation is likely to result in increased, not decreased deaths from tobacco products, because it will make it virtually impossible to research, develop, introduce, and market new potentially less hazardous tobacco products. It essentially freezes the market as it is and entrenches existing high-risk products into the market. It puts an end to any meaningful possibility of harm reduction as a tobacco control approach.

In his book “Virtually Safe Cigarettes: Reviving an Opportunity Once Tragically Rejected” (IOS Press, 2000), Dr. Gio Batta Gori (who formerly directed the National Cancer Institute’s Smoking and Health Program) describes research into potential ways to make cigarettes less hazardous. A fair amount of research was conducted on this question by the Smoking and Health Program between 1968 and 1979, but it was disbanded due to a new government policy which rejected this harm reduction approach.

Dr. Gori argues that the research conducted under this program lays the foundation for the potential development of a less hazardous cigarette. Interestingly, the major basis for believing that such a technological achievement is possible is not the belief that by selectively reducing specific components in cigarette smoke and by reducing the nicotine levels in cigarettes, a safer product can be achieved (which is precisely the approach that the FDA legislation takes in its tobacco product standards section). Instead, the basic premise is that by presenting high levels of nicotine and low levels of tar – in other words, increasing the nicotine/tar ratio – overall exposure to tar will be reduced because smokers will need to inhale less to achieve the same inhalation dose of nicotine. A major problem with existing low-yield cigarettes is that smokers increase their consumption and deepen their inhalation to achieve adequate nicotine levels.

Interestingly, the “solution” to the reduced risk cigarette is exactly the opposite of the approach being suggested by most tobacco control advocates and groups, and adopted in the FDA legislation: the reduction of nicotine levels. Instead, the only feasible and effective approach – according to Dr. Gori – is to increase the nicotine levels in combination with a variety of modifications which lower the tar. Gori presents the results of animal testing, for example, which demonstrate that a high-nicotine, high-carbon monoxide cigarette might present the best framework for a reduced risk cigarette.

Unfortunately, the current FDA legislation will not allow the development of a less hazardous cigarette – as Dr. Gori envisions – because it completely removes any incentive for tobacco companies to research and develop such a product. The barrier to introducing a reduced risk product is so great that no company would waste the millions of dollars it would take to develop the product with no meaningful prospect of ever introducing the product into the marketplace.

In my view, the best way to facilitate the development of a reduced risk product is not to regulate cigarettes with insurmountable obstacles, but instead, to allow the free market process to run its natural course. There is such a huge economic incentive for companies to produce a reduced risk product – imagine the number of smokers who would be thrilled to try such a product – that a market competition, a race to be the first to develop a safer cigarette, would take place.

Under the proposed FDA legislation, this market competition cannot and will not take place. And it could cost countless lives.

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