Wednesday, March 23, 2011

FDA Shadow Panel Issues Statement on TPSAC Menthol Report

This morning, the FDA Shadow Panel issued the following statement on the TPSAC menthol report. The statement appears on the Shadow Panel web site, at:

In summary, the Shadow Panel believes that while the report itself was strong and provided solid scientific evidence of the public health harms caused by menthol cigarettes, the committee itself was weak-willed, as it failed to actually make a recommendation based on its findings. Further, the Shadow Panel believes that this lack of action on the part of TPSAC is exactly what Philip Morris had in mind when it pushed for FDA regulation of tobacco under the Family Smoking Prevention and Tobacco Control Act. The Shadow Panel believes that this is a harbinger of things to come and indicates the ineffectiveness of this law in protecting the public’s health. The Panel urges Congress to consider repealing the Tobacco Act and designing a national tobacco control strategy that not only has some teeth, but which is based on evidence-based methods for reducing tobacco use – methods which will actually save lives.

Shadow Panel Statement on TPSAC Menthol Report

Of Mice and Menthol

A Strong Report, but a Weak-Willed Committee

On June 22, 2009 President Obama signed into law the Family Smoking Prevention and Tobacco Control Act charging the Food and Drug Administration (FDA) with regulation of tobacco products. The Tobacco Control Act provided for creation of a Tobacco Products Scientific Advisory Committee (TPSAC) to advise the FDA. One of the express charges for the TPSAC was to create a "report and recommendation" on "the issue of the impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities."

On June 8, 2010 a panel of experts shadowing the TPSAC (the FDA Tobacco Products Scientific Advisory Shadow Panel) issued a press release calling for "the elimination of the use of menthol in cigarettes." The Shadow Panel's recommendation was based on strong evidence that menthol acts as an anesthetic agent that makes cigarette smoking more appealing by masking the harshness of burning tobacco. Further, that menthol deceives smokers into thinking that cigarettes are less harsh and therefore safer, and that menthol brands are disproportionately targeted at African- Americans.

On March 18, 2011 the TPSAC issued a report entitled, "Menthol Cigarettes and Public Health: Review of the Scientific Evidence and Recommendations.” What follows is the Shadow Panel's review and assessment of the TPSAC report:

For a 231-page report that at first reads more like a legal document than a scientific one, clearly careful to keep every word within its "conceptual framework for cigarette smoking" authorized by Congress, the understated prose packs a wallop. There is surprisingly little arcane methodology or jargon. The notable exception is an appendix consisting of a lengthy series of unexplained complex equations entitled, "Results from a Population Dynamics Model of the Consequences of Menthol Cigarettes for Smoking Prevalence and Disease Risks," apparently calculated to the year 2050).

The report painstakingly defines the parameters of the public health impact of menthol cigarettes its authors sought to ascertain. The committee sought to apply an innovative "systems science" approach, which it describes as consisting of "the factors that drive the tobacco epidemic and resultant disease burden" as well as an assessment of "the potential consequences of tobacco control measures." The result is that no stone has been left unturned, and it is doubtful that a single relevant study on the subject of menthol cigarettes was overlooked.

Any attempt by the tobacco industry or pro-tobacco financial analysts to find fault either with the scientific analysis or the strength of the conclusions will be futile. If anything, the report bends over backwards to acknowledge the input of the tobacco industry and the "non-voting members of the committee," i.e., the representatives from the industry. The report even includes a quotation (page 70) from a submission by Newport maker Lorillard that the company's marketing expenditures have not been disproportionately weighted toward African-American smokers or any other ethnic group or gender. An etymologist might point out that this is technically true only by virtue of the fact that African-Americans are still a minority population. In other words, while the greater part of the advertising budget might not be specifically targeted at African-Americans, the company's spending on Newport is indeed proportionate to the high market share that brand has among African-Americans.

The summary of the evidence for a causal relationship between advertising and promotion of cigarettes and an increase in tobacco use is meticulously presented. The report importantly notes the dramatic increase in retail marketing since the end of billboard and most print advertising under the Master Settlement Agreement, but it fails to put into perspective the relative impact of such point-of-sale expenditures compared to the past century's far more ubiquitous advertising.

The report cites the 1964 Surgeon General's Report on Smoking and Health as the landmark scientific publication in the field of tobacco control. That achievement is all the more remarkable when one considers that the authors of the 1964 report completed the work of reviewing the 11,000 studies to that time on smoking and disease in less than one year, the same length of time it took to write the present report on this single aspect of smoking.

But the present report suggests we have come a long way from the 1964 report (and many subsequent ones by the Surgeon General) that did not even mention cigarette brand names. The strongest and lengthiest part of the report, Chapter 5 on Marketing and Consumer Perception, covers the gamut of product and package design, as well as marketing tactics. A fascinating section on the role of branding and labeling in consumers' taste perception and sensory evaluation cites manufacturers' various uses of the color green and includes this sentence: "Menthol packaging reflects the tobacco industry's knowledge about how color, labeling and other elements of branding will improve the consumer experience of the product's characterizing flavor."

Ultimately, the report's findings are a split decision. On the one hand, the committee did not find that menthol cigarettes increase the risk of disease. But on the other hand, it found that the availability of menthol cigarettes "has led to an increase in the number of smokers and that this increase does have adverse public health impact in the United States." The finding that menthol is associated with lower levels of cessation among African-Americans is compelling, as is the finding of a higher prevalence of menthol cigarette use by the youngest adolescents.

Despite the strength of its conclusion that menthol cigarettes substantially harm the public’s health, the committee fails to recommend a ban on menthol cigarettes. The committee's "recommendation" is printed in boldface on page 208: "Removal of menthol cigarettes from the marketplace would benefit public health in the United States." This, unfortunately, is a conclusion, not a recommendation.

The big mystery and disappointment is why the committee did not recommend the removal of menthol cigarettes from the marketplace. One answer lies in the concerns about a black market for menthol cigarettes and "after market mentholation" (i.e., do-it-yourself menthol kits with roll-your-own cigarettes) acknowledged in the final section of the report. But this is reasoning that puts the cart before the horse. In the end, the committee proved weak-willed.

The devastating impact menthol cigarettes have had on the African-American community should necessitate a greater degree of input of that community in the ultimate decision by the FDA. Upon reading this report, African-American and all anti-tobacco organizations should demand nothing less than the addition of menthol to the list of far less common but already banned candy flavorings.

The action of the TPSAC on menthol was also the first test of how effective the new FDA law will be. The Committee's failure to recommend a ban on menthol cigarettes calls into question the effectiveness of the new law and regulatory process. Not recommending the banning of menthol cigarettes means the current market of mentholated cigarettes continues unchecked. This stark reality stands in contrast to promises that FDA regulation of tobacco would be a panacea for the tobacco pandemic. Clearly, the first important test of this claim has been a failure. Congress and the FDA should revisit the viability of this law, including and up to consideration of repealing the law.

No comments: