Thursday, May 05, 2011

Article in New England Journal of Medicine Criticizes TPSAC for Failing to Recommend Menthol Ban

My perspective article, published yesterday in the New England Journal of Medicine, criticizes the FDA Tobacco Products Scientific Advisory Committee (TPSAC) for failing to recommend a ban on menthol cigarettes, arguing that this was a lost opportunity for public health.

I write: "Although some public health groups hailed as a public health victory the release of a report on menthol cigarettes by the Tobacco Products Scientific Advisory Committee (TPSAC) of the Food and Drug Administration (FDA), close examination of the report and its recommendations reveals that it actually represents a huge victory for Lorillard, the manufacturer of the leading brand of menthol cigarettes (Newport) — and a disappointing setback for the health of black Americans."

The article then points out that "the TPSAC did not recommend a ban on menthol cigarettes. Instead, the report simply stated, “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.” Thus, the committee’s basic “recommendation” is not a recommendation at all, but a conclusion that doesn’t suggest any particular action to the FDA."

I argue that "it is specifically because Congress knew that a menthol ban would substantially benefit the public’s health (by decreasing tobacco sales) that politicians chose to exempt menthol from the Tobacco Act in the first place. It is because a menthol ban would actually reduce tobacco sales that an advocacy group called the Campaign for Tobacco-Free Kids and other health groups supporting the tobacco-regulation legislation ensured that such a ban was not included in it — since it would have risked the loss of Philip Morris’s support for the law and the crumbling of the deal that had been forged with the country’s largest tobacco company. The mandate for the TPSAC to study the menthol issue was actually a compromise forged to appease the Black Congressional Caucus, which vigorously denounced the exclusion of menthol from the bill’s flavoring ban. The Campaign for Tobacco-Free Kids, for its part, opposed an amendment that would have eliminated the menthol exemption, defending that opposition by warning that if menthol were banned, a black market in contraband cigarettes was likely to be created — an argument that had been made vigorously by Lorillard."

Two members of the TPSAC - Dr. Samet and Dr. Benowitz - wrote a corresponding perspective article about the TPSAC menthol report. In it, they argue that: "The TPSAC, a scientific advisory committee, was not charged with addressing regulatory options and did not have the time or expertise to analyze regulatory scenarios, including any involving inadvertently opening a door for the introduction of contraband menthol cigarettes into the U.S. market."

The Rest of the Story

Drs. Samet and Benowitz argue that the TPSAC is a scientific body and is therefore not charged with addressing regulatory options. If every FDA scientific panel made the same argument, there would be no drugs on the market. After all, every FDA scientific panel is charged not simply with examining the science, but with making a recommendation to the agency with respect to policy: namely, whether to approve or disapprove a pharmaceutical company's application for a drug to be placed on the market.

Can you imagine if an FDA scientific advisory panel came back to the agency with a recommendation stating: “This drug treats hypertension and would therefore improve the public’s health, but there are some serious potential side effects that need to be studied.” That gives the agency no guidance in terms of what action to take. The entire point of the advisory panel is to recommend a policy action to the FDA.

Moreover, the argument that TPSAC was not charged with addressing regulatory options flies in the face of its legislative mandate. The Family Smoking Prevention and Tobacco Control Act mandated that the TPSAC issue not only a scientific report, but also a "recommendation" to the FDA regarding the regulation of menthol cigarettes.

Moreover, the Act mandated that TPSAC examine not only the public health impact of menthol cigarettes, but also the potential black market and contraband concerns. The Committee was to weigh these factors in making its recommendation to the Agency.

Here is the text of the Congressionally-mandated charge to TPSAC, in section 907(e) of the Tobacco Control Act:

‘‘(1) REFERRAL; CONSIDERATIONS.—Immediately upon the establishment of the Tobacco Products Scientific Advisory Committee under section 917(a), the Secretary shall refer to the
Committee for report and recommendation, under section 917(c)(4), 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. In its review, the Tobacco Products Scientific Advisory Committee shall address the considerations listed in subsections (a)(3)(B)(i) and (b).
‘‘(2) REPORT AND RECOMMENDATION.—Not later than 1 year after its establishment, the Tobacco Product Scientific Advisory Committee shall submit to the Secretary the report and recommendations required pursuant to paragraph (1).

It should be immediately apparent to readers that TPSAC failed to complete its mandate because it did not issue any "recommendations" to the Agency regarding the regulation of menthol cigarettes. Clearly, the legislation asks the TPSAC to make recommendations to the Agency. If it had required only a scientific report, it would have stated that the Committee issue "a report," not a "report and recommendations." The TPSAC did the former, but not the latter.

What may not be so apparent is that TPSAC was charged not only with examining the public health impact of menthol, but also the black market/contraband concerns. According to the law, TPSAC "shall address" the considerations in subsections (a)(3)(B)(i) and (b). What exactly are these considerations?

The consideration in subsection (a)(3)(B)(i) is simple. It's the public health impact of menthol cigarettes. Specifically: "(i) CONSIDERATIONS.—In making a finding described in subparagraph (A), the Secretary shall consider scientific evidence concerning— (I) the risks and benefits to the population as a whole, including users and nonusers of tobacco products, of the proposed standard; (II) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (III) the increased or decreased likelihood that those who do not use tobacco products will start using such products."

In other words, TPSAC was mandated to consider the effects of a menthol ban on disease risk, smoking initiation and smoking cessation. It did carry out that mandate.

However, TPSAC was also charged with addressing the considerations in section 907(b):

"The Secretary shall consider all other information submitted in connection with a proposed standard, including information concerning the countervailing effects of the tobacco product standard on the health of adolescent tobacco users, adult tobacco users, or nontobacco users, such as the creation of a significant demand for contraband or other tobacco products that do not meet the requirements of this chapter and the significance of such demand."

Thus, the law specifically mandates that TPSAC must consider the potential concerns regarding a black market or contraband in developing its report and recommendations. TPSAC did not carry out this mandate. Instead, it simply punted the issue back to FDA, urging the FDA to conduct the analysis that TPSAC was supposed to conduct.

More importantly, the clear intent of the legislative mandate was that TPSAC weigh the public health benefits of a menthol ban against the black market/contraband concerns and come up with an overall recommendation taking both into account. This is what would have been helpful to the FDA and this is what the law called for.

The rest of the story, then, is that not only did the TPSAC do the public a disservice by wasting all this time studying the issue but failing to make a recommendation. In addition, the TPSAC failed to carry out or fulfill its Congressional mandate.

This is a shame not only because the Committee wasted time and resources. It is a shame because the Committee wasted what could have been an opportunity to promote the one action that the FDA could have taken that would actually have improved the public's health. The Committee, however, was too weak-willed for that. It would have required actually standing up to Big Tobacco.

As I conclude in the article: "At the end of the day, it is difficult to understand the rationale for a policy that bans every other type of cigarette flavoring — including chocolate, strawberry, banana, pineapple, cherry, and kiwi — yet exempts the one flavoring that is actually used extensively by tobacco companies to recruit and maintain smokers, a finding that has been documented extensively by the TPSAC itself. Ironically, it is because removing menthol would actually improve the public’s health by reducing the consumption of cigarettes that we are not going to see such an action from the federal government. There is no political risk in banning chocolate and strawberry cigarettes, since no companies are currently selling such products and they play no role in smoking initiation. Menthol, however, is a major contributor to smoking initiation and continued addiction, and for this reason, it will continue to enjoy the protection of a federal government that seems afraid to alienate any corporation, whether it’s part of Big Pharma, Big Insurance, or Big Tobacco."

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