A year ago, when the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) began considering whether to recommend that the FDA ban menthol cigarettes, the FDA knew it had two basic choices:
1) To ban menthol cigarettes; and
2) Not to ban menthol cigarettes.
Now, after a year of time and the expenditure of a huge amount of money (taxpayer money, I might add), after substantial research and analysis, and after meeting after meeting evaluating the policy and scientific issues, the TPSAC final report does little other than to essentially tell the FDA that it has two basic choices:
1) To ban menthol cigarettes; and
2) Not to ban menthol cigarettes.
The report makes no recommendation and doesn't even offer a hint as to which of the two options would be better. It does not put forward a recommendation for either option #1 or option #2. Essentially, the entire report concludes by telling the FDA that it has these two options. But no recommendation is made in terms of which option the FDA should take.
Sorry to break the news to you, but the FDA knew it had these two options a year ago. What the Agency needed was an expert evaluation of the policy and scientific issues, leading to a recommendation of which of the two options it should take.
Can you imagine a similar "recommendation" coming out of an FDA advisory committee charged with evaluating whether the FDA should approve a new drug? Can you imagine such a committee coming out with the following recommendation:
"We recommend that the FDA consider whether to approve this new drug or not."
Thanks, but with advice like that we'd be better off saving the money and simply letting the FDA deliberate the issue itself from the beginning.
The TPSAC simply punted here, making no recommendation and simply pushing the issue back to the Agency. The FDA could not possibly have received anything less helpful than this advice: "You need to study the issue and decide what to do."
Gee, thank you. That really help clarify the situation for us.
The Rest of the Story
Both the conclusions and "recommendations" of the TPSAC report are no-brainers that were readily apparent one year ago without any expenditure of money on research or analysis. Let's break them down one by one and you'll see what I mean:
Conclusion #1: "Menthol cigarettes have an adverse impact on public health in the United States."
Of course menthol cigarettes have an adverse impact on public health in the United States. All cigarettes have an adverse impact on public health in the United States. Had TPSAC concluded that menthol cigarettes do not have an adverse impact on public health in the United States, I would have recommended that the panelists undergo a psychiatric examination. This conclusion is obvious and it didn't take a year of study to derive. We knew this a year ago. It's hard to believe that all of the Committee's research, analysis, and evaluation resulted in this obvious, self-evident conclusion. The taxpayers wasted their money if this was all they got out of the Committee's deliberations.
Conclusion #2: There are no public health benefits of menthol compared to non-menthol cigarettes."
Of course there are no public health benefits of menthol compared to non-menthol cigarettes. We already knew that. Not even the tobacco companies were alleging that menthol cigarettes provide some public health benefit. Once again, if the Committee had concluded that menthol cigarettes provide a public health benefit compared to non-menthol cigarettes, I would have recommended a psychiatric examination for the panelists before they returned home from Washington. Once again, it's hard to believe that all of the Committee's research, analysis, and evaluation resulted in this obvious, self-evident conclusion. The taxpayers wasted their money if this was all they got out of the Committee's deliberations.
"Recommendation" #1: "Removal of menthol cigarettes from the marketplace would benefit public health in the United States."
Apparently, TPSAC does not understand the difference between a recommendation and a conclusion. This is why I put the word "recommendation" in quotation marks.
TPSAC's basic "recommendation" is not a recommendation at all. It is, in fact, a conclusion. By definition, a recommendation is a suggestion or piece of advice. The TPSAC's basic "recommendation" is not a recommendation at all because it doesn't do either. It is a conclusion, devoid of any suggestion or advice.
Stating that the removal of menthol cigarettes would benefit public health doesn't suggest any particular action to the FDA. A recommendation would have looked something like this:
"We recommend that the FDA ban menthol cigarettes."
"We recommend that the FDA not ban menthol cigarettes."
Moreover, even as a conclusion, the statement is self-evident and obvious. Of course banning menthol cigarettes would have a public health benefit. We knew this a year ago. If it didn't have a public health benefit, then why was Lorillard so worried about such a potential decision? Was there ever a doubt that in the face of a ban on menthol cigarettes, some smokers would choose to quit smoking? Of course not. Lorillard certainly knew that. I knew that. And I think the FDA knew that.
In fact, it is specifically because Congress knew that a menthol ban was the one potential policy it might include in the Tobacco Act that would substantially benefit the public's health (a.k.a., decrease tobacco sales) that our politicians chose to exempt menthol in the first place.
We really didn't need a year of research and taxpayer expenditures to tell us what Lorillard told us over a year ago: Of course banning menthol will have a public health benefit. It will decrease cigarette sales because it will lead some smokers to quit. Not all smokers, of course, But some smokers. And it might deter some youth from smoking as well. Not all youth, but some youth. This conclusion was obvious from the start and in fact, it is because of a fear that a menthol ban would actually impact tobacco sales that the health groups (i.e., the Campaign for Tobacco-Free Kids and Friends) did not include such a ban in the legislation in the first place. God forbid the legislation might actually decrease cigarette sales. Then Philip Morris might not support it and the deal would crumble.
Recommendation #2: "TPSAC recommends that FDA consult with appropriate experts and carry out relevant analyses depending on the actions taken in response to this report from TPSAC."
In other words, what this is saying is: "We aren't making any recommendation here about what you should do about menthol, but in case you do decide on your own that you want to consider a menthol ban, then we recommend that you think about it carefully." Extremely helpful to the Agency. I don't think they would have thought about this had TPSAC not pointed it out.
I have to say that this is one of the most stupid processes I have observed in all my years following federal policy making and the result is as meaningless as anything I have witnessed. The report offers absolutely nothing. There is no guidance provided to the Agency. No recommendation is put forward.
The rest of the story is that TPSAC has simply punted the issue back to the FDA. They could have simply told the Agency a year ago: "We punt this back to you. We are not going to make any recommendation anyway, so we're not going to pretend to actually be carrying out a thoughtful analysis. We don't want to waste taxpayer money only to come back to you in a year and say that our conclusion is that you should consider the issues and make a decision on your own."
One of the skills I teach my students is how to write a policy memo. In such a memo, students analyze a public health policy, provide the policy options, evaluate each option, and close by making a recommendation. I have to say that if a student ever handed in a policy memo that looked like the TPSAC report, the student would fail my class. First of all, TPSAC doesn't appear to understand the difference between a conclusion and a recommendation. Second of all, the report doesn't make any recommendation. The whole point of the exercise was to offer some guidance, some suggestion for action. The report fails in that regard. In my class, that results in a failing grade. In the real-life classroom of federal public health policy making, that results in a waste of taxpayer dollars.
ADDENDUM (March 21, 2010 - 9:20 a.m.): It has been pointed out to me that the FDA's Center for Tobacco Products efforts (including expenditures on the TPSAC) are funded not by taxpayers, but by user fees assessed on cigarette companies. For this reason, it is not truly taxpayer money that I feel has been "wasted," but cigarette company user fees. This makes the issue of wasting taxpayer money a non-concern, although I still am troubled by the fact that such an intensive effort yielded, in the end, no actual recommendation for action (or non-action). Thanks to readers for pointing this out to me.