In response to the lawsuit brought by R.J. Reynolds and Lorillard against the FDA to prevent it from relying on recommendations from an advisory panel which the tobacco company plaintiffs argue is impermissibly constituted due to the financial conflicts of interest of three panelists with pharmaceutical companies that manufacture smoking cessation drugs, the Campaign for Tobacco-Free Kids has attacked these companies, accusing them of acting the way they have for decades and asserting that the lawsuit is groundless.
The entirety of the Campaign for Tobacco-Free Kids' argument for why the financial conflicts of interest of three advisory committee members is permissible under the law is as follows: "Their lawsuit is groundless. The FDA's Tobacco Products Scientific Advisory Committee was constituted and is acting in accordance with the 2009 law granting the FDA authority over tobacco products, as well as other relevant federal laws."
The Rest of the Story
As usual, the Campaign for Tobacco-Free Kids is issuing propaganda devoid of any solid argumentation. There is a serious issue that needs to be addressed and rather than presenting an argument for why it is permissible to have conflicted panelists on an FDA advisory committee, the Campaign is falling back on its usual rhetoric.
Despite the Campaign for Tobacco-Free Kids' knee-jerk dismissal of the lawsuit, the complaint puts forward a very serious issue: Are we serious about ensuring that federal advisory panels make their recommendations based on an impartial review of the science, rather than under the influence of financial conflicts of interests of the panelists?
In this case, three of the TPSAC members - Drs. Henningfield, Samet, and Benowitz - have severe financial conflicts of interest with Big Pharma. They have served as consultants to, or received funding from, pharmaceutical companies that manufacture smoking cessation drugs. The financial interest of these companies is directly affected by the recommendations that TPSAC is going to put forward on a number of items already on its agenda, including menthol and dissolvable tobacco products.
For example, a menthol ban would be a financial boost for smoking cessation drug companies. As many people affected by the menthol ban would attempt to quit smoking, such a ban would yield a direct financial benefit to companies that manufacture smoking cessation drugs. Thus, it is unacceptable to have panelists who have financial interests in these companies.
Similarly, with dissolvable tobacco products, a ban on these products would be in the best financial interests of pharmaceutical companies that manufacture smoking cessation drugs. As dissolvable tobacco products could serve as a potential competitor (these products could be marketed to help smokers quit using cigarettes), they are a potential threat to smoking cessation drugs. Once again, it is unacceptable to have panelists who have financial interests in these companies.
Rather than directly address this critical issue and explain why it believes that these severe financial conflicts of interest are permissible under the Federal Advisory Committee Act, the Campaign for Tobacco-Free Kids has relied upon its usual propaganda and rhetoric. That rhetoric may have worked years ago, but we are now living in a new era, when (ironically, thanks to the Campaign for Tobacco-Free Kids), tobacco companies are now under federal regulation. And with federal regulation, the law must be obeyed. This is what the Campaign appears to fail to understand. Ironically, this is the Campaign's own doing, as it is the Campaign which promoted the Family Smoking Prevention and Tobacco Control Act in the first place, putting the tobacco companies under federal regulation and thus giving them the protection of the laws that govern federal regulation-making.
The magnitude of the problem is perhaps illustrated best by the fact that GlaxoSmithKline has intervened directly with the FDA, urging the Agency to take dissolvable tobacco products off the market. How then, can the FDA allow a GlaxoSmithKline consultant (Henningfield) to be a part of the decision-making process on whether dissolvable tobacco products will be banned? This is every bit as bad a conflict as having a drug company consultant on an FDA advisory panel that is making a recommendation on the approval of a drug made by that company.