By TIM THORNBERRY
Kentucky Correspondent

WASHINGTON, D.C. — As the first year has passed after federal legislation gave the U.S. Food and Drug Administration (FDA) regulatory power over tobacco products, at least one group has voiced concern over the make up of an advisory committee created as part of the new law.

Americans for Limited Government (ALG) President Bill Wilson sent a letter to FDA Commissioner Margaret Hamburg calling for the agency to “reconsider” the members of the Tobacco Products Scientific Advisory Committee (TPSAC). The group was created to provide advice, information and recommendations to the commissioner on health and other issues relating to tobacco products. In the letter, Wilson claimed “nearly a majority of the TPSAC voting members have received payments from special interests with billions of dollars riding on the outcome of the committee’s analysis.” He also asked that those members in question either be dismissed or be required to abstain from issues “affecting their own financial interests.”

The letter specifically mentions those the ALG considers to have a conflict of interest and why, when it comes to serving on the panel. They include: “Jack Henningfeld, a voting member of the committee who is a consultant to GlaxoSmithKline, the maker of Nicorette gum; Neil L. Benowitz was (a) Pfizer consultant, which makes the drug Chantix that aids people who want to quit smoking.

“Benowitz has also worked for GlaxoSmithKline and Nabi Pharmaceuticals; Dorothy Hatsukami, who received grant support from Nabi Pharmaceuticals to study their nicotine vaccine; and the head of the TPSAC, Jonathan Samet, who also received grants from GlaxoSmithKline, and the organization he headed was funded by two different pharmaceutical companies.”

The letter also mentioned the possibility of these members voting on whether to ban menthol in cigarettes as a specific conflict. Part of the original legislation called for an end to flavored cigarettes.

Richard Manning, communications director for ALG, said if a panel like this is to exist it should be fair.

“Let’s make sure it’s people whose predisposition isn’t just that if they had their way they would ban the product altogether,” he said. “When the legislation was created to set up this panel, it was supposed to be people who are neutral on the issues.”

The FDA did not return calls for this story but the agency’s website contains information from a TPSAC meeting held July 15-16, where the issue of menthol in cigarettes was to be discussed.

In the published remarks made by Joshua M. Sharfstein, M.D, the principal deputy commissioner, he addressed this conflict issue, first mentioning the members in question by name, noting their expertise in their respective areas and how honored the agency was to have all of the members serving.

Sharfstein also told the members in the event the panel discussed issues that presented any kind of conflict, such as financial interests, those members would be asked to recuse themselves from the meeting.

“According to our law and regulations, when specific products come under discussion, we consider appearances that may arise from personal and business relationships in accord with the standards of ethical conduct for all government employees,” the remarks noted.

“With the guidance of ethics staff, we then determine whether an appearance concern outweighs the value of your contribution to a particular meeting. When such issues arise, we may ask additional questions of you or ask you to step back from meetings.”

The ALG had expressed its concerns to the FDA earlier this year to no avail. The letter from Wilson went on: “These committee members – with clear conflicts of interest – may vote to ban menthol in cigarettes, creating a huge new market for products like nicotine chewing gum and nicotine patches, the very same products the committee members were paid millions of dollars to help develop for the companies.

“The committee could even recommend the government spend taxpayer dollars to buy these products, resulting in billions of dollars in wasteful, corporate welfare.”

Manning said the job members are supposed to be doing is to determine whether adding menthol to cigarettes has specific health harm and should be banned based on health reasons. “Instead, what they are doing is basically putting a bunch of people (who have) a vested interest in seeing tobacco eliminated,” he said.

Manning also said ALG is not so much taking a position on the tobacco issue as taking a position on the “stacking” of the committee to obtain a political outcome that may or may not be the one which should be taken.