On Monday, the group Citizens for Responsibility and Ethics in Washington (CREW) - which focuses on government ethics and accountability - wrote to the Inspector General of the Department of Health and Human Services, urging him to investigate the participation of Dr. Jack Henningfield and Dr. Neal Benowitz on the FDA Tobacco Products Scientific Advisory Committee. The letter cites the financial conflicts of interest of Drs. Henningfield and Benowitz, who have both received money from pharmaceutical companies that make smoking cessation products.
According to the letter, Henningfield and Benowitz have "received millions of dollars in grants from pharmaceutical companies that stand to profit from decisions made by the committee. Specifically, Drs. Neal Benowitz and Jack Henningfield have received money from companies that actively market products designed to help people quit smoking."
According to CREW: "the business interests of two members of the panel, Dr. Neal L. Benowitz and Dr. Jack L. Henningfield create significant conflicts of interest. As a result, CREW requests that the Office of the Inspector General investigate to determine whether these conflicts should disqualify them from serving on the TPSAC [Tobacco Products Scientific Advisory Committee]."
Specifically, CREW notes that "Dr. Benowitz has served as a paid consultant for pharmaceutical companies, including Pfizer, GlaxoSmithKline, Novartis and Aradigm, assisting with the design, development, and marketing of smoking cessation products. ... Dr. Henningfield serves as a paid consultant for pharmaceutical companies seeking approval of smoking cessation products. The firm [Pinney Associates] has received over $2 million a year from pharmaceutical companies, over half of which is directly attributable to its work on smoking cessation products. Finally, Dr. Henningfield is a partner in a company that holds at least one patent for a nicotine replacement product -- a potential nicotine-gum delivery system -- and he has estimated that if he is successful in licensing this patent, it may be worth over a million dollars to him as a partner in that company."
The letter notes that the FDA has been widely criticized for allowing scientific panelists with conflicts of interests, but that the Agency responded by issuing new policies. However, CREW says, the appointments of Dr. Benowitz and Dr. Henningfield do not follow these policies. CREW writes: "In the wake of these systemic problems, the FDA issued new transparency and public disclosure policies for advisory committees in August 2008. ... Beyond these policies, the Federal Advisory Committee Act (FACA), under which the TPSAC was formed, mandates that any advisory committee put in place 'appropriate provisions to assure that the advice and recommendations of the advisory committee will not be inappropriately influenced by the appointing authority or any special interest...' ... The FDA's selection of membership in the TPSAC does not follow these legal mandates and the FDA's implementing guidance."
While CREW is only asking for an investigation, it makes it very clear that it believes the Inspector General should disqualify Drs. Benowitz and Henningfield from participation on the TPSAC: "Drs. Benowitz and Henningfield have clear financial conflicts of interest as defined by statute and FDA guidance. As outlined above, both stand to receive direct financial benefits from teh TPSAC's recommendations on smoking cessation products. ... Their outside financial interests will be directly and predictably affected by the recommendations from TPSAC on particular matters within its assigned jurisdiction. These conflicts unquestionably disqualify Drs. Benowitz and Henningfield from serving as members of the TPSAC."
The CREW letter follows a similar request to the FDA from Philip Morris to reconsider the appointment of Drs. Benowitz and Henningfield to the TPSAC because of their Big Pharma financial ties. In its response denying that request, the FDA fails to even acknowledge the financial conflicts of interest with Big Pharma and fails to explain whether it had determined that the conflicts of interest with pharmaceutical companies were non-disqualifying.
According to an article in the New York Times, Dr. Benowitz fails to even see any conflict of interest. He is quoted as stating: "I really don’t see any conflict. My involvement with pharmaceutical companies is aimed at reducing the risk of smoking, quitting smoking. The aim of the committee is also to reduce the adverse health consequences of tobacco use."
CREW was disappointed that FDA failed to directly address the pharmaceutical conflict of interest issue, stating: "We just thought the financial conflicts were clear. The FDA has not explained how these are unavoidable conflicts."
The Rest of the Story
The financial conflicts of interest that are the subject of Monday's letter from CREW were first highlighted here at The Rest of the Story on March 1 and March 2, as soon as the TPSAC membership was announced. I argued that these conflicts were substantial because the TPSAC will be making decisions that directly affect the profitability of pharmaceutical smoking cessation products.
I argued: "Given that the FDA has already been under siege for complaints about the undue influence of politics over science, due to the influence of industry, it is unclear why the Agency would want to compound the problem by crafting a highly conflicted panel to advise it on tobacco issues. There is enough bias in this field to begin with; we don't need to add to it by appointing a panel with numerous members who have severe, personal financial conflicts of interest."
"The rest of the story is that by virtue of its appointment of numerous members with financial conflicts of interest with Big Pharma, the FDA Tobacco Products Scientific Advisory Committee has now become a literal extension of pharmaceutical company financial interests. These companies have been given the gift of a seat at the table (actually, four seats). The ... pharmaceutical industr[y] must be laughing all the way to the bank. There's nothing like sitting on the panel of the Agency that regulates your products or makes decisions about the regulation of the products of your chief competitors."
It seems to me that two things are indisputable in this case. First, there is no question that there is a financial conflict of interest. Both Dr. Benowitz and Dr. Henningfield have significant financial interests in pharmaceutical companies that manufacture smoking cessation products whose profitability will be directly impacted by the decisions of the TPSAC about how to regulate the potential competitors to these products.
Second, there is no question that the products the TPSAC will be advising the FDA about how to regulate include direct competitors to the smoking cessation products made by these pharmaceutical companies. For example, products like electronic cigarettes (which could well fall under the jurisdiction of the FDA tobacco law, and therefore, the TPSAC), are potentially fierce competitors of pharmaceutical smoking cessation products. If electronic cigarettes prove to be effective, they could put a huge dent in the market share of pharmaceutical products and could irreversibly alter the profitability of those products.
Thus, I fail to see how one can credibly argue that there is no financial conflict of interest here or that the conflict is not relevant to the subject matter that will be considered by the Advisory Committee.
At best, the FDA could argue that there is a relevant conflict of interest, but that the Agency has carefully considered it and decided that it need not disqualify the pharmaceutical consultants from participation on the panel. Obviously, I wouldn't agree with such reasoning; however, it is imperative that the FDA directly address the issue.
I agree with CREW that the FDA's response so far has been inadequate. It can't simply ignore the conflict and pretend that it doesn't exist. It must directly answer the question: "Given this clear conflict of interest, how can the continued participation of these two pharmaceutical consultants on the advisory committee be justified?"
Perhaps most troublesome is the response of Dr. Benowitz that he fails to see any conflict of interest. If that is the case, then the conflict is even more worrisome. Conflicts of interest that are out in the open can at least be managed. But when the consultant doesn't even acknowledge that there is a conflict, then that signals trouble. You can't manage something when you're not even aware of it, and don't even acknowledge that it exists.
In light of the rest of the story, I believe that Drs. Benowitz and Henningfield should voluntarily step down from their seats on the TPSAC panel and allow the FDA to appoint two unconflicted scientists to serve.