A D.C. District Court judge has invalidated the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) report on menthol because of severe financial conflicts of interest of several of its panel members.
The decision comes in response to a lawsuit brought by Lorillard on two grounds. First, the companies alleged that three TPSAC members (Drs. Benowitz, Henningfield, and Samet) were conflicted
because "they have made tens of thousands of dollars as paid expert
witnesses in litigation against tobacco products manufacturers." Second,
the companies alleged that Drs. Benowitz, Henningfield, and Samet are
conflicted because of "their continuing financial relationships with
pharmaceutical companies that make smoking-cessation products."
As a result of the decision, the FDA will not be able to rely upon the findings and conclusions of the TPSAC menthol report. In addition, the Court instructed the agency to reconstruct TPSAC by replacing any members who have conflicts of interest. Dr. Samet is the only current TPSAC member who appears to be implicated by this instruction.
In October 2011, commenting on Lorillard's lawsuit, I wrote:
"I believe that the second grounds - the existence of severe financial
conflicts of interest by virtue of these panelists financial connections
to pharmaceutical companies that manufacture smoking cessation products
- is entirely compelling. In fact, I revealed these conflicts of
interest and called for the resignation of Drs. Henningfield, Benowitz,
and Samet from the TPSAC panel in the first few days after the TPSAC
members were announced by the FDA."
In fact, I went so far as to call for the removal
of four FDA Tobacco Products Scientific Advisory Committee (TPSAC)
panel members - Dr. Neal Benowitz, Dr. Jack Henningfield, Dr. Dorothy
Hatsukami, and Dr. Jonathan Samet - because they had significant
conflicts of interest with pharmaceutical companies that made it
impossible for them to offer objective advice to the Agency on federal
tobacco regulatory policy matters.
In September 2010, I pointed out specifically that:
"The next major issue that TPSAC will consider (after menthol), in fact,
is dissolvable tobacco products. Now that GlaxoSmithKline has come out
in strong opposition to these products and directly petitioned the FDA
to remove these products from the market, it is not possible for any
TPSAC member who has a financial conflict of interest with Glaxo (or
similar companies that manufacture smoking cessation products) to
impartially participate in discussions on this matter."
The Rest of the Story
As I had suggested in my September 2010 column, Judge Richard Leon's decision was based in large part on his finding that Dr. Benowitz's ongoing conflict of interest with pharmaceutical companies rendered him unable to objectively consider the issue of dissolvable tobacco products (DTPs).
"The FDA erred in concluding that current, ongoing financial relationships with drug manufacturers did not constitute a conflict. Since manufacturers of smoking-cessation drugs compete with manufacturers of DTPs, ... and since Dr. Benowitz stood to profit from the sale of NRT drugs, he faced a conflict with regard to providing advice in the TPSAC's report on DTPs. ... the TPSAC was charged with studying the public health impact of a drug (i.e., DTPs), and Dr. Benowitz had an ongoing business relationship (i.e., consulting work) with companies developing "alternative" or competing drugs (i.e., smoking-cessation drugs). Accordingly, I find that the FDA's conclusion with regard to Dr. Benowitz was a 'clear error of judgment.'"
Judge Leon also found that a similar conflict existed on the menthol issue because a ban on menthol would increase the market for smoking cessation drugs by causing many smokers to want to quit. Thus, having a current financial interest in a pharmaceutical company was a clear conflict of interest.
While I still disagree with Leon's finding that serving as an expert witness is a relevant conflict because I do not see any relevant financial interest in the absence of the pertinence of a matter to a specific legal contract for hire of an expert, I do agree completely with his decision regarding the pharmaceutical conflicts of interest.
Perhaps the most discouraging aspect of the story is that the FDA failed to acknowledge these conflicts of interest. I explained in a previous post why the guidelines used by the FDA to determine eligibility for the TPSAC were inappropriate. Hopefully, this decision - having exposed the ridiculousness of those guidelines - will force the FDA to reformulate the guidelines so that they do actually screen out expert panelists with relevant conflicts of interest.
Will this decision have any impact on the regulation of menthol by the FDA? No. There are plenty of other sources that the agency could rely on for information if it wishes to regulate menthol. The bottom line is that the FDA is not going to ban menthol, with or without the TPSAC report.
The major implication of this decision is that it exposes the degree to which financial conflicts of interest are plaguing the current tobacco control movement. It should force anti-smoking groups and federal agencies to take conflicts of interest more seriously.
For years, the anti-smoking groups and public health agencies have taken tobacco industry conflicts of interest seriously. Now it is time to have some integrity and fairness and to consider all corporate conflicts of interest, whether they involve Big Tobacco or Big Pharma.