Recently a study
was published in the Milbank Quarterly analyzing the voting patterns of FDA
Advisory Committee members with apparent conflicts of interest. Since I would
have to pay to actually get access to the full article, in my retired state I
relied on the abstract and on a very useful New
York Times article by Aaron Carroll for my blog today. The author, Genevieve Pham-Kanter, analyzed
the voting patterns of almost 400 FDA advisory committee members between 1997
and 2011. This involved almost 16,000 votes in almost 400 different advisory
committee meetings. Some 13% of committee members reported a financial
relationship with the sponsor who was the subject of the committee meeting.
These members could be divided into two classes; one class had multiple
financial relationships with multiple companies while the second had an
exclusive relationship with the company in question.
Overall, on average, committee
members, conflicted or not, voted in favor of the sponsor 52% of the time. When there was a conflict, they voted in
favor 63% of the time. But on a closer parsing of the data, Pham-Kanter showed
that those advisors who had multiple relationships that included competitors of
the sponsor were no more likely to vote in favor of the sponsor than advisors
without any conflict. Only advisors who had an exclusive relationship with the
sponsor were more likely to vote for the sponsor – at an astounding frequency
of 84%.
One of my many complaints about
the FDA is their inability to get competent advice in the context of their
labyrinthine rules on conflict of interest.
So I was astounded that Pham-Kanter could identify so many conflicted
committee members who were voting. It is also obvious, and should have been
intuitively obvious, that advisors who have essentially an exclusive
relationship with the sponsor would be more biased than those who consult for
multiple companies including the sponsor of a particular drug.
The take-home lesson to me is that
experts are actually experts. Those that
are in demand by multiple companies for help in analyzing or developing their
products are more likely to be the kind of experts the FDA is seeking and less
likely to let their financial and other relationships with sponsors get in the
way of their expertise. This is a little
bit the opposite of what the author of the New York Times article
concludes. Aaron Carroll suggests that
any taint of conflict is by definition bias.
But that is not at all what is demonstrated by the study he is quoting.
As I look over the many advisory
committees on anti-infectives that I attended over many years, I am struck by
the lack of true clinical trial expertise of the advisors chosen by the
FDA. This is because those folks are
mostly working in industry or have worked in industry and therefore, according to
the FDA, are forever conflicted. The current roster
(August this year) once again shows a list of academic experts and one person
from the Gates Foundation. The only
industry person, as is always (appropriately) the case, does not vote. But what would be wrong with getting some
ex-industry people? Are we worried
because they might still have stock options or are receiving retirement pay? How about some ex- or even current
consultants to industry who work with multiple clients? The FDA still desperately needs competent
outside advice. In my view, for
antibiotics especially, they don’t get it.
No comments:
Post a Comment