Healthy Skepticism Library item: 900

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Publication type: news

Gooznews .
Crawford's pledge
GoozNews 2005 Mar 19

Full text:

Acting Food and Drug Administration commissioner Lester Crawford made
several pledges Thursday during his confirmation hearing. Since the
hearing received only minor news coverage (thanks to the over-hyped
baseball steroid hearings), it’s worth highlighting one his promises
because we’ll get a chance in the next few weeks to see how seriously
he takes reform.

According to the Wall Street Journal, Crawford pledged to revamp the
agency’s process for disclosing conflicts of interest among members of
its advisory committees. A spokesperson later amplified his comment.
The FDA is “reviewing ways to make our current process for providing
disclosures more transparent and readily available to the public,” she
said.

Sen. Ted Kennedy (D-Mass) raised the issue after a dozen public
interest groups sent a letter to Crawford demanding changes in the
advisory committee process. At the mid-February hearing on the safety
of COX-2 painkillers, at least ten committee members had direct ties to
either Pfizer, Merck or Novartis, which make drugs in that class. Had
their votes been excluded, at least two of the three Cox-2 drugs on the
market would have received a thumbs-down vote.

The promise of greater and more timely disclosure by itself doesn’t
meet the demands of the public interest groups. Their letter demanded
that all future advisory committees exclude outsiders with direct ties
to manufacturers whose products are being discussed at the meeting (the
FDA almost always follows the advice of its outside advisory
committees). The letter also demanded that the number of scientists on
a committee with any ties to industry never exceed half.

The groups then went on to seek process reforms, asking for greater
disclosure and a 30-day comment period on any panel’s make-up. At
present, the FDA usually announces its panels the day before the
meeting and often leaves the public in the dark on advisers’ corporate
ties. It was these latter process reforms that Crawford presumably was
addressing in his response to Kennedy.

April will provide the public with ample opportunity to judge how
seriously the FDA takes this issue. Its Cardiology and Renal Drugs
Advisory committee meets April 5th to discuss expanding the labeling
for Norvasc, Pfizer’s calcium channel blocker for hypertension that is
already the third largest selling drug in America. Pfizer, the world’s
largest drug company, spreads tons of research dollars around and
employs dozens of leading cardiologists as part-time consultants and
speakers. Indeed, the chairman of the standing committee is Dr. Steven
Nissen of the Cleveland Clinic, who just published a Pfizer-funded
study praising Norvasc.

The FDA will have to reach beyond the usual suspects if it doesn’t want
more bad publicity about conflicts of interest on its advisory panels.
It can be done. There are thousands of cardiologists in this country,
including hundreds who teach at the nation’s 125 medical schools.
Surely the agency can find advisers who know the science, have the
skills to interpret clinical trial data and aren’t on Pfizer’s payroll.
It will be interesting to see if they try.

A second opportunity comes the following week when the FDA’s General
and Plastic Surgery Devices advisory committee meets to evaluate the
safety of silicon gel breast implants. This touchy field is filled with
conflicting science claims and protracted litigation, which makes it
all the more important that scientists and surgeons with ties to the
manufacturers keep their hands off.