Crawford's pledge

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.

Posted by gooznews at March 19, 2005 10:24 AM