March 04, 2005
FDA on the Hot Seat
I missed posting a GoozNews last week because, to be frank, I was too busy. Between an explosion of activity at the Center for Science in the Public Interest (more on that below), a paid writing gig and two Maasai singer/dancer/warriors staying at our home during their U.S. tour, something had to give.
But the world didn’t stand still. Immediately after the President’s Day holiday, the New York Times called the CSPI Integrity in Science project, which I run, to see if there were conflicts of interest among the 32 panelists who voted to keep the three Cox-2 drugs on the market. Within 24 hours, the two researchers at the project, Simone Baribeau and Christine Ishiwata, turned up at least 10 scientists with direct financial ties to Merck or Pfizer, the manufacturers of the drugs, or to Novartis, which has a Cox-2 in its pipeline.
The resulting front page article last Friday triggered an avalanche of outrage and not just from the usual quarters. Sen. Charles Grassley (R-Iowa), chairman of the Senate Finance Committee, fired off a series of probing questions to the FDA asking why it allowed scientists with conflicts of interest on the panel, which was a direct violation of the Federal Advisory Committee Act. Take their votes away and two of the three drugs would have been voted down.
The FDA’s leadership has a gun pointed at its feet and stuck on automatic. In the wake of the antidepressant and painkiller fiascoes, legislation to create an independent safety arm within the agency is gathering momentum. The understaffed safety department is currently housed within the drug approval wing, thus creating a structural conflict of interest. Will people who approve a drug later listen to underlings who say they made a mistake?
Meanwhile, FDA deputy Sandra Kweder testified on Capitol Hill this week that the agency needs more power to order label changes on drugs when the agency thinks stiffer warnings are warranted. Currently they negotiate with the companies, often leading to long delays before warnings get disseminated. It was a curious statement. Why doesn’t the agency simply say, “Negotiation over. Change the label.” Memo to Kweder: You already have the power. What’s missing is the will to challenge a powerful industry with lots of friends in the White House and on Capitol Hill.
Finally, look for the FDA to come under increasing pressure in the coming weeks to revamp its advisory committee process. The New York Times this morning editorialized that "unless the FDA makes a more aggressive effort to find unbiased experts or medical researchers start severing their ties with the industry, a whiff of bias may taint the verdicts of many advisory panels."
The agency in charge of determining if our food is safe and our drugs are safe and effective needs to “just say no” when it comes to putting industry consultants with direct conflicts of interest on its advisory panels, whose advice the agency invariably follows when approving new products.
It’s a big country. I’m sure they can find qualified scientists who are not on company payrolls. If they stick to the line that they can’t, then perhaps we’ve discovered the reason for high drug prices – every doctor in the country is on the take. The fact is that too many of them are. But many are not, and it’s time the FDA rewards their independence by giving them the coveted slots on its influential advisory panels.