Senator Questions FDA Panelists’ Ties to Industry

An advisory panel’s recommendation that the Food and Drug Administration allow two painkillers to stay on the market despite cardiac risks was marred by its members’ ties to drug makers, a senior lawmaker said Friday.

But two doctors who served on the panel suggested another explanation for close votes on the painkillers Bextra and Vioxx: a difference of perspective between physicians on the committee.

They said that some doctors who had treated arthritis patients wanted to keep open the option of prescribing so-called Cox-2 painkillers as a last resort. Other physicians, primarily concerned with broader questions of patient safety, viewed the risk of heart attacks and strokes as unacceptably high.

Late Friday, Senate Finance Committee Chairman Charles E. Grassley (R-Iowa) sent the FDA a detailed request for information on the industry ties of the 32 advisory panel members. Grassley is pursuing an overhaul of the FDA to strengthen safety monitoring of drugs after they have been approved for sale.

Grassley cited a New York Times report that 10 panel members had done consulting or other work for the companies that made the two drugs. The newspaper’s analysis showed that the votes of these 10 members tipped the balance in favor of allowing Bextra and Vioxx to remain on the market.

The 10 members were not a factor in the case of Celebrex, a third drug in the same family, which received near-unanimous support to remain on the market. During meetings Feb. 16 to 18, the advisory panel also urged much stronger warnings and other restrictions for all three medications.

“Unfortunately, the votes of the joint advisory committee are now, justly or unjustly, tainted,” Grassley wrote.

“The failure to fully disclose that joint advisory committee members had ties to the drug industry sows more seeds of doubt,” he said in the letter.

Because many academic researchers and prominent doctors do consulting work for drug companies, conflicts of interest are a recurring problem for the outside scientific panels that the FDA relies on for key advice.

The 10 panel members with potential conflicts were identified by the Center for Science in the Public Interest, an advocacy group. Two panel members had worked on projects that involved Cox-2 drugs, and others had consulting or speaking arrangements or research financed by the manufacturers of the Cox-2 drugs.

The center’s analysis showed that most of the other panel members also had industry ties, but to different manufacturers.

The FDA said it had screened panel members for conflicts according to “strict ethics guidelines.” An official said several prospective members were disqualified. Those who were approved were deemed to have scientific expertise that outweighed potential conflicts.

On Bextra, arthritis panel members voted 7-0 to allow continued marketing of the drug, while safety panel members voted 7-2 against, with one abstention. On Vioxx, arthritis panel members voted 6-1 to allow a possible return of the drug to the market, while safety panel members split 5-5.

Dr. John Farrar of the University of Pennsylvania, one of the 10 whose ties were questioned, said he had advised the FDA in advance of his relationship to Pfizer, the maker of Celebrex and Bextra. He said the company had funded his study of antiepilepsy drugs.

” I have been paid some money by a number of companies, and I don’t feel like I have a special relationship with any one company,” Farrar said. “I think what is likely to have affected the vote is a difference in perspective between physicians who deal with patients and those who deal primarily with safety issues.”

Dr. Richard Platt of Harvard University Medical School said he also disclosed Pfizer’s financial contribution to a research project he was engaged in. The work involves drug safety but does not include Cox-2 painkillers, he said.

“There were two different conversations going on at that meeting,” said Platt. “One was a very data-driven discussion about risks. Then there was a separate conversation, almost data free, with most of the [arthritis specialists] saying it’s important to have these drugs available for patients who can’t be managed in another way.”

Platt said he decided that on balance, the drugs should remain available with “draconian” restrictions.

“I came down on the side that if patients can’t make it any other way, they should be able to make an informed decision,” said Platt.

The members of the advisory committee were drawn from two other FDA panels, one specializing in arthritis drugs and the other in safety issues. The agency also invited other experts to participate.