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Critics Fault FDA's Advisory Board Policies

Debate focuses on conflict-of-interest waivers for voting members

WEDNESDAY, July 13, 2005 (HealthDay News) -- In a research climate where important medical advances are often funded by drug companies, it's not surprising that many top experts nominated to FDA advisory panels have financial ties to the industry.

In such instances, FDA officials can issue special "waivers" -- exceptions that allow for committee participation despite a conflict of interest.

In fact, 10 of 32 voting members on two recent panels convened to deliberate the safety of cox-2 inhibitor painkillers received such waivers.

Now, an article in the July 14 issue of the New England Journal of Medicine claims the ease of availability for these waivers may be tainting the FDA's drug-oversight process.

Cases such as the cox-2 committee "raise the general concern that waivers for potential conflicts are common and that the agency has paid insufficient attention to its -- and the public's -- interest in selecting scientific advisers who are independent of industry," concluded article author Dr. Robert Steinbrook, the journal's national correspondent and a former deputy editor.

Not everyone agrees that waivers are cause for worry, however.

"We know that many of the nation's best medical experts have been involved in important cutting-edge research projects funded by companies," said Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, representing the drug industry. "We feel it would be a major loss for FDA advisory panels to lose their expertise, because these people are chosen for a reason: they are very good and they are very smart."

Attempts by HealthDay to reach FDA officials for comment were unsuccessful.

It's important to note that FDA advisory panels do just that -- they advise the agency in its decision-making processes. Usually, but not always, FDA officials follow panel recommendations.

When selecting experts to join these panels, conflicts of interest inevitably arise. By FDA rules, potential panel members must provide full disclosure of any financial ties to industry that might pose a conflict and exclude them from participation. But agency guidelines also allow for waivers when "the need for the individual's services outweighs the potential for a conflict of interest."

The FDA can offer full or "limited" waivers -- the latter allowing the expert to take part in deliberations, but not allowing him or her a vote. Upon issuing a waiver, the agency issues general statements about the nature of the conflict of interest -- this is aimed at providing the public with information while respecting the individual expert's privacy.

Last winter, 32 experts sitting on a joint committee made up of two panels -- the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee -- pored over data on the safety and efficacy of the cox-2 inhibitor painkillers Bextra, Celebrex and Vioxx. According to Steinbrook, 10 of these experts had been issued general waivers allowing them a spot on the panels, despite varying levels of conflict of interest, including drug company funding for research, speaker's fees and the like.

"Of the 30 votes cast by these 10 members on whether [the cox-2s] should continue to be marketed, 28 favored marketing the drugs," Steinbrook noted.

In contrast, "of the 66 votes of the other 22 [conflict-free] members, only 37 favored marketing the drugs," he said.

In February, this joint committee voted that Celebrex and Bextra should stay on the market. They also recommended that Vioxx -- pulled from drug stores in September -- be allowed to return to U.S. pharmacies.

According to Steinbrook's analysis, if the 10 committee members who had received conflict-of-interest waivers had been removed from the process, that vote would have turned out very differently. "The committee would have voted 12 to 8 that valdecoxib [Bextra] should be withdrawn, and 14 to 8 that rofecoxib [Vioxx] should not return to the market," he wrote.

In the end, FDA officials ignored most of the panel's recommendations, anyway -- banning Bextra and keeping Vioxx off drug store shelves.

Steinbrook also cited a second panel recently under fire for conflict-of-interest troubles. In April, the FDA's General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee met to consider the safety and potential approval of various models of silicone gel-filled breast implants made by the companies Inamed and Mentor, both of Santa Barbara, Calif.

According to Steinbrook, the sole plastic surgeon on the 10-member panel "had a major role in the development of an educational CD-ROM about breast reconstructive surgery, a project that received funding from Inamed."

In their decision, the panel members came to a split recommendation -- approval of Mentor's implants, and a "no" vote for those made by Inamed. But the inclusion of a panel member with financial ties to one of the companies raised concerns among critics.

Some members of Congress have latched on to the issue, as well. Rep. Maurice Hinchey (D-N.Y.) this year sponsored a rider to an appropriations bill that would temporarily restrict the use of conflict-of-interest waivers by the FDA. The bill has made its way through the House and is now up for consideration by the Senate.

"It would end these conflicts of interest," Hinchey said. "It would say that these people with clear conflicts of interest should not be allowed on these panels."

According to Hinchey, "there definitely is a problem at the FDA." Disagreeing with Trewhitt, he contends that academia's pool of experts is deep enough to get around conflict-of-interest issues altogether.

"The FDA has said, 'Oh, it's very difficult to get expert opinions without giving these conflict-of-interest waivers. That's total baloney," he said. "We have very, very prestigious medical schools across this country with highly educated, deeply experienced people who are very capable of participating in these review committees -- with no conflict of interest."

But Trewhitt argues that's just not the case, especially when it comes to the approval of new drugs and devices.

"Most of the cutting-edge biomedical research that leads to new products, new medicines, is funded by companies," he said. "Universities simply don't have the money, and government is overwhelmingly focused on fundamental, basic research, not applied science."

Trewhitt applauded the "transparency" of the FDA's selection process, and reiterated that advisory panel recommendations can be ignored, as happened in the cox-2 case.

Hinchey isn't convinced. "The FDA is definitely biased," he said, "and it's a pro-industry bias." The New York congressman estimated the chances of his amendment's passage as "very good," but added that "it is facing stiff opposition from Republicans and from the industry." And because it's part of a budget appropriations bill, "it isn't anything that's going to last any more than a year -- even if we were able to get it through."

More information

For more on the advisory committee process, head to the FDA.

SOURCES: Jeff Trewhitt, spokesman, Pharmaceutical Research and Manufacturers of America, Washington, D.C.; Rep. Maurice Hinchey, (D-N.Y.), 22nd district; July 14, 2005, New England Journal of Medicine
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