Conflicts on FDA Panels Detailed

More than a quarter of the scientific committee members who advise the Food and Drug Administration on crucial decisions affecting such products as cancer drugs and breast implants have financial ties to industry, a study published Tuesday found.

But the analysis in the Journal of the American Medical Assn. also found that even if the scientists and physicians with financial ties to industry had recused themselves from voting, none of the final results in 221 reviewed meetings would have changed.

Conducted by leading FDA critics, the study was praised by supporters of the agency as proof that conflict-of-interest policies, strengthened in 2002 to require broader disclosure of industry interests, were working.

Still, Dr. Peter Lurie, the study’s lead author and the deputy director of Public Citizen’s Health Research Group, a consumer advocacy group, said the findings showed that the FDA should further tighten its rules. For example, although 28% of committee members disclosed financial conflicts, only 1% recused themselves from voting on related issues, a trend Lurie called unacceptable.

“I don’t think it’s acceptable to say we’re willing to take any amount of conflict up to the point at which the overall outcome changes,” he said. “Certainly we would never accept anything like that in a jury.”

An advisory committee vote can seal the fate of billions of dollars in potential revenue for drug companies because the FDA generally follows a panel’s recommendation. Committee members are often physicians from top universities and teaching hospitals -- institutions that are among the leading recipients of industry research funds.

FDA rules automatically exclude advisors from a meeting if they have investments exceeding $100,000 in a company that is likely to be affected by the result, or if their investments in such a company exceed 15% of their net worth. Those with lesser degrees of conflict may participate but must file a disclosure form, and any such conflicts are usually noted in an FDA statement at the start of each meeting.

Most of the financial ties cited in the study were not particularly large: 80% of the committee members’ consulting agreements were for $10,000 or less; 77% of research grants were for $100,000 or less; 70% of investments were $25,000 and under; and 56% of speaker fees totaled $10,000 or less.

Economist John E. Calfee of the American Enterprise Institute, a business-oriented think tank in Washington, said the study -- although perhaps not the intent of its authors -- showed that most leading doctors tended to put their professional reputations ahead of financial interests.

“It is very useful to find out that conflicts of interest in advisory committee meetings are apparently not very important,” said Calfee, who sometimes works as a consultant to industry. “It’s always hard to find unconflicted, top-rate scholars. Academics become prominent by doing research. And manufacturers need consultants. So they tend to go after the best researchers.”

The FDA had no comment on the findings, but issued a statement saying that its conflict-of-interest policy was working.

The study focused on consulting agreements, research contracts, investments and speaker fees. Consulting agreements were the most common kind of conflict of interest.

In a majority of meetings, excluding the advisors with conflicts would have reduced the margin of approval for the drug that was being considered, the study found. But it would not have changed the final outcome, partly because committees were unanimous in recommending approval.

Lurie, the study’s author, said vote totals might be an imperfect yardstick for conflicts of interest.

“Unfortunately, there is not a simple bottom line,” he said. “You may not have a conflict, while the person sitting next to you might. And you may be influenced by him.”