What's he been drinking?

According to The Pink Sheet, Robert Temple (Director of the Office of Medical Policy at the FDA) told attendees at the International Conference of Pharmacoepidemiology & Therapeutic Risk Management that he doesn't think there's a conflict of interest for someone on the medical advisory board to also conduct the clinical trials for manufacturers.

"A lot of the conflicts that people on our advisory committees have are that they did trials for these people," he said, "I don't think that's such a bad thing. . . I don't think it necessarily conflicts you."

Does he really think that some companies would refrain from paying significantly more to those physicians on the advisory board (and allow them greater latitude with protocol deviations/violations, etc.) if those same investigators were in a position to rip the data supporting their application? He must, because he also seems to think folks on advisory committees would look closely enough to question data that may be confounded by deviations they, themselves, committed (or ones similar to their own infractions) or admit that they agree a studythey willingly performed wasn't well designed and/or didn't have adequate safety protections built in.

Temple also went on to say he doesn't think these sorts of conflicts materially influenced the outcome of the COX-2 meeting

"Some of the people on the COX-2 [committee] I think were people who were just doing the studies."

He did, however, acknowledge that advisory committee members could be "biased by association" because they like and value the companies as well as the potential future rewards. This is all the more reason to keep them from conducting the trials (and to keep thought leaders, who've aided in development of a protocol or program from conducting those trials; they have their own agendas that can insert unnecessary bias and/or cause deviations that can cause confounding of the data).

I shudder to think what the Wall Street research firms would do to get some inside info from an investigator who just happens to also be on the advisory committee.

Tags: FDA; Drugs; Science; Healthcare; Medicine; ethics; clinical trials; drug development; NDA

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