Thursday, May 24, 2007

Temple vs. Nissen: Blood Rematch

Bob Temple, director of the Office of Medical Policy at FDA, admits that "some of the withering criticism of the agency is getting under his skin," according to Ed Silverman over at Pharmalot blog.

With the brouhaha over Avandia and the links in the press to the Vioxx case, FDA senses that the same band of renegade scientists are after their scalps. Temple in particular is feeling the heat. As one commenter to the Pharmalot post puts it: "Somehow I can't work up any empathy for Dr. Temple. His 25 years at the FDA have coincided with the deterioration of the agency."

"It's a particular subset of people who do that," said Temple referring to those critics that "get under his skin." "A lot of them over the years, I've considered friends. But I'm probably re-evaluating that." Temple was quoted in a RPM Report.

After 25 years at the FDA and with a possible Democratic administration looming. Temple may be positioning himself for retirement and a cushy new job with the pharmaceutical industry -- maybe even the new president of PhRMA. It could happen!

Among Temple's list of "friends" under "re-evaluation" include:
  • Steve Nissen
  • Curt Furberg
It's interesting that Temple singles out two guys who have been instrumental in the fall of Vioxx and now threaten Avandia.
Dr. Steve Nissen, of course, is the prominent Cleveland Clinic cardiologist whose analysis linked the widely used diabetes drug Avandia to higher risk of heart attack (see "Sequel for Vioxx Critic: Attack on Avandia"). Nissen also helped raise early safety concerns about Vioxx.

Dr. Curt Furberg, a health policy professor at Wake Forest University, was booted from an FDA drug-safety committee after criticizing Pfizer for some drug-trial practices. "Clearly, there are parties that would rather not see me there," Furberg said. Temple might have been a "subset" of those parties.

Furberg had spoken against Cox-2 inhibitors such as Vioxx, Celebrex and Bextra. "Basically, we showed [in an unpublished study] that [Pfizer's] Bextra is no different than Vioxx, and Pfizer is trying to suppress that information." Bextra was later withdrawn from the market.

Two days after Dr. Furberg’s remarks were published in the New York Times the FDA "disinvited" him from an advisory panel meeting that examined the safety of Cox-2 inhibitors. FDA said Dr. Furberg could not be expected to be objective and Pfizer said it had nothing to do with his removal. The FDA has had problems with other physicians on its staff and has been accused of dragging its feet regarding studies of Vioxx and other Cox-2 inhibitors.

Furberg reapplied to the FDA panel three months after his ouster and was approved. FDA officials had no comment on the reason for his reinstatement. It could be that Senator Grassley had something to do with his re-instatement.
Is drug recall history repeating itself? Does the FDA have something to hide about Avandia as it was accused of doing with Vioxx? Temple's remarks may be the tip of the iceburg:

"The [gentleman] doth protest too much, methinks."

1 comment:

  1. Anonymous1:44 PM

    There's some interesting commentary over at

    I tend to agree with Dr. Haffner's assessment of what's become of the top journals.

    In addition, I feel that NEJM's and JAMA's relationship with Nissen is a little too cozy. I don't think they hold him to the same standards they hold others. Had someone else conducted this study, I think they would've been much more critical.

    Likewise, had someone else done the ASTEROID plaque reduction trial (JAMA 2006) with no control group (e.g., lower-dose statin, or other statin), they would've gotten slammed for the trial design. And they would've gotten slammed for the weak justification Nissen offered--that it would've been unethical. This despite the fact that patients were low-to-moderate risk and statin-naive!

    I'm not really critical of Nissen or his work, per se, but of the journals' uncritical fawning over him. He could fart in a bag and get it published in NEJM.


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