Wake Forest University cardiologist Curt Furberg will participate with FDA's full Drug Safety & Risk Management Advisory Committee in the upcoming review of the COX-2 inhibitor therapeutic class.

The drug safety committee is slated to evaluate the risk/benefit profile of COX-2 inhibitors at a joint meeting with FDA's Arthritis Drugs Advisory Committee Feb. 16-18.

At the meeting, FDA will present possible explanations for the risk of cardiovascular events associated with the class, and will discuss review materials for three not-yet-approved COX-2 inhibitors (¹ Also see "COX-2 Safety Review Will Explore Possible Mechanisms To Explain Risk" - Pink Sheet, 4 February, 2005.).

FDA initiated its planning activities for the meeting following Merck's withdrawal of Vioxx . The agencyis understood to have originally planned to invite only two members from the drug safety committee.

Following the November Senate Finance Committee hearing on Vioxx (rofecoxib) and the disclosure of additional COX-2 inhibitor safety concerns, FDA is understood to have expanded its communications to include all drug safety committee members.

Furberg was one of the original two drug safety committee members initially invited by FDA to participate in the committee review. The agency also invited Jacqueline Gardner, University of Washington, to participate.

However, Furberg said that invitation was rescinded after his meta-analyses of Pfizer's Bextra (valdecoxib) demonstrating an increased risk of cardiovascular events were presented at the American Heart Association meeting in November (² Also see "Bextra Meta-Analyses Could Be Taken Up At February COX-2 Advisory Cmte." - Pink Sheet, 12 November, 2004.).

FDA subsequently announced that it had not yet made a decision about the drug safety committee member's eligibility to participate (³ Also see "FDA May Allow Furberg To Participate In COX-2 Advisory Committee" - Pink Sheet, 17 November, 2004.).

Furberg was not formally re-invited by FDA to participate in the meeting as a member of the drug safety advisory committee until the beginning of February.

The researcher, who has been candid about the risk of drugs in the past, has not been asked to present his Bextra meta-analyses. Furberg is understood to have updated his materials; the studies are likely to be raised in the committees' deliberations.

One participating committee member who has first-hand experience with COX-2 inhibitors is Arthritis Drugs Advisory Committee industry representative Stephen Geis.

Geis served as Pharmacia VP-arthritis, cardiovascular & oncology clinical development from March 2001, when Pharmacia acquired Searle, until July 2002, when Pfizer acquired Pharmacia, its Celebrex and Bextra marketing partner.

Before that, Geis served as VP-arthritis clinical development at Searle where he was responsible for the clinical development of Celebrex (celecoxib). Celebrex was the first COX-2 inhibitor to reach the market; the arthritis agent cleared FDA in 1999.

[Editor's Note: To ⁴ watch a webcast or order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]

- Steele Thomas

FDA COX-2 Review Will Include Input From Furberg, Full Rx Safety Advisory Cmte.

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