Dr. Thomas Marciniak, medical team leader of FDA's Division of Cardiovascular and Renal Products, made some expensive promises Wednesday morning. Before a panel of outside experts tasked with advising the FDA on whether to lift current restrictions on GlaxoSmithKline's ($GSK) diabetes drug Avandia, Marciniak slammed a readjudication of 2010's RECORD trial--and vowed to take Glaxo CEO Andrew Witty and 5 colleagues out to an expensive dinner in London if his views were proved wrong.
Marciniak claimed that the readjudication, undertaken by the Duke Clinical Research Institute (DCRI), could not be considered independent, citing financial backing and data that both came from Glaxo. "The readjudication was limited because it relies largely on the original database and source documents in collaboration with GSK," he said, as quoted by Reuters.
Marciniak, the morning's first presenter, set the tone for the first of two days of hearings, and the value of the DCRI readjudication was at the center of the debate. As Reuters reports, researchers for GSK and DCRI touted the RECORD reexamination as independent and comprehensive, highlighting results that showed no statistically significant cardiovascular death risk.
But when pressed by panelist Sanjay Kaul as to whether RECORD allowed an assessment of cardiovascular safety, the readjudication's principal investigator, Ken Mahaffey, admitted that whether RECORD's original design influenced the data still had yet to be determined. "The only thing that I think is still up for question is whether or not the other issues with RECORD, including the open-label trial design, had any potential bias for events getting into the database to start with," Mahaffey said, as quoted by Forbes.
The integrity of Glaxo's data handling was also called into question, with one panelist asking FDA officials whether Glaxo had assured them it had not altered any information it provided to the researchers, according to Reuters.
The debate was foreshadowed in a briefing document released by the FDA earlier this week in which agency staffers largely backed the RECORD readjudication. Marciniak was a notable exception, citing the design flaws of the previous trial. Also included was a previous review of the Duke readjudication, signed by FDA cardio division head Norman Stockbridge, which emphasized that weak trial design "hampers its ability to characterize definitively" Avandia's cardiovascular risk.
The firestorm surrounding Avandia's safety implications has been raging since 2007, when Dr. Steve Nissen of the Cleveland Clinic first brought the diabetes drug into question with an independent study that yielded evidence of cardiovascular risk. The controversy was renewed when news broke that the FDA would revisit Avandia. The drug's fierce critics, including Nissen, have been outspoken about its dangers--and about a potential hidden agenda some believe caused the FDA to reopen the case.
So are the DCRI's results sound, or will Marciniak be shelling out for dinner? Stay tuned for Day 2.
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