Biotech Values

[DewDiligence]

GSK’s own PR on the Avandia panel:

http://www.gsk.com/media/press-releases/2013/gsk-statement-in-response-to-fda-advisory-committees-vote-on-ava.html

The committee discussion overall reflected confidence in the integrity and reliability of RECORD. The independent re-examination of RECORD was conducted by the Duke Clinical Research Institute (DCRI) and confirmed the study’s original findings: that the risks of mortality and major adverse cardiac events with Avandia in combination with metformin or SU are no different than with a combination of metformin and SU [without Avandia].

… In the re-examination, DCRI not only analyzed the RECORD results under the original study protocol, but also used the latest revised definitions now under development by the FDA. Regardless of the analyses employed, the DCRI findings confirmed the original findings.