Bristol Glucophage Phase IV protocol release could impede study, Bristol asserts in case brought by HRG.
Executive Summary
BRISTOL GLUCOPHAGE PHASE IV PROTOCOL RELEASE COULD DISRUPT STUDY, ATTORNEY Michael Petty (Fox, Bennett & Turner) asserted on behalf of Bristol-Myers Squibb during a Jan. 27 hearing in D.C. federal court. The hearing was held to consider summary judgment requests in a case brought against FDA by Public Citizen's Health Research Group seeking release of Bristol's protocol for a 10,000-patient study of the oral antidiabetic Glucophage (metformin) under the Freedom of Information Act. Bristol intervened in the suit as a defendant.