The FDA discusses Brilinta

February 4, 2014- The WSJ is reporting today on a Johns Hopkins doctor who filed a federal court complaint, using the Federal False Claims Act. The WSJ reports, “In July 2011, the Food and Drug Administration approved AstraZeneca PLC’s anticlotting drug Brilinta for patients with certain severe coronary conditions. A study had shown the pill saved lives and reduced heart attacks—a real eye-opener in medicine.

But behind the scenes, a drama is unfolding over whether the drug should have been approved. In a sealed complaint filed in U.S. district court in the District of Columbia, Victor Serebruany, an adjunct medical professor at Johns Hopkins Hospital who specializes in such drugs, contends the study numbers may have been manipulated.

Dr. Serebruany has told federal investigators that the number of deaths in the study’s control group—those taking a competing drug—was unusually high compared with earlier trials. He also has questioned the tabulation of heart attacks in the study, alleging it was skewed in Brilinta’s favor, according to people familiar with the matter and documents reviewed by The Wall Street Journal. The study measured cardiovascular deaths, heart attacks and strokes.

Dr. Serebruany filed his complaint under the federal False Claims Act. Under that law, the U.S. government has the option of joining the lawsuit to recover money.”

July 20, 2011-In a somewhat surprising move, the FDA approved AstraZeneca’s anticoagulation drug branded as Brilinta (ticagrelor). This drug had the PDUFA date delayed as the FDA wrangled with the messy clinical data that failed to show any benefit in the North American cohorts. It had become a case study in the bigger problem of Big Pharma relying on CRO’s to conduct their clinical trials.  Steven Greer, MD spoke with Janet Woodcock, Director of the FDA’s CDER, about the label. In addition, Pradaxa and Xarelto, two other new anticoagulation drugs, were discussed.

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