Complaint heaps more concerns on Brilinta study

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Negative heat around the studies that supported the FDA's 2011 approval of AstraZeneca's Brilinta continued to build Monday, as the Wall Street Journal reported on a sealed complaint in which Johns Hopkins Hospital medical professor Victor Serebruany said the study's numbers may have been manipulated to make the anti-clotting drug look better than it was.

Serebruany filed his complaint under the False Claims Act. One of the troubling takeaways, according to the Journal's take on the doctor's allegations, was that the non-Brilinta patients had an unusually high death rate compared to previous studies. The Journal also noted that Serebruany's expertise in anti-platelet meds is known but that he is also controversial “partly because of his financial ties and his recent track record of repeatedly criticizing details of drug studies.”

The sealed complaint is just the latest query of the Plato study. The drugmaker announced in October that the Department of Justice was looking into the trial, which was publicly questioned in the International Journal of Cardiology by James DiNicolantonio and Ales Tomek. These doctors analyzed the data and noted that AstraZeneca-monitored sites had patient results that were more favorable for Brilinta than results at sites monitored by unaffiliated individuals.

Also among their revelations: patients who ended up in the hospital during the trial were more likely to be classified as MI if they were prescribed another anti-platelet drug, generically available clopidogrel (nee Bristol-Myers Squibb's Plavix), as opposed to Brilinta.

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