The drug in question is prasugrel (to be advertised as Effient), which watchdog Public Citizen and Johns Hopkins research director Dr. Victor Serebruany say wasn’t tested at a proper dosage by Lilly. The result, Public Citizen argues, is an unsafe drug potentially harmful in the long term may be released to the public.
This is a high-stakes issue because the drug, as a competitor to Plavix, could earn Lilly a billion dollars a year, an Associated Press story says.
The drug prevents more heart attacks than Plavix, but it also causes more internal bleeding, according to a study of over 13,000 patients conducted by Lilly.
But consumer watchdog Public Citizen says that study did not give an accurate comparison of prasugrel versus Plavix.
In a letter Wednesday, the group notes that the dose of prasugrel studied by Lilly was about 2.5 times more potent than the dose of Plavix. The scientists say that the higher dose accounted for the excess bleeding seen with prasugrel. The letter said some patients on prasugrel actually stopped forming blood-clotting platelets completely, putting them at increased risk of hemorrhages.
The story says a panel of outside advisers recommends the FDA approve the drug, because it cured 24 heart-related problems for every 10 cases of bleeding it caused. The department is mulling things over and has already missed two target dates for the drug’s review.