FDA now calling for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence how study personnel doctored data and faked results of the drug’s pivotal study in order to make it look effective.
Note they already doubted the integrity of Tavneos data five years ago: "New information that only became known to CDER [Center for Drugs Evaluation and Research] more than three years after approval shows that unblinded study personnel manipulated the results of the pivotal clinical study so the drug looked effective when the original analysis did not support that conclusion," the FDA said in a statement on Monday.
FDA now calling for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence how study personnel doctored data and faked results of the drug’s pivotal study in order to make it look effective.
Note they already doubted the integrity of Tavneos data five years ago: "New information that only became known to CDER [Center for Drugs Evaluation and Research] more than three years after approval shows that unblinded study personnel manipulated the results of the pivotal clinical study so the drug looked effective when the original analysis did not support that conclusion," the FDA said in a statement on Monday.