Study results showing that Orexigen’s obesity drug Contrave reduced the risk of heart attacks were probably “unreliable,” “misleading,” and “likely false,” according to a top official at the Food and Drug Administration (FDA).
Orexigen released the Contrave data as part of a patent filing with the Securities and Exchange Commission, over the protests the protests of the FDA, the researchers leading the clinical trial, and Takeda, Orexigen’s marketing partner, Forbes reports. Orexigen could face fines, civil penalties, or even the withdrawal of Contrave from the market.
The FDA began requiring heart trials of obesity and diabetes drugs in 2008 to show that a new drug does not cause a big increase in cardiovascular events. John Jenkins, director of the FDA Office of New Drugs, said the interim analysis in such studies must be kept confidential so that it does not compromise the integrity of completing the trial and getting a definitive answer on cardiovascular risk, Forbes reports.
Jenkins told Forbes the FDA has two major concerns. The FDA wants to make sure it “can get the definitive answer about cardiovascular risk for Contrave, meaning that the required studies can be enrolled and completed in a timely manner,” and also that “physicians and patients not make healthcare decisions based on data that are highly unreliable.”
Jenkins said interim analyses can give very misleading results compared to what the eventual outcome of the trial may be. Jenkins says drug maker Sanofi withdrew a marketing application because it was afraid to compromise a trial of one of its diabetes drugs by letting interim data slip out.
The FDA told Orexigen when Contrave was approved that it would need to do a second big study, because Orexigen had not kept the interim data fire walled. More than 100 people, including people outside the company, learned about the results, according to FDA documents, Forbes reports. Now that data has been released, experts question whether doctors or patients will be willing to participate in the second trial. In the first trial, more than two thirds of the patients had dropped off the study drug. Jenkins said the dropouts were the result of something FDA had built into the study: because it was not clear that Contrave was safe, patients were not to stay on treatment (or placebo) unless they were losing weight.