According to the director of the Food and Drug Administration (FDA) Office of New Drugs, study results showing Orexigen’s obesity drug Contrave reduced the risk of heart attacks were probably “unreliable,” “misleading,” and “likely false.”
The Contrave data was contained in a patent filing with the Securities and Exchange Commission, but the data was released despite protests from the FDA, the researchers leading the clinical trial, and Orexigen’s marketing partner, Takeda. If the problems are not addressed, Orexigen could face fines, civil penalties, or even the withdrawal of Contrave from the market, Forbes reports.
In 2008, the FDA began requiring heart trials of obesity and diabetes drugs to show that a new drug does not cause an increase in cardiovascular events. John Jenkins, director of the Office of New Drugs, said the interim analysis in such studies must be kept confidential, according to Forbes. The agency 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.” The FDA is also concerned that “physicians and patients not make healthcare decisions based on data that are highly unreliable.”
Jenkins said interim analyses can be misleading compared to the eventual outcome of the completed study. The drug maker Sanofi, for example, withdrew a marketing application because it was afraid to compromise a trial of one of its diabetes drugs by letting interim data get out.
When Contrave was approved, the FDA told Orexigen it would need to do a second study, because Orexigen had not kept the interim data confidential. More than 100 people, including people outside the company, learned about the results, according to FDA documents, Forbes reports. With this data released, experts wonder 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. This happened, Jenkins said, because of something the 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.