FDA New Drugs chief: Orexigen's sunny Contrave heart data 'likely false'
- A top FDA official had some bombshell comments for Orexigen in an interview with Forbes' Matt Herper, saying that interim data showing that the company's obesity drug Contrave may actually reduce heart risk is "unreliable" and "misleading."
- John Jenkins, director of the Office of New Drugs at the FDA, told Herper that Orexigen's actions and early, unauthorized release of the interim data could lead to civil penalties and FDA fines for the company—and possibly even proceedings to withdraw Contrave from the market.
- The FDA is already forcing Orexigen to conduct a second, new safety study for violating the agency's Data Monitoring Committee protocol.
Orexigen's stock, which went soaring after the improper, early data release suggesting that Contrave may actually have the capacity to prevent heart attacks, is already in a tail spin in the wake of Jenkins' bombshell comments.
Jenkins went to so far as to say the results were "likely false" as there is no way to prove heart benefit with just a sample of 25% of data in an interim analysis. "We’re concerned that physicians and patients not make healthcare decisions based on data that are highly unreliable," Jenkins told Forbes.
"Step back and think for a second. We required this study because we’re concerned that Contrave may cause adverse cardiovascular events because of its effect on blood pressure and heart rate. So the likelihood that that drug is going to have an early benefit is highly unlikely. So people need to be very cautious about making medical decisions based on these data, and we’re very concerned that investigators and patients may be unwilling to be in a trial based on these data when they are likely false readings of the actual effect of the drug."
You can read Jenkins' full comments to Forbes here.