At the start of March, positive results were disclosed from an interim safety trial of Orexigen Therapeutics’ weight-loss pill Contrave that appeared to show that the drug reduced cardiovascular events compared with placebo. The news caused the company’s shares to jump by over 50 percent. But the announcement also caused more than a ripple at the FDA, who are “very disappointed by Orexigen’s actions.” Ironically, it also further highlights the more typical problem on the other side of the coin: not publishing negative results (see “Silent Data”).
“In order to protect the integrity of an ongoing trial, preserving confidentiality of the interim results is essential. Disclosure of such results could negatively impact the conduct of the remaining portion of the trial by contributing to unanticipated changes in recruitment and/or retention, treatment administration, other aspects of study conduct, or loss of objectivity in safety event reporting,” said the FDA in a statement. Orexigen was required to perform the safety study regarding potential cardiovascular events by the FDA as a condition for its approval of Contrave back in September. The disclosure came about because Orexigen had applied for a patent based on the interim results and relating to Contrave’s potential to reduce cardiovascular events; certain information from the study was required for the filing, which has now been made public.
Even before the study data was leaked, the FDA said that it had already determined that the trial (LIGHT) was not robust enough to satisfy safety requirements. “The FDA required Orexigen to complete a second cardiovascular outcomes trial and that requirement remains in effect,” said the agency. However, what has been seen cannot be unseen and the FDA admits that it is “reassured” by the interim data. It has encouraged the company to complete the study since it could provide complementary or supportive information. How feasible that is now that trial participants have seen the data remains to be seen. An article in Forbes provides the analogy of trying to get toothpaste back into the tube...
In the meantime, the FDA reminds people not to get carried away. “FDA considers these preliminary data far too unreliable to conclude anything further about the cardiovascular safety of Contrave. Furthermore, these data should not be interpreted to suggest that Contrave reduces the risk for cardiovascular events.”
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References
- L. Husten, “Orexigen Released Interim Data Without Approval Of Trial Leaders”, Forbes.com (March 2015).
