Weight-Loss Drug Study Ends Early After Researchers Question Data
Results released from the first part of the study for the drug, Contrave, made by Orexigen Therapeutics, showed a big reduction in risk of heart attacks and strokes, but academics who were overseeing the study are questioning the results and say the release of information violated agreements on how the study would be handled. Elsewhere researchers probe the link between a dietary supplement with an amphetamine-type stimulant and a woman's stroke.
The New York Times:
Data Disclosure Leads Researchers To End Study Of Obesity Drug
A study of an obesity drug has ended after the manufacturer released early and ultimately misleading data, researchers said on Tuesday. The company, Orexigen Therapeutics, disclosed in March that early results from a clinical trial of its drug Contrave had shown a 41 percent reduction in the risk of heart attacks, strokes and death from cardiovascular causes. Orexigen’s stock shot up, and the information no doubt helped lift sales of Contrave. But the academic researchers who oversaw the study said on Tuesday that Orexigen had violated an agreement that the early results were not going to be shared widely, even within the company. Moreover, as participants in the trial were followed for a longer period of time, the benefit of the drug in reducing cardiovascular risks vanished. (Pollack, 5/12)
Milwaukee Journal Sentinel:
Effectiveness Of Weight Loss Drug Contrave Remains In Doubt
It will be at least seven years before people using the new weight loss drug Contrave know whether it is beneficial or harmful to their heart. Drug-makers have pulled the plug on the large clinical trial that would have assessed the cardiovascular safety of the drug, which combines the generic medications buproprion and naltrexone. ... The FDA relied on that initial 25% of study data when it approved Contrave in September, 2014, requiring that the rest of the study be continued in order to rule out increased cardiovascular risk. (Fiore and Fauber, 5/12)
CBS News:
Amphetamine-Like Stimulant In Dietary Supplement Linked To Stroke
An amphetamine-type stimulant found in dietary supplements marketed to promote weight loss and improve athletic performance could be to blame for a hemorrhagic stroke in a woman who took the supplement before working out. The case report, published in the Annals of Internal Medicine, is the first to suggest a connection between the man-made, synthetic compound called BMPEA and an exercise-induced stroke. ... In April of this year, the U.S. Food and Drug Administration issued warning letters to five companies to stop selling products containing BMPEA, stating that the stimulant does not meet the definition of a dietary ingredient. (Welch, 5/13)
