Orexigen obesity drug trial ended with misleading early results, new press release informs.
Two months ago, Orexigen Therapeutics released information on one of its drugs, Contrave, saying that company funded clinical trials showed patients’ risk of suffering from strokes, heart attacks and other cardiovascular diseases decreased with 41 percent.
Following Orexigen’s announcement, the company’s stocks skyrocketed and Contrave sales saw a significant increase in monthly sales.
However, academic researchers supervising the development of the study said that Orexigen broke the conditions of the agreement, which stipulated the company could not disclose early results – not even to the company’s staff.
Apparently, besides sharing confidential data, Orexigen also altered the information; in reality, volunteers in the trial had been monitored for longer periods than previously stated, and even so, the results showed little to no improvement in lowering heart disease risks for any of the patients.
The researchers overseeing the trials felt compelled to order the study to be terminated because of the company’s breach of trust. Scientists disclosed the accurate and updated results of the drug tests in a press announcement from Cleveland Clinic.
According to Dr. Steven Nissen, head of the cardiovascular medicine department at the Cleveland Clinic and the leader of the trial’s board, the misleading information that was released to the public had to be corrected, as many patients and providers act according to the drug’s alleged effects.
Dr. Nissen added that Orexigen is guilty of breaching the ethical and proper ways of handling data access that was stipulated in the study’s agreement. The main reason why the research could not be prolonged is the way-too-early release of incomplete results.
Even if the results would eventually prove the drug is indeed reducing the risk of cardiovascular disease, the researchers would hardly find any patients willing to continue participating in the trial. Who wants to risk being given a placebo in a clinical experiment when the drug is apparently working and already on the market?
On Tuesday, Orexigen commented on the early termination of the trial, saying that the company had already had plans of ending it back in December.
The announcement continued denying it had released misleading information to the public, pointing to the fact that those results were clearly only preliminary, and that it was waiting for trials to offer the confirmation on the cardiovascular benefits of Contrave.
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