Orexigen Therapeutics announced on Tuesday that it is ending the study on its obesity drug. The announcement was made shortly after an independent panel of experts said the company compromised the study by releasing premature and unreliable data.
In March, Orexigen released a statement that the obesity drug Contrave does not only help in weight loss but also lowers one's risk of heart attacks, strokes and deaths caused by cardiovascular disease by 41 percent, even if the study is still ongoing. Two months later, it turned out that the drug has no cardiovascular benefit.
"Patients were misled, investors were misled," said Steven Nissen, chair of cardiology at the Cleveland Clinic and the lead researcher of the study, according to Forbes. "It is so critically important that investors and other people understand why early data in a trial are unreliable or unstable."
Nissen and the rest of the researchers asked Orexigen to issue a press release with the correct study results. However, the company only released a statement that the study was stopped but did not reveal the real reason.
"The issue is patient safety," Nissen told the Wall Street Journal. "We felt it was important to get into the public domain the more reliable information. Effectively, the premature release of the data poisoned the whole trial. We had an ethical and moral duty to correct the record."
Meanwhile, Orexigen denied that it stopped the study because the drug has no cardiovascular benefit. Instead, it said that it was a recommendation of the executive steering committee, Reuters reported.
The U.S. Food and Drug Administration recommend a second trial for cardiovascular benefit to close the issue of integrity, and it seems that Orexigen is complying.
"Takeda is seeking, among other things, Orexigen to pay the entire cost of the new cardiovascular outcomes trial," Orexigen said in the statement.
