The safely trial of an obesity drug has been terminated by researchers after the release of early and misleading data by the manufacturer.
Back in March, Orexigen Therapeutics had disclosed in March that according to their previous results of clinical trials of their drug Contrave, it has shown that 41% reduction in the risk of heart attacks, strokes and other cardiovascular related diseases. The relay of this message has brought a boost in the stocks of Orexigen and has also increased the sales of Contrave.
The academic researchers who have overseen the study stated that there has been a violation in an agreement by Orexigen under which it took the decision of not sharing the early results extensively, not even within the company itself.
According to the researchers, the participants in the trial had been followed for a much longer period of time and they had observed no signs of drug benefitting the participants in reducing their cardiovascular risks. In a news release by the Cleveland Clinic, the researchers said that the company’s breach of trust obliged them to terminate the study and release the updated results of the drug.
Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and head of the trial’s steering committee, said, “We felt it was unacceptable to allow misleading interim data to be in the public domain and be acted upon by patients and providers.” He also said Orexigen had “acted improperly and unethically in violating the data access agreement” and the hasty release of data had made it difficult for them to prolong the study.
Nissen also said that it is practically unattainable that patients would be willing to stay back in the trial and risk getting a placebo if they come to know that the drug, which is already available on the market, could reduce their risk of heart attacks.
In the meantime, Orexigen released a statement on Tuesday declaring they had plans of shutting down the precious study in December. While denying misleading anyone, saying that they had stated “plainly and clearly” that the data it released had been preliminary and there had been no confirmation about the cardiovascular benefits of Contrave.
