Data released after company's early results compromises the drug.
A new drug that promised to accelerate weight loss may no longer be viable after the study’s data on cardiovascular activity was leaked.
The drug, Contrave, is being developed jointly by Orexigen Therapeutics Inc. and Takeda Pharmaceutical Co Ltd.
Initially, the company released findings that showed a 41 percent reduction in the risk of heart attack or stroke. However, upon following participants over a longer time period, the safety of the drug diminished to a 25 percent reduction in cardiovascular diseases. This information was not widely shared.
“We felt it was unacceptable to allow misleading interim data to be in the public domain and be acted upon by patients and providers,” said Dr. Steven Nissen, chairman at the Cleveland Clinic, the organization conducting the study.
Nissen went on the admit that Orexigen “acted improperly and unethically in violating the data access agreement” and perhaps had prematurely reached conclusions of the study.
The official press release from Orexigen denies any wrongdoing: “We stated plainly and clearly that the effect of Contrave on CV morbidity and mortality has not been established.”
The company’s stock, which soared after the first findings were released, have since plummeted.
Drug trials play a crucial part in the development of new medications. They ensure that the drug is safe and can be used widely across a varied population. No matter how spectacular a drug trial’s early results are, if a study becomes comprised it is no longer viable.
Contrave is just one of four prescription weight loss pills entering the market. Despite the excitement surrounding these medications, they have yet to gain widespread use in America. One reason for this is that most insurers do not cover the drugs. Additionally, many physicians due not consider obesity a disease and continue to advise the classic remedy of ‘diet and exercise’.