Last month, an editorial in the Journal of the American Medical Association (JAMA), called upon the Food and Drug Administration (FDA) to add restrictions to the previously-approved obesity drug Contrave.
The editorial voiced concerns that pharmaceutical company Orexigen has made claims about Contrave that haven’t been substantiated by research.
Here’s more about Contrave and Orexigen’s alleged false claims about the drug.
What is Contrave?
Approved in September 2014, Contrave is a drug designed to help obese people lose weight. It’s a combination of an antidepressant called Wellbutrin (generic name bupropion) and naltrexone, a drug that reverses opioid dependence and is commonly used to treat addiction. The two drugs are believed to work in symmetry together.
Contrave is the most-prescribed anti-obesity drug on the market. In 2015, Orexigen sold 664,000 units of Contrave.
Amazing Claims Based on Flimsy Evidence?
To its chagrin, the FDA had already approved Contrave based on the results of a study that was only 25% completed, provided that Contrave met all safety criteria by the end of the study. Based on those early results, Orexigen claimed that Contrave could decrease an obese person’s risk for heart attack, stroke, or death, by a staggering 41%.
To put the claim of a 41% reduction into perspective, no known drug has been shown to reduce the risk of heart attacks to that extent – including drugs created specifically for that purpose, like Lipitor and Plavix.
These spectacular (yet allegedly false claims about Contrave) led the FDA to approve Contrave before the study was finished.
FDA Pre-Approval of Contrave Backfires
Orexigen “leaked” the study’s early results to the public, despite the FDA’s instructions not to do so until the study was finished. When the claims were leaked, the drug trial was only halfway finished and the leak served to scuttle the chance of finishing the study due to bias.
With safety and efficacy of the Contrave still largely unknown, the JAMA editorial calls on the FDA to mandate disclosure about the uncertainty of the cardiovascular “misinformation” disseminated by Orexigen. There is a strong possibility that the statements about efficacy are, in fact, false claims about Contrave.
Pharma Companies Emphasize Stockholder Profits, Not Patient Health
If the above information isn’t a striking enough example of what pharmaceutical companies’ priorities are, consider this quote about Orexigen and Contrave from an investment information site:
“… Despite leading the sector, [Contrave] sales are simply much lower than what is needed to excite the Street.”
The statement suggests that Orexigen needs to find a way to sell more Contrave and boost profits – but releasing false claims about Contrave shouldn’t be allowed as a method of boosting drug sales.
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