Belviq withdrawn--Is there a double standard?


As an endocrinologist who has worked with individuals who struggle with obesity for over 20 years and active clinical investigator in drug development, I have had several thoughts since the announcement that lorcaserin (Belviq) has been withdrawn from the market. I believe that this decision by the FDA was made without the full consideration of the clinical benefits for individuals who respond to it and sadly, based on private data unavailable for analysis to the scientific community at large.

It is hard to understand how a difference of 0.6% (462 vs. 423) is considered a statistically significant difference in an age group where cancer is commonly diagnosed. This study was not powered to assess cancer risk. It was designed to assess risk of major adverse cardiac events. For cancer risk assessment, there were too few subjects, the time period of evaluation was short and there was no baseline assessment of cancer risk done for participants. Instead of withdrawing the drug from the market--why not ask Eisai to go back and get more information from former participants several years later and see if more information supports the imbalance, before taking it off the market? Set up a reporting system to collect data going forward? Or why not put a black box warning on the label or notice and let the risk be decided between the physician and the individual? This is what we do for other chronic diseases such as depression (suicide risk), pain/osteoarthritis (NSAIDs, also available over the counter), menopause (HRT). So why don’t we do this?

Because this a clear-cut example of stigma and bias---obesity is not considered a chronic disease or a disease worth treating while accepting some risk. What happened to the notion of improving “feeling, form, and function” and that risk that might be acceptable in order to improve the quality of life of individuals? Why, if gastric bypass has recently been shown to be associated with a 2-fold increase risk in colorectal cancer (which means 200% not a 0.6% increase) are we still doing this surgical procedure (for which we still see weight gain regain years later and some do not respond at all to surgery)? Unfortunately, it seems that medication for the treatment of obesity also experiences stigma as well.

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