Belviq withdrawn--Is there a double standard?

February 27, 2020

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investigator in drug development, I have had several thoughts since the announcement that lorcaserin (Belviq) has been withdrawn from the market.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.

 

Obesity doubles the risk of heart disease and stroke, as well as increasing the risk of mortality by 1.5 fold-a much greater risk than 0.6% implicated by the data review. My patients are much more likely to die of heart disease than cancer. Obesity itself is a risk for cancer—how do we design studies that will separate out the risk for cancer that will answer the question and are affordable? Will there be any future development of medications if we are required to control for everything? Can we control for everything?

 

Nothing is risk free-as individuals in a society, shouldn’t we be allowed to decide what risks to take? What is quality of life worth? My patients who have benefited with lorcaserin use, by losing 30-60 pounds, improving their blood glucose, decreasing pain and increasing mobility, living their life more comfortably and guess what, quite possibly start going to the doctor with less shame and actually getting medical evaluations—what do they do now, as they come off of medication that has helped them and they regain, do they go back into hiding where my colleagues can shame them for not taking care of themselves?

 

 

. Yet, when an individual loses weight there is clear cut impact and improvement on multiple co-morbid conditions and quality of life. Both the weight loss and maintenance are supported by medications that target these mechanisms in the brain. We still don’t understand why some individuals respond better than others to a given intervention, just as we don’t understand why some people get adverse side effects and others don’t. As physicians, do we seriously think that intermittent fasting and "keto" are the key to changing this regulation?

 

Lorcaserin did not help everyone but for those that it did, I am truly sorry that the FDA decided not to proceed more slowly and obtain more information to determine if there is a true risk of developing cancer with prolonged exposure to lorcaserin. A real risk-benefit could then be assessed. Unfortunately, as a society we still don’t recognize and respect the complex neuroendocrine regulation of weight and obesity as a pathological disease state. As a society, we need medications to help the individual who struggles with obesity and improve quality of life, and judge risks appropriately. 

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