FDA Chemist Inspects Results

A Revealing FDA Op-Ed About Lorcaserin and Obesity

Back in February we complained about “a near complete failure of transparency in drug safety decision making” by FDA. Our complaint had to do with taking lorcaserin (Belviq) off the market. Today, FDA took a step toward a bit more transparency. In the New England Journal of Medicine, senior FDA officials explained their thinking about the lorcaserin withdrawal.

But this is a good news, bad news story. The good news is transparency and an abundance of caution. However, the bad news is also important. The FDA reveals that it makes decisions based on an obsolete understanding of obesity care. That’s seriously not good.

“Due to Chance”

The final analysis of data on cancer boils down to this – a signal of a plausible small risk. But not one that rises to the level of statistical significance. The authors state this clearly:

Although we cannot exclude the possibility that the observed imbalances are due to chance, conducting another trial to confirm or refute the signal isn’t feasible.

Further, the authors concede that “the observed excess cancer risk in the trial was not large.”

So clearly, the agency acted in an abundance of caution. They saw a signal that there might be a small problem that would show up only after years of treatment. In fact, it was likely so small that it could not be detected in a clinical trial. Caution is good.

“Uncertain Benefit”

But what is not good is ignorance about obesity treatment. The point of obesity care today is not short-term weight loss. And yet, these are the terms FDA decision makers use to judge the value of this anti-obesity medicine. They write that:

The magnitude of clinical benefit associated with modest weight reduction is uncertain, and this benefit may manifest only after years of sustained weight loss.

This statement is false. Multiple guidelines for obesity care (examples here and here) tell us that modest weight loss can provide significant improvements in health status and quality of life.

And in the case of lorcaserin, clinical trials confirmed this to be true. Patients receiving lorcaserin had better overall quality of life than patients receiving only behavioral therapy. They felt better about themselves and were more satisfied with the sex lives. Their physical function was better. They could perform better at work and they experienced less public distress. In a word, their lives were better.

Clinically they were better off, too. Their cholesterol and blood pressure was better. Blood sugar control was better as well.

So no. It’s not true that the clinical benefit “is uncertain.”

Commercial Interests

Who loses in all of this? Patients who were benefiting from lorcaserin. Not everyone who tried it got a big benefit, but for some, it was dramatic. Those are the people who kept taking it. Such is the nature of this very heterogeneous disease. One size does not fit all.

The company marketing this drug, Eisai, had no incentive to argue with the FDA about withdrawing it. The sales of this drug were disappointing. Eisai stated that the agency was wrong in its conclusions, but went along with FDA’s request nonetheless. In fact, Eisai may well be better off financially for having accepted FDA’s decision.

The only people who lose are a few people living with obesity. This process did not value them. Sad to say, this happens all the time. But it should not.

Click here for the op-ed from FDA decision makers.

FDA Chemist Inspects Results, photograph by FDA / Wikimedia Commons

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September 10, 2020