Doesn't FDA Approval Mean Weight Loss Drugs Are Safe? - Reader Question

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Reader Patty asked:

”I’m confused, it seems like these new weight loss drugs have some dangerous side effects, but they are FDA approved so doesn’t that mean they are safe?”

Thanks for the great question, Patty!

There is a common misconception that FDA approval means that a drug is “safe” meaning “without risk.” In truth, FDA approval of a drug means that the FDA feels that the benefits of a given drug are worth the risks.

Drug approval is the purview of the FDA's Center for Drug Evaluation and Research (CDER). When a pharmaceutical company is ready to seek approval for a new drug, it submits the research for its drug to the CDER. A CDER team of scientists (including, but not necessarily limited to, pharmacologists, statisticians, physicians, and chemists,) reviews the research and the labeling drafted by the pharmaceutical company, does some limited testing around safety, efficacy, and quality, and if they decide that the drug’s benefits outweigh the risks the drug is approved.

It’s the risk calculation where I believe this goes predominantly wrong for weight loss drugs. The CDER team considers both the risks of the drug itself as well as the risks of the “condition” it’s meant to treat. The problem is the mountain of shoddy research (mostly created by the weight loss industry and/or those on its payroll) that “links” being higher-weight with health conditions mostly by ignoring confounding variables (I did a deeper dive into this here.) This leads to a deeply skewed risk/benefit analysis wherein the CDER team is misled to believe that simply existing in a higher-weight body is so “dangerous” that it’s worth risking the lives and quality of life of higher-weight people.

Then they approve the drugs and higher-weight people (and sometimes their healthcare providers) are led to believe that the drug is “safe” by the common definition, or at least by a risk/benefit analysis that is rooted in reality and quality resarch, not by a definition in which the FDA is willing to risk the lives and quality of life of higher-weight people to make them a little bit thinner for a short amount of time, which is the sad reality.

So no, FDA approval doesn’t mean a drug is safe by the common meaning and, when it comes to weight loss drugs and FDA approval, the bar for “safety” is, to me, frighteningly low.

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More research and resources:
https://haeshealthsheets.com/resources/

*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.