The FDA Struggle to Withdraw Makena: Problems With the Accelerated Approval Process.

This Viewpoint discusses the controversy surrounding the FDA's efforts to withdraw Makena from the market and the broader implications for the accelerated approval pathway.

Medicine, structural racism, and systems.

Medicine is having a reckoning with systemic racism. While some continue to believe medicine is apolitical and grounded purely in science, history and research reveal that medicine is inseparable from underlying systems, laws, and policies. Obesity is a useful case study. Weight loss trials have shown the immense difficulty in achieving and sustaining weight loss without addressing overlying systems. Barriers are double for Black, Indigenous, and People of Color (BIPOC) with obesity, who must contend with multiple layers of oppressive systems. Increasingly, illness is not a matter of bad luck, but is a function of oppressive structures. COVID-19 likely originates in a deteriorating environment, we have an increasing global burden of disease from oppressive sales of food, sugar, alcohol, guns, nicotine, and other harmful products, and social inequality and resource hoarding are at a peak. Medicine can and must participate in redefining these systems. In doing so, it must center the experiences of BIPOC and push change that alleviates power disparities.