September 23, 2024 — FDA is working hard to push drug companies to get more diversity into the clinical trials that are the foundation for bringing new, safe, and effective drugs into the market. In June, the agency issued guidance for diversity action plans to improve the representation of marginalized populations. But unfortunately, it has nothing to say about […]
July 4, 2024 — “I don’t eat like an American,” says our good friend and wise dietitian Linn Steward. “I spend more on food than the average American, but I economize in other areas, like clothing, travel, and entertainment. So I figure that in the long run, it all evens out.” But as we contemplate the quintessential American holiday, […]
May 24, 2024 — At a hearing this week fo the U.S. House Committee on Energy and Commerce, Representative Robin Kelly asked the Director of the FDA Center for Drug Evaluation and Research, Patrizia Cavazzoni, what the agency is doing to ensure that drug labeling adequately protects the safety of people with obesity: “Patients with obesity are frequently excluded […]
January 6, 2024 — We are hearing a cacophony lately – lots of noise about food noise. Part of what we hear is a celebration. Some people are finding blessed relief from it when they take advanced medicines for obesity like semaglutide or tirzepatide. Others see a threat in the relief that those people are finding. They deny that […]
November 20, 2023 — FDA has a bone to pick with Otsuka, the company that sells Rexulti (brexpiprazole). The agency is taking issue with false advertising by the company for this drug used in schizophrenia and severe depression. To us, this problem of inflated efficacy claims is especially noteworthy because, for people with obesity who may need this drug, […]
November 19, 2023 — “I am.” These two words define so many struggles we face in public discourse today. People define their own identities in diverse ways and fiercely defend them. Disparage a person’s identity and you are attacking them. What follows is not gentle, rational, or easily calmed. Right now, we see how potent it is in public […]
November 12, 2023 — For some time to come, we will be learning more and more about the details and implications of the landmark SELECT study published yesterday in NEJM and presented at the American Heart Association Scientific Sessions in Philadelphia. A massive crowd packed the meeting hall yesterday for good reason. These results will change the practice of […]
November 8, 2023 — Public health experts have long been accounting for it. People are living in larger bodies. Better than 40% of U.S. adults have a body weight in the range of obesity. But new reporting from JoNel Aleccia for the Associated Press tells us that pharma and the FDA are not yet accounting for this fact. It’s […]
July 7, 2023 — It’s a fact. People come in all shapes and sizes. FDA and pharmaceutical researchers know this. They know that body size and composition can have large effects on how a person responds to drugs. So why do we have such a troubling gap of body size diversity in clinical trials? In the AMA Journal of […]
May 13, 2023 — Every now and then, it feels really good to score a win. On Thursday, the New York City Council passed a bill to add weight and height to the city’s list of characteristics protected from discrimination. Presently, that list includes race, gender, age, religion, and sexual orientation. If Mayor Eric Adams signs this bill into […]
