Posts Tagged ‘clinical trials’

More Calls for People with Obesity in Drug Trials and Labels

January 26, 2024 — The calls are growing louder and more frequent to include people living with obesity in clinical trials and drug labels. Of course trials and labels for drugs that treat obesity include these patients. But the huge problem is that for everything else, more often than not, drug studies and labels exclude them. Now, the American […]

Inflated Claims and Inadequate Testing for Rexulti

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, […]

Three Details Worth Knowing About the SELECT Study

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 […]

Drug Studies, Labels, and Dosing Only for Lean Persons?

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 […]

OW2023: Testing Drugs in People Like Me

October 17, 2023 — “You’re either invisible, or the answer is to lose weight, even with mental health.” This is the sentiment that surfaced at OW2023 in research of lived experiences from people coping with both obesity and needing treatment for mental health concerns. It becomes acutely important as we learn that drug trials for conditions other than obesity […]

A Troubling Gap: Body Size Diversity in Clinical Trials

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 […]

Ultra-Processing of Study Results in Nutrition

May 29, 2023 — Expert opinion holds that ultra-processed food is not a good thing. So it’s quite natural to expect that helping people resist the convenience and taste of this ubiquitous type of food will help with dietary health outcomes. So natural that it’s quite easy to dismiss inconvenient, unexpected findings. A little ultra-processing of study results in […]

The Failure to Test Drugs in People with Obesity

March 29, 2023 — Scientists and regulators at the FDA have identified a critical gap in new drug development and labeling. It is the failure to test new drugs in people with obesity. Where there are differences in clinical responses and safety, labeling – the instructions for safe use – should reflect those differences. But in many cases, they […]

Tirzepatide Shows Good Weight Outcomes in Diabetes

October 20, 2021 — Day by day, the prospects for treating obesity are getting better. Late on Monday, detailed results from the longest study yet of tirzepatide came out in Lancet. This was a study using this new drug in people with type 2 diabetes, but the average BMI of these patients was 33. None of them had a […]