Posts Tagged ‘drug safety’

Fix the Blind Spot in Drug Trials Says Every Major Obesity Group

November 29, 2023 — It is time to translate words into action and fix the blind spot in drug trials and labeling for people with obesity. Every major obesity group in the U.S. issued this united call to action on Tuesday. This includes the ASMBS, Obesity Action Coalition, Obesity Medicine, Obesity Society, and STOP Obesity Alliance. It comes as […]

Do Cancer Drugs Work Safely for People with Obesity? Maybe

November 18, 2023 — At a time when nearly half of the U.S. population is living with obesity, this should be an easy question to answer. Obesity clearly causes some forms of cancer and as the prevalence of obesity is rising, patterns of cancer prevalence are shifting, too. So, yes, we should be able to say with great confidence […]

Compounding, Biosimilars, Generics, and the Semaglutide Supply

October 30, 2023 — It leaves our heads spinning. Normal healthcare systems cannot keep up with the demand for a breakthrough in obesity treatment. The company, Novo Nordisk, which developed semaglutide for obesity treatment, has invested billions and now is reaping many billions of dollars in sales. But despite more than a decade of preparation, they can’t keep up. […]

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 […]

Sunshine, Lollipops, Rainbows, and GLP-1 Meds

April 30, 2023 — Recent advances in medicines for treating obesity are stirring up quite a conversation. The enthusiasm for them is hard to miss. Subway ads, tabloid headlines, and celebrities are putting these meds front and center. From all this enthusiasm for the new GLP-1 medicines, the impression might be something like sunshine, lollipops, and rainbows. No doubt, […]

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 […]

A Revealing FDA Op-Ed About Lorcaserin and Obesity

September 10, 2020 — 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 […]

Landmark Cardiovascular Outcomes Study for Belviq

July 18, 2018 — For the first time ever, we have direct evidence for the long-term cardiovascular safety of an obesity medication. The drug is Belviq, also known as lorcaserin. Yesterday, Eisai released topline results for the long-awaited CAMILLIA-TIMI 61 trial. This was a five-year cardiovascular outcomes study of 12,000 patients. It was randomized and placebo controlled. CV Safety […]

Divided FDA Advisory Committee Votes to Require Cardiovascular Testing for New Obesity Drugs

March 29, 2012 — March 29, 21012 — A panel of experts at the FDA voted 17-6 in favor of requiring all new obesity drugs seeking approval to provide phase 2 or 3 safety data ruling out excess cardiovascular risk, even if the drug does not appear to have a cardiovascular profile.