Posts Tagged ‘FDA’

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 […]

Reminder: Semaglutide Is Not DIY Weight Loss

September 29, 2023 — In case you haven’t been paying attention, FDA issued a new label warning for semaglutide that should remind everyone of a key fact – it’s not suitable for DIY weight loss. The warning went onto the label for the Ozempic brand of semaglutide. It is already there for the Wegovy brand and for the Mounjaro […]

Drug Labeling That Fails People with Obesity

August 31, 2023 — It is hard to believe. But a new commentary in Health Affairs Forefront tells us once again that drug labeling fails to assure safe and effective use for many important drugs by people with obesity. These are drugs for conditions other than obesity. But people with obesity may represent half or more of the people […]

Magical Thinking for Marketing Pecans

August 7, 2023 — The headlines are great. “Pecans: the surprising superfood for obesity prevention and wellness” says one. “Pecans pack a punch in fighting obesity, diabetes and inflammation” according to another. All this magical thinking about pecans comes from a study of mice on a high-fat diet. What does this mean for humans? Mainly it means that the […]

Don’t Drink a Dozen Diet Cokes a Day

July 14, 2023 — The WHO has taken its skill for exquisitely confusing messages on public health to new heights. One of its agencies, the IARC,  declared yesterday that aspartame is “possibly carcinogenic.” At the same time, a separate committee of WHO, the JECFA, reaffirmed that it’s no problem if a person consumes up to 40 mg per kg […]

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 […]

ADA2023: A Frustrating Quest for Healthy Food

June 25, 2023 — We take it as a given – we want to eat healthy. Since 2016, FDA has been working on developing an updated definition for the meaning of “healthy” if a food seller wants to say that about one of its products. The agency is still struggling with this question today. So we were glad to […]

Disruption, Discomfort, and Hazards in Obesity

June 3, 2023 — In case you missed it, the framework for obesity care is in the midst of great change. The availability of medicines that actually work to an extent never seen before is causing everyone to question presumptions that researchers and specialists have known to be false for some time. But these great changes are giving rise […]

Cheap Copies of Semaglutide Under Scrutiny

May 8, 2023 — Semaglutide for the treatment of obesity continues to be in short supply. Late last week, Novo Nordisk announced that, because the company is still having difficulty keeping up with demand, they would limit production of the lower doses used to start patients on Wegovy. Thus, compounding pharmacies are selling cheap copies of semaglutide injection and […]

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 […]