Posts Tagged ‘FDA’

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 […]

Tirzepatide Approved for Obesity: Will Competition Help?

November 9, 2023 — In an era of tremendous change for obesity care, this is certainly a huge milestone. FDA approved tirzepatide for obesity treatment yesterday and put Lilly in the position to offer serious competition to Novo Nordisk. But the question that matters most to us is simple. How will this competition help people seeking to cope with […]

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 […]

The Long Goodbye to Brominated Vegetable Oil

November 4, 2023 — It only took half a century. Back in 1970, the FDA decided that brominated vegetable oil could no longer have GRAS – generally recognized as safe – status. This week the agency announced it plans to ban this additive to many citrus flavored drinks. The long goodbye to brominated vegetable oil  (BVO) will not be […]

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 […]