Posts Tagged ‘transparency’

One of the hottest scientific and legal debates that has long been simmering about a potential endocrine disrupting chemical is all about glyphosate. This herbicide is sold under the Roundup brand name. Last month, the journal of Regulatory Toxicology and Pharmacology issued a scathing retraction notice for a landmark glyphosate paper that has played a […]

Last week, in a meeting with senior staff from the FDA responsible for labeling, we were dumbfounded. We learned that these pharmacologists did not regard it as important for clinicians to know the half-life of posaconazole in persons with obesity. In fact, they told us “it could potentially be confusing.” On the spot this was […]

A new physiologically based pharmacokinetic (PBPK) study demonstrates that the elimination half-life of posaconazole is significantly prolonged in individuals with obesity – especially those with a BMI ≥ 35 kg/m² – compared to people with normal weight. The labeled half-life for posaconazole is typically 26–35 hours. But in persons with obesity, this can extend to nearly 58 […]

This has been quite a week for easy reading news nuggets about diabetes. First we had the news that Barbie is getting a nifty heart-shaped CGM (continuous glucose monitoring) patch and an insulin pump. Then comes a news blurb from CDC telling us that one in three teens have prediabetes. Should we celebrate the news […]

“If HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary want to bring radical transparency to U.S. healthcare, they can start by updating drug labels that lack good information for persons with larger bodies. ” In RealClearHealth yesterday, an editorial by Caroline Apovian and Ted Kyle called for policymakers at FDA to deliver […]

Change is hard and people resist it. FDA is coming to terms with the idea of radical transparency and certainly drug labels are a good place to start. When we talk about drug labels for prescription drugs, it means the lengthy “prescribing information” that FDA reviews and approves. Its purpose is to tell doctors, pharmacists, […]

Chasing the possibility of multi-billion dollar obesity medicines, pharmaceutical companies are jumping at the chance to spend billions in clinical research. But patient advocates find a reluctance from some of those same companies to take people with obesity into account in the drug labels for their products already on the market. Writing for In Vivo, […]

In some ways, it is nothing new. The medical needs of people living with obesity have been dismissed seemingly forever. But at the same time it is shocking to learn of Merck – a highly respected pharmaceutical firm – leaving doctors in the dark by choice about how one of their drugs acts differently in […]

This is a problem of human mistakes. Compounding pharmacies are exploiting the failure of pharmaceutical companies to meet the scale of need for effective obesity medicines. So people with a serious medical need for these medicines face a hideous choice. Suffer without them or take a chance on dodgy compounded products. The fact that this […]

We can point to any number of symptoms. The rise of measles because of skepticism about vaccination comes to mind. Certainly, we hear from people who reject scientific concepts about obesity. So it’s no surprise to us that a new report in PNAS documents high but declining public confidence in science. Arthur Lupia, David Allison, […]