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

Beatrice Hastings Leaning on Her ElbowPublic 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 a problem because that gives us drug studies, labels, and dosing that work only for lean persons.

For larger persons, it’s a shot in the dark. Many drugs have not been well studied in larger persons, so the dosing, safety, and effectiveness is not well understood.

A Problem for Contraceptives

Alison Edelman is an OB-GYN and researcher at Oregon Health & Science University who studies obesity and contraception. She told Aleccia that levonorgestrel is an example of a drug that may not work well in larger persons without dosing adjustments. Because this is a drug used for emergency contraception, the result can be a drug failure and an problematic pregnancy. Said Edelman:

“It’s just something that we have to chip away at because it’s so important. Unless we see representation in our study population, we don’t end up with treatments that work well for individuals.”

Speaking Up, Asking Questions

Good answers for concerns like this one only come when people ask the right questions. Right now, those questions are often skipped right past in clinical research because so many drug studies are skewed toward lean persons. But patients can be a catalyst for change. Obesity medicine physician Caroline Apovian suggests that patients ask their doctors if the standard dose of a medication is appropriate for a person of their size. It can start a critical conversation, she says:

“This is a big issue. It can be important for patients to speak up.”

Click here for the article from AP, here and here for further perspective.

Beatrice Hastings Leaning on Her Elbow, painting by Amedeo Modigliani / WikiArt

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November 8, 2023

2 Responses to “Drug Studies, Labels, and Dosing Only for Lean Persons?”

  1. November 08, 2023 at 9:31 am, Kath Williamson said:

    So important to highlight Ted. In my area of practice, home health nursing, this applies to meds given for end of life/ palliative care, where there are standard dosages for “anticipatory medication” – used if someone has an acute event/ breakthrough pain etc. There is little evidence for professionals regarding titrating dosage for people with larger bodies, so meds as given are unlikely to have same effect, leaving people in pain/ distressed, which is unequitable care.
    I am not sure if the same applies to adrenline dosages in case of anaphylaxis etc

    • November 08, 2023 at 9:39 am, Ted said:

      Thanks for bringing a dose of reality, Kath.