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Drugs aren't required to be tested in people who are obese. Here's why that's a problem
https://apnews.com/article/obesity-drug-testing-6793b43f230df482bed917f9e73f84acDrugs aren’t required to be tested in people who are obese. Here’s why that’s a problem
BY JONEL ALECCIA
Updated 10:49 AM EST, November 7, 2023
[...]
That’s because they are not required to be included in drug studies. And often, they’re explicitly excluded.
“Clinical trials and dosing instructions don’t always ensure that drugs will be safe and effective for people with obesity,” said Christina Chow, a drug researcher who’s reported on the challenges of considering obesity in drug development. “There’s no real emphasis for them to be studied at all.”
Many widely prescribed drugs and over-the-counter medications work differently in people who are obese, but exactly how and at what dose often isn’t clear. Research suggests that may include antibiotics and antifungal drugs used to treat serious infections, synthetic hormones used in Plan B emergency contraception and even ibuprofen, the common painkiller sold as Advil.
The U.S. Food and Drug Administration and the National Institutes of Health — agencies that regulate and fund drug testing — are putting new focus on the gaps in research. At a workshop last year, FDA Commissioner Dr. Robert Califf acknowledged a “deficit of evidence” about how medicines act in patients who are obese. The NIH now encourages researchers to consider the impact of excluding obese people in their studies, a spokesperson said.
[...]
BY JONEL ALECCIA
Updated 10:49 AM EST, November 7, 2023
[...]
That’s because they are not required to be included in drug studies. And often, they’re explicitly excluded.
“Clinical trials and dosing instructions don’t always ensure that drugs will be safe and effective for people with obesity,” said Christina Chow, a drug researcher who’s reported on the challenges of considering obesity in drug development. “There’s no real emphasis for them to be studied at all.”
Many widely prescribed drugs and over-the-counter medications work differently in people who are obese, but exactly how and at what dose often isn’t clear. Research suggests that may include antibiotics and antifungal drugs used to treat serious infections, synthetic hormones used in Plan B emergency contraception and even ibuprofen, the common painkiller sold as Advil.
The U.S. Food and Drug Administration and the National Institutes of Health — agencies that regulate and fund drug testing — are putting new focus on the gaps in research. At a workshop last year, FDA Commissioner Dr. Robert Califf acknowledged a “deficit of evidence” about how medicines act in patients who are obese. The NIH now encourages researchers to consider the impact of excluding obese people in their studies, a spokesperson said.
[...]