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What We’re Reading: Clinical Trial Diversity; Nicotine-Like Vape Chemicals; Weight-Loss Drug Tracker

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Despite diversity enrollment goals, clinical trials funded by the National Institutes of Health (NIH) often enroll fewer patients among underrepresented racial groups; nicotine alternatives used in vapes may be more potent and addictive than nicotine itself; telehealth company Ro built a drug supply tracker to help patients find available doses of GLP-1 drugs.

Report Finds NIH-Funded Clinical Trials Often Miss Diversity Enrollment Goals

Despite diversity enrollment goals, a recent study by the HHS Office of Inspector General found that clinical trials funded by the National Institutes of Health (NIH) often enroll fewer patients among underrepresented racial and gender groups, according to Stat. Researchers who apply for NIH funding must explain how they plan to enroll patients who represent the population affected by the condition for which treatments are being studied. The “inclusion plans” must include a numerical breakdown of targeted participant demographics by gender, ethnicity, and race. Most trials analyzed missed planned enrollment targets; some missed by a little, while others missed by a lot. They commonly recruited fewer female, Asian, Black, Native American and Alaska Native participants. Consequently, the FDA is expected to soon provide guidance on diversifying clinical trials.

FDA Claims Nicotine-Like Chemicals in Vapes May Be More Potent Than Nicotine

The FDA found that nicotine alternatives used in vapes, like 6-methyl nicotine, may be more potent and addictive than nicotine itself, according to Reuters. These synthetic substances with similar chemical structures to nicotine are not subject to US tobacco and vaping regulations, which are used to control traditional nicotine. This means manufacturers can sell vapes containing these synthetic nicotine substances in the US without seeking FDA authorization. Altria, the maker of Marlboro cigarettes in the US, recently wrote a letter to the FDA, highlighting the emerging use of 6-methyl nicotine in vapes and other smoking alternatives. It urged the FDA to evaluate the compounds and establish the same authority over them as it has over nicotine; it also noted that the growth of these chemicals “could present unknown risks to US consumers and undermine FDA’s authority” if left unchecked.

New Tracker Aims to Help Patients Locate Weight-Loss Drugs Amid Shortage

Telehealth company Ro built a drug supply tracker to help patients find available doses of GLP-1 drugs, according to Axios. The demand for these drugs has led to shortages, resulting in patients with prescriptions having trouble finding the treatments when needed. Ro’s tracker relies on the company’s supply data and user-generated reports to provide real-time availability of drugs like Zepbound and Ozempic; patients can sign up for email alerts for when drugs are in stock at local pharmacies. An AI health assistant app Together by Renee launched its similar Find My Meds feature earlier this month, which automatically calls and transfers GLP-1 prescriptions to nearby pharmacies where the drug is available for refills.

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