Pharmacy Times (8/29, Halpern) reports, “Essential trials supporting the approvals of FDA breakthrough therapy-designated drugs often used surrogate markers as primary end points – even when not approved through the accelerated approval pathway – and often lacked post-marketing studies to confirm a drug’s clinical benefit, according to the results of a study.” These discoveries “could lead to uncertainties and confusion for both clinicians and patients surrounding the use of breakthrough therapy-designated drugs and suggest that the requiring of post-marketing studies – regardless of approval pathway – could heighten certainty that key stakeholders have in the expected clinical benefit.” The findings were published in JAMA Network Open.

Related Links:

— “Frequent Use of Surrogate Markers Could Create Uncertainty for Breakthrough-Designated Drugs,”Luke Halpern, Pharmacy Times , August 29, 2024

Psychiatric News (8/29) reports, “Researchers have identified and characterized a set of neurons that specifically regulate the pain-relieving effects of opioids and not their euphoric effects, according to a study.” After employing “multiple neuroscience and computational techniques to track and manipulate neuronal activity in mice that had received shots of morphine,” investigators observed “that pain relief could be controlled by an ensemble of neurons located in a region of the brainstem called the rostral ventromedial medulla (RVM).” The findings were published in Science.

Related Links:

— “Researchers Identify Neurons That Regulate Opioid Analgesia Independent of Euphoria, Psychiatric News, August 29, 2024

CNN (8/29, Hassan ) reports, “The use of cannabis and hallucinogens ‘stayed at historically high levels’ among both younger and middle-age adults in the US in 2023, according to the latest survey…conducted by researchers at the University of Michigan since 1975 and funded by the National Institutes of Health.” Researchers observed that “about 2 in 5 adults (42%) ages 19 to 30 reported using cannabis in the previous year, with about 10% of that group saying they used cannabis nearly every day.” Additionally, “more women ages 19 to 30 reported cannabis use than men in the same age group” for the first time.

Related Links:

— “Cannabis and hallucinogen use remain at ‘historically high levels’ among young and middle-age adults, survey finds,”Carma Hassan, CNN, August 29, 2024

Reuters (8/28, Aboulenein, Niasse) reports, “More than 1 million people in the U.S. will save over $1,000 a year beginning in 2025, when an annual $2,000 cap on prescription drug out-of-pocket costs kicks in, the leading lobbying group for older Americans said on Wednesday.” As part of the Inflation Reduction Act, the cap’s prescription drug component, called Part D, “provides coverage for around 56 million people.”

The Hill (8/28, O’Connell-Domenech ) reports, “Between 3 and 4 million Medicare Part D enrollees are expected to benefit from the out-of-pocket cap every year between 2025 and 2029,” while “about 40% of Medicare drug plan enrollees – or roughly 1.4 million people – are expected to reach the new out-of-pocket cap between 2025 and 2029.” The report was published by AARP.

Related Links:

— “Biden cap on drug costs will save US seniors over $1,000 a year, study finds,”Ahmed Aboulenein and Amina Niasse, Reuters, August 28, 2024

HealthDay (8/28, Mundell ) reports, “Diabetes can age the brain by up to four years, a new study based on MRI scans shows.” However, researchers also observed that “healthy lifestyle changes could help prevent that neurological aging.” The findings were published in Diabetes Care.

Related Links:

— “Diabetes Can Age Your Brain, But Lifestyle Change Can Reverse That, HealthDay, August 28, 2024