Results From Study On Pulse Oximeters And Skin Tone Add To Confusion
The long-awaited study, which was commissioned by the FDA in hopes of reducing racial bias, found results that contradict past research findings, leaving clinicians confused. Also: FDA Commissioner Marty Makary's effort to speed drug reviews faces scrutiny; researchers look to LSD as an anxiety treatment; and more.
Rather than provide clarity on how to reduce racial bias in pulse oximeter readings, a long-awaited study commissioned by the Food and Drug Administration has muddied the path forward. (Oza, 1/12)
More pharma and tech developments 鈥
Food and Drug Administration commissioner Marty Makary's flagship effort to overhaul how the agency reviews drugs is facing intensifying scrutiny from Congress and the medical establishment over whether it's putting politics over science. (Sullivan, 1/12)
Stoke Therapeutics and the Food and Drug Administration were unable to reach agreement on an expedited submission for the company鈥檚 severe epilepsy treatment, the company said Sunday. Feuerstein, 1/11)
Veradermics Inc. filed for an initial public offering to help commercialize its hair re-growth pill. Led by dermatologist co-founders Reid Waldman and Tim Durso, Veradermics is developing an oral, non-hormonal treatment for men and women with pattern hair loss, a condition that affects 80 million people in the US, according to a filing Friday with the US Securities and Exchange Commission. (Hughes, 1/10)
This past spring, a biotech company announced the first use of a new gene-editing technology in people to fix an errant gene that causes a severe immune disorder. In June, a baby born with a life-threatening metabolic disorder was allowed to leave the hospital after a six-month sprint by scientists to create a bespoke treatment for him. And increasingly, a generation of 鈥渂ubble babies鈥 born without immune defenses are nearing their teenage years after receiving a one-time experimental gene therapy in early childhood. Therapies that target genetic illnesses at their root are no longer on the horizon. They are here. (Johnson, 1/11)
Lucas Hoffman has been burdened by anxiety for about as long as he can remember. But for a few weeks in 2024, after being treated as part of a clinical trial, the weight didn鈥檛 lift, exactly, but it became much more bearable. The treatment was LSD. The effects didn鈥檛 last, but even two years later, Hoffman, 23, said some benefits have lingered. In particular, he was able to understand, for the first time, that the anxiety doesn鈥檛 have to stop everything 鈥 that he will be OK, even when his mind and body are screaming the opposite. (Allday, 1/10)
After lawmakers blunted expansion for years, Texas鈥 medical marijuana industry is slated to see more marijuana operators coming online, current ones opening more facilities and more Texans enrolling in the program this year. (Simpson, 1/12)
In obituaries 鈥
Dr. Joel Habener, an American endocrinologist who discovered GLP-1, the protein fragment that became the basis of Ozempic, Wegovy and other blockbuster weight-loss and diabetes drugs that are transforming 21st-century medicine, died on Dec. 28 in Newton, Mass. He was 88. His death, in a retirement community, was confirmed by his brother, Stephen, who said the cause was a heart attack. Researchers and drug companies long tried and failed to find an effective treatment for obesity, and many companies gave up on what they viewed as a lost cause. (Kolata, 1/9)
