| | By Elizabeth Cooney | Good morning. The opioid crisis is often overshadowed by the coronavirus pandemic, but today we have news about prescribing guidelines and a court case that turns on when or whether prescribing turns criminal. | | | Questions raised about whether any monoclonals work against Omicron's sister variant Two conflicting studies have muddied the waters on the one Covid-19 monoclonal antibody believed to still be effective against Omicron’s sister variant of the virus, BA.2. A study posted to a preprint server Wednesday (and not peer-reviewed) concluded that sotrovimab failed to neutralize BA.2 in lab experiments. “This new finding shows that no presently approved or authorized monoclonal antibody therapy could adequately cover” BA.2, the researchers wrote. But Vir Biotechnology, which developed sotrovimab with GSK, said its research indicated that BA.2 was not resistant to the therapy. The company said yesterday it was sharing its results with regulatory agencies and governments, but its press release did not include study details. Those findings will appear on a preprint server “in the coming week,” the company said. STAT’s Andrew Joseph has more. | After Lander’s fall, who’ll be the next White House science adviser? The federal government has some holes in its scientific leadership. Eric Lander’s departure earlier this week amid a workplace abuse scandal at the White House Office of Science and Technology Policy makes three vacancies at key scientific agencies: OSTP, the FDA, and the NIH. The empty chairs call into question the Biden administration’s ability to move forward on signature research proposals such as the relaunched Cancer Moonshot, the new high-stakes research agency ARPA-H, and a $65 billion plan to remake the U.S. pandemic response. Ten federal health experts told STAT’s Lev Facher that five names stood out among the rumored candidates to replace Lander. No surprise that one of them is newly retired NIH chief Francis Collins, but read more in STAT+ to see who else may be in the running. | CDC recommends toning down guidelines for opioid prescribing The CDC has abandoned its influential recommendations that opioid prescribers should aim for certain dose thresholds when treating chronic pain. The changes came yesterday as part of a proposed update to the agency’s controversial 2016 guidelines on opioid prescribing. The recommendations aim to limit harms from long-term opioid use, allow physicians to come up with individualized patient plans, and encourage reductions in dosages when safe and with patient buy-in. Gone is language that says doctors should “avoid increasing dosage” to 90 morphine milligram equivalents or more per day or to “carefully justify” such a decision. Also: - Yesterday, a new study in The Lancet Public Health found significant gaps across the U.S. in access to naloxone, a drug that can reverse the toxic effects of an opioid overdose, and called for more community-based and pharmacy-initiated access points.
- Next month the Supreme Court will consider when opioid prescribing turns criminal. Take a closer look below.
| At this March 31 event, executives, researchers, scientists, and investors will take the stage to discuss the technologies and procedures at the cutting edge of health and medicine. Get your ticket now to learn about the latest efforts to battle diseases and help patients. | Closer look: When does opioid prescribing turn criminal? (alex hogan/stat) Doctors have wide latitude to prescribe drugs, including potentially dangerous ones, but even they face limits. The question is, what threshold do physicians have to cross — and what sort of intent do they need to have — for their prescribing to be considered a crime? It’s an issue headed to the Supreme Court March 1 in a case concerning two physicians who were convicted of unlawfully dispensing medications like opioid painkillers that have contributed to the country’s ongoing and spiraling overdose emergency. Advocates are asking the court to make clear that criminal punishments should be reserved for prescribers who knowingly write inappropriate prescriptions. It’s not that doctors who prescribe in misguided ways shouldn’t be punished, Kelly Dineen of Creighton University told STAT’s Andrew Joseph, but that “we should be reserving criminal penalties for people who are knowingly engaging in criminal conduct.” Read more. | How Delta's spread and vaccine uptake lined up Remember the Delta variant? As Omicron's predecessor swept through the U.S., counties with the highest rates of vaccination against Covid-19 had the lowest case totals, a new study focused on last summer says. CDC data for most states (except Colorado, Georgia, Texas, Virginia, and West Virginia, which had incomplete or unverifiable information) found cases climbing everywhere from July 1 through Aug. 31, but the surge was most intense where vaccination was the least common. The epidemic grew the most in southern states while most counties with low vaccination rates were rural. "These areas have been characterized by vaccination hesitancy, limited vaccine availability, and hospital staff shortages that can be associated with the successful distribution of vaccines and hence the vaccination campaign’s overall outcome," the researchers write about rural areas in JAMA Network Open. | Global elimination of rubella 'in sight,' study says Rubella, a contagious disease sometimes called German measles, causes rash and an illness usually milder than measles with one huge exception. During pregnancy, it can lead to miscarriage, stillbirth, or serious birth defects including hearing impairments, eye and heart defects, autism, diabetes mellitus, and thyroid dysfunction. Global efforts to eliminate rubella have improved since 2021, a new analysis from CDC and WHO reports, with 89% of countries providing vaccine coverage and 48% having ended rubella transmission. Vaccination improved in lower-income countries, but 21 countries have yet to introduce the vaccine into their immunization schedules. “Global [rubella] coverage has increased by 30%, and one region has eliminated rubella and a second region is close," the report says. “The commitment to elimination by all regions indicates that global rubella elimination is in sight.” | | | | | What to read around the web today - Biogen pushes back on Medicare’s limits on Alzheimer’s drug coverage — and advances a counteroffer. STAT+
- Abortions in Texas fell 60% in 1st month under new limits. Associated Press
- In attacking Lilly’s cancer therapy, FDA sends message to companies partnered with Chinese drugmakers. STAT+
- Luc Montagnier, Nobel-winning discoverer of HIV, is dead at 89. New York Times
- Senate pushes toward a vote on Robert Califf, Biden’s pick for FDA. STAT+
- How is America still this bad at talking about the pandemic? The Atlantic
| Thanks for reading! More Monday, | | | | Have a news tip or comment? Email Me | | | | | |
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