| | By Elizabeth Cooney | Good morning. Still waiting for word on whether the FDA will grant approval to lecanemab, but we have a case report from NEJM detailing a patient death during a clinical trial of the Alzheimer's drug. | | Walgreens will take steps to offer abortion pill After the FDA broadened the availability of abortion pills to many more pharmacies, including large chains, we were left with questions about how that might roll out. Walgreens answered one yesterday. The pharmacy chain confirmed to STAT’s Eric Boodman and Ed Silverman that it’s planning to get certified to distribute the abortion pill mifepristone. “We are working through the registration, necessary training of our pharmacists, as well as evaluating our pharmacy network in terms of where we normally dispense products that have extra FDA requirements and will dispense these consistent with federal and state laws,” Fraser Engerman, a spokesperson for Walgreens, said in an email. Mifepristone is the first drug in a two-drug process to terminate pregnancies of up to 10 weeks. It’s used with a second, more widely available drug, misoprostol. But patients in states with more severe restrictions will still not be able to get a prescription unless they go through a service like Aid Access that operates outside the traditional U.S. health care system. Read more. | As FDA nears a decision on a new Alzheimer's drug, a case study notes safety concerns More details have emerged on the death of a woman participating in an Alzheimer’s drug trial with the publication of a case report in NEJM yesterday. News of the death previously appeared in Science, one of three deaths noted by Science and STAT. But the new peer-reviewed version comes as doctors consider whether and how to use lecanemab, which could be approved this week. The case is complex. The woman’s genetic makeup heightened both her risk of developing Alzheimer’s and swelling or bleeding on antibody treatments such as lecanemab. In a response published with the case report, two neurologists in the trial raised questions about the role lecanemab played in her death. Outside expert Matthew Schrag of Vanderbilt said such complex cases are what physicians will see if the drug is approved and used widely. “There’s more than one thing going on here, but that’s real life,” he told STAT’s Jason Mast. Read more. | WHO official criticizes China for undercounting Covid deaths Throughout the coronavirus pandemic, global health authorities have been clamoring for more data from China. Yesterday a senior WHO official called out China for underreporting deaths from Covid-19 and urged it to use a broader definition that would more faithfully capture how the country is faring in its first big wave of Covid infection. Cases are racing across China, weeks after it abandoned its zero-Covid policy late last year following nationwide protests. Authorities are reporting low levels of deaths — five or fewer a day — which experts outside China say defies credulity. “We believe the current numbers being published from China underrepresent the true impact of the disease in terms of hospital admissions, in terms of ICU admissions, and particularly in terms of death,” Mike Ryan, head of the WHO’s health emergencies program, said yesterday during a press conference. STAT’s Helen Branswell has more. | New approaches to caring for and addressing the diverse needs of people with blood diseases Hematologic disorders comprise a vast category of diseases, and although some types can be managed to prevent symptoms or complications, others lead to a poor prognosis because their disease relapses or is refractory to treatment. Scientists are pursuing effective treatment options for patients with hematologic cancers and rare blood diseases at all stages of their journey, rethinking what is possible when it comes to standards of care and the treatment experience. Learn more. | Closer look: While debate flares over access to drugs, voluntary licensing is up in the air (MIKE REDDY FOR STAT) Brand-name drug manufacturers see patents as their lifeblood, the source of their revenue and fuel for developing future medicines. Because the world needs their drugs and pricey medications are often out of reach for low- and middle-income countries, companies enter into voluntary licensing in those nations to widen access. It’s best known for drugs to treat infectious diseases, such as HIV and hepatitis C, but Covid intensified concerns about haves and have-nots. Nearly three years after the pandemic emerged, few voluntary licensing deals allowing generic drug manufacturers to copy and distribute drugs have been reached. STAT’s Ed Silverman explains the stakes and the challenges, drawing on remarks made at a roundtable held in late October in Annecy, France. “The question isn’t can voluntary licensing work? I think the question is how can voluntary licensing work?” Charles Gore, the executive director of the Medicines Patent Pool, said during the meeting. Read Ed's special report. | In mice, experimental cancer vaccine kills and prevents brain tumors It’s a pretty bold claim. Scientists have developed a cancer vaccine that in a mouse model of glioblastoma simultaneously eliminated and prevented one of the deadliest cancers in people. Writing in Science Translational Medicine, the researchers report success destroying these brain tumors and teaching the immune system to prevent recurring ones. They did it by genetically engineering living tumor cells to kill tumor cells and stimulate the immune system to target primary, recurring, and metastatic tumors and prevent cancer. Their approach differs from other efforts using inactivated tumor cells. They added a “double kill switch” in case it might be needed to disable the CRISPR’d tumor cells so they wouldn’t seed new tumors, with future immunocompromised patients in mind. Although much more work must be done to bring this to people, the study authors say “our data demonstrate the feasibility and efficiency of our proposed immunotherapeutic approach for [glioblastoma] and advances clinical translation.” | Procrastination can hurt in more ways than one No one would ever say procrastination is a good thing, but a new Swedish study in JAMA Network Open links it to both poor mental and physical health. The survey of 3,525 college students asked them to rate their procrastination on a standard scale, then followed up every three months for a year, asking about mental health; disabling pain; poor sleep; tobacco, alcohol, or cannabis use; loneliness; and other troubles. At the end of the study, higher baseline levels of procrastination were associated with depression, anxiety, and stress; disabling arm, shoulder, and hand pain; poor sleep and physical inactivity; loneliness; and financial trouble. Other studies have connected ill health to habitually putting things off until later, but the researchers say while theirs can show only an association, it’s the first to account for where the study subjects started, making it less likely that the problems were the cause of the procrastination. | | | My apologies to readers who clicked on Rachel Cohrs's "3 drug pricing issues to watch in 2023" yesterday. I jumped the gun, but it's here now. | What we're reading - Public health agencies try to restore trust as they fight misinformation, Kaiser Health News
- Opinion video: Why saving kids is bad business in America, New York Times
- Roivant-Pfizer inflammatory bowel drug hits high expectations in mid-stage study, STAT
- California's dark history of forced sterilizations comes into focus as it seeks victims to pay reparations, Associated Press
- Geron, biotech that once sparked talk of immortality, finally gets a (more modest) success, STAT
| Thanks for reading! More tomorrow, | | Have a news tip or comment? Email Me | | | |
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