Axios Vitals: Aduhelm sparks debate

Plus, "prolonged grief" becomes a diagnoses | Monday, March 21, 2022

Open in app View in browser   Presented By Blue Cross Blue Shield Association   Axios Vitals By Tina Reed ·Mar 21, 2022 Welcome back from the weekend. Today's newsletter is 684 words, or a 3-minute read. One cool thing: In case you missed it in last week's Axios Science newsletter, a new fabric woven from sensors mimics the human eardrum to hear — working, essentially, as a fabric microphone, Axios' Alison Snyder writes.     1 big thing: Aduhelm's approval ignites FDA reform debate Data: FDA; Chart: Axios Visuals The FDA's conditional approval of a controversial Alzheimer's drug last year has sparked heightened scrutiny and an attempted overhaul of a popular regulatory pathway used to fast-track cancer drugs and certain other treatments, Axios' Caitlin Owens writes. Why it matters: Accelerated approval allows patients to access new drugs deemed to meet unfilled needs much faster than if the drug went through the regular approval process. But critics say that more needs to be done to prove these drugs actually work in the real world, which could have big implications for the pharmaceutical industry. State of play: Last year, 14 of the 50 new drugs approved by the FDA — including Biogen's Alzheimer's drug, Aduhelm — went through the accelerated approval pathway. The big picture: Although most experts and policymakers laud the pathway as a way to deliver life-saving medicines to patients in a more timely manner, Aduhelm's approval has raised questions about whether the program is being misused. Driving the news: The powerful House Energy and Commerce Committee is considering legislation sponsored by Chairman Frank Pallone that would reform that pathway as part of a larger medical innovation package. "Under the current system, some sponsors have failed to conduct trials in a timely manner," Pallone wrote before a hearing on the bill last week. "Patients deserve to know that the drugs they are taking are safe and effective." In a letter replying to Wyden's concerns about accelerated approval, recently-confirmed FDA commissioner Robert Califf said that ensuring follow-up studies are done in a timely manner will be a "high priority." What they're saying: In written testimony to the E&C committee last week, a PhRMA official said the accelerated approval pathway "is a critical tool for patients and regulators, and the biopharmaceutical industry continues to support the pathway in its current form." Read the rest.     2. "Prolonged grief" becomes a diagnosis Illustration: Shoshana Gordon/Axios   Psychiatry's most influential diagnostic manual has a new disorder in its latest edition: prolonged grief. Why it matters: The diagnoses could open up new ways of treating mental distress associated with grief and have that care paid for by insurers, the New York Times reports. The addition of prolonged grief disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM) comes at a time when many in the U.S. are grappling with loss related to the pandemic. What they're saying: The inclusion of the disorder "will mean that mental health clinicians and patients and families alike share an understanding of what normal grief looks like and what might indicate a long-term problem," said APA CEO Saul Levin in a statement last fall about the move to add prolonged grief to the DSM. But, but, but: The move was not without controversy, with some providers arguing the move categorizes a basic element of human emotions as a disorder and could lead to false positives, per the Times.     3. Black adult hospitalizations rose during Omicron Data: CDC; Chart: Baidi Wang/Axios Black adults accounted for a higher percentage of hospitalizations when Omicron was the predominant variant spreading in the U.S. (27%) than during the Delta-predominant period (22%), CDC data released Friday shows. Driving the news: The findings suggest the increased hospitalization risk during Omicron could be due, in part, to lower proportions of Black adults receiving both of their primary vaccines and booster doses, the authors write.     A message from Blue Cross Blue Shield Association Making insulin affordable for all     Blue Cross and Blue Shield companies are partnering to develop insulin for $30 per vial — reducing the cost of the medication by up to 90%. Why it's important: 1 in 4 diabetics ration their insulin due to cost. Lowering the price will help advance affordable care and protect patient health. Learn more.     4. Pic du jour Photo: Anastasia Vlasova/Getty Images   A medical nurse cares for a baby on Sunday in Kyiv, Ukraine, as seen in photo above. Nearly 20 surrogate-born babies, along with the surrogacy center's nursing staff, are living in a makeshift basement shelter, after Russia's invasion of Ukraine made it unsafe for the infants' foreign parents to retrieve them. Ukraine has been a popular location for international surrogacy, in which women can be compensated for carrying and delivering a child belonging to foreign parents.     5. While you were weekending Illustration: Aïda Amer/Axios   President Biden on Friday signed the Lorna Breen Act, which will authorize grants to support behavioral health services for front-line health care workers. (AHA) Federal officials say they want patients to know how to complain if hospitals ask them to remove their N-95 masks following a report on the practice. (Politico) Latinos in the U.S. experienced a 40% spike in drug overdose death rates in 2020, according to a new study. (Axios)     A message from Blue Cross Blue Shield Association Taking action to curb rising drug costs     Millions of people can't afford their prescriptions, and prices continue to rise. What you need to know: Blue Cross and Blue Shield companies nationwide are taking action through partnerships and policies to lower the cost of drugs. Learn more.   Like this email style and format? It's called Smart Brevity®. Over 200 orgs use it — in a tool called Axios HQ — to drive productivity with clearer workplace communications.   Axios thanks our partners for supporting our newsletters. If you're interested in advertising, learn more here. Sponsorship has no influence on editorial content. Axios, 3100 Clarendon B‌lvd, Suite 1300, Arlington VA 22201   You received this email because you signed up for newsletters from Axios. 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