CBD + Covid = major FDA headache

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Sponsored by        Hello again, D.C. Diagnosis readers. I have some exciting news! We’re hiring for several new reporters at STAT – including a duo that will dig into the insurance and hospital industries. Get ready for plenty more juicy money-in-politics stories peppering the pages of D.C. Diagnosis! I’m at nicholas.florko@statnews.com. Why a new round of CBD papers is likely to give the FDA and researchers a major headache  If you’re reading this newsletter, you’ve probably heard about two new studies showing that CBD could play a role in preventing Covid-19. (I, for one, have gotten pretty good at explaining the limits of a preclinical study in the span of a text message over the past week.)  In a new story for STAT, my colleague Andrew Joseph and I unpack why the hype around that research is prompting warnings from researchers – including the authors of one of the papers – not to take CBD to prevent Covid-19.  We also unpack the monumental task facing the FDA, which has already issued more than a dozen formal warnings to CBD companies that have used early research to promote their products as Covid-19 cures.  For more, check out our story here.  Insulin giants boosted lobbying spending As Democrats took aim at insulin prices, the poster child for drug pricing dysfunction, two insulin giants boosted their lobbying spending in an effort to shape reform efforts, my colleague Rachel Cohrs reports. Two of the three major companies that make insulin for the United States spent significantly more last year than they did in 2020, according to new federal disclosures. Eli Lilly spent $7 million on lobbying in 2021, 29% more than the year before Novo Nordisk spent $3.2 million, or 24% more than in 2020 The future of the policies Democrats have considered is unclear. Even though one of the two major policies could actually be good for insulin makers, PhRMA has decided to lobby against them both — find out why in the full story here.  Sponsor content by NATIONAL PHARMACEUTICAL COUNCIL Designing health benefits to meet unique patient needs What happens when health insurance is designed for the average population and not individual patients with different health needs? Learn about patient-centered solutions in the National Pharmaceutical Council’s new report, Myth of Average: Why Individual Patient Differences Matter. Download your copy today. One former CMS administrator has some big questions about Medicare’s Aduhelm decision Researchers at the Duke Margolis Center for Health Policy, led by former CMS administrator Mark McClellan, are raising a number of fundamental questions about Medicare’s recent decision to only pay for Aduhelm and other similar Alzheimer’s drugs when patients are enrolled in a clinical trial.  Namely, they want to know what happens if a new Alzheimer’s treatment comes out with better data — and what type of data a drug maker would need to present to actually convince Medicare to cover the drug.  Their new analysis of the decision goes on to list a number of other major questions that, frankly, you’d think would already be answered in a decision of this magnitude. They include: Would strong evidence from one Alzheimer’s drug impact Medicare coverage for the whole class? And will CMS not cover a highly effective drug if its clinical trials aren't diverse enough?  Duke-Margolis aren't the only ones with questions for CMS. The agency has already received nearly 350 comments since releasing the proposed coverage decision earlier this month. STAT stories you may have missed  Biden just launched a massive, slapdash effort to distribute free Covid-19 tests by mail. Can it turn his flagging Covid response around? Negative descriptors are more likely to appear in health records of Black patients, study finds. Once billed as a revolution in medicine, IBM’s Watson Health is sold off in parts. Opinion: We all need help working through grief and hardship. Biotech stocks are a dumpster fire. An analyst explains what's going on.  Thanks for reading! More next week, @NicholasFlorko Continue reading the latest health & science news with the STAT app Download on the App Store or get it on Google Play Tuesday, January 25, 2022       1 Exchange Pl, Suite 201, Boston, MA 02109 ©2022, All Rights Reserved. I no longer wish to receive STAT emails Update Email Preferences | Contact Us | View In Browser