| | | | |  | | By Ben Leonard, Evan Peng and Erin Schumaker | | | | | 
There's a new plan to help people addicted to fentanyl. | Jae C. Hong/AP Photo | Clinical trials are set to begin this month on a novel fentanyl-addiction therapy that its maker hopes will crush the curve of fatal fentanyl overdoses, now cresting at around 70,000 a year. Cessation Therapeutics, of Chapel Hill, N.C., has the Food and Drug Administration’s approval to begin testing its monoclonal antibody that aims to prevent fentanyl from reaching the brain. That should protect fentanyl users from some of the drug's effects, like respiratory depression, that can cause fatal overdoses. “It’s there to sequest fentanyl, to sort of Pac-Man fentanyl up before it can ever get to the brain,” said Andy Barrett, the firm’s chief scientific officer. In primates, it’s worked with fentanyl analogs and has extinguished drug-taking behavior over time. CEO Tracy Woody said if trials succeed and the treatment hits the market, she expects it will not only reduce overdoses, but also help people quit. “This not only protects you from an overdose, but it also shuts down any euphoric feeling that you would get from fentanyl,” CEO Tracy Woody said, making quitting easier. Even so: Patients would have to see a doctor monthly to get the drug, which could slow uptake. But ensuring more frequent visits with providers is good for patients, she said. What’s next? If all goes well, the treatment could be on the market by the end of 2025, Woody said. The firm is exploring emergency use authorization and expedited FDA processes to get it there faster.
| | | | HITTING YOUR INBOX AUGUST 14—CALIFORNIA CLIMATE: Climate change isn’t just about the weather. It's also about how we do business and create new policies, especially in California. So we have something cool for you: A brand-new California Climate newsletter. It's not just climate or science chat, it's your daily cheat sheet to understanding how the legislative landscape around climate change is shaking up industries across the Golden State. Cut through the jargon and get the latest developments in California as lawmakers and industry leaders adapt to the changing climate. Subscribe now to California Climate to keep up with the changes. | | | | | | | | | 
Moraine Lake, Alberta | Evan Peng | This is where we explore the ideas and innovators shaping health care. Look up! A big, bright sturgeon moon will reach its peak on Tuesday at 2:32 p.m. Eastern time. It's the first of two August supermoons. The second, a blue moon, peaks August 30. You can also livestream the moon as it rises over Rome's Colosseum via the Virtual Telescope Project. Share any thoughts, news, tips and feedback with Ben Leonard at bleonard@politico.com, Ruth Reader at rreader@politico.com, Carmen Paun at cpaun@politico.com or Erin Schumaker at eschumaker@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp. Today on our Pulse Check podcast, host Kelly Hooper talks with Daniel Payne about his reporting on the forthcoming Biden administration regulation — opposed by industry leaders and patient advocates — that would set minimum staffing requirements for nursing homes.
| | | | | | |  Senate leaders found common cause in passing the annual defense policy bill last week. | AP | The Senate passed its annual defense policy bill by a wide, bipartisan margin before skipping town for Congress’ August recess last week. It contains several significant health care provisions that could make it into law: — Coverage of assisted reproductive technology (but not in-vitro fertilization) for service members and dependents — Establishment of a program to treat service members for PTSD and other disorders related to military sexual trauma — A requirement for an annual report on military overdoses, both fatal and nonfatal — A directive for the secretary of Defense to create a plan to disrupt fentanyl trafficking — A pilot program to assess the feasibility and advisability of building up the Mexican military’s capacity to counter drug cartels What’s next? Senators must reconcile their version of the National Defense Authorization Act with the one the House passed on a party-line vote earlier this month. The House bill included myriad controversial provisions, including some on abortion and transgender care, pushed by the socially conservative wing of the GOP. It’s widely expected that the most controversial items will be removed during negotiations, allowing the bill to become law, as it has for 62 straight years.
| | | | YOUR TICKET INSIDE THE GOLDEN STATE POLITICAL ARENA: California Playbook delivers the latest intel, buzzy scoops and exclusive coverage from Sacramento and Los Angeles to Silicon Valley and across the state. Don't miss out on the daily must-read for political aficionados and professionals with an outsized interest in California politics, policy and power. Subscribe today. | | | | | | | | |  Getting transgender care is getting harder in much of the country. | AP | Youth seeking gender-affirming care must drive significantly longer to access it as laws barring the prescription of hormones or surgery to minors are passed in states, a new analysis has found. University of Michigan researchers calculated the median time it would take in each state to drive, with no traffic, to the nearest clinic offering gender-affirming drugs. The researchers accounted for clinics in states where gender-affirming care for minors is restricted. The percentage of those ages 10 to 17 who live more than an hour’s drive from a clinic offering gender-affirming drugs grew from 27.2 percent to 50 percent because of state restrictions, the researchers found. These states had the largest increase in median drive time: — Florida, from 0.5 hours to 9.0 hours — Texas, from 0.9 hours to 7.6 hours — Arkansas, from 0.9 hours to 6.2 hours — Utah, from 0.7 hours to 5.7 hours Why it matters: Since a large proportion of clinics are in states with restrictions, it’s unknown whether the clinics in states without restrictions can absorb the extra demand from out-of-state patients, the researchers wrote. And more states are considering restrictions, potentially affecting more transgender youth. | | | | Follow us on Twitter | | | | Follow us | | | | |
