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Covid funding deal near, Califf on trust in FDA, & the gap between primary care and mental health

  

 

Morning Rounds

Good morning. Two of our items touch on the toll of mental health. One is pandemic-related, one is a more constant concern. Read on.

Senate closes in on a $10 billion deal to buy Covid vaccines and therapeutics

Top Senate negotiators are working to reach a deal to provide the Biden administration with $10 billion to buy vaccines and therapeutics, Republican lawmakers said yesterday. Sen. Mitt Romney (R-Utah), who has taken the lead on finding common ground with Democrats to advance some money to replenish the government’s depleted Covid-19 response coffers, told lawmakers a bill is being drafted to provide roughly $10 billion. If that’s the final total, it will be roughly half of the $22.5 billion the White House asked for in March, and one-third of the $30 billion the federal health department estimated it could need in mid-February. The Biden administration has warned that funding shortages will threaten the supply of vaccine booster shots, monoclonal antibody treatments, antiviral pills, and tests. STAT’s Rachel Cohrs has more.

Califf concedes FDA’s Alzheimer’s drug decision affected experts’ trust in the agency

Robert Califf, the FDA’s new commissioner, acknowledged yesterday that the agency’s controversial approval of the Alzheimer’s drug Aduhelm has diminished its standing with experts. “It’s pretty clear that the controversy around this has temporarily impacted the trust in the FDA by people who pay attention to these things,” Califf said during STAT’s Breakthrough Science Summit. He added, however, that he doesn’t feel the broader public has lost trust in the FDA. Califf largely declined to explain how he plans to deal with the continued fallout of the Aduhelm approval or how he plans to win back trust among critics of the decision. “I actually look at the controversy as an opportunity now, because it’s pointing out these systemic issues that, if we solve them, there’ll be a lot less controversy in the future,” he said. STAT’s Nicholas Florko has more.

Pandemic takes a toll on students' mental health

School closures and online-only instruction during the pandemic are tied to damaging effects on students’ mental health in a new CDC survey that spells out in detail the problems high school students faced in 2021. More than a third (37%) said they experienced poor mental health and 44% reported they persistently felt sad or hopeless during the past year. Lesbian, gay, and bisexual youth, and female youth reported greater levels of poor mental health, and over a third (36%) of students said they experienced racism before or during the pandemic. But students who felt connected to adults and peers at school were less likely to report persistent sadness or hopelessness (35% vs. 53%), seriously considering suicide (14% vs. 26%), or attempting suicide (6% vs. 12%). While school connectedness sounds hopeful, fewer than half (47%) reported feeling close to people at school during the pandemic. The Associated Press has details.

Closer look: Between primary care and serious mental illness, a glaring gap

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(Adobe)

Laura Brown knows that she has high cholesterol, and that as someone who lives with bipolar 1 disorder, she faces even higher risk of cardiovascular problems. But going to a doctor’s office for routine care is almost entirely out of the question. A 35-year-old single mother whose two children have their own mental health complications, she experiences intense anxiety about leaving her home. “I know I need to, but it’s hard to find a doctor that isn’t going to look at me like I’m crazy,” Brown said. Like many people with serious mental illness, she often forgoes primary care altogether. The issue has drawn more attention over the past decade, but it’s unclear if the increase in research has created positive outcomes for patients at scale. STAT’s Theresa Gaffney digs into what needs to change.

ARPA-H will be part of the NIH — with a twist

President Biden’s “moonshot” biomedical research agency will be housed within NIH, according to two sources familiar with the decision-making process. The decision marks the end of a lengthy debate in Washington about whether the new agency, known as ARPA-H, should be independent or exist as a wing of the NIH. But there’s a twist: Instead of reporting to the NIH director, the new agency’s leader will report directly to the secretary of health and human services. Health secretary Xavier Becerra began to communicate the decision to Capitol Hill yesterday, just hours ahead of a congressionally imposed deadline. It comes on the heels of a last-ditch lobbying campaign by research advocates desperate for ARPA-H to escape the shadow of the notoriously bureaucratic and slow-moving NIH. STAT’s Lev Facher has the scoop.

Illegal pills containing fentanyl rise dramatically

This image comparing lethal doses of heroin vs. fentanyl appeared in a story that's almost as old as STAT but regularly records some of the highest traffic on our site. (New Hampshire state police forensics lab)

Fentanyl is a cheap, highly potent drug driving a growing and dangerous trend. An NIH-funded study published yesterday in Drug and Alcohol Dependence tracked how much fentanyl is in the illegal drug supply, measured by law enforcement seizures. From 2018 through 2021:

  • Pills containing illicit fentanyl increased nearly 50-fold.
  • The the proportion of pills to total seizures more than doubled.
  • Powder containing fentanyl more than tripled.

The researchers say fentanyl-related drug seizures aren’t a true measure of the drug’s availability, but their rising numbers coincide with increasing rates of overdose deaths related to synthetic opioids. Overall, nearly 106,000 people died from drug overdoses in the 12-month period ending in October 2021, a toll made higher by illicit fentanyl and other synthetic opioids. Fentanyl is about 50 times more potent than heroin, so a lethal dose could be as small as 2 milligrams.

 

What to read around the web today

  • Seriously, why not get a fourth shot? The Atlantic
  • Human blueprint breakthrough: Scientists finally publish ‘gapless’ human genome. Washington Post
  • The health tech tracker for the second quarter: the decisive industry deals and events to watch. STAT+
  • Vertex’s non-opioid painkiller meets goals in mid-stage studies. STAT+
  • In the wake of big patent decision, it’s business as usual for CRISPR therapy developers. STAT

Thanks for reading! More Monday,

@cooney_liz
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