October 17, 2023
Reporter, D.C. Diagnosis Writer

Hello and Happy Tuesday, D.C. Diagnosis readers! I’ll be a bit remote this week, which doesn’t mean I won’t be tuning into the slew of hearing from Monica Bertagnolli’s confirmation to a House Veterans Affairs discussion on how shrooms and MDMA can curb suicide. As always, send news and tips to sarah.owermohle@statnews.com.

summit 2023

See you at STAT

Permit me being a bit self/STAT-promotional, but by the time you’re reading this I’ll be on my way to Boston for our annual STAT Summit. It’s a packed agenda this week with panels on hospital pricing (hosted by my co-writer Rachel Cohrs), health inequity, cancer care breakthroughs, and the future of obesity drugs.

I’ll be moderating a panel Thursday with HHS Assistant Secretary of Health Rachel Levine on the impact of climate change on our health and what the federal or local government can and can’t do about it. Rachel will interview philanthropist Cynthia Fisher on her effort to pierce opaque hospital prices that has pulled in stars from Fat Joe to French Montana

But a panel I’m personally excited to see: STAT’s Katie Palmer will hand both an infectious disease expert and an AI interface information about a patient’s case. We’ll see what happens next. 

If you’re around, give a shout, but if you can’t make it this year, I’d still love to know what questions you want asked.


senate sagas

Three's the charm?

Rumors have been flying on K Street since last week that Senate HELP Chair Bernie Sanders is considering holding a third hearing featuring pharmaceutical industry executives on Dec. 6 on drug pricing — specifically, why drug prices are higher in the U.S. than in foreign countries, five industry lobbyists told my colleague Rachel Cohrs. But Sanders hasn't told committee members about the plans yet, and his spokesman didn't comment.


Tobacco policy

White House readies for menthol brawl

Biden is about to feel what it’s like to go up against the world’s most powerful tobacco companies. On Friday, the FDA requested White House clearance on a policy that would ultimately ban menthol cigarettes. The tobacco industry has already spent the last few months doing everything it can to drum up opposition, from drafting letters for members of Congress to rallying freedom-focused smokers, according to a review of advertising databases, leaked documents, and research reports, Nick Florko reports.

It would be one of the most consequential tobacco policies coming out of the FDA since the agency was given the authority to regulate the substance in 2009. Researchers have estimated that the ban, if finalized, could prevent hundreds of thousands of premature deaths, particularly among Black smokers, who use these products at a higher rate than other racial groups.

But now it’s with the White House regulatory office, and far from closure. As Nick notes, the OIRA is able to extensively weaken or even kill policies. Plus, the cigarette industry has already heavily courted support especially from Black lawmakers, where it makes the case that menthol bans would disproportionately target Black communities. Nick delves into it more.



breakthroughs

The scientist behind an obesity drug

It took decades for scientists to understand how a gene discovered in anglerfish in the 1980s could be harnessed for insulin. But once they did, it unleashed a storm of conversation about how it should be used, and how it should be paid for, because the product at the end of that quest was obesity drug Wegovy.

Danish scientist Lotte Knudsen was at the center of that discovery, chipping away in a Novo Nordisk lab at how GLP-1 could be maintained in the body long enough to be used at treatment. What her team developed is ultimately on track to be a blockbuster drug that the government is already grappling with paying for. Today, more than 9 million Americans are being prescribed these weekly treatments that curb appetite, tame food craving, and melt pounds. 

My colleague Megan Molteni talked extensively with Knudsen about her work and where it began, and no, it wasn’t anywhere near obesity treatment. Read more from Megan.


Post-covid

NextGen’s next move

The Biden successor to Project Warp Speed late last week dispatched another $500 million of its $5 billion budget to outpace Covid-19. The latest investments include three potential new vaccines aimed at different delivery methods (intranasal) or broadening the way mRNA can catch threats.

One of the recipients is Gritstone Bio, which my colleague Matt Herper wrote about last month. The small New York biotech could receive up to $433 million from the federal government to pursue a sweeping study about whether its broad mRNA vaccine is more effective than approved options. It’s starting with $10 million in a midstage trial.

Other projects include Codagenix, which is developing an intranasal vaccine with one of the world’s largest producers, the Serum Institute of India. Biden officials have said their $5 billion budget is enough to see these next-generation shots and treatments through. The latest dispatch comes amid a Covid-19 case surge and persistently low booster rates.


alzheimer's care

Medicare expands PET scans

The agency on Friday officially expanded its coverage policy for brain scans that detect a brain plaque associated with Alzheimer’s disease, a long-awaited decision from patients and drugmakers who argued that narrow coverage of the scans limited early detection. 

Amyloid PET scans are important tools to help determine whether patients with mild cognitive impairment are good candidates for new Alzheimer’s drugs, including Eisai and Biogen’s drug Leqembi, which means there will likely be an increase in demand for the scans as uptake increases, my colleague Rachel Cohrs writes. 

Previously, Medicare limited coverage for the drug to patients enrolled in clinical studies, and only covered one scan in a patient’s lifetime. The new coverage policy removes those restrictions and delegates decisions about how many scans to cover to regional Medicare administrators. More from Rachel.


More around STAT
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Read premium in-depth biotech, pharma, policy, and life science coverage and analysis with all of our STAT+ articles.

What we’re reading

  • Teva sues Colorado over ‘unconstitutional’ program to lower cost of epinephrine injectors, STAT
  • RFK Jr. surprise guest at event attended by top NJ GOP lawmakers, Democratic Assembly candidate, Politico Pro
  • FDA’s warning to J&J’s Abiomed signals a crackdown on digital health tools, STAT
  • Why the US is the only country that ties your health insurance to your job, Vox



Thanks for reading! More on Thursday,


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