Breaking News

NIH’s dysfunctional long Covid research, SCOTUS delays on abortion pill, and Senate waffles on insulin

April 20, 2023
Reporter, D.C. Diagnosis Writer

Hello, and happy Thursday of a hectic week back from Congress' spring break! In honor of 420 Day, I'd recommend checking out former D.C. Diagnosis author Nick Florko's excellent reporting on how some sellers are skirting state laws that strictly prohibit marijuana. Ping me at rachel.cohrs@statnews.com.

 long covid

The NIH's dysfunctional $1 billion long Covid research project

stat_longcovid_f1_2000x1125bMIKE REDDY FOR STAT

More than two years after the National Institutes of Health got $1.2 billion to study long Covid, it still hasn't enrolled a single patient in a clinical trial to test treatments. The projected start date has been pushed back at least four separate times, a new investigation reported by myself and Betsy Ladyzhets with MuckRock uncovered

Even the few trials it is planning have already drawn a firestorm of criticism, especially one intervention that experts and advocates say may actually make some patients' long Covid symptoms worse.

Patient advocates and experts are losing patience as millions of Americans suffering from long Covid wait for some sort of treatment to offer hope and relief.

"So far, I don't think we've gotten anything for a billion dollars," said Ezekiel Emanuel, a physician, vice provost for global initiatives, and co-director of the Healthcare Transformation Institute at the University of Pennsylvania. "That is just unacceptable, and it's a serious dysfunction."

The NIH is also running up against the limits of its funding, but it's not asking for any more money from Congress and has refused to allocate any of its internal funding to expand the research, either. Read the full report here.


abortion

SCOTUS puts off mifepristone decision until Friday

The Supreme Court extended a stay on limits to the FDA-approved abortion pill on Wednesday just hours before its deadline to weigh in — putting off a decision that could upend federal authority to regulate drugs.

Justice Samuel Alito's brief order gives the conservative-majority panel until the end of Friday to determine mifepristone's fate after a Texas judge ordered its withdrawal from market and an appeals court reinstated its availability but barred mail-order prescriptions, STAT's Sarah Owermohle writes. The FDA and a bevy of drugmakers argue that both those scenarios throw the drug approval process into disarray and could fuel challenges to any product activists find controversial.

To make matters more complicated, generic mifepristone maker GenBioPro sued the FDA yesterday too, demanding that the agency keep the drug on the market regardless of what the court decides. Come Friday night, the FDA and abortion access even in progressive states could be in unchartered territory.


drug pricing

Senate waffling on strategy to lower insulin costs

Senate Democrats are trying to cap insulin costs for every American, but they haven't figured out the thorniest issue: exactly how to do it

Senate Majority Leader Chuck Schumer is eventually going to have to mediate between two different proposals that would lower costs for patients, but he hasn't made any commitments yet. 

I spoke with Sen. Raphael Warnock (D-Ga.) yesterday about his conversation with Schumer this week on the issue, how he's planning to pay for his legislation capping costs at $35 per month for insured and uninsured patients, and how he's walking the tightrope of pushing reforms as a relatively new member. Here's the full dispatch from our conversation



hospitals

House GOP takes aim at hospitals

House Republicans unveiled draft bills yesterday that would be incredibly bad news for hospitals' bottom lines, my colleague Bob Herman reports

The laundry list of hospital pricing proposals includes some far-reaching policies that would authorize Medicare to pay hospitals the identical amount for the same service, regardless of where the service was performed.

Hospitals are still analyzing the bill text, but one industry lobbyist told STAT it would be "an enormous, catastrophic reduction in payment for hospitals." Read Bob's full analysis.


regulations

You mad bro?

The brand drug industry's biggest lobbying group on Wednesday railed against the substance of Medicare's plan to negotiate drug prices and the government's process for designing it. But others say the PhRMA is crying wolf, my colleague John Wilkerson reports. 

Executives for the Pharmaceutical Research and Manufacturers of America worry that Medicare officials will pay only the cost of manufacturing drugs, plus a small profit margin, even though the program guidance rejects using the unit cost of production as the starting point in price negotiations. They also warned that the program will discourage the development of drugs for cardiovascular disease, mental health and cancer, and argued that the new law discourages companies from improving upon existing drugs. 

"This is really an exercise in punishing drug manufacturers," said Lauren Neves, deputy vice president for policy and research at PhRMA. The group's full comments are here, and John's story is here


influence

Lobbying cutbacks for generics

The deadline to file lobbying reports for the first quarter of the new Congress is today, but we already have some insights from early bird filers.

The generics lobby AAM slashed its lobbying budget in half last quarter compared with last year. The group, which recently fired top executives, spent $480,000 this quarter compared with $830,000 over the same period of 2022. Disclosures show AAM also terminated its contract with Kountoupes Denham Carr & Reid.

For background, check out my colleague John Wilkerson's reporting on how generics opposed the Inflation Reduction Act, even though it may end up benefiting them in the end.


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

What we're reading

  • Josh Hawley wants the government to play a bigger role in lowering drug prices, NBC News
  • FDA's Califf talks cell and gene therapies, abortion pill, Alzheimer's drugs, STAT
  • 'I hate you, Kathie Lee Gifford!' Ozempic users report bizarre dreams, Wall Street Journal
  • Mindpath seemed like a success story for private equity in mental health. Now, it's a cautionary tale, STAT

Thanks for reading! More next week,


Enjoying D.C. Diagnosis? Tell us about your experience
Continue reading the latest health & science news with the STAT app
Download on the App Store or get it on Google Play
STAT
STAT, 1 Exchange Place, Boston, MA
©2023, All Rights Reserved.

No comments