Breaking News

Court delays abortion pill decision, NIH's long Covid study's short on results, & resistance to studying opioids

April 20, 2023
Reporter, Morning Rounds Writer
Good morning. First, huge thanks to my colleagues Theresa Gaffney, Eric Boodman, and Jason Mast for stellar editions this week. Now we have a STAT-MuckRock investigation on the still-glacial pace of the RECOVER trial studying long Covid. And news on an abortion pill and also on an opioid trial.

reproductive Health

SCOTUS extends deadline on abortion pill decision

The clock's still ticking on a case that could dictate whether an abortion pill will still be on the market in the U.S. Yesterday the U.S. Supreme Court extended a stay until the end of tomorrow that froze limits to the FDA-approved mifepristone. That stay follows a ruling by a federal judge in Texas saying FDA had acted hastily more than two decades ago. Last week an appeals court said the pill could remain available, but barred providers from sending it through the mail. 

In response, the FDA, pharmaceutical companies, and many legal experts have condemned both decisions, pointing to potentially serious and widespread consequences for any FDA-approved drug that inspires controversy. The new deadline comes hours after a generic maker of the drug, GenBioPro, sued the FDA to keep it on the market regardless of the impending decision. STAT's Sarah Owermohle has more.


addiction

FDA's plan to study opioid effectiveness hits turbulence

The tension between fueling the overdose epidemic and relieving chronic pain was on full display yesterday at an FDA scientific advisory committee's meeting on pain drugs. A proposed clinical trial would examine whether long-acting opioids are effective as long-term treatments for chronic pain, but some doctors and researchers said yesterday such a trial would be biased in favor of opioids' efficacy — and by extension, painkiller manufacturers. Others believe the pendulum has swung too far, going from too easy access to opioids to scarcity for people who need their pain eased.

The study under discussion yesterday drew criticism for its design, under which trial participants would first be switched from their current prescription opioid to extended-release morphine. A subgroup would then be moved, without notification, to a placebo group tapered off opioids over eight weeks. Panel member Mary McCann of Harvard Medical School said the trial represented "an awful lot of work for a very predictable answer." STAT's Lev Facher has more.


Health

Breast cancer screening should start based on race and risk, study suggests

Current guidelines for when to begin breast cancer screening are basically one-size-fits-all, but a new study challenges that notion. Evidence already shows a wide racial gap in death rates: Overall mortality is 40% higher for Black than for white women, despite similar prevalence, and for women under 50, the death rate for Black women is double the rate for white women. 

Based on their analysis of more than 415,000 breast cancer deaths from 2011 to 2020, researchers writing in JAMA Network Open support different ages for initial screening. Instead of screening everyone starting at 50, Black patients should begin at 42, white patients at 51, American Indian or Alaska Native at 57, and Asian or Pacific Islanders at 61. "Health policy makers may consider a risk-adapted approach to [breast cancer] screening in which individuals who are at high risk are screened earlier," the researchers say. STAT's Ambar Castillo has more.



Closer Look

NIH is spending $1 billion to study long Covid, but has little to show for it

Illustration of a giant empty pill bottle labeled "long Covid treatment" with a "coming soon" sign taped on the front to illustrate the NIH failing to come up with a cure after billions in fundingMike Reddy for STAT

It certainly seemed like good news back in 2020 when Congress dedicated $1.2 billion for NIH to understand long Covid, the sometimes-debilitating fallout millions of Americans live with after Covid infections. More than two years later, there's still no payoff. Most RECOVER studies launched across the country are observational, meaning they aren't testing treatments on patients. There's no sense of urgency, no push for further funding, no access to more dollars within NIH, and no comparison to the pace of Operation Warp Speed to develop a vaccine.

And there's little accountability, an investigation from STAT's Rachel Cohrs and MuckRock's Betsy Ladyzhets has found. NIH defended its approach and said it is planning five clinical trials of drugs (including Paxlovid) or behavioral therapies. Meanwhile, patients are waiting, all the while living with brain fog, fatigue, digestive problems, muscle weakness, or other troubling symptoms. "The NIH RECOVER study is pointless," said long Covid patient Jenn Cole, who tried to enroll in it. Read more.


public health

Americans worry about RSV while global confidence in childhood vaccines dips

Most Americans are concerned about respiratory syncytial virus, or RSV, a new survey by STAT and The Harris Poll tells us, and they're particularly worried their children or older relatives might catch it. Last fall, RSV sent infants and toddlers across the U.S. to hospitals already strained by Covid-19 and flu. Two RSV vaccines are currently under FDA review. STAT's Ed Silverman has more.

Widening the lens to look at how people around the world perceive already available childhood vaccines, a new UNICEF report finds that confidence in them flagged in 52 of 55 countries during the Covid pandemic. China, India, and Mexico were the only countries where the importance of vaccines held steady or improved. While support remained strong in almost half the countries, it dropped by more than a third in the Republic of Korea, Papua New Guinea, Ghana, Senegal, and Japan after the pandemic emerged. These sentiments coincide with the largest sustained backslide in childhood immunization in 30 years.


coronavirus

CDC endorses updated Covid vaccine plan

It wasn't a formal vote, but a CDC advisory panel yesterday signaled support for FDA's plan announced Tuesday to offer an additional bivalent Covid shot to people who are 65 and older and to those who are immunocompromised. CDC Director Rochelle Walensky later signed off on the changes. People eligible because of their age can receive another mRNA bivalent shot made by Moderna or by partners Pfizer and BioNTech four months after their last one while immunocompromised people can get another one after two months.

Yesterday's discussion also endorsed simplifying the Covid vaccine schedule. Most Americans who've had one dose of bivalent vaccine aren't included in the new plan, but both FDA and CDC have indicated another shot will be authorized for this fall. That topic may come up in June when FDA meets to consider updating strains in the vaccine. STAT's Helen Branswell has more, including some encouraging data on vaccine effectiveness presented by CDC.


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What we're reading

  • White House plans to nominate cancer center chief to lead NIH, Washington Post
  • The 'invented persona' behind a key pandemic database, Science
  •  The high hopes — and high stakes — behind Microsoft and Epic's plan to use generative AI to answer patient questions, STAT
  • Senate still hasn't made hard decisions on lowering insulin costs, STAT
  • Long Covid is being erased — again, The Atlantic
  • PhRMA execs paint grim picture of industry under Medicare drug price negotiation, STAT

Thanks for reading! More tomorrow,


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