NIH’s slow, often opaque efforts to study long Covid are sparking ire

(molly ferguson for stat)

The NIH is fumbling its first efforts to study long Covid. More than 15 months ago, Congress showered the agency with $1.2 billion to research the mysterious cases of patients who never fully recover from Covid-19 infections. But so far the NIH has brought in just 3% of the patients it plans to recruit. Critics charge that NIH is acting without urgency, taking on vague, open-ended research questions rather than testing therapies. Even the NIH admits the pace has been dissatisfying, as it balances responsibly designing large-scale research and ensuring it doesn’t buckle under bureaucracy. “Everybody is frustrated about how slow things are,” NINDS director and study co-chair Walter Koroshetz told STAT’s Rachel Cohrs. But he added that while starting enrollment “took way too much time,” the NIH stood up the study “much faster than we’ve done anything else before.” Read more.

FDA review takes a dim view of ALS drug, but also cites ‘regulatory flexibility’

Ahead of tomorrow’s meeting of outside experts to advise the FDA on an experimental ALS drug, the agency’s own reviewers said results from a single clinical trial of the Amylyx Pharmaceuticals drug “may not be sufficiently persuasive” to support approval. The agency’s scientists criticized both the data, which showed a modest slowing of disease progression but no survival benefit, and conduct of the study. The FDA also noted it can exercise “regulatory flexibility” to approve drugs for serious diseases with unmet medical needs. Tomorrow’s panel will review the clinical trial and vote on whether the data are strong enough to support its approval. Patients with ALS, their caregivers, and advocacy groups have been applying pressure on the FDA to approve a treatment against an almost universally fatal disease. Advocates will get 90 minutes tomorrow to make their case for the drug. STAT's Adam Feuerstein has more in STAT+.

Lawmakers push Becerra to keep ARPA-H independent

Health secretary Xavier Becerra has a big decision on his hands this week: Whether ARPA-H, the Biden administration’s new moonshot-focused research agency, will exist as a standalone agency or as part of the NIH. It’s a divisive question in Washington, and both sides of the debate are lobbying him hard. Last week, two powerful Democratic lawmakers who met with Becerra urged him to keep the agency independent, and House Speaker Nancy Pelosi has communicated the same position directly to the White House. But a number of key senators, White House science adviser (and former NIH director) Francis Collins, and the leaders of several science advocacy groups are pushing in the other direction. Becerra faces a Wednesday deadline on the agency’s fate, and there’s no telling what he’ll decide, STAT’s Lev Facher reports. Read more in STAT+.

Closer look: Afghan refugees grapple with grief, trauma, and barriers to mental health care

Salek Haseer (second from left) and family members pose for a photo in Germany, during their final few days in a U.S. Army camp. (Courtesy aryan fardeen)

For 17-year-old Salek Haseer, video games are an escape. They’re a way, however fleeting, to put on pause his thoughts about fleeing Afghanistan last August, about leaving his father behind and about his new home. “It’s not like I like to play the games,” Haseer said. “I play to remove my feelings.” Since resettling in Virginia with his three siblings and mother, Haseer and his family are among a wave of Afghans who have sought refuge in the U.S. in recent months. While there are mental health resources available to Afghan refugees — granted temporary protected status in the U.S. — there are significant barriers to accessing that care. There is also, for many, an urgent need for it: Families like Haseer’s are grappling with grief, depression, and post-traumatic stress disorder after living through war and having to leave their homes. STAT contributors Grace Deng and Jenny Jiin Huh have more.

Covid's racial disparities extend to cancer patients

At this juncture in the coronavirus pandemic, its disproportionate burden on Black people is clear: While accounting for 13% of the U.S. population, they number 20% of cases and 23% of deaths. Cancer also hits Black people harder. Because cancer and other conditions before infection combine for more severe illness, a new study in JAMA Network Open looked at people with both cancer and Covid-19. This retrospective cohort study of more than 3,500 people from March through November 2020 found that Black patients had worse preexisting comorbidities, severity of Covid when they sought care, and outcomes compared with white patients with cancer and Covid. Black patients were also less likely to receive the antiviral medication remdesivir for Covid than white patients, despite being sicker. “This is a call for action to eradicate root causes of racial inequities,” the authors write.

Fathers’ use of diabetes drug associated with risk of birth defects in boys

Baby boys born to fathers who took a commonly prescribed diabetes drug before their children’s conception were more likely than other babies to have genital birth defects, a large cohort study reports. A new analysis in the Annals of Internal Medicine of more than 1.2 million births from 1997 through 2016 in Denmark concludes 3.3% of babies had birth defects, but that rose to 5.5% of babies whose fathers filled a prescription for metformin in the three months when their fertilizing sperm were developing. Babies whose fathers took insulin were at no higher risk of defects, nor were unexposed siblings of babies exposed to metformin. Channa Jayasena of Imperial College London, who was not involved in the study, noted via the Science Media Centre that the authors “cannot exclude that men on metformin had worse control of their diabetes,” known to affect sperm quality.

What to read around the web today

How a Google billionaire helped pay for Biden's science office. Politico
We study virus evolution. Here’s where we think the coronavirus is going. New York Times
CMMI’s Fowler on health policy’s ‘stubborn challenges,’ her personal ties to medicine. STAT
Commentary: Global vaccination must be swifter. Nature
Opinion: How to fix the two-tier U.S. health payment system. STAT