Big questions about Biden’s response to Omicron

Top Biden administration health officials are headed to Congress today for a hearing on the Covid-19 pandemic as they face pressure over everything from testing access to school closures. The witnesses — NIAID’s Anthony Fauci, CDC’s Rochelle Walensky, FDA’s Janet Woodcock, and Dawn O’Connell, the assistant health secretary for preparedness and response — will be grilled over their response to the Omicron surge. STAT reporters assembled some questions of their own, such as when the 500 million rapid tests promised by the administration will become available, how reliable they are against Omicron, whether more boosters are in our future, and whether U.S. strategy to fight Covid needs to be reframed. Also: Children under 5 still can't be vaccinated. Did developing vaccines for the youngest children need to take this long? Read more.

A first: Man receives a heart transplant from a genetically altered pig

In a milestone for transplantation medicine that gives hope to thousands of patients waiting for scarce organ donations, a 57-year-old man with life-threatening heart disease has received a heart from a genetically modified pig, the New York Times reports. The first successful transplant of a pig’s heart into a human took place in Baltimore on Friday. The patient, David Bennett of Maryland, was too sick to qualify for a human donor heart, but yesterday he was doing well with his new organ, his surgeons at the University of Maryland Medical Center said. “We are thrilled, but we don’t know what tomorrow will bring us,” his surgeon, Bartley Griffith, told the Times. The procedure depends on years of research on gene editing and cloning (some history here) in order to develop pig organs less likely to be rejected by humans. STAT's Megan Molteni explores the ethics questions sparked by the transplant.

HHS chief orders Medicare to reconsider premium hike following price drop for Biogen’s Aduhelm

HHS Secretary Xavier Becerra has ordered Medicare to reconsider a historic hike in premiums after Biogen slashed the price for its controversial Alzheimer’s drug. “With the 50% price drop of Aduhelm on January 1, there is a compelling basis for CMS to reexamine the previous recommendation,” Becerra said in a statement yesterday, just before Medicare’s draft Aduhelm coverage decision is expected to hit tomorrow. The highly unusual step follows Medicare’s largest-ever premium increase for 2021, citing uncertainty in November around Aduhelm, a therapy that's been characterized by its questionable clinical benefit, high price, and potentially serious side effects. Biogen cut its price to $28,200 in December after dismal uptake of the drug, which many academic medical centers have refused to administer. STAT’s Rachel Cohrs has more.

Inside STAT: How a couple facing ALS used their D.C. clout to galvanize a movement

Sandra Abrevaya and her husband, Brian Wallach, at their home in Kenilworth, Ill. (Kristen Norman for STAT)

Brian Wallach has not yet willed an ALS cure into existence. But since starting from scratch in 2019, he and his wife, Sanrda Abrevaya, have galvanized what is likely the most successful patient advocacy campaign of the 21st century, culminating in President Biden’s signing legislation last month to fund $1 billion of ALS research and patient-focused programs in the next decade. It’s a case study in patient advocacy, politics, and how to balance family, sanity, and the desire to persevere with a dire diagnosis. And it’s a story about how Washington works. “Everyone has told you: Remember that there’s nothing that can be done,” he said, his wife relaying his muffled words during STAT reporter Lev Facher’s two-day visit to the couple’s Illinois home. “You look them in the eye, and you say: ‘Thank you. I’m going to prove you wrong.’” Read more.

Fourth Covid vaccine dose upped antibodies in kidney transplant patients

The Omicron variant has tested the powers of Covid-19 vaccines to protect against infection. Third doses have helped most people withstand the virus, but for people with compromised immunity, boosters haven’t necessarily been enough. A new Annals of Internal Medicine study from France — which in June (while Delta was the major threat) authorized fourth mRNA vaccine doses for organ transplant recipients who had a weak response to a third dose — finds that most kidney transplant patients did muster a stronger immune response after a fourth dose. Among 92 patients at three hospitals, antibody levels increased significantly for all but 10% of them a month after the fourth dose; one patient who had low antibody levels after the fourth dose developed a mild case of Covid. The authors say antibody levels don’t invariably protect against disease, so they urge further research. CDC said in October that immunocompromised people could receive a fourth dose of vaccine.

Breast may be best for mothers' heart health, too

We know that breastfeeding is good for babies, linked to a lower risk of infectious disease. Mothers who breastfeed benefit, too, previous research has shown, with a reduced risk of type 2 diabetes, ovarian cancer, and breast cancer. The picture has been less clear for cardiovascular health. A new meta-analysis in the Journal of the American Heart Association, reviewing data from eight studies in more than 1.1 million women around the world, concludes that women who breastfed at some point during their lifetime had a 11% lower risk of developing cardiovascular disease compared to women who never breastfed. “There is room for improvement in raising awareness of breastfeeding recommendations and communicating positive effects of lactation not only on children but also on their mothers,” the authors write.

What to read around the web today

Home Covid tests to be covered by insurers starting Saturday. Associated Press
‘People need to be reminded about flu.’ New York Times
Trial by fire: More study protocols are experiencing substantial — and costly — changes. STAT+
Anti-trans bills hurt mental health for two-thirds of LGBTQ+ youth. The 19th
Pfizer to pay Beam $300 million in gene-editing deal, amping up its mRNA ambitions. STAT+