Improving health outcomes is the stated mission of that network, called Risant Health. Kaiser Permanente formed the Washington, D.C.-based nonprofit collective of doctors, hospitals, and health insurers, last year.

“It’s outpunching its weight class, if you want to put it that way,” Jaewon Ryu, Risant’s CEO, said in an interview with STAT. Ryu was the CEO of Geisinger until it became part of Risant a few months ago.

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After a seven-week trial, the jury ordered the award to be $20 million, but the Alameda County Superior Court concluded last week the award should be reduced to $10 million. Half would be for defamation and past and future damages to the plaintiff, and the remaining $5 million would be in punitive damages. If the plaintiff agrees to the reduction, the court will order Stanford University and Stanford Health Care to pay out the sum.

The employee, patient testing technician Qiqiuia Young, alleged in a 100-page lawsuit filed in 2017 that problems began when her co-workers at Stanford Cancer Center dressed as members of the Ku Klux Klan around Halloween. Photos of at least one person — who was wearing a pillowcase as a hood and was pretending to be a KKK member — were later shown to Young.

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Researchers say the study marks a promising approach that could one day relieve some people with type 1 diabetes of the need for daily insulin injections.

“These cells clearly work,” said Jay Skyler, an endocrinologist at the University of Miami Miller School of Medicine who was not involved in the study.

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Full Medicare coverage for both items has broad bipartisan support, but the expansion has been hampered by the likely exorbitant price tags to the federal government. If the House Ways and Means Committee is able to scale back the measures to a more palatable price point, it could increase their chance of passage.

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“The U.S. is leading the world in technology development, innovation, new gadgets of all kinds, new drugs, you name it,” he said. “These advantages unfortunately are not resulting in superior health and outcomes for the U.S., population, or for most individuals in the U.S.”

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Risant plans to acquire North Carolina’s Cone Health, a Greensboro, N.C.-based system with four acute-care hospitals, more than 700 doctors, and — crucially for Risant — an accountable care organization and a health plan.

Terms of the deal weren’t disclosed, and neither Kaiser nor Cone immediately responded to requests for comment.

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And here is our regular feature in which we highlight a different person each week. This time around, we note that Enterprise Therapeutics hired Renu Gupta as chief medical officer. Previously, she was a consulting chief medical officer at Adiso Therapeutics.

But all work and no play can make for a dull chief medical officer.

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There is much to unpack from the unilateral decision by Peter Marks, the FDA’s top regulator of gene therapies, to expand the use of Sarepta’s Elevidys to nearly all Duchenne patients. Some thoughts:

Sarepta is unshackled. The broad approval — its best-case scenario — gives the company freedom to sell its gene therapy almost without restrictions. Manufacturing capacity — and how fast it can be upgraded — might be one of the only brakes right now on Sarepta’s effort to hit peak U.S. sales of $2-3 billion.

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North Texas U.S. District Court Judge Mark Pittman ruled that federal guidance limiting hospital websites’ use of these trackers exceeds the Health and Human Services Department’s authority under HIPAA, according to an opinion filed Thursday.

The American Hospital Association had sued the Office for Civil Rights, which oversees the federal privacy law known as HIPAA, last year shortly after OCR published a bulletin restricting the use of free tracking technologies, including those offered by Google and Meta. The industry association argued that OCR’s attempts to regulate these tools both exceed its authority and could cause harm to hospitals and their online visitors by depriving them of relevant and accurate information, including translation services and digital maps.

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In a surprise move, Doctors Without Borders is closing down its access-to-medicines campaign, which has been credited with ensuring needed drugs and vaccines have been made available to countless patients in low-income countries around the world, STAT reports. The organization plans to close its campaign by the end of this year and create a new effort devoted to access to products for health care. But unlike its access-to-medicines campaign, the new structure will primarily focus on products — medicines and vaccines — that Doctors Without Borders expects to need for its own relief efforts. A strategic plan for the new structure is not finalized, though, according to sources.

For a third time, Sarepta Therapeutics has convinced a top U.S. Food and Drug Administration official to overrule the prevailing view of their staff and approve a drug for Duchenne muscular dystrophy, STAT tells us. On Thursday evening, the agency announced it expanded the approval of Elevidys, Sarepta’s Duchenne gene therapy, to cover nearly all patients, regardless of age or wheelchair status, despite the fact that the drug failed a large, Phase 3 trial last year. That decision was made almost exclusively by Peter Marks, the director of the Center for Biologics Evaluation and Research, who overruled three review teams and two top lieutenants.

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Buenos dias! Writing from one of the more unique locations in my tenure as a Readout author…. Hola from a mercado in Mexico City. On tap today: Early studies show that checkpoint inhibitors may be more effective if combined with JAK inhibitors. Also, more promising anti-obesity results and perhaps a more potent PrEP for HIV.

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“It was supposed to be for six months. Then it was a year, and then it went into 18 months. I basically had achieved the goals I was there to achieve. They tried to keep me longer” but her mom removed her from Moody’s, said Ayala, who stayed there in the early 1970s and is now a disability rights advocate. “I didn’t even realize how traumatic it all was until years later when someone asked me about it, I just broke down in tears. I was a child, you know? I didn’t understand.”

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At its core, the “patients like mine” concept is simple: The outcomes of similar patients for each care choice being considered are made available to a health care provider, as if she or he asked “What happened to similar patients for whom the same choice was made?”

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Nearly two decades after Smith’s conviction, Dr. Saadi Ghatan, a professor of neurosurgery and pediatrics at Mount Sinai School of Medicine in New York and director of pediatric neurosurgery at Mount Sinai Hospital, reviewed Chandler’s neuroimaging and medical records in 2021 on behalf of the Southern Center for Human Rights, a legal nonprofit that represents Smith. Ghatan identified that Chandler’s death was the result of hypoxic-ischemic brain damage from respiratory arrest by a natural disease process, likely the result of a seizure, not shaken baby syndrome. Those findings led to the Georgia Supreme Court unanimously ruling in 2022 that a hearing should be held on Smith’s conviction. In April of this year, experts testified in a six-day hearing on whether the medical diagnosis used to convict Smith was valid. Still in prison, he awaits the judge’s decision from that hearing.

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On Thursday evening, the FDA announced it expanded the approval of Elevidys, Sarepta’s Duchenne gene therapy, to cover nearly all patients, regardless of age or wheelchair status, despite the fact that the drug failed a large, Phase 3 trial last year. 

That decision, documents concurrently released by the agency show, was made almost exclusively by Peter Marks, the agency’s director of the Center for Biologics Evaluation and Research. He overruled three review teams and two top lieutenants, who wrote that the data Sarepta submitted “cast significant uncertainty regarding the benefits of treatment.”

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BOSTON — Ginkgo Bioworks, the once-high-flying Boston life sciences firm, on Thursday said it has notified 158 employees that they will be laid off and expects to announce another batch of layoffs next week.

On May 9, Ginkgo said it would slash labor costs by at least 25 percent. But the Boston-based cell programming and biosecurity company declined to specify the number of workers who would be let go.

This week Ginkgo said in a filing with the state Executive Office of Labor and Workforce Development that it plans 158 layoffs. Joseph Fridman, a Ginkgo spokesman, said the company intended to disclose more planned layoffs to the state next week. He declined to say how many more.

Gestational diabetes has long been diagnosed between weeks 24 and 28 of pregnancy. But a recent randomized control study called Treatment of Booking Gestational Diabetes Mellitus, or TOBOGM, which was started in 2018 and whose results were published earlier this year, found that treating gestational diabetes before week 20 reduced the risk of severe perinatal complications, including preterm birth, low birthweight, stillbirth, and respiratory distress. The early treatment was most effective in women who had high blood glucose levels after an oral glucose tolerance test, which measures how well the body can metabolize the sugar in a very sweet, Gatorade-like drink. 

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The decision will likely be greeted by many families and doctors as a turning point in the fight against the muscle-wasting disease, even if it’s not nearly the seismic shift some had hoped for just a couple of years ago.

Gene therapy had long been seen as one of the approaches that might cure or at least halt the fatal condition. But clinical trials have presented a far murkier reality. Three different randomized studies of Duchenne gene therapies, including the only two conducted with Elevidys, have failed to reach their primary endpoints. And reports have circulated of boys — Duchenne mostly affects boys — whose conditions begin to decline just a couple years after treatment.

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On Thursday, Change will begin to notify health care providers, insurance companies, and other customers that their patients’ data was stolen in the company’s February cyberattack, the company said in a statement. Change, a unit of UnitedHealth Group, plans to send letters to individual patients starting in late July.

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Specific details were not released, but the deal was announced after a U.K. cost-effectiveness watchdog decided to recommend the Vertex medicines for coverage by the NHS. Last November, the National Institute for Health and Care Excellence acknowledged the medications offered notable clinical benefits, but did not endorse the value, pending further deliberations and public comments.

The arrangement will cover a groundbreaking treatment called Trikafta — which is known as Kaftrio in the U.K. — and two other cystic fibrosis medications sold by the company for all existing and future patients in England, as well as any license extensions made later. Vertex and the agencies also agreed to “work together” to provide access for the next iteration of Trikafta, a triple combination medication.

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