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Holmes verdict in, a challenge for FDA’s vaccines and biologics chief, & why a ‘human guinea pig’ quit Moderna's trial

    

 

Morning Rounds Elizabeth Cooney

Jury finds Theranos founder Elizabeth Holmes guilty of fraud

Elizabeth Holmes walks into federal court in San Jose, Calif., last month (NIC COURY/AP)

Elizabeth Holmes, the former Theranos CEO who promised to revolutionize medicine but whose company collapsed under the weight of its many misrepresentations, was found guilty of fraud yesterday, capping a saga that came to symbolize Silicon Valley hubris. After seven days of deliberations, a federal jury found Holmes, 37, guilty of defrauding investors while raising money for Theranos. Holmes was convicted of conspiracy to defraud investors and three counts of wire fraud. The jury found her not guilty of conspiring to defraud patients and cleared her on two individual patient-related charges and one count of lying in paid advertisements. Under Holmes, Theranos claimed it could provide quick, accurate medical test results from just a few drops of blood pricked from a finger. In reality, the company’s devices could do no such thing. STAT’s Damian Garde has more.

A new challenge for FDA’s vaccines and biologics chief: getting back to normal

No part of the FDA has been tested by the pandemic quite like the Center for Biologics Evaluation and Research and its Office of Vaccines Research and Review. Now that center, which put much of its work on hold to review Covid-19 vaccine applications at record speed, is trying to get back to normal. “2022 will have to be a year where we transition to working alongside the pandemic, as opposed to being dominated by the pandemic,” Peter Marks, the director of CBER, told STAT’s Nicholas Florko during a wide-ranging interview. “I think it will take us six to 12 months to recover.” STAT+ subscribers can read more about what's next.

CDC panel to weigh boosters for 12- to 15-year-olds

Independent experts who advise the CDC on vaccination policy will meet tomorrow to discuss yesterday’s move by the FDA to extend emergency use authorization for the Pfizer-BioNTech Covid-19 booster shot to include teens aged 12 to 15. It’s possible the panel will issue a "permissive recommendation," saying these youths may get a booster if they wish, but stopping short of urging them to do so. If the committee goes this route, it will likely be because of outstanding questions about the risk of myocarditis and pericarditis — inflammation of the heart and tissue surrounding the heart, respectively — that may be associated with a booster in this age group. The ACIP’s guidance must be approved by CDC Director Rochelle Walensky before it can come into effect. Read more.

Inside STAT: Why a ‘human guinea pig’ is opting out of Moderna's vaccine trials

A vial of the Moderna Covid-19 vaccine. (Mark Lennihan/AP)

In July 2020, Jeremy Menchik, an associate professor of international relations and religion at Boston University, volunteered to be in Moderna’s Covid-19 vaccine trial. One of about 30,000 “human guinea pigs,” he gladly allowed a company that had never brought a vaccine to market use his body as a test subject, which entailed seven visits to a hospital, 24 phone calls, dozens of diary entries, questions about his private life, five blood draws, and numerous nasopharyngeal swabs. But if he knew then what he knows now about the company’s quest for profits, he wouldn’t have participated, he writes in this STAT First Opinion. “Science for outrageous profit that costs people their lives is not noble. That is why I can no longer in good conscience be part of Moderna’s trials, and I urge other Moderna trial participants to resign as well.”

Emergency medics remain locked out of electronic health records — and lessons to be learned

A few years back, Travis Ogden’s ambulance crew raced to revive a 4-year-old who’d drowned, the color starting to return to her lips as they rushed to the hospital. After doctors there took over, Ogden and his crew were left wondering about her fate, but what happens beyond the emergency room doors by and large remains a mystery. That matters for the emergency medics who care about the patients they treat, but perhaps more important, it could make a crucial difference for the next patient if they could only learn the patient’s medical history when they arrive on the scene or what really triggered their crisis. “Everybody wants to win when you’re fighting death,” Ogden said. “Not knowing if you win — it’s the same as a loss.” STAT contributor Marion Renault has more.

7 in 10 cancer patients suffer financial hardship, study finds

It’s called financial toxicity: the economic hardship patients undergo while dealing with difficult diagnoses. A study out today followed 380 patients being treated at community oncology groups across the U.S. after they were diagnosed with metastatic colon cancer. They told the researchers that insurance didn’t protect them from serious money problems. While 98% of them had insurance, 71% fell deeper into debt, took out a new loan, sold or refinanced a home, or experienced at least a 20% decline in income — or a combination of these over the year they answered quarterly surveys. That’s a bigger proportion than found by other surveys conducted longer after cancer diagnosis. Age, race, marital status, employment status, or annual income did not make a significant difference, researchers report in the Journal of the National Cancer Institute.

 

What to read around the web today

  • Desperate patients are shelling out thousands for a long Covid cure. Is it for real? Mother Jones
  • Stop wasting COVID tests, people. The Atlantic
  • Texas is trying to create the next research triangle for biotech. Will it work? STAT+
  • When three shots are not enough. New York Times
  • Drug makers ring in the new year with 5% price hikes on hundreds of medicines. STAT+

Thanks for reading! More tomorrow,

@cooney_liz
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