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Biogen's battle-tested new CEO, telehealth's scramble, & CRISPR-CAR-T's mashup

  

 

Morning Rounds

Good morning. We're still watching for more midterm election news on this Veterans Day. We have some from Colorado — stay tuned for more results in the coming days and weeks.

Prescribing certain drugs online may be coming to an end

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Time is running out for health tech companies that can prescribe controlled substances online during the pandemic — and for their patients. When the public health emergency ends, so could the model that allowed companies to prescribe medicines from ADHD drugs to substance use disorder treatment and off-label ketamine for depression without ever seeing a patient in-person. Unless Congress or the DEA intervene, a 2008 law might require patients to visit clinics first before following up with online prescriptions. 

At issue is the Ryan Haight Act, named for a teen who died of an overdose after obtaining an online prescription for Vicodin without ever meeting the prescriber. The DEA was directed to devise rules for exemptions, but until it does, telehealth providers must be ready to scramble. STAT’s Mohana Ravindranath and Katie Palmer explain.

CRISPR-powered CAR-T clears safety bar

It’s an intriguing marriage of two biomedical advances (and acronyms): CRISPR and CAR-T. CRISPR is the gene-editing technology and CAR-T is the bespoke therapy that trains a patient’s immune cells outside the body to fight cancer when returned. Now scientists at the biotech PACT Pharma and UCLA have infused individualized cocktails of CRISPR-edited immune cells into 16 cancer patients with minimal side effects. Each received a custom mixture of T cells carrying new receptors tuned to their specific tumors. It didn’t cure anyone’s cancer, but it didn’t kill anyone either, STAT’s Megan Molteni points out.

And the cells got there a new way: Instead of viral vectors carrying them, this arsenal of cancer-seeking T cells arrived thanks to CRISPR and a zap of electricity, the scientists report in Nature. While one outside expert called it “what the future of CRISPR-powered medicine can be,” it may have to wait. PACT disclosed it had ended the trial early, as a “business decision.” Read more

Little progress made in diversifying U.S. genetics workforce

A first-ever survey of the American human genetics workforce finds little progress has been made to diversify the pool of people who work in the booming field, STAT’s Usha Lee McFarling tells us. This lack of diversity is a problem common throughout STEM and biomedical fields, but has gained particular attention in genetics research because of the longstanding issue of bias in genetic studies due to the focus on predominantly white populations.

The survey of more than 4,300 people showed that the field remains 67% white, 17.5% Asian, 1.5% Black, 2% Hispanic, 1.1% Middle Eastern or North African, less than 1% Native American or Alaskan Native, less than 1% Native Hawaiian or Pacific Islander, and 4.8% multiracial. About 15% of respondents chose not to self-identify their ancestry. Three-quarters of those responding to the survey were women; 6.9% identified as LGBTIA and 0.5% identified as transgender or nonbinary. The report, conducted by the American Society for Human Genetics in collaboration with other genetics groups, is considered a first step toward further diversifying the genetics workforce.

Closer look: Biogen’s new CEO, clear-eyed about challenges, set to take reins

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Christopher Viehbacher, who will start as Biogen’s CEO on Monday, knows that running the company may be one of the toughest jobs in the pharma industry. But he said in an exclusive interview with STAT that after years of working as an investor, and coaching and mentoring other executives, he missed being on the playing field himself. “I’m not the type of guy to go run something that is smoothly running,” said Viehbacher, a former CEO of Sanofi. “That’s not my thing.”
 
Biogen, certainly, has been beset by troubles over the past two years, with the disastrous rollout of the Alzheimer’s drug Aduhelm. The question now is whether Viehbacher’s swashbuckling style will mesh with a company that — its Alzheimer’s drug development aside — has perhaps become one of the most risk-averse biotechs in Boston. STAT's Matthew Herper, Adam Feuerstein, and Jason Mast have more.

Colorado set to legalize ‘medicinal psychedelics’

Colorado looks poised to legalize magic mushrooms after the group opposing the ballot question conceded defeat Wednesday. Proposition 122 has garnered 51.4% of the vote, although the referendum was still too close to call officially. Colorado would become the second state to legalize psychedelics, following Oregon’s 2020 passage of a similar ballot question. Like Oregon, Colorado plans to create licensed “healing centers” where people can take magic mushrooms under supervision.

Psilocybin, the psychedelic molecule in magic mushrooms, is being studied as treatment for mental health conditions including post-traumatic stress disorder and depression, but the studies are so far too few and too small to reach the standards that the FDA needs to consider for medicinal approval. STAT’s Olivia Goldhill has more.

3 million middle and high school students use tobacco products 

Tobacco use at any age is unsafe, but it’s a particular problem for young people because it can set the stage for lifetime addiction. A new CDC study found that nearly 1 in 9 middle and high school students currently use tobacco products, which translates into an estimated 3.08 million students. For the ninth year in a row, e-cigarettes were the most popular product overall and cigars were the most commonly used form of combustible tobacco. 

Tobacco use was highest among these groups:
  • Non-Hispanic American Indian or Alaska Native (13.5%)
  • Lesbian, gay, or bisexual (16%)
  • Transgender (16.6%)
And among those reporting:
  • Severe psychological distress (18.3%) 
  • Low family affluence (12.5%)
  • Low academic achievement (27.2%)

The report’s authors singled out greater exposure to tobacco advertising and more stores selling tobacco, along with other social determinants of health, as possible risk factors.

 

What we're reading

  • Chances of finding Covid-virus ancestor ‘almost nil,’ say virologists, Nature
  • Iran’s doctors have joined the uprising — and are paying the price, Washington Post
  • For its first two medicines, EQRx abandons its bold strategy to lower drug prices, STAT
  • Female college athletes say pressure to cut body fat is toxic, New York Times
  • Juul secures financing to avoid bankruptcy, plans to cut 30% of jobs, Wall Street Journal
  • Unexpected troubles hit large medical billing firm R1 RCM, part-owned by Ascension, STAT

Thanks for reading! More Monday,

@cooney_liz
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