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Verily's ties to FDA, gender-affirming clinic history redux, & health policy Ph.D. in a PowerPoint slide

 

Morning Rounds

Good morning. For all the Nobel watchers, the prize in physics went to Alain Aspect, John Clauser, and Anton Zeilinger “for experiments with entangled photons, establishing the violation of Bell inequalities and pioneering quantum information science.”

Verily's ties to FDA are adding up

Alphabet raised a few eyebrows when it recently poured $1 billion into its spinout Verily, which is engaged in the business of evidence generation. That means building tools and technical infrastructure for pharma and digital health enterprises hoping to run the next generation of clinical trials. It also means Verily’s ranks are filling up with some FDA veterans, STAT’s Katie Palmer reports. These scientific, policy, and legal experts come to the company as regulators weigh the still-controversial idea of using data gathered outside traditional clinical trials — known as real-world evidence — to make decisions about drugs and medical devices.

A few notable names: Amy Abernethy, formerly FDA’s principal deputy commissioner and acting chief information officer. Kyle Thomson, former associate chief counsel at FDA. And of course, FDA Commissioner Robert Califf — who led health policy and strategy for Verily and Google Health between his first and second stint as commissioner. Read more.

Get a Ph.D. in health policy — from this slide


(Congressional budget office)

When my colleague Bob Herman calls out a single PowerPoint slide, it’s time to pay attention. This one is from a Congressional Budget Office report on health care spending in the U.S., which is not usually on my reading list. But look: It’s a “concise explanation of a half-century’s worth of research and arguments about health care spending in the U.S.,” Bob writes. Its conclusion — capping the prices that hospitals, doctors, and other providers charge private health insurers would lower health care prices significantly more than making providers reveal their prices or bulking up antitrust enforcement — cuts to the chase on how to make a dent in health care spending.

No, people who are insured through their jobs aren’t immune. And no, at long last, shopping around never, ever works. So let’s all add Ph.D. to our resumes now. Thanks, Bob. (Be sure to sign up for his weekly newsletter, Health Care Inc.)

Figuring out why CAR-T doesn't always work

A few weeks ago we told you about research delving into why some people do better after CAR-T therapy for their blood cancers than others. That study looked at certain immune cells called regulatory T cells that counteract the specially trained CAR-T cells, preventing them from fighting the cancer. Now STAT’s Angus Chen takes a deeper dive into this questions, telling us about another, separate study that reached a similar conclusion — and the different paths researchers took to get there.

It's a problem, but it’s actually a hopeful one, Sattva Neelapu, a cancer immunologist at MD Anderson who did not work on either study, told Angus. There are three overarching reasons behind why scientists think CAR-T sometimes fails: the patient’s individual biology, the tumor biology, and CAR-T manufacturing. This falls into the third bucket, Neelapu said, and it’s something that should be relatively easy to fix. Read more.

Closer look: The story of the nation’s first clinic for gender-affirming surgery is a familiar one

(NICOLAS ASFOURIAFP/GETTY IMAGES)

It’s happened before and it’s happening again, a new paper and commentary in the Annals of Internal Medicine say. Nearly 60 years ago, Johns Hopkins Hospital opened the Gender Identity Clinic, a first-of-its-kind clinic to provide gender-affirming surgery that was followed by more than a dozen new clinics opening across the country in the next decade. But the Johns Hopkins clinic closed in 1979 after internal politics and pushback from hospital leadership sealed its fate, Johns Hopkins medical school student Walker Magrath writes.

At the time, the institution said gender-affirming surgeries didn’t benefit patients, but methods used to determine its fate were swiftly questioned by experts, who noted the conclusions might be unreasonable based on the statistics used. Now, “history is repeating itself,” Alex Keuroghlian, who co-authored the editorial, told STAT’s Theresa Gaffney. Read more.

PET scans less likely to find amyloid in Black and Hispanic adults despite higher dementia rates

Treatments for Alzheimer’s disease have been very much in the news of late, from last week’s surprisingly positive results for the experimental therapy lecanemab to the continuing fallout over Aduhelm. What the two drugs have in common are their target: amyloid, the toxic protein that builds up in the brains of people with this form of dementia. Now a large new study in JAMA Neurology raises more questions about amyloid as a biomarker (and hypothesis): PET scans used to diagnose dementia based on amyloid deposits showed that fewer Black, Hispanic, and Asian patients than white patients test positive.

That defies previous research that has found that Black and Hispanic people in the U.S. are up to twice as likely as white people to be diagnosed with dementia. The researchers say higher rates of hypertension, diabetes, and social factors that influence cognitive decline in Black and Hispanic people may explain the difference — and the fact that previous research on amyloid lacked diversity in participants. "If diverse groups are less likely to benefit from amyloid-directed therapies ..., there is a risk these novel treatment options may exacerbate existing racial and ethnic disparities in dementia care," they write.

People with disabilities routinely overlooked in clinical trials, study says

Speaking of clinical trials and the populations they may overlook (see item above), a new study in Health Affairs calls attention to research studies that exclude people with disabilities. Despite federal regulations, including the ADA, and research guidelines, people with disabilities remain underrepresented. One in four Americans has a disability, so it’s easy to understand the potential public health impact of clinical trials not doing enough to include or accommodate people with disabilities.

The current study analyzed 97 research protocols testing treatments for dementia, depression, diabetes, or lung cancer. Those criteria often ruled out people with psychiatric disorders, substance use, HIV or hepatitis, or cognitive or intellectual conditions, usually without explaining why or offering ways to overcome the exclusion. The researchers call for clear scientific and ethical justification of such requirements. “We recommend that eligibility criteria be as inclusive as possible and only as restrictive as necessary,” they write.

 

What we're reading

  • ‘Cycles of panic and neglect’: Head of Pandemic Prevention Institute explains its early death, Science
  • Nursing home surprise: Advantage plans may shorten stays to less time than Medicare covers, Kaiser Health News
  • 'A terrible cycle': Hurricane Fiona, natural disasters expose mental health crisis in Puerto Rico, USA Today
  • Many trials to confirm benefits of drugs granted accelerated approvals are running late, STAT
  • Planned Parenthood plans mobile abortion clinic in Illinois, Associated Press
  • Opinion: How can the latest Alzheimer’s therapy reach patients? Follow this trustworthy process, STAT

Thanks for reading! More tomorrow,

@cooney_liz
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