Today: FDA advisers are asked to 'predict the future' for Covid vaccines

Today advisers to the FDA will consider how — and whether — Covid-19 vaccines should be reformulated to target new viral strains. It seems almost a given that the FDA will tell manufacturers that it is time to change the composition of their Covid vaccines for the fall, STAT’s Helen Branswell writes, but how and to what are questions that still need answering. As Peter Marks of the FDA told her, the expert panel is being asked to predict the future.

Vaccine makers have already tested updated versions of the shots tailored to the first virus that emerged from Wuhan, but one question remains: Should the vaccines be updated to include two strains — the original virus and a version of Omicron, a bivalent vaccine — or just Omicron itself? Helen and Matthew Herper will be live-blogging today’s meeting here.

Court rules doctors must knowingly violate opioid-prescribing standards for it to be a crime

Intent matters, the Supreme Court ruled yesterday in a case considering whether doctors should be punished for prescribing drugs in a way that amounts to unlawful distribution. The court decided prosecutors must prove that a doctor “knew that he or she was acting in an unauthorized manner, or intended to do so,” said the opinion, written by Justice Stephen Breyer. It comes amid the ongoing opioid epidemic and concern for pain patients not getting the relief they need.

The unanimous ruling follows the cases of Xiulu Ruan of Alabama who was sentenced to 21 years in prison in 2017 after being found guilty of running what the Justice Department called a pill mill, and Shakeel Kahn of Wyoming, who was sentenced to 25 years in prison in 2019 for crimes including drug distribution resulting in death. STAT’s Andrew Joseph has more.

'Mind-blowing': Jennifer Doudna on CRISPR's evolution from science paper to treatment

(Jeff Chiu/AP)

Ten years ago a new paper in Science was pitched as a discovery that might lead to a new “editing tool for genomes.” That tool was CRISPR, for which two of its authors, Jennifer Doudna (shown above) and Emmanuelle Charpentier, won the Nobel Prize in chemistry. Doudna talked with STAT’s Megan Molteni about what’s transpired since then.

Are you surprised this paper didn’t make a bigger splash?
It kind of speaks to the way that scientific discoveries happen. Only in retrospect did it become clear to people who weren’t specialists what an important moment that was.

What do you make of how fast it has evolved?
Recently I had the opportunity to speak over Zoom with Victoria Gray — the first sickle cell patient in the U.S. to be treated with CRISPR. To see that real-world impact within 10 years of that original publication? That’s just mind-blowing to me.

Read the full interview here.

Closer look: Keeping race out of machine learning doesn't help avoid bias

We’ve all heard by now that machine learning tools can carry the racial biases of the humans who enter the information they use. New research tells us that even carefully trained models developed to ignore race can still find it. Two cases in point: One study showed algorithms built on providers’ case notes could predict race even if it wasn't included. Another paper determined self-reported race from CT scans and X-rays. How? “Race is imprinted all over medical data,” STAT’s Katie Palmer writes. “Not just in the words physicians use, but the vital signs and medical images they collect using devices designed with ‘typical’ patients in mind.”

Even if excluding race worked, you might not want to. In a synthetic experiment, race-redacted notes recommended analgesia for acute pain less frequently for Black patients than for white patients. Read more.

Why did FDA ban Juul?

If you were surprised when the FDA pulled Juul off the market last week, you’re not alone. The agency said it had concerns about the e-cigarette company’s toxicology data because Juul hadn’t adequately answered the FDA’s questions about caustic chemicals possibly leaching from the company’s proprietary pods. Several tobacco regulatory experts told STAT’s Nicholas Florko the full picture might not be so straightforward.

They need more data to discern just how big of a public health risk the company’s products might actually pose, but there’s a hitch: The FDA can’t release more information about Juul’s application, and Juul doesn’t seem particularly eager to disclose that data, either. A newly filed lawsuit by Juul challenging the FDA’s decision also redacts almost all the information that might answer the FDA’s concerns. Read more about what we know — and what we may never know.

Socially responsible hospitals make the Lown list

Sixty-six U.S. hospitals have been declared “most socially responsible” by the Lown Institute, a health care think tank whose index measures health equity, value, and outcomes. Its list does not mirror the U.S. News ranking of elite hospitals, whose top 20 earned C's on the Lown list of such metrics as racial inclusivity of patients, employee pay equity, and avoidance of unnecessary procedures.

These five hospitals — out of 3,606 — lead the Lown list:

Adventist Health Howard Hospital. Willits, Calif.
Duke Regional Hospital, Durham, N.C.
Tristar Horizon Medical Center, Dickson, Tenn.
Boston Medical Center, Boston
Salinas Valley Memorial Hospital, Salinas, Calif.

In its third year, the Lown analysis also recognizes 15 hospitals that earned A's while weathering an especially high burden during the pandemic’s first year: 26 or more weeks with at least 10% of inpatient beds filled by Covid patients.

What to read around the web today

Genetic screening results just got harder to handle under new abortion rules, Kaiser Health News
Facebook is bombarding cancer patients with ads for unproven treatments, MIT Technology Review
New guidelines encourage breastfeeding longer, but call for more parental support, New York Times
America is sliding into the long pandemic defeat, The Atlantic
Pharma largely failed to follow human rights principles with its Covid-19 vaccines and drugs, STAT