Democrats’ TGIF moment, pathologists defend their turf, & Biogen’s back at the FDA’s doorstep

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Democrats’ TGIF moment

After more than a year of negotiations, House Democrats are set to pass the sweeping health care, climate and tax bill that the Senate cleared last weekend, including drug pricing legislation. The House convenes in the morning Friday, but vote times haven’t been set yet, my colleague Rachel Cohrs reports. Even skeptical moderate House members have expressed their support, and the package is expected to pass. The next stop will be the president’s desk.

There may be another significant drug pricing vote coming later this fall, too, on insulin. Last weekend, Democrats’ proposal to cap insulin costs at $35 for patients with private insurance violated Senate rules and Republicans voted to strike it from the package. Now, Republicans are taking some heat for their votes, and in-cycle Sens. Chuck Grassley (Iowa) and Ron Johnson (Wis.) have tried to use procedure to defend their position.

Senate Majority Leader Chuck Schumer said on MSNBC this week that he’s going to bring up the issue again in the fall when the Senate returns to Washington, though he didn’t specify which bill he’s going to bring up — a simple cost cap introduced by Sen. Raphael Warnock, or a more complicated proposal led by Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine).

Fighting the spread of monkeypox

Earlier this week, the White House and FDA tag-teamed on a strategy to stretch the current supply of monkeypox vaccines by changing how it is administered: from subcutaneously, under the skin, to intradermally, or between the layers of skin. The new delivery method will increase the number of recipients of the Jynneos vaccine five times, extending the supply of 400,000 vials of vaccine to up to 1 million people, according to the White House.

But there are still many unknowns about how monkeypox spreads, as my colleague Megan Molteni reports in a must-read piece on the science of its transmission. And while you’re at it, don’t miss this story from STAT’s Theresa Gaffney, on how the queer community is relying on each other to find monkeypox vaccines, possible remedies, and emotional support, mostly via Twitter and Instagram, in the face of inconsistent messaging from public health authorities.

A whopping 9K comments about … lab tests

A new proposal from CMS would expand the list of personnel able to perform moderate and complex laboratory testing to nurses — much to the chagrin of pathologists. The American Society for Clinical Pathology spurred their members to submit an eye-popping 9000+ public comments opposing the proposed rule, saying that letting nurses perform the tests “recklessly disregards patient health.”

This is the third time the ASCP and other laboratory professional groups have pushed back against letting nurses perform complex laboratory testing: the first push was in 2016 and the second in 2018. The American Association of Nurse Practitioners didn’t respond to a request for comment on this latest effort, but back in 2018, they argued that nurse practitioners who meet the same education or experience requirements should have the “the same opportunity to fulfill this role as their physician colleagues.”

Is this Aduhelm: the sequel?

Two drugmakers, Biogen and Eisai, are working on a Phase 3 clinical trial of another Alzheimer’s disease therapy aimed at toxic brain plaques, with data due out next month, my colleagues Damian Garde and Adam Feuerstein report. If this sounds familiar — it is. Biogen was also the company behind Aduhelm, the controversial drug to treat Alzheimer’s that the FDA approved without clear evidence that the therapy actually slows down the cognitive decline associated with the disease.

Biogen and Eisai submitted the new drug, lecanemab, under the FDA’s accelerated approval pathway, based on the same criteria as Aduhelm — so the agency could soon have another high-profile decision on its hands. The controversy over Aduhelm drew a great deal of criticism of accelerated approval, including from Congress.

Whether we will see the same hullabaloo in Washington over lecanemab that we saw over Aduhelm — and whether it might raise the same debates over pricing and cost — will likely come down to the results of Biogen’s clinical trial. Read more from Damian and Adam, here.

What we’re reading

• Popular diabetes drug found to contain potential carcinogen, Bloomberg
• As billionaires race to fund anti-aging projects, a much-discussed trial goes overlooked, STAT
• “God, no, not another case.” Covid-related stillbirths didn’t have to happen, ProPublica
• The FDA’s ‘breakthrough’ medical devices are finally hitting the market in numbers, STAT