Closer Look
Divide and conquer: The strategy behind pharma's flurry of lawsuits challenging drug pricing reform
Have you been following the lawsuits filed by pharma companies and trade groups seeking to overturn a new law that allows Medicare to negotiate certain drug prices? The legal actions have been coming fast and furious, first from Merck and Bristol Myers Squibb, followed by the U.S. Chamber of Commerce and PhRMA. The courts where they filed are across the country and the arguments sound familiar. As STAT's Rachel Cohrs puts it, they're dividing and conquering to advance different legal arguments.
To wit: The Merck and Bristol Myers Squibb lawsuits, which rely on the same legal reasoning, were filed by the same firm and even a few of the same attorneys. The PhRMA and Chamber of Commerce suits were also similar to each other, despite different arguments. The scattershot approach could mean the U.S. Supreme Court may have to resolve conflicting decisions, legal experts told Rachel. Read more.
drug supply
Looming penicillin shortage most acute for pregnant adults with syphilis and their newborns
Supply chain problems combined with greater demand for the safest penicillin to treat syphilis in pregnancy and early childhood add up to a critical shortage. Pfizer, which manufactures Bicillin, said it will run out of the version for children as early as the end of this month and for adults in September. That could make already rising syphilis rates climb higher, racial disparities grow wider, and access to the drug in lower-income countries become harder.
"For pregnant adults, this really is the drug of choice," said Erin Fox of University of Utah Health. "Even if you have a penicillin allergy, they will work to desensitize you." The sexually transmitted infection, passed during pregnancy to a newborn, can cause birth defects or death. Having syphilis also weakens how well the body fights HIV and limits how well it responds to HIV treatments. STAT's Bree Iskandar and Abdullahi Tsanni have more.
policy
Medicare puts out new details for covering the Alzheimer's drug Leqembi
We may be near a turning point for a treatment that would slow the inexorable decline after an Alzheimer's diagnosis. Right now most people with mild cognitive impairment who would qualify for Eisai and Biogen's drug Leqembi are on Medicare, which says only those who are enrolled in clinical trials can receive the medication. But full FDA approval could come in just weeks. Yesterday Medicare released the first details about how it plans to collect data from doctors about the drug, which costs $26,500 a year without insurance:
- Patient registry: Doctors must submit information about the patients' diagnosis, blood thinner use, scans or tests of amyloid plaques, any brain swelling or bleeding, and cognitive test results.
- Genotyping patients: It's not required, but may be on offer because patients with two copies of the e4 variant of the ApoE gene are at higher risk of brain swelling or bleeding.
STAT's Rachel Cohrs has more.
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