Breaking News

Drugmakers face penalties for price hikes, EPA moves on 'forever chemicals,' & the rise of vector-borne diseases

March 15, 2023
Reporter, Morning Rounds Writer
Good morning. Today we're watching a Texas courtroom to see what unfolds at a hearing on an abortion medication.

 

politics

Biden administration goes after drugmakers for hiking prices

In a glimpse of how major drug pricing reforms passed in last year's Inflation Reduction Act might play out, the Biden administration said today it will penalize drugmakers for raising prices faster than inflation on 27 medications administered in doctors' offices. On the list are treatments for blood cancer, bladder cancer, lung cancer, chemotherapy-related nausea, bacterial infections, and transplant drugs. Pfizer had the most drugs on the list, which includes AbbVie for its blockbuster rheumatoid arthritis drug, Humira, as well as manufacturers Gilead, Endo, Leadiant Biosciences, and Kamada.

Manufacturers will have to pay penalties for the drugs they sell in the Medicare program, but invoices won't go out until 2025. Medicare patients could see savings sooner because the law requires that their costs exclude price hikes higher than the rate of inflation. The law's biggest change, to empower Medicare to negotiate drug prices, won't take effect for several years. STAT's Rachel Cohrs breaks it down here.


Health

In a first, EPA proposes limits for 'forever chemicals' in drinking water

For the first time, the EPA has proposed enforceable regulations for six "forever chemicals," or PFAS, in drinking water, the agency announced yesterday. It may seem like a long time coming since contaminant-limiting amendments to the Safe Drinking Water Act were made in 1996, but there was one surprise: Instead of setting thresholds for just PFOA and PFOS, EPA also took aim at four more PFAS: PFNA, GenX chemicals, PFHxS, and PFBS.

Still, these are just six of more than 12,000 known "forever chemicals" used in waterproof workout gear, burger wrappers, and cosmetics, as well as firefighting foams and in making nonstick coatings for pans. Their dangers include links to cancer, kidney and liver disease, Crohn's disease, low birth rates, and lower vaccine response. Don't expect changes overnight: Water utilities would begin monitoring for the six PFAS three years after the rule is finalized. STAT's Brittany Trang has more


reproductive health

Hearing on abortion pill opens in Texas today

Today a judge in Texas will hear arguments in a case that could end the availability nationwide of an abortion pill — even where it's legal — and cast a shadow on any FDA-approved drug. All this will unfold in Amarillo, Texas, where, the Washington Post revealed last weekend, a conservative federal judge appointed by former President Trump tried to delay putting today's hearing on the public docket to minimize threats and possible protests.

The suit challenges the FDA's 2000 approval of mifepristone, which is used in half of all abortions. As STAT's Eric Boodman reminded us, if the judge sides with the anti-abortion groups that filed the lawsuit, an appeal could end up before the Supreme Court, in front of the same justices that overturned Roe v. Wade. Meanwhile, more than a dozen Democratic lawmakers have urged pharmacy chains to provide the "strongest possible legal access" to mifepristone for patients, STAT's Ed Silverman tells us.



Closer Look

Climate change is pushing vector-borne diseases to new highs, but preparation lags behind

Thumy Phan for STAT

An outbreak you likely never have heard of hit Arizona in the summer and fall of 2021, when the world was otherwise understandably fixated on Covid-19. But in Maricopa County and elsewhere in the state, there were more than 1,700 reported cases and 127 deaths from West Nile virus, whose emergence in 1999 was a harbinger of vector-borne disease to come in greater numbers, pushed by climate change and brought to humans here by mosquitoes, ticks, and other animals.

It's not just West Nile virus. There's also dengue, which resurfaced in the U.S. in 2009 and in 2022 infected 57 people in Florida via local transmission. Experts worry that both research and surveillance of vector-borne diseases is underfunded at the local and national level, leaving us vulnerable to illnesses local clinicians may not recognize and for which there may not be vaccines. STAT contributor Sara Van Note has more.


science

National Academies urges change in how genetics research applies racial and ethnic labels

Reaffirming that race is a social not biological construct, a new report calls out genetics researchers for inconsistently and inappropriately using racial and ethnic labels and calls for better ways to capture the complex patterns of human genetic variation: "It is time for us to reshape how genetics studies are conceptualized, conducted, and interpreted," the National Academies of Sciences, Engineering, and Medicine authors wrote, noting that outdated methods of grouping people may result in poor scientific results and misguided interpretations. 

Census-style categories such as Black, Asian, or Hispanic aren't appropriate to study genetic variation because such groups aren't homogenous to begin with and genetic variation within them shifts over time. The report's authors didn't offer a new list, but said racial descriptors should be avoided, except in health disparities studies that may need such categories to study harms occurring to certain populations. STAT's Usha Lee McFarling has more.


health

Mediterranean diet cuts women's heart disease risk by 25%, study says

At first glance, research affirming the Mediterranean diet's heart benefits doesn't seem surprising, but the authors of this study in Heart believe it's the first meta-analysis to show that it's true in women. Pooling 16 female-only studies, they found that women who most closely followed the diet rich in whole grains, vegetables, fruit, legumes, nuts, and extra-virgin olive oil had a 24% lower risk of heart disease and a 23% lower risk of dying over the study's 12 years. 

That's striking because sex differences in heart disease have only recently been explored. There are caveats: Like many other nutrition studies, this one is observational and relies on women's recall of what they ate. How the Mediterranean diet works isn't known, but its antioxidant and gut microbiome effects on inflammation and other risk factors may play a role. The authors call for more research on women, including the effects of premature menopause, preeclampsia, and gestational diabetes.


Correction: In an item yesterday about how getting more sleep might mean better vaccine response, I incorrectly described which hepatitis vaccines were used in the study. In addition to flu, they were hepatitis A or B vaccines. (There is no vaccine for hepatitis C.)


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What we're reading

  • Novo Nordisk to lower insulin prices by up to 75% amid growing pressure, STAT
  • In Minnesota, researchers explore how to audit health AI models on a patient level, STAT
  • Neuromarketing and the battle for your brain, Wired

  • Mexico to use traditional medicine, more Cuban doctors, Associated Press

  • Adam's Take: Amylyx's ALS drug launch starts strong. That could be trouble for the FDA, STAT

Thanks for reading! More tomorrow,


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