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Reporting from the frontiers of health and medicine
Updated: 2 hours 22 min ago

STAT+: Colombia issues a compulsory license for an HIV medicine and ‘plants a flag for global health equity’

3 hours 42 min ago

After months of deliberation, the Colombian government has issued a compulsory license for an HIV medicine, the first time the country has taken such a step, one that also marks a significant move in the increasingly global battle over access to medicines.

The license is designed so that tens of thousands of Colombians can obtain a lower-cost version of dolutegravir, a medicine that is manufactured and sold by ViiV Healthcare, a company that specializes in HIV treatments and is largely controlled by GSK. Dolutegravir is recommended by the World Health Organization as part of the preferred first-line treatment regimen for people living with HIV.

A compulsory license allows a country to grant a license to a public agency or a generic drugmaker to copy a patented medicine without the consent of the brand-name company that owns the patent. The right to take this step, which can be used to lower the cost of a prescription medicine, was memorialized in a World Trade Organization agreement. (Here is a primer.)

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STAT+: FTC’s noncompete ban immediately challenged in Texas district lawsuit

6 hours 47 min ago

Vindication came swiftly on Wednesday for those who predicted legal challenges to the Federal Trade Commission’s brand-new noncompete ban, which could upend practices in the health care industry.

Four business groups, including the prominent U.S. Chamber of Commerce, filed a lawsuit in the Eastern District of Texas on Wednesday morning, not even a full day after FTC commissioners voted narrowly in favor of the sweeping prohibition on agreements that prevent employees from working for competitors. All four said their members use noncompetes and would be harmed if the rule takes effect.

Texas’ Eastern District has proven a friendly — and popular — venue for those battling the Biden administration’s health care efforts. Last year, three provider lobbying groups withdrew their lawsuits in Washington, D.C. against a federal surprise billing ban to instead support a similar case in the district, which ultimately prevailed.

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STAT+: Takeda is fourth big company to leave BIO since December

7 hours 10 min ago

WASHINGTON — Takeda Pharmaceuticals has left the biotechnology industry’s main lobbying group, the fourth departure of a major member since December, the company confirmed.

“Takeda decided not to renew its membership with the Biotechnology Innovation Organization at the end of March 2024, aligned with the end of Takeda’s Fiscal Year,” a company spokesperson said.

Pfizer, UCB, and WuXi AppTech also recently ended their membership with the trade group, though the circumstances of WuXi’s departure were unusual. In response to BIO’s opposition to a bill that would make it difficult for WuXi to do business in the United States, the chair of the House Select Committee on the Chinese Communist Party asked the Justice Department to investigate whether BIO was lobbying for the Chinese Communist Party. BIO CEO John Crowley asked WuXi to quit the organization soon thereafter.

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Supreme Court judges wrestle with abortion access in emergency cases

9 hours 55 min ago

WASHINGTON — Nearly two years after the Supreme Court overturned Roe v. Wade, justices are wrestling with a litany of state abortion restrictions, and whether they undercut federal law.

The latest abortion battle before the court centers on national requirements that doctors do everything they can to stabilize an emergency room patient, including performing an abortion if necessary. The Biden administration sued Idaho in the months after the court’s Dobbs decision in 2022, arguing the state’s new abortion ban clashed with the requirements of the Emergency Medical Treatment and Labor Act (EMTALA).

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Watch: What we know about traces of H5N1 bird flu found in pasteurized milk

10 hours 14 min ago

Genetic evidence of the H5N1 bird flu virus was found in grocery store milk in the United States this week, according to the Food and Drug Administration. The news follows the discovery that the avian flu has been detected in dairy cows.

But what do traces of virus in pasteurized milk mean for consumers? In this video, STAT explains what is known about the safety of milk on grocery shelves.

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She was too sick for a traditional transplant. So she received a pig kidney and a heart pump

10 hours 27 min ago

NEW YORK — Doctors have transplanted a pig kidney into a New Jersey woman who was near death, part of a dramatic pair of surgeries that also stabilized her failing heart.

Lisa Pisano’s combination of heart and kidney failure left her too sick to qualify for a traditional transplant, and out of options. Then doctors at NYU Langone Health devised a novel one-two punch: Implant a mechanical pump to keep her heart beating and days later transplant a kidney from a genetically modified pig.

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USDA orders H5N1 testing of some dairy cows to limit spread of bird flu

10 hours 35 min ago

The U.S. Department of Agriculture moved to try to limit spread of the H5N1 bird flu virus among dairy cattle on Wednesday, issuing a federal order that will require an animal to test negative for the virus before it can be moved across state lines. It also requires laboratories and state veterinarians to report to the USDA any animals that have tested positive for H5N1 or any other influenza A virus.

In addition, farms that move cattle across state lines and have animals that test positive for H5N1 or any influenza A virus will be required to open their books to investigators, so they can trace movement of cattle from infected herds.

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STAT+: Biogen’s Alzheimer’s drug launch on ‘steady pace’ as logistical hurdles recede

12 hours 58 min ago

Biogen on Wednesday reported first-quarter earnings that beat Wall Street expectations largely on reduced expenses. Total revenue was slightly weak overall, but sales were stronger for two newly launched medicines — Leqembi and Skyclarys — that matter most to the biotech’s turnaround effort.

Shares rose 5% to $202 in early trading.

Here’s what you need to know from Biogen’s earnings and conference call:

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Decline in heart failure deaths has been undone, led by people under 45

13 hours 5 min ago

Heart failure mortality rates are moving in the wrong direction, a new analysis reports, reversing a decline in deaths that means more people in the United States are dying of the condition today than 25 years ago. The concerning conclusion comes as newer medications are raising hopes for better outcomes in the years to come.

A research letter published Wednesday in JAMA Cardiology tracked U.S. death certificate data from 1999 through 2021, revealing a steady drop in deaths until 2012, when rates plateaued, then began to rise steadily, and accelerated upward once the Covid-19 pandemic arrived. Disparities between men and women and among racial and ethnic groups moved up almost in lockstep, but there was one glaring exception: age. 

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STAT+: A spending frenzy on obesity drugs

13 hours 36 min ago

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Good morning! Today we have some developments about Novo Nordisk’s insulin business, a side of the company that people don’t really talk about anymore, and some news about their GLP-1 business, a side that people can’t stop talking about.

The need-to-know this morning
  • A quick rundown of Biogen’s first quarter earnings: Skyclarys sales of $78 million beat expectations and should assuage concerns about a slow commercial launch. Leqembi sales of $19 million were also better than the lowered expectations, with a “significant increase” in new patient starts seen in March. Adjusted earnings were $3.67 on total revenue of $2.29 billion. Biogen reaffirmed its 2024 guidance.
  • Roche also reported first quarter earnings. In an interview with Bloomberg, CEO Thomas Schinecker said Roche is “open to potential mergers and larger acquisition transactions” to boosts its cardiovascular, metabolism disorders, neuroscience, and oncology portfolios.
Novo’s move to pull an insulin highlights a policy gap

About a year ago, Novo Nordisk announced that it would cut the price of several insulin products by up to 75%. But then several months later, it decided to discontinue one of those products, the basal insulin Levemir.

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STAT+: Pharmalittle: We’re reading about GLP-1 spending, biosimilar patient costs, and more

14 hours 48 min ago

Hello, everyone, and welcome to the middle of the week. Congratulations on making it this far. It is, after all, an accomplishment worth noting. And now, the next step is to forge ahead. And why not? Just consider the alternatives. On that optimistic note, please join us for a needed cup or three of stimulation. Our choice today is, once again, honey almond, the latest addition to the Pharmalot pantry. Meanwhile, here are some items of interest to get you going. Have a wonderful day, and do drop us a line when you hear something juicy. …

A recent series of events highlights a key gap in policy efforts to make insulin available in the U.S. at affordable prices, STAT explains. A year ago, when Novo Nordisk announced it would cut the price of different insulins by up to 75%, President Biden, lawmakers, and patient groups all saw the move as a win. But Novo now plans to discontinue the basal insulin Levemir later this year in the U.S. and patients are already running into supply problems and insurance cutoffs, leaving them with few options. The problem: Even if officials can get drugmakers to cut prices, the companies can yank a drug off the market, without guaranteeing that other manufacturers will continue to make the compound.

Spending on GLP-1 drugs like Ozempic and Wegovy ballooned last year and are set to cost the U.S. health care system and the federal government still more this year and beyond, STAT writes. One study from the American Society of Health-System Pharmacists found that GLP-1 treatments were a main driver of the increase in overall drug spending by health entities such as pharmacies and hospitals last year. In particular, expenditures on Novo Nordisk’s semaglutide — sold as Ozempic for diabetes and Wegovy for obesity — doubled to $38.6 billion, making the drug the top-selling medicine in 2023.

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Chocolate milk will stay on school lunch menus, as USDA reverses course

15 hours 34 min ago

WASHINGTON — Chocolate milk in schools is here to stay.

The U.S. Department of Agriculture announced Wednesday that it has abandoned a previous proposal to restrict the sale of flavored milk in elementary and middle schools. Instead, the USDA will enforce a limit on added sugars in flavored milk starting in the fall of 2025.

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STAT+: Biosimilars haven’t always yielded lower out-of-pocket costs for patients, study finds

16 hours 16 min ago

Two years after biosimilars became available in the U.S., a higher proportion of patients using brand-name biologics were paying out-of-pocket costs, which were also, on average, 12% higher than before, according to a recent study. In addition, patients who used biosimilars often did not pay lower out-of-pocket costs than those who were given brand-name biologic medicines.

Although the trends varied widely by drug, the authors argued their findings suggest the heralded arrival of biosimilars — which are nearly identical variants of brand-name biologics but yield the same health outcomes — failed to fully deliver on their promise. Biosimilars may have lowered health care spending and insurance premiums, but did not produce sufficient direct savings for many patients, they maintained.

“The whole purpose of biosimilars was to introduce competition into the marketplace and lead the [U.S.] health care system to affordable medications,” said Benjamin Rome, one of the study authors and a faculty member at the Program on Regulation, Therapeutics, and Law at Harvard Medical School and Brigham and Women’s Hospital. “The fact that it’s so hard to find savings consistently is disappointing.”

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STAT+: New studies suggest GLP-1 health care costs have only begun to climb

18 hours 34 min ago

Spending on GLP-1 drugs like Ozempic and Wegovy ballooned last year and they’re set to cost the U.S. health care system and the federal government still more this year and beyond, two new reports released Wednesday show.

One study from the American Society of Health-System Pharmacists found that GLP-1 treatments were a main driver of the increase in overall drug spending by health entities such as pharmacies and hospitals last year. In particular, expenditures on Novo Nordisk’s semaglutide — sold as Ozempic for diabetes and Wegovy for obesity — doubled to $38.6 billion, making the drug the top-selling medicine in 2023.

The other report, by health policy research organization KFF, looked at the impact of the recent approval of Wegovy to prevent cardiovascular complications. Medicare is barred from covering drugs for weight loss purposes, but the new approval means the federal payer can now cover Wegovy when prescribed to reduce heart risks. As a result, Medicare could spend $2.8 billion in a year on the single drug, the researchers conservatively estimate.

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Massive amounts of H5N1 vaccine would be needed if there’s a bird flu pandemic. Can we make enough?

19 hours 34 min ago

The unsettling reality of H5N1 bird flu circulating in dairy cow herds in multiple parts of the United States is raising anxiety levels about whether this dangerous virus, which has haunted the sleep of people who worry about influenza pandemics for more than 20 years, could be on a path to acquiring the ability to easily infect people.

To be clear, there is no evidence that this is currently the case — the sole confirmed human case reported in Texas three weeks ago was in a farm worker who had contact with cattle. There is no way to predict if the virus will acquire the capacity to spread between people, or when and under what conditions it would make that fateful leap if it does.

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Opinion: Balancing hope and reality: The promise and peril of blood-based colorectal cancer screening

19 hours 34 min ago

As a gastroenterologist and cancer researcher, my mission is to help my patients live longer, healthier, and cancer-free lives. A rise in the number of younger Americans diagnosed with colorectal cancer worries me — early-age onset colorectal cancer is expected to surge by more than 140% by 2030. But because colorectal cancer is preventable with early screening and detection, it’s possible to reduce the number of Americans diagnosed with this disease in the prime of their lives.

The New England Journal of Medicine recently published a pivotal paper that found a blood test can detect the early stages of colorectal cancer, which is one of a handful of cancers that is increasing every year in Americans younger than age 50.

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STAT+: HCA to expand the use of AI tool to automate clinical documentation in ER

19 hours 34 min ago

HCA Healthcare, the largest for-profit hospital chain in the United States, is planning to expand the use of an artificial intelligence tool to document doctor-patient interactions in its emergency rooms.

The plans for a broader roll out of the AI tool across its network comes nearly a year after the 184-hospital health system started working with medical documentation company Augmedix to pilot its ambient scribe technology at a handful of ER departments within the HCA network.

“The whole goal here was to develop a product that was affordable so that HCA can deploy it across their entire system, their entire network,” Augmedix CEO Manny Krakaris told STAT. An HCA spokesperson confirmed that the hospital chain plans to expand the use of Augmedix Go to more hospitals but did not specify a timeline for the rollout.

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STAT+: Novo Nordisk’s move to discontinue an insulin leaves patients to ‘pick up the pieces’

19 hours 35 min ago

A year ago, when Novo Nordisk announced it would cut the price of multiple insulin products by up to 75%, President Biden, lawmakers, and patient groups all counted the move as a win.

But several months later, Novo decided to discontinue one of those products, the basal insulin Levemir.

Though the insulin won’t officially be off the market until the end of this year, patients are already running into supply disruptions and insurance cutoffs, leaving them with few options. The discontinuation, which is happening only in the U.S., has now drawn alarm from some Democratic senators, who sent a letter to Novo last week demanding an explanation.

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STAT+: Anticompetitive hospital mergers skate by due to FTC’s shallow resources

Tue, 04/23/2024 - 21:01

Over the past two decades, hundreds of hospital mergers have escaped federal antitrust scrutiny and led to both higher prices and less competition, a new study shows.

But the study’s authors, and other researchers, believe the Federal Trade Commission’s hands often are tied. The agency simply doesn’t have enough money or people to crack down on all anticompetitive hospital deals, and some state laws shield hospital mergers from federal review completely.

“The resources available are just not commensurate with what the agency needs,” said Zack Cooper, an associate professor of health policy and economics at Yale University and one of the co-authors of the study. “This isn’t a story of the FTC not knowing what to do. I actually think they really know, very clearly, what to do. It’s a lack of resources, person power, and potentially willingness to do it.”

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STAT+: FTC’s noncompete ban would force sweeping changes in health care, if it survives legal battle

Tue, 04/23/2024 - 16:31

The Federal Trade Commission approved a far-reaching noncompete ban Tuesday that could force sweeping changes across the health care industry. But those changes may not take effect for years — if they ever do — because the contentious rule will almost certainly be held up in litigation.

Commissioners voted three to two in favor of approving the final rule banning noncompete agreements across all sectors of the economy, a change the agency says will lead to more new businesses and higher earnings for workers. Currently, almost one in five Americans are subject to noncompete agreements, most of which would vanish in late August if the final rule takes effect as planned.

Crucially for the health care industry, the noncompete ban does not apply to nonprofit companies, as the FTC determined it only has jurisdiction over for-profit companies. That means the ban likely won’t apply to most of the country’s hospitals, the majority of which are nonprofit, and some of the country’s biggest health insurers.

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