In an analysis in JAMA Network Open, researchers suggest the agency could use large language models or LLMs to enhance Sentinel, the surveillance system for drugs and devices it regulates. Sentinel draws upon clinical records and insurance claims, and the agency uses its analyses to adjust drug labels, convene advisory committees and disseminate drug safety communication, the authors noted. 

AI, the authors suggested, could extract reports of drug safety events from a wider set of sources, including free-text data from electronic health records. But there are still some risks, the biggest of which is the so-called hallucination that LLMs have been known to introduce — by generating false information, LLMs could over- or understate the risks for certain products, for instance. 

Continue to STAT+ to read the full story…

The authors analyzed 40 years of data from a National Science Foundation survey that tracks Ph.D. graduates. They then combined this data with the average team size in a researcher’s field at the time they earned their doctorate, calculated based on the number of authors listed on published research. Doing so showed that, as team size has risen, young researchers have become less likely to earn tenure and secure research funding, and are more likely to leave science altogether. 

Read the rest…

I’ve been masking consistently in public since 2020, when the Covid-19 pandemic began, because I have a kidney transplant and will take immunosuppressant medication for the rest of my life. Unfortunately, my lifesaving medication also makes me more susceptible to infectious diseases like measles, the flu, and Covid-19. Even when people like me are vaccinated against the virus, we are at higher risk of being infected and are more likely to experience adverse health outcomes, including hospitalization and death.

Read the rest…

The trial of vutrisiran, from Alnylam Pharmaceuticals, was already announced as positive, with the drug successfully cutting the risk of death and cardiovascular complications in patients with the disease, called transthyretin amyloid cardiomyopathy, or ATTR-CM. Given the strong data, the RNA-interference therapy is expected to win regulatory approval.

But Alnylam’s drug is not the only option for patients. Pfizer has a pair of competing therapies, and BridgeBio has one nearing approval. Investors and cardiologists have been anticipating the full results of Alnylam’s HELIOS-B trial, which are scheduled to be presented next Friday, Aug. 30, in London at the annual meeting of the European Society of Cardiology. 

Continue to STAT+ to read the full story…

A growing area of focus is on the development of complex generics. These include products with complex active ingredients and complex drug-device combinations, among others. Complex generics are typically difficult to develop, regulatory pathways for them can be convoluted, and the regulatory frameworks differ across health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Read the rest…

It’s the second legal challenge to the rule, following the American Clinical Laboratory Association’s suit in May. The suit, filed in Texas by the Association for Molecular Pathology and University of Texas pathologist Michael Laposata, claims that the FDA overstepped its regulatory bounds when deciding to regulate lab-developed tests. 

“We filed this lawsuit to ask the Court to vacate the FDA rule given the agency’s lack of authority to regulate LDTs and to avert the significant and harmful disruption to laboratory medicine,” said AMP president Maria Arcila in a statement. 

Continue to STAT+ to read the full story…

Instead, their plan this election cycle evokes President Biden’s slogan to “finish the job” — even though they’re running a new candidate. With the notable exception of calling to erase medical debt by working with states, Democrats are largely eyeing marginal extensions or reinstatements of their prior policy achievements. 

The Democrats’ platform, released Monday, is six times the length of Republicans’ brief 16-page policy plan. The most impactful proposals require cooperation from Congress, which may not be decided in Democrats’ favor, even if they are able to maintain the White House. 

Continue to STAT+ to read the full story…

A self-interested plea from Peter Orszag

Peter Orszag, CEO of Lazard, went on CNBC last week and criticized how the Federal Trade Commission and Department of Justice were gumming up health care mergers. Look closely at what he said (emphasis mine):

Read the rest…

Since news of the epidemic, the media has circulated images of patients infected with mpox. Some of these photographs show mpox on patients’ arms, legs, and hands, but others are headshots that resemble mugshots of African people with mpox covering their faces. The photos include an African patient somberly looking into a camera, a doctor’s hand pointing at vesicles on an African child’s face, and a disturbing image of a child who has his hands raised, as if being held up by the police, revealing pustules on his face, hands, and chest. I am purposely not linking to them, because these images tend to pathologize, even criminalize, the patients.

Read the rest…

The list of the first 10 drug prices negotiated for Medicare may emerge as a double-edged sword in pending litigation between the Biden administration and pharmaceutical industry, intensifying the debate over the legal future of the program, Bloomberg Law writes. Nine lawsuits filed by drug companies and trade groups are working their way through the courts. The list of negotiated prices is one piece of a puzzle that has been the foundation of several claims debating how far the government will go with price cuts. The unveiled prices may serve to either give a much needed boost in support for theories that the program causes financial harm to drugmakers, or further bolster U.S. claims that an actual negotiation took place.

As the Federal Trade Commission scrutinizes the pharmaceutical industry, there is growing debate about whether the regulator may next target a deal that some experts say could make it easier for Novo Nordisk to boost production of a key drug — at the expense of competitors, STAT explains. At issue is a complicated transaction sparked by sporadic shortages of one of the world’s hottest-selling medications — the weight loss treatment Wegovy. The deal is designed to solve what has been a critical and seemingly intractable problem for the company, but it is also raising questions about fair play and the longer-term effect on consumers.

Continue to STAT+ to read the full story…

The company — or, at least, what existed at its founding in 2013 — hoped to pull data from images of healthy and diseased cells, and use that data to identify drugs gathering dust on pharmaceutical company shelves that could be repurposed as rare disease treatments. 

The founders were a medical school dropout, an entrepreneur whose most recent success was with a custom sign-making e-commerce shop, and an exacting University of Utah scientist. They didn’t have much in terms of intellectual property — their technology was based around two tools widely shared on the internet, free for anyone to use. And the startup was based in Salt Lake City, Utah — an area better known for its ski slopes and connection to the Church of Jesus Christ of Latter-day Saints than drug development.  

Continue to STAT+ to read the full story…

But while standards exist for assessing and managing distress in patients, it’s often “hidden” in family members, sometimes with devastating consequences, said Weiva Sieh, an epidemiologist at MD Anderson Cancer Center. In a study published in JAMA Oncology on Thursday, spouses of cancer patients were found to be at significantly higher risk of suicide attempt and death compared to those married to people without cancer.  

Read the rest…

Orszag’s comments, made last week on TV, reveal how policymakers can end up profiting from the laws they help create. In this case, the biggest piece of health care legislation in the past half-century has been a fountain of wealth for the financial advisers that help hospitals, health insurers, and other large companies merge with each other.

Orszag, the CEO of Lazard, served in President Barack Obama’s administration and was an architect of the ACA. He lamented last week how antitrust reviewers at Lina Khan’s Federal Trade Commission and Jonathan Kanter’s Antitrust Division at the Department of Justice are increasingly thwarting or stalling deals that have proliferated since the law went into effect in 2010. 

Continue to STAT+ to read the full story…

As the Federal Trade Commission scrutinizes the pharmaceutical industry, there is growing debate about whether the regulator may next target a deal that some experts say could make it easier for Novo Nordisk to boost production of a key drug — at the expense of competitors.

At issue is a complicated transaction sparked by sporadic shortages of one of the world’s hottest-selling medications — the weight loss treatment Wegovy. The deal is designed to solve what has been a critical and seemingly intractable problem for the company, but it is also raising questions about fair play and the longer-term effect on consumers.

Here’s why: Last February, Novo Holdings, the investment arm of Novo Nordisk’s parent foundation, agreed to pay $16.5 billion for Catalent, one of the world’s largest so-called contract development and manufacturing organizations. These companies play a crucial, behind-the-scenes role helping drugmakers clear complex production and regulatory hurdles before their medicines reach the marketplace.

Continue to STAT+ to read the full story…

Using dollops of investors’ cash and massive loans, private equity firms have taken over hundreds of hospitals, thousands of nursing homes, and tens of thousands of medical practices, leaving the hospitals, nursing homes, and practices — not the investors — on the hook to pay off the debt.

Read the rest…

The four-day event in Chicago will kick off as former President Trump increases attacks on rising inflation, economic hardship, and border control policies under the Biden administration. The Republican candidate has not dwelled much on health care in his campaign rhetoric. But Democrats see topics from reproductive rights to lower drug prices as winning issues with voters.

Read the rest…

First, the Food and Drug Administration declined to approve the MDMA-assisted therapy for post-traumatic stress disorder developed by Lykos Therapeutics, a company that he founded. The next day, the journal Psychopharmacology retracted three studies on the treatment, in which many authors were associated with Lykos or the nonprofit Doblin founded, the Multidisciplinary Association for Psychedelic Studies (MAPS). 

On Thursday, Lykos announced it would cut 75% of its staff — and Doblin left the company’s board. Now, MAPS is cutting 33% of its own 42-person staff, it said, in an effort to conserve resources as it hones its focus to drug decriminalization and globalizing access to MDMA. 

Continue to STAT+ to read the full story…

To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor received in response to them. You can submit a Letter to the Editor here, or find the submission form at the end of any First Opinion essay.

Read the rest…

And here is our regular feature in which we highlight a different person each week. This time around, we note that Cerevance hired Sagar Vaidya as chief medical officer. Previously, he worked at Travere Therapeutics, where he was vice president, clinical development.

But all work and no play can make for a dull chief medical officer. “When I was younger, I played in a rock band,” he tells us. “I played guitar and have played the instrument for about 20 years. But during the pandemic, I had some down time and picked up a new instrument — the tabla — an Indian instrument. It was a chance to pick up something new. It’s a challenging instrument, but a lot of fun.

Continue to STAT+ to read the full story…

And what do the prices actually tell us? Well, there’s CMS’ estimate for how much would have been saved by the Medicare program had the MFPs been in effect in 2023 ($6 billion), and the estimate for how much seniors will save out-of-pocket just from the lower prices ($1.5 billion) in 2026.

However, knowing what to make of discounts from list prices ranging from 38% for Imbruvica for blood cancers to 79% for Januvia for diabetes is trickier. Those of us who work in drug pricing daily are closely examining and evaluating the methods used to determine these prices. Which of the many factors outlined in the legislation most influenced CMS’ determination of initial price offers? How did manufacturers leverage the data they were entitled to provide to prove the case of the value of their medicines?  The short answer: We don’t know. At least not yet.

Continue to STAT+ to read the full story…