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Epic’s overhauled sepsis model, Verily’s close FDA ties, & AI for biopsies

4 hours 31 min ago

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Epic overhauls sepsis model amid scrutiny 

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STAT+: Pharmalittle: U.S. Supreme Court asks solicitor general for views on ‘skinny label’ case; Express Scripts and Kroger are mired in dispute

9 hours 15 min ago

Good morning, everyone, and how are you today? We are doing just fine, thank you, despite the soggy skies overhead. After all, as the Morning Mayor used to say: “Every new day should be unwrapped like a precious gift.” So while you tug on the ribbon, we will brew another cup of stimulation — chocolate raspberry is our choice — and continue foraging for items of interest. Speaking of which, here is the latest selection. Meanwhile, we hope you have a smashing day and achieve all your goals. One small note, we will back on Thursday as we sequester tomorrow to observe ancient rituals. A colleague will be here in our stead. Ta-ta!

The U.S. Supreme Court asked the Biden administration for an opinion on whether it should hear a challenge by Teva Pharmaceuticals to a $235 million award to GlaxoSmithKline in a patent dispute over generic heart medication, Reuters notes. Teva appealed a lower court ruling that reinstated the jury award for GSK. The case could affect the future of so-called “skinny labels,” which allow generic drugmakers to avoid patent lawsuits if a generic drug label omits potentially infringing uses of a brand-name drug. Teva has argued that it followed U.S. Food and Drug Administration instructions to “carve out” from its label a patented method for using the drug to treat heart failure.

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Opinion: Messaging — the unrecognized coefficient in pandemic control — matters

14 hours 3 min ago

A little over a century ago, scientists working in laboratories discovered that microbes were the cause of many epidemics. Once they understood that, they began to put their faith more and more in laboratory science. This major transformation, called the bacteriological revolution, began in the 1880s.

During this period, diphtheria was one of the leading causes of death among mostly poor children in New York City. Physicians and government authorities believed that the disease was uncontrollable, and New Yorkers were told that they just needed to live with it. But as historian Evelynn Hammonds points out in her powerful book, “Childhood’s Deadly Scourge: The Campaign to Control Diphtheria in New York City, 1880-1930,” public health authorities were more optimistic — and more pragmatic.

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STAT+: CAR-T therapy doesn’t work in all cancer cases. Scientists are starting to figure out why

14 hours 8 min ago

When CAR-T therapy works against blood cancer, it can work spectacularly, but cancer still returns for many patients. In lymphoma, scientists are just beginning to work out why over half of treated patients don’t experience lasting remission, depending on the product. Now two separate research teams have identified a possible culprit in the mix of engineered immune cells created as part of CAR-T therapy.

To find it, research groups from Stanford and Harvard conducted similar, but independent experiments to better understand the different types of cells that arise during manufacturing or how they evolve once in the body. Pharma companies engineer T cells from the patient’s own immune system to carry a synthetic chimeric antigen receptor, which hyperactivates the T cell and allows it to identify and destroy cancer cells.

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STAT+: At Verily, a growing line of business builds on a revolving door to the FDA

14 hours 12 min ago

After years spent building a seemingly slapdash set of medical initiatives, Verily seems to have a game plan.

The Alphabet life sciences spinout is doubling down on the business of evidence generation, trying to build the tools and technical infrastructure that will help pharma and digital health customers run the next generation of clinical trials. It’s an area that Verily and its investors — who just poured $1 billion into the company — are predicting can become a lucrative line of business. And Verily is backing up that bet by filling its ranks with some of the Food and Drug Administration’s top scientific, policy, and legal experts. 

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‘History is repeating itself’: The story of the nation’s first clinic for gender-affirming surgery

Mon, 10/03/2022 - 14:01

Nearly 60 years ago, Johns Hopkins Hospital opened a first-of-its-kind clinic to provide gender-affirming surgery. The Gender Identity Clinic blazed a new trail, with more than a dozen new clinics opening across the country in the decade that followed.

But in 1979, the clinic shut its doors. And while the institution claimed for years that the decision was made based on the evidence — which, they argued, showed such surgeries didn’t benefit patients — new research by a Johns Hopkins medical school student reveals a different story. The student, Walker Magrath, dug through years of archived correspondence and notes at both Johns Hopkins and Harvard University, and found that internal politics and pushback from hospital leadership ultimately caused the clinic to close.

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Get a Ph.D. in health policy — from a single Powerpoint slide

Mon, 10/03/2022 - 12:40

Looking for an actually concise explanation of a half-century’s worth of research and arguments about health care spending in the U.S.? You’re in luck: Government budget wonks, against all odds, condensed it down to a single PowerPoint slide.

The slide is part of a broader report from the Congressional Budget Office that finds that capping the prices that hospitals, doctors, and other providers charge private health insurers would lower health care prices significantly more than making providers reveal their prices or bulking up antitrust enforcement.

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Opinion: How can the latest Alzheimer’s therapy reach patients? Follow this trustworthy process

Mon, 10/03/2022 - 10:36

The press release issued by pharmaceutical companies Eisai and Biogen on Sept. 27 might someday be remembered as the beginning of a revolution in Alzheimer’s diagnosis and treatment.

Years and years of failed Alzheimer’s trials created, and then fortified, doubts about whether drugs that attacked amyloid, a brain protein linked to Alzheimer’s disease, were a valid approach to its treatment. Those doubts may have been quelled.

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STAT+: Pharmalittle: Price of new ALS drug prompts criticism; many drug price hikes exceeded U.S. inflation rate

Mon, 10/03/2022 - 06:13

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-too familiar routine of online meetings, phone calls, and deadlines has returned. But what can you do? The world, such as it is, keeps spinning. So to nudge it in a good direction, we are firing up the coffee kettle and brewing a cup of stimulation. Our choice today is the seasonal pumpkin spice. Please feel free to join us. And as always, here is a rundown of interesting developments to help you get started on your journey today. We hope all goes well and that you conquer the world. …

Moderna refused to hand over to China the core intellectual property behind the development of its Covid-19 vaccine, leading to a collapse in negotiations on its sale there, The Financial Times reports. During talks in 2020 and 2021, the company turned down a request to hand over the recipe for its vaccine due to commercial and safety concerns, although Moderna is still “eager” to sell the product to China. To date, China offered two routes for foreign Covid-19 vaccine makers: do a full tech transfer to a domestic company or establish a manufacturing facility in China with a local partner, while keeping control of the underlying technology. Moderna was pressed to take the former option.

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STAT+: Many trials to confirm benefits of drugs granted accelerated approvals are running late

Mon, 10/03/2022 - 05:44

Amid heightened debate over a regulatory program for speeding the approval of some medicines, a new government analysis finds extensive delays in the clinical trials that drug makers are required to conduct after approvals.

At issue is accelerated approval, which the U.S. Food and Drug Administration established in 1982 in an effort to get medicines for hard-to-treat diseases to patients sooner than they might under the usual pathways to the marketplace. As a condition of approval, a pharmaceutical company must confirm the effectiveness of its medicine through one or more clinical trials by a certain date.

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Nobel Prize in medicine awarded for research into the evolutionary history of humankind

Mon, 10/03/2022 - 03:17

A Swedish scientist won the 2022 Nobel Prize in medicine or physiology on Monday for his groundbreaking research into the evolutionary history of humankind.

Svante Pääbo, of the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, accomplished something widely believed to be impossible: recovering and reading DNA from 40,000-year-old bones. By developing new techniques for working with ancient genetic material — which is often heavily degraded and contaminated by microorganisms — he led teams that sequenced the genome of the Neanderthal, and discovered a previously unknown hominin, Denisova. Pääbo unlocked scientists’ understanding of how genes from these extinct relatives have been passed down to present-day humans.

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Opinion: Better use of health savings accounts: lessons from Singapore

Mon, 10/03/2022 - 01:55

Today, 9 in 10 Americans have health insurance, more than ever before, yet health care is less affordable than ever. Up to 100 million U.S. adults carry medical debt. Skyrocketing inflation is forcing people to decide between spending money on medical care or other necessities like food and housing. People typically spend thousands of dollars, in addition to premiums, before insurance kicks in. And rising out-of-pocket costs are just one side of the story: Health insurance premiums are going up, too. Employer-sponsored insurance cost a whopping $22,221 per family in 2021. That’s one-third of the median household income.

The insurance system in the U.S. is broken. Rather than continuing to plow money into insurance and expensive case, families should be stowing that cash away for future health care needs. That’s what they do in Singapore. There, people save toward their own health care needs via mandatory individual health savings accounts — with the government serving as the safety net.

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To prevent unnecessary biopsies, scientists train an AI model to predict breast cancer risk from MRI scans

Mon, 10/03/2022 - 01:50

A biopsy that turns out to have benign results can be a relief. But in some cases, it could also mean a patient whose risk of cancer was low from the start has gone through an unnecessarily invasive procedure.

By and large, radiologists recommend that patients whose breast MRI scans raise suspicion of a cancerous growth get a biopsy done. But MRIs often pick up on benign lesions that other mammograms and ultrasound may not. This leads to some patients having their lesions falsely classified as higher risk than they are, and undergoing a biopsy.

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Opinion: Will there be a Supreme assault on public health?

Mon, 10/03/2022 - 01:45

In just seven days last June, the U.S. Supreme Court set back public health by 50 years. The court’s conservative majority rolled back efforts to address the pressing threat of climate change, expanded access to deadly firearms, and eliminated the right to abortion by overturning Roe v. Wade. Earlier, it had eviscerated public health powers to curb the Covid-19 pandemic.

We fear this is just the start.

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White House’s open-access research directive scrambles long-entrenched models, raising key questions

Mon, 10/03/2022 - 01:40

In August, the White House’s Office of Science and Technology Policy released a memo directing all federal agencies to form plans to make all federally funded research publications and data publicly available without embargo by the end of 2025.

Most people who heard the news likely envisioned making a cup of coffee on Jan. 1, 2026, opening up JAMA’s or Nature’s website, and being able to read any article for free.

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STAT+: Epic overhauls popular sepsis algorithm criticized for faulty alarms

Mon, 10/03/2022 - 01:35

Epic Systems has revamped its widely criticized sepsis prediction model in a bid to improve its accuracy and make its alerts more meaningful to clinicians trying to snuff out the deadly condition.

Corporate documents obtained by STAT show that Epic is now recommending that its model be trained on a hospital’s own data before clinical use, a major shift aimed at ensuring its predictions are relevant to the actual patient population a hospital treats. The documents also indicate Epic is changing its definition of sepsis onset to a more commonly accepted standard and reducing its reliance on clinician orders for antibiotics as a way to flag the condition.

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Harassment prompts children’s hospitals to strip websites, threatening access to gender-affirming care

Mon, 10/03/2022 - 01:30

Children’s hospitals that have been targeted on social media for providing gender-affirming care — and even some that haven’t — are stripping information about those services from their websites. Advocates fear the changes could make it even harder for transgender adolescents to get care.

Though the harassment has been most pronounced at Boston Children’s Hospital, right-wing pundits have singled out at least 20 other children’s hospitals on social media. All but three have modified the information that’s available about gender-affirming care for their patients, often by removing information about physicians or the services offered, according to a STAT analysis of their websites.

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STAT+: Up and down the ladder: The latest comings and goings

Fri, 09/30/2022 - 07:16

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that Gandeeva Therapeutics hired Matthew Lucas as chief scientific officer. Most recently, he worked at Black Diamond Therapeutics, where he was senior vice president, drug discovery. In the past, he worked at Yumanity Therapeutics, Cubist Pharmaceuticals, and Roche.

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STAT+: Pharmalittle: FDA approves a medicine to combat ALS; Medicare drug-price talks are poised to become a legal battle

Fri, 09/30/2022 - 06:21

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, to be honest. We do, however, hope to find time to catch up on our reading, have a listening party with Mrs. Pharmalot, and, of course, promenade with our official mascot. And what about you? Autumn is here, so this presents another wonderful opportunity to enjoy the great outdoors — perhaps, a long walk or long drive is in order. You could stock up on pumpkins and apples along the way. You could also stock up on winter gear before prices rise still more. Or if you feel a little social, you could make time for someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

The U.S. Food and Drug Administration approved a new medicine for ALS from Amylyx Pharmaceuticals, providing a desperately needed new treatment option for a devastating disease, STAT writes. The medicine, called Relyvrio, is not a cure but proved to moderately slow the progression of the neurological disease, which causes weakened muscles, paralysis, and death. Amylyx did not immediately disclose how much it will charge for Relyvrio, but the company is conducting a larger, longer clinical trial to confirm the benefits, with data expected in late 2023 or early 2024. In a rare commitment, the company has promised to remove the drug from the market if that study is not successful.

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Opinion: How the Inflation Reduction Act can help decarbonize the health care industry

Fri, 09/30/2022 - 01:55

The climate crisis — the greatest threat to human health in history — is often framed “in ways that pay little attention to its health dimensions,” as the authors of The Lancet’s annual “Countdown: Tracking Progress on Health and Climate Change” report were forced to remind us.

This tragic reality was on display in Health Affairs, JAMA, Kaiser Health News, and The Lancet itself, among others, when they limited their reporting on the recently passed Inflation Reduction Act to its enhanced Affordable Care Act subsidies and drug cost reforms. They failed to highlight for the health care industry that the IRA’s tax credit provisions for renewable energy, formerly called energy security, are for the first time refundable for tax-exempt entities. This means that the largest greenhouse gas polluters in the health care industry — the vast majority of hospitals that are nonprofit or tax exempt — can take advantage of these economic subsidies to reduce greenhouse gas emissions.

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