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Updated: 2 hours 55 min ago

HIPAA won’t protect you, if prosecutors want your reproductive health records

Fri, 06/24/2022 - 15:12

With Roe v. Wade now overturned, patients are wondering whether federal laws will shield their reproductive health data from state law enforcement, or legal action more broadly. The answer, currently, is no.

If there’s a warrant, court order, or subpoena for the release of those medical records, then a clinic is required to hand them over. And patients and providers may be made legally vulnerable by the enormous trail of health-related data we all generate through our devices every day.

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Court rules Juul can temporarily keep selling e-cigarettes while it prepares challenge to FDA ban

Fri, 06/24/2022 - 14:57

WASHINGTON – Juul’s e-cigarettes won’t be pulled off the shelves just yet. A federal court ruled late Friday that the company’s vaping products can stay on the market while the company prepares its full legal challenge to this week’s Food and Drug Administration ban.

The move is the latest in a whirlwind 24 hours for the vaping company, which was ordered to shut down all U.S. sales Thursday afternoon. The company sued the FDA over that decision Thursday evening. The company is also now considering bankruptcy, the Wall Street Journal reported.

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The Biden administration wants to get tough on states’ abortion pill restrictions. It won’t be easy

Fri, 06/24/2022 - 13:16

WASHINGTON — Attorney General Merrick Garland is hinting he’s ready to get tough on states that block access to an FDA-approved pill used to terminate pregnancies.

He’s got a lot of work ahead of him.

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Supreme Court decision suggests the legal right to contraception is also under threat

Fri, 06/24/2022 - 12:36

Over the past half century, Roe v. Wade has been a bedrock of constitutional rights extending beyond abortion. The Supreme Court decision overturning this ruling, issued Friday, makes clear that those other rights founded on the same principle of privacy, including gay sex, same-sex marriage, interracial marriage, and the freedom to use contraception, are now also called into question.

Writing for the majority in Dobbs v. Jackson, Justice Samuel Alito states that “​​nothing in this opinion should be understood to cast doubt on precedents that do not concern abortion.” ​​But, in a solo concurring opinion, Justice Clarence Thomas explicitly calls on the Court to overturn other such constitutional rights.

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Supreme Court overturns Roe v. Wade; states can ban abortion

Fri, 06/24/2022 - 07:40

WASHINGTON — The Supreme Court has ended constitutional protections for abortion that had been in place nearly 50 years in a decision by its conservative majority to overturn Roe v. Wade. Friday’s outcome is expected to lead to abortion bans in roughly half the states.

The decision, unthinkable just a few years ago, was the culmination of decades of efforts by abortion opponents, made possible by an emboldened right side of the court that has been fortified by three appointees of former President Donald Trump.

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

Fri, 06/24/2022 - 07:15

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 Abcuro hired H. Jeffrey Wilkins as chief medical officer. Previously, he held the same position at Avalo Therapeutics.

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STAT+: Pharmalittle: Sarepta halts a Duchenne clinical trial over safety; Why the CVS Health whistleblower lawsuit comes at a pivotal moment

Fri, 06/24/2022 - 06:23

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 coming together. For the moment, we expect to stroll about with the official mascot and manicure the Pharmalot grounds. Otherwise, we hope to hang with Mrs. Pharmalot and have a listening party. And what about you? This is a fine time to enjoy the great outdoors. You could stay indoors and stream a moving picture. Looking ahead, you could make a summer getaway plan or stock up on sundry items before prices rise again next week. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon…

Sarepta Therapeutics has temporarily stopped a clinical trial of its second-generation medicine for patients with a certain type of Duchenne muscular dystrophy due to a serious safety incident reported by a patient, STAT reports. The U.S. Food and Drug Administration placed a clinical hold on the Sarepta drug, called SRP-5051, after a patient in the study experienced a “serious” decrease in blood-based magnesium, a condition known as hypomagnesemia. SRP-5051 belongs to a new class of treatments, which Sarepta refers to as its “PPMO platform,” that has become more important for the company following significant setbacks with its efforts to develop a one-time gene therapy for Duchenne.

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Opinion: Digital back doors can lead down the path to health inequity

Fri, 06/24/2022 - 01:30

For years, racism mandated that Black people and other people of color in the United States use back doors to enter restaurants, movie theaters, and other public places. While these practices have ended, digital back doors may once again make them and others second-class citizens when it comes to health.

Digital back doors are technological processes and tools used in health care, such as racially biased algorithms, infrastructural limitations, and dirty data. These unwittingly exacerbate existing health inequities, which the World Health Organization defines as “systematic differences in the health status of different population groups.”

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Covid-19 vaccines prevented nearly 20 million deaths in a year, study estimates

Thu, 06/23/2022 - 15:30

Covid-19 vaccines cut the potential global death toll by more than half in the first year they were available, according to a study published Thursday in The Lancet Infectious Diseases.

The study modeled the spread of the disease in 185 territories and countries and found that without Covid vaccines, 31.4 million people would have died of the disease between December 2020 and 2021. While the pandemic has taken a devastating toll around the globe, with more than 3.5 million deaths since the first vaccine was administered in December 2020, the study estimated that vaccinations also prevented 19.8 million deaths.

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STAT+: FDA halts study of Sarepta treatment for Duchenne muscular dystrophy due to safety concern

Thu, 06/23/2022 - 13:38

Sarepta Therapeutics said Thursday that it has temporarily stopped a clinical trial of its second-generation medicine for patients with a certain type of Duchenne muscular dystrophy due to a serious safety incident reported by a patient.

The Food and Drug Administration placed a clinical hold on the Sarepta drug, called SRP-5051, after a patient in the study experienced a “serious” decrease in blood-based magnesium, a condition known as hypomagnesemia.

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STAT+: A CVS whistleblower lawsuit comes at a pivotal moment for the FTC’s probe of pharma and PBMs

Thu, 06/23/2022 - 13:10

Three years ago, a former CVS Health executive told a U.S. Senate committee hearing that the company — which has deep tentacles into the Byzantine system for making prescription drugs available — ensures that its customers receive the lowest-cost medicines.

“When those lower list prices result in the lowest net cost for the patient as well as for the plan, then absolutely, that is the preferred drug on formulary,” said Derica Rice, who was an executive vice president at the time. He was responding to questions about the ways in which CVS places medicines on its formularies, or list of medicines covered by health insurance, created by its pharmacy benefits unit.

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Listen: Juul’s doomsday, Merck’s buyout plans, & the next Theranos verdict

Thu, 06/23/2022 - 12:02

Just how powerful is the FDA? Is Merck about to spend $40 billion? And what’s a “Puff Bar”?

We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. STAT Washington correspondent Nicholas Florko joins us to discuss the FDA’s decision to ban the sale of Juul Labs vaping products and a proposal to reduce the amount of nicotine in cigarettes. We’ll also explain the latest news in the life sciences, including a rumored blockbuster buyout and the next Theranos verdict.

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STAT+: A cautionary tale: How one biotech stock trader lost a small fortune, but emerged wiser

Thu, 06/23/2022 - 11:00

Too many of my Twitter interactions with biotech-loving retail investors are unpleasant. If I write an article raising doubts about a small drugmaker’s clinical trial results, or if I call out misleading statements made by an overly promotional biotech CEO, the responses I receive from people who own the stock generally run the gamut from “f—k you, you clueless a–hole” to “I hope you get cancer and die.”

And sometimes, the replies to my work get really nasty.

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How pregnancy could prove the potential of smartwatches

Thu, 06/23/2022 - 08:48

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday. 

How pregnancy could prove the potential of smartwatches

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FDA orders Juul e-cigarettes off the market in the U.S.

Thu, 06/23/2022 - 08:01

WASHINGTON — The Food and Drug Administration has ordered all vaping products made by the controversial company Juul off the market, the agency announced Thursday morning — but not for the reason you might expect.

The FDA says it is pulling Juul products off the market not because of the company’s historic appeal to youth, but because of concerning toxicology data and risk of “potentially harmful chemicals leaching from the company’s proprietary e-liquid pods.”

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STAT+: Pharmalittle: Senate bill would allow insulin makers to lock in profits; GSK, Novartis pledge funds for diseases that mostly affect the poor

Thu, 06/23/2022 - 06:13

Rise and shine, everyone, another busy day is on the way. We can tell because Mrs. Pharmalot and the official mascot have long since departed for their morning constitutional, another food delivery is imminent, and our to-do list has already grown. This calls, as you may imagine, for a cup or three of stimulation. Our choice today is pumpkin spice, which has been hiding in the back of our pantry. Meanwhile, here is the latest laundry list of interesting items to help you on your journey today. We hope all goes well and you conquer the world. But while you do, please remember to keep in touch. We appreciate juicy tips…

A new proposal that senators claim would fix insulin pricing would actually allow drugmakers to lock in their current profits from the medicine for the foreseeable future, STAT explains. The bill, introduced Wednesday by Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine), proposes a complicated redesign of how insulin products are priced, and what patients pay for them. The proposal could help a minority of patients who use insulin, and Senate leadership is hoping to speed it to a vote this summer. But the fix would likely spread costs to all Medicare patients, insurers, and the federal government, without actually changing how much drug makers make on the medicine.

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STAT+: Uniqure’s Huntington’s gene therapy lowers key protein in small trial

Thu, 06/23/2022 - 04:05

A gene therapy for Huntington’s disease made by the Dutch biotech firm Uniqure showed early promise in a preliminary study of a handful of patients, the company said Wednesday.

Evaluable data were available from only four patients who had received the treatment, code-named AMT-130, and three in a control group who had undergone a sham treatment. All were in the early stages of the fatal neurodegenerative disease.

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STAT+: Despite fanfare, the FDA’s step toward lowering nicotine levels in cigarettes is a very early one

Thu, 06/23/2022 - 02:00

WASHINGTON — When the Food and Drug Administration said Tuesday it would eventually lower the level of tobacco in cigarettes to non-addictive levels, the American Heart Association called it “historic.” Powerful lawmakers applauded the action. The New York Times put the announcement on its front page — writing that the move “would put the United States at the forefront of global antismoking efforts.”

And while lowering nicotine levels in cigarettes would be a massive deal, the FDA this week only took a first, very small step, toward that goal. And it has even taken that small step before, though to far less fanfare.

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STAT+: With cryptocurrency and NFTs, ‘decentralized science’ seeks to upend drug industry financing

Thu, 06/23/2022 - 01:55

When Alok Tayi’s daughter was born last year, he found himself in a place no parent wants to be: a newborn intensive care unit.

His daughter had been born with respiratory and neurological issues. But she was comparatively lucky — after a surgery this spring at Boston Children’s Hospital, she’s home and healthy. That wasn’t the case for all of the newborns in the NICU. Some of the parents Tayi met were grappling with the news that their child had a rare, untreatable condition.

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Opinion: Signals from monkeypox: Create an external advisory group to start preparing for the next pandemic

Thu, 06/23/2022 - 01:50

As the U.S. reels from a more than 1 million reported deaths due directly to the Covid-19 pandemic, another infectious disease — monkeypox — is beginning to percolate. Cases of monkeypox, which scientists have been warning about for years, continue to rise worldwide.

Covid-19 followed by monkeypox offers an opportunity to reflect on what can be done to reduce the impact of this and future pandemics.

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