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Updated: 52 min 35 sec ago

Opinion: People in mental health crises need help, not handcuffs

19 hours 58 min ago

A mental health crisis can be a frightening thing to the individual experiencing it as well as to people witnessing it. Those in its throes need help, but all too often get handcuffs.

We have seen that scenario play out from the inside and the outside. It’s time for it to change.

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Public health experts urge socially distant Fourth of July celebrations, as the coronavirus surges across the U.S.

20 hours 14 min ago

Some communities are being preemptive: Los Angeles and Miami closed their beaches, New York City is shooting off “unannounced displays” of fireworks, so people won’t gather for a planned show. In cities from Anchorage to El Paso to Bloomington, Ind., forget about the parade.

But whether and how much the Fourth of July weekend boosts transmission of Covid-19 depends in no small part on the choices and actions of individual people. So health officials, clinicians, and infectious disease experts are pleading with the public to take precautions and minimize the risk that they might unknowingly spread the coronavirus or put themselves in a position to contract it.

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Listen: Remdesivir’s controversial cost, early vaccine promise, and AI at the end of life

Thu, 07/02/2020 - 10:34

What’s a fair price for remdesivir? How do we know whether vaccines work? And does AI have a place in end-of-life care?

We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we dig into the long-awaited price for Gilead Sciences’ Covid-19 treatment and break down the disparate reactions from lawmakers, activists, and Wall Street analysts. Then, STAT’s Matthew Herper joins us to discuss some of the first detailed data on a potential vaccine for the novel coronavirus. Finally, we talk about a new use for AI: nudging clinicians to broach delicate conversations with patients about their end-of-life goals and wishes.

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Trial of Moderna Covid-19 vaccine delayed, investigators say, but July start still possible

Thu, 07/02/2020 - 09:52

A 30,000-patient trial of Moderna’s coronavirus vaccine candidate, expected to start next week, has been delayed, a potential hurdle in the company’s ambitious effort to deliver key data by Thanksgiving.

Moderna is making changes to the trial plan, called a protocol, which has pushed back the expected start date of the Phase 3 study, according to investigators. The investigators, who spoke on condition of anonymity, emphasized that protocol changes are common but said it’s not clear how long the start will be delayed.

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STAT Plus: Alexion to pay $21 million for failing to record bribes paid to doctors in other countries

Thu, 07/02/2020 - 07:33

Alexion Pharmaceuticals (ALXN) agreed to pay more than $21 million for maintaining a false set of accounting books in connection with bribes paid to government officials in Russia and Turkey in order to boost use of its most important drug. The settlement also covers inaccurate financial records concerning payments that were made to patient advocacy groups, among others, in Brazil and Colombia.

Between 2010 and 2015, the company paid more than $1.3 million to a consultant in Turkey who used some of the money to bribe government officials to ensure prescriptions for Soliris, a treatment for combatting a rare blood disorder. Not only were the payments recorded inaccurately, but were done in pencil, so the numbers could later be changed, according to an order filed by the Securities and Exchange Commission in federal court.

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STAT Plus: Pharmalittle: Trump officials maintain Covid-19 vaccine won’t be influenced by politics; Novartis pays $678 million to settle kickback charges

Thu, 07/02/2020 - 06:18

And so, another working week will soon come to an end. Not a moment too soon, yes? For those who think this may sound premature, there is a holiday tomorrow on this side of the pond, so we are getting a head start on our weekend daydreaming. Our agenda is rather modest, given the circumstances. We do hope to hang with a couple of the short people, promenade with our energetic mascot and catch up on our reading. And what about you? This is a fine time to enjoy the outdoors. You could also putter around your castle. Or reach out to someone feeling isolated. Well, whatever you do, have a grand time. Enjoy, but be safe and wear a mask. This virus will not just disappear. See you soon…

Top Trump administration health officials are seeking to reassure the public that any potential Covid-19 vaccine will only be approved if it is safe and that the fast-track process will not be influenced by political pressure, The Hill reports. To assuage some of that concern, the agency released a guidance that outlines conditions for approving a vaccine. Those include requiring any vaccine to be at least 50% more effective than a placebo in preventing the disease.

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Opinion: Pharma companies need extra anti-corruption vigilance during a pandemic

Thu, 07/02/2020 - 01:45

Companies have made important efforts over the past two decades to combat the problem of transnational corruption. What was once a relatively obscure regulatory niche has become a major concern for multinational corporations worldwide.

The emergence and spread of Covid-19 has exacerbated the risk of transnational corruption for most industries. But given the extraordinary pressure the pandemic has placed on the health care and life sciences industries to quickly develop and deliver solutions, these companies face a heightened risk. The pharmaceutical industry has increasingly taken proactive steps to guard against transnational corruption, but to address the amplified scope of the risk, industry leaders will need to recalibrate the way they prioritize and address it.

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Opinion: A powerful law gives HHS the right to take control of remdesivir manufacturing and distribution

Thu, 07/02/2020 - 01:40

A rare bright spot followed the emergence of Covid-19 and its spread across the globe: the discovery that remdesivir, an experimental antiviral originally developed by Gilead Sciences and the U.S. government for use against Ebola, works against SARS-CoV-2, the virus that causes Covid-19.

Remdesivir isn’t a miracle drug. It has not been proven to significantly reduce patients’ risk of dying from Covid-19, though evidence from an NIH-led clinical trial indicates that it helps patients with severe Covid-19 recover more quickly, meaning they can leave the hospital sooner and return home. We urgently need more and better evidence of remdesivir’s (likely modest) benefits.

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Fever checks are a flawed way to flag Covid-19 cases. Experts say smell tests might help

Thu, 07/02/2020 - 01:35

Workplaces do it. Newly reopened public libraries do it. LAX does it. Some restaurants, bars, and retail stores started doing it when governors let them serve customers again: Use temperature checks — almost always with “non-contact infrared thermometers” — to identify people who might have, and therefore spread, the infectious disease.

Unfortunately, temperature checks could well join the long list of fumbled responses to the pandemic, from the testing debacle to federal officials’ about-face on masks.

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Does asthma increase Covid-19 risk? Emerging research suggests a complicated connection

Thu, 07/02/2020 - 01:30

A growing body of research on Covid-19 suggests that the virus’ link to asthma is far more complex than experts might have anticipated.

Early in the pandemic, researchers racing to identify the conditions common among the sickest patients zeroed in on lung conditions, including asthma. A potential link seemed possible: The virus that causes Covid-19 can lead to severe lung inflammation, and other viruses can set off dangerous asthma attacks. But emerging research — including a recent retrospective analysis of Covid-19 patients in 10 hospitals — has complicated the picture of the connection between asthma and critical cases of Covid-19. 

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STAT Plus: Novartis pays $678 million to settle a long-running case over alleged kickbacks to doctors

Wed, 07/01/2020 - 18:36

After seven years of sparring, Novartis (NVS) has agreed to pay $678 million to settle a lawsuit in which the federal government alleged the drug maker used kickbacks to doctors — including fishing trips and lavish restaurant meals — in order to boost prescriptions of several medicines.

The settlement ends a long-running battle that began in 2011, when a former Novartis sales rep named Oswald Bilotta filed a whistleblower lawsuit claiming the company ran so-called speaker programs that were actually blatant marketing tools, rather than educational sessions for doctors. And as a result of the bribes, the drug maker caused federal health care programs to overpay for medicines.

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STAT Plus: Africa Union urges member countries to remove intellectual property barriers to Covid-19 vaccines

Wed, 07/01/2020 - 12:35

Amid growing concern over access to Covid-19 medical products, the organization that represents dozens of African nations urged its members to work with the World Health Organization to obtain a vaccine, but also not let pharmaceutical patents remain an obstacle.

In a communiqué, the Africa Union called for an “equitable and timely distribution” of a Covid-19 vaccine by partnering with the COVID-19 Vaccine Global Access, or Covax, program that was started by the WHO as part of its Access to COVID-19 Tools Accelerator, or ACT. The collaboration to develop Covid-19 products involves the World Bank and the Bill & Melinda Gates Foundation, among others.

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Experimental HIV drug seems effective at a twice-a-year dose, study finds

Wed, 07/01/2020 - 08:00

An experimental new HIV treatment could, with just one dose, reduce the amount of virus in an infected person for up to six months. But experts aren’t convinced the advance will significantly change how we treat HIV anytime soon.

A group of researchers from Gilead Sciences developed a new drug dubbed lenacapavir, described Wednesday in Nature, that targets an HIV protein called capsid that has been nearly untargetable until now. Targeting capsid weakens the HIV virus’ outer coating, making it harder for the virus to infect our cells or protect itself from our body’s defenses. Current HIV treatments — which most patients must take daily — target proteins involved in the early stages of the virus’ life cycle, but targeting capsid affects multiple phases.

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STAT Plus: Drug makers sue to block Minnesota law making it cheaper to get insulin in emergencies

Wed, 07/01/2020 - 06:31

WASHINGTON — The drug industry lobbying association PhRMA sued the state of Minnesota over a newly enacted law meant to prevent people who can’t afford their insulin from rationing it.

The law, the Alec Smith Emergency Insulin Act, which is named after a 26-year-old man who died after rationing his insulin, allows Minnesotans who would otherwise forgo their insulin to immediately pick up a 30-day supply of the drug from a pharmacy for $35. Drug makers would be forced to provide the insulin for free or face hefty fines. The law was slated to go into effect Wednesday.

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STAT Plus: Pharmalittle: FDA sets Covid-19 vaccine guidance; White House grabs much of the remdesivir supply

Wed, 07/01/2020 - 06:17

Rise and shine, everyone, another busy day is on the way. Yes, indeed, the middle of the week is already here, which means there is much to do. No doubt, you can relate on some level. So please join us as we grab a cup of stimulation — we are sticking with maple bourbon for the moment — and tackle the Zoom and Skype calls that are piling up. Meanwhile, here is the latest grab bag of items of interest to help you along. Hope you conquer the world today, such as it is, and do stay in touch …

The Food and Drug Administration released guidance for approving a Covid-19 vaccine, saying the vaccine has to prevent or decrease disease severity in at least 50% of people who are inoculated, Reuters informs us. “The guidelines are pretty standard, they look pretty much like influenza vaccine guidelines,” says Gregory Poland, director of Mayo Vaccine Research Group. “I don’t think that’s a high bar. I think that’s a low to maybe an appropriate bar for a first-generation Covid-19 vaccine.”

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Covid-19 vaccine from Pfizer and BioNTech shows positive results

Wed, 07/01/2020 - 05:46

An experimental Covid-19 vaccine being developed by the drug giant Pfizer and the biotech firm BioNTech spurred immune responses in healthy patients, but also caused fever and other side effects, especially at higher doses.

The first clinical data on the vaccine were disclosed Wednesday in a paper released on medRXiv, a preprint server, meaning it has not yet been peer-reviewed or published in a journal. 

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STAT Plus: Some U.S. government contracts for Covid-19 research could skirt affordable pricing laws

Wed, 07/01/2020 - 04:00

A new report finds that the U.S. government awarded several drug makers contracts for coronavirus research using agreements that would allow authorities to bypass laws that could ensure taxpayer-funded medicines or vaccines are affordable.

In recent months, the Department of Defense and the Biomedical Advanced Research and Development Authority signed or extended contracts with four companies — the Janssen unit at Johnson & Johnson (JNJ), the Genentech unit at Roche (RHHBY), Regeneron Pharmaceuticals (REGN), and Ology Bioservices — for research on either Covid-19 vaccines or medicines.

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Opinion: Hospitals must treat infection control as a priority, not a profit center

Wed, 07/01/2020 - 01:45

For years, hospitals penny-pinching on infection control has been an open secret. Whether Covid-19 will puncture that pre-pandemic complacency is open question. But it’s long past time for every hospital to treat infection control as a priority, not as a profit center.

Even before Covid-19 appeared, tens of thousands of patients died each year from preventable infections acquired during treatment. The contagious nature of the coronavirus has vastly increased the number of those at risk, with health care workers themselves now routinely endangered.

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Opinion: Structural racism is why I’m leaving organized psychiatry

Wed, 07/01/2020 - 01:40

The killings of George Floyd, Ahmaud Arbery, Breonna Taylor, and so many others are leading many Americans to reflect on structural racism in society and resolve to do things differently. They have led me to make the difficult decision to end my membership with organized psychiatry, specifically the American Psychiatric Association.

After years of committing myself to the APA and believing that organized psychiatry was an effective vehicle by which progress could be made, racism is driving me and other Black physician leaders out of organized psychiatry, just as it has pushed Black physician leaders out of academic medicine.

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No one wants to go back to lockdown. Is there a middle ground for containing Covid-19?

Wed, 07/01/2020 - 01:35

First came the freezes.

Governors last month started to “press pause” on the next phases of their reopenings as Covid-19 cases picked back up. Now, in certain hot spots, they are starting to roll back some of the allowances they’d granted: no more elective medical procedures in some Texas counties. Bars, only reopened for a short time, are shuttered again in parts of California. And on Monday, Arizona’s governor ordered a new wave of gym, bar, and movie theater closures for at least the next month.

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