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Merck’s COVID-19 pill narrowly wins FDA panel’s support

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Merck’s COVID-19 pill narrowly wins FDA panel’s support

By a slim margin, advisors to the U.S. Meals and Drug Administration voted Tuesday to suggest authorization of a brand new capsule that sufferers with early circumstances of COVID-19 can take at house, although its preliminary promise gave technique to a much more modest profit.

The antiviral drug from Merck & Co., molnupiravir, is already approved for emergency use in Britain. The FDA is predicted to determine inside days whether or not to observe go well with. The company isn’t required to just accept the influential panel’s recommendation, but when it does, it should in all probability suggest the drug’s use for under a slim slice of sufferers, with sturdy cautions and shut monitoring.

In a 13-10 vote, the FDA advisory panel made clear that newly contaminated People who’re at excessive danger of hospitalization or loss of life want a extra accessible COVID-19 therapy than present antibody remedies, which require an IV infusion by a skilled healthcare supplier.

As mutations within the coronavirus threaten to erode the effectiveness of 5 present antibody therapies, lots of the FDA’s advisors mentioned they welcomed the arrival of a capsule that’s much less prone to be undermined by new viral variants.

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On the similar time, the specialists heaped skepticism on the experimental pink capsule that can in all probability by no means be utilized in youngsters, seems to pose risks to creating fetuses, and has not been examined in vaccinated individuals struggling breakthrough infections.

Merck tacitly acknowledged that it will not search approval for the drug’s use in youngsters after experiments in animals urged it may disrupt the expansion of bone and cartilage. And the pharmaceutical firm didn’t embrace pregnant ladies in its medical trials after animal testing additionally urged the drug may trigger abnormalities in fetal improvement.

If the FDA does permit the emergency use of molnupiravir in ladies of childbearing age, the company might require them to take a being pregnant take a look at earlier than getting a prescription. As well as, the FDA would in all probability require that being pregnant outcomes be monitored if the capsule is prescribed to ladies who’ve conceived.

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The brand new antiviral capsule initially appeared to stop extreme COVID-19 in as many as half of newly contaminated individuals who had been at excessive danger of hospitalization or loss of life. However a extra full evaluation discovered that molnupiravir decreased the danger of extreme illness by solely 30% in unvaccinated high-risk adults who started taking it inside 5 days of testing constructive for a coronavirus an infection and struggling gentle signs.

Harvard infectious illness specialist Dr. Lindsey R. Baden, who chairs the FDA advisory committee, known as molnupiravir’s obvious effectiveness “wobbly.” He mentioned his personal determination to suggest that the FDA grant emergency-use authorization was “extremely troublesome” in mild of many unanswered questions concerning the drug’s dangers.

However he mentioned “there are populations” for whom the drug’s advantages would outweigh its dangers, together with unvaccinated individuals with underlying circumstances similar to weight problems and superior age.

A number of different panel members echoed Baden’s tepid endorsement.

John M. Coffin, a Tufts College HIV and most cancers researcher, mentioned he had been hoping a capsule can be developed to securely and successfully deal with COVID-19.

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“I’m unsure that is the one we’ve been ready for,” mentioned Coffin, who voted in favor of authorization. “However it’s all we’ve obtained for the time being.”

That might not be true for lengthy. Pfizer, the pharmaceutical agency that turned an mRNA vaccine for COVID-19 round in lower than a 12 months, has requested the FDA to grant emergency-use authorization for an antiviral capsule it proposes to name Paxlovid.

A preliminary evaluation of early medical trials urged mildly sick COVID-19 sufferers who took Paxlovid inside three to 5 days of a confirmed an infection had been 86% much less prone to be hospitalized or die than had been those that obtained a placebo capsule.

One other key query concerning the Merck drug is whether or not it must be supplied to sufferers who’ve been vaccinated or who’ve some immunity as a result of a earlier bout with COVID-19. Merck didn’t research the drug in vaccinated individuals, however knowledge from a handful of sufferers with prior infections urged it had little profit for them.

Among the FDA advisors additionally nervous that too little testing had been carried out to rule out what one known as the “theoretical chance” that the drug may promote genetic mutations in sufferers that would give rise to sicknesses similar to most cancers years later. These fears had been prompted by animal assessments that discovered mutations in fast-growing cells similar to bone marrow.

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Molnupiravir’s novel methodology of motion has raised one other concern. The drug blunts the development of COVID-19 by dashing the speed of random mutations within the coronavirus’ replication equipment. The drug-induced mutations cripple the virus, inflicting it to sputter and die. An FDA employees report on molnupiravir mentioned that genetic adjustments in RNA may “theoretically be remodeled” in ways in which trigger it to be folded into wholesome human DNA. That might spell catastrophe for the people affected.

Panel members additionally nervous that accelerating RNA mutations in doubtlessly tens of millions of sufferers may have an unintended impact on the general public’s well being by dashing the emergence of latest coronavirus variants.

The risks might be biggest when the antiviral is prescribed to COVID-19 sufferers with compromised immune programs, who are likely to harbor the virus for longer intervals of time and subsequently spawn extra mutations. Individuals who begin a five-day course of the antiviral however neglect to take all their doses may additionally turn into fertile incubators of mutations that permit the virus to bypass the immune system’s defenses, members mentioned.

These worries might be swept away if molnupiravir reliably shortens infections and reduces the time that the virus replicates inside sufferers’ our bodies. However, as Coffin mentioned, the trade-off is “not clear.”

In voting in opposition to authorization, College of Utah infectious illness specialist Dr. Sankar Swaminathan known as molnupiravir’s effectiveness “modest at greatest.”

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The danger of mutations in particular person sufferers nonetheless must be fleshed out, he mentioned. Till that’s carried out, he forged his no vote as a result of “the big potential inhabitants affected [and] the danger of widespread impact on start defects,” together with the chance that fathers may put their offspring in jeopardy as a result of mutations of their sperm cells.

A number of panel members, together with some who endorsed molnupiravir, expressed hope that the FDA would contemplate withdrawing emergency-use authorization if a simpler drug with fewer worrisome security alerts had been to return alongside.

Pfizer’s drug is a part of a decades-old household of antiviral tablets often called protease inhibitors, a normal therapy for HIV and hepatitis C. They work in another way and haven’t been linked to the form of mutation issues raised by Merck’s drug.

The Related Press contributed to this report.

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Cluster of farmworkers diagnosed with rare animal-borne disease in Ventura County

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Cluster of farmworkers diagnosed with rare animal-borne disease in Ventura County

A cluster of workers at Ventura County berry farms have been diagnosed with a rare disease often transmitted through sick animals’ urine, according to a public health advisory distributed to local doctors by county health officials Tuesday.

The bacterial infection, leptospirosis, has resulted in severe symptoms for some workers, including meningitis, an inflammation of the brain lining and spinal cord. Symptoms for mild cases included headaches and fevers.

The disease, which can be fatal, rarely spreads from human to human, according to the U.S. Centers for Disease Control and Prevention.

Ventura County Public Health has not given an official case count but said it had not identified any cases outside of the agriculture sector. The county’s agriculture commissioner was aware of 18 cases, the Ventura County Star reported.

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The health department said it was first contacted by a local physician in October, who reported an unusual trend in symptoms among hospital patients.

After launching an investigation, the department identified leptospirosis as a probable cause of the illness and found most patients worked on caneberry farms that utilize hoop houses — greenhouse structures to shelter the crops.

As the investigation to identify any additional cases and the exact sources of exposure continues, Ventura County Public Health has asked healthcare providers to consider a leptospirosis diagnosis for sick agricultural workers, particularly berry harvesters.

Rodents are a common source and transmitter of disease, though other mammals — including livestock, cats and dogs — can transmit it as well.

The disease is spread through bodily fluids, such as urine, and is often contracted through cuts and abrasions that contact contaminated water and soil, where the bacteria can survive for months.

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Humans can also contract the illness through contaminated food; however, the county health agency has found no known health risks to the general public, including through the contact or consumption of caneberries such as raspberries and blackberries.

Symptom onset typically occurs between two and 30 days after exposure, and symptoms can last for months if untreated, according to the CDC.

The illness often begins with mild symptoms, with fevers, chills, vomiting and headaches. Some cases can then enter a second, more severe phase that can result in kidney or liver failure.

Ventura County Public Health recommends agriculture and berry harvesters regularly rinse any cuts with soap and water and cover them with bandages. They also recommend wearing waterproof clothing and protection while working outdoors, including gloves and long-sleeve shirts and pants.

While there is no evidence of spread to the larger community, according to the department, residents should wash hands frequently and work to control rodents around their property if possible.

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Pet owners can consult a veterinarian about leptospirosis vaccinations and should keep pets away from ponds, lakes and other natural bodies of water.

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Political stress: Can you stay engaged without sacrificing your mental health?

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Political stress: Can you stay engaged without sacrificing your mental health?

It’s been two weeks since Donald Trump won the presidential election, but Stacey Lamirand’s brain hasn’t stopped churning.

“I still think about the election all the time,” said the 60-year-old Bay Area resident, who wanted a Kamala Harris victory so badly that she flew to Pennsylvania and knocked on voters’ doors in the final days of the campaign. “I honestly don’t know what to do about that.”

Neither do the psychologists and political scientists who have been tracking the country’s slide toward toxic levels of partisanship.

Fully 69% of U.S. adults found the presidential election a significant source of stress in their lives, the American Psychological Assn. said in its latest Stress in America report.

The distress was present across the political spectrum, with 80% of Republicans, 79% of Democrats and 73% of independents surveyed saying they were stressed about the country’s future.

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That’s unhealthy for the body politic — and for voters themselves. Stress can cause muscle tension, headaches, sleep problems and loss of appetite. Chronic stress can inflict more serious damage to the immune system and make people more vulnerable to heart attacks, strokes, diabetes, infertility, clinical anxiety, depression and other ailments.

In most circumstances, the sound medical advice is to disengage from the source of stress, therapists said. But when stress is coming from politics, that prescription pits the health of the individual against the health of the nation.

“I’m worried about people totally withdrawing from politics because it’s unpleasant,” said Aaron Weinschenk, a political scientist at the University of Wisconsin–Green Bay who studies political behavior and elections. “We don’t want them to do that. But we also don’t want them to feel sick.”

Modern life is full of stressors of all kinds: paying bills, pleasing difficult bosses, getting along with frenemies, caring for children or aging parents (or both).

The stress that stems from politics isn’t fundamentally different from other kinds of stress. What’s unique about it is the way it encompasses and enhances other sources of stress, said Brett Ford, a social psychologist at the University of Toronto who studies the link between emotions and political engagement.

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For instance, she said, elections have the potential to make everyday stressors like money and health concerns more difficult to manage as candidates debate policies that could raise the price of gas or cut off access to certain kinds of medical care.

Layered on top of that is the fact that political disagreements have morphed into moral conflicts that are perceived as pitting good against evil.

“When someone comes into power who is not on the same page as you morally, that can hit very deeply,” Ford said.

Partisanship and polarization have raised the stakes as well. Voters who feel a strong connection to a political party become more invested in its success. That can make a loss at the ballot box feel like a personal defeat, she said.

There’s also the fact that we have limited control over the outcome of an election. A patient with heart disease can improve their prognosis by taking medicine, changing their diet, getting more exercise or quitting smoking. But a person with political stress is largely at the mercy of others.

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“Politics is many forms of stress all rolled into one,” Ford said.

Weinschenk observed this firsthand the day after the election.

“I could feel it when I went into my classroom,” said the professor, whose research has found that people with political anxiety aren’t necessarily anxious in general. “I have a student who’s transgender and a couple of students who are gay. Their emotional state was so closed down.”

That’s almost to be expected in a place like Wisconsin, whose swing-state status caused residents to be bombarded with political messages. The more campaign ads a person is exposed to, the greater the risk of being diagnosed with anxiety, depression or another psychological ailment, according to a 2022 study in the journal PLOS One.

Political messages seem designed to keep voters “emotionally on edge,” said Vaile Wright, a licensed psychologist in Villa Park, Ill., and a member of the APA’s Stress in America team.

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“It encourages emotion to drive our decision-making behavior, as opposed to logic,” Wright said. “When we’re really emotionally stimulated, it makes it so much more challenging to have civil conversation. For politicians, I think that’s powerful, because emotions can be very easily manipulated.”

Making voters feel anxious is a tried-and-true way to grab their attention, said Christopher Ojeda, a political scientist at UC Merced who studies mental health and politics.

“Feelings of anxiety can be mobilizing, definitely,” he said. “That’s why politicians make fear appeals — they want people to get engaged.”

On the other hand, “feelings of depression are demobilizing and take you out of the political system,” said Ojeda, author of “The Sad Citizen: How Politics is Depressing and Why it Matters.”

“What [these feelings] can tell you is, ‘Things aren’t going the way I want them to. Maybe I need to step back,’” he said.

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Genessa Krasnow has been seeing a lot of that since the election.

The Seattle entrepreneur, who also campaigned for Harris, said it grates on her to see people laughing in restaurants “as if nothing had happened.” At a recent book club meeting, her fellow group members were willing to let her vent about politics for five minutes, but they weren’t interested in discussing ways they could counteract the incoming president.

“They’re in a state of disengagement,” said Krasnow, who is 56. She, meanwhile, is looking for new ways to reach young voters.

“I am exhausted. I am so sad,” she said. “But I don’t believe that disengaging is the answer.”

That’s the fundamental trade-off, Ojeda said, and there’s no one-size-fits-all solution.

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“Everyone has to make a decision about how much engagement they can tolerate without undermining their psychological well-being,” he said.

Lamirand took steps to protect her mental health by cutting social media ties with people whose values aren’t aligned with hers. But she will remain politically active and expects to volunteer for phone-banking duty soon.

“Doing something is the only thing that allows me to feel better,” Lamirand said. “It allows me to feel some level of control.”

Ideally, Ford said, people would not have to choose between being politically active and preserving their mental health. She is investigating ways to help people feel hopeful, inspired and compassionate about political challenges, since these emotions can motivate action without triggering stress and anxiety.

“We want to counteract this pattern where the more involved you are, the worse you are,” Ford said.

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The benefits would be felt across the political spectrum. In the APA survey, similar shares of Democrats, Republicans and independents agreed with statements like, “It causes me stress that politicians aren’t talking about the things that are most important to me,” and, “The political climate has caused strain between my family members and me.”

“Both sides are very invested in this country, and that is a good thing,” Wright said. “Antipathy and hopelessness really doesn’t serve us in the long run.”

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Video: SpaceX Unable to Recover Booster Stage During Sixth Test Flight

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Video: SpaceX Unable to Recover Booster Stage During Sixth Test Flight

President-elect Donald Trump joined Elon Musk in Texas and watched the launch from a nearby location on Tuesday. While the Starship’s giant booster stage was unable to repeat a “chopsticks” landing, the vehicle’s upper stage successfully splashed down in the Indian Ocean.

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