On the brink of ruin, Juul files emergency petition to fight FDA ban

Packages of Juul e-cigarettes are displayed for sale in the Brazil Outlet shop on June 22, 2022 in Los Angeles, California.

Enlarge / Packages of Juul e-cigarettes are displayed for sale in the Brazil Outlet shop on June 22, 2022 in Los Angeles, California. (credit: Getty | Mario Tama)

With its business going up in smoke, e-cigarette giant Juul filed an emergency motion Monday to halt the Food and Drug Administration’s decision to deny the company authorization to market any of its products in the US, effectively forcing it out of business.

The decision was leaked to The Wall Street Journal last Wednesday, June 22, and the regulator publicly announced the decision Thursday. On Friday, a panel of federal appeals court judges granted Juul a temporary administrative stay, allowing the company to continue to sell its products while the court reviews Juul’s emergency petition to halt the FDA’s decision. Juul had until noon Monday to submit its petition. The administrative stay is not based on the merits of Juul’s argument in any way, the judges noted.

Meanwhile, The Wall Street Journal reported Friday that in addition to fighting the FDA denial, Juul is also considering filing for bankruptcy. The report cited unnamed people familiar with the matter. Juul did not immediately respond to Ars’ request for comment regarding a possible bankruptcy filing.

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#e-cigarettes, #fda, #juul, #medicine, #nicotine, #policy, #science

Pig heart transplant failure: Doctors detail everything that went wrong

Image of long arrays of cells stained pink.

Enlarge / Much of the heart is composed of muscle cells like the ones shown here. (credit: Ed Reschke)

Earlier this year, news broke of the first experimental xenotransplantation: A human patient with heart disease received a heart from a pig that had been genetically engineered to avoid rejection. While initially successful, the experiment ended two months later when the transplant failed, leading to the death of the patient. At the time, the team didn’t disclose any details regarding what went wrong. But this week saw the publication of a research paper that goes through everything that happened to prepare for the transplant and the weeks following.

Critically, this includes the eventual failure of the transplant, which was triggered by the death of many of the muscle cells in the transplanted heart. But the reason for that death isn’t clear, and the typical signs of rejection by the immune system weren’t present. So, we’re going to have to wait a while to understand what went wrong.

A solid start

Overall, the paper paints a picture of organ recipient David Bennett as a patient who was on the verge of death when the transplant took place. He was an obvious candidate for a heart transplant and was only kept alive through the use of a device that helped oxygenate his blood outside his body. But the patient had what the researchers refer to as “poor adherence to treatment,” which led four different transplant programs to deny him a human heart transplant. At that point, he and his family agreed to participate in the experimental xenotransplant program.

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#genetic-engineering, #medicine, #science, #transplants, #xenotransplant

FDA reportedly preparing to force Juul products off the US market

Mint and menthol pods for Juul Labs Inc. e-cigarettes are displayed for sale at a store in Princeton, Illinois, in September 2019.

Enlarge / Mint and menthol pods for Juul Labs Inc. e-cigarettes are displayed for sale at a store in Princeton, Illinois, in September 2019. (credit: Getty | Bloomberg)

The Food and Drug Administration is reportedly preparing to deny authorization of Juul’s tobacco- and menthol-flavored products, effectively forcing the e-cigarette giant out of the US market, according to a report by The Wall Street Journal.

In their reporting, the Journal cited unnamed people familiar with the matter, who also said the FDA could announce its denial as early as today, Wednesday, June 22.

If the report is accurate, the move will come on the heels of an FDA announcement on Tuesday that the regulator is working on plans to establish a maximum nicotine level for cigarettes and other combusted tobacco products. It’s a move aimed at making the products less appealing to youth, less addictive, and less deadly.

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#biology, #e-cigarettes, #fda, #juul, #medicine, #nicotine, #science, #tobacco, #vaping

Venomous Snail Unlocks New Diabetes Drugs

A cone snail’s poison helps to form a fast-acting insulin

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#advances, #animals, #biology, #health, #medicine

COVID rebounds: Immune responses may be reignited by cleanup of viral scraps

A box of Paxlovid, the Pfizer antiviral drug.

Enlarge / A box of Paxlovid, the Pfizer antiviral drug. (credit: Getty | Europa Press News)

Pfizer’s antiviral pill Paxlovid is among the most treasured tools for hammering COVID-19; it can knock back the relative risk of hospitalization and death by 89 percent in unvaccinated patients at high risk of severe disease. But, as use of the convenient drug has grown in the US, so have troubling reports of rebound cases—people who took the pill early in their infection, began feeling better, and even tested negative but then slid back into symptoms and tested positive again days later.

It’s still unclear just how common the phenomenon is, but it certainly happens in some proportion of Paxlovid-treated patients. In May, the Centers for Disease Control and Prevention even issued a health alert over the rebound reports.

But, amid the rising awareness, it has also become clear that patients who have not been treated with Paxlovid can also rebound. In fact, in Pfizer’s clinical trials of Paxlovid, researchers noted that about 1 percent to 2 percent of both treatment and placebo groups had rebounds.

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#antiviral, #biology, #covid-19, #medicine, #nih, #paxlovid, #rebound, #sars-cov-2, #science, #symptoms

Long COVID 20-50% less likely after omicron than delta in vaccinated people

A long COVID patient sits with her daughter in her wheelchair while receiving a saline infusion at her Maryland home on Friday, May 27, 2022.

Enlarge / A long COVID patient sits with her daughter in her wheelchair while receiving a saline infusion at her Maryland home on Friday, May 27, 2022. (credit: Getty | The Washington Post)

Among adults vaccinated against COVID-19, the odds of developing long COVID amid the omicron wave were about 20 percent to 50 percent lower than during the delta period, with variability based on age and time since vaccination.

The finding comes from a case-control observational study published this week in The Lancet by researchers at Kings College London. The study found that about 4.5 percent of the omicron breakthrough cases resulted in long COVID, while 10.8 percent of delta breakthrough cases resulted in the long-term condition.

While the news may seem a little reassuring to those nursing a breakthrough omicron infection, it’s cold comfort for public health overall since the omicron coronavirus variant is much more transmissible than delta.

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#biology, #covid-19, #delta, #infectious-disease, #long-covid, #medicine, #omicron, #public-health, #sars-cov-2, #science, #variants

EU warns of BA.4/BA.5 uprising, braces for next wave of cases

Members of the public queue outside a pharmacy to receive COVID-19 antigen tests in Paris on January 6, 2022.

Enlarge / Members of the public queue outside a pharmacy to receive COVID-19 antigen tests in Paris on January 6, 2022. (credit: Getty | LUDOVIC MARIN)

Omicron subvariants BA.4 and BA.5 are on the rise in the European Union, spurring officials there to warn that a surge of COVID-19 cases will likely follow in the coming weeks.

In an alert Monday, the European Center for Disease Prevention and Control cautioned that various factors would influence how bad the expected BA.4/BA.5 wave will be. Those factors include the extent of vaccination and past infection in the population, as well as timing since those events because protection from both wanes over time.

BA.4 and BA.5 are clumped together because they share the same mutations in the genetic coding for their spike proteins, though they have differing mutations elsewhere in their genome. Both have a transmission advantage over the initial omicron subvariant, BA.1, as well as subvariants BA.2 and BA.2.12.1.

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Monkeypox spreading via direct, physical contact, CDC says as US cases hit 45

Monkeypox spreading via direct, physical contact, CDC says as US cases hit 45

(credit: CDC | UK Health Security Agency)

The US has now identified 45 monkeypox cases scattered across 15 states and the District of Columbia, while the multinational outbreak has reached more than 1,300 confirmed cases from at least 31 countries. No deaths have been reported.

In a press briefing Friday, US health officials provided updates on efforts to halt the spread of the virus and dispel unfounded concerns that the virus is spreading through the air.

To date, no cases of airborne transmission have been reported in the outbreak, which has almost entirely been found spreading through sexual networks of men who have sex with men. Monkeypox may spread through large, short-range respiratory droplets, and health care providers are encouraged to mask and take other precautions during specific procedures, such as intubation. But the general potential for spread via smaller, long-range aerosols is more speculative and theoretical.

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#biology, #cdc, #infectious-disease, #medicine, #monkeypox, #outbreak, #science, #transmission

US can’t afford fall boosters for all—even after cuts to test and PPE spending

A sign for a vaccine site stands in Staten Island on November 29, 2021, in New York City.

Enlarge / A sign for a vaccine site stands in Staten Island on November 29, 2021, in New York City. (credit: Getty | Spence Platt)

With pandemic funding running out, the Biden administration is repurposing $10 billion to buy next-generation COVID-19 booster doses for the fall, as well as treatments, including the anti-viral Paxlovid and monoclonal antibodies.

The funding will be pilfered from federal programs that support COVID-19 test availability and domestic production, as well as stockpiles of essential resources, such as personal protective equipment (PPE) and ventilators. Funding for research on coronavirus vaccines and new treatments will also take a hit.

“These were incredibly painful decisions,” White House COVID-19 Response Coordinator Ashish Jha said in a press briefing Thursday.

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#biology, #booster, #boosters, #covid-19, #infectious-disease, #medicine, #ppe, #public-health, #sars-cov-2, #science, #testing, #testing-capacity, #vaccines

Correcting Misinformation about How ‘Plan B’ Works

As states move to limit access to abortion, some are taking aim at the popular form of emergency contraception

— Read more on ScientificAmerican.com

#biology, #health, #medicine, #reproduction

FDA advisors overwhelmingly endorse Novavax COVID-19 vaccine

Empty vials of the Novavax Inc. Nuvaxovid COVID-19 vaccine arranged at the Tegel Vaccine Center in Berlin, Germany, on Monday, March 7, 2022.

Enlarge / Empty vials of the Novavax Inc. Nuvaxovid COVID-19 vaccine arranged at the Tegel Vaccine Center in Berlin, Germany, on Monday, March 7, 2022. (credit: Getty | Bloomberg )

A committee of independent, expert advisors for the Food and Drug Administration voted overwhelmingly to authorize the two-dose Novavax COVID-19 vaccine Tuesday, with 21 of 22 committee members voting in favor of the vaccine and one member abstaining.

The endorsement is only for a two-dose primary series in adults, not for boosters. The FDA is not obligated to follow the advice of its committee—the Vaccines and Related Biological Products Advisory Committee (VRBPAC)—but the agency typically heeds its advice. If the FDA authorizes the vaccine, the Centers for Disease Control and Prevention will need to sign off on use before it becomes available.

The decision regarding the Novavax vaccine, which is already authorized in dozens of other countries, is not a straightforward one in the US. The vaccine has some advantages over currently approved vaccines but has several strikes against it.

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#biology, #clinical-trial, #covid-19, #fda, #infectious-disease, #medicine, #novavax, #public-health, #sars-cov-2, #science, #vaccine

BA.4, BA.5 gain ground in US, pose higher risk of breakthrough infections

A person holds a positive SARS-CoV-2 rapid test on February 17, 2022 in Berlin, Germany.

Enlarge / A person holds a positive SARS-CoV-2 rapid test on February 17, 2022 in Berlin, Germany. (credit: Getty | Thomas Trutschel)

Omicron subvariant BA.2.12.1 has overtaken BA.2 as the dominant version of the pandemic coronavirus in the US, now accounting for an estimated 59 percent of cases nationwide. But BA.2.12.1’s reign may end as quickly as it began, with yet another batch of omicron subvariants gaining ground—BA.4 and BA.5—and threatening to cause more breakthrough infections.

BA.2.12.1 has a transmission advantage over BA.2, which itself has an edge over the initial omicron subvariant, BA.1, that caused a towering surge of US cases in mid-January. BA.2 peaked in mid-April, accounting for 76 percent of US cases at its height. But then came BA.2.12.1, which is named for being the 12th lineage stemming from BA.2 and the first branch of that BA.2.12 lineage.

When BA.2 peaked in mid-April, BA.2.12.1 accounted for about 18 percent of cases. It reached about 43 percent prevalence by mid-May and has since overtaken BA.2, which currently accounts for only about 35 percent of cases. BA.2.12.1 is dominant in every region of the country, except for the Northwest, according to the Centers for Disease Control and Prevention.

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US officials monitoring over 400 people for monkeypox; 21 cases confirmed

A negative stain electron micrograph of a monkeypox virus virion in human vesicular fluid.

Enlarge / A negative stain electron micrograph of a monkeypox virus virion in human vesicular fluid. (credit: Getty | BSIP)

Health officials in the US have confirmed 21 cases of monkeypox across 11 states amid a multinational outbreak that has grown to more than 800 cases in over two dozen countries.

In a press briefing Friday, the Centers for Disease Control and Prevention discussed details of the 17 US cases that officials have clinical data. The officials noted that genetic sequencing from some of the cases revealed two distinct lineages of the monkeypox virus, which may indicate that monkeypox has been quietly spreading among humans for much longer than previously known. It also deepens concern over whether the current outbreak can be contained entirely.

Low risk overall

So far, there have been no deaths reported in the US or multinational outbreak. Among the 17 well-documented US cases, all patients are reported to be doing well and are isolating.

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#biology, #cdc, #infectious-disease, #medicine, #monkeypox, #outbreak, #science, #virus

June 21 is expected start date of COVID vaccination for kids under 5

White House COVID-19 Response Coordinator Dr. Ashish Jha speaks alongside White House Press Secretary Karine Jean-Pierre during the daily press briefing at the White House on June 02, 2022 in Washington, DC.

Enlarge / White House COVID-19 Response Coordinator Dr. Ashish Jha speaks alongside White House Press Secretary Karine Jean-Pierre during the daily press briefing at the White House on June 02, 2022 in Washington, DC. (credit: Getty | Kevin Dietsch)

COVID-19 vaccination for children ages 6 months to under five years—the only age group yet to be eligible for vaccination—is expected to get underway on June 21, White House COVID-19 response coordinator Ashish Jha said in a press briefing Thursday.

The Food and Drug Administration is now reviewing data from Moderna and Pfizer-BioNTech on their respective vaccines for the young age group. The agency will convene its panel of independent expert advisors to review the data on June 15 and vote on whether the vaccines should be granted emergency use authorization.

If the panel votes in favor of authorization, the FDA will likely grant authorization quickly. Once that happens, shipments of federal supplies of the vaccines will begin going out to states for distribution. But, before they can go into little arms, the Centers for Disease Control and Prevention will need to have its own advisory committee meeting to review the data and vote on a recommendation. And for the final step, the CDC Director Rochelle Walensky will need to endorse the recommendation.

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#biology, #children-under-5, #covid-19, #fda, #medicine, #science, #vaccines

An IVF Embryo Test Aims to Prevent Miscarriages: Is It Worth It?

The test could help ensure a successful pregnancy but still leaves hopeful parents with some difficult decisions

— Read more on ScientificAmerican.com

#health, #medicine

Experts warn of continued monkeypox spread as hundreds of cases found worldwide

A negative stain electron micrograph of a monkeypox virus virion in human vesicular fluid.

Enlarge / A negative stain electron micrograph of a monkeypox virus virion in human vesicular fluid. (credit: Getty | BSIP)

The multinational monkeypox outbreak continues to pose a low risk to the general public, and, for now, it seems unlikely that cases will mushroom into a global pandemic, according to the World Health Organization and the US Centers for Disease Control and Prevention.

But, experts are concerned that the virus could continue to spread and that transmission may escape containment without an urgent and thorough public health response.

The outbreak tally continues to increase rapidly, with hundreds of cases now reported across at least 23 countries. In an update released Sunday, May 29, WHO reported 257 confirmed cases and around 120 suspected cases from 23 countries. Those figures are already significantly outdated. As of Monday, Our World in Data reported 555 confirmed cases worldwide. On Tuesday, the United Kingdom reported 190 cases, up from the 106 that WHO reported Sunday. Likewise, the US total has increased to 15 cases, up from 10 reported last week.

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#biology, #cdc, #infectious-disease, #medicine, #monkeypox, #outbreak, #public-health, #science, #smallpox, #who

US gun violence is a health crisis with evidence-based solutions, experts plea

Mourners visit a memorial for victims of Tuesday's mass shooting at an elementary school in Uvalde, Texas.

Enlarge / Mourners visit a memorial for victims of Tuesday’s mass shooting at an elementary school in Uvalde, Texas. (credit: Getty | Anadolu Agency)

In the wake of yet another preventable American gun violence tragedy—one that involved the slaughter of 21 people, including 19 children in a Texas elementary school—doctors, nurses, hospital administrators, health experts, and scientists are once again demanding a long-overdue, evidence-based public health response to the uniquely American public health crisis of gun violence.

This is “very much our lane,” Dr. Bindi Naik-Mathuria, a pediatric surgeon at Baylor College of Medicine in Houston, told NBC.

She spoke vividly about the immediate impacts that AR-15-style weapons have on a human body—particularly the smallest ones. In the Uvalde, Texas school shooting this week, the gunman used an AR-15-style rifle (the Daniel Defense DDM4 V7 rifle), which he bought online. AR-15-style rifles are often used in mass shootings. They use a common military-caliber ammunition. The bullets don’t always pass cleanly through flesh, but can instead become “unstable” and tumble, causing devastating damage that can leave victims unrecognizable and with an exceptionally low chance of survival.

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#american-medical-association, #deaths, #firearms, #gun-control, #gun-violence, #mass-shootings, #medicine, #rifles, #science

CDC presumes community spread of monkeypox; 9 cases now in 7 states

A 2003 photo of the arms and legs of a 4-year-old girl infected with monkeypox in Liberia.

Enlarge / A 2003 photo of the arms and legs of a 4-year-old girl infected with monkeypox in Liberia. (credit: Getty | BSIP)

Monkeypox is presumed to have spread within the US, and nine cases have now been identified in seven states, according to the director of the Centers for Disease Control and Prevention, Rochelle Walensky.

In a press briefing Thursday, Walensky said the nine cases were from Massachusetts, New York, Florida, Utah, Washington, California, and Virginia. Most of the nine cases had recent international travel to areas with active monkeypox cases, but not all.

“We need to presume that there is some community spread,” Walensky said. “But there is active contact tracing that is happening right now to understand whether and how these cases might have been in contact with each other or with others in other countries.”

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#biology, #cases, #cdc, #infectious-disease, #medicine, #monkeypox, #outbreak, #public-health, #science, #virus

Antifatness in the Surgical Setting

Weight bias compounds health problems, and surgeons need to recognize and stop it

— Read more on ScientificAmerican.com

#health, #medicine

More than 1 in 5 COVID survivors may develop long COVID, CDC study suggests

A woman breathes into a tube while a health care worker looks on.

Enlarge / A long-COVID patient in Germany takes a pulmonary function test at Hufeland Clinic’s Center for Pneumology. (credit: Getty | picture alliance)

More than one in five adults in the US who have recovered from COVID-19 may end up developing a long-term condition linked to the viral infection, according to a study published this week by the Centers for Disease Control and Prevention.

The post-COVID conditions span heart, lung, kidney, cardiovascular, gastrointestinal, neurological, and mental health conditions. Overall, COVID survivors had nearly twice the risk of developing respiratory and lung conditions, including pulmonary embolisms, compared with uninfected controls. The most common post-COVID conditions were respiratory conditions and musculoskeletal pain.

Among COVID survivors, people ages 18 to 64 were more likely than older survivors to develop cardiac dysrhythmia and musculoskeletal pain. The risks for survivors 65 and up were greater for kidney failure, blood clots, cerebrovascular disease, muscle disorders, neurological conditions, and mental health conditions.

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#biology, #cdc, #covid-19, #infectious-disease, #long-covid, #medical-conditions, #medicine, #public-health, #science

Sliding to mild? Nope—omicron BA.2 caused worse COVID symptoms than BA.1

Sliding to mild? Nope—omicron BA.2 caused worse COVID symptoms than BA.1

Enlarge (credit: Getty | Xinhua News Agency)

Despite early suggestions that the omicron coronavirus subvariant BA.1 would be mild, a massive wave of infections in January caused spikes in hospitalizations and more excess deaths than earlier variants. And subsequent omicron subvariants don’t appear to be easing up.

According to a preprint study involving data from more than 1.5 million people in the United Kingdom, an infection with the omicron subvariant BA.2 was more likely to be symptomatic, more likely to cause a larger number of symptoms, and more likely to cause symptoms that people said affected their daily lives “a lot,” compared to an infection with BA.1.

In fact, BA.2 wasn’t just worse than BA.1; it was bad overall. The study authors analyzed symptom reports linked to infections of the ancestral coronavirus strain and variants alpha, delta, omicron BA.1, and omicron BA.2. The authors found that BA.2 infections were the most likely to cause symptoms compared with all the other variants. And the finding held up when the authors adjusted for time since a booster dose in people who were triple vaccinated, suggesting that waning vaccine protection could not explain the increase in symptom reporting.

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#biology, #covid-19, #infectious-disease, #medicine, #omicron, #sars-cov-2, #science, #symptoms, #variants

The Weight of Stigma: Heavier Patients Confront the Burden of Bias

Research shows that anti-fat bias lowers the quality of care for higher-weight patients. Here is one patient’s story.

— Read more on ScientificAmerican.com

#fitness, #health, #health-care, #medicine

Science Still Doesn’t Understand How Our Sex Affects Our Health

Our X and Y chromosomes represent the biggest genetic difference in our species. Medicine routinely ignores their influence. Why?

— Read more on ScientificAmerican.com

#health, #innovations-in, #medicine

How To Treat COVID at Home

Some over-the-counter medications can help symptoms, and there are ways to ease isolation

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#health, #medicine

What we can learn from the Tuskegee Syphilis Study, 50 years later

Dr. Walter Edmondson of PHS draws a blood sample from a Tuskegee study participant in Milstead, Macon County, Georgia, 1953.

Enlarge / Dr. Walter Edmondson of PHS draws a blood sample from a Tuskegee study participant in Milstead, Macon County, Georgia, 1953. (credit: National Archives/Public domain)

This year marks the 50th anniversary of The New York Times’ exposé of the infamous Tuskegee Syphilis Study, thanks to a frustrated social worker who tipped off the press. By the time it broke in 1972, experiments had been conducted on unsuspecting Black men in the area surrounding Tuskegee, Alabama, for 40 years. All 400 or so of the male subjects had contracted syphilis, and all had been told they were receiving treatment for the disease—except they were not.

The researchers in charge of the study instead deliberately withheld treatment in order to monitor the progression of the disease as it advanced unchecked. The study’s exposure led to a public outcry and heated debate over informed consent, ultimately giving rise to a number of regulations to prevent such an ethical lapse in the future. The Tuskegee Syphilis Study has since become a vital case study in bioethics, but public awareness of its existence is spotty at best. A new paper published in the American Journal of Respiratory and Critical Care Medicine seeks to remedy that, and it argues that federal regulation is not enough to prevent similar unethical research.

“Citizens have an obligation to remember the victims of any major catastrophe, as people do with 9/11,” the paper’s author, Martin Tobin, told Ars. “The men in Tuskegee suffered major injury, including death, at the hands of the premier health arm of the US government. A failure to remember what happened to these men is to add another layer of injury to what they already endured.”

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#bioethics, #ethics, #features, #gaming-culture, #informed-consent, #institutional-racism, #medicine, #science, #syphilis, #tuskegee-study

How to Tell Whether a Cancer Is Caused by Plain Bad Luck

A new study offers a possible answer to the question “Why me?”

— Read more on ScientificAmerican.com

#cancer, #health, #medicine

A Simple Solution Would Make COVID Antivirals More Accessible, Pharmacists Say

The Biden administration’s Test to Treat program aims to make the treatments available at pharmacies, yet it requires a medical provider to prescribe the drugs

— Read more on ScientificAmerican.com

#health, #medicine, #pharmaceuticals

Can Drugs Reduce the Risk of Long COVID? What Scientists Know So Far

Researchers are trying to establish whether existing COVID-19 vaccines and treatments can prevent lasting symptoms

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#health, #medicine, #pharmaceuticals

Reporting bias makes homeopathy trials look like they work

Image of bottles with leaves in them.

Enlarge / If homeopathic remedies had this much nonwater material in them, we probably wouldn’t be having this discussion. (credit: Iryna Veklich / Getty Images)

One of the more productive ways that the methods of science can be used is to look at the scientific process itself. A “meta-science” study (like a recent one published on brain scans) can help tell us when research approaches aren’t producing reliable data and can potentially show what we might need to change to get those approaches to work.

Now, someone’s applied a bit of meta-science to an area of research where we shouldn’t expect to see improvements: homeopathy. A group of Austrian researchers looked into why a reasonable fraction of the clinical trials on homeopathy produce positive results. The biggest factor, the researchers found, is that the trials that show homeopathy is ineffective are less likely to get published.

A method to the madness

There are plenty of ways to test potential treatments but, over the years, problems have been identified in almost all of them. That’s left the double-blind, randomized clinical trial as the most trusted method of getting rid of some of the biases that make other approaches less reliable. But even in double-blind trials, problems can creep in. There’s always a bias toward publishing positive results—ones where the treatments have an effect.

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#clinical-trials, #homeopathy, #medicine, #science

Two months after receiving a pig heart, transplant patient dies

Image of surgeons surrounding a patient.

Enlarge / The transplant team with the replacement heart. (credit: The transplant team with the replacement heart.)

On Wednesday, the University of Maryland Medical Center announced that David Bennett, the first human to receive a pig heart transplant, died on Tuesday, March 8. His death comes roughly two months after the transplant; the cause of death wasn’t specified.

The university’s statement is short on details, and those will be critical for understanding the prospects for future transplants of this sort. Bennett was in very poor health at the time of the transplant, with his heart requiring mechanical assistance to keep him alive, so there are many potential explanations for his death that have nothing to do with the transplant. All the university is revealing is that the organ was not immediately rejected by Bennett’s immune system and that his health had started declining several days prior to his death.

Understanding the causes of his death is critical because Bennett will not be the last human to receive a pig organ. Shortly after his transplant, a different group published results from an early clinical trial using hearts from the same genetically engineered pigs. In this case, the hearts were transplanted into brain-dead individuals rather than being used to keep someone alive, but the trial clearly represented a step toward normal transplants.

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#biology, #health, #heart-transplant, #medicine, #pigs, #science, #transplants, #xenotransplant

Extensive study finds small drop in brain volume after COVID-19

Extensive study finds small drop in brain volume after COVID-19

Enlarge (credit: Getty Images)

Infection by SARS-CoV-2 causes a dizzying array of symptoms beyond the respiratory distress that is its most notable feature. These range from intestinal distress to blood clots to the loss of smell, and symptoms vary wildly from person to person.

Figuring out exactly what the virus does inside the human body is likely to take years. But we got a bit of data this week from a detailed study of images of the brains of COVID patients. The images were taken before and after the patients were infected. The results suggest some regions of the brain connected to the olfaction system may shrink slightly in the wake of an infection, although the effect is minor and its consequences are unclear.

Hitting the biobank

This is yet another study that relies on the UK’s Biobank. The Biobank lets users of the UK’s National Health Service volunteer to link their medical records to their genetic profiles and provide medical researchers with a resource of large, population-level studies of risk. In this case, a research team largely based in the UK combed the Biobank for people who had had brain scans prior to a SARS-CoV-2 infection.

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#biology, #covid-19, #health, #medicine, #neuroscience, #pandemic, #sars-cov-2, #science, #virology

Messenger RNA Therapies Are Finally Fulfilling Their Promise

Instructing our cells to make specific proteins could control influenza, autoimmune diseases, even cancer

— Read more on ScientificAmerican.com

#biology, #features, #health, #medicine, #pharmaceuticals, #technology

CDC issues new guidance on mask use

Image of a color-coded map of the US.

Enlarge / The new standards place most of the country in a state where mask use is optional. (credit: CDC)

In a widely expected move, the Centers for Disease Control and Prevention announced new guidelines for the use of masks and other precautions to limit the spread of COVID-19. While the precautions people should take—vaccinations and mask use—are largely unchanged, the metrics that will trigger changes in suggested precautions will shift from being focused purely on case counts to including information on the severity of cases and hospital capacity.

The move had been hinted at for weeks, and it comes in response to a wide range of pressures. These include the rapidly falling numbers of new cases following the peak of omicron infections earlier this year, changes made in policies at the state level, and a general fatigue regarding pandemic precautions among the public. During a press call announcing the changes, however, CDC head Rochelle Walensky said the agency had been considering the changes for some time.

What’s new

Walensky announced the changes by saying, “We’re in a stronger place today,” before elaborating that this is because, “with widespread population immunity, the overall risk of severe disease is lower.” Given that situation, the CDC has decided to shift the focus of its advice to cases of severe illness and the strain those put on the health care system.

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#cdc, #covid-19, #masks, #medicine, #pandemic, #sars-cov-2, #science

Nasal Spray COVID Preventives Are Finally in Development

Different methods of drug delivery give us more tools to fight disease

— Read more on ScientificAmerican.com

#features, #health, #medicine, #pharmaceuticals

These Eye Drops Could Replace Your Reading Glasses

Solutions to age-related vision problems now come in a bottle. How well do they work?

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#health, #medicine

New spinal implant gets paralyzed people up and walking

Image of two men standing behind walkers.

Enlarge / Two formerly paralyzed individuals go for a stroll in Lausanne, Switzerland. (credit: EPFL)

Spinal cord injuries are life-altering, as they prevent the transmission of nerve impulses past the point of injury. That means no sensory inputs make it to the brain, and no signals from the brain make it to the muscles normally controlled by the brain. But improvements in our understanding of neurobiology have raised the hope that we can eventually restore some control over paralyzed limbs.

Some of these efforts focus purely on nerve cells, attempting to get them to grow through the damage at the site of injury and restore a functional spinal cord. Others attempt to use electronics to bypass the injury entirely. Today, there was very good news for the electronics-focused effort: researchers have designed a spinal implant that can control the leg muscles of paralyzed individuals, allowing them to walk with assistance within hours of the implant being activated.

Skipping the brain

Much of the spinal cord is composed of long extensions made by nerve cells, termed axons. These axons allow nerve impulses to travel long distances, which is necessary for information to travel back and forth to the brain. Sensory inputs, like pain in your elbow or tickling of your feet, ride axons up the spinal cord into the brain. The brain in turn sends signals back down the spinal cord, controlling your breathing or moving your arms.

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#biology, #implants, #medicine, #neurobiology, #paralysis, #science

COVID Smell Loss and Long COVID Linked to Inflammation

Hamsters eating Cocoa Krispies reveal inflammation pathways from the olfactory system to the brain

— Read more on ScientificAmerican.com

#health, #health-care, #medicine

For T-cells, omicron is nothing unusual

Image of two spherical objects with a set of processes between them.

Enlarge / False-color image of a T-cell (orange) latching on to a cell in preparation for killing it. (credit: Getty Images)

From the start, the omicron variant had people worried because its version of the spike protein carried mutations in many of the sites that are recognized by antibodies. This meant that antibodies generated to combat earlier variants like delta were less likely to recognize the newcomer. These fears have played out in the form of lowered immunity to omicron, along with the failure of some antibody-based therapies.

But all those fears were focused on the immune system’s antibody response; the immune system also produces T-cells that recognize the virus, and it’s not clear how omicron affected their response. Based on two recently published papers, the answer is “not much at all,” which could help explain why the vaccines continue to protect from severe disease.

Those other cells

The T-cell-based immune response works very differently from that of antibody-producing cells. It relies on the fact that all cells chop up a small fraction of the proteins they make. Specialized proteins then grab on to some of the resulting protein fragments and display them on the cell’s surface. Once on the surface, they can be recognized by a receptor on the surface of T-cells.

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#biology, #covid-19, #immunology, #medicine, #pandemic, #sars-cov-2, #science, #t-cells, #vaccines

How Many COVID Vaccine Boosters Will We Need?

Endless boosting might not be a practical or sustainable strategy, scientists say

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#health, #medicine, #public-health, #vaccines

Why Omicron Is Putting More Kids in the Hospital

The huge jump in cases means more hospitalizations. And children’s small airways can be more easily blocked by infections

— Read more on ScientificAmerican.com

#health, #medicine

These Are the Latest COVID Treatments

But shortages mean that new antivirals and other drugs may be hard to come by

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#health, #health-care, #medicine, #pharmaceuticals

The genetic engineering behind pig-to-human transplants

Image of young pigs in a plastic container.

Enlarge / Cloned piglets that are engineered to be useful for organ transplants to humans. (credit: Getty Images / Staff)

Last week, when we reported on the first pig-to-human heart transplant, we complained that the commercial company behind the operation wasn’t more forthcoming about the genetic engineering that converted the pig into a viable donor.

We now know much more about porcine genetic engineering thanks to a new paper covering a different, more cautious test procedure. The work described in the paper is a transplant of pig kidneys into a brain-dead recipient and is meant to pave the way for trials in viable humans. The publication that describes the work contains extensive details on the genetic engineering used to ensure that the pig tissue would survive in a human host.

A test case

According to The New York Times, the recipient was rendered brain-dead by a motorcycle accident. He had signed up as an organ donor and was kept alive while his organs were screened; his next of kin gave informed consent to his body’s use in the experimental procedure.

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#biology, #genetic-engineering, #medicine, #organ-transplants, #science, #xenotransplants

Immune system vs. virus: Why omicron had experts worried from the start

Illustration of antibodies responding to an infection of SARS-CoV-2.

Enlarge / Illustration of antibodies responding to an infection of SARS-CoV-2. (credit: Getty Images/Kateryna Kon/Science Photo Library)

Right from omicron’s first description, researchers were concerned about the variant of the SARS-CoV-2 virus. Looking over the list of mutations it carried, scientists could identify a number that would likely make the variant more infectious. Other mutations were even more worrying, as they would likely interfere with the immune system’s ability to recognize the virus, allowing it to pose a risk to those who had been vaccinated or suffered from previous infections.

Buried in the subtext of these worries was a clear implication: Scientists could simply look at the sequence of amino acids in the spike protein of a coronavirus and get a sense of how well the immune system would respond to it.

That knowledge is based on years of studying how the immune system operates, combined with a lot of specific information regarding its interactions with SARS-CoV-2. What follows is a description of these interactions, along with their implications for viral evolution and present and future variants.

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#antibodies, #b-cells, #biology, #covid-19, #immunology, #medicine, #pandemic, #sars-cov-2, #science, #t-cells, #vaccines

Some COVID Patients Need Amputations to Survive

Impaired blood flow leads to loss of limbs

— Read more on ScientificAmerican.com

#health, #medicine

Pig heart transplanted to human for the first time

Image of surgeons surrounding a patient.

Enlarge / The transplant team with the replacement heart. (credit: The transplant team with the replacement heart.)

On Monday, the University of Maryland School of Medicine announced that its staff had done the first transplant of a pig’s heart into a human. The patient who received it had end-stage heart disease and was too sick to qualify for the standard transplant list. Three days after the procedure, the patient was still alive.

The idea of using non-human organs as replacements for damaged human ones—called xenotransplantation—has a long history, inspired by the fact that there are more people on organ waiting lists than there are donors. And, in recent years, our ability to do targeted gene editing has motivated people to start genetically modifying pigs in order to make them better donors. But the recent surgery wasn’t part of a clinical trial, so it shouldn’t be viewed as an indication that this approach is ready for widespread safety and efficacy testing.

Instead, the surgery was authorized by the FDA under its “compassionate use” access program. This allows those faced with life-threatening illnesses to receive investigational treatments that haven’t gone through rigorous clinical testing yet.

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#biology, #gene-editing, #medicine, #science, #transplants, #xenotransplants

Tracking Facebook connections between parent groups and vaccine misinfo

Tracking Facebook connections between parent groups and vaccine misinfo

Enlarge (credit: Getty | Joe Amon)

Misinformation about the pandemic and the health measures that are effective against SARS-CoV-2 has been a significant problem in the US. It’s led to organized resistance against everything from mask use to vaccines and has undoubtedly ended up killing people.

Plenty of factors have contributed to this surge of misinformation, but social media clearly helps enable its spread. While the companies behind major networks have taken some actions to limit the spread of misinformation, internal documents indicate that a lot more could be done.

Taking more effective action, however, would benefit from more clearly identifying what the problems are. And, to that end, a recent analysis of the network of vaccine misinformation provides information that might be helpful. It finds that most of the worst misinformation sources are probably too small to stand out as being in need of moderation. The analysis also shows that the pandemic has brought mainstream parenting groups noticeably closer to groups devoted to conspiracy theories.

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#computer-science, #medicine, #misinformation, #pandemic, #science, #vaccines

Genetic Therapies for Brain Diseases

Hopes are high for a class of drug that could treat neurodegenerative conditions—but a recent clinical trial has brought the field up short

— Read more on ScientificAmerican.com

#features, #health, #medicine, #neurology

New data on using J&J vaccine to boost itself

Image of injection syringes.

Enlarge (credit: RAJESH JANTILAL / GETTY IMAGES)

Based on various measures, the Johnson & Johnson COVID-19 vaccine has appeared to be less effective than those based on mRNA technology. It has also been associated with some rare blood clotting complications that recently caused the CDC to revise its endorsement of the vaccine. Still, the vaccine is easy to produce, transport, and store, and there have been some indications that it provides longer-lasting protection than some alternatives. And there have also been indications that at least some of the efficacy differences came from its use as a single-dose vaccine.

With all vaccines now expected to include a booster significantly after the initial vaccine dose, we’re starting to get a sense of how the J&J vaccine performs in more than one dose. Early results indicated that a J&J vaccine boosted by an mRNA dose provides a big increase in protective antibodies. But a J&J/J&J combination didn’t look to be as effective.

Recent research preprints, however, may indicate that the protection continues to increase over time, engages non-antibody-producing immune cells, and provides some protection against the omicron variant.

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#covid-19, #immunology, #medicine, #pandemic, #sars-cov-2, #science, #vaccines

After COVID-19 Successes, Researchers Push to Develop mRNA Vaccines for Other Diseases

mRNA vaccines are now in the limelight as a key tool for tackling COVID-19, but the technology was originally developed for other diseases, such as cancer, that researchers are now hoping to treat

— Read more on ScientificAmerican.com

#features, #health, #medicine

Medical Algorithms Need Better Regulation

Many do not require FDA approval, and those that do often do not undergo clinical trials

— Read more on ScientificAmerican.com

#computing, #forum, #health, #inequality, #medicine, #technology