health

sketchy-botox-shots-spark-multistate-outbreak-of-botulism-like-condition

Sketchy Botox shots spark multistate outbreak of botulism-like condition

botox, botulism, butulinum toxin, CDC, health, Illinois, Science, tennessee / /

Yikes —

So far at least six people in two states have fallen ill; four of them were hospitalized.

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A woman in New Jersey receiving a Botox treatment at a Botox party in a New Jersey salon hosted by a radio station.

Enlarge / A woman in New Jersey receiving a Botox treatment at a Botox party in a New Jersey salon hosted by a radio station.

Sketchy cosmetic injections of what seem to be counterfeit Botox are behind a multistate outbreak of botulism-like illnesses, state health officials report.

So far, at least six people have fallen ill in two states: four in Tennessee and two in Illinois. Four of the six people required hospitalization for their condition (two in Tennessee and both cases in Illinois).

The Centers for Disease Control and Prevention is reportedly planning to nationwide alert to notify clinicians of the potentially counterfeit Botox and advise them to be on the lookout for botulism-like illnesses. The agency did not immediately respond to Ars’ request for information.

Botox is a regulated drug product that contains purified, controlled quantities of the botulinum neurotoxin, which is made by certain Clostridium bacterial species, especially Clostridium botulinum. The toxin causes muscle paralysis by blocking the release of a neurotransmitter. When people are exposed to the toxin from wound infections or by accidentally eating contaminated foods, it can lead to full paralysis, including in muscles used for breathing. But, the toxin can also be used safely for cosmetic procedures to smooth facial wrinkles—when well-regulated and approved doses administered by licensed medical professionals are used.

All of those important conditions for use did not seem to be met in the cases identified so far. Tennessee reported that its four cases were linked to injections given in “non-medical settings such as homes or cosmetic spas.” Investigators found that the injections were of “products with unclear origin” and that information collected so far suggests the products were counterfeit.

The two people sickened in Illinois, meanwhile, both received injections from a nurse in LaSalle County who was “performing work outside her authority.” State officials said the injections were of Botox or a similar, possibly counterfeit product.

The early symptoms of botulism can include double or blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, and difficulty breathing, Tennessee health officials noted. After that, people may suffer descending, symmetric muscle weakness that progresses over hours to days, requiring hospitalization and treatment with an anti-toxin.

Illinois officials reported that the cases reported similar symptoms, such as blurred or double vision, droopy face, fatigue, shortness of breath, difficulty breathing, and a hoarse voice, after getting their injections.

“Illinois residents should exercise caution when considering cosmetic treatment,” Illinois Department of Public Health Director Sameer Vohra said in a statement. “Receiving these treatments in unlicensed, unapproved settings can put you or your loved ones at serious risk for health problems. Please only seek cosmetic services under the care of licensed professionals trained to do these procedures and who use FDA approved products. If you are experiencing any health problems after a recent cosmetic treatment, please contact your healthcare provider immediately for help and assistance.”

Sketchy Botox shots spark multistate outbreak of botulism-like condition Read More »

teen’s-vocal-cords-act-like-coin-slot-in-worst-case-ingestion-accident

Teen’s vocal cords act like coin slot in worst-case ingestion accident

airway, Coin, foreign object, health, NEJM, Science / /

What are the chances? —

Luckily his symptoms were relatively mild, but doctors noted ulceration of his airway.

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Teen’s vocal cords act like coin slot in worst-case ingestion accident

Most of the time, when kids accidentally gulp down a non-edible object, it travels toward the stomach. In the best-case scenarios for these unfortunate events, it’s a small, benign object that safely sees itself out in a day or two. But in the worst-case scenarios, it can go down an entirely different path.

That was the case for a poor teen in California, who somehow swallowed a quarter. The quarter didn’t head down the esophagus and toward the stomach, but veered into the airway, sliding passed the vocal cords like they were a vending-machine coin slot.

Radiographs of the chest (Panel A, postero- anterior view) and neck (Panel B, lateral view). Removal with optical forceps (Panel C and Video 1), and reinspection of ulceration (Panel D, asterisks)

Enlarge / Radiographs of the chest (Panel A, postero- anterior view) and neck (Panel B, lateral view). Removal with optical forceps (Panel C and Video 1), and reinspection of ulceration (Panel D, asterisks)

In a clinical report published recently in the New England Journal of Medicine, doctors who treated the 14-year-old boy reported how they found—and later retrieved—the quarter from its unusual and dangerous resting place. Once it passed the vocal cords and the glottis, the coin got lodged in the subglottis, a small region between the vocal cords and the trachea.

Luckily, when the boy arrived at the emergency department, his main symptoms were hoarseness and difficulty swallowing. He was surprisingly breathing comfortably and without drooling, they noted. But imaging quickly revealed the danger his airway was in when the vertical coin lit up his scans.

“Airway foreign bodies—especially those in the trachea and larynx—necessitate immediate removal to reduce the risk of respiratory compromise,” they wrote in the NEJM report.

The teen was given general anesthetic while doctors used long, optical forceps, guided by a camera, to pluck the coin from its snug spot. After grabbing the coin, they re-inspected the boy’s airway noting ulcerations on each side matching the coin’s ribbed edge.

After the coin’s retrieval, the boy’s symptoms improved and he was discharged home, the doctors reported.

Teen’s vocal cords act like coin slot in worst-case ingestion accident Read More »

$158,000-als-drug-pulled-from-market-after-failing-in-large-clinical-trial

$158,000 ALS drug pulled from market after failing in large clinical trial

ALS, Amylyx, clinical trial, fda, health, Science / /

Off the market —

The drug is now unavailable to new patients; its maker to lay off 70% of employees.

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$158,000 ALS drug pulled from market after failing in large clinical trial

Amylyx, the maker of a new drug to treat ALS, is pulling that drug from the market and laying off 70 percent of its workers after a large clinical trial found that the drug did not help patients, according to an announcement from the company Thursday.

The drug, Relyvrio, won approval from the Food and Drug Administration in September 2022 to slow the progression of ALS (amyotrophic lateral sclerosis, or Lou Gehrig’s disease). However, the data behind the controversial decision was shaky at best; it was based on a study of just 137 patients that had several weaknesses and questionable statistical significance, and FDA advisors initially voted against approval. Still, given the severity of the neurogenerative disease and lack of effective treatments, the FDA ultimately granted approval under the condition that the company was working on a Phase III clinical trial to solidify its claimed benefits.

Relyvrio—a combination of two existing, generic drugs—went on the market with a list price of $158,000.

Last month, the company announced the top-line results from that 48-week, randomized, placebo-controlled trial involving 664 patients: Relyvrio failed to meet any of the trial’s goals. The drug did not improve patients’ physical functions, which were scored on a standardized ALS-specific test, nor did it improve quality of life, respiratory function, or overall survival. At that time, the co-CEOs of the company said they were “surprised and deeply disappointed” by the result, and the company acknowledged that it was considering voluntarily withdrawing the drug from the market.

In the announcement on Thursday, the company called Relyvrio’s market withdrawal a “difficult moment for the ALS community.” Patients already taking the medication who wish to continue taking it will be able to do so through a free drug program, the company said. It is no longer available to new patients, effective Thursday.

Amylyx is now “restructuring” to focus on two other drug candidates that treat different neurodegenerative disease. The change will include laying off 70 percent of its workforce, which, according to The Washington Post, includes more than 350 employees.

Relyvrio is part of a series of similarly controversial drugs for devastating neurodegenerative diseases that have gained FDA approval despite questionable data. In January, drug maker Biogen announced it was abandoning Aduhelm, a highly contentious Alzheimer’s drug that failed two large trials prior to its heavily criticized approval.

$158,000 ALS drug pulled from market after failing in large clinical trial Read More »

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Hong Kong monkey encounter lands man in ICU with rare, deadly virus

B virus, CDC, health, Hong Kong, ICU, infection, macaques, Monkey, Science / /

rare but deadly —

The man had recently visited a country park known for its macaque monkeys.

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This photo taken in August 2014 shows macaque monkeys in a country park in Hong Kong.

Enlarge / This photo taken in August 2014 shows macaque monkeys in a country park in Hong Kong.

A 37-year-old man is fighting for his life in an intensive care unit in Hong Kong after being wounded by monkeys during a recent park visit and contracting a rare and deadly virus spread by primates.

The man, who was previously in good health, was wounded by wild macaque monkeys during a visit to Kam Shan Country Park in late February, according to local health officials. The park is well known for its conservation of wild macaques and features an area that locals call “Monkey Hill” and describe as a macaque kingdom.

On March 21, he was admitted to the hospital with a fever and “decreased conscious level,” health officials reported. As of Wednesday, April 3, he was in the ICU listed in critical condition. Officials reported the man’s case Wednesday after testing of his cerebrospinal fluid revealed the presence of B virus.

B virus, also known as herpes B virus or herpesvirus simiae, is a common infection in macaques, usually causing asymptomatic or mild disease. Infections in humans are extremely rare, but when they occur, they usually come from macaque encounters and are often severe and deadly. The infection can start out a lot like the flu, but the virus can move to the brain and spinal cord, causing brain damage, nerve damage, and death. The US Centers for Disease Control and Prevention estimates that about 70 percent of untreated infections in humans are fatal.

Despite the presence of macaques around Hong Kong, the man’s case is the first known B virus infection documented there. The virus was discovered in 1932, and since then only 50 human infections have been documented as of 2019, the CDC reports. Of those 50 people infected, 21 died. The agency notes that in one case, from 1997, a researcher was infected and died after bodily fluid from an infected monkey splashed into her eye. Still, contracting the virus is rare, even among people exposed to macaques. The CDC reports that there are hundreds of reports of macaque bites and scratches each year in US animal facilities, and infections remain very uncommon.

However low the risk, health officials recommend keeping your distance from wild monkeys and not feeding or touching them. If you are bitten or scratched, wash the wound immediately and seek medical attention.

Hong Kong monkey encounter lands man in ICU with rare, deadly virus Read More »

101-studies-flagged-as-bogus-covid-cure-pusher-sees-career-unravel

101 studies flagged as bogus COVID cure pusher sees career unravel

COVID-19, Didier Raoult, health, hydroxychloroquine, research ethics, Science / /

Career-killer —

It’s a past-due reckoning for French microbiologist Didier Raoult, critics say.

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Microbiologist Didier Raoult addresses a press conference on COVID-19 at the IHU medical institute in Marseille on April 20, 2022.

Enlarge / Microbiologist Didier Raoult addresses a press conference on COVID-19 at the IHU medical institute in Marseille on April 20, 2022.

A scientific journal published by Elsevier has reportedly posted a stunning 101 expressions of concern on studies connected to Didier Raoult, a disgraced French microbiologist who gained international prominence amid the pandemic by promoting, with little evidence, that the malaria drug hydroxychloroquine could treat COVID-19—a claim that has now been firmly debunked.

According to Retraction Watch, the journal New Microbes and New Infections posted 101 expressions of concern on Raoult’s works recently, including a 2023 study that drew sharp criticism. The study involved giving hydroxychloroquine to tens of thousands of COVID-19 patients after data indicated that it wasn’t effective and the French government rescinded permission for its use against COVID-19. An op-ed in the major French newspaper Le Monde described the study as “the largest ‘wild’ therapeutic trial known to date.”

The expressions of concern also come as Raoult saw his tenth study retracted, Retraction Watch noted.

While Raoult’s unfounded claims about hydroxychloroquine drew initial attention to his COVID-19-related work—with critics quickly noting flaws and weaknesses in his studies—his high-profile claims led critics and sleuths to dive deeper into his extensive publication record. There, they claim they found evidence of long-standing and egregious ethics violations, which were recently laid out in an investigative report by Science Magazine.

Essentially, critics claim Raoult and the institute that he led until 2021, the Hospital Institute of Marseille Mediterranean Infection (IHU), conducted hundreds of studies on humans without appropriate ethical approval or oversight or adequate consent from all participants, the Science investigation found. The IHU work spanned a wide variety of research topics, which involved collecting a variety of biological samples from patients, including vaginal swabs, feces, blood, urine, and breast milk.

However, critics noted 248 IHU studies that reused the same ethical approval code, “09-022,” despite being very different studies that included different kinds of sampling. The critics claim that the studies required separate ethical approvals and additional oversight. They also found that at least 17 studies relied on vulnerable populations, including refugees and people living in homeless shelters, raising serious questions about consent. Some of the studies were also conducted in African countries, where evidence of local ethical approval was either absent or incomplete.

Raoult told the magazine that his research groups had the appropriate ethical approval and said that his critics, whom he described as stalkers and cyber harassers, did not understand how French biomedical laws work.

In Elsevier’s expressions of concern and a linked “Publisher’s Note” from November, the publisher said that the concern was over “the articles’ adherence to Elsevier’s publishing ethics policies and the appropriate conduct of research involving human participants.” Elsevier is still investigating the matter but indicated that the expressions of concern are added “if it is deemed that there is a particular need to alert readers to serious concerns while [the] investigation is ongoing.”

Raoult has had nearly 50 studies likewise flagged over ethical concerns in PLOS journals, Retraction Watch noted. The latest of his studies to be retracted was in the journal Scientific Reports, with the editors there also stating it was due to a lack of ethical oversight. “The paper cites approval from an institutional ethics committee in France, but samples used in this study were also sourced from Algeria, Saudi Arabia, and Niger,” the retraction notice says. “The Authors were not able to provide documentation of approval from ethics committees in these countries or of compliance with local regulations regarding the use of such samples in research.”

Raoult is currently under criminal investigation in France.

101 studies flagged as bogus COVID cure pusher sees career unravel Read More »

bird-flu-flare:-cattle-in-5-states-now-positive-as-texas-egg-farm-shuts-down

Bird flu flare: Cattle in 5 states now positive as Texas egg farm shuts down

bird flu, CDC, Chickens, dairy cows, eggs, health, hens, Highly pathogenic avian influenza, influenza, Science, USDA / /

flare-up —

The risk to the general public remains low, federal officials say.

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Chicken eggs are disposed of at a quarantined farm with bird flu in Israel's northern village of Margaliot on January 3, 2022.

Enlarge / Chicken eggs are disposed of at a quarantined farm with bird flu in Israel’s northern village of Margaliot on January 3, 2022.

The flare-up of highly pathogenic bird flu continues to widen in US livestock after federal officials confirmed last week that the virus has spread to US cows for the first time. The virus has now been detected in dairy cows in at least five states, a single person in Texas exposed to infected cows, and an egg farm in Texas, all spurring yet more intense monitoring and biosecurity vigilance as the situation continues to evolve.

As of Tuesday, seven dairy herds in Texas, two in Kansas, and one each in Idaho, Michigan, and New Mexico had tested positive for the virus. The affected dairy herd in Michigan had recently received cows from one of the infected herds in Texas. It remains unclear if there is cow-to-cow transmission of the flu virus.

The virus—a highly pathogenic H5N1 avian influenza or HPAI—has been devastating wild birds worldwide for the past several years. Throughout the devastating outbreak, the flu virus has spilled over to various species, including big cats in zoos, river otters, bears, dolphins, seals, squirrels, and foxes. While cows were an unexpected addition to the list, federal officials noted last week that affected dairy farms had found dead wild birds on their farms, suggesting that wild birds introduced the virus to the cows, not an intermediate host.

On Monday, the Centers for Disease Control and Protection reported that a person in Texas who had contact with infected dairy cows had tested positive for the HPAI. The person’s only symptom was eye redness. The CDC said the person was treated with an antiviral for flu and was recovering. It is the second case of HPAI found in a person in the US. The first case was in a person in Colorado who was directly exposed to poultry infected with the virus. In that case, the person’s only symptom was fatigue over a few days. The person recovered. The CDC considers the risk of HPAI to the general public to be low.

Low risk

Meanwhile, the virus continues to spread to less-surprising animals: chickens. On Tuesday, Cal-Maine Foods, Inc., the country’s largest producer of fresh eggs, reported that HPAI was detected in one of its facilities in Texas. The facility is located in Parmer County, which sits at the border of Texas and New Mexico. It’s unclear if the egg facility is close to any of the affected dairy herds. Cal-Maine, following the US Department of Agriculture biosecurity protocols, immediately shut down the facility. Approximately 1.6 million hens and 337,000 pullets—young hens—were culled. Cal-Maine said the hens represented about 3.6 percent of the company’s total flock.

Since the outbreak began in wild birds, the virus has led to the deaths of over 82 million commercial and backyard birds in the US, with 48 states affected and over 1,000 outbreaks reported. The infections have spurred increases in egg and poultry prices.

It’s unclear if the virus will have the same effect on milk or beef, but so far, it appears that it will not. In the infected herds, the virus appears to only be affecting a small percentage of animals, particularly older animals, and they generally recover. As the USDA puts it there’s “little to no associated mortality reported.” Milk from sick cows is always diverted from the milk supply, but even if milk contaminated with HPAI were to make it into the supply, the virus would be destroyed in the pasteurization process.

Still, the continued, widespread outbreak and spillovers of HPAI in various species highlight the ever-present risk that influenza viruses could mix together, combining genetic fragments of different strains (genetic reassortment) to create a new strain that could spark outbreaks or even a pandemic in humans. In the current outbreak among dairy cattle, federal researchers were quick to check the genetic sequence of the HPAI, finding that, so far, the strain lacks mutations in key genetic regions that would signal the virus has become more infectious to humans. For now, the USDA and the CDC report that the risk to the public is low.

Bird flu flare: Cattle in 5 states now positive as Texas egg farm shuts down Read More »

medicare-forced-to-expand-forms-to-fit-10-digit-bills—a-penny-shy-of-$100m

Medicare forced to expand forms to fit 10-digit bills—a penny shy of $100M

car T-cell therapies, CMS, drug pricing, health, medicare, Pharmaceutical industry, Science / /

more zeros —

Previously, some doctors had to divide bills by 10 and submit 10 claims to get costs covered.

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High angle close-up view still life of an opened prescription bottles with pills and medication spilling onto ae background of money, U.S. currency with Lincoln Portrait.

In a disturbing sign of the times, Medicare this week implemented a change to its claims-processing system that adds two extra digits to money amounts, expanding the fields from eight digits to 10. The change now allows for billing and payment totals of up to $99,999,999.99, or a penny shy of $100 million.

In a notice released last month, the Centers for Medicare & Medicaid Services (CMS) explained the change, writing, “With the increase of Part B procedures/treatments exceeding the $999,999.99 limitation, CMS is implementing the expansion of display screens for monetary amount fields related to billing and payment within [the Fiscal Intermediary Shared System (FISS)] to accept and process up to 10 digits ($99,999,999.99).”

The FISS is the processing system used by hospitals and doctors’ offices to process Medicare claims.

Stat news, which first reported the update, noted that it’s not the first time CMS has struggled to make room for ever-increasing drug and treatment prices in its claims processing systems. In 2022, the agency had to give technical advice to doctors submitting claims for chimeric antigen receptor (CAR) T-cell therapy, which is used to treat blood cancers. CAR T-cell therapies run around half a million dollars, or eight digits. But in a different claims processing system, called the Multi-Carrier System (MCS), the money amount fields only included seven digits. In that case, rather than expanding the field, the CMS requested that doctors divide the bill by either five or 10, depending on the size, and then bill Medicare five or 10 separate times for a single claim.

CAR T-cell therapies aren’t the only treatments with eye-popping price points these days. Just last month, the drug Lenmeldy, a lifesaving gene therapy for a tragic childhood condition, set the current record for the highest drug price in the world at $4.25 million. Before Lenmeldy arrived, the hemophilia B drug Hemgenix held that record, with its price set at $3.5 million.

While these advanced therapies come with mind-boggling prices, prescription drug costs in the US are a problem across the board. In a KFF poll published in August, 28 percent of US adults reported difficulty affording their prescription medication, while 31 percent reported not taking their medicine as prescribed in the past year due to the cost. A federal report from 2022 found that Americans pay nearly three times more for prescription drugs than people in 33 other wealthy countries.

Medicare forced to expand forms to fit 10-digit bills—a penny shy of $100M Read More »

china-has-a-big-problem-with-super-gonorrhea,-study-finds

China has a big problem with super gonorrhea, study finds

antibiotic, antibiotic resistance, bacterial infection, CDC, ceftriaxone, china, drug resistance, gonorrhea, health, Science, sexually transmitted infection, sti / /

Alarming —

Drug-resistant gonorrhea is a growing problem—one that doesn’t heed borders.

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A billboard from the AIDS Healthcare Foundation is seen on Sunset Boulevard in Hollywood, California, on May 29, 2018, warning of a drug-resistant gonorrhea.

Enlarge / A billboard from the AIDS Healthcare Foundation is seen on Sunset Boulevard in Hollywood, California, on May 29, 2018, warning of a drug-resistant gonorrhea.

Health officials have long warned that gonorrhea is becoming more and more resistant to all the antibiotic drugs we have to fight it. Last year, the US reached a grim landmark: For the first time, two unrelated people in Massachusetts were found to have gonorrhea infections with complete or reduced susceptibility to every drug in our arsenal, including the frontline drug ceftriaxone. Luckily, they were still able to be cured with high-dose injections of ceftriaxone. But, as the US Centers for Disease Control and Prevention bluntly notes: “Little now stands between us and untreatable gonorrhea.”

If public health alarm bells could somehow hit a higher pitch, a study published Thursday from researchers in China would certainly accomplish it. The study surveyed gonorrhea bacterial isolates—Neisseria gonorrhoeae—from around the country and found that the prevalence of ceftriaxone-resistant isolates nearly tripled between 2017 and 2021. Ceftriaxone-resistant strains made up roughly 8 percent of the nearly 3,000 bacterial isolates collected from gonorrhea infections in 2022. That’s up from just under 3 percent in 2017. The study appears in the CDC’s Morbidity and Mortality Weekly Report.

While those single-digit percentages may seem low, compared to other countries they’re extremely high. In the US, for instance, the prevalence of ceftriaxone-resistant strains never went above 0.2 percent between 2017 and 2021, according to the CDC. In Canada, ceftriaxone-resistance was stable at 0.6 percent between 2017 and 2021. The United Kingdom had a prevalence of 0.21 percent in 2022.

Ceftriaxone is currently the first-line treatment for gonorrhea because Neisseria gonorrhoeae has spent the past several decades building up resistance to pretty much everything else. As the CDC notes, in the 1980s, the drugs of choice for gonorrhea infections were penicillin and tetracycline. But the bacteria developed resistance. By the 1990s, the CDC was forced to switch to a class of antibiotics called fluoroquinolones, including ciprofloxacin (Cipro). But fluoroquinolone-resistance developed, too, and resistance to Cipro is now widespread. In the early 2000s, the CDC began having to tweak the recommendations as resistance spread to new places and populations.

Resistance rising

By 2007, the agency switched to cephalosporins, including cefixime. In 2010, the CDC updated the treatment again, recommending that doctors combine cephalosporins with one of two other types of antibiotics—azithromycin or doxycycline—to try to thwart the development of resistance. But, it also was no use. Two years later, in 2012, the CDC updated recommendations when cefixime resistance developed. In 2020, azithromycin was also abandoned. The cephalosporin ceftriaxone is the last drug standing in the US to treat gonorrhea infections.

Resistance of gonococcal isolates to ciprofloxacin, penicillin, tetracycline, azithromycin, cefixime, ceftriaxone, and spectinomycin—13 Gonococcal Resistance Surveillance Program sentinel sites, China, 2022.

Enlarge / Resistance of gonococcal isolates to ciprofloxacin, penicillin, tetracycline, azithromycin, cefixime, ceftriaxone, and spectinomycin—13 Gonococcal Resistance Surveillance Program sentinel sites, China, 2022.

In China, the swift spread of ceftriaxone-resistance isolates is alarming. The data stems from 2,804 isolates, representing 2.9 percent of all cases reported in China during 2022. Those figures come from 13 of the country’s 19 provinces. While the overall prevalence of ceftriaxone-resistance isolates was 8.1 percent among the 2,804 isolates, five of those 13 provinces had prevalence rates above 10 percent. Three provinces had prevalence rates above 25 percent. In all, 18 isolates were resistant to all the antibiotics tested except for a bygone antibiotic called spectinomycin, which is discontinued in the US and elsewhere.

The study has limitations. For one, the reported number of gonorrhea cases are very likely an undercount of actual cases. Beyond gaps in reporting, many people with gonorrhea have no symptoms and, as such, don’t seek treatment. Additionally, the isolates the researchers did have represented less than 3 percent of reported cases, so it’s possible the prevalence rates don’t represent the isolates of the entire country. Also, the researchers didn’t have detailed case data that might help identify specific risk factors for resistance development, such as the antibiotic treatments patients had. The authors did note that antibiotics are only given by prescription in China.

“These findings underscore the urgent need for a comprehensive approach to address antibiotic-resistant N. gonorrhoeae in China, including identifying factors contributing to this high resistance rate, especially in provinces where the percentage of gonococcal isolates resistant to ceftriaxone is >10 percent,” the authors write.

But they also note that this is not just an alarming finding for China but also a “pressing public health concern” for the entire world. “These resistant clones have spread internationally, and collaborative cross-border efforts will be essential to monitoring and mitigating its further spread,” they write.

China has a big problem with super gonorrhea, study finds Read More »

puerto-rico-declares-public-health-emergency-as-dengue-cases-rise

Puerto Rico declares public health emergency as dengue cases rise

Aedes aegypti, dengue, health, Infectious disease, mosquitoes, Puerto Rico, Science, viral infection / /

emergency —

Cases so far are up 140 percent compared to this point last year.

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Female Aedes aegypti mosquito as she was in the process of obtaining a

Female Aedes aegypti mosquito as she was in the process of obtaining a “blood meal.”

Puerto Rico has declared a public health emergency amid an ongoing outbreak of dengue infections, a mosquito-spread viral infection that can cause fever, aches, rash, vomiting, and, in about 5 percent of cases, a severe disease marked by internal bleeding and shock.

The US territory has tallied 549 cases since the start of the year, representing a 140 percent increase compared with cases tallied at this point last year, according to the territory’s health department. The Associated Press reported that more than 340 of the 549 cases have been hospitalized.

In 2023, the island nation of more than 3.2 million people had over 1,000 cases of dengue throughout the year.

But this year’s cases are rising rapidly, leading health officials to warn residents to be vigilant and take prevention measures. That includes wearing insect repellent and draining or treating any standing water where mosquitoes can breed. The mosquitoes that transmit dengue—Aedes aegypti—seem to prefer breeding in artificial containers, such as flower pots, buckets, water drums, vases, plastic containers of any kind, the inner rings of discarded automobile tires, and trash in general. They can breed in tiny amounts of water, such as in bottle caps.

Puerto Rico’s outbreak of dengue is part of a larger regional trend, the island’s health department noted. Last year, the Americas saw the highest number of dengue cases ever recorded, totaling 4,565,911, according to the Pan American Health Organization (PAHO), a division of the World Health Organization. So far this year, the region has reported 3,578,414 cases, including 1,039 deaths. The bulk of the cases are in Brazil, which has reported over 2.9 million cases so far. Paraguay has reported over 191,000 cases, and Argentina has reported over 134,000 cases.

In a December 2023 risk assessment, the PAHO deemed the risk to human health from dengue to be “high” in the region. The report noted that the effects of climate change are driving higher rainfall, higher temperatures, and more humidity, allowing A. aegypti to expand into new areas and increase breeding. A. aegypti are already found in much of South America, Central America, and the southeastern US.

This post was updated to include additional case tallies. 

Puerto Rico declares public health emergency as dengue cases rise Read More »

cows-in-texas-and-kansas-test-positive-for-highly-pathogenic-bird-flu

Cows in Texas and Kansas test positive for highly pathogenic bird flu

avian influenza, bird flu, cows, dairy cows, H5N1, health, kansas, milk, Science, texas, USDA / /

viral spread —

The risk to the public is low, and the milk supply is safe.

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Image of cows

Wild migratory birds likely spread a deadly strain of bird flu to dairy cows in Texas and Kansas, state and federal officials announced this week.

It is believed to be the first time the virus, a highly pathogenic avian influenza (HPAI), has been found in cows in the US. Last week, officials in Minnesota confirmed finding an HPAI case in a young goat, marking the first time the virus has been found in a domestic ruminant in the US.

According to the Associated Press, officials with the Texas Animal Health Commission confirmed the flu virus is the Type A H5N1 strain, which has been ravaging bird populations around the globe for several years. The explosive, ongoing spread of the virus has led to many spillover events into mammals, making epidemiologists anxious that the virus could adapt to spread widely in humans.

For now, the risk to the public is low. According to a release from the US Department of Agriculture (USDA), genetic testing by the National Veterinary Services Laboratories indicated that H5N1 strain that spread to the cows doesn’t appear to contain any mutations that would make it more transmissible to humans. Though the flu strain was found in some milk samples from the infected cows, the USDA emphasized that all the milk from affected animals is being diverted and destroyed. Dairy farms are required to send only milk from healthy animals to be processed for human consumption. Still, even if some flu-contaminated milk was processed for human consumption, the standard pasteurization process inactivates viruses, including influenza, as well as bacteria.

So far, officials believe the virus is primarily affecting older cows. The virus was detected in milk from sick cows on two farms in Kansas and one in Texas, as well as in a throat swab from a cow on a second Texas farm. The USDA noted that farmers have found dead birds on their properties, indicating exposure to infected birds. Sick cows have also been reported in New Mexico. Symptoms of the bird flu in cows appear to include decreased milk production and low appetite.

But so far, the USDA believes the spread of H5N1 will not significantly affect milk production or the herds. Milk loss has been limited; only about 10 percent of affected herds have shown signs of the infection, and there has been “little to no associated mortality.” The USDA suggested it will remain vigilant, calling the infections a “rapidly evolving situation.”

While federal and state officials continue to track the virus, Texas officials aim to assure consumers. “There is no threat to the public and there will be no supply shortages,” Texas Agriculture Commissioner Sid Miller said in a statement. “No contaminated milk is known to have entered the food chain; it has all been dumped. In the rare event that some affected milk enters the food chain, the pasteurization process will kill the virus.”

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workers-with-job-flexibility-and-security-have-better-mental-health

Workers with job flexibility and security have better mental health

absenteeism, anxiety, health, job flexibility, job security, Mental Health, psychological distress, return-to-office, Science / /

Healthier work —

Job flexibility and security were linked to significantly less psychological distress and anxiety.

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Workers with job flexibility and security have better mental health

Office Space

American workers who have more flexibility and security in their jobs also have better mental health, according to a study of 2021 survey data from over 18,000 nationally representative working Americans.

The study, published Monday in JAMA Network Open, may not be surprising to those who have faced return-to-office mandates and rounds of layoffs amid the pandemic. But, it offers clear data on just how important job flexibility and security are to the health and well-being of workers.

For the study, job flexibility was assessed in terms of ease of adjusting work schedules, advance notice of scheduling changes, and whether schedules were changed by employers often. People who reported greater flexibility in their job had 26 percent lower odds of serious psychological distress, which was measured on a validated, widely used questionnaire that assesses depression, nervousness, hopelessness, and worthlessness, among other forms of distress. Greater job flexibility was also linked to 13 percent lower odds of experiencing daily anxiety, 11 percent lower odds of experiencing weekly anxiety, and 9 percent lower odds of experiencing anxiety a few times a year.

Job security also appeared to be a boon for mental health. Workers were asked how likely they thought that they may lose their job or get laid off in the next 12 months. Those who reported feeling more secure in their positions had 25 percent lower odds of serious psychological distress. Job security was also associated with 27 percent lower odds of experiencing daily anxiety and 21 percent lower odds of experiencing weekly anxiety.

The study, led by Monica Wang of Boston University’s School of Public Health, also looked at how job flexibility and security affected job absenteeism, finding mixed results. Both job flexibility and security were linked to fewer days where workers reported working while they were sick—suggesting that flexibility and security enabled workers to make use of sick leave when they needed it. In line with that finding, more job flexibility led to more days where workers reported being absent due to illness in the three months prior to the survey. Greater job security, on the other hand, led to fewer absences over the previous three and 12 months.

It’s unclear why that would be the case, but the researchers speculated that “Job security may lead to lower work absenteeism due to higher work satisfaction, decreased job-related stress, and financial security,” they wrote.

Overall, the study’s findings indicate “the substantive impact that flexible and secure jobs can have on mental health in the short-term and long-term,” the researchers conclude.

They do note limitations of the study, the main one being that the study identifies associations and can’t determine that job flexibility and security directly caused mental health outcomes and the work absence findings. Still, they suggest that workplace policies could improve the mental health of employees. This includes flexible scheduling, leave policies, and working arrangements, including remote and hybrid options, which can all allow workers to accommodate personal and family needs. For improving job security, the researchers recommend longer-term contracts and long-term strategies to invest in employees, such as “uptraining,” skill development, and advancement opportunities.

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lifesaving-gene-therapy-for-kids-is-world’s-priciest-drug-at-$4.25m

Lifesaving gene therapy for kids is world’s priciest drug at $4.25M

drug pricing, fda, gene therapy, health, metachromatic leukodystrophy, Orchard, rare genetic conditions, Science / /

promising but pricey —

It’s unclear if government and private insurance plans can cover the costs.

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A mother with her twin 6-year-old boys who have metachromatic leukodystrophy, a genetic disease that leaves them unable to move. Photo taken on September 3, 2004.

Enlarge / A mother with her twin 6-year-old boys who have metachromatic leukodystrophy, a genetic disease that leaves them unable to move. Photo taken on September 3, 2004.

In a medical triumph, US Food and Drug Administration on Monday approved a gene therapy that appears to trounce a rare, tragic disease that progressively steals children’s ability to talk, move, and think, leading to a vegetative state and death. For those who begin to slip away in infancy, many die by age 5. But, with the new therapy, 37 children in an initial trial were all still alive at age 6. Most could still talk, walk on their own, and perform normally on IQ tests, which was unseen in untreated children. Some of the earliest children treated have now been followed for up to 12 years—and they continue to do well.

But, the triumph turned bittersweet today, Wednesday, as the company behind the therapy, Lenmeldy, set the price for the US market at $4.25 million, making it the most expensive drug in the world. The price is $310,000 higher than what experts calculated to be the maximum fair price for the lifesaving drug; the nonprofit Institute for Clinical and Economic Review, or ICER, gave a range last October of between $2.29 million to $3.94 million.

The price raises questions about whether state, federal, and private health insurance plans will be able to shoulder the costs. “Unless states have allocated appropriately for it, and looked at the drug pipeline, they may not be prepared for what could be significant cost spikes,” Edwin Park, a research professor at the McCourt School of Public Health at Georgetown University, told CNN.

It’s also unclear whether the drug can reach the children who need it in time. Lenmeldy must be given before symptoms develop or early on in symptom development in children. However, diagnosis of the rare genetic condition can be slow, and many children treated so far were identified because older siblings, now too old for treatment, developed the condition first.

Devastating disease

Stat, for instance, spoke with the mother of an 8-year-old with the condition, who can no longer talk or move, has frequent seizures, and requires a feeding tube and 28 different medications. Meanwhile, her 3-year-old brother, who has the same genetic mutation, is a typical toddler—he was able to get the new treatment when he was six months old. To get it, the family flew him to Milan, Italy, where Lenmeldy was first developed. It was approved for use in Europe in 2021.

The condition Lenmeldy treats is called metachromatic leukodystrophy (MLD), which occurs in about 40 children in the US each year. MLD is caused by a mutation in the gene that codes for the enzyme arylsulfatase A (ARSA). Without this enzyme, the body can’t break down sulfatides, a fatty substance that then builds up to toxic levels in the brain and peripheral nervous system. Sulfatides are essential components of myelin, the fatty insulation on nerve cells critical for quick transmission of electrical impulses. But, too much sulfatides leads to a loss of myelin, which gradually destroys myelin producing cells and leads to nervous system damage.

Lenmeldy prevents that damage by giving the body a working copy of the ARSA gene. In a one-time infusion, patients are given a dose of their own blood stem cells that have been genetically engineered to contain a functional ARSA gene. Patients undergo chemotherapy to clear out their own stem cells from bone marrow so the genetically modified cells can replace them. The engineered stem cells then produce myeloid cells that travel around the body in the blood, producing ARSA enzyme that can halt progression of MLD.

It’s unknown how long the therapy lasts, but it’s clearly buying children time and giving them hope for a full, normal life.

“MLD is a devastating disease that profoundly affects the quality of life of patients and their families,” Nicole Verdun, director of the FDA’s Office of Therapeutic Products, said in a statement. “Advancements in treatment options offer hope for improved outcomes and the potential to positively influence the trajectory of disease progression.”

It “has the potential to stop or slow the progression of this devastating childhood disease with a single treatment, particularly when administered prior to the onset of symptoms,” Bobby Gaspar, CEO of Lenmeldy’s maker, Orchard Therapeutics, said in a statement Wednesday. “We are committed to enabling broad, expedient, and sustainable access to this important therapy for eligible patients with early-onset MLD in the US.”

The company is working on expanding newborn screening to include tests for MLD, to try to find children early, Orchard reported. Still, with such a rare condition, it’s unclear if the pricey drug will be a moneymaker for the company. Stat notes that Orchard has previously abandoned four therapies for other rare genetic conditions because of the difficulty in meeting regulatory standards for essentially custom therapies and questions about whether health plans will pay the steep, multimillion-dollar prices. In April of last year, Belgium, Ireland, and the Netherlands walked away from price negotiations with the company, saying they couldn’t come to an agreement on this “extremely expensive therapy.”

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