health

life-threatening-rat-pee-infections-reach-record-levels-in-nyc

Life-threatening rat pee infections reach record levels in NYC

health, Science / /

Epeedemic —

Between 2001 and 2020, there was an average of 3 cases per year. Last year’s tally was 24.

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A rat looks for food while on a subway platform at the Columbus Circle - 59th Street station on May 8, 2023, in New York City.

Enlarge / A rat looks for food while on a subway platform at the Columbus Circle – 59th Street station on May 8, 2023, in New York City.

A life-threatening bacterial infection typically spread through rat urine sickened a record number of people in New York City last year—and this year looks on track for another all-time high, the NYC Department of Health and Mental Hygiene reports.

The infection is leptospirosis, which can cause a range of symptoms, including non-specific ones like fever, headache, chills, muscle aches, vomiting, diarrhea, and cough. But, if left untreated, can become severe, causing kidney failure, liver damage, jaundice, hemorrhage, bloody eyes (conjunctival suffusion), respiratory distress, and potentially death.

The bacteria that causes it—spirochete bacteria of the genus Leptospira—infect rats, which shed the bacteria in their urine. The germs jump to people through direct contact with open wounds or mucous membranes.

New York City has long been in a (mostly losing) war with its rat population, which last year was estimated to be as many as 3 million. Mayor Eric Adams has made fighting the rat population a key initiative, and just last week, the city council proposed the latest strategy to curtail the furry brown rodent’s colony: birth control in the form of salty pellets.

Still, leptospirosis has not been a prime concern from the rats’ mischief until recently. Between 2001 and 2020, the city logged an average of just three leptospirosis cases a year—and some of those were travel related. But, things took a turn during the pandemic when the rat population seemed to boom. From 2021 and 2022, the average shot up to 15. In 2023, there were 24 cases, the highest number of cases ever recorded for a single year. And as of April 10, there have been six cases so far.

That number of cases so far this year is concerning given that Leptospira bacteria are “fragile,” as the NYC health department puts it. They die quickly in the freezing temperatures of winte and the dry heat of summer. Their main time to thrive is in warm, moist conditions. Last year, the months with the most cases were June and October. The health department noted that climate change, which is causing excessive rain and unseasonably warm temperatures, may be partly driving the uptick in cases.

In a health advisory released last week, the city’s health department advised clinicians to be on the lookout for cases, which are treated with common oral antibiotics when mild or intravenous doses when severe. Symptoms typically develop in 5 to 14 days after an exposure, but can show up anywhere from 2 to 30 days.

Of the 98 locally acquired cases that the city has recorded between 2001 and 2023, nearly all were in men (94 percent) and the median age was 50, with a range of 20 to 80 years. Most often, the cases occurred in the Bronx (37), followed by Manhattan (28), Brooklyn (19), Queens (10), and Staten Island (4). Cases presented to clinicians with acute kidney and liver failure and occasionally severe respiratory involvement. Of the 98 cases, six died.

The cases are typically related to living or working environments with rat urine, contaminated soil and water, or materials frequently contaminated with rat urine, such as trash bags or food waste bins. The health department noted that human-to-human transmission is rare.

New York isn’t the only city plagued by leptospirosis cases. Last year, doctors in the Netherlands reported the case of an 18-year-old with jaundiced, bloody eyes, who had developed leptospirosis after falling into a canal that was likely contaminated with rodent urine.

Life-threatening rat pee infections reach record levels in NYC Read More »

bogus-botox-poisoning-outbreak-spreads-to-9-states,-cdc-says

Bogus Botox poisoning outbreak spreads to 9 states, CDC says

botox, botulism, CDC, health, injection, outbreak, Science / /

botched shots —

All of the case have been in women, nine of whom were hospitalized.

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A package of counterfeit Botox.

A package of counterfeit Botox.

At least 19 women across nine US states appear to have been poisoned by bogus injections of Botox, the Centers for Disease Control and Prevention reported late Monday.

Nine of the 19 cases—47 percent—were hospitalized and four—21 percent—were treated with botulinum anti-toxin. The CDC’s alert and outbreak investigation follows reports in recent days of botulism-like illnesses linked to shady injections in Tennessee, where officials reported four cases, and Illinois, where there were two. The CDC now reports that the list of affected states also includes: Colorado, Florida, Kentucky, Nebraska, New Jersey, New York, and Washington.

In a separate alert Tuesday, the Food and Drug Administration said that “unsafe, counterfeit” versions of Botox had been found in several states, and the toxic fakes were administered by unlicensed or untrained people and/or in non-medical or unlicensed settings, such as homes or spas. The counterfeit products appeared to have come from an unlicensed source, generally raising the risks that they’re “misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe,” the FDA said.

The CDC and the FDA listed the various symptoms that followed injections of the counterfeit Botox, which include: blurred or double vision, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, constipation, incontinence, shortness of breath or difficulty breathing, weakness, and difficulty lifting one’s head. “These symptoms are similar to those seen when botulinum toxin spreads to other parts of the body,” the FDA wrote. Anyone experiencing those symptoms after an injection should go to the emergency room or contact a health care professional.

Botox is a regulated drug containing purified, controlled doses of botulinum toxin, a neurotoxin made by Clostridium bacteria that causes muscle paralysis by blocking a neurotransmitter. It’s often injected into the face to reduce the appearance of wrinkles. The CDC reported that all 19 cases identified so far are in women between the ages of 25 and 59. Eighteen of the 19 specifically reported getting the injections for cosmetic purposes.

But harmful exposure to the toxin—such as from an infection, eating contaminated foods, or use of counterfeit Botox—can cause botulism or at least botulism-like illnesses. In severe cases, botulism can progress to descending, symmetric muscle weakness, full muscle paralysis, and can sometimes be fatal. The CDC reported that some of the people in the outbreak were hospitalized and treated with anti-toxin out of concern that the toxin had spread beyond the injection site. However, the agency noted that five people were specifically tested for botulism, and all tested negative.

In an email to Ars late last week, the CDC recommended that anyone interested in a Botox injection do so using “an FDA-approved product, administered by licensed providers and in licensed settings.” The agency added in its alert Monday: ” If in doubt, don’t get the injection.”

The FDA, meanwhile, provided detailed information on how to ensure your shot of Botox is the real thing. FDA-approved Botox is made by AbbVie, and authentic Botox products come in unit doses of 50, 100, and 200. The outside of the box should say “BOTOX® COSMETIC / onabotulinumtoxinA / for Injection” or “OnabotulinumtoxinA / BOTOX® / for injection,” and it should list the manufacturer as either “Allergan Aesthetics / An AbbVie Company” or “abbvie.” The active ingredient should be listed as “OnabotulinumtoxinA” on the box.

In contrast, some of the counterfeit versions the FDA has tracked down so far were sold in 150-unit doses (not made by AbbVie), only appear to have “Allergan” on the box (not the full manufacturer name), and the active ingredient is displayed as “Botulinum Toxin Type A” instead of  “OnabotulinumtoxinA.” The counterfeit versions also have had non-English language text on the outside of the box and displayed a lot number of C3709C3. Any one of these features is a sign that the product is counterfeit. Images of the counterfeit products from the FDA are below.

Bogus Botox poisoning outbreak spreads to 9 states, CDC says Read More »

us-drug-shortages-reach-record-high-with-323-meds-now-in-short-supply

US drug shortages reach record high with 323 meds now in short supply

adderall, ASHP, cancer drugs, DEA, drug shortages, fda, generic drugs, health, pharmacists, pharmacy, Science / /

Terrible —

The shortages affect everything from generic cancer drugs to ADHD medication.

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Takeda Pharmaceutical Co. Adderall XR brand medication arranged at a pharmacy in Provo, Utah, in November 2023.

Enlarge / Takeda Pharmaceutical Co. Adderall XR brand medication arranged at a pharmacy in Provo, Utah, in November 2023.

Drug shortages in the US have reached an all-time high, with 323 active and ongoing shortages already tallied this year, according to data collected by the American Society of Health-System Pharmacists (ASHP).

The current drug shortage total surpasses the previous record of 320, set in 2014, and is the highest recorded since ASHP began tracking shortages in 2001.

“All drug classes are vulnerable to shortages,” ASHP CEO Paul Abramowitz said in a statement Thursday. “Some of the most worrying shortages involve generic sterile injectable medications, including cancer chemotherapy drugs and emergency medications stored in hospital crash carts and procedural areas. Ongoing national shortages of therapies for attention-deficit/hyperactivity disorder [ADHD] also remain a serious challenge for clinicians and patients.”

Erin Fox, associate chief pharmacy officer of University of Utah Health, told CBS MoneyWatch, that most of the drugs in short supply are generic, older products, and around half are injectable drugs that require more stringent manufacturing processes.

There are myriad reasons for the hundreds of drug shortages now facing doctors and patients, many of which remain unclear. But, as Ars has reported before, the root cause of shortages of low-cost, off-patent generic drugs is well established. These drugs have razor-thin to non-existent profit margins, driven by middle managers who have, in recent years, pushed down wholesale prices to rock-bottom levels. In some cases, generic manufacturers lose money on the drugs, disincentivizing other players in the pharmaceutical industry from stepping in to bolster fragile supply chains. Several generic manufacturers have filed for bankruptcy recently.

For other drugs, the situation is more complicated. The ADHD drug Adderall, for instance, has been in critical shortage since October 2022, causing millions of patients around the country to struggle to fill their prescriptions. It began when a manufacturing delay for one manufacturer kicked off a shortfall. Although that problem has since been resolved, it came amid a significant increase in Adderall prescriptions, which spiked further during the pandemic when telehealth prescribing became more common. Additionally, because Adderall—made of amphetamine-mixed salts—is a controlled substance, the Drug Enforcement Administration sets limits or “quotas” on how much of it manufacturers can make. Such quotas can exacerbate shortages, ASHP said.

But, in a joint letter with the Food and Drug Administration last August, the DEA said that, by its data, manufacturers of amphetamine products (including Adderall) only sold approximately 70 percent of their allotted quotas in 2022. That meant that there were approximately 1 billion more doses that they could have produced but did not make or ship. At the time, the agencies said its 2023 data was trending in the same direction.

In 60 percent of cases, manufacturers do not know or do not provide reasons why their drugs fall into short supply, ASHP found.

The organization has put forth policy recommendations to prevent shortages and improve supply chains, advocating for federal and regulatory changes. “Much work remains to be done at the federal level to fix the root causes of drug shortages,” Abramowitz said. “ASHP will continue to engage with policymakers regularly as we guide efforts to draft and pass new legislation to address drug shortages and continue to strongly advocate on behalf of our members for solutions that work.”

US drug shortages reach record high with 323 meds now in short supply Read More »

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 »

hong-kong-monkey-encounter-lands-man-in-icu-with-rare,-deadly-virus

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.

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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.

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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. 

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