health

blockbuster-weight-loss-drugs-slashed-from-nc-state-plan-over-ballooning-costs

Blockbuster weight-loss drugs slashed from NC state plan over ballooning costs

GLP-1, health, insurance, insurance coverage, North Carolina, prescription drug, prescription drug pricing, Science, wegovy, weight loss / /

Patients vs. profits —

The plan spent $102M on the weight-loss drugs last year, 10% of total drug costs.

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Wegovy is an injectable prescription weight loss medicine that has helped people with obesity.

Enlarge / Wegovy is an injectable prescription weight loss medicine that has helped people with obesity.

The health plan for North Carolina state employees will stop covering blockbuster GLP-1 weight-loss drugs, including Wegovy and Zepbound, because—according to the plan’s board of trustees—the drugs are simply too expensive.

Last week, the board voted 4-3 to end all coverage of GLP-1 medications for weight loss on April 1. If the coverage is dropped, it is believed to be the first major state health plan to end coverage of the popular but pricey weight-loss drugs. The plan will continue to pay for GLP-1 medications prescribed to treat diabetes, including Ozempic.

The North Carolina State Health Plan covers nearly 740,000 people, including teachers, state employees, retirees, and their family members. In 2023, monthly premiums from the plan ranged from $25 for base coverage for an individual to up to $720 for premium family coverage. Members prescribed Wegovy paid a co-pay of between $30 and $50 per month for the drug, while the plan’s cost was around $800 a month.

In 2021, just under 2,800 members were taking the drugs for weight loss, but in 2023, the number soared to nearly 25,000 members, costing the plan $102 million. That’s about 10 percent of what the plan pays for all prescription drugs combined. If the current coverage continued, the plan’s pharmacy benefit manager, CVS Caremark, estimated that by 2025, the plan’s premiums would have to rise $48.50 across the board to offset the costs of the weight-loss drugs.

Without insurance, the list price of Wegovy is $1,349 per month, totaling $16,188 for a year of treatment. The average reported salary for members of North Carolina’s health plan is $56,431.

Last October, the board voted to grandfather the 25,000 or so current users, maintaining coverage for them moving forward, but then to stop offering new coverage to members. However, according to CVS Caremark, the move would mean losing a 40 percent rebate from Wegovy’s maker, Novo Nordisk. This would be a loss of $54 million, bringing projected 2024 costs to $139 million.

A spokesperson for Novo Nordisk called the vote to end coverage entirely “irresponsible,” according to a statement given to media. “We do not support insurers or bureaucrats inserting their judgment in these medically driven decisions,” the statement continued.

While the costs of weight-loss drugs are high everywhere, the pricing is particularly bitter for North Carolinians—Novo Nordisk manufactures Wegovy in Clayton, North Carolina, southeast of Raleigh.

“It certainly adds insult to injury,” Ardis Watkins, executive director of the State Employees Association of North Carolina, a group that lobbies on behalf of state health plan members, according to The New York Times. “Our economic climate that has been made so attractive to businesses to locate here is being used to manufacture a drug that is wildly marked up.”

While it appears to be the first time such a large state health plan has dropped coverage of the weight-loss drugs, North Carolina is not alone in wrestling with the costs. The University of Texas’ employee plan ceased coverage of Wegovy and Saxenda, another weight-loss drug, in September. Connecticut’s state health plan, meanwhile, added restrictions on how members could get a prescription covered. Some state health plans that cover GLP-1 medications for weight-loss have prior authorization procedures to try to limit use.

“Every state has been wrestling with it, every professional association that my staff is a part of has had some discussion about it,” Sam Watts, director of the North Carolina State Health Plan, told Bloomberg. “But to our knowledge, we’re the first major state health plan to act on it.”

Blockbuster weight-loss drugs slashed from NC state plan over ballooning costs Read More »

measles-is-“growing-global-threat,”-cdc-tells-doctors-in-alert-message

Measles is “growing global threat,” CDC tells doctors in alert message

CDC, health, Infectious disease, measles, MMR vaccines, outbreak, pandemic, Science, vaccines, WHO / /

Alert —

Since December, there have been 23 measles cases in the US, including two outbreaks.

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A baby with measles.

Enlarge / A baby with measles.

The Centers for Disease Control and Prevention is putting clinicians on alert about the growing risk of measles cases and outbreaks amid a global surge in transmission.

In an outreach message sent Thursday, the CDC told clinicians to look out for patients who have a rash accompanied by a fever and other symptoms of measles, as well as patients who have recently traveled to countries with ongoing measles outbreaks.

Between December 1, 2023, and January 23, 2024, there have been 23 confirmed measles cases in the US, including seven direct importations by international travelers and two outbreaks with more than five cases each, the CDC noted. Most of the cases were in unvaccinated children and teens.

Measles outbreaks in the US are typically sparked by unvaccinated or undervaccinated US residents who pick up the infection abroad and then, when they return, transmit the disease to pockets of their communities that are also unvaccinated or undervaccinated.

Globally and in the US, vaccination rates against measles—via the measles, mumps, and rubella vaccine (MMR)—have fallen in recent years due to pandemic-related health care disruption and vaccine hesitancy fueled by misinformation.

“The increased number of measles importations seen in recent weeks is reflective of a rise in global measles cases and a growing global threat from the disease,” the CDC’s outreach message, titled “Stay Alert for Measles Cases,” read.

According to data from the World Health Organization, the European region saw an over 40-fold rise in measles cases in 2023 as compared with 2022. The region tallied over 42,200 measles cases last year, compared with just 941 in 2022.

This week, the WHO reported a rapid escalation of measles cases in Kazakhstan (which the WHO considers part of the European region). Kazakhstan has recorded the highest incidence of measles cases in the region, with 13,677 cases in 2023. That corresponds to over 639 cases per million in the population. In the news release Tuesday, Kazakhstan’s health minister reported that there are “currently 2,167 children in hospital with measles, 27 of them in a serious condition.”

The outbreak is largely spurred by unvaccinated children who missed their routine immunizations during the pandemic. Sixty-five percent of the reported measles cases are in children under age 5, the WHO noted. The country is now trying to catch children up on their vaccines to curb the outbreak.

“Measles is highly infectious, but fortunately, can be effectively prevented through vaccination,” WHO’s Regional Director for Europe, Hans Henri P. Kluge, said in the news release. “I commend Kazakhstan for the urgent measures being taken to stop the spread of this dangerous disease.”

Meanwhile, measles is flaring up in many other places. Last week, the UK Health Security Agency warned of the potential for an ongoing measles outbreak to spread. As of January 18, there were 216 confirmed cases and 103 probable cases in the West Midlands region since October 2023. Authorities warned that any areas with low MMR vaccination rates are at risk of an outbreak.

The vast majority of Americans have received their MMR vaccines on schedule. In this case, the two standard, recommended doses are considered 97 percent effective against measles, and the protection is considered for life. But anyone who is unvaccinated or undervaccinated is at high risk of infection in the event of an exposure. The virus can linger in air space for up to two hours after an infected person leaves the area, the CDC notes, and is highly infectious—up to 90 percent of unvaccinated people exposed will fall ill. Once infected, people are infectious from four days before the telltale measles rash develops to four days afterward.

Measles is “growing global threat,” CDC tells doctors in alert message Read More »

tens-of-thousands-of-pregnancies-from-rape-occurring-in-abortion-ban-states

Tens of thousands of pregnancies from rape occurring in abortion-ban states

Abortion, abortion ban, health, pregnancy, rape, reproductive health, Science, texas / /

Outraging —

States with bans logged 10 or fewer legal abortions per month, despite rape exceptions.

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Pro-choice protesters march in Texas, carrying signs that say

Enlarge / Pro-choice protesters march outside the Texas State Capitol on Sept. 1, 2021, in Austin, Texas.

Getty Images | The Washington Post

Fourteen states have banned abortions at any gestational age since the Supreme Court overruled Roe v. Wade in 2022. Since the enactment of those abortion bans, an estimated 64,565 people became pregnant as a result of rape in those states. But, while five of the 14 states have exceptions for rape, all of the states logged only 10 or fewer legal abortions per month since their respective bans were enacted.

The finding, published this week in JAMA Internal Medicine, is a stark look at the effects of such bans on reproductive health care. The study did not assess how many of the estimated 64,565 pregnancies resulted in births, but it makes clear that tens of thousands of pregnant rape survivors, including children, were forced to turn to illegal procedures, self-managed abortions, or burdensome travel to states where abortion is legal—cost-prohibitive to many—as an alternative to carrying a rape-related pregnancy to term.

It also showed that legal exceptions for rape don’t work. The states with those exceptions apply stringent time limits on the pregnancy and require victims to report their rapes to law enforcement, which likely disqualifies most. The US Department of Justice estimates that only 21 percent of victims report their rape to police, for myriad reasons.

In an editor’s note accompanying the study, a trio of JAMA Internal Medicine editors—who are also medical researchers at the University of California, San Francisco, Harvard, and NYC Health and Hospitals—note the findings “demonstrate the scope of the problem,” as the number of rape-related pregnancies is “exponentially larger” than the number of legal abortions in those states.

“As physicians, we do not see abortion as a political, religious, or legal issue. Rather we see access to safe abortions as a necessary part of reproductive health services to protect the physical and mental well-being of patients. The best solution to this problem is a national law protecting the right of all people to choose to terminate pregnancy,” they write.

Study design

The study, led by a researcher at Planned Parenthood of Montana, is only an estimate because hard, state-level numbers are impossible to come by. The researchers pulled rape data from the DOJ’s Bureau of Justice Statistics, the FBI, and the Centers for Disease Control and Prevention’s National Intimate Partner and Sexual Violence survey, a specially designed survey to ascertain reported and unreported rapes.

With national data from various sources, the researchers estimated the proportion of rape survivors that are female individuals ages 15 to 45, and they further adjusted for the number of rapes that are vaginal. To estimate state-level rapes, they proportioned the rapes by states based on the FBI’s 2022 crime data, which includes rapes. They then multiplied each state’s rapes by the fraction of rapes likely to result in pregnancy. And finally, adjusted for the months between July 1, 2022 and January 1, 2024 that an abortion ban was in effect in each of the 14 states. Among the 14 states, the number of months in which a ban was in effect ranged from four to 18 months.

In all, the researchers estimated 519,981 completed vaginal rapes in the 14 abortion ban states which resulted in a collective total of 64,565 pregnancies during the four to 18 months that bans were in effect. Of the rape-related pregnancies, an estimated 5,586 (9 percent) were in states with rape exceptions, and 58,979 (91 percent) were in states with no exception.

Texas, the abortion-ban state with the largest population, had an estimated 26,313 (41 percent) of all rape-related pregnancies under its ban, which was enacted for 16 months during the study time frame. The state’s large number drew outrage from Democratic state lawmakers, particularly in light Gov. Greg Abbott’s vow to “eliminate rape” in Texas after a 2021 six-week abortion ban took effect (the state enacted a total ban in August 2022).

“Women and girls across our state are enduring unwanted pregnancies, suffering from life-endangering complications in desired pregnancies and fleeing the state for medical care,” the 13 Democratic state senators said in a Thursday news release, as reported by the Houston Chronicle. “We cannot allow this to be the new norm.”

Tens of thousands of pregnancies from rape occurring in abortion-ban states Read More »

the-puzzling-case-of-a-baby-who-wouldn’t-stop-crying—then-began-to-slip-away

The puzzling case of a baby who wouldn’t stop crying—then began to slip away

babybig, botulism, health, infant botulism, medical case, NEJM, New England Journal of Medicine, Science, toxins / /
A studio portrait of a crying baby.

Enlarge / A studio portrait of a crying baby.

It’s hard to imagine a more common stressor for new parents than the recurring riddle: Why is the baby crying? Did she just rub her eyes—tired? Is he licking his lips—hungry? The list of possible culprits and vague signs, made hazier by brutal sleep deprivation, can sometimes feel endless. But for one family in New England, the list seemed to be swiftly coming to an end as their baby continued to slip away from them.

According to a detailed case report published today in the New England Journal of Medicine, it all started when the parents of an otherwise healthy 8-week-old boy noticed that he started crying more and was more irritable. This was about a week before he would end up in the pediatric intensive care unit (PICU) of the Massachusetts General Hospital.

His grandmother, who primarily cared for him, noticed that he seemed to cry more vigorously when the right side of his abdomen was touched. The family took him to his pediatrician, who could find nothing wrong upon examination. Perhaps it was just gas, the pediatrician concluded—a common conclusion.

Rapid decline

But when the baby got home from the doctor’s office, he had another crying session that lasted hours, which only stopped when he fell asleep. When he woke, he cried for eight hours straight. He became weaker; he had trouble nursing. That night, he was inconsolable. He had frantic arm and leg movements and could not sleep. He could no longer nurse, and his mother expressed milk directly into his mouth. They called the pediatrician back, who directed them to take him to the emergency room

There, he continued to cry, weakly and inconsolably. Doctors ordered a series of tests—and most were normal. His blood tests looked good. He tested negative for common respiratory infections. His urinalysis looked fine, and he passed his kidney function test. X-rays of his chest and abdomen looked normal, ultrasound of his abdomen also found nothing. Doctors noted he had high blood pressure, a fast heart rate, and that he hadn’t pooped in two days. Throughout all of the testing, he didn’t “attain a calm awake state,” the doctors noted. They admitted him to the hospital.

Four hours after he first arrived at the emergency department, he began to show signs of lethargy. Meanwhile, magnetic resonance imaging of his head found nothing. A lumbar puncture showed possible signs of meningitis—high red-cell count and protein levels—and doctors began courses of antibiotics in case that was the cause.

Six hours after his arrival, he began losing the ability to breathe. His oxygen saturation had fallen from an initial 97 percent to an alarming 85 percent. He was put on oxygen and transferred to the PICU. There, doctors noted he was difficult to arise, his head bobbed, his eyelids drooped, and he struggled to take in air. His cry was weak, and he made gurgling and grunting noises. He barely moved his limbs and couldn’t lift them against gravity. His muscles went floppy. Doctors decided to intubate him and start mechanical ventilation.

The puzzling case of a baby who wouldn’t stop crying—then began to slip away Read More »

elizabeth-holmes-barred-from-federal-health-programs-for-90-years

Elizabeth Holmes barred from federal health programs for 90 years

Elizabeth Holmes, exclusion, federal health program, fraud, health, HHS, Science / /

Excluded —

The former Theranos CEO is barred from receiving payments from federal health program.

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Theranos CEO and founder Elizabeth Holmes.

Theranos CEO and founder Elizabeth Holmes.

Elizabeth Holmes—the disgraced and incarcerated founder of the infamous blood-testing startup Theranos—is barred from participating in federal health programs for nine decades, according to an announcement from the health department Friday.

The exclusion means that Holmes is barred from receiving payments from federal health programs for services or products, which significantly restricts her ability to work in the health care sector. It also prevents her from participating in Medicare, Medicaid, and other federal health care programs. With a 90-year term, the exclusion is lifelong for Holmes, who is currently 39.

The exclusion was announced by Inspector General Christi Grimm of the Department of Health and Human Services’ Office of Inspector General.

Holmes is serving an 11-year, three-month sentence for defrauding investors of her blood-testing startup, Theranos, which she founded in 2003. At the time, Holmes claimed to have developed proprietary technology that could perform hundreds of medical tests using just a small drop of blood from a finger prick. The remarkable claim helped her drive the company’s valuation to a stunning $9 billion in 2014, and set up lucrative partnerships. But, in reality, the technology never worked. The company collapsed in 2018, and she was convicted of fraud in 2022.

In today’s announcement, the health department noted that the statutory minimum on exclusions for convictions like Holmes’ is just five years. But other factors are considered when determining the term, including how long the fraud took place, the length of the prison sentence, and the amount of restitution ordered. In addition to her 11-year prison sentence, Holmes was ordered to pay approximately $452,047,200 in restitution, the HHS-OIG noted.

“Accurate and dependable diagnostic testing technology is imperative to our public health infrastructure. False statements related to the reliability of these medical products can endanger the health of patients and sow distrust in our health care system,” Grimm said. “As technology evolves, so do our efforts to safeguard the health and safety of patients, and HHS-OIG will continue to use its exclusion authority to protect the public from bad actors.”

HHS-OIG also excluded former Theranos President Ramesh Balwani from federal health programs for 90 years. Balwani was also convicted of fraud and is serving a nearly 13-year sentence.

Elizabeth Holmes barred from federal health programs for 90 years Read More »

big-pharma-hiked-the-price-of-775-drugs-this-year-so-far:-report

Big Pharma hiked the price of 775 drugs this year so far: Report

brand name drugs, drug pricing, health, merck, mounjaro, Ozempic, Pharmaceutical industry, sanders, Science / /

up and up —

Meanwhile, Senate to consider subpoenas to force pharma CEOs testify on prices.

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Sen. Bernie Sanders (I-Vt.).

Enlarge / Sen. Bernie Sanders (I-Vt.).

Pharmaceutical companies have raised the list prices of 775 brand-name drugs so far this year, with a median increase of 4.5 percent, exceeding the rate of inflation, according to an analysis conducted for the Wall Street Journal.

Drugmakers typically raise prices at the start of the year, and Ars reported on January 2 that companies had plans to raise the list prices of more than 500 prescription medications. The updated analysis, carried out by 46brooklyn Research, a nonprofit drug-pricing analytics group, gives a clearer picture of pharmaceutical companies’ activities this month.

High-profile drugs Ozempic (made by Novo Nordisk) and Mounjaro (Eli Lilly), both used for Type II diabetes and weight loss, were among those that saw price increases. Ozempic’s list price went up 3.5 percent to nearly $970 for a month’s supply, while Mounjaro went up 4.5 percent to almost $1,070 a month. The annual inflation rate in the US was 3.4 percent for 2023.

The asthma medication Xolair (Novartis) and the Shingles vaccine Shingrix (GlaxoSmithKline) saw price increases above 7.5 percent, the Wall Street Journal noted. The highest prices were around 10 percent. For some drugs, the single-digit percentage increases can equal hundreds or even thousands of dollars. For instance, the cystic fibrosis treatment Trikafta (Vertex Pharmaceuticals) went up 5.9 percent to $26,546 for a 28-day supply. And the psoriasis therapy Skyrizi (AbbVie) saw an increase of 5.8 percent, bringing the price to $21,017.

Lawmakers’ responses

The list price is typically not the price that people and health insurance plans pay, and pharmaceutical companies say they sometimes don’t make more money from raising list prices. Instead, they argue that the higher list prices allow them to negotiate large discounts and rebates from pharmacy middle managers, whose revenue and dealings are opaque. Drugmakers who spoke with the Wall Street Journal attributed this year’s price hikes to market conditions, inflation, and the value the drugs provide. Overall, the tactics increase the cost of health care.

The hefty hikes come as the federal government is trying to crack down on the high prices of drugs in the US, which pays far more for prescription medications than other high-income countries. Last year, Medicare began, for the first time, negotiating the prices of 10 costly drugs. The negotiations were a provision of the 2022 Inflation Reduction Act. And a provision in 2021’s American Rescue Plan Act now forces drugmakers to pay Medicaid large rebates if their drug price increases outpace inflation.

But, it’s not enough to provide Americans with relief from high drug prices. On Thursday, Stat reported that Senate health committee chair Bernie Sanders (I-Vt) took steps to subpoena pharmaceutical CEOs regarding a Congressional investigation on high drug prices. Sanders invited Johnson & Johnson CEO Joaquin Duato, Merck CEO Robert Davis, and Bristol Myers Squibb CEO Chris Boerner to testify—but only Boerner agreed, and only on the condition that he would not be the only CEO testifying. The trio were invited to a hearing titled “Why Does the United States Pay, By Far, The Highest Prices In The World For Prescription Drugs?,” which was originally scheduled for January 25. Now, Sanders will hold a committee vote on January 31 on whether to issue subpoenas for the CEOs of Johnson & Johnson and Merck. If the committee votes in favor, it will be the first time it has issued a subpoena in more than 40 years.

All three companies have sued the federal government over the new regulations requiring them to negotiate prices with Medicare. J&J and Merck accused Sanders of calling them to testify as retribution for their legal action.

“You have opted not for the most effective way of securing information relevant to the Committee’s important work on drug prices, but for a broad-ranging public spectacle, with witnesses you can question on pending litigation you disagree with,” Merck wrote to Sanders.

Sanders called the two CEOs’ refusal to testify “absolutely unacceptable.”

Big Pharma hiked the price of 775 drugs this year so far: Report Read More »

what-do-threads,-mastodon,-and-hospital-records-have-in-common?

What do Threads, Mastodon, and hospital records have in common?

AI, Computer science, fediverse, health, medicine / /
A medical technician looks at a scan on a computer monitor.

It’s taken a while, but social media platforms now know that people prefer their information kept away from corporate eyes and malevolent algorithms. That’s why the newest generation of social media sites like Threads, Mastodon, and Bluesky boast of being part of the “fediverse.” Here, user data is hosted on independent servers rather than one corporate silo. Platforms then use common standards to share information when needed. If one server starts to host too many harmful accounts, other servers can choose to block it.

They’re not the only ones embracing this approach. Medical researchers think a similar strategy could help them train machine learning to spot disease trends in patients. Putting their AI algorithms on special servers within hospitals for “federated learning” could keep privacy standards high while letting researchers unravel new ways to detect and treat diseases.

“The use of AI is just exploding in all facets of life,” said Ronald M. Summers of the National Institutes of Health Clinical Center in Maryland, who uses the method in his radiology research. “There’s a lot of people interested in using federated learning for a variety of different data analysis applications.”

How does it work?

Until now, medical researchers refined their AI algorithms using a few carefully curated databases, usually anonymized medical information from patients taking part in clinical studies.

However, improving these models further means they need a larger dataset with real-world patient information. Researchers could pool data from several hospitals into one database, but that means asking them to hand over sensitive and highly regulated information. Sending patient information outside a hospital’s firewall is a big risk, so getting permission can be a long and legally complicated process. National privacy laws and the EU’s GDPR law set strict rules on sharing a patient’s personal information.

So instead, medical researchers are sending their AI model to hospitals so it can analyze a dataset while staying within the hospital’s firewall.

Typically, doctors first identify eligible patients for a study, select any clinical data they need for training, confirm its accuracy, and then organize it on a local database. The database is then placed onto a server at the hospital that is linked to the federated learning AI software. Once the software receives instructions from the researchers, it can work its AI magic, training itself with the hospital’s local data to find specific disease trends.

Every so often, this trained model is then sent back to a central server, where it joins models from other hospitals. An aggregation method processes these trained models to update the original model. For example, Google’s popular FedAvg aggregation algorithm takes each element of the trained models’ parameters and creates an average. Each average becomes part of the model update, with their input to the aggregate model weighted proportionally to the size of their training dataset.

In other words, how these models change gets aggregated in the central server to create an updated “consensus model.” This consensus model is then sent back to each hospital’s local database to be trained once again. The cycle continues until researchers judge the final consensus model to be accurate enough. (There’s a review of this process available.)

This keeps both sides happy. For hospitals, it helps preserve privacy since information sent back to the central server is anonymous; personal information never crosses the hospital’s firewall. It also means machine/AI learning can reach its full potential by training on real-world data so researchers get less biased results that are more likely to be sensitive to niche diseases.

Over the past few years, there has been a boom in research using this method. For example, in 2021, Summers and others used federated learning to see whether they could predict diabetes from CT scans of abdomens.

“We found that there were signatures of diabetes on the CT scanner [for] the pancreas that preceded the diagnosis of diabetes by as much as seven years,” said Summers. “That got us very excited that we might be able to help patients that are at risk.”

What do Threads, Mastodon, and hospital records have in common? Read More »

cdc-reports-dips-in-flu,-covid-19,-and-rsv—though-levels-still-very-high

CDC reports dips in flu, COVID-19, and RSV—though levels still very high

annual flu shot, CDC, COVID-19, deaths, flu season, health, influenza, influenza-like illness, respiratory viruses, RSV, Science, vaccines / /

a break? —

The dips may be due to holiday lulls and CDC is monitoring for post-holiday increase.

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The influenza virus from an image produced from an image taken with transmission electron microscopy. Viral diameter ranges from around 80 to 120 nm.

Enlarge / The influenza virus from an image produced from an image taken with transmission electron microscopy. Viral diameter ranges from around 80 to 120 nm.

Key indicators of seasonal flu activity declined in the first week of the year, signaling a possible reprieve from the high levels of respiratory virus transmission this season—but the dip may only be temporary.

On Friday, the Centers for Disease Control and Prevention released its latest flu data for the week ending on January 6. Outpatient visits for influenza-like illnesses (ILI) were down that week, the first decline after weeks of rapid increases. Flu test positivity and hospitalizations were also down slightly.

Percent of outpatient visits for respiratory illnesses by week.

Enlarge / Percent of outpatient visits for respiratory illnesses by week.

But transmission is still elevated around the country. Fourteen states have ILI activity at the “very high” level in the current data, down from 22 the week before. And 23 states have “high” activity level, up from 19 the week before. (You can see the week-by-week progression of this year’s flu season in the US here.)

The CDC says it is monitoring for “a second period of increased influenza activity that often occurs after the winter holidays.”

Map of ILI activity by state.

Enlarge / Map of ILI activity by state.

Flu isn’t the only virus that seems to be letting up a little in the data, at least for now. COVID-19 data also showed some dips, with the CDC reporting that “Despite test positivity (percentage of tests conducted that were positive), emergency department visits, and hospitalizations remaining elevated nationally, the rates have stabilized, or in some instances decreased, after multiple weeks of continual increase.”

The CDC speculates that some of the declines in indicators could be due to people not seeking medical care during the holidays as they would otherwise. COVID-19 wastewater activity levels remain “very high,” with all regions showing high or increasing levels. The South and Midwest have the highest levels in the latest data, but there are some early indications that rises in the Midwest and Northeast may be slowing down.

Meanwhile, RSV activity remains elevated, though some areas are starting to see declines.

The CDC notes that it’s not too late to get vaccinated against COVID-19, flu, and (for those ages 60 and over) RSV. So far, 21 percent of adults have received the 2023–2024 COVID-19 vaccine, including 41.5 percent of people ages 65 and up. Around 363,000 people have died from COVID-19 in the US since September.

For flu, about 47 percent of adults have received their annual shot, including 74 percent of people ages 65 and up. On Thursday, researchers in Canada published the first estimates of flu vaccine effectiveness this season, finding the current annual shots are 61 percent effective against the most common strain of flu circulating in the US (influenza A(H1N1)pdm09) and 49 percent effective against the less common influenza A(H3N2) and 75 percent effective against influenza B.

The CDC estimates that there have been at least 14 million flu cases, 150,000 hospitalizations, and 9,400 deaths from flu so far this season so far, the agency reported. In the first week of this year, 13 children died of flu, bringing this season’s total to 40.

CDC reports dips in flu, COVID-19, and RSV—though levels still very high Read More »

covid-shots-protect-against-covid-related-strokes,-heart-attacks,-study-finds

COVID shots protect against COVID-related strokes, heart attacks, study finds

65+, adults, blood clot, CDC, COVID-19, fda, health, heart attack, Science, stroke, vaccine / /

stay up to date —

Data provides more evidence older people should stay up to date on COVID vaccines.

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A vial of the updated 2023-2024 formula of Pfizer's COVID-19 vaccine at a CVS Pharmacy in Eagle Rock, California, on September 14, 2023.

Enlarge / A vial of the updated 2023-2024 formula of Pfizer’s COVID-19 vaccine at a CVS Pharmacy in Eagle Rock, California, on September 14, 2023.

Staying up to date on COVID-19 vaccines can cut the risk of COVID-related strokes, blood clots, and heart attacks by around 50 percent in people ages 65 years or older and in those with a condition that makes them more vulnerable to those events, according to a new study from the Centers for Disease Control and Prevention.

The finding, published this week in the CDC’s Morbidity and Mortality Weekly Report, should help ease concerns that the shots may conversely increase the risk of those events—collectively called thromboembolic events. In January 2023, the CDC and the Food and Drug Administration jointly reported a preliminary safety signal from their vaccine-monitoring systems that indicated mRNA COVID-19 vaccines may increase the risk of strokes in the 21 days after vaccination of people ages 65 and older. Since that initial report, that signal decreased, becoming statistically insignificant. Other vaccine monitoring systems, including international systems, have not picked up such a signal. Further studies (summarized here) have not produced clear or consistent data pointing to a link to strokes.

In May, the FDA concluded that the evidence does not support any safety concern and reported that “scientists believe factors other than vaccination might have contributed to the initial finding.”

But, the statistical blip could potentially cause lingering concerns. While clinicians had noted lower rates of thromboembolic events among vaccinated people, the authors of the new study noted that, until now, there were no rigorous estimates of how effective COVID-19 vaccines are at preventing those events.

For their analysis, they primarily looked at two groups of patients: A group of 12.7 million Medicare beneficiaries ages 65 and older and a group of around 78,600 Medicare beneficiaries ages 18 and older with end-stage renal disease (ESRD) on dialysis, a condition that increases their risk for thromboembolic events, including COVID-19-related thromboembolic events. Using medical claims records from September 2022 to March 2023, the researchers compared rates of thromboembolic events among the people in those groups that had gotten a bivalent COVID-19 booster dose and those who had only gotten the original monovalent COVID-19 vaccine in the past. To be considered a COVID-related thromboembolic event, the event had to occur within a week of or a month after a COVID-19 diagnosis.

Protective effect

In the group of 12.7 million patients ages 65 and older, about 5.7 million (45 percent) had gotten the bivalent booster, making them up to date on their COVID-19 vaccinations at the time. The remaining 7 million (55 percent) had only gotten the original vaccine.

During the study period, 17,746 patients who were not up to date on their COVID shots got COVID-19 and experienced a COVID-related thromboembolic event. Of the bivalent boosted patients, there were 4,255 COVID-related thromboembolic events. The researchers adjusted for confounding factors, such as age, race, and time of vaccination, and estimated that the bivalent booster was overall 47 percent effective at preventing COVID-related thromboembolic events, which again include strokes, blood clots, and heart attacks.

A sub-analysis including the time since vaccination indicated that the estimated effectiveness waned about two months after receipt of the vaccine, dropping early effectiveness of 54 percent down to 42 percent at 60 days or more.

Among the 78,600 patients ages 18 and up with ESRD, 23,229 (29.5 percent) received a bivalent dose and thus were up to date on their COVID-19 vaccines. The remaining patients (70.5 percent) had only received an original vaccine, and of those, 917 experienced a COVID-19-related thromboembolic event after getting the pandemic virus. Among the up-to-date patients, there were only 123 events. After adjustments, the researchers estimated that the vaccines’ effectiveness against thromboembolic events was 51 percent in this group, which also waned slightly over time.

The study has limitations, such as that it can’t account for previous COVID-19 infections, which could alter people’s risk of developing complications from COVID-19, including thromboembolic events. It relied on medical claims, which have limitations, and it’s possible there are other confounding factors, such as the use of Paxlovid and behavioral differences. Last, Medicare beneficiaries are not representative of the whole population.

But, given the data available, the study authors concluded that it appears the bivalent vaccine dose “helped provide protection against COVID-19–related thromboembolic events compared with more distant receipt of original monovalent doses alone.” The authors recommend that, “to prevent COVID-19–related complications, including thromboembolic events, adults should stay up to date with recommended COVID-19 vaccination.”

The CDC currently estimates that only 21 percent of adults ages 18 and up have received the latest COVID-19 booster dose, including 41.5 percent of adults ages 65 and up.

COVID shots protect against COVID-related strokes, heart attacks, study finds Read More »

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Chromium found in lead-tainted fruit pouches may explain contamination

adulteration, CDC, children, chromium, cinnamon, cinnamon applesauce, contamination, fda, fruit pouches, health, lead, lead chromate, lead poisoning, Science, spices, WanaBana / /

Nightmare —

Lead chromate, an artificial coloring, has been used in other spices to conceal poor quality.

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The three recalled pouches linked to lead poisonings.

Enlarge / The three recalled pouches linked to lead poisonings.

The Food and Drug Administration has discovered a second metal contaminant—chromium—in the recalled cinnamon applesauce pouches found to contain cinnamon contaminated with extremely high levels of lead. The products have now poisoned nearly 300 young children in 37 states.

The health implications of the additional contaminant are not clear. There is no antidote for chromium exposure, and the Centers for Disease Control and Prevention recommends supportive care. But the finding does hint at the possible motivation behind the tragic poisonings.

In the FDA’s announcement, the agency noted that “The lead-to-chromium ratio in the cinnamon apple puree sample is consistent with that of lead chromate (PbCrO4).” This is a notorious adulterant of spices used to artificially bolster their color and weight.

Lead chromate is a vibrant yellow substance that has frequently turned up in turmeric sourced from India and Bangladesh. In a 2017 study by public health researchers at Boston University, 16 of 32 turmeric products bought in markets in the Boston area had lead levels over the FDA’s allowable lead level for candy (the FDA does not have guidelines for lead levels in spices, specifically). Two samples, the only two samples sourced from Bangladesh, exceeded the allowable lead level by two orders of magnitude. The researchers had conducted the study after a string of lead poisoning cases in US children were linked to contaminated spices, including turmeric. Other studies have also identified spices as a source of lead exposure in US children.

The 2017 study highlighted the reason that lead chromate is used as an adulterant. A media outlet in Bangladesh quoted one turmeric trader’s explanation: “Traders use the artificial color [lead chromate] to hide the marks of pest attacks and other spots on raw turmeric. It is used during boiling and polishing to make the spice look brighter to attract big buyers, including spice processing firms.”

The FDA’s testing does not definitively conclude that lead chromate was in the contaminated cinnamon, which was sourced from an Austrofoods manufacturing facility in Ecuador and used in the recalled applesauce pouches. But it does bolster the FDA’s suspicion that the poisonings were the result of “economically motivated adulteration,” a specific category of food fraud defined by the FDA.

Jim Jones, FDA’s deputy commissioner for human foods, told Politico in December that the agency believed then that the contamination was economically motivated. “My instinct is they didn’t think this product was going to end up in a country with a robust regulatory process,” Jones said. “They thought it was going to end up in places that did not have the ability to detect something like this.”

Health effects

For the hundreds of US children poisoned by the applesauce pouches, the finding of chromium adds yet more nightmarish uncertainty of possible long-term health effects. Lead is a potent neurotoxic metal that can damage the brain and nervous system. In developing toddlers and younger children, the effects of the acute exposures could manifest as learning and behavior problems, as well as hearing and speech problems in the years to come.

The effects of chromium exposure are less clear. Chromium is a naturally occurring metal and an essential trace nutrient. But there are two notable forms: chromium III and the more toxic chromium VI. The FDA’s testing couldn’t identify which form of chromium was present in the cinnamon applesauce pouches, but the more toxic chromium VI is what’s present in lead chromate. Chromium VI is considered a carcinogen, and chronic, prolonged inhalation and skin exposure is associated with chronic lung disease and ulceration of skin and mucous membranes, the CDC notes. But the effects of eating chromium VI are not well studied or understood beyond the immediate, nonspecific effects of an acute exposure—which might include abdominal pain, nausea, vomiting, diarrhea, anemia, and kidney and liver dysfunction.

The CDC and the FDA note that it’s possible that even if chromium VI contaminated the applesauce pouches, the acidity of the applesauce and the stomach may have converted the chromium VI to chromium III.

The FDA recommends that the families of children exposed to the recalled pouches—especially those with elevated blood lead levels—should inform their health care providers of potential chromium exposure. The CDC provided clinical guidance for doctors on how to test and care for children with exposure.

The recalled cinnamon applesauce pouches include WanaBana apple cinnamon fruit puree pouches (sold nationally and through multiple retailers, including Amazon and Dollar Tree), Schnucks-brand cinnamon-flavored applesauce pouches and variety packs (sold at Schnucks and Eatwell Markets grocery stores), and Weis-brand cinnamon applesauce pouches (sold at Weis grocery stores).

According to the CDC’s latest numbers, which, as of the time of publication, were last updated on December 29, there have been a total of 287 cases identified across 37 states.

Chromium found in lead-tainted fruit pouches may explain contamination Read More »

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Experimental antibiotic kills deadly superbug, opens whole new class of drugs

Acinetobacter baumannii, antibiotic, antibiotic resistance, bacteria, carbapenem-resistant Acinetobacter baumannii, CRAB, drug development, Gram-negative bacteria, health, LPS, roche, Science / /

fingers crossed —

The relatively large molecule clogs a transport system, leading to lethal toxicity.

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This Scanning Electron Microscope image depicts several clusters of aerobic Gram-negative, non-motile <i>Acinetobacter baumannii</i> bacteria under a magnification of 24,730x.” src=”https://cdn.arstechnica.net/wp-content/uploads/2024/01/10096-800×544.jpg”></img><figcaption> <p><a data-height=Enlarge / This Scanning Electron Microscope image depicts several clusters of aerobic Gram-negative, non-motile Acinetobacter baumannii bacteria under a magnification of 24,730x.

A new experimental antibiotic can handily knock off one of the world’s most notoriously drug-resistant and deadly bacteria —in lab dishes and mice, at least. It does so with a never-before-seen method, cracking open an entirely new class of drugs that could yield more desperately needed new therapies for fighting drug-resistant infections.

The findings appeared this week in a pair of papers published in Nature, which lay out the extensive drug development work conducted by researchers at Harvard University and the Swiss-based pharmaceutical company Roche.

In an accompanying commentary, chemists Morgan Gugger and Paul Hergenrother of the University of Illinois at Urbana-Champaign discussed the findings with optimism, noting that it has been more than 50 years since the Food and Drug Administration has approved a new class of antibiotics against the category of bacteria the drug targets: Gram-negative bacteria. This category—which includes gut pathogens such as E. coli, Salmonella, Shigella, and the bacteria that cause chlamydia, the bubonic plague, gonorrhea, whooping cough, cholera, and typhoid, to name a few—is extraordinarily challenging to kill because it’s defined by having a complex membrane structure that blocks most drugs, and it’s good at accumulating other drug-resistance strategies

Weighty finding

In this case, the new drug—dubbed zosurabalpin—fights off the Gram-negative bacterium carbapenem-resistant Acinetobacter baumannii, aka CRAB. Though it may sound obscure, it’s an opportunistic, invasive bacteria that often strikes hospitalized and critically ill patients, causing deadly infections worldwide. It is extensively drug-resistant, with ongoing emergence of pan-resistant strains around the world—in other words, strains that are resistant to every current antibiotic available. Mortality rates of invasive CRAB infections range from 40 to 60 percent. In 2017, the World Health Organization listed it as a priority 1: critical pathogen, for which new antibiotics are needed most urgently.

Zosurabalpin may just end up being that urgently needed drug, as Gugger and Hergenrother write in their commentary: “Given that zosurabalpin is already being tested in clinical trials, the future looks promising, with the possibility of a new antibiotic class being finally on the horizon for invasive CRAB infections.”

An international team of researchers, led by Michael Lobritz and Kenneth Bradley at Roche, first identified a precursor of zosurabalpin through an unusual screen. Most new antibiotics are small molecules—those that have molecular weights of less than 600 daltons. But in this case, researchers searched through a collection of 45,000 bigger, heavier compounds, called tethered macrocyclic peptides (MCPs), which have weights around 800 daltons. The molecules were screened against a collection of Gram-negative strains, including an A. baumannii strain. A group of compounds knocked back the bacteria, and the researchers selected the top one—with the handy handle of RO7036668. The molecule was then optimized and fine-tuned, including charge balancing, to make it more effective, soluble, and safe. This resulted in zosurabalpin.

Deadly drug

In further experiments, zosurabalpin proved effective at killing a collection of 129 clinical CRAB isolates, many of which were difficult-to-treat isolates. The experimental drug was also effective at ridding mice of infections with a pan-resistant A. baumannii isolate, meaning however the drug worked, it could circumvent existing resistance mechanisms.

Next, the researchers worked to figure out how zosurabalpin was killing off these pan-resistant, deadly bacteria. They did this using a standard method of subjecting the bacteria to varying concentrations of the antibiotic to induce spontaneous mutations. For bacteria that developed tolerance to zosurabalpin, the researchers used whole genome sequencing to identify where the mutations were. They found 43 distinct mutations, and most were in genes encoding LPS transport and biosynthesis machinery.

Experimental antibiotic kills deadly superbug, opens whole new class of drugs Read More »

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ChatGPT bombs test on diagnosing kids’ medical cases with 83% error rate

AI, chatgpt, health, pediatric diagnosistics, Science / /

Not there yet —

It was bad at recognizing relationships and needs selective training, researchers say.

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Dr. Greg House has a better rate of accurately diagnosing patients than ChatGPT.

Enlarge / Dr. Greg House has a better rate of accurately diagnosing patients than ChatGPT.

ChatGPT is still no House, MD.

While the chatty AI bot has previously underwhelmed with its attempts to diagnose challenging medical cases—with an accuracy rate of 39 percent in an analysis last year—a study out this week in JAMA Pediatrics suggests the fourth version of the large language model is especially bad with kids. It had an accuracy rate of just 17 percent when diagnosing pediatric medical cases.

The low success rate suggests human pediatricians won’t be out of jobs any time soon, in case that was a concern. As the authors put it: “[T]his study underscores the invaluable role that clinical experience holds.” But it also identifies the critical weaknesses that led to ChatGPT’s high error rate and ways to transform it into a useful tool in clinical care. With so much interest and experimentation with AI chatbots, many pediatricians and other doctors see their integration into clinical care as inevitable.

The medical field has generally been an early adopter of AI-powered technologies, resulting in some notable failures, such as creating algorithmic racial bias, as well as successes, such as automating administrative tasks and helping to interpret chest scans and retinal images. There’s also lot in between. But AI’s potential for problem-solving has raised considerable interest in developing it into a helpful tool for complex diagnostics—no eccentric, prickly, pill-popping medical genius required.

In the new study conducted by researchers at Cohen Children’s Medical Center in New York, ChatGPT-4 showed it isn’t ready for pediatric diagnoses yet. Compared to general cases, pediatric ones require more consideration of the patient’s age, the researchers note. And as any parent knows, diagnosing conditions in infants and small children is especially hard when they can’t pinpoint or articulate all the symptoms they’re experiencing.

For the study, the researchers put the chatbot up against 100 pediatric case challenges published in JAMA Pediatrics and NEJM between 2013 and 2023. These are medical cases published as challenges or quizzes. Physicians reading along are invited to try to come up with the correct diagnosis of a complex or unusual case based on the information that attending doctors had at the time. Sometimes, the publications also explain how attending doctors got to the correct diagnosis.

Missed connections

For ChatGPT’s test, the researchers pasted the relevant text of the medical cases into the prompt, and then two qualified physician-researchers scored the AI-generated answers as correct, incorrect, or “did not fully capture the diagnosis.” In the latter case, ChatGPT came up with a clinically related condition that was too broad or unspecific to be considered the correct diagnosis. For instance, ChatGPT diagnosed one child’s case as caused by a branchial cleft cyst—a lump in the neck or below the collarbone—when the correct diagnosis was Branchio-oto-renal syndrome, a genetic condition that causes the abnormal development of tissue in the neck, and malformations in the ears and kidneys. One of the signs of the condition is the formation of branchial cleft cysts.

Overall, ChatGPT got the right answer in just 17 of the 100 cases. It was plainly wrong in 72 cases, and did not fully capture the diagnosis of the remaining 11 cases. Among the 83 wrong diagnoses, 47 (57 percent) were in the same organ system.

Among the failures, researchers noted that ChatGPT appeared to struggle with spotting known relationships between conditions that an experienced physician would hopefully pick up on. For example, it didn’t make the connection between autism and scurvy (Vitamin C deficiency) in one medical case. Neuropsychiatric conditions, such as autism, can lead to restricted diets, and that in turn can lead to vitamin deficiencies. As such, neuropsychiatric conditions are notable risk factors for the development of vitamin deficiencies in kids living in high-income countries, and clinicians should be on the lookout for them. ChatGPT, meanwhile, came up with the diagnosis of a rare autoimmune condition.

Though the chatbot struggled in this test, the researchers suggest it could improve by being specifically and selectively trained on accurate and trustworthy medical literature—not stuff on the Internet, which can include inaccurate information and misinformation. They also suggest chatbots could improve with more real-time access to medical data, allowing the models to refine their accuracy, described as “tuning.”

“This presents an opportunity for researchers to investigate if specific medical data training and tuning can improve the diagnostic accuracy of LLM-based chatbots,” the authors conclude.

ChatGPT bombs test on diagnosing kids’ medical cases with 83% error rate Read More »