health

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 »

chromium-found-in-lead-tainted-fruit-pouches-may-explain-contamination

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 »

experimental-antibiotic-kills-deadly-superbug,-opens-whole-new-class-of-drugs

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 »

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

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 »

fda-would-like-to-stop-finding-viagra-in-supplements-sold-on-amazon

FDA would like to stop finding Viagra in supplements sold on Amazon

Amazon, cialis, drugs, fda, health, Policy, supplements, Viagra / /

Well, that’s one kind of energy —

“Big Guys Male Energy Supplement” turns out to be a vehicle for prescription drugs.

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Image of a pile of blue pills that forms the shape of a male symbol.

If you were to search for a product called “Mens Maximum Energy Supplement” on Amazon, you’d be bombarded with everything from caffeine pills to amino acid supplements to the latest herb craze. But at some point last year, the FDA had purchased a specific product by that name from Amazon and sent it off to one of its labs to find out if the self-proclaimed “dietary supplement” contained anything that would actually boost energy.

In August, the FDA announced that the supposed supplement was actually a vehicle for a prescription drug that offered a very specific type of energy boost. It contained sildenafil, a drug much better known by its brand name: Viagra.

Four months later, the FDA is finally getting around to issuing a warning letter to Amazon, giving it 15 days to not only address Mens Maximum Energy Supplement and a handful of similar vehicles for prescription erection boosters, but also asking for an explanation of how the company is going to keep similarly mislabelled prescription drugs from being hawked on its site in the future.

Prescription energy

Mens Maximum Energy Supplement was just one of seven products that the FDA found for sale on Amazon that contained either Sildenafil or Tadalafil (marketed as Cialis). The product names ranged from the jokey (WeFun and Genergy) to the vaguely suggestive (Round 2) to the verbose (Big Guys Male Energy Supplement and X Max Triple Shot Energy Honey). All of them were marketed as supplements and contained no indication of their active ingredients.

And that, as the FDA explains to Amazon in detail, means selling those products violates a whole host of laws and regulations. They’re being marketed as dietary supplements, but don’t fit the operative legal definition of these supplements. They’re offering prescription drugs without providing directions for their intended and safe use. They contain no warnings about unsafe doses or how long they can be used safely.

The FDA points out that these rules exist for very good reasons. Both of the drugs found in these supplements inhibit an enzyme called a type-5 phosphodiesterase which, among other things, influences the circulatory system. One potential side effect is a dangerous drop in blood pressure. Both Sildenafil and Tadalafil can also have dangerous interactions with a specific class of drugs often taken by those with diabetes, high blood pressure, or heart disease.

Legal remedies

The FDA’s letter makes it clear that the highlighted supplements aren’t intended to be an exhaustive list of the products that Amazon offers in violation of federal law. And it is very explicit about the fact that it is Amazon’s responsibility (and not the FDA’s) to ensure compliance: “You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.”

And Amazon clearly has its work cut out for it. None of the products cited by the FDA’s letter appear to still be for sale under the same name at Amazon—a company spokesperson told Ars that it pulled them in response to the original FDA findings. But searches for them at Amazon brought up a number of similar products, many of which included pills with the blue color that Viagra was marketed with.

So, the FDA wants to see a plan that describes how Amazon will not only deal with the products at issue in this letter, but prevent all similar violations in the future: “Include an explanation of each step being taken to prevent the recurrence of violations, including steps you will take to ensure that Amazon will no longer introduce or deliver for introduction into interstate commerce unapproved new drugs and/or misbranded products with undeclared drug ingredients, as well as copies of related documentation.”

Amazon is being given 15 days to respond to the warning letter. Failure to adequately address these violations, the FDA warns, will result in legal action.

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Injection of “smart insulin” regulates blood glucose levels for one week

biochemistry, diabetes, glucose, health, insulin, Science / /

Sugary treat treatment —

Tests in animals show the material works like the body’s own system.

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Image of a syringe above three drug vials

Enlarge / Smart insulin has the potential to make injections far less frequent.

People with type I diabetes have to inject themselves multiple times a day with manufactured insulin to maintain healthy levels of the hormone, as their bodies do not naturally produce enough. The injections also have to be timed in response to eating and exercise, as any consumption or use of glucose has to be managed.

Research into glucose-responsive insulin, or “smart” insulin, hopes to improve the quality of life for people with type I diabetes by developing a form of insulin that needs to be injected less frequently, while providing control of blood-glucose levels over a longer period of time.

A team at Zhejiang University, China, has recently released a study documenting an improved smart insulin system in animal models—the current work doesn’t involve any human testing. Their insulin was able to regulate blood-glucose levels for a week in diabetic mice and minipigs after a single subcutaneous injection.

“Theoretically, [smart insulin is] incredibly important going forward,” said Steve Bain, clinical director of the Diabetes Research Unit in Swansea University, who was not involved in the study. “It would be a game changer.”

Polymer cage

The new smart insulin is based on a form of insulin modified with gluconic acid, which forms a complex with a polymer through chemical bonds and strong electrostatic attraction. When insulin is trapped in the polymer, its signaling function is blocked, allowing a week’s worth of insulin to be given via a single injection without a risk of overdose.

Crucial to the “glucose responsive” nature of this system is the fact that the chemical structures of glucose and gluconic acid are extremely similar, meaning the two molecules bind in very similar ways. When glucose meets the insulin-polymer complex, it can displace some of the bound insulin and form its own chemical bonds to the polymer. Glucose binding also disrupts the electrostatic attraction and further promotes insulin release.

By preferentially binding to the polymer, the glucose is able to trigger the release of insulin. And the extent of this insulin release depends on how much glucose is present: between meals, when the blood-glucose level is fairly low, only a small amount of insulin is released. This is known as basal insulin and is needed for baseline regulation of blood sugar.

But after a meal, when blood-glucose spikes, much more insulin is released. The body can now regulate the extra sugar properly, preventing abnormally high levels of glucose—known as hyperglycemia. Long-term effects of hyperglycemia in humans include nerve damage to the hands and feet and permanent damage to eyesight.

This system mimics the body’s natural process, in which insulin is also released in response to glucose.

Better regulation than standard insulin

The new smart insulin was tested in five mice and three minipigs—minipigs are often used as an animal model that’s more physiologically similar to humans. One of the three minipigs received a slightly lower dose of smart insulin, and the other two received a higher dose. The lower-dose pig showed the best response: its blood-glucose levels were tightly controlled and returned to a healthy value after meals.

During treatment, the other two pigs had glucose levels that were still above the range seen in healthy animals, although they were greatly reduced compared to pre-injection levels. The regulation of blood-glucose was also tighter compared to daily insulin injections.

It should be noted, though, that the minipig with the best response also had the lowest blood-glucose levels before treatment, which may explain why it seemed to work so well in this animal.

Crucially, these effects were all long lasting—better regulation could be seen a week after treatment. And injecting the animals with the smart insulin didn’t result in a significant immune response, which can be a common pitfall when introducing biomaterials to animals or humans.

Don’t sugarcoat it

The study is not without its limitations. Although long-term glucose regulation was seen in the mice and minipigs examined, only a few animals were involved in the study—five mice and three minipigs. And of course, there’s always the risk that the results of animal studies don’t completely track over to clinical trials in humans. “We have to accept that these are animal studies, and so going across to humans is always a bit of an issue,” said Bain.

Although more research is required before this smart insulin system can be tested in humans, this work is a promising step forward in the field.

Nature Biomedical Engineering, 2023. DOI: 10.1038/s41551-023-01138-7

Ivan Paul is a freelance writer based in the UK, finishing his PhD in cancer research. He is on X @ivan_paul_.

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Great British Bake Off’s festive Christmas desserts aren’t so naughty after all

baking, chemistry, cooking shows, Food science, Great British Bake Off, health, nutrition, Science / /

A Christmas miracle? —

Study: Several ingredients actually reduce rather than increase risk of death or disease.

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four smiling people at a festive picnic table munching on a tasty snack

Enlarge / Great British Bake Off judges Paul Hollywood and Prue Leith (top) and presenters Alison Hammond and Noel Fielding.

Mark Bourdillon/Love Productions/Channel 4

The Great British Bake Off (TGBBO)—aka The Great British Baking Show in the US and Canada—features amateur bakers competing each week in a series of baking challenges, culminating in a single winner. The recipes include all manner of deliciously decadent concoctions, including the occasional Christmas dessert. But many of the show’s Christmas recipes might not be as bad for your health as one might think, according to a new paper published in the annual Christmas issue of the British Medical Journal, traditionally devoted to more light-hearted scientific papers.

TGBBO made its broadcast debut in 2010 on the BBC, and its popularity grew quickly and spread across the Atlantic. The show was inspired by the traditional baking competitions at English village fetes (see any British cozy murder mystery for reference). Now entering its 15th season, the current judges are Paul Hollywood and Prue Leith, with Noel Fielding and Alison Hammond serving as hosts/presenters, providing (occasionally off-color) commentary. Each week features a theme and three challenges: a signature bake, a technical challenge, and a show-stopper bake.

The four co-authors of the new BMJ study—Joshua Wallach of Emory University and Yale University’s Anant Gautam, Reshma Ramachandran, and Joseph Ross—are avid fans of TGBBO, which they declare to be “the greatest television baking competition of all time.” They are also fans of desserts in general, noting that in medieval England, the Catholic Church once issued a decree requiring Christmas pudding four weeks before Christmas. Those puddings were more stew-like, containing things like prunes, raisins, carrots, nuts, spices, grains, eggs, beef, and mutton. Hence, those puddings were arguably more “healthy” than the modern take on desserts, which contain a lot more butter and sugar in particular.

But Wallach et al. wondered whether even today’s desserts might be healthier than popularly assumed and undertook an extensive review of the existing scientific literature for their own “umbrella review.” It’s actually pretty challenging to establish direct causal links in the field of nutrition, whether we’re talking about observational studies or systemic reviews and meta-analyses. For instance, many of the former focus on individual ingredients and do not take into account the effects of overall diet and lifestyle. They also may rely on self-reporting by study participants. “Are we really going to accurately report how much Christmas desserts we frantically ate in the middle of the night, after everyone else went to bed?” the authors wrote. Systemic reviews are prone to their own weaknesses and biases.

“But bah humbug, it is Christmas and we are done being study design Scrooges,” the authors wrote, tongues tucked firmly in cheeks. “We have taken this opportunity to ignore the flaws of observational nutrition research and conduct a study that allows us to feel morally superior when we happen to enjoy eating the Christmas dessert ingredients in question (eg, chocolate). Overall, we hoped to provide evidence that we need to have Christmas dessert and eat it too, or at least evidence that will inform our collective gluttony or guilt this Christmas.”

The team scoured the TGBBO website and picked 48 dessert recipes for Christmas cakes, cookies, pastries, and puddings, such as Val’s Black Forest Yule Log, or Ruby’s Boozy Chai, Cherry and Chocolate Panettones. There were 178 unique ingredients contained in those recipes, and the authors classified those into 17 overarching ingredient groups: baking soda, powder and similar ingredients; chocolate; cheese and yogurt; coffee; eggs; butter; food coloring, flavors and extracts; fruit; milk; nuts; peanuts or peanut butter; refined flour; salt; spices; sugar; and vegetable fat.

Wallach et al. identified 46 review articles pertaining to health and nutrition regarding those classes of ingredients for their analysis. That yielded 363 associations between the ingredients and risk of death or disease, although only 149 were statistically significant. Of those 149 associations, 110 (74 percent) reduced health risks while 39 (26 percent) increased risks. The most common ingredients associated with reduced risk are fruits, coffee, and nuts, while alcohol and sugar were the most common ingredients associated with increased risk.

Take Prue Leith’s signature chocolate Yule log, for example, which is “subtly laced with Irish cream liqueur.” Most of the harmful ingredient associations were for the alcohol content, which various studies have shown to increase risk of liver cancer, gastric cancer, colon cancer, gout, and atrial fibrillation. While alcohol can evaporate during cooking or baking, in this case it’s the cream filling that contains the alcohol, which is not reduced by baking. (Leith has often expressed her preference for “boozy bakes” on the show.)

By contrast, Rav’s Frozen Fantasy Cake contains several healthy ingredients, most notably almonds and passion fruit, and thus carried a significant decreased risk for disease or death. Ditto for Paul Hollywood’s Stollen, which contains almonds, milk, and various dried fruits. “Overall, without the eggs, butter, and sugar, this dessert is essentially a fruit salad with nuts,” the authors wrote. That is, of course, a significant caveat, because the eggs, butter, and sugar kinda make the dessert. But Wallach et al. note that most of the dietary studies condemning sugar focused on the nutritional effects of sugar-sweetened beverages, and none of TGBBO Christmas dessert recipes used such beverages, “no doubt because they would have resulted in bakes with a soggy bottom.”

The BMJ study has its limitations, relying as it does on evidence from prior observational studies. Wallach et al. also did not take into account how much of each ingredient was used in any given recipe. Regardless of whether the recipe called for a single berry or an entire cup of berries, that ingredient was weighted the same in terms of its protective effects countering the presumed adverse effects of butter. Would a weighted analysis have been more accurate? Sure, but it would also have been much less fun.

So, is this a genuine Christmas miracle or an amusing academic exercise in creative rationalization? Maybe we shouldn’t overthink it. “It is Christmas so just enjoy your desserts in moderation,” the authors concluded.

BMJ, 2023. DOI: 10.1136/bmj‑2023‑077166  (About DOIs).

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MDMA—aka ecstasy—submitted to FDA as part of PTSD therapy

fda, health, maps, mdma, psychedelics, PTSD, Science, therapy / /

Groovy —

If FDA approved, it would require the DEA to reclassify MDMA.

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Girl with an ecstasy tablet on her tongue.

Enlarge / Girl with an ecstasy tablet on her tongue.

A corporation dedicated to studying the benefits of psychedelic drugs filed an application with the Food and Drug Administration this week for approval to use MDMA—aka ecstasy or molly—in combination with talk therapy to treat post-traumatic stress disorder.

If approved, it would be the first-of-its-kind combination treatment—a psychedelic-assisted therapy. An approval would also require the Drug Enforcement Administration to reclassify MDMA, which is currently in the DEA’s most restricted category, Schedule I, which is defined as drugs “with no currently accepted medical use and a high potential for abuse.” The category also includes LSD, heroin, and marijuana.

The public benefit corporation (PBC) that filed the FDA application was created by MAPS, The Multidisciplinary Association for Psychedelic Studies, which has been supporting this type of work since 1986. The application is based on positive data from two randomized, double-blind, placebo-controlled Phase III studies, which were funded and organized by MAPS and MAPS PBC.

The first study, published in Nature Medicine in 2021, involved a total of 90 participants with moderate PTSD. It found that MDMA-assisted talk therapy (aka psychotherapy) significantly improved Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores compared with participants who were given talk therapy with a placebo. In the second study, published in September in Nature Medicine, the finding held up among 104 participants with moderate or severe PTSD (73 percent had severe PTSD).

In both trials, participants took 80 to 180 mg doses of MDMA or a placebo at the start of three eight-hour sessions, which were spaced around a month apart. Between those experimental treatment sessions, participants also had three 90-minute sessions for participants to process the experimental experience.

MDMA—3,4-methylenedioxymethamphetamine—affects neurotransmitters in the brain, increasing the activity of serotonin, dopamine, and norepinephrine, to be specific. This leads people who take the drug to experience euphoria, hallucinations, sharpened sensory perception, and sociability, but it can also induce confusion, depression, and paranoia. Its use in psychotherapy has been explored for decades.

In a statement this week, MAPS PBC CEO Amy Emerson celebrated the FDA submission. “The filing of our [new drug application] is the culmination of more than 30 years of clinical research, advocacy, collaboration, and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” she said.

MAPS founder and President Rick Doblin also celebrated the submission this week, saying in a statement: “When I started MAPS in 1986, the FDA was still blocking all research with psychedelics. … By breaking that barrier, we have opened doors for others to conduct their own promising research into psychedelic-assisted therapies with psilocybin, ayahuasca, ketamine, and more. The novel approaches undertaken in psychedelic-assisted therapy research have led to fundamental shifts in our understanding of how these devastating mental health conditions can be treated.”

So far, the MDMA-assisted therapy has drawn criticism for its expected inaccessibility. The treatment outlined in the two MDMA trials involves lengthy—and likely pricey—therapy sessions with highly trained therapists. The Washington Post published an estimated price of between $13,000 to $15,000 per treatment round, and it’s unclear for now whether it would be covered by health insurance if approved by the FDA. “Most people in the world won’t be able to afford these clinics,” Allen Frances, a Duke University professor emeritus of psychiatry, told the Post.

Now that the NDA is submitted, the FDA has 60 days to determine whether it will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively), MAPS PBS noted. MAPS is seeking a priority review. In 2017, the FDA granted MDMA “Breakthrough Therapy,” designed to help hasten the development and review of drugs for serious conditions when evidence indicates they may substantially improve upon current therapies.

The only psychedelic with FDA approval to date is esketamine, a variation of ketamine, which was approved in 2019 to treat treatment-resistant depression.

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humana-also-using-ai-tool-with-90%-error-rate-to-deny-care,-lawsuit-claims

Humana also using AI tool with 90% error rate to deny care, lawsuit claims

AI, claim denial, coverage, health, humana, insurance, insurance coverage, medicare, medicare advantage, nH Predict, nursing home, post-acute care, Science, unitedhealth / /

AI denials —

The AI model, nH Predict, is the focus of another lawsuit against UnitedHealth.

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Signage is displayed outside the Humana Inc. office building in Louisville, Kentucky, US, in 2016.

Enlarge / Signage is displayed outside the Humana Inc. office building in Louisville, Kentucky, US, in 2016.

Humana, one the nation’s largest health insurance providers, is allegedly using an artificial intelligence model with a 90 percent error rate to override doctors’ medical judgment and wrongfully deny care to elderly people on the company’s Medicare Advantage plans.

According to a lawsuit filed Tuesday, Humana’s use of the AI model constitutes a “fraudulent scheme” that leaves elderly beneficiaries with either overwhelming medical debt or without needed care that is covered by their plans. Meanwhile, the insurance behemoth reaps a “financial windfall.”

The lawsuit, filed in the US District Court in western Kentucky, is led by two people who had a Humana Medicare Advantage Plan policy and said they were wrongfully denied needed and covered care, harming their health and finances. The suit seeks class-action status for an unknown number of other beneficiaries nationwide who may be in similar situations. Humana provides Medicare Advantage plans for 5.1 million people in the US.

It is the second lawsuit aimed at an insurer’s use of the AI tool nH Predict, which was developed by NaviHealth to forecast how long patients will need care after a medical injury, illness, or event. In November, the estates of two deceased individuals brought a suit against UnitedHealth—the largest health insurance company in the US—for also allegedly using nH Predict to wrongfully deny care.

Humana did not respond to Ars’ request for comment for this story. United Health previously said that “the lawsuit has no merit, and we will defend ourselves vigorously.”

AI model

In both cases, the plaintiffs claim that the insurers use the flawed model to pinpoint the exact date to blindly and illegally cut off payments for post-acute care that is covered under Medicare plans—such as stays in skilled nursing facilities and inpatient rehabilitation centers. The AI-powered model comes up with those dates by comparing a patient’s diagnosis, age, living situation, and physical function to similar patients in a database of 6 million patients. In turn, the model spits out a prediction for the patient’s medical needs, length of stay, and discharge date.

But, the plaintiffs argue that the model fails to account for the entirety of each patient’s circumstances, their doctors’ recommendations, and the patient’s actual conditions. And they claim the predictions are draconian and inflexible. For example, under Medicare Advantage plans, patients who have a three-day hospital stay are typically entitled to up to 100 days of covered care in a nursing home. But with nH Predict in use, patients rarely stay in a nursing home for more than 14 days before claim denials begin.

Though few people appeal coverage denials generally, of those who have appealed the AI-based denials, over 90 percent have gotten the denial reversed, the lawsuits say.

Still, the insurers continue to use the model and NaviHealth employees are instructed to hew closely to the AI-based predictions, keeping lengths of post-acute care to within 1 percent of the days estimated by nH Predict. NaviHealth employees who fail to do so face discipline and firing. ” Humana banks on the patients’ impaired conditions, lack of knowledge, and lack of resources to appeal the wrongful AI-powered decisions,” the lawsuit filed Tuesday claims.

Plaintiff’s cases

One of the plaintiffs in Tuesday’s suit is JoAnne Barrows of Minnesota. On November 23, 2021, Barrows, then 86, was admitted to a hospital after falling at home and fracturing her leg. Doctors put her leg in a cast and issued an order not to put any weight on it for six weeks. On November 26, she was moved to a rehabilitation center for her six-week recovery. But, after just two weeks, Humana’s coverage denials began. Barrows and her family appealed the denials, but Humana denied the appeals, declaring that Barrows was fit to return to her home despite being bedridden and using a catheter.

Her family had no choice but to pay out-of-pocket. They tried moving her to a less expensive facility, but she received substandard care there, and her health declined further. Due to the poor quality of care, the family decided to move her home on December 22, even though she was still unable to use her injured leg, go the bathroom on her own, and still had a catheter.

The other plaintiff is Susan Hagood of North Carolina. On September 10, 2022, Hagood was admitted to a hospital with a urinary tract infection, sepsis, and a spinal infection. She stayed in the hospital until October 26, when she was transferred to a skilled nursing facility. Upon her transfer, she had eleven discharging diagnoses, including sepsis, acute kidney failure, kidney stones, nausea and vomiting, a urinary tract infection, swelling in her spine, and a spinal abscess. In the nursing facility, she was in extreme pain and on the maximum allowable dose of the painkiller oxycodone. She also developed pneumonia.

On November 28, she returned to the hospital for an appointment, at which point her blood pressure spiked, and she was sent to the emergency room. There, doctors found that her condition had considerably worsened.

Meanwhile, a day earlier, on November 27, Humana determined that it would deny coverage of part of her stay at the skilled nursing facility, refusing to pay from November 14 to November 28. Humana said Hagood no longer needed the level of care the facility provided and that she should be discharged home. The family paid $24,000 out-of-pocket for her care, and to date, Hagood remains in a skilled nursing facility.

Overall, the patients claim that Humana and UnitedHealth are aware that nH Predict is “highly inaccurate” but use it anyway to avoid paying for covered care and make more profit. The denials are “systematic, illegal, malicious, and oppressive.”

The lawsuit against Humana alleges breach of contract, unfair dealing, unjust enrichment, and bad faith insurance violations in many states. It seeks damages for financial losses and emotional distress, disgorgement and/or restitution, and to have Humana barred from using the AI-based model to deny claims.

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