health

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FDA approves first non-opioid pain medicine in more than 20 years

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The approval “is an important public health milestone in acute pain management,” Jacqueline Corrigan-Curay, J.D., M.D., acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.”

The company behind the drug, Vertex, said a 50 mg pill that works for 12 hours will have a wholesale cost of $15.50, making the daily cost $31 and the weekly cost $217. The cost is higher than cheap, generic opioids. But, a report from The Institute for Clinical and Economic Review in December estimated that suzetrigine would be “slightly cost-saving” relative to opioids if the price was set at $420 per week, given the drug’s ability to avert opioid addiction cases.

In a statement, Reshma Kewalramani, the CEO and President of Vertex, trumpeted the approval as a “historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year … [W]e have the opportunity to change the paradigm of acute pain management and establish a new standard of care.”

FDA approves first non-opioid pain medicine in more than 20 years Read More »

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States say they’ve been shut out of Medicaid amid Trump funding freeze

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Amid the Trump administration’s abrupt, wide-scale freeze on federal funding, states are reporting that they’ve lost access to Medicaid, a program jointly funded by the federal government and states to provide comprehensive health coverage and care to tens of millions of low-income adults and children in the US.

The funding freeze was announced in a memo dated January 27 from Matthew Vaeth, the acting director of the Office of Management and Budget, and was first reported Monday evening by independent journalist Marisa Kabas. The freeze is intended to prevent “use of Federal resources to advance Marxist equity, transgenderism, and green new deal social engineering policies,” Vaeth wrote. The memo ordered federal agencies to complete a comprehensive analysis of all federal financial assistance programs to ensure they align with the president’s policies and requirements.

“In the interim, to the extent permissible under applicable law, Federal agencies must temporarily pause all activities related to obligation or disbursement of all Federal financial assistance, and other relevant agency activities that may be implicated by the executive orders…” Vaeth wrote.

Illinois was the first state to report that it had lost access to Medicaid. According to the Chicago Sun-Times, Gov. JB Pritzker’s office expected the freeze to go into effect at 5 pm Eastern Time today but found the state locked out this morning. The Times noted that Medicaid covered about 3.9 million people in Illinois in 2023, including low-income adults, children, pregnant people, and people with disabilities.

In a post Tuesday afternoon on the social media platform Bluesky, Senator Ron Wyden (D-Ore.) reported that all 50 states have since lost access. “My staff has confirmed reports that Medicaid portals are down in all 50 states following last night’s federal funding freeze,” Wyden wrote. “This is a blatant attempt to rip away health care from millions of Americans overnight and will get people killed.”

States say they’ve been shut out of Medicaid amid Trump funding freeze Read More »

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Dead babies, critically ill kids: Pediatricians make moving plea for vaccines

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As federal lawmakers prepare to decide whether anti-vaccine advocate Robert F. Kennedy Jr. should be the next secretary of the Department of Health and Human Services, pediatricians from around the country are making emotional pleas to protect and support lifesaving immunizations.

The American Academy of Pediatrics (AAP) has assembled nearly 200 stories and dozens of testimonials on the horrors of vaccine-preventable deaths and illnesses that pediatricians have encountered over their careers. The testimonials have been shared with two Senate committees that will hold hearings later this week: the Senate Committee on Finance and the Senate Committee on Health, Education, Labor, and Pensions (HELP).

“I remember that baby’s face to this day”

In a statement on Monday, AAP President Susan Kressly noted that the stories come from a wide range of pediatricians—from rural to urban and from small practices to large institutions. Some have recalled stories of patients who became ill with devastating diseases before vaccines were available to prevent them, while others shared more recent experiences as vaccine misinformation spread and vaccination rates slipped.

In one, a pediatrician from Raleigh, North Carolina, spoke of a baby in the 1990s with Streptococcus pneumoniae meningitis, a life-threatening disease. “I remember holding a baby dying of complications of pneumococcal meningitis at that time. I remember that baby’s face to this day—but, thanks to pneumococcal vaccination, have never had to relive that experience since,” the doctor said. The first pneumococcal vaccine for infants was licensed in the US in 2000.

A doctor in Portland, Maine, meanwhile, faced the same disease in a patient who was unvaccinated despite the availability of the vaccine. “As a resident, I cared for a young, unvaccinated child admitted to the pediatric intensive care unit with life-threatening Streptococcus pneumoniae meningitis. This devastating illness, once common, has become rare thanks to the widespread use of pneumococcal conjugate vaccines. However, this child was left vulnerable…and [their parents] now faced the anguish of watching their child fight for their life on a ventilator.”

Kressly emphasizes that “One unifying theme of these stories: vaccines allow children to grow up healthy and thrive. As senators consider nominees for federal healthcare agencies, we hope these testimonies will help paint a picture of just how important vaccinations are to children’s long-term health and wellbeing.”

Dead babies, critically ill kids: Pediatricians make moving plea for vaccines Read More »

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WHO starts cutting costs as US withdrawal date set for January 2026

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“Just stupid”

On January 23, WHO Director-General Tedros Adhanom Ghebreyesus sent a memo to staff announcing the cost-cutting measures. Reuters obtained a copy of the memo.

“This announcement has made our financial situation more acute,” Tedros wrote, referring to the US withdrawal plans. WHO’s budget mainly comes from dues and voluntary contributions from member states. The dues are a percentage of each member state’s gross domestic product, and the percentage is set by the UN General Assembly. US contributions account for about 18 percent of WHO’s overall funding, and its two-year 2024-2025 budget was $6.8 billion, according to Reuters.

To prepare for the budget cut, WHO is halting recruitment, significantly curtailing travel expenditures, making all meetings virtual, limiting IT equipment updates, and suspending office refurbishment.

“This set of measures is not comprehensive, and more will be announced in due course,” Tedros wrote, adding that the agency would do everything it could to protect and support staff.

The country’s pending withdrawal has been heavily criticized by global health leaders and US experts, who say it will make the world less safe and weaken America. In a CBS/KFF Health News report examining the global health implications of the US withdrawal, Kenneth Bernard, a visiting fellow at the Hoover Institution at Stanford University who served as a top biodefense official during the George W. Bush administration, did not mince words:

“It’s just stupid,” Bernard said. “Withdrawing from the WHO leaves a gap in global health leadership that will be filled by China,” he said, “which is clearly not in America’s best interests.”

WHO starts cutting costs as US withdrawal date set for January 2026 Read More »

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For real, we may be taking blood pressure readings all wrong

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For people who had high blood pressure readings only when sitting (normal readings while lying down), there was no statistically significant difference in risk of coronary heart disease, heart failure, or stroke compared to people with normal blood pressure. The only statistically significant differences were a 41 percent higher risk of fatal coronary heart disease (compared to the 78 percent seen in those with high readings lying down) and an 11 percent higher risk of all-cause mortality.

(In this study, high blood pressure readings were defined for both positions as those with systolic readings (the top number) of 130 mm Hg or greater or diastolic readings (the bottom number) of 80 mm Hg or greater.)

The people with the highest risks across the board were those who had high blood pressure readings while both sitting and lying down.

“These findings suggest that measuring supine [lying down] BP may be useful for identifying elevated BP and latent CVD risk,” the researchers conclude.

Strengths and hypotheses

For now, the findings should be considered preliminary. Such an analysis and finding should be repeated with a different group of people to confirm the link. And as to the bigger question of whether using medication to lower supine blood pressure (rather than seated blood pressure) is more effective at reducing risk, it’s likely that clinical trials will be necessary.

Still, the analysis had some notable strengths that make the findings attention-worthy. The study’s size and design are robust. Researchers tapped into data from the Atherosclerosis Risk in Communities (ARIC) study, a study established in 1987 with middle-aged people living in one of four US communities (Forsyth County, North Carolina; Jackson, Mississippi; suburban Minneapolis, Minnesota; and Washington County, Maryland).

For real, we may be taking blood pressure readings all wrong Read More »

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Florida man eats diet of butter, cheese, beef; cholesterol oozes from his body

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What could go wrong with eating an extremely high-fat diet of beef, cheese, and sticks of butter? Well, for one thing, your cholesterol levels could reach such stratospheric levels that lipids start oozing from your blood vessels, forming yellowish nodules on your skin.

That was the disturbing case of a man in Florida who showed up at a Tampa hospital with a three-week history of painless, yellow eruptions on the palms of his hands, soles of his feet, and elbows. His case was published today in JAMA Cardiology.

Painless yellowish nodules were observed on the patient’s palms (A) and elbows. B, Magnified view of the palmar lesions. These lesions are consistent with xanthelasma, likely resulting from severe hypercholesterolemia associated with a high-fat carnivore diet. Credit: JAMA Cardiologym 2024, Marmagkiolis et al.

The man, said to be in his 40s, told doctors that he had adopted a “carnivore diet” eight months prior. His diet included between 6 lbs and 9 lbs of cheese, sticks of butter, and daily hamburgers that had additional fat incorporated into them. Since taking on this brow-raising food plan, he claimed his weight dropped, his energy levels increased, and his “mental clarity” improved.

Meanwhile, his total cholesterol level exceeded 1,000 mg/dL. For context, an optimal total cholesterol level is under 200 mg/dL, while 240 mg/dL is considered the threshold for ‘high.’ Cardiologists noted that prior to going on his fatty diet, his cholesterol had been between 210 mg/dL to 300 mg/dL.

Florida man eats diet of butter, cheese, beef; cholesterol oozes from his body Read More »

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Trump orders US withdrawal from the World Health Organization

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The United States noticed its withdrawal from the World Health Organization (WHO) in 2020 due to the organization’s mishandling of the COVID-19 pandemic that arose out of Wuhan, China, and other global health crises, its failure to adopt urgently needed reforms, and its inability to demonstrate independence from the inappropriate political influence of WHO member states.  In addition, the WHO continues to demand unfairly onerous payments from the United States, far out of proportion with other countries’ assessed payments.  China, with a population of 1.4 billion, has 300 percent of the population of the United States, yet contributes nearly 90 percent less to the WHO.

Health experts fear that a US withdrawal from the agency would significantly diminish the agency’s resources and capabilities, leave the world more vulnerable to health threats, and isolate the US, hurting its own interests and leaving the country less prepared to respond to another pandemic. The New York Times noted that a withdrawal would mean that the US Centers for Disease Control and Prevention would lose, among many things, access to global health data that the WHO compiles.

It remains legally unclear if Trump can unilaterally withdrawal the country from the WHO, or if the withdrawal also requires a joint act with Congress.

Trump orders US withdrawal from the World Health Organization Read More »

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DC-area veterinarians on heightened alert amid potential inauguration risks

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Veterinarians in the Washington, DC region have been put on alert for any unusual illnesses in their non-human patients amid today’s presidential inauguration—a nod to the significance of potential zoonotic bioterror threats.

In a recent letter to Virginia veterinarians, the state health department requested assistance in the “enhanced surveillance,” while noting that, currently, there is no report of threats or bioterrorism-related illnesses.

“As with any large-scale public event, there will be heightened security, and the region will be on alert or signs of bioterrorism or other potential threats,” the letter read. “Enhanced surveillance is being conducted out of an abundance of caution.”

Health officials are asking veterinarians to report any animals who develop an unusual, severe illness within 14 days of exposure to the National Mall area during the inaugural period between January 19 and January 21. The cases could include animals who travel to the area or who live there. If such a case arises, veterinarians should report the case “rapidly by phone” to the officials in the state’s Zoonotic Disease Program. That includes State Public Health Veterinarian Julia Murphy.

In an interview with Ars Technica, Murphy noted that the health department has requested enhanced surveillance from veterinarians in the past. “We did a similar thing for the last inauguration,” she said.

The recruitment of veterinarians highlights the threat posed by zoonotic diseases—that is, those that can transmit between animals and humans. And it demonstrates the value of a “One Health” approach to health, which recognizes the interconnection between animals, humans, and shared environments.

In emerging outbreaks or bioterror events, animal illnesses have the potential to act as sentinels—the first to show signs of a disease—as well as be informative for understanding the geographic scope and severity of an event, Murphy explained. For instance, the bacterium Francisella tularensis, which causes a potentially serious illness called tularemia, is particularly dangerous for rabbits and rodents. “Their incubation period can be quite short—typically, not always—but it can often be shorter than in people,” she said, referring to the time between an exposure to an illness and when symptoms develop. F. tularensis is considered a potential bioterror weapon and appears on the federal list of Select Agents and Toxins.

DC-area veterinarians on heightened alert amid potential inauguration risks Read More »

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More cancer, less death? New alcohol-risk reviews offer conflicting takeaways

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Two big, somewhat conflicting studies on alcohol risks will influence new guidelines.

Heavy drinking is clearly bad for your health. But it’s long been questioned whether moderate drinking is also risky—and, if so, how risky, exactly.

Health researchers have consistently found links between alcohol consumption and several types of cancers (namely mouth, throat, colon, rectal, liver, and breast), as well as liver diseases, injuries, and traffic accidents. But nailing down the health risks from the lower levels of drinking has been tricky. For one, much of the data on moderate drinking is from observational studies in different countries, cultures, and populations. They cannot determine if alcohol is the direct cause of any given association, and they may be swayed by other lifestyle factors. The resulting data can be noisy and inconsistent.

Moreover, many studies rely on people to self-report whether they drink and, if so, how much, which is problematic because people may not accurately assess and/or report how much they actually drink. A related problem is that studies in the past often compared drinkers to people who said they didn’t drink. But, the trouble is, non-drinking groups are often some mix of people who are lifelong abstainers and people who used to drink but quit for some reason—maybe because of health effects. This latter group has the potential to have lingering health effects from their drinking days, which could skew any comparisons looking for health differences.

Then there’s the larger, common problem with any research focused on food or beverages: some have been sponsored or somehow swayed by industry, casting suspicion on the findings, particularly the ones indicating benefits. This has been a clear problem for alcohol research. For instance, in 2018, the National Institutes of Health shut down a $100 million trial aimed at assessing the health effects (and potential benefits) of moderate drinking after it came to light that much of the funding was solicited from the alcohol industry. There was a lot of questionable communication between NIH scientists and alcohol industry representatives.

With all of that in the background, there’s been clamorous debate about how much risk, if any, people are swallowing with their evening cocktail, gameday beer, or wine with dinner.

Currently, the US dietary guidance recommends that if adults drink, they should stick to drinking in moderation, defined as “alcohol intake to two drinks or fewer in a day for men and one drink or fewer in a day for women.” But recently, health experts in the US and abroad have started calling for lower limits, noting that more data has poured in that fortifies links to cancers and other risks. In 2023, for instance, Canada released recommendations that people limit their alcohol consumption to two drinks or fewer per week—that’s down significantly from the previously recommended limit of 10 drinks per week for women and 15 drinks per week for men.

Two reviews

Now, it’s America’s turn to decide if they’ll set the bar lower, too. This year, the US will update its dietary guidelines, which are carried out by the Department of Health and Human Services and the Department of Agriculture every five years. The federal government has requested two big scientific reviews to assess the current knowledge of the health effects of alcohol, which will both inform any potential revisions to the alcohol guidelines. Now, both studies have been released and are open for discussion.

One is from the National Academies of Sciences, Engineering, and Medicine (the National Academies), which was tasked by Congress to review the current evidence on alcohol with a focus on how moderate drinking potentially affects a specific set of health outcomes. The review compared health outcomes in moderate drinkers with those of lifelong abstainers. For the review, the National Academies set up a committee of 14 experts.

The other report is from the Interagency Coordinating Committee on the Prevention of Underage Drinking (ICCPUD), which set up a Technical Review Subcommittee on Alcohol Intake and Health. For its report, the subcommittee looked not just at moderate drinking but health outcomes of a range of alcohol consumption compared to lifelong abstainers.

Based on top-line takeaways and tone, the two reports seem to have very different findings. While the National Academies review found a mix of benefits and harms from moderate drinking (one drink per day for women, and two per day for men), the ICCPUD review suggested that even the smallest amounts of alcohol (one drink per week) increased risk of death and various diseases. However, a closer look at the data shows they have some common ground.

The National Academies review

First, for the National Academies’ review, experts found sufficient evidence to assess the effects of moderate drinking on all-cause mortality, certain cancers, and cardiovascular risks. On the other hand, the reviewers found insufficient evidence to assess moderate drinking’s impact on weight changes, neurocognition, and lactation-related risks.

For all-cause mortality, a meta-analysis of data from eight studies found that moderate drinkers had a 16 percent lower risk of all-cause mortality (death from any cause) compared with lifelong abstainers. A meta-analysis of three studies suggested the risk of all-cause mortality was 23 percent lower for females who drank moderately compared to never-drinking females. Data from four studies indicated that moderate drinking males had a 16 percent lower risk of all-cause mortality than never-drinking males. Additional analyses found that the risk of all-cause mortality was 20 percent lower for moderate drinkers less than age 60 and 18 percent lower for moderate drinkers age 60 and up.

“Based on data from the eight eligible studies from 2019 to 2023, the committee concludes that compared with never consuming alcohol, moderate alcohol consumption is associated with lower all-cause mortality,” the review states. The reviewers rated the conclusion as having “moderate certainty.”

Cancer and cardiovascular disease

For a look at cancer risks, a meta-analysis of four studies on breast cancer found that moderate drinkers had an overall 10 percent higher risk than non-drinkers. An additional analysis of seven studies found that for every 10 to 14 grams of alcohol (0.7 to one standard drink) consumed per day, there was a 5 percent higher risk of breast cancer. The data indicated that people who drank higher amounts of alcohol within the moderate range had higher risks than those who drank lower amounts in the moderate range (for instance, one drink a day versus 0.5 drinks a day).

For context, the average lifetime risk of being diagnosed with breast cancer in non-drinking females is about 11 to 12 percent. A 10 percent relative increase in risk would raise a person’s absolute risk to around 12 to 13 percent. The average lifetime risk of any female dying of breast cancer is 2.5 percent.

Overall, the reviewers concluded that “consuming a moderate amount of alcohol was associated with a higher risk of breast cancer,” and the conclusion was rated as having moderate certainty.

A meta-analysis on colorectal cancer risks found a “statistically nonsignificant higher risk” in moderate drinkers compared to non-drinkers. However, studies looking at alcohol consumption at the highest levels of moderate drinking for males (e.g., two drinks per day) suggested a higher risk compared to males who drank lower amounts of alcohol in the moderate range (one drink per day).

The review concluded that there was insufficient evidence to support a link between moderate drinking and oral cavity, pharyngeal, esophageal, and laryngeal cancers.

Finally, for cardiovascular risks, meta-analyses found moderate drinking was associated with a 22 percent lower risk of heart attacks and an 11 percent lower risk of stroke (driven by lower risk of ischemic stroke, specifically). The reviewers rated these associations as low certainty, though, after noting that there was some concern for risk of bias in the studies.

For cardiovascular disease mortality, meta-analyses of four studies found an 18 percent lower risk of death among moderate drinkers compared with non-drinkers. Broken down, there was a 23 percent lower risk in female drinkers and 18 percent lower risk in male drinkers. The lower risk of cardiovascular disease mortality was rated as moderate certainty.

The ICCPUD review

The ICCPUD subcommittee’s report offered a darker outlook on moderate drinking, concluding that “alcohol use is associated with increased mortality for seven types of cancer (colorectal, female breast, liver, oral cavity, pharynx, larynx, esophagus [squamous cell type]),” and “increased risk for these cancers begins with any alcohol use and increases with higher levels of use.”

The review modeled lifetime risks of cancer and death and relative risks for a long list of problems, including infectious diseases, non-communicable diseases, and injuries. Also, it didn’t just focus on non-drinkers versus moderate drinkers, but it assessed the relative risk of six levels of drinking: one drink a week; two drinks a week; three drinks a week; seven drinks a week (one a day); 14 drinks a week (two a day), and 21 drinks a week (three a day).

Overall, the analysis is very much a rough draft. There are some places where information is missing, and some of the figures are mislabeled and difficult to read. There are two figures labeled Figure 6, for instance and Figure 7 (which may be Figure 8), is a graph that doesn’t have a Y-axis, making it difficult to interpret. The study also doesn’t discuss the level of potential bias of individual studies in its analyses. It also doesn’t make note of statistically insignificant results, nor comment on the certainty of any of its findings.

For instance, the top-line summary states: “In the United States, males and females have a 1 in 1,000 risk of dying from alcohol use if they consume more than 7 drinks per week. This risk increases to 1 in 100 if they consume more than 9 drinks per week.” But a look at the modeling behind these estimates indicates the cutoffs of when drinkers would reach a 0.1 percent or 1 percent risk of dying from alcohol use are broad. For males, a 0.1 percent lifetime risk of an alcohol-attributed death is reached at 6.5 standard drinks, with a 95 percent confidence interval spanning less than one drink per week and 13.5 drinks per week. “This lifetime risk rose to 1 in 100 people above 8.5 drinks per week,” the text reads, but the confidence interval is again between one and 14 drinks per week. So, basically, at anywhere between about one and 14 drinks a week, a male’s lifetime risk of dying from alcohol may be either 0.1 or 1 percent, according to this modeling.

Death risks

Regarding risk of death, the study did not look at all-cause mortality, like the National Academies review. Instead, it focused on deaths from causes specifically linked to alcohol. For both males and females, modeling indicated that the total lifetime risk of any alcohol-attributed death for people who consumed one, two, three, or seven drinks per week was statistically non-significant (the confidence intervals for each calculation spanned zero). Among those who have 14 drinks per week, the total lifetime risk of death was about 4 in 100 from all causes, with unintentional injuries being the biggest contributor for males and liver diseases being the biggest contributor for females. Among those who have 21 drinks per week, the risk of death was about 7 in 100 for males and 8 in 100 for females. Unintentional injuries and liver diseases were again the biggest contributors to the risk.

Some experts have speculated that the lower risk of all-cause mortality found in the National Academies’ analysis (which has been seen in previous studies) may be due to healthy lifestyle patterns among people who drink moderately rather than the protective effects of alcohol. The line of thinking would suggest that healthy lifestyle choices, like regular exercise and a healthy diet, can negate certain risks, including the potential risks of alcohol. However, the ICCPUD emphasizes the reverse argument, noting that poor health choices would likely exacerbate the risks of alcohol. “[A]lcohol would have a greater impact on the health of people who smoke, have poor diets, engage in low physical activity, are obese, have hepatitis infection, or have a family history of specific diseases than it would other individuals.”

Relative risks

In terms of relative risk of the range of conditions, generally, the ICCPUD study found small, if any, increases in risk at the three lowest levels of drinking, with risks rising with higher levels. The study’s finding of breast cancer risk was in line with the National Academies’ review. ICCPUD found that pre-menopausal females who drink moderately (one drink per day) had a 6 percent higher risk of breast cancer than non-drinkers, while post-menopausal moderate drinkers had a 17 percent higher risk. (You can see the complete set of relative risk estimates in Table A6 beginning on page 70 of the report.)

For some cancers, moderate drinking raised the risk substantially. For instance, males who have two drinks per day see their risk of esophageal cancer more than double. But, it’s important to note that the absolute risk for many of these cancers is small to begin with. The average risk of esophageal cancer in men is 0.8 percent, according to the American Cancer Society. With the increased risk from moderate drinking, it would be below 2 percent. Still, alcohol consumption increased the risks of nearly all the cancers examined, with the higher levels of alcohol consumption having the highest risk.

As for cardiovascular risks, ICCPUD’s review found low risk in several of the categories. The risk of ischemic heart disease was lower than that of nondrinkers at all six drinking levels. The risk of ischemic stroke was lower among drinkers who had one, two, three, or seven drinks per week compared to non-drinkers. At 14 and 21 drinks per week, the risk of ischemic stroke rose by 8 percent.

Photo of Beth Mole

Beth is Ars Technica’s Senior Health Reporter. Beth has a Ph.D. in microbiology from the University of North Carolina at Chapel Hill and attended the Science Communication program at the University of California, Santa Cruz. She specializes in covering infectious diseases, public health, and microbes.

More cancer, less death? New alcohol-risk reviews offer conflicting takeaways Read More »

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Wegovy and Ozempic top list of 15 drugs up for next price negotiations

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Blockbuster weight-loss and diabetes drugs Wegovy and Ozempic top the list of 15 drugs selected for the second round of federal price negotiations, which are scheduled to begin this year, with resulting bargained prices going into effect in 2027.

The first round of negotiations, involving 10 high-cost drugs, wrapped up in August, with resulting prices being 38 percent to 79 percent lower than list prices. Those negotiated prices will go into effect in 2026 and are expected to save people with Medicare prescription drug coverage $1.5 billion in out-of-pocket costs.

“Last year we proved that negotiating for lower drug prices works,” Xavier Becerra, secretary of the Department of Health and Human Services (HHS), said in a statement. “Now we plan to build on that record by negotiating for lower prices for 15 additional important drugs for seniors.”

The list of 15 drugs in the next round is below, in the order provided by HHS. According to the health department, about 5.3 million people with Medicare prescription drug coverage used at least one of these drugs between 2023 and 2024. In that time frame, they collectively accounted for about $41 billion in total gross covered prescription drug costs, or about 14 percent.

1 Ozempic; Rybelsus; Wegovy Weight loss, Type 2 diabetes
2 Trelegy Ellipta Asthma and COPD
3 Xtandi Prostate cancer
4 Pomalyst Multiple myeloma and Kaposi sarcoma
5 Ibrance Breast cancer
6 Ofev Idiopathic pulmonary fibrosis
7 Linzess IBS and chronic constipation
8 Calquence Blood cancers
9 Austedo; Austedo XR Huntington’s disease
10 Breo Ellipta Asthma and COPD
11 Tradjenta Type 2 diabetes
12 Xifaxan Diarrhea and irritable bowel syndrome
13 Vraylar Mental health and mood disorders
14 Janumet; Janumet XR Type 2 diabetes
15 Otezla Psoriasis and psoriatic arthritis

Topping the list are three versions of semaglutide drugs sold by Novo Nordisk: Wegovy, used for weight loss and to reduce the risks of cardiovascular disease; Ozempic, used for Type 2 diabetes; and Rybelsus, used for Type 2 diabetes. The drugs are as costly as they are popular. Wegovy has a list price of around $1,350, while Ozempic’s is nearly $1,000.

Wegovy and Ozempic top list of 15 drugs up for next price negotiations Read More »

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Maker of weight-loss drugs to ask Trump to pause price negotiations: Report

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Popular prescriptions

For now, Medicare does not cover drugs prescribed specifically for weight loss, but it will cover GLP-1 class drugs if they’re prescribed for other conditions, such as Type 2 diabetes. Wegovy, for example, is covered if it is prescribed to reduce the risk of heart attack and stroke in adults with either obesity or overweight. But, in November, the Biden administration proposed reinterpreting Medicare prescription-coverage rules to allow for coverage of “anti-obesity medications.”

Such a move is reportedly part of the argument Lilly’s CEO plans to bring to the Trump administration. Rather than using drug price negotiations to reduce health care costs, Ricks aims to play up the potential to reduce long-term health care costs by improving people’s overall health with coverage of GLP-1 drugs now. This argument would presumably be targeted at Mehmet Oz, the TV presenter and heart surgeon Trump has tapped to run the Centers for Medicare and Medicaid Services.

“My argument to Mehmet Oz is that if you want to protect Medicare costs in 10 years, have [the Affordable Care Act] and Medicare plans list these drugs now,” Ricks said to Bloomberg. “We know so much about how much cost savings there will be downstream in heart disease and other conditions.”

An October report from the Congressional Budget Office strongly disputed that claim, however. The CBO estimated that the direct cost of Medicare coverage for anti-obesity drugs between 2026 and 2034 would be nearly $39 billion, while the savings from improved health would total just a little over $3 billion, for a net cost to US taxpayers of about $35.5 billion.

Maker of weight-loss drugs to ask Trump to pause price negotiations: Report Read More »

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Biofilms, unwashed hands: FDA found violations at McDonald’s ex-onion supplier

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Perhaps most concerning, FDA inspectors noted that employees were never seen washing their hands. Instead, they wore gloves, and if they touched dirty surfaces or items, they would simply put hand sanitizer on their dirty gloves and carry on. What they should have been doing was removing their dirty gloves, washing their hands, and getting clean gloves. However, the FDA inspectors never saw this happen, and managers confirmed that hand sanitizing gloves was common practice.

The inspectors also noted that the facility’s equipment was always wet. Employees applied sanitizing solutions on knives and other equipment used to dice and chop fresh produce. The sanitizing solution is meant to be air-dried before use, but Taylor Farms employees immediately used the equipment—still dripping with sanitizing solution—to cut RTE produce.

On one day of the inspection, FDA agents saw employees chop RTE lettuce with equipment that was wet with sanitizing solution at the maximum concentration, which was 200 ppm. In another instance, the inspectors saw an employee mix cleaning chemicals together to make a sanitizing solution, which the employee said was done “routinely.” When inspectors asked about the mixture, Taylor Farms “could not find the source of this recipe,” nor could they find the manufacturer label or other information stating the mixture was designed for use.

“Highest expectations”

In a statement to CBS, Taylor Farms said that it “immediately took steps to address” the problems found in the FDA’s inspection, which resulted in no “administrative or regulatory action” against the company.

“Taylor Farms is confident in our best-in-class food safety processes, and in turn, the quality and safety of our products,” the company said in the statement. “As is common following an inspection, FDA issued observations of conditions that could be improved at one of our facilities.” The company added that “no illnesses or public health threat has been linked to these observations” in the inspection.

McDonald’s, meanwhile, said it had stopped getting onions from the facility.

“We hold our suppliers to the highest expectations and standards of food safety. Prior to this inspection, and unrelated to its findings, McDonald’s stopped sourcing from Taylor Farms’ Colorado Springs facility,” McDonald’s said in a statement.

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