health

covid-shot-now-or-later?-just-getting-it-at-all-is-great,-officials-respond.

COVID shot now or later? Just getting it at all is great, officials respond.

CDC, COVID-19, fda, flu, health, HHS, Infectious disease, respiratory virus, RSV, Science, vaccines / /

Viral defences —

As the summer wave peaks, officials are prepping for the coming winter wave.

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A 13-year-old celebrates getting the Pfizer-BioNTech COVID-19 vaccine in Hartford, Connecticut, on May 13, 2021.

Enlarge / A 13-year-old celebrates getting the Pfizer-BioNTech COVID-19 vaccine in Hartford, Connecticut, on May 13, 2021.

With the impending arrival of the 2024–2025 COVID-19 vaccines approved yesterday, some Americans are now gaming out when to get their dose—right away while the summer wave is peaking, a bit later in the fall to maximize protection for the coming winter wave, or maybe a few weeks before a big family event at the end of the year? Of course, the group pondering such a question is just a small portion of the US.

Only 22.5 percent of adults and 14 percent of children in the country are estimated to have gotten the 2023–2024 vaccine. In contrast, 48.5 percent of adults and 54 percent of children were estimated to have gotten a flu shot. The stark difference is despite the fact that COVID-19 is deadlier than the flu, and the SARS-CoV-2 virus is evolving faster than seasonal influenza viruses.

In a press briefing Friday, federal health officials were quick to redirect focus when reporters raised questions about the timing of COVID-19 vaccination in the coming months and the possibility of updating the vaccines twice a year, instead of just once, to keep up with an evolving virus that has been producing both summer and winter waves.

“The current problem is not that the virus is evolving so much, at least in terms of my estimation,” Peter Marks, the top vaccine regulator at the Food and Drug Administration, told journalists. “It’s that we don’t have the benefits of the vaccine, which is [to say] that it’s not vaccines that prevent disease, it’s vaccination. It’s getting vaccines in arms.” When exactly to get the vaccine is a matter of personal choice, Marks went on, but the most important choice is to get vaccinated.

Estimates for this winter

The press briefing, which featured several federal health officials, was intended to highlight the government’s preparations and hopes for the upcoming respiratory virus season. The FDA, the Centers for Disease Control and Prevention, and the Department of Health and Human Services (HHS) are urging all Americans to get their respiratory virus vaccines—flu, COVID-19, and RSV.

CDC Director Mandy Cohen introduced an updated data site that provides snapshots of local respiratory virus activity, national trends, data visualizations, and the latest guidance in one place. HHS, meanwhile, highlighted a new outreach campaign titled “Risk Less. Do More.” to raise awareness of COVID-19 and encourage vaccination, particularly among high-risk populations. For those not at high risk, health officials still emphasize the importance of vaccination to lower transmission and prevent serious outcomes, including long COVID. “There is no group without risk,” Cohen said, noting that the group with the highest rates of emergency department visits for COVID-19 were children under the age of 5, who are not typically considered high risk.

So far, CDC models are estimating that this year’s winter wave of COVID-19 will be similar, if not slightly weaker on some metrics, than last year’s winter wave, Cohen said. But she emphasized that many assumptions go into the modeling, including how the virus will evolve in the near future and the amount of vaccine uptake. The modeling assumes the current omicron variants stay on their evolutionary path and that US vaccination coverage is about the same as last year. Of course, beating last year’s vaccine coverage could blunt transmission.

COVID shot now or later? Just getting it at all is great, officials respond. Read More »

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FDA green-lights fall COVID-19 boosters

Comirnaty, COVID-19, health, moderna, mRNA, Pfizer, Spikevax, vaccines / /

Shoot me up —

Updated mRNA vaccines from Pfizer and Moderna are ready to roll.

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FDA green-lights fall COVID-19 boosters

Getty Images

As the COVID-19 case count continues to tick upward, the US Food and Drug Administration has approved an updated vaccine for use ahead of the northern hemisphere winter. The emergency use authorization covers updated mRNA vaccines from both Pfizer and Moderna.

The booster shots will target the JN.1 and KP.2 strains of SARS-CoV-2, both of which are omicron variants. Last year’s booster keyed on omicron subvariant XBB.1.5, which has long since lost the evolutionary arms race.

Both Spikevax (Moderna) and Comirnaty (Pfizer) vaccines have been updated. While the vaccine is targeted toward those 12 and over, parents of children aged six months through 11 years are also eligible for the updated vaccines under the FDA’s emergency use authorization.

“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”

Updated vaccines will hit hospitals and pharmacies soon, as Moderna and Pfizer are ready to ship vaccines. Once injected, the boosters will take a couple of weeks to hit peak protection, and they will offer that level of protection for a few months after the shot. Keep that in mind as you think about timing your booster for maximum efficacy.

FDA green-lights fall COVID-19 boosters Read More »

town-urges-curfew-over-mosquito-spread-disease-that-kills-up-to-50%-of-people

Town urges curfew over mosquito-spread disease that kills up to 50% of people

CDC, curfew, deaths, Eastern equine encephalitis, eee, health, Infectious disease, massachusetts, mosquito, Oxford, Science, virus / /

“Critical risk” —

Eastern Equine Encephalitis is very rare in the US, but when it strikes, it’s bad.

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A mosquito collected to test for mosquito-borne diseases.

Enlarge / A mosquito collected to test for mosquito-borne diseases.

A small town in Massachusetts is urging residents to stay indoors in the evenings after the spread of a dangerous mosquito-spread virus reached “critical risk level.”

The virus causes Eastern equine encephalitis (EEE), which kills between 30 and 50 percent of people who are stricken—who are often children under the age of 15 and the elderly. Around half who survive are left permanently disabled, and some die within a few years due to complications. There is no treatment for EEE. So far, one person in the town—an elderly resident of Oxford—has already become seriously ill with neuroinvasive EEE.

EEE virus is spread by mosquitoes in certain swampy areas of the country, particularly in Atlantic and Gulf Coast states and the Great Lakes region. Mosquitoes shuttle the virus between wild birds and animals, including horses and humans. In humans, the virus causes very few cases in the US each year—an average of 11, according to the Centers for Disease Control and Prevention. But given the extreme risk of EEE, health officials take any spread seriously.

On August 16, the Massachusetts Department of Public Health announced the state’s first case and declared a “critical risk level” in the four communities of Douglas, Oxford, Sutton, and Webster. These all cluster in Worcester county near the state’s borders with Rhode Island and Connecticut.

Curfew

While the state health department did not identify the man as a resident of Oxford, the town’s manager confirmed his residence in a memorandum Wednesday. The manager, Jennifer Callahan, reported that the man remains hospitalized. She also reported that a horse across the border in Connecticut had recently died of EEE.

Also on Wednesday, the four towns—Douglas, Oxford, Sutton, and Webster—issued a joint health advisory, which included a recommended curfew.

Last night, The Oxford Board of Health voted to adopt the advisory, according to the Boston Globe. The recommendation is for residents to avoid mosquito’s peak activity time. They should “finish outdoor activities before 6: 00 PM through September 30th, 2024 and before 5: 00 PM October 1st, 2024 until the first hard frost.” The advisory also recommends residents wear insect repellent, wear protective clothing, and mosquito-proof their homes.

Officials emphasized that the curfew is a recommendation, not mandatory. However, to use town properties—such as recreation fields—people will first need to file an indemnification form and provide proof of adequate insurance coverage to the town.

To date, there have been only three cases of EEE in the US this year. One in Massachusetts, one in Vermont, and the last in New Jersey. All three are neuroinvasive. The CDC says that about 30 percent of cases are fatal, while Massachusetts health officials report that about half of people who develop EEE in the state have died.

In 2019, there was a multi-state outbreak of EEE, leading to a high of 38 cases. Twelve of the cases occurred in Massachusetts, and six died.

Town urges curfew over mosquito-spread disease that kills up to 50% of people Read More »

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CEO of failing hospital chain got $250M amid patient deaths, layoffs, bankruptcy

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“Outrageous corporate greed” —

Steward Health Care System, run by CEO Ralph de la Torre, filed for bankruptcy in May.

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Hospital staff and community members held a protest in front of Carney Hospital in Boston on August 5 as Steward has announced it will close the hospital.

Enlarge / Hospital staff and community members held a protest in front of Carney Hospital in Boston on August 5 as Steward has announced it will close the hospital. “Ralph” refers to Steward’s CEO, Ralph de la Torre, who owns a yacht.

As the more than 30 hospitals in the Steward Health Care System scrounged for cash to cover supplies, shuttered pediatric and neonatal units, closed maternity wards, laid off hundreds of health care workers, and put patients in danger, the system paid out at least $250 million to its CEO and his companies, according to a report by The Wall Street Journal.

The newly revealed financial details bring yet more scrutiny to Steward CEO Ralph de la Torre, a Harvard University-trained cardiac surgeon who, in 2020, took over majority ownership of Steward from the private equity firm Cerberus. De la Torre and his companies were reportedly paid at least $250 million since that takeover. In May, Steward, which has hospitals in eight states, filed for Chapter 11 bankruptcy.

Critics—including members of the Senate Committee on Health, Education, Labor, and Pensions (HELP)—allege that de la Torre and stripped the system’s hospitals of assets, siphoned payments from them, and loaded them with debt, all while reaping huge payouts that made him obscenely wealthy.

Alleged greed

For instance, de la Torre sold the land under the system’s hospitals to a large hospital landlord, Medical Properties Trust, leaving Steward hospitals on the hook for large rent payments. Under de la Torre’s leadership, Steward also paid a management consulting firm $30 million a year to “provide executive oversight and overall strategic directive.” But, de la Torre was the majority owner of the consulting firm, which also employed other Steward executives. As the WSJ put it, Steward “effectively paid its CEO’s firm, which employed Steward executives, for executive- management services for Steward.”

In 2021, while the COVID-19 pandemic strained hospitals, Steward distributed $111 million to shareholders. With de la Torre owning 73 percent of the company at the time, his share would have been around $81 million, the WSJ reported. That year, de la Torre bought a 190-foot yacht for $40 million. He also owns a $15 million custom-made luxury fishing boat called Jaruco. The Senate Help Committee, meanwhile, notes that a Steward affiliate owned two jets, one valued at $62 million and a second “backup” jet valued at $33 million.

In 2022, de la Torre got married in an elaborate wedding on Italy’s Amalfi Coast and bought a 500-acre Texas ranch for at least $7.2 million. His new wife, Nicole Acosta, 29, is a competitive equestrian who trains at a facility near the ranch. She competes on a horse that was sold in 2014 for $3.5 million, though it’s unclear how much the couple paid for it. Besides the ranch, de la Torre, 58, owns an 11,108-square-foot mansion in Dallas valued at $7.2 million, the WSJ reported.

While de la Torre was living a lavish lifestyle, Steward hospitals faced dire situations—as they had been for years. An investigation by the Senate HELP committee noted that Steward had shut down several hospitals in Massachusetts, Ohio, Arizona, and Texas between 2014 and this year, laying off thousands of health care workers and leaving communities in the lurch. It closed several pediatric wards in Massachusetts and Texas; in Florida, it closed neonatal units and eliminated maternity services. In Louisiana, Steward patients faced “immediate jeopardy.”

“Third-world medicine”

In a July hearing, Sen. Bill Cassidy (R-LA), ranking member of the HELP Committee, spoke of the conditions at Glenwood Regional Medical Center in West Monroe, Louisiana, which Steward allegedly mismanaged. “According to a report from the Centers for Medicare and Medicaid Services, a physician at Glenwood told a Louisiana state inspector that the hospital was performing ‘third-world medicine,'” Cassidy said.

Further, “one patient died while waiting for a transfer to another hospital because Glenwood did not have the resources to treat them,” the Senator said.  “Unfortunately, Glenwood is not unique,” he went on. “At a Steward-owned Massachusetts hospital, a woman died after giving birth when doctors realized mid-surgery that the supplies needed to treat her were previously repossessed due to Steward’s financial troubles.” The hospital reportedly owed the supplier $2.5 million in unpaid bills.

Additionally, the WSJ investigation dug up records that showed that a pest control company discovered 3,000 bats living in one of Steward’s Florida hospitals. In Arizona, a Phoenix-area hospital was without air conditioning during scorching temperatures, and its kitchen was closed for health-code violations. The state ordered it to shut down last week.

“Dr. de la Torre and his executive teams’ poor financial decisions and gross mismanagement of its hospitals is shocking,” Cassidy said. “Patients’ lives are at risk. The American people deserve answers.”

Outrage

Senate HELP Committee chair Bernie Sanders (I-VT) went further, saying that the US health care system “is designed not to make patients well, but to make health care executives and stockholders extraordinarily wealthy. … Perhaps more than anyone else in America, Ralph de la Torre, the CEO of Steward Health Care, epitomizes the type of outrageous corporate greed that is permeating throughout our for-profit health care system.”

Sanders lamented how de la Torre’s payouts could have instead benefited patients and communities, asking: “How many of Steward’s hospitals could have been prevented from closing down, how many lives could have been saved, how many health care workers would still have their jobs if Dr. de la Torre spent $150 million on high-quality health care instead of a yacht, two private jets and a luxury fishing boat?”

On July 25, the committee voted 16–4 to subpoena de la Torre so they could ask him such questions in person. To date, de la Torre has refused to voluntarily appear before the committee and declined to comment on the WSJ report. The committee’s vote marks the first time since 1981 that it has issued a subpoena.

Separately, Steward and de la Torre are under investigation by the Department of Justice over allegations of fraud and corruption in a deal to run hospitals in Malta.

CEO of failing hospital chain got $250M amid patient deaths, layoffs, bankruptcy Read More »

how-accurate-are-wearable-fitness-trackers?-less-than-you-might think

How accurate are wearable fitness trackers? Less than you might think

health, health tracker, health tracking, Science, syndication, Tech / /

some misleading metrics —

Wide variance underscores need for a standardized approach to validation of devices.

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How accurate are wearable fitness trackers? Less than you might think

Corey Gaskin

Back in 2010, Gary Wolf, then the editor of Wired magazine, delivered a TED talk in Cannes called “the quantified self.” It was about what he termed a “new fad” among tech enthusiasts. These early adopters were using gadgets to monitor everything from their physiological data to their mood and even the number of nappies their children used.

Wolf acknowledged that these people were outliers—tech geeks fascinated by data—but their behavior has since permeated mainstream culture.

From the smartwatches that track our steps and heart rate, to the fitness bands that log sleep patterns and calories burned, these gadgets are now ubiquitous. Their popularity is emblematic of a modern obsession with quantification—the idea that if something isn’t logged, it doesn’t count.

At least half the people in any given room are likely wearing a device, such as a fitness tracker, that quantifies some aspect of their lives. Wearables are being adopted at a pace reminiscent of the mobile phone boom of the late 2000s.

However, the quantified self movement still grapples with an important question: Can wearable devices truly measure what they claim to?

Along with my colleagues Maximus Baldwin, Alison Keogh, Brian Caulfield, and Rob Argent, I recently published an umbrella review (a systematic review of systematic reviews) examining the scientific literature on whether consumer wearable devices can accurately measure metrics like heart rate, aerobic capacity, energy expenditure, sleep, and step count.

At a surface level, our results were quite positive. Accepting some error, wearable devices can measure heart rate with an error rate of plus or minus 3 percent, depending on factors like skin tone, exercise intensity, and activity type. They can also accurately measure heart rate variability and show good sensitivity and specificity for detecting arrhythmia, a problem with the rate of a person’s heartbeat.

Additionally, they can accurately estimate what’s known as cardiorespiratory fitness, which is how the circulatory and respiratory systems supply oxygen to the muscles during physical activity. This can be quantified by something called VO2Max, which is a measure of how much oxygen your body uses while exercising.

The ability of wearables to accurately measure this is better when those predictions are generated during exercise (rather than at rest). In the realm of physical activity, wearables generally underestimate step counts by about 9 percent.

Challenging endeavour

However, discrepancies were larger for energy expenditure (the number of calories you burn when exercising) with error margins ranging from minus-21.27 percent to 14.76 percent, depending on the device used and the activity undertaken.

Results weren’t much better for sleep. Wearables tend to overestimate total sleep time and sleep efficiency, typically by more than 10 percent. They also tend to underestimate sleep onset latency (a lag in getting to sleep) and wakefulness after sleep onset. Errors ranged from 12 percent to 180 percent, compared to the gold standard measurements used in sleep studies, known as polysomnography.

The upshot is that, despite the promising capabilities of wearables, we found conducting and synthesizing research in this field to be very challenging. One hurdle we encountered was the inconsistent methodologies employed by different research groups when validating a given device.

This lack of standardization leads to conflicting results and makes it difficult to draw definitive conclusions about a device’s accuracy. A classic example from our research: one study might assess heart rate accuracy during high-intensity interval training, while another focuses on sedentary activities, leading to discrepancies that can’t be easily reconciled.

Other issues include varying sample sizes, participant demographics, and experimental conditions—all of which add layers of complexity to the interpretation of our findings.

What does it mean for me?

Perhaps most importantly, the rapid pace at which new wearable devices are released exacerbates these issues. With most companies following a yearly release cycle, we and other researchers find it challenging to keep up. The timeline for planning a study, obtaining ethical approval, recruiting and testing participants, analyzing results, and publishing can often exceed 12 months.

By the time a study is published, the device under investigation is likely to already be obsolete, replaced by a newer model with potentially different specifications and performance characteristics. This is demonstrated by our finding that less than 5 percent of the consumer wearables that have been released to date have been validated for the range of physiological signals they purport to measure.

What do our results mean for you? As wearable technologies continue to permeate various facets of health and lifestyle, it is important to approach manufacturers’ claims with a healthy dose of skepticism. Gaps in research, inconsistent methodologies, and the rapid pace of new device releases underscore the need for a more formalized and standardized approach to the validation of devices.

The goal here would be to foster collaborative synergies between formal certification bodies, academic research consortia, popular media influencers, and the industry so that we can augment the depth and reach of wearable technology evaluation.

Efforts are already underway to establish a collaborative network that can foster a richer, multifaceted dialogue that resonates with a broad spectrum of stakeholders—ensuring that wearables are not just innovative gadgets but reliable tools for health and wellness.The Conversation

Cailbhe Doherty, assistant professor in the School of Public Health, Physiotherapy and Sports Science, University College Dublin. This article is republished from The Conversation under a Creative Commons license. Read the original article.

How accurate are wearable fitness trackers? Less than you might think Read More »

explosion-of-cicada-eating-mites-has-the-state-of-illinois-scratching

Explosion of cicada-eating mites has the state of Illinois scratching

CDC, cicadas, health, itch mites, mites, outbreak, rash, Science / /

Attack of the mites —

The good news: There’s little risk beyond the rash. The bad: The rash is awful.

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A cicada from a 17-year cicada brood clings to a tree on May 29, 2024, in Park Ridge, Illinois. The state experienced an emergence of cicadas from Brood XIII and Brood XIX simultaneously. This rare occurrence hasn't taken place since 1803.

Enlarge / A cicada from a 17-year cicada brood clings to a tree on May 29, 2024, in Park Ridge, Illinois. The state experienced an emergence of cicadas from Brood XIII and Brood XIX simultaneously. This rare occurrence hasn’t taken place since 1803.

A plague of parasitic mites has descended upon Illinois in the wake of this year’s historic crop of cicadas, leaving residents with raging rashes and incessant itching.

The mighty attack follows the overlapping emergence of the 17-year Brood XIII and the 13-year Brood XIX this past spring, a specific co-emergence that only occurs every 221 years. The cacophonous boom in cicadas sparked an explosion of mites, which can feast on various insects, including the developing eggs of periodical cicadas. But, when the mites’ food source fizzles out, the mites bite any humans in their midst in hopes of finding their next meal. While the mites cannot live on humans, their biting leads to scratching. The mite, Pyemotes herfsi, is aptly dubbed the “itch mite.”

“You can’t see them, you can’t feel them, they’re always here,” Jennifer Rydzewski, an ecologist for the Forest Preserve District of DuPage County, told Chicago outlet The Daily Herald. “But because of the cicadas, they have a food source [and] their population has exploded.”

The mites are around 0.2 millimeters in length and very difficult to see with the naked eye, according to agriculture experts at Pennsylvania State University. They have four pairs of legs and are tan with a reddish tinge. Female itch mites can produce up to 250 offspring, which emerge from her abdomen as adults. Emerged adult offspring quickly mate, with the males then dying off and the newly fertilized females dispersing to find their own food source.

Itchy outbreak

Besides “itch mites” these parasites have also been called the “oak leaf itch mite” or “oak leaf gall mite,” because they have often been found feasting on the larvae of oak gall midges. These midges are a type of fly that lays eggs on oak trees. The resulting larvae feast on the tree, spurring the formation of unusual growths (galls) around the larvae.

The first known outbreak of itch mites in the US occurred in Kansas in August 2004. The Kansas Department of Health and Environment had called in the Centers for Disease Control and Prevention to help investigate a puzzling outbreak of rashes in Crawford County. At the start, 300 residents in the small city of Pittsburg reported extremely itchy rashes, primarily on the limbs, neck, and face. The rashes looked similar to those from insect bites, but few of the affected people recalled being bitten by anything.

With the help of entomologists, outbreak investigators pinned the rashes to the itch mites. The area had experienced a mild winter and cooler summer temps, leading to an explosion of oak gall midges and subsequent infestation of oak galls. A detailed investigation determined that county residents were nearly four times more likely to have an itchy rash if they had a pin oak tree on their property. Once the itch mites invade a gall-infected oak tree, more than 16,000 mites can emerge from the galls on a single leaf. The mites can then drop from trees and are even small enough to be carried by the wind, giving them ample opportunity to find their way onto humans.

By the end of the outbreak, investigators estimated that 54 percent of the roughly 38,000 residents in Crawford County—that is, around 20,500 people—had been bitten by the mites.

Profuse parasites

But oak gall midges are far from the only insect the itch mites feed upon. In 2007, the emergence of a particularly prolific brood of cicadas led to an outbreak of itch mites in the Chicago area. The Illinois Department of Public Health noted that the “proposed common name ‘oak leaf itch mite’ for P. herfsi is misleading and contributed to the delay in identifying the causative agent of the 2007 Illinois outbreak.” The department noted that at least five insect orders and nine insect families are prey to the mites.

In the US, cases of itch mite rashes have been documented in at least Illinois, Nebraska, Ohio, Oklahoma, Pennsylvania, Missouri, Tennessee, and Texas.

If bitten, humans develop an itchy red rash, typically with pimple-like bumps, which can stick around for up to two weeks. The rash develops between 10 to 16 hours after exposure, which can make it difficult to identify the source. But, the mites typically don’t produce groupings of bite marks like bedbugs or burrowing like scabies.

To try to avoid rashes, experts recommend wearing protective clothing when outside—including gloves while gardening or doing yard work—and washing clothes and showering after a potential exposure. The insect repellent DEET is often recommended, but anecdotal reports indicate DEET may not be entirely effective. If you already have a rash, the only thing to do is treat the symptoms with things like ice packs, soothing lotions (like calamine), oral antihistamines, over-the-counter hydrocortisone creams, and, if needed, prescription topical steroids. The good news is that the mites will not live on you and are not known to spread any diseases.

Explosion of cicada-eating mites has the state of Illinois scratching Read More »

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Big-name drugs see price drops in first round of Medicare negotiations

Big pharma, drug prices, health, medicare, Pharmaceutical industry, PhRMA, price negotiations, Science / /

price cut —

If the prices were set in 2023, Medicare would have saved $6 billion.

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Prescription drugs are displayed at NYC Discount Pharmacy in Manhattan on July 23, 2024.

Enlarge / Prescription drugs are displayed at NYC Discount Pharmacy in Manhattan on July 23, 2024.

In the first round of direct price negotiations between Medicare and drug manufacturers, prices for 10 expensive and commonly used drugs saw price cuts between 38 percent to 79 percent compared to their 2023 list prices, the White House and the US Department of Health and Human Services (HHS) announced Thursday. The new negotiated prices will take effect on January 1, 2026.

The 10 drugs that were up for negotiations are used to treat various conditions, from diabetes, psoriasis, blood clots, heart failure, and chronic kidney disease to blood cancers. About 9 million people with Medicare use at least one of the drugs on the list. In 2023, the 10 drugs accounted for $56.2 billion in total Medicare spending, or about 20 percent of total gross spending by Medicare Part D prescription drug coverage. But in 2018, spending on the 10 drugs was just about $20 billion, rising to 46 billion in 2022—a 134 percent rise. In 2022, Medicare enrollees collectively paid $3.4 billion in out-of-pocket costs for these drugs.

The 10 drugs as well as their use, 2023 costs, negotiated prices, and savings.

Enlarge / The 10 drugs as well as their use, 2023 costs, negotiated prices, and savings.

For now, it’s unclear how much the newly set prices will actually save those who have Medicare enrollees in 2026. Overall costs and out-of-pocket costs will depend on each member’s coverage plans and other drug spending. Additionally, in 2025, Medicare Part D enrollees will have their out-of-pocket drug costs capped at $2,000, which alone could significantly lower costs for some beneficiaries before the negotiated prices take effect.

If the newly negotiated prices took effect in 2023, HHS estimates it would have saved Medicare $6 billion. HHS also estimates that the prices will save Medicare enrollees $1.5 billion in out-of-pocket costs in 2026.

The price negotiations have been ongoing since last August when HHS announced the first 10 drugs up for negotiation. Medicare said it held three meetings with each of the drug manufacturers since then. For five drugs, the process of offers and counteroffers resulted in an agreed-upon price, with Medicare accepting revised counteroffers from drugmakers for four of the drugs. For the other five drugs, Medicare made final written offers on prices that were eventually accepted. If a drugmaker had rejected the offer, it would have either had to pay large fees or pull its drug from Medicare plans.

“The negotiations were comprehensive. They were intense. It took both sides to reach a good deal,” HHS Secretary Xavier Becerra told reporters Wednesday night.

“Price-setting scheme”

Both the price negotiations and the $2,000 cap are provisions in the Inflation Reduction Act (IRA), signed into law by President Biden in 2022. In a statement Thursday, Biden highlighted that Vice President Kamala Harris cast the tie-breaking vote to pass the legislation along party lines and that they are both committed to fighting Big Pharma. “[T]he Vice President and I are not backing down,” Biden said. “We will continue the fight to make sure all Americans can pay less for prescription drugs and to give more breathing room for American families.”

“Today’s announcement will be lifechanging for so many of our loved ones across the nation,” Harris said in her own statement, “and we are not stopping here.” She noted that the list of drugs up for Medicare negotiation will increase in each year, with an additional 15 drugs added in 2025.

In a scathing response to the negotiated prices, Steve Ubl—president of the industry group Pharmaceutical Research and Manufacturers of America (PhRMA)—called the negotiations a “price-setting scheme” and warned that patients would be disappointed. “There are no assurances patients will see lower out-of-pocket costs because the [IRA] did nothing to rein in abuses by insurance companies and PBMs who ultimately decide what medicines are covered and what patients pay at the pharmacy,” Ubl said. He went on to warn that IRA “fundamentally alters” the incentives for drug development and, as such, fewer drugs will be developed to treat cancer and many other conditions.

In a December 2023 report, the Congressional Budget Office estimated that “over the next 30 years, 13 fewer new drugs (of 1,300 estimated new drugs) will come to market as a result of the law.”

The pharmaceutical industry has unleashed a bevy of legal challenges to the negotiations, claiming they are unconstitutional. So far, it has lost every ruling.

Big-name drugs see price drops in first round of Medicare negotiations Read More »

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Mpox outbreak is an international health emergency, WHO declares

africa, CDC, health, Infectious disease, mpox, outbreak, Science, WHO / /

PHEIC —

The declaration is “the highest level of alarm under international health law.”

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A negative stain electron micrograph of a mpox virus virion in human vesicular fluid.

Enlarge / A negative stain electron micrograph of a mpox virus virion in human vesicular fluid.

The World Health Organization on Wednesday declared an international health emergency over a large and rapidly expanding outbreak of mpox that is spilling out of the Democratic Republic of the Congo.

It is the second time in about two years that mpox’s spread has spurred the WHO to declare a public health emergency of international concern (PHEIC), the highest level of alarm for the United Nations health agency. In July 2022, the WHO declared a PHEIC after mpox cases had spread across the globe, with the epicenter of the outbreak in Europe, primarily in men who have sex with men. The outbreak was caused by clade II mpox viruses, which, between the two mpox clades that exist, is the relatively mild one, causing far fewer deaths. As awareness, precautions, and vaccination increased, the outbreak subsided and was declared over in May 2023.

Unlike the 2022–2023 outbreak, the current mpox outbreak is driven by the clade II virus, the more dangerous version that causes more severe disease and more deaths. Also, while the clade I virus in the previous outbreak unexpectedly spread via sexual contact in adults, this clade II outbreak is spreading in more classic contact patterns, mostly through skin contact of household members and health care workers. A large proportion of those infected have been children.

To date, Democratic Republic of the Congo (DRC), where the virus is endemic, has reported more than 22,000 suspect mpox cases and more than 1,200 deaths since the start of January 2023. In recent months, the outbreak has spilled out into multiple neighboring countries, including Burundi, Central African Republic, Republic of the Congo, Rwanda, Kenya, and Uganda.

Earlier on Wednesday, the WHO convened an emergency committee to review the situation, in which experts from affected countries presented data to independent international experts. The committee concluded that the outbreak constituted a PHEIC, and WHO Director-General Dr. Tedros Adhanom Ghebreyesus followed their recommendation.

“The emergence of a new clade of mpox, its rapid spread in eastern DRC, and the reporting of cases in several neighboring countries are very worrying,” Tedros said in a statement announcing the PHEIC. “On top of outbreaks of other mpox clades in DRC and other countries in Africa, it’s clear that a coordinated international response is needed to stop these outbreaks and save lives.”

On Tuesday, the Africa Centers for Disease Control and Prevention declared a similar emergency. Africa CDC Director General Dr. Jean Kaseya said the declaration will “mobilize our institutions, our collective will, and our resources to act—swiftly and decisively. This empowers us to forge new partnerships, strengthen our health systems, educate our communities, and deliver life-saving interventions where they are needed most.”

For now, the US Centers for Disease Control and Prevention assess the risk to the US public to be “very low,” given that there is limited and no direct travel between the US and the epicenter of the outbreak. So far, no clade I cases have been detected outside of central and eastern Africa.

Mpox outbreak is an international health emergency, WHO declares Read More »

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31% of Republicans say vaccines are more dangerous than diseases they prevent

CDC, Democrat, health, pandemic, partisan, Republican, Science, vaccines / /

Vaccines save lives —

The partisan divide on vaccine falsehoods threatens the health of children nationwide.

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Polio victim Larry Montoya is at the airport for the arrival of cases of vaccine, which were distributed as part of the KO Polio campaign, September 5, 1962.

Enlarge / Polio victim Larry Montoya is at the airport for the arrival of cases of vaccine, which were distributed as part of the KO Polio campaign, September 5, 1962.

Public sentiment on the importance of safe, lifesaving childhood vaccines has significantly declined in the US since the pandemic—which appears to be solely due to a nosedive in support from people who are Republican or those who lean Republican, according to new polling data from Gallup.

In 2019, 52 percent of Republican-aligned Americans said it was “extremely important” for parents to get their children vaccinated. Now, that figure is 26 percent, falling by half in just five years. In comparison, 63 percent of Democrats and Democratic leaners said it was “extremely important” this year, down slightly from 67 percent in 2019.

Overall, only 40 percent of Americans now say it is extremely important for parents to vaccinate their children, down from 58 percent in 2019 and 64 percent in 2001.

More broadly, 93 percent of the Democratic group said it was “extremely” or “very” important for parents to vaccinate their children this year, while only 52 percent of the Republican group said the same.

On the other end of the spectrum, 11 percent of the Republican group said vaccinating children was “not important at all,” and an additional 8 percent said it was “not very important.” For the Democratic group, only 1 percent was reported in each of those categories.

Dangerous disinformation

Perhaps most concerning, the data indicated that a growing number of Americans view vaccines as more dangerous than the diseases they prevent—including polio, measles, tetanus, rotavirus, diphtheria, whooping cough, meningitis, and RSV, among others. Now, 20 percent of Americans overall think vaccines are more of a threat than the dangerous diseases they effectively prevent.

The partisan divide is most stark on this sentiment. In 2019, the two parties were about the same. Twelve percent of the Republican group and 10 percent of the Democratic group held this erroneous belief. But now, a whopping 31 percent of the Republican group say vaccines are a more significant threat than dangerous diseases, while the percentage among the Democratic group fell to 5 percent.

Republicans and Republican leaners are much more likely than Democrats and Democratic leaners to believe the false and debunked claim that vaccines are linked to autism—19 percent of the Republican group believe this falsehood compared to 4 percent of the Democratic group.

The polling data aligns with national vaccination trends tracked by the Centers for Disease Control and Prevention. During the pandemic, rates of routine vaccination among kindergartners slipped from the protective target of 95 percent—which prevents infectious diseases from spreading widely—to 93 percent. Additionally, nonmedical exemptions from vaccinations have reached an all-time high of 3 percent nationally. At least 10 states have exemption rates at or above 5 percent, preventing them from reaching the protective target of 95 percent vaccination coverage.

31% of Republicans say vaccines are more dangerous than diseases they prevent Read More »

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Troubling bird flu study suggests human cases are going undetected

bird flu, CDC, dairy, H5N1, health, human infections, Infectious disease, outbreak, poultry, Science, vaccine / /

Poor surveillance —

A small sample of farm workers is enough to confirm fears about H5N1 outbreak.

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Troubling bird flu study suggests human cases are going undetected

Tony C. French/Getty

A small study in Texas suggests that human bird flu cases are being missed on dairy farms where the H5N1 virus has taken off in cows, sparking an unprecedented nationwide outbreak.

The finding adds some data to what many experts have suspected amid the outbreak. But the authors of the study, led by researchers at the University of Texas Medical Branch in Galveston, went further, stating bluntly why the US is failing to fully surveil, let alone contain, a virus with pandemic potential.

“Due to fears that research might damage dairy businesses, studies like this one have been few,” the authors write in the topline summary of their study, which was posted online as a pre-print and had not been peer-reviewed.

The study authors, led by Gregory Gray, were invited to two undisclosed dairy farms in Texas that experienced H5N1 outbreaks in their herds starting in early and late March, respectively. The researchers had a previously approved research protocol to study novel respiratory viruses on dairy farms, easing the ability to quickly begin the work.

Rare study

“Farm A” had 7,200 cows and 180 workers. Illnesses began on March 6, and nearly 5 percent of the herd was estimated to be affected during the outbreak. “Farm B” had 8,200 cows and 45 workers. After illnesses began on March 20, an estimated 14 percent of the herd was affected.

The researchers first visited Farm A on April 3 and Farm B on April 4, collecting swabs and samples at each. Based on the previously approved protocol, they were limited to taking nasal swabs and blood samples from no more than 10 workers per farm. On Farm A, 10 workers provided nasal swabs and blood samples. On Farm B, only seven agreed to give nasal swabs, and four gave blood samples.

While swabs from cows, milk, a dead bird, and a sample of fecal slurry showed signs of H5N1, all of the nasal swabs from the 14 humans were negative. However, when researchers looked for H5N1-targeting antibodies in their blood—an indicator that they were previously infected—two of the 14, about 14 percent, were positive.

Both of the workers with previous infections, a man and a woman, were from Farm A. And both reported having flu-like symptoms. The man worked inside cattle corrals, close to the animals, and he reported having a cough at the time the samples were taken. The woman, meanwhile, worked in the cafeteria on the farm and reported recently recovering from an illness that included fever, cough, and sore throat. She noted that other people on the farm had similar respiratory illnesses around when she did.

The finding suggests human cases of H5N1 are going undetected. Moreover, managing to find evidence of two undetected infections in a sample of just 14 workers suggests it may not be hard to find more. The Centers for Disease Control and Prevention estimates that around 200,000 people work with livestock in the US.

A “compelling case”

To date, the virus has infected at least 175 dairy farms in 13 states. The official tally of human cases in the dairy outbreak is 14: four in dairy farm workers and 10 in workers on poultry farms with infections linked to the dairy outbreak.

“I am very confident there are more people being infected than we know about,” Gray told KFF, which first reported on the study. “Largely, that’s because our surveillance has been so poor.”

Known infections in humans have all been mild so far. But experts are anxious that with each new infection, the wily H5N1 virus is getting new opportunities to adapt further to humans. If the virus evolves to cause more severe disease and spread from human to human, it could spark another pandemic.

Federal officials are also worried about this potential threat. In a press briefing Tuesday, Nirav Shah, the CDC’s principal deputy director, announced a $5 million effort to vaccinate farm workers—but against seasonal flu.

Shah explained that the CDC is concerned that if farm workers are infected with H5N1 and the seasonal flu at the same time, the viruses could exchange genetic segments—a process called reassortment. This could give rise to the pandemic threat experts are worried about. By vaccinating the workers against the seasonal flu, it could potentially prevent the viruses from comingling in one person, Shah suggested.

The US does have a bird flu-specific vaccine available. But in the briefing, Shah said that the use of that vaccine in farm workers is not planned for now, though there’s still active discussion on the possibility. The lack of severe disease and no documented human-to-human transmission from H5N1 infections both argue against deploying a new vaccine, Shah said. “There has to be a strong and compelling case,” he added. Shah also suggested that the agency expects vaccine uptake to be low among farm workers.

Troubling bird flu study suggests human cases are going undetected Read More »

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7 million pounds of meat recalled amid deadly outbreak

CDC, deaths, health, Infectious disease, listeria, Listeria monocytogenes, Meat, outbreak, recall, Science, USDA / /

7 million pounds across 71 products —

Authorities worry that the contaminated meats are still sitting in people’s fridges.

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Shelves sit empty where Boar's Head meats are usually displayed at a Safeway store on July 31, 2024, in San Anselmo, California.

Enlarge / Shelves sit empty where Boar’s Head meats are usually displayed at a Safeway store on July 31, 2024, in San Anselmo, California.

Over 7 million pounds of Boar’s Head brand deli meats are being recalled amid a bacterial outbreak that has killed two people. The outbreak, which began in late May, has sickened a total of 34 people across 13 states, leading to 33 hospitalizations, according to the US Department of Agriculture.

On June 26, Boar’s Head recalled 207,528 pounds of products, including liverwurst, beef bologna, ham, salami, and “heat and eat” bacon. On Tuesday, the Jarratt, Virginia-based company expanded the recall to include about 7 million additional pounds of meat, including 71 different products sold on the Boar’s Head and Old Country brand labels. The products were sold nationwide.

The meats may be contaminated with Listeria monocytogenes, a foodborne pathogen that is particularly dangerous to pregnant people, people over the age of 65, and people with compromised immune systems. Infections during pregnancy can cause miscarriage, stillbirth, premature delivery, or a life-threatening infection in newborns. For others who develop invasive illness, the fatality rate is nearly 16 percent. Symptoms of listeriosis can include fever, muscle aches, headache, stiff neck, confusion, loss of balance, and convulsions that are sometimes preceded by diarrhea or other gastrointestinal symptoms.

The problem was discovered when the Maryland Department of Health—working with the Baltimore City Health Department—collected an unopened liverwurst product from a retail store and found that it was positive for L. monocytogenes. In later testing, the strain in the liverwurst was linked to those isolated from people sickened in the outbreak.

According to the Centers for Disease Control and Prevention, six of the 34 known cases were identified in Maryland, and 12 were identified in New York. The other 11 states have only reported one or two cases each. However, the CDC expects the true number of infections to be much higher, given that many people recover without medical care and, even if people did seek care, health care providers do not routinely test for L. monocytogenes in people with mild gastrointestinal illnesses.

In the outbreak so far, there has been one case in a pregnant person, who recovered and remained pregnant. The two deaths occurred in New Jersey and Illinois.

In a statement on the company’s website, Boar’s Head said that it learned from the USDA on Monday night that L. monocytogenes strain in the liverwurst linked to the multistate outbreak. “Out of an abundance of caution, we decided to immediately and voluntarily expand our recall to include all items produced at the Jarratt facility. We have also decided to pause ready-to-eat operations at this facility until further notice. As a company that prioritizes safety and quality, we believe it is the right thing to do.”

The USDA said it is “concerned that some product may be in consumers’ refrigerators and in retail deli cases.” The USDA, the company, and CDC warn people not to eat the recalled products. Instead, they should either be thrown away or returned to the store where they were purchased for a full refund. And if you’ve purchased one of the recalled products, the USDA also advises you to thoroughly clean your fridge to prevent cross-contamination.

7 million pounds of meat recalled amid deadly outbreak Read More »

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People are overdosing on off-brand weight-loss drugs, FDA warns

diabetes, fda, GLP-1, health, Science, semaglutide, weight loss / /

Dosage disarray —

Bad math and unclear directions are behind overdoses of up to 20 times the normal amount.

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

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

The US Food and Drug Administration has approved two injectable versions of the blockbuster weight-loss and diabetes drug, semaglutide (Wegovy and Ozempic). Both come in pre-filled pens with pre-set doses, clear instructions, and information about overdoses. But, given the drugs’ daunting prices and supply shortages, many patients are turning to imitations—and those don’t always come with the same safety guardrails.

In an alert Friday, the FDA warned that people are overdosing on off-brand injections of semaglutide, which are dispensed from compounding pharmacies in a variety of concentrations, labeled with various units of measurement, administered with improperly sized syringes, and prescribed with bad dosage math. The errors are leading some patients to take up to 20 times the amount of intended semaglutide, the FDA reports.

Though the agency doesn’t offer a tally of overdose cases that have been reported, it suggests it has received multiple reports of people sickened by dosing errors, with some requiring hospitalizations. Semaglutide overdoses cause nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis, and gallstones, the agency reports.

Bad math

In typical situations, compounding pharmacies provide personalized formulations of FDA-approved drugs, for instance, if a patient is allergic to a specific ingredient, requires a special dosage, or needs a liquid version of a drug instead of a pill form. But, when commercially available drugs are in short supply—as semaglutide drugs currently are—then compound pharmacies can legally step in to make their own versions if certain conditions are met. However, these imitations are not FDA-approved and, as such, don’t come with the same safety, quality, and effectiveness assurances as approved drugs.

In the warning Friday, the FDA said that some patients received confusing instructions from compounding pharmacies, which indicated they inject themselves with a certain number of “units” of semaglutide—the volume of which may vary depending on the concentration—rather than milligrams or milliliters. In other instances, patients received U-100 (1-milliliter) syringes to administer 0.05-milliliter doses of the drug, or five units. The relatively large syringe size compared with the dose led some patients to administer 50 units instead of five.

The figure demonstrates how syringe size could lead some to an incorrect dosage.

Enlarge / The figure demonstrates how syringe size could lead some to an incorrect dosage.

FDA-approved semaglutide drugs, meanwhile, are dosed in milligrams and come in standardized concentrations. The agency received several reports of health care providers incorrectly converting from milligrams to units or milliliters, leading them to calculate the wrong dosages. With these math errors, some patients administered five to 10 times more semaglutide than intended.

“FDA recognizes the substantial consumer interest in using compounded semaglutide products for weight loss,” the agency wrote. “However, compounded drugs pose a higher risk to patients than FDA-approved drugs.” The agency urged patients and prescribers to only use compounded versions when absolutely necessary.

People are overdosing on off-brand weight-loss drugs, FDA warns Read More »