health

us-vaccinations-fall-again-as-more-parents-refuse-lifesaving-shots-for-kids

US vaccinations fall again as more parents refuse lifesaving shots for kids

CDC, health, kindergartners, measles, MMR, polio, Science, vaccination rate, vaccine hesitancy, whooping cough / /

Measles, whopping cough, polio, tetanus—devastating and sometimes deadly diseases await comebacks in the US as more and more parents are declining routine childhood vaccines that have proved safe and effective.

The vaccination rates among kindergartners have fallen once again, dipping into the range of 92 percent in the 2023–2024 school year, down from about 93 percent the previous school year and 95 percent in 2019–2020. That’s according to an analysis of the latest vaccination data published today by the Centers for Disease Control and Prevention.

The analysis also found that vaccination exemptions rose to an all-time high of 3.3 percent, up from 3 percent in the previous school year. The rise in exemptions is nearly entirely driven by non-medical exemptions—in other words, religious or philosophical exemptions. Only 0.2 percent of all vaccination exemptions are medically justified.

The new stats mean that more parents are choosing to decline lifesaving vaccines and, for the fourth consecutive year, the US has remained below the 95 percent vaccination target that would keep vaccine-preventable diseases from spreading within communities. In fact, the country continues to slip further away from that target.

Based on data from 49 states plus the District of Columbia (Montana did not report data), 80 percent of jurisdictions saw declines in vaccinations of all four key vaccines assessed: MMR, against measles, mumps, and rubella; DTaP, against diphtheria, tetanus, and pertussis (whooping cough); VAR, against chickenpox; and polio.

Vulnerable kids

Coverage for MMR fell to 92.7 percent in 2023–2024, down from 93.1 percent in the previous school year. That means that about 280,000 (7.3 percent) kindergartners in the US are at risk of measles, mumps, and rubella infections. Likewise, DTaP coverage fell to 92.3 percent, down from 92.7 percent. Polio vaccination fell to 92.6 percent from 93.1 percent, and VAR was down to 92.4 percent from 92.9 percent.

US vaccinations fall again as more parents refuse lifesaving shots for kids Read More »

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There’s another massive meat recall over Listeria—and it’s a doozy

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Another nationwide meat recall is underway over Listeria contamination—and its far more formidable than the last.

As of October 15, meat supplier BrucePac, of Durant, Oklahoma, is recalling 11.8 million pounds of ready-to-eat meat and poultry products after routine federal safety testing found Listeria monocytogenes, a potentially deadly bacterium, in samples of the company’s poultry. The finding triggered an immediate recall, which was first issued on October 9. But, officials are still working to understand the extent of the contamination—and struggling to identify the hundreds of potentially contaminated products.

“Because we sell to other companies who resell, repackage, or use our products as ingredients in other foods, we do not have a list of retail products that contain our recalled items,” BrucePac said in a statement updated October 15.

Depending on the packaging, the products may have establishment numbers 51205 or P-51205 inside or under the USDA mark of inspection. But, for now, consumers’ best chance of determining whether they’ve purchased any of the affected products is to look through a 342-page list of products identified by the US Department of Agriculture so far.

The unorganized document lists fresh and frozen foods sold at common retailers, including 7-Eleven, Aldi, Amazon Fresh, Giant Eagle, Kroger, Target, Trader Joe’s, Walmart, and Wegmans. Affected products carry well-known brand names, such as Atkins, Boston Market, Dole, Fresh Express, Jenny Craig, Michelina’s, Taylor Farms, and stores’ brands, such as Target’s Good & Gather. The recalled products were made between May 31, 2024 and October 8, 2024.

In the latest update, the USDA noted that some of the recalled products were also distributed to schools, but the agency hasn’t identified the schools that received the products. Restaurants and other institutions also received the products.

There’s another massive meat recall over Listeria—and it’s a doozy Read More »

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Drugmakers can keep making off-brand weight-loss drugs as FDA backpedals

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The judge in the case, District Judge Mark Pittman, granted the FDA’s request, canceling an October 15 hearing, and ordering the parties to submit a joint status report on November 21.

Drugmakers respond

The move was celebrated by the Outsourcing Facilities Association (OFA), which filed the lawsuit.

“We believe that this is a fair resolution in light of the agency’s rash decision to take the drug off of the list at a time when the agency has acknowledged ‘supply disruptions,’ which immediately created a major access issue for patients everywhere,” OFA Chairperson Lee Rosebush said in a statement. “Most important, should the FDA repeat its removal decision when a shortage still genuinely exists, we will return to court.”

The move is also likely to please patients who have come to rely on cheaper, more readily available compounded versions of the drugs. For some, compounded products may have been their only access to tirzepatide.  Still, those drugs are not without risk. The FDA has repeatedly emphasized that compounded drugs are not FDA-approved and do not go through the same safety, efficacy, and quality reviews. And the agency has warned of dosing errors and other safety concerns with compounded versions.

The one party that is certainly unhappy with the FDA’s move is Eli Lilly, which had reportedly sent cease-and-desist letters to compounders. In an emailed statement to Ars, a spokesperson for Lilly said that there was sufficient supply of the company’s drug and continued use of compounded versions is unwarranted. “Nothing changes the fact that, as FDA has recognized, Mounjaro and Zepbound are available and the shortage remains ‘resolved,'” the spokesperson said.

Lilly also noted the FDA’s safety concerns about the compounded versions, adding that its own examination of some compounded products found impurities, bacteria, strange coloring, incorrect potency, puzzling chemical structures, and, in one case, a product that was just sugar alcohol.

“All doses of Lilly’s FDA-approved medicines are available and it is important that patients not be exposed to the risks in taking untested, unapproved knockoffs,” the spokesperson said.

In terms of the supply “disruptions” the FDA mentioned and that some patients and pharmacies have reportedly experienced, Lilly said that the supply chain was complex and there are many reasons why a given pharmacy may not have a specific dose at hand, such as limited refrigerated storage space.

Drugmakers can keep making off-brand weight-loss drugs as FDA backpedals Read More »

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Routine dental X-rays are not backed by evidence—experts want it to stop

bitewings, cavities, dentistry, dentists, health, radiation, Science, X-rays / /

The actual recommendations might surprise you—along with the state of modern dentistry.

An expert looking at a dental X-ray and saying “look at that unnecessary X-ray,” probably. Credit: Getty | MilanEXPO

Has your dentist ever told you that it’s recommended to get routine dental X-rays every year? My (former) dentist’s office did this year—in writing, even. And they claimed that the recommendation came from the American Dental Association.

It’s a common refrain from dentists, but it’s false. The American Dental Association does not recommend annual routine X-rays. And this is not new; it’s been that way for well over a decade.

The association’s guidelines from 2012 recommended that adults who don’t have an increased risk of dental caries (myself included) need only bitewing X-rays of the back teeth every two to three years. Even people with a higher risk of caries can go as long as 18 months between bitewings. The guidelines also note that X-rays should not be preemptively used to look for problems: “Radiographic screening for the purpose of detecting disease before clinical examination should not be performed,” the guidelines read. In other words, dentists are supposed to examine your teeth before they take any X-rays.

But, of course, the 2012 guidelines are outdated—the latest ones go further. In updated guidance published in April, the ADA doesn’t recommend any specific time window for X-rays at all. Rather, it emphasizes that patient exposure to X-rays should be minimized, and any X-rays should be clinically justified.

There’s a good chance you’re surprised. Dentistry’s overuse of X-rays is a problem dentists do not appear eager to discuss—and would likely prefer to skirt. My former dentist declined to comment for this article, for example. And other dentists have been doing that for years. Nevertheless, the problem is well-established. A New York Times article from 2016, titled “You Probably Don’t Need Dental X-Rays Every Year,” quoted a dental expert noting the exact problem:

“Many patients of all ages receive bitewing X-rays far more frequently than necessary or recommended. And adults in good dental health can go a decade between full-mouth X-rays.”

Data is lacking

The problem has bubbled up again in a series of commentary pieces published in JAMA Internal Medicine today. The pieces were all sparked by a viewpoint that Ars reported on in May, in which three dental and health experts highlighted that many routine aspects of dentistry, including biannual cleanings, are not evidence-based and that the industry is rife with overdiagnosis and overtreatment. That viewpoint, titled “Too Much Dentistry,” also appeared in JAMA Internal Medicine.

The new pieces take a more specific aim at dental radiography. But, as in the May viewpoint, experts also blasted dentistry more generally for being out of step with modern medicine in its lack of data to support its practices—practices that continue amid financial incentives to overtreat and little oversight to stop it, they note.

In a piece titled “Too Much Dental Radiography,” Sheila Feit, a retired medical expert based in New York, pointed out that using X-rays for dental screenings is not backed by evidence. “Data are lacking about outcomes,” she wrote. If anything, the weak data we have makes it look ineffective. For instance, a 2021 systemic review of 77 studies that included data on a total of 15,518 tooth sites or surfaces found that using X-rays to detect early tooth decay led to a high degree of false-negative results. In other words, it led to missed cases.

Feit called for gold-standard randomized clinical trials to evaluate the risks and benefits of X-ray screenings for patients, particularly adults at low risk of caries. “Financial aspects of dental radiography also deserve further study,” Feit added. Overall, Feit called the May viewpoint “a timely call for evidence to support or refute common clinical dental practices.”

Dentistry without oversight

In a response published simultaneously in JAMA Internal Medicine, oral medicine expert Yehuda Zadik championed Feit’s point, calling it “an essential discussion about the necessity and risks of routine dental radiography, emphasizing once again the need for evidence-based dental care.”

Zadik, a professor of dental medicine at The Hebrew University of Jerusalem, noted that the overuse of radiography in dentistry is a global problem, one aided by dentistry’s unique delivery:

“Dentistry is among the few remaining health care professions where clinical examination, diagnostic testing including radiographs, diagnosis, treatment planning, and treatment are all performed in place, often by the same care practitioner” Zadik wrote. “This model of care delivery prevents external oversight of the entire process.”

While routine X-rays continue at short intervals, Zadik notes that current data “favor the reduction of patient exposure to diagnostic radiation in dentistry,” while advancements in dentistry dictate that X-rays should be used at “longer intervals and based on clinical suspicion.”

Though the digital dental X-rays often used today provide smaller doses of radiation than the film X-rays used in the past, radiation’s harms are cumulative. Zadik emphasizes that with the primary tenet of medicine being “First, do no harm,” any unnecessary X-ray is an unnecessary harm. Further, other technology can sometimes be used instead of radiography, including electronic apex locators for root canal procedures.

“Just as it is now unimaginable that, in the past, shoe fittings for children were conducted using X-rays, in the future it will be equally astonishing to learn that the fit of dental crowns was assessed using radiographic imaging,” Zadik wrote.

X-rays do more harm than good in children

Feit’s commentary also prompted a reply from the three authors of the original May viewpoint: Paulo Nadanovsky, Ana Paula Pires dos Santos, and David Nunan. The three followed up on Feit’s point that data is weak on whether X-rays are useful for detecting early decay, specifically white spot lesions. The experts raise the damning point that even if dental X-rays were shown to be good at doing that, there’s still no evidence that that’s good for patients.

“[T]here is no evidence that detecting white spot lesions, with or without radiographs, benefits patients,” the researchers wrote. “Most of these lesions do not progress into dentine cavities,” and there’s no evidence that early treatments make a difference in the long run.

To bolster the point, the three note that data from children suggest that X-ray screening does more harm than good. In a randomized clinical trial published in 2021, 216 preschool children were split into two groups: one that received only a visual-tactile dental exam, while the others received both a visual-tactile exam and X-rays. The study found that adding X-rays caused more harm than benefit because the X-rays led to false positives and overdiagnosis of cavitated caries needing restorative treatment. The authors of the trial concluded that “visual inspection should be conducted alone in regular clinical practice.”

Like Zadik, the three researchers note that screenings for decay and cavities are not the only questionable use of X-rays in dental practice. Other common dental and orthodontic treatments involving radiography—practices often used in children and teens—might also be unnecessary harms. They raise the argument against the preventive removal of wisdom teeth, which is also not backed by evidence.

Like Feit, the three researchers reiterate the call for well-designed trials to back up or refute common dental practices.

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.

Routine dental X-rays are not backed by evidence—experts want it to stop Read More »

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Why a diabetes drug fell short of anticancer hopes

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Studies suggested it could treat cancer, but the clinical trials were a bust.

Multi-pipettes

Pamela Goodwin has received hundreds of emails from patients asking if they should take a cheap, readily available drug, metformin, to treat their cancer.

It’s a fair question: Metformin, commonly used to treat diabetes, has been investigated for treating a range of cancer types in thousands of studies on laboratory cells, animals, and people. But Goodwin, an epidemiologist and medical oncologist treating breast cancer at the University of Toronto’s Mount Sinai Hospital, advises against it. No gold-standard trials have proved that metformin helps treat breast cancer—and her recent research suggests it doesn’t.

Metformin’s development was inspired by centuries of use of French lilac, or goat’s rue (Galega officinalis), for diabetes-like symptoms. In 1918, researchers discovered that a compound from the herb lowers blood sugar. Metformin, a chemical relative of that compound, has been a top type 2 diabetes treatment in the United States since it was approved in 1994. It’s cheap—less than a dollar per dose—and readily available, with few side effects. Today, more than 150 million people worldwide take the stuff.

Illustration of French lilac plant.

The French lilac, Galega officinalis, has been used medicinally since medieval times, including for symptoms associated with diabetes. Investigations of the plant’s chemical galegine led to the development of metformin, a related molecule synthesized in the lab. Credit: Wikimedia Commons

Metformin has a variety of effects, such as improving immune function and the body’s responses to insulin, which in turn regulates blood sugar. It can also slow growth of cancer cells in the lab. Many of these benefits seem to stem from metformin’s action in the cell’s powerhouses, the mitochondria, where it slows the production of energy and limits the generation of damaging chemicals called free radicals.

Researchers have considered metformin for treating a plethora of conditions, from glaucoma to polycystic ovary syndrome to pimples. “It really has a reputation of being a potential wonder drug,” says Michael Pollak, an oncologist and researcher at McGill University in Montreal. “There’s still a lot of work to be done on metformin.” (Pollak consults for biotechnology companies interested in metformin analogs as medicines.)

But the latest research has convinced Pollak and some others that treatment of cancers should be taken off the list.

More studies, but no proof

One of the first hints linking metformin to anticancer effects came in a short note in the British Medical Journal in 2005. Researchers analyzed medical records of almost 12,000 people from the Tayside region of Scotland who were newly diagnosed with diabetes between 1993 and 2001. Of those, more than 900 went on to develop cancer. Interestingly, those who’d taken metformin at some point during the study period were 23 percent less likely to have received a later cancer diagnosis.

This finding fueled further research on people with diabetes taking metformin and the risk for breast cancer, liver cancer, ovarian and endometrial cancer, and other types. The authors of a 2013 analysis, covering more than 1 million patients in 41 observational studies like the original one, concluded that metformin “might be associated with a significant reduction in the risk of cancer.” But such associations are not proof.

Researchers went on to explore the link in studies with cells in dishes and in lab animals, finding that metformin slowed growth of blood, breast, endometrial, lung, liver, stomach, and thyroid cancer cells. It also seemed to make cancer cells extra sensitive to chemotherapy drugs. In one mouse study, scientists grafted human breast, prostate, or lung cancer cells into the animals and treated them with either standard chemotherapy drugs, metformin, or a combination of both. The combination worked best, preventing tumor growth and prolonging relapse.

These findings made sense to researchers. Metformin treats metabolic problems in diabetes, and cancer has also been linked to metabolic issues such as obesity. Even before the 2005 British Medical Journal study, Goodwin had noticed that breast cancer patients with high insulin did worse than those with normal insulin levels.

That logic, plus the promising data, led scientists to conduct a number of randomized controlled trials—the gold-standard experiment in medicine. Researchers would enroll people with cancer and split them into two groups. One group would get standard cancer therapy plus metformin; the other group would get standard therapy plus a placebo, a pill containing no medication.

And metformin flopped, big time. While a number of studies are ongoing, trials for two types of cancer recently reported no benefit overall from metformin. In June 2024, at the American Society of Clinical Oncology meeting in Chicago, researchers reported a Canadian trial with 407 men with low-risk prostate cancer. The enrollees had been diagnosed within six months before starting the trial and had decided to monitor their cancer without starting immediate treatment. Half took metformin and half took a placebo. After biopsies at 18 and 36 months to test whether their disease had progressed, there was no difference between the two groups.

A larger British and Swiss trial including nearly 1,900 patients with newly diagnosed or relapsed prostate cancer that had spread to other body parts was reported at the European Society for Medical Oncology Congress in Barcelona, Spain, in September. This trial also found that metformin plus standard treatment, compared to standard treatment alone, did not improve overall prostate cancer survival in the study population.

A multinational study of breast cancer helmed by Goodwin also led to disappointment. The researchers enrolled more than 3,600 patients between 2010 and 2013; these patients had been diagnosed about a year before enrollment and had already undergone chemotherapy and surgery. In addition to standard cancer treatment, half received metformin and half received a placebo.

By 2016, it was clear that metformin wasn’t doing anything to enhance survival for about 1,100 participants with a particular cancer subtype. When the study wrapped in 2020, the researchers analyzed the rest of the patients, counting how many were alive and free of breast or any other form of cancer. Metformin made no difference in those results, or to survival overall, the team reported in 2022.

Fatal flaws in the research

In retrospect, researchers think they know why earlier studies oversold metformin’s potential. Many of the studies that examined medical records had a crucial flaw, says Samy Suissa, a pharmacoepidemiologist at McGill.

Here’s what happens: Researchers sift through old medical records to see if someone ever took metformin. Then they compare cancer rates among people who took the drug at any point to those who never took it. But you have to be alive to take metformin. Anyone who died, of cancer or other causes, before having a chance at a metformin prescription is left out of the calculations. This skews the results; it’s called the “immortal time bias.” It makes any drug, metformin or otherwise, look like it helps patients to survive because it can only be taken by people who are alive, says Suissa.

Plus, scientists are more likely to publish studies that show metformin is promising than ones where it makes no difference, skewing the scientific literature.

As for those studies of cells in dishes and of lab animals, many experiments used much higher doses of metformin than are used in people. Too much metformin risks a buildup of lactate, a byproduct of low oxygen metabolism that acidifies the blood and can be fatal.

Researchers still suspect metformin might treat specific subgroups of cancer. For example, the authors of the prostate cancer trial presented in Barcelona suggested that metformin might help patients whose cancer has spread to other tissues or multiple sites in their bones. And Goodwin saw a hint in her trial that it might help women whose cancers contain a certain version of a cell-growth gene called ERBB2. But it would require another trial, focused on women with that particular cancer, to prove it.

And there are now better treatments for those patients than there were more than a decade ago when Goodwin started her study, reducing the opportunity to test metformin. Goodwin doesn’t currently have the funding to follow up on this theory.

It may also be that the clinical trials recruited patients with cancers that were too far along. “I always thought we were asking too much of metformin,” says Victoria Bae-Jump, a gynecological oncologist at the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill. “Maybe it just needs to be earlier in the pathway of growth.” Bae-Jump is now testing metformin in women who have early-stage endometrial cancer or a precursor to it.

Others are investigating metformin for people who have precancerous lesions in their mouths. “The idea would be to keep them from progressing, or reverse the tissues to be more normal,” says Frank Ondrey, a head and neck cancer surgeon at the Masonic Cancer Center of the University of Minnesota in Minneapolis. In a small, uncontrolled study of 23 people, metformin halved lesion size in four of them. Ondrey is involved in two ongoing studies, one a randomized, controlled trial, to further test metformin in people with precancerous lesions; these should yield results within a few years.

Subdued expectations

Metformin is also being tested for other conditions such as dementia and a genetic disorder called fragile X syndrome. And perhaps the ultimate potential use for metformin is to slow aging itself. “I think it’s much easier to treat aging and prevent cancer than to treat cancer,” says Nir Barzilai, a geroscientist at Albert Einstein College of Medicine in New York and president of the nonprofit Academy for Health & Lifespan Research. Through its enhancement of insulin action and metabolism plus its minimization of free radical production, metformin influences all the key hallmarks of aging, such as problems with DNA, mitochondria and stem cells, says Barzilai.

He and colleagues are gathering funds for a randomized, controlled trial of metformin in 3,000 people age 65 through 79 who are showing signs of age-related disease already. The trial will test whether fewer people taking metformin die over six years. Barzilai, who is 68, says he is confident in metformin’s anti-aging ability and already takes the drug himself.

Others, mindful of what happened with cancer, are more circumspect. Pollak says that many of the studies in other areas of medicine are too small to prove metformin works, and Suissa notes that some of the studies finding benefits in populations taking metformin, including for longevity, have the same problems the oh-so-promising early cancer research did.

In short, Suissa says, “Don’t believe everything you hear.”

This story originally appeared in Knowable Magazine.

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Knowable Magazine explores the real-world significance of scholarly work through a journalistic lens.

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Rare bear meat at gathering gives 10 people a scare—and parasitic worms

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If you’re going to eat a bear, make sure it’s not rare.

You’d be forgiven for thinking that once the beast has been subdued, all danger has passed. But you might still be in for a scare. The animal’s flesh can be riddled with encased worm larvae, which, upon being eaten, will gladly reproduce in your innards and let their offspring roam the rest of your person, including invading your brain and heart. To defeat these savage squirmers, all one must do is cook the meat to at least 165° Fahrenheit.

But that simple solution continues to be ignored, according to a report today in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report. In this week’s issue, health officials in North Carolina report that rare bear meat was served at a November 23 gathering, where at least 22 people ate the meat and at least 10 developed symptoms of a worm infection. Of the 10, six were kids and teens between the ages of 10 and 18.

The infection is from the roundworm Trichinella, which causes trichinellosis. While the infection is rarely fatal, the nematodes tend to burrow out of the bowels and meander through the body, embedding in whatever muscle tissue they come across. A telltale sign of an infection in people is facial swelling, caused when the larvae take harbor in the muscles of the face and around the eyes. Of the 10 ill people in North Carolina, nine had facial swelling.

Local health officials were onto the outbreak when one person developed flu-like symptoms and puzzling facial swelling. They then traced it back to the gathering. The report doesn’t specify what kind of gathering it was but noted that 34 attendees in total were surveyed, from which they found the 22 people who ate the rare meat. The 10 people found with symptoms are technically considered only “probable” cases because the infections were never diagnostically confirmed. To confirm a trichinellosis infection, researchers need blood samples taken after the person recovers to look for antibodies against the parasite. None of the 10 people returned for blood draws.

Rare bear meat at gathering gives 10 people a scare—and parasitic worms Read More »

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Over 86% of surveyed health care providers are short on IV fluids

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Trucks and Gatorade

Federal officials, meanwhile, are working with Baxter to help support increasing supplies, setting up temporary imports, and expediting consideration of any shelf-life extension requests.

In a letter earlier this week, Department of Health and Human Services Secretary Xavier Becerra told health care leaders that the department is “working tirelessly to mitigate the sterile solutions supply chain disruptions” and, beyond the current crisis, is also working to diversify the supply chain so it is less reliant on a single plant.

For now, though, “HHS is encouraging all providers and health systems, regardless of whether they have experienced a disruption in their supply, to take measures to conserve these critical products,” the letter read. Some hospitals have already reported giving patients Gatorade and Pedialyte to conserve IV fluid supplies.

In one bright spot in the current disruptions, fears that Hurricane Milton would disrupt another IV fluid manufacturing plant in Florida were not realized this week. B. Braun Medical’s manufacturing site in Daytona Beach was not seriously impacted by the storm, the company announced, and production resumed normally Friday. Prior to the storm, with the help of the federal government, B. Braun reportedly moved more than 60 truckloads of IV fluid inventory north of Florida for safekeeping. That inventory will be returned to the Daytona facility, according to reporting by the Associated Press.

Over 86% of surveyed health care providers are short on IV fluids Read More »

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Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad

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Compounding pharmacies are suing the Food and Drug Administration so they can keep making imitation versions of popular—and lucrative—tirzepatide drugs, namely knockoffs of Mounjaro for diabetes and Zepbound for weight loss.

Generally, compounding pharmacies make customized formulations of drugs for patients with specific needs, like when a patient has an allergy to a filler ingredient or if a child needs a liquid version of a drug that normally comes as a capsule. But larger compounding operations are also legally allowed to make imitations of branded drugs if those drugs are in short supply, acting as a stopgap for patients.

Tirzepatide has certainly been in short supply in recent years. Given the high prevalence of diabetes and obesity in America and the drug’s effectiveness, demand for tirzepatide and other drugs in the new GLP-1 class have skyrocketed, and many patients have struggled to fill prescriptions. The FDA placed tirzepatide on its drug shortage list in December of 2022—and that’s where it remained until last week.

On October 2, the FDA announced that the tirzepatide shortage had been resolved and that the nation’s supply of GLP-1 drugs was stabilizing, though other drugs in the class, including semaglutide, remain in short supply.

“FDA confirmed with the drug’s manufacturer [Eli Lilly] that their stated product availability and manufacturing capacity can meet the present and projected national demand,” the agency said in its announcement. However, it cautioned that patients and prescribers “may still see intermittent localized supply disruptions” as the drugs move through the supply chain.

End of an era

With the resolution, compounding pharmacies are no longer able to produce tirzepatide. And the FDA highlighted the point to the drug makers, writing in bold that the agency “reminds compounders of the legal restrictions on making copies of FDA-approved drugs.”

Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad Read More »

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Your doctor’s office could be reading your blood pressure all wrong

blood pressure, health, hypertension, JAMA, Science / /

Under pressure

Before participants took readings in any of the positions, the researchers had them simulate walking into a doctor’s appointment. They walked for two minutes and then sat calmly in position for five minutes before taking the three readings. Before moving onto the next position, they got up and walked again and sat for another five minutes. The participants were also randomized into groups that took the first three readings (desk 1, lap, side) in different orders, with all groups ending on desk 2.

The researchers then compared the differences between desk 1 and desk 2 to differences between lap and desk 1 and side and desk 1 for each participant. The desk 1-desk 2 differences captured intrinsic variability of blood pressure reading within each participant. The comparisons to lap-desk 1 and side-desk 1 captured changes based on the improper arm positions.

In all, there was little difference in the desk 1-desk 2 comparison, with participants having a mean difference of -0.21 mm Hg in systolic blood pressure and 0.09 in diastolic. But, the improper arm positions had significant effects on the readings. Lap arm position resulted in a mean increase of 4 mm Hg in both systolic and diastolic readings. Side arm position led to systolic readings that were 6.5 mm Hg higher and diastolic readings that were 4 mm Hg higher. For those with high blood pressure readings—about 36 percent of the participants—the wrong arm position caused yet higher readings, with systolic readings about 9 mm Hg higher than desk readings.

The authors speculate that simple physiological mechanisms likely explain the increase in blood pressure when the arm is lower than the heart—more gravitational pull, compensatory constriction of blood vessels, and muscle contraction may lead to higher pressure. As for why health care providers are known to sometimes use these wrong arm positions, it may be a lack of awareness, training, equipment, and/or resources.

The authors of the study call for more training and education about proper blood pressure measurements, which are essential for appropriate management of hypertension and prevention of cardiovascular disease.

Your doctor’s office could be reading your blood pressure all wrong Read More »

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SCOTUS denial ends saga of Shkreli’s infamous 5,000% drug price scheme

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The legal saga over Martin Shkreli’s infamous 5,000 percent price hike of a life-saving anti-parasitic drug has ended with a flat denial from the highest court in the land.

On Monday, the Supreme Court rejected Shkreli’s petition to appeal an order to return $64.6 million in profits from the pricing scheme of Daraprim, a decades-old drug used to treat toxoplasmosis. The condition is caused by a single-celled parasite that can be deadly for newborns and people with compromised immune systems, such as people who have HIV, cancer, or an organ transplant.

Federal prosecutors successfully argued in courts that Shkreli orchestrated an illegal anticompetitive scheme that allowed him to dramatically raise the price of Daraprim overnight. When Shkreli and his pharmaceutical company, Vyera (formerly Turing), bought the rights to the drug in 2015, the price of a single pill jumped to $750 after being priced between $13.50 and $17.50 earlier that year. And Shkreli quickly came to epitomize callous greed in the pharmaceutical industry.

In a lawsuit filed in 2021, the Federal Trade Commission and seven state attorneys general accused Shkreli of building a “web of anticompetitive restrictions to box out the competition.” In January of 2022, US District Court Judge Denise Cote agreed, finding that Shkreli’s conduct was “egregious, deliberate, repetitive, long-running, and ultimately dangerous.”

SCOTUS denial ends saga of Shkreli’s infamous 5,000% drug price scheme Read More »

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Helene ravaged the NC plant that makes 60% of the country’s IV fluid supply

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Hurricane Helene’s catastrophic damage and flooding to the Southeastern states may affect the country’s medical supply chain.

Hospitals nationwide are bracing for a possible shortage of essential intravenous fluids after the cataclysmic storm inundated a vital manufacturing plant in North Carolina.

The plant is Baxter International’s North Cove manufacturing facility in Marion, which is about 35 miles northeast of Asheville. Helene unleashed unprecedented amounts of rain throughout the western part of the state, killing dozens and ravaging numerous communities, homes, and other structures, including the plant.

The North Cove plant produces 60 percent of the country’s supply of IV solutions, typically producing 1.5 million bags per day, according to the American Hospital Association. The dozens of sterile solutions Baxter makes at the facility are used for everything from intravenous rehydration and drug delivery to peritoneal dialysis used to treat kidney failure.

“Our hearts and thoughts are with all those affected by Hurricane Helene,” Baxter CEO José Almeida said in a statement on September 29. “The safety of our employees, their families, and the communities in which we operate remains our utmost concern, and we are committed to helping ensure reliable supply of products to patients. Remediation efforts are already underway, and we will spare no resource—human or financial—to resume production and help ensure patients and providers have the products they need.”

Critical supply

On October 2, Mass General Brigham, Massachusetts’ largest hospital and health care system, warned employees via email of a “serious and immediate IV fluid shortage,” according to the Boston Globe.

Helene ravaged the NC plant that makes 60% of the country’s IV fluid supply Read More »

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Human case of H5N1 suspected in California amid rapid dairy spread

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California’s infections bring the country’s total number of affected herds to 255 in 14 states, according to the USDA.

In a new release Thursday, California health officials worked to ease alarm about the human case, emphasizing that the risk to the general public remains low.

“Ongoing health checks of individuals who interact with potentially infected animals helped us quickly detect and respond to this possible human case. Fortunately, as we’ve seen in other states with human infections, the individual has experienced mild symptoms,” Tomás Aragón, director of California’s Department of Public Health, said. “We want to emphasize that the risk to the general public is low, and people who interact with potentially infected animals should take prevention measures.”

The release noted that in the past four months, the health department has distributed more than 340,000 respirators, 1.3 million gloves, 160,000 goggles and face shields, and 168,000 bouffant caps to farm workers. The state has also received 5,000 doses of seasonal flu vaccine earmarked for farm workers and is working to distribute those vaccines to local health departments.

Still, herd infections and human cases continue to tick up. Influenza researchers and other health experts are anxiously following the unusual dairy outbreak—the first time an avian influenza is known to have spilled over to and caused an outbreak in cattle. The more opportunities the virus has to spread and adapt to mammals, the more chances it could begin spreading among humans, potentially sparking an outbreak or even a pandemic.

Human case of H5N1 suspected in California amid rapid dairy spread Read More »