health

new-fda-approved-drug-makes-severe-food-allergies-less-life-threatening

New FDA-approved drug makes severe food allergies less life-threatening

fda, food allergies, health, omalizumab, peanut, Science, Xolair / /

Taking the edge off —

Injections over several months allowed people to tolerate larger doses of trigger foods.

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Peanuts

Enlarge / Peanuts

Living with food allergies can be a fraught existence. There is no cure, and the standard management is to be ever vigilant of everything you eat and have an emergency shot of epinephrine constantly handy in case an accidental ingestion leads to a swift, life-threatening reaction. But, for the millions of people in the US who live with such allergies, a new drug may dull the threat.

On Friday, the Food and Drug Administration approved the antibody drug omalizumab (brand name Xolair) as an injection to lessen allergic reactions to foods in people ages 1 and up. In a trial of 168 children and adults with multiple food allergies, participants who received shots of omalizumab for 16 to 20 weeks were much more likely to tolerate a test dose of allergy-inducing foods at the end than those who received a placebo.

Omalizumab—which was previously approved to treat asthma, hives, and nasal polyps—works by binding to a class of antibodies in the body called immunoglobulin E (IgE) that are specifically involved in allergic responses. The monoclonal antibody drug binds IgE, blocking it from binding to its target receptor, thus preventing it from triggering the immune responses that lead to allergy symptoms.

“This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies,” Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in today’s announcement. “While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.”

The trial began in 2019 and was run by the National Institute of Allergy and Infectious Diseases and is still ongoing. But an interim analysis of early data was enough to convince the FDA of the drug’s benefit.

More tolerance

For the trial, researchers recruited people who had an allergy to peanuts, as well as at least two other food allergies, including milk, egg, wheat, cashew, hazelnut, or walnut. Those assigned to get omalizumab received shots every two to four weeks for 16 to 20 weeks. Afterward, researchers looked at whether participants could handle 600 milligrams or more of peanut protein, which is equivalent to eating about 2.5 or more peanuts. Of those who got the shot, 68 percent (75 of 110 subjects) handled the peanut doses without moderate to severe allergy symptoms, such as whole-body hives, persistent coughing, or vomiting. In the placebo group, only 6 percent (3 of 55 subjects) managed this.

As secondary tests, the researchers tried other allergy-triggering foods at the higher dose of 1,000 milligrams or more. For cashews, 42 percent (27 of 64) of participants who received omalizumab tolerated the challenge without moderate or severe allergic reactions, compared with 3 percent (1 of 30) in the placebo group. For milk, 66 percent (25 of 38 subjects) who received the drug tolerated the dairy, while only 11 percent (2 of 19) of the placebo group did so. For egg, 67 percent (31 of 46 subjects) on the drug tolerated the dose, compared to 0 percent of the 19 who received placebo.

The benefits of omalizumab were not universal. The FDA notes that 17 percent of the people who received the drug had no significant improvement in their sensitivity to allergy-triggering food. As such, the FDA cautions that even if people receive Xolair, they should still avoid the foods that trigger their allergies.

The trial is ongoing, and researchers plan to look at the longevity of the drug’s effectiveness and whether it can be paired with another strategy to ratchet down food allergies: oral immunotherapy (OIT), which uses small, daily doses of an allergen to build tolerance over time. For the look at longevity, some trial participants will get shots for an additional 24 weeks, followed by more food challenges to see if the drug remains useful at easing allergic responses over the prolonged time period. For the OIT part of the trial, participants will get another 16 weeks of injections and, halfway through that, some will undergo multi-allergen OIT. They will then be followed for 44 additional weeks.

The FDA says the most common side effects of omalizumab are injection site reactions and fever, but the agency also warns of the possibility of joint pain, rash, parasitic infections, malignancies, and abnormal laboratory tests.

New FDA-approved drug makes severe food allergies less life-threatening Read More »

can-you-sanitize-the-inside-of-your-nose-to-prevent-covid?-nope,-fda-says.

Can you sanitize the inside of your nose to prevent COVID? Nope, FDA says.

COVID-19, fda, health, nasal spray, SARS-CoV-2, Science, warning letter / /

doesn’t pass the sniff test —

There are a lot of COVID nasal sprays for sale, but little data to show they work.

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Can you sanitize the inside of your nose to prevent COVID? Nope, FDA says.

More than four years after SARS-CoV-2 made its global debut, the US Food and Drug Administration is still working to clear out the bogus and unproven products that flooded the market, claiming to prevent, treat, and cure COVID-19.

The latest example is an alcohol-based sanitizer meant to be smeared inside the nostrils. According to its maker, the rub can protect you from becoming infected with SARS-CoV-2 and other nasty germs, like MRSA, and that protection lasts up to 12 hours after each swabbing. That all sounds great, but according to the FDA, none of it is proven. In a warning letter released Tuesday, the agency determined the sanitizer, called Nozin, is an unapproved new drug and misbranded.

While ethyl alcohol is used in common topical antiseptics, like hand sanitizers, the FDA does not generally consider it safe for inside the nostrils—and the agency is unaware of any high-quality clinical data showing the Nozin is safe, let alone effective. The FDA also noted that, for general over-the-counter topical antiseptics, calling out specific pathogens it can fight off—like SARS-CoV-2 and MRSA—is not allowed under agency rules without further FDA review. Making claims about protection duration is also not allowed.

The FDA’s warning letter is nothing to sneeze at; the letter threatens seizure and injunction for failing to adequately respond.

Nozin’s maker, Maryland-based Global Life Technologies Corp., did not immediately respond to a request for comment from Ars. On its website, the company touts its product’s effectiveness with a link to a published study from 2014, indicating that use of Nozin lowered the colonization levels of S. aureus and other bacteria in the noses of 20 healthy health care workers. The study did not address protection from infection or carriage of any viruses. The company also lists unpublished studies indicating that the product can kill bacteria in laboratory conditions, does not irritate skin, and lowered bacterial growth in the noses of 30 people over a 12-hour period.

This is far from the first dubious, nasal-based COVID product the FDA has called out. There was the Corona-cure nasal spray of 2020, and the Halodine and the NanoBio Protect nasal antiseptics of 2021. That year, the Federal Trade Commission sued a company called Xlear over allegedly false claims that its nasal spray can prevent and treat COVID-19. At least two more nasal spray makers received FDA warning letters in 2022.

To date, the FDA has not approved any nasal sprays to prevent or treat COVID-19, and the scant data on their efficacy remains inconclusive. But there are still plenty of such products for sale online. Most, like Nozin, claim to work by killing bacteria and viruses directly. One product, a nitric oxide nasal spray called Sanotize, is currently in a Phase III clinical trial to test whether it can prevent SARS-CoV-2 infections. Others claim to work by coating the nasal passage with the gelling agent iota-carrageenan to provide a barrier to viral entry. A pilot clinical trial of 400 health care workers in Argentina published in 2021 found that the use of an iota-carrageenan nasal spray led to a 4 percent absolute risk reduction in SARS-CoV-2 infection.

Can you sanitize the inside of your nose to prevent COVID? Nope, FDA says. Read More »

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CDC to update its COVID isolation guidance, ditching 5-day rule: Report

CDC, COVID-19, COVID-19 vaccine, health, isolation, masks, Science / /

update —

The agency is reportedly moving from the fixed time to a symptom-based isolation period.

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CDC to update its COVID isolation guidance, ditching 5-day rule: Report

The Centers for Disease Control and Prevention is preparing to update its COVID-19 isolation guidance, moving from a minimum five-day isolation period to one that is solely determined by symptoms, according to a report from The Washington Post.

Currently, CDC isolation guidance states that people who test positive for COVID-19 should stay home for at least five days, at which point people can end their isolation as long as their symptoms are improving and they have been fever-free for 24 hours.

According to three unnamed officials who spoke with the Post, the CDC will update its guidance to remove the five-day minimum, recommending more simply that people can end their isolation any time after being fever-free for 24 hours without the aid of medication, as long as any other remaining symptoms are mild and improving. The change, which is expected to be released in April, would be the first to loosen the guidance since the end of 2021.

In an email to Ars, a CDC spokesperson did not confirm or deny the report, saying only that, “There are no updates to COVID guidelines to announce at this time. We will continue to make decisions based on the best evidence and science to keep communities healthy and safe.”

The Post notes that the proposed update to the guidance matches updated guidance from California and Oregon, as well as other countries.

The officials who spoke with the outlet noted that the loosened guidelines reflect that most people in the US have developed some level of immunity to the pandemic coronavirus from prior infections and vaccinations.

A report earlier this month found that the 2023–2024 COVID-19 vaccine was about 54 percent effective at preventing symptomatic COVID-19 when compared against people who had not received the latest vaccine. However, the CDC estimates that only about 22 percent of adults have received the updated shot.

Currently, the CDC recommends that people wear a mask for 10 days after testing positive unless they have two negative tests 48 hours apart. The Post reported that it’s unclear if the CDC will update its mask recommendation.

CDC to update its COVID isolation guidance, ditching 5-day rule: Report Read More »

judge-tosses-big-pharma-suit-claiming-drug-price-negotiation-is-unconstitutional

Judge tosses Big Pharma suit claiming drug price negotiation is unconstitutional

Astrazeneca, drug pricing, health, medicare, Pharmaceutical industry, PhRMA, Science / /

tossed —

The judge ruled that the court lacks jurisdiction.

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Stephen Ubl, president and chief executive officer of Pharmaceutical Research and Manufacturers of America (PhRMA), speaks during a Bloomberg Live discussion in Washington, DC, on Tuesday, Sept. 19, 2017.

Enlarge / Stephen Ubl, president and chief executive officer of Pharmaceutical Research and Manufacturers of America (PhRMA), speaks during a Bloomberg Live discussion in Washington, DC, on Tuesday, Sept. 19, 2017.

A federal judge in Texas dismissed a lawsuit Monday brought by a heavy-hitting pharmaceutical trade group, which argued that forcing drug makers to negotiate Medicare drug prices is unconstitutional.

The dismissal is a small win for the Biden administration, which is defending the price negotiations on multiple fronts. The lawsuit dismissed Monday is just one of nine from the pharmaceutical industry, all claiming in some way that the price negotiations laid out in the Inflation Reduction Act of 2022 are unconstitutional. The big pharmaceutical companies suing the government directly over the negotiations include Johnson & Johnson, Bristol Myers Squibb, Novo Nordisk, Merck, and AstraZeneca.

Last month, a federal judge in Delaware heard arguments from AstraZeneca’s lawyers, which reportedly went poorly. AstraZeneca argued that Medicare’s new power to negotiate drug prices violates the company’s rights under the Fifth Amendment’s due process clause. The forced negotiations deprive the company of “property rights in their drug products and their patent rights” without due process, AstraZeneca claimed. But Colm Connolly, chief judge of the US District Court of Delaware, was skeptical of how that could be the case, according to a Stat reporter who was present for the hearing. Connolly noted that AstraZeneca doesn’t have to sell drugs to Medicare. “You’re free to do what you want,” Connolly reportedly said. “You may not make as much money.”

At a later point, Connolly bluntly commented: “I don’t find their argument compelling.”

Though the plaintiffs in the now-dismissed Texas also made an argument based on the Fifth Amendment’s due process clause, the case didn’t make it that far. US District Judge David Ezra in Austin, Texas, dismissed the case brought by one of the case’s three plaintiffs, saying the court lacked jurisdiction. And, because that one plaintiff is the only one based in the Western District of Texas, where the lawsuit was filed, he dismissed the case completely.

The three plaintiffs in the case were PhRMA, a powerful drug industry trade group representing high-profile drug makers, including Pfizer, GSK, Eli Lilly, and Sanofi; the Global Colon Cancer Association (GCCA); and the Texas-based National Infusion Center Association (NICA). Lawyers for the Biden administration filed a motion to dismiss the case, arguing that NICA is not a proper plaintiff.

Ezra found that for NICA to bring constitutional claims against Medicare’s price negotiations in a court, it is first required under federal rules to bring those claims through an administrative review process under the Medicare Act or the Centers for Medicare and Medicaid Services. Without a prior administrative review, the court has no jurisdiction.

“The Court lacks jurisdiction over NICA’s claims because the claims here ‘arise under’ the Medicare Act and the claims do not fall under the exception carved out for when claims may completely avoid judicial or administrative review. Therefore, NICA’s claims are dismissed without prejudice,” Ezra wrote in his ruling.

And, with the one Texas-based plaintiff, NICA, knocked out of the case, the Western Texas district is now the “improper venue” for a case brought by the remaining two plaintiffs, PhRMA and GCCA.

Ezra noted that in such situations, a judge can transfer the case to a court that would be considered a proper venue. But Ezra declined, noting that neither the plaintiffs nor defendants suggested a proper venue. And, even if they did, it likely wouldn’t matter, Ezra reasoned, because PhRMA and GCCA also haven’t gone through an administrative review.

“[T]he same federal jurisdictional defect likely exists for PhRMA and GCCA, as nothing suggests that either party has presented its claims to the [Health] Secretary,” Ezra wrote.

Ezra dismissed the case “without prejudice,” meaning the claims could be refiled. A spokesperson for PhRMA told FiercePharma: “We are disappointed with the court’s decision, which does not address the merits of our lawsuit, and we are weighing our next legal steps.”

Meanwhile, the first round of Medicare drug price negotiations is underway. Earlier this month, the federal government sent out its opening offers in the price negotiation process for the first 10 drugs selected. The bargaining will continue through the coming months, with an ending deadline of August 1, 2024. The prices will go into effect at the beginning of 2026.

Judge tosses Big Pharma suit claiming drug price negotiation is unconstitutional Read More »

ai-cannot-be-used-to-deny-health-care-coverage,-feds-clarify-to-insurers

AI cannot be used to deny health care coverage, feds clarify to insurers

AI, algorithm, Artificial Intelligence, CMS, health, healthcare, humana, medicare advantage, NaviHealth, nH Predict, Science, unitedhealth / /

On Notice —

CMS worries AI could wrongfully deny care for those on Medicare Advantage plans.

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A nursing home resident is pushed along a corridor by a nurse.

Enlarge / A nursing home resident is pushed along a corridor by a nurse.

Health insurance companies cannot use algorithms or artificial intelligence to determine care or deny coverage to members on Medicare Advantage plans, the Centers for Medicare & Medicaid Services (CMS) clarified in a memo sent to all Medicare Advantage insurers.

The memo—formatted like an FAQ on Medicare Advantage (MA) plan rules—comes just months after patients filed lawsuits claiming that UnitedHealth and Humana have been using a deeply flawed, AI-powered tool to deny care to elderly patients on MA plans. The lawsuits, which seek class-action status, center on the same AI tool, called nH Predict, used by both insurers and developed by NaviHealth, a UnitedHealth subsidiary.

According to the lawsuits, nH Predict produces draconian estimates for how long a patient will need post-acute care in facilities like skilled nursing homes and rehabilitation centers after an acute injury, illness, or event, like a fall or a stroke. And NaviHealth employees face discipline for deviating from the estimates, even though they often don’t match prescribing physicians’ recommendations or Medicare coverage rules. For instance, while MA plans typically provide up to 100 days of covered care in a nursing home after a three-day hospital stay, using nH Predict, patients on UnitedHealth’s MA plan rarely stay in nursing homes for more than 14 days before receiving payment denials, the lawsuits allege.

Specific warning

It’s unclear how nH Predict works exactly, but it reportedly uses a database of 6 million patients to develop its predictions. Still, according to people familiar with the software, it only accounts for a small set of patient factors, not a full look at a patient’s individual circumstances.

This is a clear no-no, according to the CMS’s memo. For coverage decisions, insurers must “base the decision on the individual patient’s circumstances, so an algorithm that determines coverage based on a larger data set instead of the individual patient’s medical history, the physician’s recommendations, or clinical notes would not be compliant,” the CMS wrote.

The CMS then provided a hypothetical that matches the circumstances laid out in the lawsuits, writing:

In an example involving a decision to terminate post-acute care services, an algorithm or software tool can be used to assist providers or MA plans in predicting a potential length of stay, but that prediction alone cannot be used as the basis to terminate post-acute care services.

Instead, the CMS wrote, in order for an insurer to end coverage, the individual patient’s condition must be reassessed, and denial must be based on coverage criteria that is publicly posted on a website that is not password protected. In addition, insurers who deny care “must supply a specific and detailed explanation why services are either no longer reasonable and necessary or are no longer covered, including a description of the applicable coverage criteria and rules.”

In the lawsuits, patients claimed that when coverage of their physician-recommended care was unexpectedly wrongfully denied, insurers didn’t give them full explanations.

Fidelity

In all, the CMS finds that AI tools can be used by insurers when evaluating coverage—but really only as a check to make sure the insurer is following the rules. An “algorithm or software tool should only be used to ensure fidelity,” with coverage criteria, the CMS wrote. And, because “publicly posted coverage criteria are static and unchanging, artificial intelligence cannot be used to shift the coverage criteria over time” or apply hidden coverage criteria.

The CMS sidesteps any debate about what qualifies as artificial intelligence by offering a broad warning about algorithms and artificial intelligence. “There are many overlapping terms used in the context of rapidly developing software tools,” the CMS wrote.

Algorithms can imply a decisional flow chart of a series of if-then statements (i.e., if the patient has a certain diagnosis, they should be able to receive a test), as well as predictive algorithms (predicting the likelihood of a future admission, for example). Artificial intelligence has been defined as a machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments. Artificial intelligence systems use machine- and human-based inputs to perceive real and virtual environments; abstract such perceptions into models through analysis in an automated manner; and use model inference to formulate options for information or action.

The CMS also openly worried that the use of either of these types of tools can reinforce discrimination and biases—which has already happened with racial bias. The CMS warned insurers to ensure any AI tool or algorithm they use “is not perpetuating or exacerbating existing bias, or introducing new biases.”

While the memo overall was an explicit clarification of existing MA rules, the CMS ended by putting insurers on notice that it is increasing its audit activities and “will be monitoring closely whether MA plans are utilizing and applying internal coverage criteria that are not found in Medicare laws.” Non-compliance can result in warning letters, corrective action plans, monetary penalties, and enrollment and marketing sanctions.

AI cannot be used to deny health care coverage, feds clarify to insurers Read More »

anti-abortion-group’s-studies-retracted-before-supreme-court-mifepristone-case

Anti-abortion group’s studies retracted before Supreme Court mifepristone case

Abortion, fda, health, mifepristone, retraction, Science, Scientific publishing, Supreme Court / /

retracted —

A large number of other, non-retracted studies find mifepristone to be very safe.

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Mifepristone (Mifeprex) and misoprostol, the two drugs used in a medication abortion, are seen at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022.

Enlarge / Mifepristone (Mifeprex) and misoprostol, the two drugs used in a medication abortion, are seen at the Women’s Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022.

Scientific journal publisher Sage has retracted key abortion studies cited by anti-abortion groups in a legal case aiming to revoke regulatory approval of the abortion and miscarriage medication, mifepristone—a case that has reached the US Supreme Court, with a hearing scheduled for March 26.

On Monday, Sage announced the retraction of three studies, all published in the journal Health Services Research and Managerial Epidemiology. All three were led by James Studnicki, who works for The Charlotte Lozier Institute, a research arm of Susan B. Anthony Pro-Life America. The publisher said the retractions were based on various problems related to the studies’ methods, analyses, and presentation, as well as undisclosed conflicts of interest.

Two of the studies were cited by anti-abortion groups in their lawsuit against the Food and Drug Administration (Alliance for Hippocratic Medicine v. FDA), which claimed the regulator’s approval and regulation of mifepristone was unlawful. The two studies were also cited by District Judge Matthew Kacsmaryk in Texas, who issued a preliminary injunction last April to revoke the FDA’s 2000 approval of mifepristone. A conservative panel of judges for the 5th Circuit Court of Appeals in New Orleans partially reversed that ruling months later, but the Supreme Court froze the lower court’s order until the appeals process had concluded.

Mifepristone, considered safe and effective by the FDA and medical experts, is used in over half of abortions in the US.

Criticism

Amid the legal dispute, the now-retracted studies drew immediate criticism from experts, who pointed out flaws. Of the three, the most influential and heavily criticized is the 2021 study titled “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015” (PDF). The study suggested that up to 35 percent of women on Medicaid who had a medication abortion between 2001 and 2015 visited an emergency department within 30 days afterward. Its main claim was that medication abortions led to a higher rate of emergency department visits than surgical abortions.

Critics noted a number of problems: The study looked at all emergency department visits, not only visits related to abortion. This could capture medical care beyond abortion-related conditions, because people on Medicaid often lack primary care and resort to going to emergency departments for routine care. When the researchers tried to narrow down the visits to just those related to abortion, they included medical codes that were not related to abortion, such as codes for ectopic pregnancy, and they didn’t capture the seriousness of the condition that prompted the visit. Medication abortions can cause bleeding, and women can go to the emergency department if they don’t know what amount of bleeding is normal. The study also counted multiple visits from the same individual patient as multiple visits, likely inflating the numbers. Last, the study did not put the data in context of emergency department use by Medicaid beneficiaries in general over the time period.

In contrast to Studnicki’s study, the American College of Obstetricians and Gynecologists notes that studies looking at tens of thousands of medication abortions have concluded that “Serious side effects occur in less than 1 percent of patients, and major adverse events—significant infection, blood loss, or hospitalization—occur in less than 0.3 percent of patients. The risk of death is almost non-existent.”

Anti-abortion group’s studies retracted before Supreme Court mifepristone case Read More »

humans-are-living-longer-than-ever-no-matter-where-they-come-from 

Humans are living longer than ever no matter where they come from 

Biology, health, Longevity, public health, Science / /

Live long and prosper? —

Disease outbreaks and human conflicts help dictate regional differences in longevity.

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An older person drinking coffee in an urban environment.

Most of us want to stay on this planet as long as possible. While there are still differences depending on sex and region, we are now living longer as a species—and it seems life spans will only continue to grow longer.

Researcher David Atance of Universidad de Alcalá, Spain, and his team gathered data on the trends of the past. They then used their findings to project what we can expect to see in the future. Some groups have had it harder than others because of factors such as war, poverty, natural disasters, or disease, but the researchers found that morality and longevity trends are becoming more similar regardless of disparities between sexes and locations.

“The male-female gap is decreasing among the [clusters],” they said in a study recently published in PLOS One.

Remembering the past

The research team used specific mortality indicators—such as life expectancy at birth and most common age at death–to identify five global clusters that reflect the average life expectancy in different parts of the world. The countries in these clusters changed slightly from 1990 to 2010 and are projected to change further by 2030 (though 2030 projections are obviously tentative). Data for both males and females was considered when deciding which countries belonged in which cluster during each period. Sometimes, one sex thrived while the other struggled within a cluster—or even within the same country.

Clusters that included mostly wealthier countries had the best chance at longevity in 1990 and 2010. Low-income countries predictably had the worst mortality rate. In 1990, these countries, many of which are in Africa, suffered from war, political upheaval, and the lethal spread of HIV/AIDS. Rwanda endured a bloody civil war during this period. Around the same time, Uganda had tensions with Rwanda, as well as Sudan and Zaire. In the Middle East, the Gulf War and its aftermath inevitably affected 1990 male and female populations.

Along with a weak health care system, the factors that gave most African countries a high mortality rate were still just as problematic in 2010. In all clusters, male life spans tended to differ slightly less between countries than female life spans. However, in some regions, there were differences between how long males lived compared to females. Mortality significantly increased in 1990 male populations from former Soviet countries after the dissolution of the Soviet Union, and this trend continued in 2010. Deaths in those countries were attributed to violence, accidents, cardiovascular disease, alcohol, an inadequate healthcare system, poverty, and psychosocial stress.

Glimpsing the future

2030 predictions must be taken with caution. Though past trends can be good indicators of what is to come, trends do not always continue. While things may change between now and 2030 (and those changes could be drastic), these estimates project what would happen if past and current trends continue into the relatively near future.

Some countries might be worse off in 2030. The lowest-income, highest-mortality cluster will include several African countries that have been hit hard with wars as well as political and socioeconomic challenges. The second low-income, high-mortality cluster, also with mostly African countries, will now add some Eastern European and Asian countries that suffer from political and socioeconomic issues most have recently been involved in conflicts and wars or still are, such as Ukraine.

The highest-income, lowest-mortality cluster will gain some countries. These include Chile, which has made strides in development that are helping people live longer.

Former Soviet countries will probably continue to face the same issues they did in 1990 and 2010. They fall into one of the middle-income, mid-longevity clusters and will most likely be joined by some Latin American countries that were once in a higher bracket but presently face high levels of homicide, suicide, and accidents among middle-aged males. Meanwhile, there are some other countries in Latin America that the research team foresees as moving toward a higher income and lower mortality rate.

Appearances can be deceiving

The study places the US in the first or second high-income, low-mortality bracket, depending on the timeline. This could make it look like it is doing well on a global scale. While the study doesn’t look at the US specifically, there are certain local issues that say otherwise.

A 2022 study by the Centers for Disease Control and Prevention suggests that pregnancy and maternal care in the US is abysmal, with a surprisingly high (and still worsening) maternal death rate of about 33 deaths per 100,000 live births. This is more than double what it was two decades ago. In states like Texas, which banned abortion after the overturn of Roe v. Wade, infant deaths have also spiked. The US also has the most expensive health care system among high-income countries, which was only worsened by the pandemic.

The CDC also reports that life expectancy in the US keeps plummeting. Cancer, heart disease, stroke, drug overdose, and accidents are the culprits, especially in middle-aged Americans. There has also been an increase in gun violence and suicides. Guns have become the No. 1 killer of children and teens, which used to be car accidents.

Whether the US will stay in that top longevity bracket is also unsure, especially if maternal death rates keep rising and there aren’t significant improvements made to the health care system. There and elsewhere, there’s no way of telling what will actually happen between now and 2030, but Atance and his team want to revisit their study then and compare their estimates to actual data. The team is also planning to further analyze the factors that contribute to longevity and mortality, as well as conduct surveys that could support their predictions. We will hopefully live to see the results.

PLOS One, 2024. DOI:  10.1371/journal.pone.0295842

Humans are living longer than ever no matter where they come from  Read More »

biogen-dumps-dubious-alzheimer’s-drug-after-profit-killing-fda-scandal

Biogen dumps dubious Alzheimer’s drug after profit-killing FDA scandal

aducanumab, Aduhelm, Alzheimer's, Biogen, clinical trial, fda, health, Science / /
Multistory glass office building.

Enlarge / The exterior of the headquarters of biotechnology company Biogen in Cambridge, Massachusetts.

Biotechnology company Biogen is abandoning Aduhelm, its questionable Alzheimer’s drug that has floundered on the market since its scandal-plagued regulatory approval in 2021 and brow-raising pricing.

On Wednesday, the company announced it had terminated its license for Aduhelm (aducanumab) and will stop all development and commercialization activities. The rights to Aduhelm will revert back to the Neurimmune, the Swiss biopharmaceutical company that discovered it.

Biogen will also end the Phase 4 clinical trial, ENVISION, that was required by the Food and Drug Administration to prove Biogen’s claims that Aduhelm is effective at slowing progression of Alzheimer’s in its early stages—something two Phase 3 trials failed to do with certainty.

In the announcement, Biogen noted it took a financial hit of $60 million in the fourth quarter of 2023 to close out its work on Aduhelm, which the company at one point reportedly estimated would bring in as much as $18 billion in revenue per year.

The saga

But the data never appeared to support such lofty aspirations. The drug is intended to work against the clumps of misfolded beta-amyloid protein that accumulate in the brains of people with Alzheimer’s. Though a small, early clinical trial showed the drug could reduce plaques in the brains of people with Alzheimer’s, it initially failed two identically designed Phase 3 trials. The trials, which collectively enrolled nearly 3,300 patients, intended to evaluate if the drug could slow the progression of Alzheimer’s in its early stages.

In March 2019, the company announced that it was ending both trials after a futility analysis indicated that the drug wasn’t working. But later that year, Biogen stunningly reversed course, saying that additional data had rolled in from the trials after the March announcement. A new analysis of the data from one of the two trials indicated that a subset of patients given the highest dose showed a small benefit on cognitive tests—though the patients in the other trial still saw no benefit. The data also found that 40 percent of patients given the high dose developed brain swelling.

Biogen boldly submitted its data to the FDA for approval. In November 2020, a panel of independent advisors for the FDA voted resoundingly against Aduhelm’s approval. Ten of 11 committee members voted against the drug while the remaining member voted “uncertain.” After voting no, one member commented on the “incongruity” of Biogen’s presentation of the drug and the actual data. “It just feels to me like the audio and the video on the TV are out of sync, and there are literally a dozen red threads that suggests concerns about the consistency of evidence—a dozen,” the member said. The FDA, too, in its own statistical analysis of the data, concluded that “there is no compelling substantial evidence of treatment effect or disease slowing.”

Biogen dumps dubious Alzheimer’s drug after profit-killing FDA scandal Read More »

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

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

Patients vs. profits —

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Alert —

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

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A baby with measles.

Enlarge / A baby with measles.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Outraging —

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

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

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

Getty Images | The Washington Post

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

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

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

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

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

Study design

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

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

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

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

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

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

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

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A studio portrait of a crying baby.

Enlarge / A studio portrait of a crying baby.

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

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

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

Rapid decline

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

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

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

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

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