health

unvaccinated-florida-kids-exposed-to-measles-can-skip-quarantine,-officials-say

Unvaccinated Florida kids exposed to measles can skip quarantine, officials say

anti-vaccine, Florida, health, Ladapo, measles, MMR, Science, vaccines / /

Bad idea —

On Tuesday, nearly 20 percent of the school’s 1,067 students were reportedly absent.

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Florida Surgeon General Dr. Joseph Ladapo speaks during a press conference at Neo City Academy in Kissimmee, Florida.

Enlarge / Florida Surgeon General Dr. Joseph Ladapo speaks during a press conference at Neo City Academy in Kissimmee, Florida.

Paul Hennessy/SOPA Images/LightRocket via Getty Images

A sixth student at Florida’s Manatee Bay Elementary School outside of Fort Lauderdale has a confirmed case of measles, health officials announced late Tuesday. However, health officials are not telling unvaccinated students who were potentially exposed to quarantine.

The school has a low vaccination rate, suggesting that the extremely contagious virus could spark a yet larger outbreak. But in a letter sent to parents late Tuesday, Florida Surgeon General Joseph Ladapo—known for spreading anti-vaccine rhetoric and vaccine misinformation—indicated that unvaccinated students can skip the normally recommended quarantine period.

The letter, signed by Ladapo, noted that people with measles can be contagious from four days before the rash develops through four days after the rash appears. And while symptoms often develop between 8 to 14 days after exposure, the disease can take 21 days to appear. As such, the normal quarantine period for exposed and unvaccinated people, who are highly susceptible to measles, is 21 days.

“Because of the high likelihood of infection, it is normally recommended that children stay home until the end of the infectious period, which is currently March 7, 2024,” Ladapo’s letter states, adding that the date could change as the situation develops. “However, due to the high immunity rate in the community, as well as the burden on families and educational costs of healthy children missing school, [the health department] is deferring to parents or guardians to make decisions about school attendance.”

Local media outlets reported that, on Tuesday, more than 200 of the school’s 1,067 students were absent.

The measles cluster began Friday when a third grader, who had not recently traveled, was diagnosed with the vaccine-preventable illness. Over the weekend, three additional cases were identified, leading the local health department to release a health advisory. Two additional cases were identified this week. It’s unclear if all six children are unvaccinated.

According to a county vaccine study, only 89.31 percent of the school’s students were vaccinated in the 2023/2024 school year, suggesting that around 114 students are susceptible due to their vaccination status.

The measles virus spreads easily through respiratory transmission and can linger in air space for up to two hours after an infected person has been in an area. Among people susceptible to the virus—those who are unvaccinated or have compromised immune systems—up to 90 percent will become infected upon exposure. People who are fully vaccinated, meanwhile, are considered protected. Two doses of the Measles, Mumps, and Rubella (MMR) vaccine are 97 percent effective at preventing the disease.

Measles symptoms include high fever, runny nose, red and watery eyes, and a cough, as well as a telltale rash that develops after initial symptoms. About 1 in 5 unvaccinated people with measles are hospitalized, according to the Centers for Disease Control and Prevention, while 1 in 20 infected children develop pneumonia and up to 3 in 1,000 children die of the infection.

Unvaccinated Florida kids exposed to measles can skip quarantine, officials say Read More »

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Ala. hospital halts IVF after state’s high court ruled embryos are “children”

Alabama, assisted reproductive technology, children, embryo, fertility, frozen embryo, health, IVF, Science / /

Consequences —

Anger and uncertainty spread in wake of Friday’s ruling by the state’s Supreme Court.

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Nitrogen tanks holding tens of thousands of frozen embryos and eggs sit in the embryology lab at New Hope Fertility Center in New York City on December 20, 2017.

Enlarge / Nitrogen tanks holding tens of thousands of frozen embryos and eggs sit in the embryology lab at New Hope Fertility Center in New York City on December 20, 2017.

The University of Alabama at Birmingham (UAB) health system is halting in vitro fertilization treatment in the wake of a ruling by the state’s Supreme Court on Friday that deemed frozen embryos to be “children,” The ruling opens up anyone who destroys embryos to liability in a wrongful death lawsuit, according to multiple media reports.

The announcement—the first facility to report halting IVF services—is the much-feared outcome of Friday’s ruling, which was widely decried by reproductive health advocates.

“We are saddened that this will impact our patients’ attempt to have a baby through IVF, but we must evaluate the potential that our patients and our physicians could be prosecuted criminally or face punitive damages for following the standard of care for IVF treatments,” UAB said a statement to media. The statement noted that egg retrieval would continue but that egg fertilization and embryo development are now paused.

Ars has reached out to UAB for further comment and will update this story with any additional information.

Production of extra embryos is a normal part of IVF treatment for several reasons. Most notably, not all embryos will be viable, implant in a uterus, and lead to a live birth. So, creating as many embryos as possible is a common strategy to ensure that people who wish to conceive have the best chance of doing so. Embryos can also be screened for genetic conditions, allowing only the healthiest to be implanted, while those with debilitating or fatal abnormalities can be discarded.

In 2021, approximately 238,126 patients in the US had 413,776 rounds of IVF, resulting in 97,128 live-born infants, according to the Centers for Disease Control and Prevention. The percentage of egg retrievals that lead to a live birth ranges from 54 percent to 9 percent, depending on a patient’s age.

But, the standard practices of IVF used for hundreds of thousands of patients each year were thrown into question and upheaval Friday when the Alabama Supreme Court ruled that all embryos, even those outside of a uterus or frozen in storage, are “children” under state law. Anyone who destroys them is liable under the state’s Wrongful Death of a Minor Act, the court concluded. Chief Justice Tom Parker cited his religious beliefs and quoted the Bible to support the stance.

Reproductive health experts quickly speculated that the ruling would roll back IVF treatment in the state. Some facilities, such as the case of UAB, may halt treatment entirely. While others may choose to fertilize eggs conservatively, adding cost and time to the already arduous process of IVF. Genetic screening of embryos from couples who carry debilitating or fatal mutations may no longer be possible. Doctors could be sued if an embryonic ball of a few cells does not survive the treatment. Insurance rates for fertility clinics could skyrocket. Patients, meanwhile, may have to keep unneeded embryos frozen indefinitely.

On Tuesday, The Washington Post reported that the ruling had created a wave of anger, shock, and confusion across the state. Patients are considering moving frozen embryos—some leftover from IVF rounds, some purposely banked for future use—to storage facilities out of the state. Lawyers cautioned that divorce settlements that stipulate frozen embryos must be destroyed may now be void.

But the fear and confusion don’t end there. Health advocates worry more states will follow Alabama’s lead. And, if small clumps of cells gain personhood rights in more states, liability could spread to contraceptive use and people who suffer a miscarriage.

Ala. hospital halts IVF after state’s high court ruled embryos are “children” Read More »

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Musk claims Neuralink patient doing OK with implant, can move mouse with brain

elon musk neuralink, health, Neuralink, Policy / /

Neuralink brain implant —

Medical ethicists alarmed by Musk being “sole source of information” on patient.

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A person's hand holidng a brain implant device that is about the size of a coin.

Enlarge / A Neuralink implant.

Neuralink

Neuralink co-founder Elon Musk said the first human to be implanted with the company’s brain chip is now able to move a mouse cursor just by thinking.

“Progress is good, and the patient seems to have made a full recovery, with no ill effects that we are aware of. Patient is able to move a mouse around the screen by just thinking,” Musk said Monday during an X Spaces event, according to Reuters.

Musk’s update came a few weeks after he announced that Neuralink implanted a chip into the human. The previous update was also made on X, the Musk-owned social network formerly named Twitter.

Musk reportedly said during yesterday’s chat, “We’re trying to get as many button presses as possible from thinking. So that’s what we’re currently working on is: can you get left mouse, right mouse, mouse down, mouse up… We want to have more than just two buttons.”

Neuralink itself doesn’t seem to have issued any statement on the patient’s progress. We contacted the company today and will update this article if we get a response.

“Basic ethical standards” not met

Neuralink’s method of releasing information was criticized last week by Arthur Caplan, a bioethics professor and head of the Division of Medical Ethics at NYU Grossman School of Medicine, and Jonathan Moreno, a University of Pennsylvania medical ethics professor.

“Science by press release, while increasingly common, is not science,” Caplan and Moreno wrote in an essay published by the nonprofit Hastings Center. “When the person paying for a human experiment with a huge financial stake in the outcome is the sole source of information, basic ethical standards have not been met.”

Caplan and Moreno acknowledged that Neuralink and Musk seem to be “in the clear” legally:

Assuming that some brain-computer interface device was indeed implanted in some patient with severe paralysis by some surgeons somewhere, it would be reasonable to expect some formal reporting about the details of an unprecedented experiment involving a vulnerable person. But unlike drug studies in which there are phases that must be registered in a public database, the Food and Drug Administration does not require reporting of early feasibility studies of devices. From a legal standpoint Musk’s company is in the clear, a fact that surely did not escape the tactical notice of his company’s lawyers.

But they argue that opening “the brain of a living human being to insert a device” should have been accompanied with more public detail. There is an ethical obligation “to avoid the risk of giving false hope to countless thousands of people with serious neurological disabilities,” they wrote.

A brain implant could have complications that leave a patient in worse condition, the ethics professors noted. “We are not even told what plans there are to remove the device if things go wrong or the subject simply wants to stop,” Caplan and Moreno wrote. “Nor do we know the findings of animal research that justified beginning a first-in-human experiment at this time, especially since it is not lifesaving research.”

Clinical trial still to come

Neuralink has been criticized for alleged mistreatment of animals in research and was reportedly fined $2,480 for violating US Department of Transportation rules on the movement of hazardous materials after inspections of company facilities last year.

People “should continue to be skeptical of the safety and functionality of any device produced by Neuralink,” the nonprofit Physicians Committee for Responsible Medicine said after last month’s announcement of the first implant.

“The Physicians Committee continues to urge Elon Musk and Neuralink to shift to developing a noninvasive brain-computer interface,” the group said. “Researchers elsewhere have already made progress to improve patient health using such noninvasive methods, which do not come with the risk of surgical complications, infections, or additional operations to repair malfunctioning implants.”

In May 2023, Neuralink said it obtained Food and Drug Administration approval for clinical trials. The company’s previous attempt to gain approval was reportedly denied by the FDA over safety concerns and other “deficiencies.”

In September, the company said it was recruiting volunteers, specifically people with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis. Neuralink said the first human clinical trial for PRIME (Precise Robotically Implanted Brain-Computer Interface) will evaluate the safety of its implant and surgical robot, “and assess the initial functionality of our BCI [brain-computer interface] for enabling people with paralysis to control external devices with their thoughts.”

Musk claims Neuralink patient doing OK with implant, can move mouse with brain Read More »

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Measles erupts in Florida school where 11% of kids are unvaccinated

CDC, Florida, health, Infectious disease, measles, Science, Transmission, vaccination rate, virus / /

outbreak potential —

Over 100 children at the school are susceptible to virus.

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A child with measles.

Enlarge / A child with measles.

Florida health officials on Sunday announced an investigation into a cluster of measles cases at an elementary school in the Fort Lauderdale area with a low vaccination rate, a scenario health experts fear will become more and more common amid slipping vaccination rates nationwide.

On Friday, Broward County Public School reported a confirmed case of measles in a student at Manatee Bay Elementary School in the city of Weston. A local CBS affiliate reported that the case was in a third-grade student who had not recently traveled. On Saturday, the school system announced that three additional cases at the same school had been reported, bringing the current reported total to four cases.

On Sunday, the Florida Department of Health in Broward County (DOH-Broward) released a health advisory about the cases and announced it was opening an investigation to track contacts at risk of infection.

At Manatee Bay Elementary School, the number of children at risk could be over 100 students. According to a Broward County vaccine study reported by the local CBS outlet, only 89.31 percent of students at Manatee Bay Elementary School were fully immunized in the 2023/2024 school year, which is significantly lower than the target vaccination coverage of 95 percent. The school currently has 1,067 students enrolled, suggesting that up to 114 students are vulnerable to the infection based on their vaccination status.

Measles is one of the most contagious viruses known. It spreads via respiratory and airborne transmission. The virus can linger in air space for up to two hours after an infected person has been in an area. People who are not vaccinated or have compromised immune systems are susceptible, and up to 90 percent of susceptible people exposed to the virus will become infected. Measles symptoms typically begin around eight to 14 days after exposure, but the disease can incubate for up to 21 days. The symptoms begin as a high fever, runny nose, red and watery eyes, and a cough before the telltale rash develops. Infected people can be contagious from four days before the rash develops through four days after the rash appears, according to the Centers for Disease Control and Prevention. About 1 in 5 unvaccinated people with measles is hospitalized, the CDC adds, while 1 in 20 infected children develop pneumonia and up to 3 in 1,000 children die of the infection.

Those who are not immunocompromised and are fully vaccinated against measles (who have received two doses of the Measles, Mumps, and Rubella (MMR) vaccine) are generally not considered at risk. The two doses are about 97 percent effective at preventing measles and protection is considered to be life-long.

The DOH-Broward said it is now “identifying susceptible contacts that may be candidates for post-exposure prophylaxis through MMR or immunoglobulin.”

While the risk of measles is generally low in the US—the country declared it eliminated in 2000—the threat of large outbreaks is growing as vaccination rates slip. Many cases in the US are linked to travel from countries where the virus still circulates. But, if a travel-related case lands in a pocket with low vaccination coverage, the virus can take off. Such was the case in 2019, when the country tallied 1,274 measles cases and nearly lost its elimination status.

Health officials typically consider vaccination coverage of 95 percent or greater to protect from ongoing transmission. In the years since the COVID-19 pandemic began, vaccination rates among US kindergartners have slipped to 93 percent, and vaccination exemptions reached an all-time high in the latest data from the 2022-2023 school year. There are now at least 10 states that have vaccination exemption rates above 5 percent, meaning that even if every non-exempt child is vaccinated, those states will not have enough coverage to reach the 95 percent target.

The CDC has tallied 20 measles cases in the US so far this year. But that is the tally as of February 15; it does not include any of the Florida cases reported since Friday. In 2023, there were 58 measles cases reported to the CDC.

This story was updated to include additional information about measles infection outcomes.

Measles erupts in Florida school where 11% of kids are unvaccinated Read More »

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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 »

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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 »

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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.”

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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.

–

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

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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.”

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