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alarming-superbug-from-deadly-eyedrop-outbreak-has-spread-to-dogs

Alarming superbug from deadly eyedrop outbreak has spread to dogs

antibiotics, CDC, drug resistance, eyedrop, EzriCare, fda, infectious diseases, outbreak, Pseudomonas aeruginosa, Science / /

gone to the dogs —

It’s unclear how the dogs became infected with the same strain in the eyedrops.

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A dog gets examined by veterinary technicians in Texas.

Enlarge / A dog gets examined by veterinary technicians in Texas.

Two separately owned dogs in New Jersey tested positive last year for a dreaded, extensively drug resistant bacterial strain spread in the US by contaminated artificial eye drops manufactured in India. Those drops caused a deadly multi-state outbreak in humans over many months last year, with at least 81 people ultimately infected across 18 states. Fourteen people lost their vision, an additional four had eyeballs surgically removed, and four people died.

The preliminary data on the dogs—presented recently at a conference of disease detectives hosted by the Centers for Disease Control and Prevention—highlights that now that the deadly outbreak strain has been introduced around the US, it has the potential to lurk in unexpected places, spread its drug resistance to fellow bacteria, and cause new infections in people and animals who may have never used the drops.

The two dogs in New Jersey were not known to have received the drops linked to the outbreak: EzriCare Artificial Tears and two additional products made by the same manufacturer, which were recalled in February 2023. Such over-the-counter products are sometimes used in animals as well as people. But the dogs’ separate owners said they didn’t recall using the drops either. They also didn’t report any exposures in health care settings or recent international travel that could explain the infections. One of the dogs did, at one point, receive eye drops, but they were not an outbreak-associated brand. The only connection between the two dogs was that they were both treated at the same veterinary hospital, which didn’t stock the outbreak-associated eyedrops.

The dogs’ infections were caught between March and June 2023 when clinicians at the veterinary hospital were working to address a chronic cough in one of the dogs and a stubborn ear infection in the other, according to CBS News, which was present for the CDC’s conference of its Epidemic Intelligence Service in Atlanta. The ear and lung swabs were sent to an academic veterinary laboratory in Pennsylvania, where a microbiologist noticed that bacteria from both swabs had uncommon drug-resistance features. The microbiologist then uploaded genetic sequences of the bacterial strains to a national database, where they caught the attention of the CDC and state health authorities.

The genetic sequences uploaded were of the carbapenemase-producing carbapenem-resistant Pseudomonas aeruginosa (CP-CRPA) strain—and they were highly similar to the bacterial strain identified in the deadly eyedrop outbreak. These bacteria are extensively resistant to antibiotics, resisting even last-line drugs, and can silently colonize animals and humans for months or years. An investigation ensued.

Infection gaps

Emma Price, the CDC epidemic intelligence service officer who presented the investigation’s findings at the conference, suggested it was fortunate they were able to make the connection. “Because [the academic veterinary laboratory] had a grant and a veterinary microbiologist works there, he did his great due diligence and uploaded the results. That’s how we got the notification, because the strain matched the outbreak strain,” Price told CBS News.

However, the disease detectives were ultimately unable to identify exactly how the two dogs became infected. “Shared exposures included treatment in the veterinary hospital’s surgical preparation and recovery areas for both canines and ophthalmology department visits by either the affected canine or another animal in the same household,” Price and colleagues wrote in their findings. But all of the sampling done of the veterinary hospital where the dogs were treated turned up negative for the eyedrop outbreak strain.

In the process of the investigation, the epidemiologists also conducted an infection control assessment of the veterinary hospital, finding a variety of “gaps.” These included problems with hand hygiene practices, personal protective equipment use—including use of gloves—and equipment and environmental cleaning and disinfection at the hospital. Price noted that these problems are not uncommon and that there is a general lack of emphasis on infection control in veterinary settings.

Though Price and her colleagues were unable to identify the direct route of infection, they suspect the dogs were likely infected either by exposure to a contaminated product or secondary transmission at the veterinary hospital.

Both dogs have since made full recoveries, but because CRPA strains can silently colonize many body sites on both humans and animals, it’s possible that the bacteria still linger on the dogs or on the other pets and people in their households. Price warned the owners of possible future transmission and recommended they flag this risk to their health care providers. She also noted the potential for the bacteria to spread from dog to dog. It would be ideal to “keep the dogs away from other dogs in the future, which we understand is a difficult thing to do,” she said.

Alarming superbug from deadly eyedrop outbreak has spread to dogs Read More »

dea-to-reclassify-marijuana-as-a-lower-risk-drug,-reports-say

DEA to reclassify marijuana as a lower-risk drug, reports say

cannabis, DEA, fda, health, marijuana, Policy, research, Scheduling, Science / /

downgrade —

Marijuana to move from Schedule 1, the most dangerous drug group, to Schedule 3.

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Medical marijuana growing in a facility in Canada.

Enlarge / Medical marijuana growing in a facility in Canada.

The US Drug Enforcement Administration is preparing to reclassify marijuana to a lower-risk drug category, a major federal policy change that is in line with recommendations from the US health department last year. The upcoming move was first reported by the Associated Press on Tuesday afternoon and has since been confirmed by several other outlets.

The DEA currently designates marijuana as a Schedule 1 drug, defined as drugs “with no currently accepted medical use and a high potential for abuse.” It puts marijuana in league with LSD and heroin. According to the reports today, the DEA is moving to reclassify it as a Schedule 3 drug, defined as having “a moderate to low potential for physical and psychological dependence.” The move would place marijuana in the ranks of ketamine, testosterone, and products containing less than 90 milligrams of codeine.

Marijuana’s rescheduling would be a nod to its potential medical benefits and would shift federal policy in line with many states. To date, 38 states have already legalized medical marijuana.

In August, the Department of Health and Human Services advised the DEA to move marijuana from Schedule 1 to Schedule 3 based on a review of data by the Food and Drug Administration. The recommendation came after the FDA, in August, granted the first approval of a marijuana-based drug. The drug, Epidiolex (cannabidiol), is approved to treat rare and severe forms of epilepsy. The approval was expected to spur the DEA to downgrade marijuana’s scheduling, though some had predicted it would have occurred earlier. Independent expert advisors for the FDA voted unanimously in favor of approval, convinced by data from three high-quality clinical trials that indicated benefits and a “negligible abuse potential.”

The shift may have a limited effect on consumers in states that have already eased access to marijuana. In addition to the 38 states with medical marijuana access, 24 states have legalized recreational use. But, as a Schedule 3 drug, marijuana would still be regulated by the DEA. The Associated Press notes that the rule change means that roughly 15,000 dispensaries would need to register with the DEA, much like pharmacies, and follow strict reporting requirements.

One area that will clearly benefit from the change is scientific research on marijuana’s effects. Many academic scientists are federally funded and, as such, they must follow federal regulations. Researching a Schedule 1 drug carries extensive restrictions and rules, even for researchers in states where marijuana is legalized. A lower scheduling will allow researchers better access to conduct long-awaited studies.

It’s unclear exactly when the move will be announced and finalized. The DEA must get sign-off from the White House Office of Management and Budget (OMB) before proceeding. A source for NBC News said Attorney General Merrick Garland may submit the rescheduling to the OMB as early as Tuesday afternoon. After that, the DEA will open a public comment period before it can finalize the rule.

The US Department of Justice told several outlets that it “continues to work on this rule. We have no further comment at this time.”

DEA to reclassify marijuana as a lower-risk drug, reports say Read More »

20%-of-grocery-store-milk-has-traces-of-bird-flu,-suggesting-wider-outbreak

20% of grocery store milk has traces of bird flu, suggesting wider outbreak

bird flu, CDC, cows, fda, H5N1, health, Infectious disease, milk, Science, USDA, virus / /

widespread —

The milk is still considered safe, but disease experts are alarmed by the prevalence.

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20% of grocery store milk has traces of bird flu, suggesting wider outbreak

The Food and Drug Administration reported late Thursday that about 20 percent of retail milk samples from around the country tested positive for genetic fragments of the bird flu, aka highly pathogenic avian influenza (HPAI) virus H5N1. While retail milk is still considered to be safe, the finding suggests that the spread of the virus in cows is more extensive than is currently known.

The FDA used a test called quantitative polymerase chain reaction (qPCR), which can only detect the presence of genetic fragments. In pasteurized retail milk, it is highly likely that those genetic snippets are merely remnants of virus particles destroyed during pasteurization. The FDA is currently conducting additional testing using egg inoculation tests, a gold standard for detecting a live virus, to confirm the effectiveness of pasteurization. Meanwhile, the director of the National Institute of Allergy and Infectious Diseases, Jeanne Marrazzo, told reporters Wednesday that tests at the agency’s federal labs so far did not identify live virus from any of its sampling. Additionally, several previous studies have found that pasteurization of eggs—which is done at a lower temperature than it is for milk—was effective at destroying H5N1.

While experts are largely unconcerned with the safety of commercial milk, the potential for wide, unrecognized spread of bird flu in dairy herds is alarming. To date, the US Department of Agriculture has only confirmed infections in 33 herds in eight states. The FDA acknowledged that of its positive samples, “a greater proportion of positive results [are] coming from milk in areas with infected herds.” But with tens of thousands of dairy herds in the US, the finding suggests that infections are being missed. It does not necessarily suggest that 20 percent of all cows are affected, since milk is pooled for commercial distribution. But 33 herds alone are unlikely to explain the high prevalence.

Last week, The New York Times reported that the one dairy herd that tested positive for bird flu in North Carolina did not show any symptoms of the infection. The possibility of asymptomatic spread of the virus among cows will make containment and monitoring far more difficult—and could explain why infections may be easily missed. On Wednesday, the USDA issued a federal order requiring dairy cattle to have a negative H5N1 test before being moved across state lines.

For now, the risk to the public is still considered low by the Centers for Disease Control and Prevention. But the more the bird flu virus spreads among mammals—and mammals with close contact with humans—the more opportunities it has to evolve to jump to and among people, experts warn.

20% of grocery store milk has traces of bird flu, suggesting wider outbreak Read More »

fragments-of-bird-flu-virus-genome-found-in-pasteurized-milk,-fda-says

Fragments of bird flu virus genome found in pasteurized milk, FDA says

avian influenza, bird flu, CDC, cows, dairy cows, fda, flu, H5N1, Infectious disease, influenza, milk, pasteurization, Science, Uncategorized / /

Milk testing —

The test cannot tell if the virus is live. The FDA still assess milk supply as safe.

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Cows being milked

Enlarge / Cows being milked

The Food and Drug Administration on Tuesday announced that genetic fragments from the highly-pathogenic avian influenza virus H5N1 have been detected in the pasteurized, commercial milk supply. However, the testing completed so far—using quantitative polymerase chain reaction (qPCR)—only detects the presence of viral genetic material and cannot tell whether the genetic material is from live and infectious viral particles or merely remnants of dead ones killed by the pasteurization process.

Testing is now ongoing to see if viable, infectious H5N1 can be identified in milk samples.

So far, the FDA still believes that the milk supply is safe. “To date, we have seen nothing that would change our assessment that the commercial milk supply is safe,” the agency said in a lengthy explanation of the finding and ongoing testing.

H5N1 made its startling jump to US dairy cows recently, with the first ever documented cases in a Texas herd confirmed on March 25. It has spread widely since then with at least 32 herds in eight states now known to be infected. The unexpected spread to bovines has raised fears that the virus is evolving to infect mammals more efficiently, and so poses a heightened risk of spread to and among humans.

But amid the alarming outbreak among the country’s dairy herds, federal agencies have appeared confident that the virus poses little risk to no risk to the safety of the milk supply.

“At this time, there continues to be no concern that this circumstance poses a risk to consumer health, or that it affects the safety of the interstate commercial milk supply because products are pasteurized before entering the market” the FDA wrote in an FAQ published Friday. “Pasteurization has continually proven to inactivate bacteria and viruses, like influenza, in milk.”

In the announcement Tuesday, the FDA also highlighted that multiple studies have shown that the pasteurization process for eggs, which uses lower temperatures than what is used for milk, is effective at inactivating H5N1.

Nevertheless, the FDA, along with the Centers for Disease Control and Prevention and the US Department of Agriculture, have continued to investigate potential risks, including establishing whether pasteurization can inactivate this specific virus. The FDA noted in its announcement Tuesday that, while pasteurization is expected to kill the virus, pasteurization is “different than complete sterilization.”

As such, it carried out the qPCR tests, expecting it might find some genetic fragments in the pasteurized milk because virus has been detected in raw milk. “Based on available information, pasteurization is likely to inactivate the virus, however the process is not expected to remove the presence of viral particles,” the FDA explained. “Therefore, some of the samples collected have indicated the presence of HPAI [Highly Pathogenic Avian Influenza] using quantitative polymerase chain reaction (qPCR) testing.”

The FDA did not indicate how many samples it has tested, where the samples were collected from, or the level of viral genetic material the samples contained.

The agency is now working on assessing whether it can identify if any virus particles are infectious using egg inoculation tests, which are considered a gold-standard for determining viral viability. It added that it will release results from those tests and others in “the next few days to weeks.”

“[W]e take this current situation and the safety of the milk supply very seriously. We recognize the importance of releasing further, actionable information,” the FDA said.

Meanwhile, the agency reported that the CDC’s food safety group has been closely monitoring emergency department data and flu testing data for any unusual trends in flu-like illness, flu, or conjunctivitis, which could indicate spread of H5N1 to people. “To date, surveillance systems do not show any unusual trends or activity,” the FDA said.

Fragments of bird flu virus genome found in pasteurized milk, FDA says Read More »

concern-grows-as-bird-flu-spreads-further-in-us-cows:-32-herds-in-8-states

Concern grows as bird flu spreads further in US cows: 32 herds in 8 states

avian influenza, bird flu, CDC, cows, dairy cows, fda, H5N1, herds, infection, milk, outbreak, Science, USDA, virus / /

Rapidly evolving —

Experts say the US is not sharing as much data on the outbreak as it should.

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Greylag geese sit on a field and rest while a cow passes by in the background.

Enlarge / Greylag geese sit on a field and rest while a cow passes by in the background.

Researchers around the world are growing more uneasy with the spread of highly pathogenic avian influenza (H5N1) in US dairy cows as the virus continues to make its way into new herds and states. Several experts say the US is not sharing enough information from the federal investigation into the unexpected and growing outbreak, including genetic information from isolated viruses.

To date, the US Department of Agriculture has tallied 32 affected herds in eight states: Idaho, Kansas, Michigan, New Mexico, North Carolina, Ohio, South Dakota, and Texas. In some cases, the movement of cattle between herds can explain the spread of the virus. But the USDA has not publicly clarified if all the herds are linked in a single outbreak chain or if there is evidence that the virus has spilled over to cows multiple times. Early infections in Texas were linked to dead wild birds (pigeons, blackbirds, and grackles) found on dairy farms. But the USDA reportedly indicated to Stat News that the infections do not appear to be all linked to the Texas cases.

Spread of the virus via cattle movements indicates that there is cow-to-cow transmission occurring, the USDA said. But it’s unclear how the virus is spreading between cows. Given that even the most symptomatic cows show few respiratory symptoms, the USDA speculates that the most likely way it is spreading is via contaminated milking equipment.

Adding to the uncertainty of the virus’s spread, The New York Times on Friday reported that the one herd found infected with H5N1 in North Carolina showed no symptoms of the virus. This raises the possibility that the virus could be silently spreading in unknown numbers of other asymptomatic herds and states. In its most recent FAQ document, the USDA encouraged testing for H5N1 if herds show clinical symptoms, such as lethargy, fever, low milk production, and loose stools. But the Times noted that the agency has begun reimbursing farms for testing asymptomatic cows.

Meanwhile, the USDA also reported that it has evidence that H5N1 from dairy farms has spread back into birds in nearby poultry farms, but how this is happening is also unknown.

Data gaps

All the uncertainty and widespread transmission raises concern about how the virus is evolving to infect mammals and whether it is heading for humans. Last week, the chief scientist for the World Health Organization, Jeremy Farrar, told reporters in Geneva that the spread of the virus in US dairy cows is an “enormous concern,” according to CNN.  “The great concern, of course, is that in doing so and infecting ducks and chickens—but now increasingly mammals—that that virus now evolves and develops the ability to infect humans. And then critically, the ability to go from human-to-human transmission.”

In particular, experts are wary that the dairy cow outbreaks could spill over to nearby pig farms as it’s doing with nearby poultry farms. Pigs can be infected with both bird flu viruses and human flu viruses, making them potential melting pots for new recombinant flu strains.

So far, the USDA says that genetic sequences of H5N1 viruses infecting cows has not revealed any mutations that “would make it more transmissible to humans and between people.” But last Thursday, Stat reported that international experts have faulted the USDA for not sharing more genetic data from its investigation, among other information. Until this weekend, the agency had only shared a few genetic sequences in an international database of viral genome sequences (GISAID).

“A country with capacity like the United States should be able to generate this information within days,” Marion Koopmans, head of the department of viroscience at Erasmus Medical Center in the Dutch city of Rotterdam told Stat last week. “I would expect very fast, very transparent updates, and it’s somewhat amazing not to see that happening.”

On Sunday, facing mounting criticism, the USDA announced the release of 239 genetic sequences to GISAID. It noted it is also adding raw data to a US federal database “in the interest of public transparency and ensuring the scientific community has access to this information as quickly as possible.” The agency said it will continue to make such data available on a rolling basis.

Dr. Rosemary Sifford, the USDA’s chief veterinarian, told the Times, “Please recall that we’ve been engaged in this for less than a month. We are working very hard to generate more information,” she said.

Overall, the USDA and the US Centers for Disease Control and Prevention continue to consider the risk to the public to be low. Farmworkers and others who have direct contact with infected animals are encouraged to take precautions, however.

While deadly to birds, H5N1 in cows is relatively mild, rarely if ever causing deaths. Milk from sick animals contains high levels of virus, but it is being destroyed. Even if some infected milk makes its way into the milk supply, the Food and Drug Administration is confident that the virus would be killed in the pasteurization process. “Pasteurization has continually proven to inactivate bacteria and viruses, like influenza, in milk,” the agency said in an FAQ Friday. Some experts have called for data confirming this, though.

Concern grows as bird flu spreads further in US cows: 32 herds in 8 states Read More »

us-drug-shortages-reach-record-high-with-323-meds-now-in-short-supply

US drug shortages reach record high with 323 meds now in short supply

adderall, ASHP, cancer drugs, DEA, drug shortages, fda, generic drugs, health, pharmacists, pharmacy, Science / /

Terrible —

The shortages affect everything from generic cancer drugs to ADHD medication.

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Takeda Pharmaceutical Co. Adderall XR brand medication arranged at a pharmacy in Provo, Utah, in November 2023.

Enlarge / Takeda Pharmaceutical Co. Adderall XR brand medication arranged at a pharmacy in Provo, Utah, in November 2023.

Drug shortages in the US have reached an all-time high, with 323 active and ongoing shortages already tallied this year, according to data collected by the American Society of Health-System Pharmacists (ASHP).

The current drug shortage total surpasses the previous record of 320, set in 2014, and is the highest recorded since ASHP began tracking shortages in 2001.

“All drug classes are vulnerable to shortages,” ASHP CEO Paul Abramowitz said in a statement Thursday. “Some of the most worrying shortages involve generic sterile injectable medications, including cancer chemotherapy drugs and emergency medications stored in hospital crash carts and procedural areas. Ongoing national shortages of therapies for attention-deficit/hyperactivity disorder [ADHD] also remain a serious challenge for clinicians and patients.”

Erin Fox, associate chief pharmacy officer of University of Utah Health, told CBS MoneyWatch, that most of the drugs in short supply are generic, older products, and around half are injectable drugs that require more stringent manufacturing processes.

There are myriad reasons for the hundreds of drug shortages now facing doctors and patients, many of which remain unclear. But, as Ars has reported before, the root cause of shortages of low-cost, off-patent generic drugs is well established. These drugs have razor-thin to non-existent profit margins, driven by middle managers who have, in recent years, pushed down wholesale prices to rock-bottom levels. In some cases, generic manufacturers lose money on the drugs, disincentivizing other players in the pharmaceutical industry from stepping in to bolster fragile supply chains. Several generic manufacturers have filed for bankruptcy recently.

For other drugs, the situation is more complicated. The ADHD drug Adderall, for instance, has been in critical shortage since October 2022, causing millions of patients around the country to struggle to fill their prescriptions. It began when a manufacturing delay for one manufacturer kicked off a shortfall. Although that problem has since been resolved, it came amid a significant increase in Adderall prescriptions, which spiked further during the pandemic when telehealth prescribing became more common. Additionally, because Adderall—made of amphetamine-mixed salts—is a controlled substance, the Drug Enforcement Administration sets limits or “quotas” on how much of it manufacturers can make. Such quotas can exacerbate shortages, ASHP said.

But, in a joint letter with the Food and Drug Administration last August, the DEA said that, by its data, manufacturers of amphetamine products (including Adderall) only sold approximately 70 percent of their allotted quotas in 2022. That meant that there were approximately 1 billion more doses that they could have produced but did not make or ship. At the time, the agencies said its 2023 data was trending in the same direction.

In 60 percent of cases, manufacturers do not know or do not provide reasons why their drugs fall into short supply, ASHP found.

The organization has put forth policy recommendations to prevent shortages and improve supply chains, advocating for federal and regulatory changes. “Much work remains to be done at the federal level to fix the root causes of drug shortages,” Abramowitz said. “ASHP will continue to engage with policymakers regularly as we guide efforts to draft and pass new legislation to address drug shortages and continue to strongly advocate on behalf of our members for solutions that work.”

US drug shortages reach record high with 323 meds now in short supply Read More »

$158,000-als-drug-pulled-from-market-after-failing-in-large-clinical-trial

$158,000 ALS drug pulled from market after failing in large clinical trial

ALS, Amylyx, clinical trial, fda, health, Science / /

Off the market —

The drug is now unavailable to new patients; its maker to lay off 70% of employees.

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$158,000 ALS drug pulled from market after failing in large clinical trial

Amylyx, the maker of a new drug to treat ALS, is pulling that drug from the market and laying off 70 percent of its workers after a large clinical trial found that the drug did not help patients, according to an announcement from the company Thursday.

The drug, Relyvrio, won approval from the Food and Drug Administration in September 2022 to slow the progression of ALS (amyotrophic lateral sclerosis, or Lou Gehrig’s disease). However, the data behind the controversial decision was shaky at best; it was based on a study of just 137 patients that had several weaknesses and questionable statistical significance, and FDA advisors initially voted against approval. Still, given the severity of the neurogenerative disease and lack of effective treatments, the FDA ultimately granted approval under the condition that the company was working on a Phase III clinical trial to solidify its claimed benefits.

Relyvrio—a combination of two existing, generic drugs—went on the market with a list price of $158,000.

Last month, the company announced the top-line results from that 48-week, randomized, placebo-controlled trial involving 664 patients: Relyvrio failed to meet any of the trial’s goals. The drug did not improve patients’ physical functions, which were scored on a standardized ALS-specific test, nor did it improve quality of life, respiratory function, or overall survival. At that time, the co-CEOs of the company said they were “surprised and deeply disappointed” by the result, and the company acknowledged that it was considering voluntarily withdrawing the drug from the market.

In the announcement on Thursday, the company called Relyvrio’s market withdrawal a “difficult moment for the ALS community.” Patients already taking the medication who wish to continue taking it will be able to do so through a free drug program, the company said. It is no longer available to new patients, effective Thursday.

Amylyx is now “restructuring” to focus on two other drug candidates that treat different neurodegenerative disease. The change will include laying off 70 percent of its workforce, which, according to The Washington Post, includes more than 350 employees.

Relyvrio is part of a series of similarly controversial drugs for devastating neurodegenerative diseases that have gained FDA approval despite questionable data. In January, drug maker Biogen announced it was abandoning Aduhelm, a highly contentious Alzheimer’s drug that failed two large trials prior to its heavily criticized approval.

$158,000 ALS drug pulled from market after failing in large clinical trial Read More »

scotus-mifepristone-case:-justices-focus-on-anti-abortion-groups’-legal-standing

SCOTUS mifepristone case: Justices focus on anti-abortion groups’ legal standing

Abortion, alito, barrett, clarence thomas, comstock, drug approval, fda, gorsuch, kagan, ketanji brown jackson, medication abortion, mifepristone, Policy, Science, SCOTUS / /
Demonstrators participate in an abortion-rights rally outside the Supreme Court as the justices of the court hear oral arguments in the case of the <em>US Food and Drug Administration v. Alliance for Hippocratic Medicine</em> on March 26, 2024 in Washington, DC.” src=”https://cdn.arstechnica.net/wp-content/uploads/2024/03/GettyImages-2115237711-800×533.jpeg”></img><figcaption> <p><a data-height=Enlarge / Demonstrators participate in an abortion-rights rally outside the Supreme Court as the justices of the court hear oral arguments in the case of the US Food and Drug Administration v. Alliance for Hippocratic Medicine on March 26, 2024 in Washington, DC.

The US Supreme Court on Tuesday heard arguments in a case seeking to limit access to the abortion and miscarriage drug mifepristone, with a majority of justices expressing skepticism that the anti-abortion groups that brought the case have the legal standing to do so.

The case threatens to dramatically alter access to a drug that has been safely used for decades and, according to the Guttmacher Institute, was used in 63 percent of abortions documented in the health care system in 2023. But, it also has sweeping implications for the Food and Drug Administration’s authority over drugs, marking the first time that courts have second-guessed the agency’s expert scientific analysis and moved to restrict access to an FDA-approved drug.

As such, the case has rattled health experts, reproductive health care advocates, the FDA, and the pharmaceutical industry alike. But, based on the line of questioning in today’s oral arguments, they have reason to breathe a sigh of relief.

Standing

The case was initially filed in 2022 by a group of anti-abortion organizations led by the Alliance for Hippocratic Medicine. They collectively claimed that the FDA’s approval of mifepristone in 2000 was unlawful, as were FDA actions in 2016 and 2021 that eased access to the drug, allowing for it to be prescribed via telemedicine and dispensed through the mail. The anti-abortion groups justified bringing the lawsuit by claiming that the doctors in their ranks are harmed by the FDA’s actions because they are forced to treat girls and women seeking emergency medical care after taking mifepristone and experiencing complications.

The FDA and numerous medical organizations have emphatically noted that mifepristone is extremely safe and the complications the lawsuit references are exceedingly rare. Serious side effects occur in less than 1 percent of patients, and major adverse events, including infection, blood loss, or hospitalization, occur in less than 0.3 percent, according to the American College of Obstetricians and Gynecologists. Deaths are almost non-existent.

Still, a conservative federal judge in Texas sided with the anti-abortion groups last year, revoking the FDA’s 2000 approval. A conservative panel of judges for the Court of Appeals for the 5th Circuit in New Orleans then partially overturned the ruling, undoing the lower court’s ruling on the 2000 approval, allowing the FDA’s approval to stand, but still finding the FDA’s 2016 and 2021 actions unlawful. The ruling was frozen until the Supreme Court weighed in.

Today, many of the Supreme Court Justices went back to the very beginning: the claimed scenario that the plaintiff doctors have been or will imminently be harmed by the FDA’s actions. At the outset of the hearings, Solicitor General Elizabeth Prelogar argued that the plaintiffs had not been harmed, and, even if they were, they already had federal protections and recourse. Any doctor who consciously objects to caring for a patient who has had an abortion already has federal protections that prevent them from being forced to provide that care, Prelogar argued. As such, hospitals have legal obligations and have set up contingency and staffing plans to prevent violating those doctors’ federal conscious objection protections.

SCOTUS mifepristone case: Justices focus on anti-abortion groups’ legal standing Read More »

lifesaving-gene-therapy-for-kids-is-world’s-priciest-drug-at-$4.25m

Lifesaving gene therapy for kids is world’s priciest drug at $4.25M

drug pricing, fda, gene therapy, health, metachromatic leukodystrophy, Orchard, rare genetic conditions, Science / /

promising but pricey —

It’s unclear if government and private insurance plans can cover the costs.

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A mother with her twin 6-year-old boys who have metachromatic leukodystrophy, a genetic disease that leaves them unable to move. Photo taken on September 3, 2004.

Enlarge / A mother with her twin 6-year-old boys who have metachromatic leukodystrophy, a genetic disease that leaves them unable to move. Photo taken on September 3, 2004.

In a medical triumph, US Food and Drug Administration on Monday approved a gene therapy that appears to trounce a rare, tragic disease that progressively steals children’s ability to talk, move, and think, leading to a vegetative state and death. For those who begin to slip away in infancy, many die by age 5. But, with the new therapy, 37 children in an initial trial were all still alive at age 6. Most could still talk, walk on their own, and perform normally on IQ tests, which was unseen in untreated children. Some of the earliest children treated have now been followed for up to 12 years—and they continue to do well.

But, the triumph turned bittersweet today, Wednesday, as the company behind the therapy, Lenmeldy, set the price for the US market at $4.25 million, making it the most expensive drug in the world. The price is $310,000 higher than what experts calculated to be the maximum fair price for the lifesaving drug; the nonprofit Institute for Clinical and Economic Review, or ICER, gave a range last October of between $2.29 million to $3.94 million.

The price raises questions about whether state, federal, and private health insurance plans will be able to shoulder the costs. “Unless states have allocated appropriately for it, and looked at the drug pipeline, they may not be prepared for what could be significant cost spikes,” Edwin Park, a research professor at the McCourt School of Public Health at Georgetown University, told CNN.

It’s also unclear whether the drug can reach the children who need it in time. Lenmeldy must be given before symptoms develop or early on in symptom development in children. However, diagnosis of the rare genetic condition can be slow, and many children treated so far were identified because older siblings, now too old for treatment, developed the condition first.

Devastating disease

Stat, for instance, spoke with the mother of an 8-year-old with the condition, who can no longer talk or move, has frequent seizures, and requires a feeding tube and 28 different medications. Meanwhile, her 3-year-old brother, who has the same genetic mutation, is a typical toddler—he was able to get the new treatment when he was six months old. To get it, the family flew him to Milan, Italy, where Lenmeldy was first developed. It was approved for use in Europe in 2021.

The condition Lenmeldy treats is called metachromatic leukodystrophy (MLD), which occurs in about 40 children in the US each year. MLD is caused by a mutation in the gene that codes for the enzyme arylsulfatase A (ARSA). Without this enzyme, the body can’t break down sulfatides, a fatty substance that then builds up to toxic levels in the brain and peripheral nervous system. Sulfatides are essential components of myelin, the fatty insulation on nerve cells critical for quick transmission of electrical impulses. But, too much sulfatides leads to a loss of myelin, which gradually destroys myelin producing cells and leads to nervous system damage.

Lenmeldy prevents that damage by giving the body a working copy of the ARSA gene. In a one-time infusion, patients are given a dose of their own blood stem cells that have been genetically engineered to contain a functional ARSA gene. Patients undergo chemotherapy to clear out their own stem cells from bone marrow so the genetically modified cells can replace them. The engineered stem cells then produce myeloid cells that travel around the body in the blood, producing ARSA enzyme that can halt progression of MLD.

It’s unknown how long the therapy lasts, but it’s clearly buying children time and giving them hope for a full, normal life.

“MLD is a devastating disease that profoundly affects the quality of life of patients and their families,” Nicole Verdun, director of the FDA’s Office of Therapeutic Products, said in a statement. “Advancements in treatment options offer hope for improved outcomes and the potential to positively influence the trajectory of disease progression.”

It “has the potential to stop or slow the progression of this devastating childhood disease with a single treatment, particularly when administered prior to the onset of symptoms,” Bobby Gaspar, CEO of Lenmeldy’s maker, Orchard Therapeutics, said in a statement Wednesday. “We are committed to enabling broad, expedient, and sustainable access to this important therapy for eligible patients with early-onset MLD in the US.”

The company is working on expanding newborn screening to include tests for MLD, to try to find children early, Orchard reported. Still, with such a rare condition, it’s unclear if the pricey drug will be a moneymaker for the company. Stat notes that Orchard has previously abandoned four therapies for other rare genetic conditions because of the difficulty in meeting regulatory standards for essentially custom therapies and questions about whether health plans will pay the steep, multimillion-dollar prices. In April of last year, Belgium, Ireland, and the Netherlands walked away from price negotiations with the company, saying they couldn’t come to an agreement on this “extremely expensive therapy.”

Lifesaving gene therapy for kids is world’s priciest drug at $4.25M Read More »

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Deadly morel mushroom outbreak highlights big gaps in fungi knowledge

CDC, fda, food poisoning, fungi, health, montana, morel mushrooms, outbreak, Science, sushi, toxin / /

This fungi’s not fun, guys —

Prized morels are unpredictably and puzzlingly deadly, outbreak report shows.

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Mature morel mushrooms in a greenhouse at an agriculture garden in Zhenbeibu Town of Xixia District of Yinchuan, northwest China's Ningxia Hui Autonomous Region.

Enlarge / Mature morel mushrooms in a greenhouse at an agriculture garden in Zhenbeibu Town of Xixia District of Yinchuan, northwest China’s Ningxia Hui Autonomous Region.

True morel mushrooms are widely considered a prized delicacy, often pricey and surely safe to eat. But these spongey, earthy forest gems have a mysterious dark side—one that, on occasion, can turn deadly, highlighting just how little we know about morels and fungi generally.

On Thursday, Montana health officials published an outbreak analysis of poisonings linked to the honeycombed fungi in March and April of last year. The outbreak sickened 51 people who ate at the same restaurant, sending four to the emergency department. Three were hospitalized and two died. Though the health officials didn’t name the restaurant in their report, state and local health departments at the time identified it as Dave’s Sushi in Bozeman. The report is published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

The outbreak coincided with the sushi restaurant introducing a new item: a “special sushi roll” that contained salmon and morel mushrooms. The morels were a new menu ingredient for Dave’s. They were served two ways: On April 8, the morels were served partially cooked, with a hot, boiled sauce poured over the raw mushrooms and left to marinate for 75 minutes; and on April 17, they were served uncooked and cold-marinated.

The mystery poison worked fast. Symptoms began, on average, about an hour after eating at the restaurant. And it was brutal. “Vomiting and diarrhea were reportedly profuse,” the health officials wrote, “and hospitalized patients had clinical evidence of dehydration. The two patients who died had chronic underlying medical conditions that might have affected their ability to tolerate massive fluid loss.”

Of the 51 sickened, 46 were restaurant patrons and five were employees. Among them, 45 (88 percent) recalled eating morels. While that’s a high percentage for such an outbreak investigation, certainly enough to make the morels the prime suspect, the health officials went further. With support from the CDC, they set up a matched case-control study, having people complete a detailed questionnaire with demographic information, food items they ate at the restaurant, and symptoms.

Mysterious poison

Forty-one of the poisoned people filled out the questionnaire, as did 22 control patrons who ate at the restaurant but did not report subsequent illness. The analysis indicated that the odds of recalling eating the special sushi roll were nearly 16 times higher among the poisoned patrons than among the controls. The odds of reporting any morel consumption were nearly 11 times higher than controls.

The detailed consumption data also allowed the health officials to model a dose response, which suggested that with each additional piece of the special roll a person recalled eating, their odds of sickness increased nearly threefold compared with people who reported eating none. Those who ate four or more pieces of the roll had odds nearly 22.5 times higher. A small analysis focusing on the five employees sickened, which was not included in the published study but was noted by the Food and Drug Administration, echoed the dose-response finding, indicating that sickness was linked with larger amounts of morel consumption.

When the officials broke down the analysis by people who ate at the restaurant on April 17, when the morels were served uncooked, and those who ate at the restaurant on April 8, when the mushrooms were slightly cooked, the cooking method seemed to matter. People who ate the uncooked rather than the slightly cooked mushrooms had much higher odds of sickness.

This all strongly points to the morels being responsible. At the time, the state and local health officials engaged the FDA, as well as the CDC, to help tackle the outbreak investigation. But the FDA reported that “samples of morel mushrooms collected from the restaurant were screened for pesticides, heavy metals, toxins, and pathogens. No significant findings were identified.” In addition, the state and local health officials noted that DNA sequencing identified the morels used by the restaurant as Morchella sextelata, a species of true morel. This rules out the possibility that the mushrooms were look-alike morels, called “false morels,” which are known to contain a toxin called gyromitrin.

The health officials and the FDA tracked down the distributor of the mushrooms, finding they were cultivated and imported fresh from China. Records indicated that 12 other locations in California also received batches of the mushrooms. Six of those facilities responded to inquiries from the California health department and the FDA, and all six reported no illnesses. They also all reported cooking the morels or at least thoroughly heating them.

Deadly morel mushroom outbreak highlights big gaps in fungi knowledge Read More »

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Apple’s AirPods Pro could be getting a “hearing aid mode” later this year

airpods, AirPods Pro, Apple, fda, fda approval, hearing, hearing aids, hearing impairment, ios 18, Tech / /

Cheaper hearing aids —

In development for some time, AirPods could finally get the FDA label this fall.

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AirPods arranged at an Apple Store

Enlarge / Apple AirPods on display at the company’s Fifth Avenue store in New York in Feb. 2024.

Bing Guan/Bloomberg via Getty Images

Apple’s AirPods Pro are getting closer to becoming fully fledged hearing aids and marketed as such, according to Bloomberg’s Mark Gurman. The move could have a large impact on the hearing aid market, which has already been recently shaken up by over-the-counter models.

Gurman writes that AirPods Pro are due to receive a hearing-aid function in iOS 18, arriving this fall and likely to be announced and outlined at a Worldwide Developers Conference in June. The Wall Street Journal reported in the fall of 2021 that Apple was working toward a future AirPods Pro model that functioned as a hearing aid and would also be able to monitor body posture and even body temperature.

It was not clear from Gurman or the Journal’s reporting whether the hearing aid function would be available only in a new model of AirPods Pro or offered as a software update on prior models. Since the Journal’s report, Apple has released both a second-generation model of AirPods Pro and a refresh of that model with a USB-C port.

“Hearing aid” may also not be technically accurate, depending on Apple’s aims. The US Food and Drug Administration in 2022 provided for a new category of “Personal sound amplification products,” or PSAPs, that do not need to meet the stricter requirements for an FDA-approved hearing aid. This new category offered huge cost savings to people with mild to moderate hearing loss and kicked off a generation of hearing aids that connected to a smartphone over Bluetooth for setup, tuning, and monitoring. These are distinct from over-the-counter hearing aids, which, while still notably cheaper than “professional fit” hearing aids, are still regulated by the FDA.

A study in late 2022 found that first-generation AirPods Pro, with their “Live Listen” feature activated, could meet four of the five PSAP standards and just barely missed a sound-pressure threshold. Notably, the AirPods Pro, tested in relatively quiet environments, helped people hear about as well as hearing aid models that cost up to $10,000, within the PSAP standards.

The next version of Apple’s mobile operating system, iOS 18, is rumored to contain a multitude of features beyond AirPods updates. MacRumors (leaning on Gurman’s subscriber-only newsletter reporting) suggests that generative AI features, RCS support for text messages, and revamps to many core Apple apps are due.

Apple’s AirPods Pro could be getting a “hearing aid mode” later this year Read More »

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Don’t use these six cinnamon products, FDA warns after concerning lead tests

CDC, cinnamon, contamination, fda, lead, lead poisoning, Science / /

More lead —

The FDA is putting manufacturers on notice to do more to keep contaminants out.

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Don’t use these six cinnamon products, FDA warns after concerning lead tests

Six different ground cinnamon products sold at retailers including Save A Lot, Dollar Tree, and Family Dollar contain elevated levels of lead and should be recalled and thrown away immediately, the US Food and Drug Administration announced Wednesday.

The brands are La Fiesta, Marcum, MK, Swad, Supreme Tradition, and El Chilar, and the products are sold in plastic spice bottles or in bags at various retailers. The FDA has contacted the manufacturers to urge them to issue voluntary recalls, though it has not been able to reach one of the firms, MTCI, which distributes the MK-branded cinnamon.

Products identified by the FDA as containing elevated lead levels.

Enlarge / Products identified by the FDA as containing elevated lead levels.

The announcement comes amid a nationwide outbreak of lead poisoning in young children linked to cinnamon applesauce pouches contaminated with lead and chromium. In that case, it’s believed that a spice grinder in Ecuador intentionally added extreme levels of lead chromate to cinnamon imported from Sri Lanka, likely to improve its weight and/or appearance. Food manufacturer Austrofoods then added the heavily contaminated cinnamon, without any testing, to cinnamon applesauce pouches marketed to toddlers and young children across the US. In the latest update, the Centers for Disease Control and Prevention has identified 468 cases of lead poisoning that have been linked to the cinnamon applesauce pouches. The cases span 44 states and are mostly in very young children.

The alarming contamination spurred the FDA to conduct more sampling of cinnamon products, focusing an initial survey on products from discount retail stores, the agency said. The FDA makes note that the elevated lead levels found in the six products announced this week are significantly lower than what was seen in the cinnamon added to the applesauce pouches. The six products contained lead at levels ranging from 2.03 to 3.4 parts per million (ppm), while samples of the cinnamon added to the applesauce had levels ranging from 2,270 ppm to 5,110 ppm in the cinnamon.

The FDA has previously reported that 2.5 ppm is the limit being considered for bark spices, which includes cinnamon, by the international standard-setting body, Codex Alimentarius Commission.

So the six newly identified products are right around or just over that potential threshold and do not pose the same level of risk as the applesauce pouches. But the FDA warned that the elevated levels in the ground cinnamon could cause elevated blood lead levels after prolonged use, which the agency defined as months to years. This, in turn, could contribute to harmful health effects, particularly in children who absorb lead more readily than adults and are still developing. Lead is a potent neurotoxic metal that can damage the brain and nervous system, which for young children can lead to learning, behavior, and developmental problems.

“Today’s actions serve as a signal to industry that more needs to be done to prevent elevated levels of contaminants from entering our food supply,” Jim Jones, the FDA’s Deputy Commissioner for Human Foods, said in a statement. “Food growers, manufacturers, importers, and retailers share a responsibility for ensuring the safety of the foods that reach store shelves. The levels of lead we found in some ground cinnamon products are too high and we must do better to protect those most vulnerable to the negative health outcomes of exposure to elevated levels of lead.”

Don’t use these six cinnamon products, FDA warns after concerning lead tests Read More »