Enlarge / A dog gets examined by veterinary technicians in Texas. (credit: Getty | Michael Paulsen )

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.

Enlarge / Medical marijuana growing in a facility in Canada. (credit: Getty | Richard Lautens )

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.

Enlarge (credit: Getty | Jeffrey Greenberg )

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.

Enlarge / Cows being milked (credit: Getty | Edwin Remsberg )

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 .

Enlarge / Greylag geese sit on a field and rest while a cow passes by in the background. (credit: Getty | Daniel Bockwoldt )

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.

Enlarge / Takeda Pharmaceutical Co. Adderall XR brand medication arranged at a pharmacy in Provo, Utah, in November 2023. (credit: Getty | George Frey )

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."

Enlarge (credit: Amlyx )

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 .

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. (credit: Getty | Anna Moneymaker )

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.

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. (credit: Getty | John Ewing/Portland Press Herald )

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 .