California
California petitions FDA to undo RFK Jr.'s new limits on abortion pill mifepristone
California and three other states petitioned the U.S. Food and Drug Administration Thursday to ease its new restrictions on the abortion pill mifepristone, citing the drug’s proven safety record and arguing the new limits are unnecessary.
“The medication is a lifeline for millions of women who need access to time-sensitive, critical healthcare — especially low-income women and those who live in rural and underserved areas,” said California Atty. Gen. Rob Bonta, who filed the petition alongside the attorneys general of Massachusetts, New York and New Jersey.
The petition cites Senate testimony by Health and Human Services Secretary Robert F. Kennedy Jr. last month, in which Kennedy said he had ordered FDA administrator Martin Makary to conduct a “complete review” of mifepristone and its labeling requirements.
The drug, which can be received by mail, has been on the U.S. market for 25 years and taken safely by millions of Americans, according to experts. It is the most common method of terminating a pregnancy in the U.S., with its use surging after the Supreme Court overturned Roe vs. Wade in 2022.
The Supreme Court upheld access to the drug for early pregnancies under previous FDA regulations last year, but it has remained a target of anti-abortion conservatives. The Trump administration has given Kennedy broad rein to shake up American medicine under his “Make America Healthy Again” banner, and Kennedy has swiftly rankled medical experts by using dubious science — and even fake citations — to question vaccine regimens and research and other longstanding public health measures.
At the Senate hearing, Kennedy cited “new data” from a flawed report pushed by anti-abortion groups — and not published in any peer-reviewed journal — to question the safety of mifepristone, calling the report “alarming.”
“Clearly, it indicates that, at very least, the label should be changed,” Kennedy said.
Sen. Josh Hawley (R-Mo.) on Monday posted a letter from Makary to X, in which Makary wrote that he was “committed to conducting a review of mifepristone” alongside “the professional career scientists” at the FDA.
Makary said he could not provide additional information given ongoing litigation around the drug.
The states, in their 54-page petition, wrote that “no new scientific data has emerged since the FDA’s last regulatory actions that would alter the conclusion that mifepristone remains exceptionally safe and effective,” and that studies “that have frequently been cited to undermine mifepristone’s extensive safety record have been widely criticized, retracted, or both.”
Democrats have derided Kennedy’s efforts to reclassify mifepristone as politically motivated and baseless.
“This is yet another attack on women’s reproductive freedom and scientifically-reviewed health care,” Gov. Gavin Newsom said the day after Kennedy’s Senate testimony. “California will continue to protect every person’s right to make their own medical decisions and help ensure that Mifepristone is available to those who need it.”
Bonta said Thursday that mifepristone’s placement under the FDA’s Risk Evaluation and Mitigation Strategy program for drugs with known, serious side effects — or REMS — was “medically unjustified,” unduly burdened patient access and placed “undue strain on the nation’s entire health system.”
He said mifepristone “allows people to get reproductive care as early as possible when it is safest, least expensive, and least invasive,” is “so safe that it presents lower risks of serious complications than taking Tylenol,” and that its long safety record “is backed by science and cannot be erased at the whim of the Trump Administration.”
The FDA has previously said that fewer than 0.5% of women who take the drug experience “serious adverse reactions,” and deaths are exceedingly rare.
The REMS program requires prescribers to add their names to national and local abortion provider lists, which can be a deterrent for doctors given safety threats, and pharmacies to comply with complex tracking, shipping and reporting requirements, which can be a deterrent to carrying the drug, Bonta said.
It also requires patients to sign forms in which they attest to wanting to “end [their] pregnancy,” which Bonta said can be a deterrent for women using the drug after a miscarriage — one of its common uses — or for those in states pursuing criminal penalties for women seeking certain abortion care.
Under federal law, REMS requirements must address a specific risk posed by a drug and cannot be “unduly burdensome” on patients, and the new application to mifepristone “fails to meet that standard,” Bonta said.
The states’ petition is not a lawsuit, but a regulatory request for the FDA to reverse course, the states said.
If the FDA will not do so nationwide, the four petitioning states asked that it “exercise its discretion to not enforce the requirements” in their states, which Bonta’s office said already have “robust state laws that ensure safe prescribing, rigorous informed consent, and professional accountability.”
California
Neil Thwaites promoted to ‘Vice President of Global Sales & California Commercial Performance’ for Alaska Airlines and Hawaiian Airlines – Alaska Airlines, Hawaiian Airlines and Horizon Air
Thwaites will lead the strategy and execution of all sales activities for the combined Alaska Airlines and Hawaiian Airlines team. His responsibilities include growing indirect revenue on Alaska’s expanding international and domestic network, as well as expanding Atmos for Business, a new program designed for small- and medium-sized companies.
Thwaites joined Alaska Airlines in January 2022 as regional vice president in California. Since stepping into the role, Thwaites has significantly sharpened the airline’s focus and scale in key markets and communities across the state, strengthening Alaska’s position as we continue to grow in California. He will continue to be based at the company’s California offices in Burlingame. The moves take effect Dec. 13, with Thwaites also continuing to lead his current California commercial planning and performance function in addition to Global Sales.
Prior to Alaska, Thwaites worked in multiple positions within the airline industry, including a decade holding roles in London, New York, and Los Angeles for British Airways (a fellow oneworld member); most recently as ‘VP, Sales – Western USA’, where he was responsible for market development strategy and indirect revenue for both British Airways and Iberia across the western U.S.
Thwaites is originally from the United Kingdom and graduated from the University of Brighton with a double honors degree in Business Administration & Law.
California
Tiny tracker following monarch butterflies during California migration
SAN FRANCISCO (KGO) — When this monarch butterfly hits the sky it won’t be traveling alone. In fact, an energetic team of researchers will be following along with a revolutionary technology that’s already unlocking secrets that could help the entire species survive.
“I’ve described this technology as a spaceship compared to the wheel, like using a using a spaceship compared to the invention of the wheel. It’s teaching us so, so much more,” says Ray Moranz, Ph.D., a pollinator conservation specialist with the Xerces Society.
Moranz is part of a team that’s been placing tiny tracking devices on migrating monarchs. The collaboration is known as Project Monarch Science. It leverages solar powered radio tags that are so light they don’t affect the butterfly’s ability to fly. And they’re allowing researchers to track the Monarch’s movements in precise detail. With some 400 tags in place, the group already been able to get a nearly real time picture of monarch migrations east of the Rockies, with some populations experiencing dramatic twists and turns before making to wintering grounds in Mexico.
“They’re trying to go southward to Mexico. They can’t fight the winds. Instead, some of them were letting themselves be carried 50 miles north, 100 miles north, 200 miles the wrong way, which we are all extremely alarmed by and for good reason. Some of these monarchs, their migration was delayed by two or three weeks.
According to estimates, migrating monarch populations have dropped by roughly 80% or more across the country. And the situation with coastal species here in California is especially dire. Blake Barbaree is a senior scientist with Point Blue Conservation Science. He and his colleagues are tracking Northern California populations now clustered around Santa Cruz.
MORE: Monarch butterflies to be listed as a threatened species in US
“This year, there’s it’s one of the lowest, populations recorded in the winter. And the core zones have been in Santa Cruz County and up in Marin County. So we’ve undertaken an effort to understand how the monarchs are really using these different groves around Santa Cruz by tagging some in the state parks around town,” Barbaree explains.
He says being able to track individual monarchs could help identify microhabitats in the area that help them survive, ranging from backyard pollinator gardens to protected open space to forest groves.
“So we’re really getting a great insight to how reliant they are on these big trees, but also the surrounding area and people’s even backyards. And then along the way around the coast, how they’re transitioning among some of these groves. And we’re looking for some of the triggers for those movements. Right. Why are they doing this and what’s what’s driving them to do that? So those questions are still a little bit further out as we get to analyze some more some more of the data,” he believes.
And that data is getting even more precise. The tags, developed by Cellular Tracking Technologies, can be monitored from dedicated listening stations. But the company is also able to crowdsource signals detected by cellphone networks on phones with Bluetooth connectivity and location access activated. And they’ve also helped develop an app that allows volunteers, citizen scientists, and the general public to track and report Monarch locations themselves using their smartphones.
CEO Michael Lanzone says the initial response has been overwhelming.
MORE: New butterflies introduced in SF’s Presidio after species went extinct in 1940s
“We were super surprised to see 3,000 people download the monarch app. It’s like, you know, but people really love monarchs. There’s something that people just relate to,” says Lanzone who like many staffers at Cellular Tracking Technologies, has a background in wildlife ecology.
A number of groups are pushing to have the monarchs designated nationally as a threatened species. If that ultimately happens, researchers believe the tracking data could help put better protections in place.
“They’re highly vulnerable to, you know, some of the different things that that that we as humans do around using pesticides and also potentially cutting, you know, cutting down trees for various reasons. Sometimes they’re for safety and sometimes it’s, you know, for development. But so having an understanding of how we can do those things more sensibly and protect the places that they need the most,” says Point Blue’s Barbaree.
And it’s happening with the help of researchers, citizen scientists, and a technology weighing no more than a few grains of rice.
The smartphone app is called Project Monarch Science. You can download it for free and begin tracking.
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California
Poisonings from ‘death cap’ mushrooms in California prompt warning against foraging
After a string of poisonings from “death cap” mushrooms — one of them fatal — California health officials are urging residents not to eat any foraged mushrooms unless they are trained experts.
Doctors in the San Francisco Bay Area have blamed the wild mushroom, also called Amanita phalloides, for 23 poisoning cases reported to the California Poison Control System since Nov. 18, according to Dr. Craig Smollin, medical director for the system’s San Francisco division.
“All of these patients were involved with independently foraging the mushrooms from the wild,” Smollin, who is a professor of emergency medicine at the University of California, San Francisco, said at a news conference Tuesday. “They all developed symptoms within the first 24 hours, including nausea, vomiting, diarrhea and abdominal pain.”
Smollin said some of the patients were parts of cohorts that had consumed the same batch of foraged mushrooms. The largest group was about seven people, he said.
All of the patients were hospitalized, at least briefly. One died. Five remain in hospital care. One has received a liver transplant, and another is on a donation list awaiting a transplant, Smollin said. The patients are 1½ to 56 years old.
Mushroom collectors said death cap mushrooms are more prevalent in parts of California this season than in years past, which could be driving the increase in poisonings.
“Any mushroom has years that it’s prolific and years that it is not. … It’s having a very good season,” said Mike McCurdy, president of the Mycological Society of San Francisco. He added that the death cap was one of the top two species he identified during an organized group hunt for fungi last week, called a foray.
In a news release, Dr. Erica Pan, California’s state public health officer, warned that “because the death cap can easily be mistaken for edible safe mushrooms, we advise the public not to forage for wild mushrooms at all during this high-risk season.”
Dr. Cyrus Rangan, a pediatrician and medical toxicologist with the California Poison Control System, said the “blanket warning” is needed because most people do not have the expertise to identify which mushrooms are safe to eat.
Still, he said, “it’s rare to see a case series like this.”
The California Poison Control System said in a news release that some of the affected patients speak Spanish and might be relying on foraging practices honed outside the United States. Death cap mushrooms look similar to other species in the Amanita genus that are commonly eaten in Central American countries, according to Heather Hallen-Adams, the toxicology chair of the North American Mycological Association. Because death caps are not often found in that region, foragers might not realize the potential risk of lookalikes in California, she said.
Anne Pringle, a professor of mycology at the University of Wisconsin-Madison, said there is a litany of poisoning cases in which people misidentify something because their experience is not relevant to a new region: “That’s a story that comes up over and over again.”
Over the past 10 years, mushroom foraging has boomed in the Bay Area and other parts of the country. At the same time, information resources about mushroom toxicity — reliable and otherwise — have proliferated, as well, including on social media, phone apps and artificial intelligence platforms. Experts said those sources should be viewed with skepticism.
Longtime mushroom hunters maintain that the practice can be done safely. McCurdy, who has collected and identified mushrooms since the 1970s, said he bristled at the broad discouragement of foraging.
“No, that’s ridiculous. … After an incident like this, their first instinct is to say don’t forage,” he said. “Experienced mushroom collectors won’t pay any attention to that.”
But McCurdy suggested that people seek expertise from local mycological societies, which are common in California, and think critically about the sources of information their lives may be relying on.
Pringle and McCurdy both said they have seen phone apps and social media forums misidentify mushrooms.
“I have seen AI-generated guidebooks that are dangerous,” Pringle said.
The death cap is an invasive species that originated in Europe and came to California in the 1930s, most likely with imported nursery trees. The mushroom is usually a few inches tall with white gills, a pale yellow or green cap and often a ring around the base of its stalk.
The species is found across the West Coast and the Eastern Seaboard, as well as in Florida and Texas, according to Hallen-Adams, who is also an associate professor of food science at the University of Nebraska-Lincoln.
In California, it typically grows near oak trees, though occasionally pines, too. The mushroom’s body is typically connected to tree roots and grows in a symbiotic relationship with them.
The toxin in death cap mushrooms, called amatoxin, can damage the kidneys, liver and gastrointestinal tract if it is ingested. It disrupts the transcription of genetic code and the production of proteins, which can lead to cell death.
Hallen-Adams said the U.S. Poison Centers average about 52 calls involving amatoxin each year, but “a lot of things don’t get called into poison centers — take that with a grain of salt.”
Amatoxin poisoning is not the most common type from mushrooms, but it is the most dangerous, she added: “90% of lethal poisonings worldwide are going to be amatoxin.”
It takes remarkably little to sicken a person.
“One cubic centimeter of a mushroom ingested could be a fatal dose,” Hallen-Adams said.
Symptoms of amatoxin poisoning often develop within several hours, then improve before they worsen. There is no standard set of medical interventions that doctors rely on.
“It’s a very difficult mushroom to test for,” Rangan said, and “also very difficult to treat.”
One drug that doctors have leaned on to treat some of the California patients — called silibinin — is still experimental and difficult to obtain.
“All of our silibinin comes from Europe,” Hallen-Adams said.
Death cap mushrooms have continued to grow abundantly since their introduction, and Pringle’s research has shown that the species can reproduce bisexually and unisexually — with a mate or by itself, alone — which gives it an evolutionary advantage.
“If Eve can make more of herself, she doesn’t need Adam,” Pringle said. “One of the things I’m really interested in is how you might stop the invasion, how you might cure a habitat of its death caps. And I have no solutions to offer you at the moment.”
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