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Column: A stem cell clinic tees up a Supreme Court challenge to rules protecting patients' health and safety

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Column: A stem cell clinic tees up a Supreme Court challenge to rules protecting patients' health and safety

For years, the Food and Drug Administration has taken up arms against clinics hawking unproven and ineffective stem cell treatments to desperate patients looking for cures of intractable diseases and conditions such as Alzheimer’s, Parkinson’s, multiple sclerosis and even erectile dysfunction.

As the FDA has repeatedly cautioned, there is no scientifically validated evidence that these treatments work. They’re typically not covered by insurance. For the clinics, however, they’re money-makers, with fees of $9,000 or more per treatment; the clinics often recommend multiple treatments.

But now the FDA’s campaign against these bogus therapies is facing serious headwinds on two fronts.

[The FDA is] likely to be subjected to enormous political pressure during Trump 2.0 to weaken oversight of cell and regenerative products.

— Paul S. Knoepfler, UC Davis

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One is the Supreme Court. A California stem cell network that recently lost a lawsuit brought by the FDA has signaled that it intends to appeal to the Supreme Court. It’s far from certain that the court will take up the appeal, at this stage — but a majority of the justices have looked favorably on efforts to rein in administrative agencies such as the FDA.

“I think it’s highly unlikely … but not impossible” that the court will take up the stem cell case, says Henry T. Greely, an expert in the legal issues involving bioscientific technologies.

The case doesn’t have the customary hallmarks of cases that warrant Supreme Court action, Greely told me, such as disagreements among appellate circuits requiring resolution. But it may suit the ideological bent of four justices — the minimum number required to place a case on the Supreme Court docket.

“Some of these justices really hate administrative agency power,” Greely says.

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In a landmark ruling last year, the Supreme Court struck down a 40-year-old precedent—the Chevron doctrine — that required courts to accept federal agencies’ interpretations of the laws they administer as long as their interpretations weren’t openly unreasonable. That sharply narrowed agency authority. The FDA has ranked high on the list of agencies that conservatives see as exercising excessive authority.

It may not take a Supreme Court decision to hamper the FDA’s campaign against bogus stem cell treatments.

“Just the possibility that [the Supreme Court] could take this case may have a chilling effect on FDA activity in the stem cell clinic space,” Paul S. Knoepfler, a UC Davis biologist who has assiduously tracked the industry, told me. Even without the case, he says, the FDA is “likely to be subjected to enormous political pressure during Trump 2.0 to weaken oversight of cell and regenerative products.”

That brings us to the second threat, coming from Donald Trump’s nominee as secretary of Health and Human Services, Robert F. Kennedy Jr. Even before his nomination, Kennedy made clear that he was girding to go to war against the FDA, which would come under his jurisdiction at HHS.

In an Oct. 25 tweet, he declared “FDA’s war on public health is about to end.” He specifically accused the agency of “aggressive suppression” of stem cells as well as “psychedelics, peptides, … raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine … and anything else that advances human health and can’t be patented by Pharma.”

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Kennedy wasn’t clear what he meant by his reference to stem cells or whether he was referring to the unproven stem cell treatments marketed by the clinics facing FDA regulation.

Many of the other items in his litany have been shown to be ineffective for their marketed purposes — ivermectin and hydroxychloroquine, for example, have been touted as treatments for COVID-19 even though scientific studies have shown them to be useless against the disease. I asked Kennedy to clarify his reference to stem cells but haven’t received a reply.

Here’s a brief primer on what these clinics are selling. Typically, their method involves removing fat cells from a customer via liposuction, treating the fat ostensibly to extract stem cells, and injecting those cells into the customer’s body.

For instance, Cell Surgical Network, a defendant in the FDA’s California case, boasts of offering “innovative solutions” for spine disease, knee problems and other orthopedic conditions; lupus, Crohn’s and other autoimmune diseases; ALS, Parkinson’s and multiple sclerosis; cardiac conditions; and glaucoma, among other issues. None of these claims has been supported by scientific research.

The only stem cell products the FDA has approved for use are stem cells extracted from umbilical cord blood, and then only for rare blood disorders.

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Like other clinics, Cell Surgical has asserted that its products are exempt from oversight because, as reimplantations of a customer’s own tissue, they don’t meet the law’s definition of “drugs.”

They also claim the “same surgical procedure” exemption from FDA regulation, which the agency typically applies to procedures in which a patient’s tissue is given only minimal processing before being used, such as in skin grafting or coronary artery bypass surgery. The FDA holds that the stem cell clinics subject the tissues to significant processing and that the procedures are separate surgical events.

Before the FDA acted, both the Florida and California clinic networks had been operating for years. The Florida company had been operating since at least 2014, and Lander and Berman had founded their California Stem Cell Treatment Center in Rancho Mirage in 2010. By 2018, the FDA said in its lawsuit, Lander had claimed that affiliated clinics had administered the technique he and Berman developed to more than 6,000 patients.

Yet the FDA sometimes seems to be fighting a losing battle, or at least a whack-a-mole battle, against clinics offering dubious stem cell treatments. There are just too many — more than 1,000, by Knoepfler’s reckoning — making pitches to desperate customers seeking cures against intractable conditions.

That has left things up to state and local regulators, but the record there is spotty. A notable recent success can be chalked up to Georgia Atty. Gen. Chris Carr, who announced on Jan. 8 that in conjunction with the Federal Trade Commission he had obtained judgments totaling more than $5.1 million from the operators of bogus stem cell clinics. The sum includes refunds of more than $3.3 million for 479 customers, most of whom were “older or disabled adults” who had been “sold expensive, unproven stem cell products.”

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In June 2019, federal Judge Ursula Ungaro of Miami ordered U.S. Stem Cell of Florida effectively shut down, siding with the FDA in a lawsuit the agency had filed in May 2018.

The FDA’s case against California-based Cell Surgical Network and its affiliates took a somewhat different course. The agency filed suit in California federal court against the network and its physician-proprietors, Elliott B. Lander and the late Mark Berman, the same day it sued the Florida firm. But it lost at the trial stage in August 2022, when federal Judge Jesus Bernal of Riverside accepted the defendants’ claim that they were entitled to the “same surgical procedure” exemption from FDA oversight.

Bernal’s decision, however, was overturned last September by the San Francisco-based 9th Circuit Court of Appeals, which found in a 3-0 ruling that the FDA’s interpretation of the law “is the only interpretation that makes sense.” The appeals court sent the case back to Bernal with instructions to reconsider the case in light of its finding.

That’s where things stood until Jan. 6, when Cell Surgical Network and its affiliated defendants asked the appellate court to suspend its order to remand the case to Bernal, pending an appeal to the Supreme Court. The FDA opposed the motion, arguing that the Supreme Court is unlikely to take up the case. The appellate court rejected the network’s motion Tuesday, but the network hasn’t indicated that it intends to drop the Supreme Court appeal. I asked its lawyers if their plans have changed but haven’t received a reply.

As I’ve written before, undermining the FDA’s authority has been a right-wing project for years. That’s because the agency’s duty is to stand in the way of businesses desiring to push unsafe and ineffective nostrums at unwary consumers, and also in the way of a perverse idea that personal freedom includes the freedom to be gulled by charlatans.

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In 2018, then-President Trump signed a right-to-try law that purportedly gave victims of terminal diseases access to experimental treatments that might save them.

But despite claims that it was designed as a “compassionate measure” for terminal patient, the law was a scam perpetrated by the Koch network and its allies, aimed at undermining the FDA’s authority to make sure our drugs are safe and effective. Sen. Ron Johnson (R-Wis.) ultimately gave the game away, informing then-FDA Commissioner Scott Gottlieb, a critic of the law, that its purpose was to “diminish the FDA’s power over people’s lives, not increase it.”

In 2023, GOP-appointed judges on the right wing-dominated 5th Circuit Court of Appeals ruled that the FDA had exceeded its authority in advising against the use of ivermectin against COVID. “The FDA can inform,” the court said, “but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.” (Emphasis in the original.)

There may not be much distance between that finding by the 5th Circuit and a decision by the current Supreme Court majority that the FDA overstepped its bounds in not only informing consumers of the dangers of taking unproven and even dangerous stem cell treatments, but blocking the treatments by seeking to put clinics that sell them.

“MAGA loves stem cell clinics,” Greely says. “Why? It gives people a chance to make a lot of money, and because it’s a change for people to say ‘no bureaucrat is going to tell me what to do.’”

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If the trend continues along these lines, you can expect more providers collecting more dollars by pushing worthless therapies to desperate customers. The threat to Americans’ health will be very real indeed.

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How our AI bots are ignoring their programming and giving hackers superpowers

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How our AI bots are ignoring their programming and giving hackers superpowers

Welcome to the age of AI hacking, in which the right prompts make amateurs into master hackers.

A group of cybercriminals recently used off-the-shelf artificial intelligence chatbots to steal data on nearly 200 million taxpayers. The bots provided the code and ready-to-execute plans to bypass firewalls.

Although they were explicitly programmed to refuse to help hackers, the bots were duped into abetting the cybercrime.

According to a recent report from Israeli cybersecurity firm Gambit Security, hackers last month used Claude, the chatbot from Anthropic, to steal 150 gigabytes of data from Mexican government agencies.

Claude initially refused to cooperate with the hacking attempts and even denied requests to cover the hackers’ digital tracks, the experts who discovered the breach said. The group pummelled the bot with more than 1,000 prompts to bypass the safeguards and convince Claude they were allowed to test the system for vulnerabilities.

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AI companies have been trying to create unbreakable chains on their AI models to restrain them from helping do things such as generating child sexual content or aiding in sourcing and creating weapons. They hire entire teams to try to break their own chatbots before someone else does.

But in this case, hackers continuously prompted Claude in creative ways and were able to “jailbreak” the chatbot to assist them. When they encountered problems with Claude, the hackers used OpenAI’s ChatGPT for data analysis and to learn which credentials were required to move through the system undetected.

The group used AI to find and exploit vulnerabilities, bypass defences, create backdoors and analyze data along the way to gain control of the systems before they stole 195 million identities from nine Mexican government systems, including tax records, vehicle registration as well as birth and property details.

AI “doesn’t sleep,” Curtis Simpson, chief executive of Gambit Security, said in a blog post. “It collapses the cost of sophistication to near zero.”

“No amount of prevention investment would have made this attack impossible,” he said.

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Anthropic did not respond to a request for comment. It told Bloomberg that it had banned the accounts involved and disrupted their activity after an investigation.

OpenAI said it is aware of the attack campaign carried out using Anthropic’s models against the Mexican government agencies.

“We also identified other attempts by the adversary to use our models for activities that violate our usage policies; our models refused to comply with these attempts,” an OpenAI spokesperson said in a statement. “We have banned the accounts used by this adversary and value the outreach from Gambit Security.”

Instances of generative AI-assisted hacking are on the rise, and the threat of cyberattacks from bots acting on their own is no longer science fiction. With AI doing their bidding, novices can cause damage in moments, while experienced hackers can launch many more sophisticated attacks with much less effort.

Earlier this year, Amazon discovered that a low-skilled hacker used commercially available AI to breach 600 firewalls. Another took control of thousands of DJI robot vacuums with help from Claude, and was able to access live video feed, audio and floor plans of strangers.

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“The kinds of things we’re seeing today are only the early signs of the kinds of things that AIs will be able to do in a few years,” said Nikola Jurkovic, an expert working on reducing risks from advanced AI. “So we need to urgently prepare.”

Late last year, Anthropic warned that society has reached an “inflection point” in AI use in cybersecurity after disrupting what the company said was a Chinese state-sponsored espionage campaign that used Claude to infiltrate 30 global targets, including financial institutions and government agencies.

Generative AI also has been used to extort companies, create realistic online profiles by North Korean operatives to secure jobs in U.S. Fortune 500 companies, run romance scams and operate a network of Russian propaganda accounts.

Over the last few years, AI models have gone from being able to manage tasks lasting only a few seconds to today’s AI agents working autonomously for many hours. AI’s capability to complete long tasks is doubling every seven months.

“We just don’t actually know what is the upper limit of AI’s capability, because no one’s made benchmarks that are difficult enough so the AI can’t do them,” said Jurkovic, who works at METR, a nonprofit that measures AI system capabilities to cause catastrophic harm to society.

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So far, the most common use of AI for hacking has been social engineering. Large language models are used to write convincing emails to dupe people out of their money, causing an eight-fold increase in complaints from older Americans as they lost $4.9 billion in online fraud in 2025.

“The messages used to elicit a click from the target can now be generated on a per-user basis more efficiently and with fewer tell-tale signs of phishing,” such as grammatical and spelling errors, said Cliff Neuman, an associate professor of computer science at USC.

AI companies have been responding using AI to detect attacks, audit code and patch vulnerabilities.

“Ultimately, the big imbalance stems from the need of the good-actors to be secure all the time, and of the bad-actors to be right only once,” Neuman said.

The stakes around AI are rising as it infiltrates every aspect of the economy. Many are concerned that there is insufficient understanding of how to ensure it cannot be misused by bad actors or nudged to go rogue.

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Even those at the top of the industry have warned users about the potential misuse of AI.

Dario Amodei, the CEO of Anthropic, has long advocated that the AI systems being built are unpredictable and difficult to control. These AIs have shown behaviors as varied as deception and blackmail, to scheming and cheating by hacking software.

Still, major AI companies — OpenAI, Anthropic, xAI, and Google — signed contracts with the U.S. government to use their AIs in military operations.

This last week, the Pentagon directed federal agencies to phase out Claude after the company refused to back down on its demand that it wouldn’t allow its AI to be used for mass domestic surveillance and fully autonomous weapons.

“The AI systems of today are nowhere near reliable enough to make fully autonomous weapons,” Amodei told CBS News.

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iPic movie theater chain files for bankruptcy

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iPic movie theater chain files for bankruptcy

The iPic dine-in movie theater chain has filed for Chapter 11 bankruptcy protection and intends to pursue a sale of its assets, citing the difficult post-pandemic theatrical market.

The Boca Raton, Fla.-based company has 13 locations across the U.S., including in Pasadena and Westwood, according to a Feb. 25 filing in U.S. Bankruptcy Court in the Southern District of Florida, West Palm Beach division.

As part of the bankruptcy process, the Pasadena and Westwood theaters will be permanently closed, according to WARN Act notices filed with the state of California’s Employment Development Department.

The company came to its conclusion after “exploring a range of possible alternatives,” iPic Chief Executive Patrick Quinn said in a statement.

“We are committed to continuing our business operations with minimal impact throughout the process and will endeavor to serve our customers with the high standard of care they have come to expect from us,” he said.

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The company will keep its current management to maintain day-to-day operations while it goes through the bankruptcy process, iPic said in the statement. The last day of employment for workers in its Pasadena and Westwood locations is April 28, according to a state WARN Act notice. The chain has 1,300 full- and part-time employees, with 193 workers in California.

The theatrical business, including the exhibition industry, still has not recovered from the pandemic’s effect on consumer behavior. Last year, overall box office revenue in the U.S. and Canada totaled about $8.8 billion, up just 1.6% compared with 2024. Even more troubling is that industry revenue in 2025 was down 22.1% compared with pre-pandemic 2019’s totals.

IPic noted those trends in its bankruptcy filing, describing the changes in consumer behavior as “lasting” and blaming the rise of streaming for “fundamentally” altering the movie theater business.

“These industry shifts have directly reduced box office revenues and related ancillary revenues, including food and beverage sales,” the company stated in its bankruptcy filing.

IPic also attributed its decision to rising rents and labor costs.

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The company estimated it owed about $141,000 in taxes and about $2.7 million in total unsecured claims. The company’s assets were valued at about $155.3 million, the majority of which coming from theater equipment and furniture. Its liabilities totaled $113.9 million.

The chain had previously filed for bankruptcy protection in 2019.

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Startup Varda Space Industries snags former Mattel plant in El Segundo

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Startup Varda Space Industries snags former Mattel plant in El Segundo

In an expansion of its business of processing pharmaceuticals in Earth’s orbit, Varda Space Industries is renting a large El Segundo plant where toy manufacturer Mattel used to design Hot Wheels and Barbie dolls.

The plant in El Segundo’s aerospace corridor will be an extension of Varda Space Industries’ headquarters in a much smaller building on nearby Aviation Boulevard.

Varda will occupy a 205,443-square-foot industrial and office campus at 2031 E. Mariposa Ave., which will give it additional capacity to manufacture spacecraft at scale, the company said.

Originally built in the 1940s as an aircraft facility, the complex has a history as part of aerospace and defense industries that have long shaped the South Bay and is near a host of major defense and space contractors. It is also close to Los Angeles Air Force Base, headquarters to the Space Systems Command.

Workers test AstroForge’s Odin asteroid probe, which was lost in space after launch this year.

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(Varda Space Industries)

Varda is one of a new generation of aerospace startups that have flourished in Southern California and the South Bay over the last several years, particularly in El Segundo, often with ties to SpaceX.

Elon Musk’s company, founded in 2002 in El Segundo, has revolutionized the industry with reusable rockets that have radically lowered the cost of lifting payloads into space. Though it has moved its headquarters to Texas, SpaceX retains large-scale operations in Hawthorne.

Varda co-founder and Chief Executive Will Bruey is a former SpaceX avionics engineer, and the company’s spacecraft are launched on SpaceX’s workhorse Falcon 9 rockets from Vandenberg Space Force Base in Santa Barbara County.

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Varda makes automated labs that look like cylindrical desktop speakers, which it sends into orbit in capsules and satellite platforms it also builds. There, in microgravity, the miniature labs grow molecular crystals that are purer than those produced in Earth’s gravity for use in pharmaceuticals.

It has contracts with drug companies and also the military, which tests technology at hypersonic speeds as the capsules return to Earth.

Its fifth capsule was launched in November and returned to Earth in late January; its next mission is set in the coming weeks. Varda has more than 10 missions scheduled on Falcon 9s through 2028.

For the last several decades, the Mariposa Avenue property served as the research and development center for Mattel Toys. El Segundo has also long been a center for the toy industry as companies like to set up shop in the shadow of Mattel.

The Mattel facility “has always been an exceptional property with a legacy tied to aerospace innovation, and leasing to Varda Space Industries feels like a natural continuation of that story,” said Michael Woods, a partner at GPI Cos., which owns the property.

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“We are proud to support a company that is genuinely pushing the boundaries of what’s possible, and are excited to watch Varda grow and thrive here in El Segundo,” Woods said.

As one of the country’s most active hubs of aerospace and defense innovation, El Segundo has seen its industrial property vacancy fall to 3.4% on demand from space companies, government contractors and technology startups, real estate brokerage CBRE said.

Successful startups often have to leave the neighborhood when they want to expand, real estate broker Bob Haley of CBRE said. The 9-acre Mattel facility was big enough to keep Varda in the city.

Last year, Varda subleased about 55,000 square feet of lab space from alternative protein company Beyond Meat at 888 Douglas St. in El Segundo, which it started moving into in June.

Varda will get the keys to its new building in December and spend four to eight months building production and assembly facilities as it ramps up operations. By the end of next year, it expects to have constructed 10 more spacecraft.

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In the future, Varda could consolidate offices there, given its size. Currently, though, the plan is to retain all properties, creating a campus of three buildings within a mile of one another that are served by the company’s transportation services, Chief Operating Officer Jonathan Barr said.

“We already have Varda-branded shuttles running up and down Aviation Boulevard,” he said.

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