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

Published

1 year ago

January 17, 2025

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

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.

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.”

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.

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.”

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.

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.’”

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.

Business

Commentary: Trump wants to let companies make fewer disclosures, thus keeping investors in the dark

Published

2 hours ago

July 9, 2026

Press Room

Commentary: Trump wants to let companies make fewer disclosures, thus keeping investors in the dark

Trump’s SEC is considering eliminating the mandate for quarterly corporate financial reports, but even some big investors call it a lousy idea.

This being the “information age,” it would be understandable if investors sometimes feel inundated with too much information to wade through about the stocks in their mutual fund portfolios.

The Securities and Exchange Commission, bowing like a puppy to the urgings of President Trump, is considering exactly the wrong solution to this supposed burden. It’s proposing to allow public companies to give their investors less information, as though that’s a good thing.

On May 8, the SEC proposed rescinding its mandate that public companies report financial results on a quarterly schedule. Instead, it suggests, semiannual and annual reports should suffice.

This takes an already-unlevel playing field where Main Street investors are already disadvantaged, and makes it more unlevel.

— Dennis Kelleher, Better Markets

The SEC left its proposal open for public comment for 60 days, meaning the window closed Monday. By then, the agency had received more than 68,000 comments, according to a tracker posted online by accounting professor Tzachi Zach of Ohio State.

Almost 99.9% of the comments were negative. Several organizations of institutional investors and auditing professionals, as well as a tsunami of individual investors, expressed opposition.

A similar initiative the SEC aired in 2018, during Trump’s first term, received an overwhelmingly negative response and was eventually dropped.

The tide of opposition coming from individual investors shouldn’t be surprising. “Taking away basic quarterly information means investors are blind for six months at a time,” says Dennis Kelleher, co-founder and chief executive of the investor advocacy nonprofit Better Markets.

That’s especially true for small investors, though perhaps not so much for major institutions, insiders or deep-pocketed individuals. “If you’re a big dog, you’ll get the information anyway,” Kelleher told me. “And insiders, who are trading in their own stock all the time, will have the information. This takes an already-unlevel playing field where Main Street investors are already disadvantaged, and makes it more unlevel.”

Trump set off the latest initiative with a social media post on Sept. 15, advocating the move to a six-month reporting schedule. It read, in part, “This will save money, and allow managers to focus on properly running their companies. Did you ever hear the statement that, ‘China has a 50 to 100 year view on management of a company, whereas we run our companies on a quarterly basis???’ Not good!!!”

As was usual with Trump, his argument was a string of uninformed and irrelevant non sequiturs.

It’s doubtful that eliminating quarterly reports will save much, if any, money. Most 10-Qs are cookie cutter documents disclosing financial figures already embedded in corporate records.

The idea that managers would become empowered to “focus on properly running their companies” if only they were relieved of the burden of preparing a report every three months is just malarkey: Any CEOs who feel the impulse to drop everything and involve themselves in what is essentially an automated process can’t be very good at their jobs.

As for China’s “50 to 100 year view on management of a company,” what would that even mean, even if it were true? China doesn’t operate on a 50 to 100 year corporate horizon, but rather on a string of five-year plans. The most recent of these was adopted by the government in March, covers the period up to 2030, and is its 15th in a row.

Despite the flaws in Trump’s arguments, Trump’s SEC Chairman Paul Atkins, a former corporate lawyer and securities industry consultant, fell into line. Within a few days of Trump’s post, he showed up on CNBC to minimize the potential effect of the change. Private companies rely on semiannual reports, after all, he noted, although the idea of taking private companies as models for publicly traded corporations might not strike experienced investors as the wisest thing.

Atkins cited an enduring chestnut, for which there’s no evidence, that quarterly reporting is responsible for “short-term thinking” in corporate suites (though he admitted that his evidence was “anecdotal”). And he suggested that small investors have ample access to corporate information even without quarterly reports — why, he said, they can just tune in to CNBC!

“To propose change in what our rules are now would be a good way forward,” he said. “So I welcome the president’s putting this up for discussion.”

Something more insidious undergirds the SEC’s proposal than its immediate effect on corporate behavior. The agency rationalizes its proposal as seeking “a tradeoff between reducing regulatory burdens … and promoting efficient financial markets through timely disclosure.”

The problem here, Kelleher points out, is that “reducing regulatory burdens” isn’t part of the SEC’s mission in any way, shape or form. It’s a regulatory agency, and its mission since its founding in 1934 has been to protect investors, not to make things fluffier for stock issuers.

The history of financial disclosure in the U.S. shows a long-term trend favoring more disclosure, not less. In the 1880s, quarterly reporting by railroads and other transportation companies were common.

Early on, pressure for more frequent disclosure came not from government regulators, who barely existed before 1934, but from investors. The reporting of quarterly earnings, notes corporate finance expert Owen Lamont of Acadian Asset Management, was “a bottom-up historical phenomenon reflecting voluntary arrangements between firms and investors, not a top-down phenomenon imposed by law.”

By 1931, according to financial historians, 63% of New York Stock Exchange-listed firms were publishing their quarterly earnings. The Big Board mandated that frequency for most listed companies in 1939. The SEC mandated semiannual reports in 1955 and quarterly reports, as Atkins said, in 1970.

The evidence in favor of dropping the quarterly reports is uniformly thin. Some advocates cite a 2018 op-ed in the Wall Street Journal by JPMorgan Chase CEO Jamie Dimon and Warren Buffett that was headlined “Short-Termism Is Harming the Economy.”

Couple of points about this: First, the target of Dimon and Buffett wasn’t quarterly financial reporting, but quarterly earnings guidance — that is, the practice of some top executives who project their earnings into the future. (This guidance usually comes at the same time they issue their SEC disclosures.)

It’s guidance, they wrote, that is “a major driver” of short-termism in corporate behavior. That’s because management is giving itself a target it feels obligated to meet, even if factors outside its control interfere with the quest.

Furthermore, Dimon and Buffett wrote, “Our views on quarterly earnings forecasts should not be misconstrued as opposition to quarterly and annual reporting.” They called transparency about financial and operating results “an essential aspect of U.S. public markets … so that the public, including shareholders and other stakeholders, can reliably assess real progress.”

Individual investors may be unmoved by the SEC’s proposal because — let’s be candid — how many of them read quarterly earnings reports, anyway? But that’s unimportant, Kelleher says, because other market participants are reading them. “So that information is in the marketplace, and that’s what actually enables price discovery, so stock prices roughly reflect what’s going on at a company, most of the time.”

More to the point, the quarterly reports reflect the highest-quality, detailed information, the information the SEC requires executives to disclose on pain of facing a civil lawsuit from the agency or even criminal liability for faking data. “Main Street investors, whether they read quarterly reports or not, are the real beneficiaries,” Kelleher says.

That’s so. The bottom line is that quarterly financial reporting helps investors. It doesn’t promote short-term behavior and its costs, modest as they are, don’t outweigh its benefits.

Over the decades, scandal-ridden corporations have hidden fraudulent behavior in the interstices between mandated disclosures—think Enron, WorldCom and Tyco, among others. Why give any corporation, even an honest one, the opportunity to disclose less?

Business

Fire-damaged Pacific Palisades shopping center sets reopening date

Published

12 hours ago

July 8, 2026

Press Room

Fire-damaged Pacific Palisades shopping center sets reopening date

The luxury shopping center in Pacific Palisades will reopen next month after more than $100 million in renovations forced by the January 2025 wildfire that devastated the Los Angeles neighborhood.

Palisades Village will reopen Aug. 15, owner Rick Caruso announced Wednesday. The outdoor center survived the blaze that destroyed homes and other businesses but needed refurbishment to eliminate contaminants that the fire could have spread.

Crews are putting finishing touches on mall buildings after tearing them down to the studs, treating the wood and rebuilding the walls, Caruso said.

“Everybody’s working, and stores are moving their products in,” he said. “It’s a really cool feeling that people have really locked arms and are working together.”

An electrician installs lighting for a restaurant at Rick Caruso’s Palisades Village on Thursday. The shopping center is scheduled to reopen mid-August.

(Myung J. Chun / Los Angeles Times)

Pacific Palisades resident Allison Polhill, who is rebuilding the home of 30 years that her family lost in the blaze, said she is “thrilled” at the prospect of returning to the mall she used to frequent. Its comeback is a boost for the community, she said.

“Every single step that we make to reopen our commercial corridors is going to bring more people back into the Palisades,” said Polhill, who expects to move back into her home at the end of August.

A total of 6,822 structures were destroyed in the Palisades fire, including more than 5,500 residences and 100 commercial businesses, according to the California Department of Forestry and Fire Protection.

Caruso previously attributed the mall’s survival to the hard work of private firefighters and the fire-resistant materials used in the mall’s construction.

The $200-million shopping and dining center opened in 2018 with a movie theater and a roster of upmarket tenants, including Erewhon, which may be the only grocer in the heart of the fire-ravaged neighborhood when it opens.

Caruso’s company was able to fill the mall with tenants despite the long shutdown.

Palisades Village is 99% leased, with the majority of tenants returning, said Jackie Levy, chief financial and revenue officer. Nearly one-third of the shops and restaurants are new to the property.

A firefighter carries a hose back to his rig while walking through a destroyed home in Pacific Palisades.

Last year, Pacific Palisades-based fashion designer Elyse Walker said she would reopen her eponymous store in Palisades Village after losing her 25-year flagship location on Antioch Street to the inferno.

Other neighborhood shops destroyed in the fire that are reopening at the mall include K Bakery and Loomey’s Toys, which caters to children up to age 12 and used to be across the street from Palisades Elementary Charter School.

“It’s been a journey and I’m excited because I wasn’t sure that there was going to be a place to come back to,” said toy store owner Amanda Rastegar. “Hopefully we can bring some of that magic back.”

Rastegar’s home in the Palisades survived but was damaged by the fire. The family returned about eight weeks ago. Her last memory of the fire was a burning supermarket.

“I just couldn’t wrap my brain around what was happening,” she said. “By the time I left, Gelson’s was on fire.”

Among the returning tenants is Angelini Ristorante & Bar. Well-known Los Angeles chef Gino Angelini said he will be in the kitchen next month for a return of the Italian restaurant.

“We won’t do a big celebrity open,” he said. “We want to have a very soft opening and see our customers come back.”

Construction takes place at Rick Caruso's Palisades Village

An elaborate celebration would not feel “correct for me,” Angelini said, because the devastation has been “very sad” for so many.

Other new tenants include local chef Nancy Silverton, who has agreed to move in with a new Italian steakhouse called Spacca Tutto. Women’s activewear retailer LESET will open its first West Coast location.

Caruso said he is optimistic that customers will return to the center, even though many Pacific Palisades residents are still dispersed. One tracking system estimated that about 30% of the Village’s customer base was impacted by the fire, he said.

“That means 70% did not get impacted, so there’s a lot of customers still left out there,” Caruso said. Historically, the center drew customers from as far away as Beverly Hills and Calabasas, as well as Malibu, Brentwood and Santa Monica.

He also hopes many will be inspired to visit the revived mall.

“I believe in the goodness of people and I believe that people are going to want to support the Palisades,” he said. “They’re going to want to be there and support the businesses that have had the courage and the heart to reopen.”

Business

Walmart’s EV chargers are coming to California with discounts for members

Published

23 hours ago

July 8, 2026

Press Room

Walmart’s EV chargers are coming to California with discounts for members

Walmart is rapidly expanding its network of electric vehicle chargers designed for customers to use while they shop.

The network could help fill gaps in EV infrastructure in states with greater need for chargers. Walmart, which has more than 5,000 locations in the U.S. and hundreds in California, says more than 90% of Americans live within 10 miles of one of its stores.

The chargers also offer an incentive for customers to choose Walmart — Walmart Plus members will receive a 10% discount off an average price of $0.46 per kilowatt-hour of energy at the company’s chargers.

Walmart chargers are already available at more than 75 locations in 17 states, with Texas boasting the most charging stations, followed by Florida and Arizona.

Matthew Nelson, Walmart’s director of energy policy, said last week on LinkedIn that the network will soon reach 29 states, including California.

“We are delivering on the promise of affordable, reliable and convenient charging,” Nelson said in his post.

According to Walmart’s website, six charging stations are coming to California soon, though the company did not offer a specific timeline.

The chargers will be installed at stores in Antelope, Brea, Fresno, Stockton, Suisun City and Vallejo.

Most charging sites in California will include eight to 16 fast-charging stalls, said Walmart spokesperson Kelsey Bohl.

The company first announced plans in April 2023 to install its own EV chargers at Walmart and Sam’s Club stores, with a goal of installing thousands of chargers by 2030. Partnering with ABB E-Mobility and Alpitronic, it added 25 new charging sites this past May and six more in June.

“Walmart is building a leading retail-integrated EV fast-charging network, focused on delivering an affordable, reliable and convenient charging experience where customers already shop,” Bohl said in an emailed statement. “Customers can charge while they shop, access stations through the Walmart app they already use, and benefit from affordable pricing.”

The charging stations already available include 612 individual charging stalls using 400-kilowatt chargers. Each stall has a dual charging cord with both Combined Charging System and North American Charging Standard connectors. The standard connectors, designed by Tesla, are smaller and lighter than the combined systems.

The primary way to pay for the chargers is through the Walmart app, but the company is also experimenting with built-in credit card readers to allow those without the app to use the stations.

Customers can check charger availability on the Walmart app. The company said the chargers will be available 24 hours a day.