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Column: Mark Berman, pusher of unproven stem cell therapies, dies while awaiting verdict in FDA lawsuit

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Column: Mark Berman, pusher of unproven stem cell therapies, dies while awaiting verdict in FDA lawsuit

For years, California beauty surgeon Mark Berman was a pacesetter of that nook of the healthcare world pushing unproven and unapproved stem cell therapies for a number of medical circumstances.

Berman aired his claims for what he known as “magic cells” in a e-book, video appearances and thru a community of affiliated clinics across the nation. These claims caught the eye of the Meals and Drug Administration, which has been attempting to stamp out clinics claiming that stem cell injections can deal with illnesses and circumstances comparable to Alzheimer’s, Parkinson’s, autism and even— most lately — COVID-19.

I can not condone exploitation of determined people who find themselves led to consider that they are going to be cured and even helped by a clinic or a tablet or any purported remedy that’s not based mostly in science.

— Jeanne Loring, Scripps Analysis Institute

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A 2018 lawsuit the FDA filed towards Berman, his skilled accomplice Elliot Lander and their two stem cell companies is awaiting a verdict from U.S. District Decide Jesus Bernal in Riverside. Whichever approach it goes, Bernal’s ruling would set the stage for the subsequent section of the FDA’s marketing campaign towards stem cell clinics — both endorsing its place that the injection process quantities to administering unlawful medication or erecting an impediment to enforcement of its guidelines.

Berman died April 19, in response to his workplace. His dying hasn’t been publicly introduced. An electronic mail despatched final week to a affected person and signed by an workplace supervisor at Cell Surgical Community, which Berman co-founded with urologist Elliot Lander in 2012, said that he died after being hospitalized in early January.

Lander instructed me by electronic mail, “The household will launch all pertinent info in an obituary which has not been accomplished and revealed but.” Berman’s son, Sean, confirmed that an obit is being written.

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Berman’s dying supplies us with a possibility to evaluation the FDA’s marketing campaign towards clinics purveying bogus stem cell therapies.

The company’s targets are clinics that depend on a way just like the one promoted by Berman and his colleagues at clinics branded because the California Stem Cell Therapy Heart in Rancho Mirage and Beverly Hills and at scores of clinics affiliated with the Cell Surgical Community. The therapy facilities have been co-founded by Berman and Lander in 2010.

The strategy begins with extracting fats from a buyer by way of liposuction. The fats is then refined to isolate what is named the “stromal vascular fraction,” or SVF, which Berman asserted is wealthy in stem cells. The SVF is then reinjected into the client.

Clients of greater than 1,000 clinics across the nation, a few of that are affiliated with the Cell Surgical Community, have been charged as a lot as a number of thousand {dollars} for such procedures, that are seldom, if ever, lined by medical health insurance.

In a 2015 e-book titled “The Stem Cell Revolution,” Berman and Lander asserted that their colleagues within the community have been treating “a variety of circumstances” comparable to Alzheimer’s, autism, cerebral palsy, a number of sclerosis, muscular dystrophy, Parkinson’s, stroke and traumatic mind damage.

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Extra lately, Berman, Lander and different stem cell promoters have been implying that stem cells can be utilized to deal with COVID-19.

The FDA’s place on these claims is crystal clear. The company observes that there isn’t a scientifically validated proof for these therapy claims. The company has warned potential clients to avoid the claims’ promoters.

“Don’t consider the hype,” the company says on its web site. “Some unscrupulous suppliers supply stem cell merchandise which might be each unapproved and unproven,” in addition to “probably harmful.”

The FDA says it has not authorized stem cell therapies for any circumstances aside from uncommon blood system illnesses, for which it has authorized therapies utilizing blood-forming stem cells derived from umbilical wire blood. The company has particularly warned towards claims that stem cells can be utilized to deal with autism, macular degeneration, blindness, power ache, fatigue; neurological problems comparable to a number of sclerosis, Alzheimer’s and Parkinson’s; or cardiovascular or pulmonary illnesses.

The company additionally has warned towards claims, that are additionally unproven, that stem cells can be utilized for “the therapy or prevention of COVID-19, acute respiratory misery syndrome (ARDS), or some other complication associated to COVID-19.”

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In sensible phrases, nevertheless, the FDA’s marketing campaign has not been going effectively. In 2017, the FDA closed a loophole that allowed the stem cell clinics to proceed pitching unproven, ineffective and probably hazardous stem cell therapies on to customers. The stem cells extracted from fats, the FDA dominated, have been medication underneath the regulation, which means that the clinics would should be licensed and subjected to inspection.

However the company unwisely gave clinics as much as three years to adjust to its new laws. Then it prolonged the deadline by six months due to the pandemic, so its interval of regulatory “forbearance” expired Could 31, 2021.

By then, a torrent of shady operations had poured into the sphere — so many who the duty of defending the general public from them could exceed the FDA’s capabilities. In line with a research by Leigh Turner of UC Irvine, by midyear 2021 there have been 1,480 companies working 2,754 clinics nationwide.

“That hardly looks like progress,” Turner instructed me final 12 months. “The issue the FDA faces is 4 instances bigger than what existed in 2016. The FDA solely has so many staff and so many inspectors. They don’t actually have sufficient inspectors to ship them to 1,480 companies.”

Earlier than his dying at age 69, Berman and his associates reportedly had been learning whether or not stem cells could possibly be used to deal with COVID. In testimony throughout the federal trial, Berman said that Cell Surgical Community was working with a Florida stem cell firm, American Cell Expertise, “to deal with COVID-19 sufferers” in accordance with a therapy protocol the community developed, as an FDA post-trial transient filed in June describe his statements from the witness field.

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Sean Berman, Mark Berman’s son, who says he’s a advisor to ACT, instructed me that so far as he’s conscious, no sufferers have been handled for COVID in response to the protocol the FDA talked about.

Lander appeared to point, nevertheless, {that a} research of some kind had taken place. “No sufferers have been ever charged any charges in our Covid-19 research,” he instructed me by electronic mail.

Particulars about Berman’s dying haven’t been made public.

An individual who answered the telephone at California Stem Cell Therapy Heart instructed me that Berman died of “issues from Covid.”

Lander, nevertheless, instructed me: “Any one who represented themselves to be an agent of California Stem Cell over the telephone was neither educated sufficient, nor licensed, to debate Dr. Berman’s medical historical past.”

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One affected person says Berman’s workers canceled a pre-op process in January, stating that Berman had COVID. The affected person, who doesn’t need to be recognized, says Berman’s workplace stored providing to reschedule the appointment, however finally the process didn’t happen.

The FDA has been taking a look at Berman’s operations at the very least since 2017. In two inspection experiences in July 2017, the company listed quite a few “objectionable circumstances” on the California Stem Cell Therapy Heart services in Rancho Mirage and Beverly Hills that it asserted have been in violation of regulatory requirements .

The experiences criticized sterilization procedures, coaching and record-keeping on the places. At Rancho Mirage, at the very least 4 “severe adversarial occasions” after stem cell procedures had not been investigated by the clinic or reported to the FDA as required, the company mentioned.

They included a affected person’s retinal detachment after the SVF was injected into the affected person’s eyes, hospitalization of one other affected person for “confusion and headache,” and two instances of an infection.

Berman and Lander wrote of their e-book that that they had discovered “extraordinary security and no severe adversarial results associated to SVF deployment.”

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The FDA’s most decided assault on Berman got here within the lawsuit filed in Riverside federal court docket in Could 2018, aimed basically at forcing him and his services to stop treating sufferers with the fats extractions. The lawsuit was largely an identical to 1 the company filed the identical day towards U.S. Stem Cell, a Florida clinic operator, in Miami federal court docket.

Each units of plaintiffs mounted related defenses — mainly that they have been merely treating sufferers with their very own tissues, so their merchandise fell exterior the FDA definition of a drug and thus have been exempt from the company’s jurisdiction. The FDA disagreed. The extracted tissues have been so totally manipulated earlier than reinjection, the company argued, that they have been correctly outlined as a drug and didn’t qualify for the exemption.

The 2 lawsuits have adopted divergent paths. In Miami, District Decide Ursula Ungaro agreed with the FDA in a serious victory for the company’s marketing campaign towards stem cell clinics.

Ungaro held in June 2019 that the SVF was certainly a drug and subsequently used illegally. She additional noticed that U.S. Stem Cell’s procedures “contain the next threat of communicable illness and different security issues and are subsequently topic to FDA regulation.” Her resolution siding with the company by way of abstract judgment — that’s, with out trial — successfully shut down U.S. Stem Cell’s clinic.

Ungaro’s ruling was upheld in June by the U.S. eleventh Circuit Court docket of Appeals in Atlanta.

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In Riverside, nevertheless, Bernal denied the FDA’s movement for abstract judgment. As an alternative, he held a seven-day trial in Could 2021. Submit-trial briefs by either side have been submitted in August, however Bernal has but to problem a verdict. There are not any indications of when he may rule.

Berman’s dying gained’t require Bernal to droop his deliberations, as there are nonetheless three different defendants — Lander, California Stem Cell Therapy Heart and Cell Surgical Community.

The FDA, in its post-trial transient in June, correctly raised the alarm that the defendants may be aiming their pitch at victims of COVID-19, regardless of the dearth of proof that stem cells are efficient in treating the illness. Why ought to that be a shock? The sector of stem cell clinics has been feeding on the desperation of sick folks nearly since its inception.

“Has a physician ever instructed you ‘there’s nothing we will do?’” Berman and Lander wrote of their e-book. “We sincerely hope you gained’t settle for that as the ultimate reply.” The FDA’s response has been, in impact: Beware, as a result of they don’t have the reply both.

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Column: Disneyland has already turned my hometown into a giant tourist trap. What's next?

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Column: Disneyland has already turned my hometown into a giant tourist trap. What's next?

Somewhere in my personal papers is a folded up, tattered poster of Mickey Mouse commemorating his long reign as the world’s most famous rodent. It shows scenes from some of his iconic shorts — “Steamboat Willie,” “The Band Concert,” “Brave Little Tailor” — above the legend “Thanks Mickey for 60 Years!”

Signed, Disneyland.

My fourth-grade classmates and I received the posters in the fall of 1988 at Patrick Henry Elementary School in Anaheim, along with a T-shirt of a tuxedoed Mickey wearing sneakers and a free trip to the Happiest Place on Earth for his birthday bash. We cheered alongside kids from around the world and rode rides until the evening. I can still hum parts of the gratingly cheery song from the parade held in Mickey’s honor. (A quick YouTube search confirmed I have the melody right.)

The poster hung on my wall through junior high, even though I was more of a Donald Duck fan. It was a symbol for me that a company whose products and productions I loved cared about us Anaheim kids. How cool was it that one of the world’s most popular theme parks was in my hometown? And how cool was it that they let us kids hang out with Mickey on his birthday for free?

I hadn’t thought about my souvenir for decades until yesterday, when the Anaheim City Council passed yet another Disneyland-friendly ordinance. Zoning regulations will be relaxed so Disney can build new attractions and hotels on its 490-acre campus, and three public roads will be sold to Disney for $40 million.

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In return, Disney promises to undertake nearly $2 billion in construction over the next decade, donate $30 million to a yet-to-be-formed public housing trust run by Anaheim, give $8 million toward improving city parks and pay $45 million in “transportation improvements,” according to the website for DisneylandForward, the name Disney has bestowed on its plans.

A Disney-funded study by Cal State Fullerton’s Woods Center for Economic Analysis and Forecasting predicted that the company’s most ambitious proposals — a full build-out of Disneyland and Disney California Adventure, and a new hotel — will create tens of thousands of jobs and generate $244 million in annual tax revenue.

Who could possibly be against this windfall of cash and fun? Me, of course!

The Anaheim City Council unanimously approved the agreement despite the lack of concrete plans from Disney — all it’s revealing right now is “possibilities” inspired by attractions from its theme parks worldwide, according to the DisneylandForward website. There might be more specifics in the Woods Center forecast, but city officials and the public alike can see only a nine-page summary because Disney claims it contains proprietary information.

This cryptic Mouse long ago replaced the Mickey of my childhood memories. By the time I became a reporter, I knew that Disney has long treated Anaheim as a political chamois, looking to squeeze as much as possible out of Orange County’s largest city.

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Walt Disney Co. Chief Executive Bob Iger at “Mickey’s 90th Spectacular” at the Shrine Auditorium in 2018.

(Valerie Macon / AFP via Getty Images)

In 1996, the city paid for a $108.2-million parking structure — at the time, the largest in the world — that it leases to Disney for a buck a year, allowing the company to keep all the revenue and eventually assume ownership. A 2017 Times analysis found that Disney had “secured subsidies, incentives, rebates and protections from future taxes” worth more than $1 billion over the previous two decades. Disney has repaid that goodwill with millions of dollars in donations to political action committees that push pro-Mickey candidates.

Two years ago, FBI agents and city-funded independent investigators characterized a Disneyland Resort lobbyist as part of a “cabal” that has undue influence over city politics. Meanwhile, the cost of a one-day pass to the Mouse House has increased from $43 in 2000 to $194 as of last year. Nightly fireworks at the resort scare dogs, set off car alarms in working-class neighborhoods and make the 5 Freeway a smoky mess.

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Yet, to paraphrase the most famous quote in “The Usual Suspects,” the greatest trick Disney ever pulled was convincing Anaheimers that its bad side doesn’t exist. The few DisneylandForward skeptics have been easily drowned out by supporters.

Unions? Leaders showed up to support DisneylandForward when the Anaheim City Council first voted on it in April. The council? From Republican Stephen Faessel to progressive Carlos Leon to independent Jose Diaz, they hardly asked any hard-hitting questions. The millions of visitors to the Disneyland Resort, half of whom seem to be my cousins and friends? They’re celebrating like Ewoks at the end of “Return of the Jedi” at the thought of more rides to enjoy and swag to grab.

Only a few of us cranks are pointing to the environmental impact report finding that the construction noise and permanent change in air quality as a result of the expansion would be “significant and unavoidable.” Or pulling out a calculator to crunch the numbers in the Woods Center report.

For instance, the study says that if Disneyland maximizes its acreage and builds a new hotel, that will create 28,352 jobs, translating into $1.8 billion in income for those employees.

Sounds nice and big. But it doesn’t say what kind of jobs and whether they’d be permanent or full time. The $63,487 average yearly salary from those jobs is considered low-income for a one-person household in Orange County, according to the California Department of Housing and Community Development. These are hardly the jobs Anaheimers need to be able to afford to live here, let alone live a good life.

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I still remember when Anaheim was a city of factories and blue-collar jobs that allowed my immigrant elders and my cousins to buy homes. Near the granny flat where I lived before transferring to Patrick Henry were a lumberyard, a Kwikset factory and a trucking depot where my dad would pick up cargo containers.

All those places vanished decades ago. Now, there are hipster hangouts, beer gardens and high-priced apartments, because Anaheim leaders took Disney’s lead and transformed my hometown into one giant tourist trap, with longtime residents little better than an afterthought.

Which brings me back to that Mickey Mouse 60th anniversary poster. I eventually took it down because the edges were fraying, and I thought it would be a collectors’ item one day. I thought Disneyland had bestowed on me yet another wonderful prize.

I looked up the poster on eBay recently. I can get one for $20. But, hey: At least I got something free from Disney back in the day.

In 2016, the company vowed to give all Anaheim sixth-graders free Disneyland tickets in honor of its 60th anniversary if they did community service projects.

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The promotion was supposed to continue for a decade but was discontinued in 2021, during the pandemic. It has yet to be reinstated, even though Disney just announced that its theme park division increased revenue in the second fiscal quarter to $8.39 billion.

Stay classy, Mouse House!

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Q&A: David Simon isn't a starry-eyed dreamer, but he's all in on Hollywood

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Q&A: David Simon isn't a starry-eyed dreamer, but he's all in on Hollywood

David Simon is so bullish on Hollywood he’s building a new movie studio there from the ground up and renovating another one that dates to the days of silent films.

They’re the largest of 10 projects the real estate developer has going in Hollywood at a time when many other Los Angeles builders have paused work in the face of high interest rates and construction costs that make it harder to build profitably.

Simon is banking on the lasting stamina of the entertainment industry even as it goes through structural changes in the age of streaming, and the enduring appeal of Hollywood as the place to make movies and television shows.

Through his company BARDAS Investment Group, Simon recently launched construction of Echelon Studios, a $450-million complex on Santa Monica Boulevard west of the 101 Freeway on a site formerly occupied by a Sears store. It will include five soundstages and support facilities, including offices and space to keep trucks, production equipment and actors’ trailers.

Simon recently launched construction of the $450-million Echelon Studios complex, shown in a rendering, on Santa Monica Boulevard on the site previously occupied by a Sears store.

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( Bob Hale / Rios)

Less than a mile away on Romaine Street, Simon is preparing to launch a $600-million renovation and expansion of Echelon at Television Center, which was once home to Technicolor’s film manufacturing laboratory and Metro Pictures Corp., which became part of Metro-Goldwyn-Mayer in the 1920s. Among Metro’s stars were Rudolph Valentino, Lillian Gish, Ramon Novarro and Buster Keaton.

Before he founded his own company in 2018, he oversaw two large-scale Hollywood projects for Kilroy Realty: the $420-million office, residential and retail redevelopment of the former CBS headquarters in Hollywood now known as Columbia Square and the $450-million office and residential redevelopment of the former Academy of Motion Picture Arts and Sciences headquarters site now known as On Vine.

The Times spoke with Simon to discuss his Hollywood projects, as well as his predictions about the future of the neighborhood and the local entertainment industry. The interview has been edited for brevity and clarity.

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The historic Art Deco Echelon Television Center studio complex in Hollywood, which will undergo a $600-million makeover.

The historic Art Deco Echelon Television Center studio complex in Hollywood, which will undergo a $600-million makeover.

(Luis Sinco / Los Angeles Times)

You chose a long time ago to focus your efforts on Hollywood. What made you think it had a leg up on other real estate markets?

I always knew Hollywood is the biggest brand in the world. Everybody knows what Hollywood is — films, television, celebrity — and that is just a great brand to have while you’re developing. It was surprising that there was not a lot of institutional investment there for many years. What really got me going was the CNN building.

What happened with that building? Larry King used to broadcast his shows there.

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We had the opportunity to buy the building in the early 2000s when I was with Broadreach Capital Partners and we didn’t want to lose its high-profile tenant, CNN. They had a deal on the table to move to the Sherman Oaks Galleria.

I remember asking the question, “If we bought the building, would you be interested in staying if we built you a new studio? And the answer was, “Yes,” and we did a 20-year lease with them. That really said to me that there’s a market in Hollywood and there’s really no focus from an institutional landlord mindset, no investment dollars coming in, because there hadn’t been new studios or soundstages built for decades.

You continued to work for other developers until six years ago when you formed your own company. What made you think it was time to take the leap?

We said, “This industry is really growing. There seems to be strong demand for content, streamers are growing and a lot of production is happening.” We thought there was a need to create new and inspiring environments in the entertainment capital of the world for media and content creators.

What’s your company doing now?

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We’ve got about 1.6 million square feet in development. All entitlements are in place with the exception of Television Center, which is still going through city approvals. This is all about creating a portfolio of assets that caters to this entertainment user base. Between our two studios we’ll have about 10 soundstages and a nice critical mass.

A lot of other developers are on the sidelines waiting for conditions to improve. Why are you plowing ahead?

My partners at Bain Capital Real Estate and I are not naive to where the world is today, where interest rates are and the cost of debt and construction costs and everything that’s going on in the world. But we’re of the mind that our locations are great. They’re infill locations in the heart of Hollywood.

The demand for media and content is having its ups and downs like any growing industry does. There will be consolidations and things like that, but at the end of the day, that demand is going to continue to be there. And for that demand to be there, quality product, what I call the manufacturing facilities, needs to be put in place and it needs to be state of the art.

Would that slow down the trend of movie and television production leaving L.A. for other cities?

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With artificial intelligence, LED screens and other technology [filmmakers] can create scenes inside of a soundstage that feels like you’re in New York or Paris, but you’re really in L.A. The more that content can be created locally, the better for the talent.

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Ex-Fatburger boss used company funds for Rolls-Royce and other luxuries in $47-million scheme, indictment says

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Ex-Fatburger boss used company funds for Rolls-Royce and other luxuries in $47-million scheme, indictment says

A federal grand jury this week indicted Andrew Wiederhorn, the former chief executive of the company that owns the Fatburger and Johnny Rockets restaurant chains, on federal charges alleging a $47-million “sham loan” scheme.

Wiederhorn, the current controlling shareholder of the publicly traded Fat Brands Inc., is accused of concealing millions of dollars in reportable compensation and taxable income from the Internal Revenue Service and evading the payment of millions in taxes, according to the indictment returned Thursday.

Company money — categorized as “shareholder loans” — was disbursed to Wiederhorn and his family “for their personal benefit,” according to the indictment. Some of that money went toward private-jet travel, vacations, a nearly half-million-dollar Rolls-Royce Phantom, other luxury automobiles, jewelry and a piano.

According to the indictment, Wiederhorn “had no intention of repaying these sham ‘loans.’”

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“Instead of looking out for shareholders, the defendant allegedly treated the company as his personal slush fund, in violation of federal law,” U.S. Atty. Martin Estrada said in a statement.

Nicola Hanna, Wiederhorn’s attorney, referred to the charges as “wrong on both the facts and the law.”

“Mr. Wiederhorn consulted and followed the advice of world-class professionals in all of his business dealings,” Hanna, the former U.S. attorney for the Central District of California, said in a statement. “We look forward to making clear in court that this is an unfortunate example of government overreach — and a case with no victims, no losses and no crimes.”

Wiederhorn was allegedly assisted by the company’s former chief financial officer, Rebecca D. Hershinger, and his outside accountant, William J. Amon, who were also charged in the 22-count indictment. Fat Brands has also been charged.

Brian Hennigan, counsel for FAT Brands Inc., said the charges were “unprecedented, unwarranted, unsubstantiated and unjust.” He added that they were “based on conduct that ended over three years ago and ignore the company’s cooperation with the investigation.”

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Hershinger’s defense attorney, Michael Proctor, in a statement called the charges “baseless” and said that, while Hershinger was at FAT Brands, “she disclosed all material facts to the company’s outside auditors, and complied with her legal and ethical obligations.”

The indictment lists a wide variety of felony counts against Wiederhorn, including wire fraud, endeavoring to obstruct the administration of the IRS, tax evasion and false statements and omission of material facts in statements to accountants in connection with audits and reviews.

Between 2010 and 2021, the indictment alleges, Wiederhorn took the money from Fat Brands and its affiliate, Fog Cutter Capital Group Inc.

In 2022, The Times reported that Wiederhorn faced a criminal probe. As part of the inquiry, his son’s L.A. home was raided by agents; investigators also sought to raid Wiederhorn’s Beverly Hills mansion.

Last year, Wiederhorn publicly announced he was stepping down as CEO, framing it as a way to “eliminate the distraction” of the ongoing federal probe. Weeks later, however, Wiederhorn “removed every director other than himself” from the board of Fat Brands and “reconstituted” a new board with directors “under his control,” according to the indictment.

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Wiederhorn graduated from USC, and at age 21 founded Wilshire Credit Corp., drawing in a $300-million investment from Eli Broad, an early backer. The Oregon native returned to Portland and launched Fog Cutter Capital in 1997. With a net worth of about $140 million, Fog Cutter bought a controlling interest in Fatburger in 2003.

Around that time, federal investigators were scrutinizing Wiederhorn’s businesses, and in 2004 he pleaded guilty in U.S. District Court in Oregon to charges of paying an illegal gratuity to an associate and to filing a false tax return. He served 15 months in federal prison and paid a $2-million fine.

The day before his guilty plea, Fog Cutter Capital gave him a $2-million bonus and agreed to keep paying him while he sat behind bars.

Out of prison, Wiederhorn tried to burnish his reputation and appeared on the reality TV show “Undercover Boss” at a Fatburger outlet in Arizona. He moved to Southern California and told The Times in 2017 that he never intentionally did anything wrong.

He took Fat Brands public around 2017 and led an expansion of more than 2,000 outlets, including sports bar Twin Peaks, Italian restaurant chain Fazoli’s, Round Table Pizza and Marble Slab Creamery.

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Yet investors have chafed at Wiederhorn’s business decisions and in litigation accused him of “looting” the company of cash while his relatives enjoyed six-figure salaries on the corporate payroll. One shareholder suit filed in 2021 accused him of “running Fat Brands into the ground and bleeding it of its cash.”

Last month, Wiederhorn went on Fox Business channel to talk about California’s minimum wage increase for fast-food workers. He said prices would go up because “operators can’t afford it.”

“Everyone wants their employees to make more money, but there’s a cost to that and a restaurant operator just doesn’t have that margin,” he said.

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