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.

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.

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.

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.”

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.

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.”

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.”

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.

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.