Valley doctors named in federal complaint

The U.S. Department of Justice today filed a civil complaint against two Southern California surgeons and their companies for allegedly offering unproven stem cell treatments at clinics in Rancho
Mirage and Beverly Hills without government approval.

Federal prosecutors in Los Angeles are seeking a permanent injunction to stop Drs. Elliot B. Lander and Mark Berman, the California Stem Cell Treatment Center Inc. and Cell Surgical Network Corp. of Rancho Mirage from marketing stem cell products without the approval of the U.S. Food and Drug
Administration.

“Marketing unproven and potentially unsafe treatments puts consumers at risk,” said acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice will continue to work with the FDA to make sure manufacturers of experimental therapies
conduct their research within the safe and legal bounds for drug innovation.”

Lander told CBS Local 2 that in November of 2007 the FDA released some guidance language that declared that, he explained, “your stem cells from your fat, should be a drug. If it’s defined as a drug, it has to be studied as a drug, manufactured as a drug, and marketed as a drug, which would basically eradicate our surgical industry.”

Lander said the FDA asked his and other large companies to sign a consent decree authorizing or validating that the “stromal vascular fraction” or SVF from fat were drugs.

“We refused to sign,” said Lander, “because we don’t believe that someone’s fat from their own stem cells from their own bodies is a drug and should ever be a drug and it would absolutely eliminate access to those cells for all Americans, and in good conscience we couldn’t sign it.”

Berman added that the FDA has long known about his clinics’ same-day treatments, which he said have shown overwhelmingly positive results.

“We disagree with the mischaracterization that these treatments are dangerous,” Berman said. “All we’re doing is taking advantage of the cells in your own body. We’ve always been transparent with what we do.”
Berman and Lander control the operations of about 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center and Cell Surgical, which market treatments that have not been proven safe, the DOJ alleges in the complaint.

The government contends that the defendants manufacture SVF products from patients’ body fat, which the companies then market as stem cell-based treatments for a host of serious conditions and
diseases, including cancer, pulmonary disease, arthritis, stroke, ALS and multiple sclerosis.
“Your stem cells are not a drug,” Berman said. “They’re your own property. We’re not manufacturing a drug.”
Prosecutors allege the defendants manufacture the products without Federal Drug Administration approval and without proof of safety and efficacy.
The Justice Department filed the complaints at the request of the FDA.
But Berman contends that his treatments are innovative and highly successful. For example, he said, of 2,400 patients suffering from knee osteoarthritis, 82 percent have shown positive results after stem cell therapy.

“The tissue adjacent and in and around your fat has four types of stem cells that can easily be released and be used for regenerative purposes,” added Lander. “This is technology we’ve been using safely for 8 years, We have 8500 patients on our database. We have no infections and an extremely low complication rate.”
According to the complaint, the defendants and their affiliates have used their products on thousands of patients without first obtaining necessary FDA approvals. In some cases, adverse events that harmed patients occurred after treatment with the products, the government alleges.

Lander addressed those allegations with CBS Local 2 in November of 2017.
In addition, the complaint alleges that the defendants’ misbranded products fail to include adequate directions for use, such as dosages, warnings and side effects.

“The technology that we’re using is spreading rapidly around the world and it’s becoming one of the leading technologies for cell therapy because it’s cheap and simple and it uses your own cells,” said Lander.
“In many ways it’s a threat as what’s perceived to be the future of stem cell therapy, which would be that big pharma would generate specially engineered lines of stem cells and commercialize them and monetize them and sell them to doctors in a bottle. Here we are going on 10, 20 years and there’s still no approved regenerative stem cell therapy. Even though there are companies with billions of dollars behind them and they’re still not approved because the FDA process of approving a stem cell drug is so onerous and so challenging.”
According to the complaint, recent FDA inspections showed that the products are not manufactured, processed, packed or held in conformance with current good manufacturing practice, and they are adulterated as a matter of law.
A similar complaint was also filed against Sunrise, Florida-based US Stem Cell Clinic LLC.

Read the entire statement from Cell Surgical Network

The Cell Surgical Network (CSN) intends to vigorously defend the lawsuit filed today by the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration. CSN strongly rejects the idea that a person’s own cells should be regulated by FDA as a drug. On behalf of all Americans, we look forward to protecting patients’ rights and the physician-patient relationship. We share FDA’s concern for patient safety, but do not believe that FDA regulation of a surgical procedure that simply harnesses the healing power of a patient’s own cells, without altering the biological characteristics of those cells, is the answer. The decision of whether or not the surgical procedure is performed should be made by the patient and physician – not the FDA or any other arm of the federal government.