In its most aggressive action against the growing stem cell industry, the FDA is awaiting a ruling on its lawsuit in federal court.
A picture of a patient’s eye one week after receiving stem cell injections from U.S. Stem Cell in 2015 shows widespread retinal hemorrhages. The patient’s doctor said the patient was in pain and later suffered significant loss of vision.
But the FDA’s slow response has permitted U.S. Stem Cell to continue operating four years after those first reports of blindness. Although the company stopped injecting its fat-derived treatments into eyes after the patients sued, it continues to sell the therapy to people with spinal injuries, Parkinson’s disease, multiple sclerosis and other serious chronic conditions.
FDA officials declined to discuss the lawsuit, or respond to critics who say the agency should have sought a temporary restraining order to shut down U.S. Stem Cell years ago. Former FDA officials said that such orders are extraordinarily difficult to obtain, and that the agency is wary that a loss in court could undermine its ability to regulate the industry.
In a long interview at her company’s main clinic in Weston, Fla., an hour north of Miami, Comella accused the FDA of overstepping its authority — which, she said, does not extend to any of her treatments. She said that adverse events are rare, and that doctors trained by U.S. Stem Cell have provided relief to more than 10,000 people, many of them suffering from intractable conditions.
In 2014, Comella formed the Academy of Regenerative Practices, an advocacy group that has set up a legal-defense fund for clinics under government scrutiny. The group has accused the FDA of squelching innovation and denying patients with incurable diseases access to potentially lifesaving treatments.
Last year in Tallahassee, Comella successfully lobbied state legislators to kill a measure that would have required stem cell clinics to register with the Florida Health Department, submit to annual inspections and have a physician on staff. In addition to treating patients, U.S. Stem Cell has long played a major role in the industry’s growth. The company has trained more than 700 doctors — for a fee of $7,500 in person or $2,500 online — and sells clinical equipment, Comella said, helping many American clinics get their start.
“Of course, we don’t understand the mechanisms of action,” she said. “I suppose you would have to talk directly to God to get that.”Kristin Comella, chief scientific officer of U.S. Stem Cell, is pictured in her office in Weston, Fla. She has accused the FDA of overstepping its authority, which she says does not apply to any of her treatments. The FDA’s rules on the processing and marketing of human cells, including stem cells, date to 2005.
International scientific groups, leading stem cell researchers and medical groups such as the American Lung Association and the American Academy of Ophthalmology began issuing warnings: Although stem cells may eventually be used to treat many diseases, the research is in its early stages, they said, and the therapies at cash-based clinics are unproven and premature.
Albini and other eye doctors soon decided to act on their own. In March 2017, they published an article in the New England Journal of Medicine that drew national attention to the women’s cases. It had been more than two years since Albini’s complaint. Mark Schwartz, who was deputy director of compliance for biologics during the Obama administration, said he did not remember the case and could not explain the delay.
Instead of retreating, U.S. Stem Cell was expanding. It struck a deal with General American Capital Partners, a Florida private equity firm, which agreed to invest $2.5 million to open 10 new clinics — including the South Miami operation that treated the 59-year-old woman who wound up in a coma. The expansion clinics have since closed.
If the FDA wins, legal experts say, it would force U.S. Stem Cell to stop selling the therapy, and send a chilling message across the industry. It also could strengthen the agency’s hand in future lawsuits. Meanwhile, the FDA has given the industry at large until 2020 to comply with the new rules. So far, few companies have made any move to do so, FDA officials said.
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