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WASHINGTON – Hundreds of clinics offering unproven stem cell procedures took a big hiatus from the U.S. government in 2017: they would have three years to prove their dubious treatments were safe and effective before regulators started cracking down.
But when the Food and Drug Administration’s grace period expired at the end of May – extended by six months due to the pandemic – the consequences became clear: Hundreds of other clinics were selling the unapproved treatments for arthritis, the Alzheimer’s disease, COVID-19 and many other conditions.
“It backfired,” says Leigh Turner, a bioethicist at the University of California, Irvine. “The magnitude of the problem is much greater for the FDA today than it was in the beginning.”
The continued spread of for-profit clinics promoting stem cells and other so-called “regenerative” therapies – including concentrated blood products – illustrates how quickly experimental medicine can move beyond government oversight. No clinic has yet obtained FDA approval for a stem cell offering and regulators are now faced with a huge, uncooperative industry arguing that it shouldn’t be subject to regulation.
Although emerging research suggests that stem cells could one day be used widely for a number of medical conditions, experts say they shouldn’t be used outside of well-controlled studies or a handful of uses. established. For example, stem cells taken from the blood or bone marrow have long been used to treat leukemia and other blood diseases.
Many clinics use so-called adult stem cells collected from tissue like fat or bone marrow – not the more versatile but controversial stem cells of embryos used in research.
Turner and other experts have followed the growth of the clinics for nearly a decade. Clinics charge between $ 2,000 and $ 25,000 for adult stem cell injections and other infusions they advertise for an assortment of illnesses, including diabetes, autism, cancer, multiple sclerosis, and blood disorders. vision. Some clinics use stem cells derived from fat, harvested by liposuction and then injected back into patients, with the goal of repairing joints or fighting disease. Others use bone marrow or blood taken from the umbilical cord after birth.
There is no government tally of the number of clinics operating in the United States, but Turner counted more than 1,200 in 2019, up from 570 clinics that he and a co-author identified in 2016. He is working on one. update but said the number has consistently grown.
The FDA has repeatedly warned Americans to avoid unapproved and unproven stem cell therapies, which have sometimes caused blindness, bacterial infections, and tumors. During the FDA’s three-plus years of “enforcement discretion,” the agency has sent formal warning letters to more than a dozen companies performing the riskiest procedures. Regulators also prevailed in a Florida court case to shut down a large clinic offering unproven treatments. Another case against a similar prominent company is pending in California.
“It’s time to get the data we need” to evaluate clinic stem cell procedures, FDA’s Dr. Peter Marks told an industry conference in June. He highlighted a multi-year effort by the FDA to help clinics throughout the review process.
Many stem cell physicians continue to claim that their office procedures are outside the purview of the FDA. But the FDA has concluded that treating stem cells and giving them to critically ill patients is like creating a new drug, which the agency is regulating.
The FDA has not disclosed how many clinics have sought approval since 2017, but public comments suggest it was troubling to be low.
“We were very disappointed with the number of clinics that entered,” said Dr. Wilson Bryan of the FDA at the same conference.
Bryan, who heads the FDA’s cell therapies division, added he was “extremely concerned” about the number of stem cells and related offerings still available.
Tracking injuries resulting from procedures is difficult. Drug manufacturers and hospitals are required to report drug-related complications to the FDA, but no such requirement exists for individual physicians. And patients often don’t know where to report problems.
David Stringham of Provo, Utah, said having surgery for joint pain at a local clinic was “the worst decision of my life.”
In 2018, Stringham was looking for an alternative to surgery for the chronic pain in his right shoulder and elbows after years of weightlifting. He paid $ 2,400 for injections of so-called platelet-rich plasma at a clinic. It doesn’t involve stem cells, but the procedure is similar: Doctors take a sample of blood, process it to concentrate the platelets, and then inject them back into the patient’s problem areas in an attempt to speed healing.
The procedure went well, but within hours Stringham was ravaged by back, shoulder and arm pain.
“It was a crazy pain and I kept calling them and telling them ‘something is wrong’,” the 51-year-old said. “And to this day, I’m not doing well.”
The clinic gave Stringham pain medication and told him to be patient. But things haven’t improved even after months of physiotherapy. Since then, a neurologist has told Stringham he likely suffered nerve damage where he was injected.
Her case was included in a Pew Charitable Trusts review of 360 reported injuries from stem cells and other regenerative procedures between 2004 and 2020. Almost all of the reports came from medical journals, government publications, social media or news reports. Only five were from the FDA’s Medical Injury Database.
“There are a lot of holes in the security system,” said Liz Richardson of Pew, who led the project.
The FDA did not clearly assert its authority over these clinics until 2017. The following year, it began sending form letters to some 400 clinics warning them that they might be in violation of FDA rules. But the names of the clinics have not been made public and such warnings are often ignored.
Traditional medicine researchers welcome the FDA’s actions, but say it is impossible to assess their effect.
“The business model is, ‘We can keep bringing these products until things get serious with the FDA – and then we can just take our website down,” said Laertis Ikonomou, cell researcher. strains at the University of Buffalo who is also leading a working group on the subject for the International Society for Cell and Gene Therapy.
He and other experts say the clinics have damaged the reputation of legitimate stem cell research while siphoning off patients who might otherwise enroll in studies.
Lawyers representing stem cell clinics say they have no choice but to resist FDA regulation.
“The FDA is pushing them down this path of drug development, which no one is taking because it requires a million dollars of toxicology and animal studies just to show that something is safe for humans,” Marc Scheineson said. , a former lawyer for the FDA.
For now, people on both sides are waiting to see what the FDA does.
“We shouldn’t feel overly confident that the FDA has concluded this,” said Turner, the bioethicist. “They’ve really put in the resources and they’re trying to do something here, but I think they’re just overwhelmed and overwhelmed.”
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Follow Matthew Perrone on Twitter: @ AP – FDA Editor
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The Associated Press’s Department of Health and Science receives support from the Department of Science Education at Howard Hughes Medical Institute. The AP is solely responsible for all content.
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