Thursday, October 21, 2021

US stem cell clinics boom while FDA halts action

WASHINGTON (AP) — Hundreds of clinics advancing unproven stem cell procedures caught a major break from the U.S. government in 2017: They’ll have three years to show their questionable treatments were safe and work before regulators crack down on them. did.

But when the Food and Drug Administration’s grace period expired in late May — extended by six months because of the pandemic — the results became clear: Hundreds more clinics are selling unapproved treatments for arthritis, Alzheimer’s, COVID-19 and many other conditions. Were were

“It had the opposite effect,” says Leigh Turner, a bioethicist at the University of California, Irvine. “The scale of the problem is much bigger for the FDA than it is today.”

The continued proliferation of for-profit clinics promoting stem cells and other so-called “regenerative” therapies — including concentrated blood products — shows how quickly experimental medicine can overtake government oversight. No clinic has yet won FDA approval for any stem cell offering and regulators now face a vast, uncooperative industry, which they argue should not be subject to regulation.

Although emerging research suggests that stem cells may someday have widespread use for a number of medical conditions, experts say they should not be used outside of well-controlled studies or a handful of established uses. For example, stem cells collected 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 such as fat or bone marrow – the more versatile but not controversial stem cells from embryos used in research.

Turner and other experts have tracked the development 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 diseases, including diabetes, autism, cancer, multiple sclerosis and vision problems. Some clinics use stem cells derived from fat, which are harvested via liposuction and then re-injected into patients, with the aim of repairing joints or fighting disease. Others use blood drawn from the bone marrow or umbilical cord after birth.

There is no government count of how many clinics operate in the US, but Turner counted more than 1,200 of them in 2019, up from 570 clinics identified by him and a co-author in 2016. He is working on an update, but says the numbers remain consistent. Grown up

The FDA has repeatedly warned Americans to stay away from unapproved and unproven stem cell therapies, which sometimes lead to blindness, bacterial infections, and tumors. During the more than three years of the FDA’s “enforcement discretion,” the agency sent formal warning letters to more than a dozen businesses that were performing the riskiest procedures. A Florida court case also led regulators to shut down a major clinic offering unproven treatments. Another case against a similar flagship company is pending in California.

“It’s really time to get the data we need,” FDA’s Dr. Peter Marks told an industry conference in June to assess the clinic’s stem cell procedures. He pointed to a multi-year effort by the FDA to help clinics through the review process.

Many stem cell doctors continue to argue that their in-office procedures are outside the purview of the FDA. But the FDA has concluded that processing stem cells and giving them to patients with serious diseases is the equivalent of creating a new drug, which the agency controls.

The FDA hasn’t disclosed how many clinics have sought approval since 2017, but public comments suggest it was too low.

“We’re very disappointed with the number of clinics we’ve come across,” FDA’s Dr. Wilson Bryan said at the same conference.

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Bryan, who directs the FDA’s cell therapy division, said he is “extremely concerned” about how many stem cells and related offerings are available.

Injuries from procedures are difficult to track. Drug manufacturers and hospitals are required to report drug-related complications to the FDA, but there is no such requirement for individual doctors. And patients often don’t know where to report problems.

David Stringham of Provo, Utah, says going through a joint pain procedure at a local clinic was “the worst decision of my life.”

In 2018, Stringham was looking into the option of surgery for chronic pain in his right shoulder and elbow after years of weightlifting. He paid $2,400 for an injection of so-called platelet-rich plasma at a clinic. It doesn’t involve stem cells but the process is similar: Doctors take a blood sample, process it to concentrate platelets and then re-inject them into the patient’s problem areas in an attempt to speed up healing.

The process went smoothly, but within hours Stringham developed pain in his back, shoulders and arms.

“It was an insane amount of pain and I kept calling him ‘something is not right’,” the 51-year-old said. “And to this day I am not perfect.”

The clinic gave Stringham medicine for the pain and told him to be patient. But even after months of physical therapy, the situation did not improve. Since then, a neurologist has told Stringham that he likely suffered nerve damage at the sites where he was injected.

His case was included in a Pew Charitable Trust review of 360 reported injuries from stem cells and other regenerative procedures between 2004 and 2020. Almost all reports came from medical journals, government publications, social media or news reports. Just five came from the FDA’s database for medical injuries.

“There are a lot of holes in the security system,” said Pew’s Liz Richardson, who led the project.

The FDA had not explicitly claimed its authority over such clinics until 2017. The next year, it began sending form letters to some 400 clinics, warning that they were in violation of FDA regulations. But the names of the clinics are not publicized, and warnings like these are often ignored.

Conventional medicine researchers welcome the FDA’s actions but say it is impossible to assess their effectiveness.

“The business model is this: ‘We can continue to offer these products until things get serious with the FDA – and then we can take our website down’,” says a stem cell specialist at the University at Buffalo. Researcher Lartis Iaconomo, who also heads the International Society for Cell and Gene Therapy, a task force on the topic.

He and other experts say the clinics have damaged the reputation of legitimate stem cell research, as well as stripping away patients who might otherwise enroll in the study.

Lawyers representing the stem cell clinics say they have no choice but to oppose the FDA regulation.

Mark Sheenson, a former FDA attorney, said, “The FDA is pushing them down this drug development path that no one is taking because it requires a million dollars of toxicology and animal studies, which are not human safe to use.”

For now, people on both sides are waiting to see what the FDA does.

“We shouldn’t be too confident that the FDA has wrapped it up,” said bioethicist Turner. “They’ve really invested some resources and they’re trying to do something here but I think they’re just unmatched and overwhelmed.”

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