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William Wan
National Correspondent for Health, Science and Information
In a cold-blooded decision in the burgeoning stem cell industry, a federal judge ruled in favor of the Food and Drug Administration on Monday in a lawsuit against a Florida-based stem cell company whose treatments blinded at least four patients.
Judge Ursula Ungaro agreed that the FDA had the power to regulate a procedure that has become widespread in the booming industry: using the fat of patients to create a stem cell-based treatment.
The judge ruled that the FDA was entitled to an injunction ordering US stem cells to stop the proceedings.
The judgment represents a major victory for the government, which is increasingly trying to limit the sector, even as it has developed rapidly in recent years.
"This case is a major victory in the FDA's work to protect public health," said the agency in a statement. "We have taken steps, like this case, against clinics that abuse patients' trust and put their health at risk. We will continue to promote the healthy and scientific development of regenerative medicine products, but we will not tolerate those who try to circumvent the law and put patients at risk. "
Scientists, medical associations and health officials have criticized stem cell clinics for selling unproven, science-proven treatments not approved by the government for a wide range of unrelated conditions, such as the Parkinson's disease, multiple sclerosis, joint pain and erectile dysfunction.
"This ruling indicates that the FDA has the power to define a certain type of stem cell-based product as a drug," which requires FDA approval and compliance with the rules of other agencies. said Paul Knoepfler, a stem cell biologist at the University of California at Davis. "There are potentially hundreds of clinics using the same model, and this decision basically states that the FDA can – provided it is not overruled on appeal – say that you are using an unapproved drug, and that's all." is a big problem. "
As of 2015, at least four patients were blinded after US stem cells were administered and clinics associated with the company injected them with stem cell therapy.
The slowness of the FDA's initial response to patient injury has allowed US stem cells to continue to function four years after these first cases of blindness. Although the company has stopped injecting her fat-derived treatments into her eyes after the lawsuit, she continues to sell the treatment to people with spinal cord injury, Parkinson's disease, multiple sclerosis plaques and other serious chronic diseases.
Last year, just three weeks after the government filed a complaint, another patient had a catastrophic reaction after going to a South Miami, Florida clinic affiliated with the US Stem. Cell. A 59-year-old woman felt malfunctioning and started vomiting two hours after receiving injections for arthritis pain.
His case was described in a report of an adverse event filed with the FDA and obtained by the Washington Post through the Freedom of Information Act.
In Monday's judgment, Ungaro stated that, unless the company orders otherwise, "it is reasonably probable that the Defendants will continue to violate" the regulations by offering unapproved treatments.
With $ 6.7 million in revenue last year, the United States has created three clinics and trained 150 physicians, making it one of the most influential stem cell companies in the country. Over the past year, he hired a major law firm to defend himself against the lawsuit and formed formidable allies close to President Trump, including Roger Stone, a GOP member, and Christopher Ruddy, chief executive officer of Newsmax. .
US Stem Cells and Scientific Lead Kristin Comella did not respond to calls for comment.
In the lawsuit, the government accused the company of "openly violating the law and endangering patients by making an unapproved experimental drug". Responding in court, the new FDA regulation was described as "taking power" and claimed that his treatment was medical. procedure that can not be regulated as a drug.
Ungaro noted in his summary judgment that the clinic made "many assertions" about the benefits of the treatment. derived from fat cells for a range of diseases, including Parkinson's disease, lung diseases and diabetes. She added that the clinic had boasted that her therapy was superior to conventional medicine by treating these serious diseases. She also said the FDA had inspected the clinic seven times between October 2015 and May 2017.
The decision does not automatically prevent other companies from offering the same treatment, said Sam Halabi, a law professor at the University of Missouri. "But this sends a very strong signal to the market, and other judges will look at this decision very seriously and use it as a crucial roadmap for similar trials to appear before them," he said. declared.
Leigh Turner, a bioethicist at the University of Minnesota and a long-time critic of stem cell clinics, is pleased with the decision made, but asked if it would spur other companies to withdraw from the market. "Will some just say that there are so many companies that the FDA will not knock on our door, so we will continue?" He asked.
Turner said some clinics would "play the odds" and continue to perform fat-based procedures, while others could simply switch to questionable types of stem cell treatment not addressed in the decision, such as stem cell products related to birth. "I do not expect to see the direct sales sector disappear," he said. "These companies are too well established and there is too much money to be made.
Former FDA Commissioner Scott Gottlieb called the decision a "crucial decision," saying the FDA "is firmly rooted" to challenge the practices of clinics offering unapproved stem cell therapies. "It was a winning case for the FDA," he said. "This is very important in that it establishes the agency's ability to regulate in this space and opens the door to more enforcement."
Gottlieb, who has beefed up the FDA's action against clinics offering untested treatments, said the move sends a strong message to the sector and will strengthen agencies' efforts to take immediate action "against companies putting money on the table. patients in immediate danger ".
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