FDA Continues Whack-A-Mole Efforts To Crack Down On Dangerous But Trendy Stem Cell Clinics
Dangerous and mostly unregulated stem cell clinics have cropped up across the county, offering pricey, unproven treatments for anything from sore knees to failing hearts. The FDA has sent letters to 20 companies warning them about their practices, but it's proving difficult to regulate the ever-expanding field.
The New York Times:
Risky Stem-Cell Treatments Come Under F.D.A. Scrutiny — Again
The Food and Drug Administration warned rogue stem-cell clinics on Wednesday to stop selling unproven treatments that could harm patients. The agency’s latest effort, like most of its previous ones, consisted only of letters to companies and clinics. One letter warned a company making products from umbilical-cord blood that it was violating federal law, and other letters told 20 clinics and stem-cell makers that they appeared to be subject to F.D.A. review for approval and that they should contact the agency about how to comply. (Grady, 4/3)
The Washington Post:
FDA Sends Letters To 20 Companies In Attempt To Rein In Stem Cell Industry
The letters are part of an ongoing attempt by the FDA to rein in the booming industry , which critics say has injured dozens of patients and cheated thousands more. In recent years, hundreds of clinics have have popped up selling stem cell procedures — not covered by insurance, unproven by science and unauthorized by the government — that purveyors claim can treat ailments ranging from creaky knees to Alzheimer’s, Crohn’s disease and multiple sclerosis. (Wan and McGinley, 4/3)
The Wall Street Journal:
FDA Probes More Stem-Cell Treatment Companies
“Most forms of regenerative medicine are still in early stages of development, and adult stem cells and stem cells from birthing tissues have not been shown to be safe and effective for use” in treating patients, said FDA Commissioner Scott Gottlieb and Peter Marks, director of the FDA’s center on biologic therapies, in a statement. The FDA warning letter issued to Cord for Life Inc., of Altamonte Springs, Fla., said that the company’s products are intended for therapeutic uses such as orthopedic conditions. But they are, in the FDA’s view, subject to federal regulation as drugs and as human cells or cellular or tissue-based products. (Burton, 4/3)
The Washington Post:
This Clinic’s Experimental Stem Cell Treatment Blinded Patients. Years Later, The Government Is Still Trying To Stop It.
In the summer of 2015, ophthalmologist Thomas Albini examined a patient who had suddenly lost vision in both eyes. The woman, 78, had macular degeneration and had visited a Miami clinic offering a new treatment: injections of stem cells made from fat in her belly. Instead of getting better, the woman’s vision deteriorated significantly. Peering into her eyes, Albini said, he saw clumps of blood floating inside. The next day, a second patient appeared in Albini’s emergency room at the University of Miami complaining of blindness and searing pain after receiving eye injections from the same company, U.S. Stem Cell. (McGinley and Wan, 4/3)
In case you missed it: Elite Hospitals Plunge Into Unproven Stem Cell Treatments
In other news from the administration —
The Washington Post:
NIH Police Yank Iranian Graduate Student From Lab As Agency Clamps Down On Security
The National Institutes of Health is requiring all visitors — including patients — to disclose their citizenship as a condition of entry, a policy that has unnerved staff scientists and led to recent disputes with at least two Iranian scientists invited to make presentations, only to be blocked from campus. In one incident, a Georgetown University graduate student arriving for a job interview was held up at security, then allowed to proceed to one of the campus buildings. But as he prepared to make a presentation, NIH police arrived, removed him from a lab and escorted him off campus, according to a complaint Monday to a group that represents staff scientists. (Bernstein, Sun and Rein, 4/3)
