FDA Targets Stem Cell Clinics Offering Pricey, But Unproven, Treatments
The clinics have largely avoided regulation because they use stem cells from their patients' own bodies. Critics call the therapies dangerous quackery. In other Food and Drug Administration news, the Los Angeles Times looks at why it took so long for the FDA to warn the public about the dirty scopes that caused dozens of patients to get sick.
FDA Crackdown Could Shut Stem Cell Clinics Peddling Unproven Treatments
Federal regulators are preparing to crack down on scores of clinics across the United States that offer pricey stem cell therapies for conditions ranging from autism to multiple sclerosis to erectile dysfunction without any scientific evidence that they work. (McFarling, 2/8)
Los Angeles Times:
Why It Took Years For The FDA To Warn About Infections Tied To Medical Scopes
An outbreak at a Pennsylvania hospital in late 2012 should have been an early warning that a reusable medical scope was spreading deadly infections and nearly impossible to disinfect. But staff at the federal Food and Drug Administration lost the report, one of multiple missteps that allowed doctors and hospitals to continue using the scope for three more years even as dozens of patients were sickened. The missing paperwork, revealed in a recent Senate inquiry, underscores the serious shortcomings in the antiquated national database used to monitor the safety of medical devices, which even the FDA has long admitted is flawed. (Peterson, 2/8)