Yet more derelictions of duty by the federal Food and Drug Administration are happening now, in its handling of largely hokum treatments and health-threatening devices. The latest examples: drug safety regulators step back from their oversight of those who peddle sketchy “stem-cell” treatments for a bevy of ills. And twiddle their thumbs as who knows how many more young people get addicted to nicotine because experts just aren’t ready to regulate e-cigarettes and vaping.
Here’s what the Associated Press reported about the agency and how it has allowed a boom in unsupported therapies using so-called stem cells (real versions, shown above):
“Hundreds of clinics pushing unproven stem cell procedures caught a big break from the U.S. government in 2017: They would have three years to show that their questionable treatments were safe and effective before regulators started cracking down. But when the Food and Drug Administration’s grace period expired in late May — extended six months due to the pandemic — the consequences became clear: Hundreds more clinics were selling the unapproved treatments for arthritis, Alzheimer’s, Covid-19 and many other conditions. ‘It backfired,’ said Leigh Turner, a bioethicist at UC Irvine. ‘The scale of the problem is vastly larger for FDA today than it was at the start.’ The continuing spread of for-profit clinics promoting stem cells and other so-called ‘regenerative’ therapies — including concentrated blood products — illustrates how quickly experimental medicine can outpace government oversight. No clinic has yet won FDA approval for any stem cell offering and regulators now confront an enormous, uncooperative industry that contends it shouldn’t be subject to regulation.”