Was Judge’s Decision On FDA Authority Over Stem Cell Clinic A Shot Across The Bow Or An Easily Dismissed Pinprick?
The stem cell industry is regarded as unregulated and dangerous, but recently a judge granted FDA the authority to oversee a popular procedure at a bustling Florida clinic. While safety advocates cheered the decision, it's unclear how much of an impact that will have on an industry that's comprised of hundreds of such clinics scattered across the country.
The New York Times:
A Judge Rules Against One Stem-Cell Clinic. There Are Hundreds Of Them.
A judicial ruling this month that will stop questionable stem-cell treatments at a clinic in Florida is widely seen as a warning to a flourishing industry that has attracted huge numbers of patients, who pay thousands of dollars for unproven, risky procedures. But with little regulatory oversight for the hundreds of clinics operating these lucrative businesses across the country, it’s too soon to tell how far the impact might reach. (Grady, 6/10)
In other news —
Stat:
Stem Cell Clinics Co-Opt Clinical-Trials Registry To Market Unproven Therapies, Critics Say
A few weeks ago, if you’d been scouring the ever-expanding mass of digitized federal paperwork, you might have noticed a contradiction. On the one hand, the Food and Drug Administration issued a letter stating that what an Arizona distributor was selling as stem cell therapies were “unapproved” and posed “safety concerns.” On the other, a National Institutes of Health database — clinicaltrials.gov — went right on listing the same merchant’s studies, with a link to the company’s website and the word “Recruiting” displayed invitingly in green. (Boodman, 6/11)
