The U.S. government is finally cracking down on shady doctors pushing unproven & dangerous stem cell treatments in an effort to police the growing, decentralized regenerative medicine field that's run rampant in recent years.
The Food and Drug Administration (FDA) laid out a new framework for regulating cell-based medicines, including the hundreds of private clinics that have sprung up across the country.
Many of these uncertified clinics offer stem cell injections for all sorts of diseases, such as arthritis, multiple sclerosis, blindness, and even Alzheimer's. Clinics charge $5,000, up to $50,000, for these treatments, despite the lack of evidence they're safe or effective.
Here are the highlights of the proposed framework.
Legit, credited stem cell researchers have called to close this loophole for a decade. Hopefully, the FDA's promise to target their enforcement on these 'bad actors' can reduce the risks to patients' health.
"We're going to be prioritizing places where we see products - not just being promoted inappropriately - but putting patients at potential risk," FDA Commissioner Scott Gottlieb told reporters on a conference call.
"By exploiting the lack of consumer understanding of this area, as well as the fear and uncertainties posed by the diseases these bad actors claim to treat, they're jeopardizing the legitimacy and advancement of the entire field."
Stem cell researcher Paul Knoepfler says the FDA's framework is a "positive sign", especially with clinics now needing FDA approval to promote any experimental stem cell treatment.
"Now that the FDA's policies are clear, will it back them up with action?" said Knoepfler, from the University of California, Davis. "Does it have the resources?"
But, Knoepfler was quick to note some bad news in the guidelines: the FDA is giving these fake clinics 36 months to comply with the new regulations.
That's far too indulgent.
"Three years is a long time for potentially non-compliant clinics to still be raking in the dough from patients," Knoepfler suggests.
Indeed, this may even cause a rise in unproven stem cell clinics, as fake practitioners will look to maximize their profits in the three-year period.
"This is nowhere close to a red line; at best, it's amber," says Leigh Turner, a University of Minnesota bioethicist, of the FDA's enforcement plans.
"A lot of people running these businesses are going to see this as an opportunity to carry on as before, or if they're not in the business, to dive into the marketplace."
Many of the new 'clinics' offering shady stem cell therapies are using adult stem cells, isolated from fat. The fake physicians collect the fluid via liposuction, add some chemicals, and inject it back into the body.
This type of procedure left three Florida women nearly or completely blind, according to a report published in the New England Journal of Medicine. Proceeding the incident was another stem cell practitioner having their license revoked by the Florida Medical Board, after the doctor's treatment killed two patients through an IV drip of stem cells into their bloodstream.
The FDA took action in August against the clinics in Florida and California. They targeted Sunrise, a Florida-based US Stem Cell Clinic, for marketing unapproved procedures for heart disease, Parkinson's disease, and other conditions. U.S. marshals also seized unproved vaccines from StemImmune Inc. of San Diego.
The FDA's new guidelines and authority to regulate such stem cell procedures will hopefully protect the people from dangerous practices like the chaos down South.
Apart from cracking down on unproven, uncertified stem cell clinics, the guidelines aim to simplify just how much processing a cell can undergo, before it must be regulated by the FDA.
They also plan to speed up reviews on promising stem cell treatments and genetic therapies, which has been longed for by drug and biotech companies.
"I think it's another example of the FDA supporting innovation while promoting its strong safety standards," said Michael Werner of the Alliance for Regenerative Medicine, which represents drugmakers in the U.S.
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|Tags: Stem Cell Research|