Page 28 - ARUBA TODAY

A28 SCIENCE
Friday 17 November 2017

U.S. health agency to crack down on risky stem cell offerings

By MATTHEW PERRONE procedures for heart dis-
AP Health Writer ease, Parkinson’s disease
WASHINGTON (AP) — U.S. and other conditions. And
health authorities an- U.S. marshals, under FDA
nounced plans Thursday instructions, seized vials of
to crack down on doctors an unproven vaccine from
pushing stem cell proce- StemImmune Inc. of San
dures that pose the grav- Diego.
est risks to patients amid an The FDA’s authority to reg-
effort to police a burgeon- ulate stem cell procedures
ing medical field that pre- is a murky area that has
viously has received little been debated for years.
oversight. Typically the agency does
The Food and Drug Admin- not regulate individual
istration laid out a strategy doctors or their in-office
for regulating cell-based procedures, focusing in-
medicine, including hun- stead on products devel-
dreds of private clinics that oped by drug and medical
have opened across the device manufacturers. But
nation in the last decade. FDA has asserted its author-
Many of the businesses In this Dec. 5, 2014 file photo, a doctor injects a patient with a solution he says is rich in adult stem ity in certain cases when
promote stem cell injec- cells, at his practice in Beverly Hills, Calif. doctors begin processing
tions for dozens of diseases Associated Press stem cells and marketing
including arthritis, multiple Gottlieb said the agency cells from bone marrow stream. them to treat serious dis-
sclerosis and even Alzheim- plans to use discretion in transplants have long been In August the FDA took eases.
er’s. They can cost $5,000 overseeing lower-risk pro- used to treat leukemia and action against clinics in Guidelines released by
to $50,000, but there’s little cedures such as injections other blood diseases. Florida and California. The the agency Thursday aim
research that such proce- for achy joints, adding that Most of the new clinics of- agency issued a warning to clarify how much pro-
dures are safe or effective. this approach would al- fer adults stem cells isolat- letter to Sunrise, Florida- cessing cells can under-
Researchers for years have low the agency to get the ed from fat. Practitioners based US Stem Cell Clinic go before triggering FDA
called for a crackdown. “most bang for our regu- collect the fluid from pa- for marketing unapproved regulation.q
FDA officials said they will latory buck.” He also said tients via liposuction, treat
focus their enforcement the agency needs to be it with chemicals and then
efforts on “bad actors” “nimble and creative” in inject it back into the body
who inject stem cell mix- its regulation to encourage to treat various conditions.
tures into the bloodstream, legitimate researchers in Three Florida women were
nervous system or eyes. the field. left nearly or completely
Regulators say those pro- Stem cells have long been blind by one such fat-
cedures pose the biggest recognized for their abil- based procedure, accord-
risk to patients. ity to reproduce and re- ing to a report published
“We’re going to be priori- generate tissue. And while earlier this year in the New
tizing places where we see emerging research sug- England Journal of Medi-
products — not just being gests that they will even- cine. The Florida Medical
promoted inappropriately tually be used to treat a board previously revoked
— but putting patients at range of debilitating dis- the license of another stem
potential risk,” FDA Com- eases, they are currently cell practitioner after two
missioner Scott Gottlieb only approved for a hand- patients died under his
told reporters on a confer- ful of medical procedures. care after receiving IV drips
ence call. For instance, adult stem of stem cells to the blood-