A picture of a patient’s eye one week after receiving stem cell injections from U.S. Stem Cell in 2015 shows widespread retinal hemorrhages, according to ophthalmologist Thomas Albini. He said the patient suffered significant loss of vision. (Thomas Albini)
MIAMI —
In the summer of 2015, ophthalmologist Thomas Albini examined a patient
who had suddenly lost vision in both eyes. The woman, 78, had macular
degeneration and had visited a Miami clinic offering a new treatment:
injections of stem cells made from fat in her belly.
Instead
of getting better, the woman’s vision deteriorated significantly.
Peering into her eyes, Albini said, he saw clumps of blood floating
inside.
The next day, a second patient appeared
in Albini’s emergency room at the University of Miami complaining of
blindness and searing pain after receiving eye injections from the same
company, U.S. Stem Cell. Albini reported the cases to the U.S. Food and
Drug Administration, urging an investigation.
Now,
the FDA is suing to stop the company’s treatments in federal court in
Fort Lauderdale, Fla., in one of the government’s most aggressive
actions against the burgeoning stem cell business. With the judge
expected to rule any day on the government’s charge that U.S. Stem Cell
is “openly violating the law and endangering patients,” legal experts
say the case could constrain a lucrative industry accused by doctors,
lawyers and federal officials of harming dozens of people.
But
the FDA’s slow response has permitted U.S. Stem Cell to continue
operating four years after those first reports of blindness. Although
the company stopped injecting its fat-derived treatments into eyes after
the patients sued, it continues to sell the therapy to people with
spinal injuries, Parkinson’s disease, multiple sclerosis and other serious chronic conditions.
Last
spring, just three weeks after the government filed suit, another
patient had a catastrophic reaction after visiting a South Miami clinic
affiliated with U.S. Stem Cell. The 59-year-old woman felt faint and
started vomiting two hours after receiving injections for arthritis
pain.
Her case — which has not previously been
reported — was described in an “adverse event” report filed with the FDA
and obtained by The Washington Post through the Freedom of Information
Act, as well as in a second report filed with the Florida Health
Department. The woman was taken to a hospital, the reports said, and
spent more than a month in a coma.
“It’s
frustrating that these clinics are still operating, and surprising that
authorities aren’t moving faster — even now,” said Albini, an
ophthalmology professor who has emerged as a vocal critic of the stem
cell industry.
FDA officials declined to discuss
the lawsuit, or respond to critics who say the agency should have
sought a temporary restraining order to shut down U.S. Stem Cell years
ago. Former FDA officials said that such orders are extraordinarily
difficult to obtain, and that the agency is wary that a loss in court
could undermine its ability to regulate the industry.
“People
have the right to legal recourse,” said Robert Califf, who served as
FDA commissioner during the Obama administration. “You don’t want a
situation where a judge could make a ruling that would be a bad
precedent. The FDA has to be very careful.”
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