Tuesday, June 11, 2019

Judge Ungaro rules for FDA in fight with stem cell clinic

Interesting case.  The NY Times covers it here:
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.

The decision, by a federal court on June 3, empowered the Food and Drug Administration to stop U.S. Stem Cell, a private clinic in Sunrise, Fla., from injecting patients with an extract made from their own liposuctioned belly fat.

The clinic had claimed that the extract contained stem cells with healing and regenerative powers that could treat a range of illness and injuries, from back problems to Parkinson’s disease, arthritis, and heart and lung diseases.

But medical experts say there is no proof that these treatments work, and three patients, who each paid $5,000 to be treated at U.S. Stem Cell in 2015, went blind after the fat extracts were injected into their eyes to treat macular degeneration.

In granting the F.D.A.’s request for an injunction against the clinic, Judge Ursula Ungaro agreed with the agency that extracting stem cells from fat requires so much processing that it essentially transforms them into a drug. That alteration firmly places such treatments under the jurisdiction of the F.D.A., which has the authority to regulate drugs.

“There is a reasonable likelihood that the defendants will continue to violate the Food, Drug, and Cosmetic Act,” the federal law that gives the F.D.A. its regulatory authority, Judge Ungaro wrote. She also noted that when the agency warned U.S. Stem Cell about unsafe practices at the clinic, the company responded not by correcting the problems, but by arguing that it was exempt from F.D.A. regulation.

Here's the order.


Anonymous said...

So much for deregulation. Your government wants you dead.

Anonymous said...

Did you even read the article?

Anonymous said...

Rest easy my liberal friends, affirmative action is safe and sound:

"Kavanaugh, who graduated Yale Law in 1990, had been known prior to his appointment for selecting mostly female law clerks, which he argued during his confirmation hearing was to do his part in evening the balance of males to females getting the opportunity to clerk for a judge.

He continued that tradition when he hired all female law clerks for his first year on the Supreme Court."

Anonymous said...

Gimme a U...an N....an AGRO
what do ya got?


Anonymous said...

1:04 Springsteen knows your government wants you dead
"So they put a rifle in my hand
and sent me off to a foreign land
and told me to kill the yellow man..."

Born in the USA

Anonymous said...

The next time a prosecutor laughs at you because your client says the video was altered, send them this:


Anonymous said...

Wrong song - CCR had it:

"Some folks are born made to wave the flag
Ooh, they're red, white and blue
And when the band plays "Hail to the chief"
Ooh, they point the cannon at you, Lord
It ain't me, it ain't me, I ain't no senator's son, son
It ain't me, it ain't me, I ain't no fortunate one, no"