FDA Wins Right To Regulate Adult Stem-Cell Treatments

ananyo writes "A court decision on 23 July could help to tame the largely unregulated field of adult stem-cell treatments. The US District Court in Washington DC affirmed the right of the Food and Drug Administration (FDA) to regulate therapies made from a patient's own processed stem cells. The case hinged on whether the court agreed with the FDA that such stem cells are drugs. The judge concurred, upholding an injunction brought by the FDA against Regenerative Sciences, based in Broomfield, Colorado. The FDA had ordered Regenerative Sciences to stop offering 'Regenexx', its stem cell treatment for joint pain, in August 2010. As Slashdot has noted before, they are far from the only company offering unproven stem cell therapies."

Comments

Re:Everything

[MozeeToby]

Injecting stem cells randomly into the body is probably not a good idea. Stem cells aren't magically fix everything machines. There's a significant risk of cancer if nothing else and I'd be shocked if there weren't other potential issues as well. Why do we have people running around defending hack doctor's rights to inject them on unsuspecting and uninformed patients? And don't say the patients are informed, the research on risks hasn't even been completed yet, how could they possibly be informed of risks that the administering doctor doesn't even know about?

Lets go to an extreme, how would you feel about the FDA telling a doctor that they can't inject stomach acid into a person's blood stream? Other than the risks being more obvious, what's the difference?

Re:And not a thing will be done about it

[Anonymous Coward]

So what you're saying is - don't mess with tx.

Wat?

[Quiet_Desperation]

Quick! I need an ideological purist to tell me what to think about this!

Re:And not a thing will be done about it

[Baloroth]

From TFA:

The court disagreed on both counts, noting that “the biological characteristics of the cells change during the process”, and that this, together with other factors, means the cells are more than “minimally manipulated”.

Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis, agrees. “It is much too simplistic to think that stem cells are removed from the body and then returned to the body without a ‘manufacturing process’ that includes risk of transmission of communicable diseases,” he says. “Maintaining the FDA’s role as watchdog and regulatory authority is imperative.”

They aren't just taking pieces from one part and injecting them into another. They are taking pieces, modifying them, and then re-injecting them. It's quite possible that a procedure that didn't modify the cells would be fine with the FDA: in fact, TFA mentions that the company in question offers 3 other processes that have much quicker turn-around which the FDA has not taken issue with (they have also not approved them, so we'll see if they decide to tackle them later as well or not).