Slashdot Mirror
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."
I think almost everyone is fine with government regulating dangerous unproven medical treatments with potentially horrific side-effects.
"None can love freedom heartily, but good men; the rest love not freedom, but license." --John Milton
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?
This doesn't really sound like a good thing. I understand the desire to want to regulate unproven stem cell therapies. However, if history has shown us anything it is not regulation that they seek, but to stifle the industry entirely. Likely so the large pharma stock holders can hold on to their dividends. Maybe I am understanding this wrong? Anybody with more understanding of the matter, feel free to enlighten me.
I would think there should be government mandated transparency but the government should not decide which drugs we are allowed to take. If you are given all the known facts upfront, you should be able to make your own choice.
The FDA, a government bureaucracy, has "rights"?
Liberty in your lifetime
" If you are given all the known facts upfront, you should be able to make your own choice."
Yet people still start to smoke, tobacco. When learned about how it effects others in the area who shown not to make the choice, they still continue.
Or you have stupid parents who believe some crazy nut job and will not vaccinate their children. In fear of a 0.001% increase of an other illness, while the vaccine will have a 5% chance of saving the child's life.
Given the Fact there will be a charismatic conspiracy nut that will refute the claims, that will attract a big following.
If something is so important that you feel the need to post it on the internet... It probably isn't that important.
Shouldn't be that bad? They are taking cells and injecting them where they don't naturally occur. That can have side effects such as cancer. I'm not saying it's not promising but there have been far too many wild claims about it and far too many clinics treating it as some magic cure without any regard for patient safety.
You know some doctors that are having amazing results, but can't manage to prove it in a double blind study?
You know some conmen, not doctors.
They're not banning it, they're regulating it.
I'd absolutely condone last-ditch treatment for individuals but then that's often done anyway - in a controlled and reportable manner. In that way we can learn something from the outcome and improve the treatment in the future so everyone benefits.
This is about preventing organisations using stem cells as the latest snake oil cure-all while circumventing regulation on a 'oh but it's just your own cells so it's not a medical procedure' which is patently false.
It's either an effective medical procedure and needs regulating, or isn't and they're guilty of false advertising.
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