Exclusive: Doctors Skirt FDA To Provide Human Stem Cell Therapy

[cvictorg]

http://singularityhub.com/2010/03/09/colorado-doctors-skirt-fda-jurisdiction-to-provide-human-stem-cell-therapies-video/

[Bulldog]

Interesting.


Still, it’s possible that even though RSI is doing what many other doctors routinely do (develop a new therapy for use in their own practice) that the federal government could try to bring them to court. The FDA seems to have taken the stance that all stem cells (whether used autologously or not) are drugs. As such, they would need FDA approval, and would likely only be developed by large pharmaceutical companies.

How in the hell can the FDA say that YOUR OWN stem cells are drugs?!

[chilln]

How in the hell can the FDA say that YOUR OWN stem cells are drugs?!


Your own testosterone, ie: autologous testosterone (if someone cared to extract it and purify it) would also correctly be labeled as a controlled substance - AKA a "drug" to some people.

If you were to extract and purify your own testosterone, the FDA would rightly consider your autologous concentrated testosterone to require controls - same as synthetic man made bioidentical testosterone, because it could be abused by you. Most people would still require the assistance of a medical professional adviser to train you how to use it, and to continue to monitor your skills in monitoring your "autologous testosterone.

In this fictional but useful example, you won't succeed with any legal argument that you have the right to re-use your own testosterone any way you like, because you didn't extract it and purify it yourself.. Ie: because someone helped you extract it and purify it, that makes that person an accomplice in whatever mishap you encounter in the use of your "autologous testosterone".

In this fictional but useful example, the law which makes "autologous testosterone" into a controlled substance is only in a very small way designed to protect you from yourself. It's mostly designed to protect your accomplices who extracted and purified the testosterone, from a damages law suit brought by you, if you do self-harm while administering your testosterone, because they didn't warn you you could hurt yourself with your "autologous testosterone".

###

The FDA's position on stem cells is that the process of extracting and concentrating your own stem cells creates a substance which in some cases is exceptionally beneficial, and in other cases is potentially dangerous - eg: if injected into a part of your body which could go cancerous if the cell proliferation effects of the stem cell growth are unchecked.

Therefore, just like the "autologous testosterone" example above, an individual could potentially abuse the use of their own stem cells, and thus the people who extracted and purified your stem cells, require protection from any damages suit you may to undertake.

One of those protections is that the law requires that you make use of the assistance of a medical professional adviser, to train you how to use your autologous stem cells, and to continue to monitor your skills in monitoring your "autologous stem cells".

This assistance / training is forced on you by the process of controlling the substance - ie: by making the autologous stem cells a "controlled substance" (some people call this a drug).

.

[Bulldog]

Your own testosterone, ie: autologous testosterone (if someone cared to extract it and purify it) would also correctly be labeled as a controlled substance - AKA a "drug" to some people.

If you were to extract and purify your own testosterone, the FDA would rightly consider your autologous concentrated testosterone to require controls - same as synthetic man made bioidentical testosterone, because it could be abused by you. Most people would still require the assistance of a medical professional adviser to train you how to use it, and to continue to monitor your skills in monitoring your "autologous testosterone.

In this fictional but useful example, you won't succeed with any legal argument that you have the right to re-use your own testosterone any way you like, because you didn't extract it and purify it yourself.. Ie: because someone helped you extract it and purify it, that makes that person an accomplice in whatever mishap you encounter in the use of your "autologous testosterone".

In this fictional but useful example, the law which makes "autologous testosterone" into a controlled substance is only in a very small way designed to protect you from yourself. It's mostly designed to protect your accomplices who extracted and purified the testosterone, from a damages law suit brought by you, if you do self-harm while administering your testosterone, because they didn't warn you you could hurt yourself with your "autologous testosterone".

###

The FDA's position on stem cells is that the process of extracting and concentrating your own stem cells creates a substance which in some cases is exceptionally beneficial, and in other cases is potentially dangerous - eg: if injected into a part of your body which could go cancerous if the cell proliferation effects of the stem cell growth are unchecked.

Therefore, just like the "autologous testosterone" example above, an individual could potentially abuse the use of their own stem cells, and thus the people who extracted and purified your stem cells, require protection from any damages suit you may to undertake.

One of those protections is that the law requires that you make use of the assistance of a medical professional adviser, to train you how to use your autologous stem cells, and to continue to monitor your skills in monitoring your "autologous stem cells".

This assistance / training is forced on you by the process of controlling the substance - ie: by making the autologous stem cells a "controlled substance" (some people call this a drug).

.

I guess I can see that argument. I still don't agree with it. I believe that the process of the extraction, purification and culturing of the autologous stem cells should be regulated. But I don't necessarily believe that the autologous stem cells themselves should be regulated. But that's just my opinion, which doesn't mean squat in the grand scheme of things.

[cpeil2]

Interesting.



How in the hell can the FDA say that YOUR OWN stem cells are drugs?!


They are subject to regulation as "biologics".