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stem cell treatments need FDA approval??? - DEBATED IN COURT

Discuss stem cells, adult and embryonic, and their therapeutic potential for MS here.

stem cell treatments need FDA approval??? - DEBATED IN COURT

Postby Liberation » Mon Feb 06, 2012 1:44 pm

It is not about MS, but might have an impact on us. I think the story is quite familiar:

Where it gets fun is the arguments that are going to be debated in court: the clinic argues that stem cell therapy is the practice of medicine and isn't FDA jurisdiction but the FDA is saying that stem cells are drugs, which would then have it BE the FDA jurisdiction.


Full article here:

http://www.examiner.com/multiple-sclero ... th-the-fda
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Re: stem cell treatments need FDA approval??? - DEBATED IN C

Postby georgegoss » Wed Feb 15, 2012 10:35 am

Liberation wrote:It is not about MS, but might have an impact on us. I think the story is quite familiar:

Where it gets fun is the arguments that are going to be debated in court: the clinic argues that stem cell therapy is the practice of medicine and isn't FDA jurisdiction but the FDA is saying that stem cells are drugs, which would then have it BE the FDA jurisdiction.


Full article here:

http://www.examiner.com/multiple-sclero ... th-the-fda


Thanks for sharing this, Lib. Indeed this could very well have a direct impact for the use of MSC's for MS in the US.

I can see both sides of the argument. . . the stem cell clinic is arguing that the person's own stem cells are being re-infused to the same person so it is only a medical procedure that does not involve infusing drugs to the human body. But on the other hand, the FDA is arguing that because drugs (colony stimulating factors) are used for the ex-vivo MSC replication/expansion, then it should be controlled by the FDA. It will be interesting to see how this unfolds.
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Re: stem cell treatments need FDA approval??? - DEBATED IN C

Postby Liberation » Tue Feb 21, 2012 3:21 am

New article on the legal battle....

“If you interview the average person, I think you would find that there should be some oversight. If you start to look at this product as being the patient’s own stem cell, how can the FDA claim Regenerative is manufacturing [cells] – they’re culturing them,” Angle told me in response to a question about the agency’s rationale to sue the company on the claim that its manipulation of stem cells is tantamount to manufacturing a new drug. Read more on...
http://stemcell-news.org/2012/02/stem-c ... iewpoints/

On one hand, I am really pleased that an authority like FDA or EMA are trying to protect us from reckless practices, but on the other hand I feel that they do not strike a good balance between risks and benefits. Many MS patients can not wait for decades for FDA approval. They have not much to lose. I do not understand why debelatating illnesses like MS ()mainly PPMS and SPMS) can not get fast track designation in general.

I can also not understand why we have to wait for FDA or EMA approval in such cases when the drug is already in use for decades with no side effects, but its efficacy was just noticed in MS. E.g. blood pressure drugs, Viagra or neurohormones, etc. just to name a few. As for stem cells, HSTC has been administered with really good track record for a long time, but no insurance covers it and it is not available in many countries.
Last edited by Liberation on Tue Feb 21, 2012 9:21 am, edited 1 time in total.
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Re: stem cell treatments need FDA approval??? - DEBATED IN C

Postby georgegoss » Tue Feb 21, 2012 4:08 am

In early 2009 when I was searching for a hospital to perform HSCT for my MS I contacted the FDA to ask them about restrictions to perform the procedure in the USA. . . . they told me that HSCT is approved (for cancer treatment) in the USA and that any hospital was free to perform the procedure "off label" for me if they wanted without worring about Government restriction or sanctions. However, the 50 or so transplantation facilities I contacted in the USA at that time refused to perform the procedure for me for my MS. Not because of FDA restrictions, but because they were scared of loosing a ton of money from a lawsuit because of medical liability if I died or were harmed by the procedure. This is why I went to Heidelberg to receive my HSCT where the treatment facilities do not have the same fear because Germany has strict tort limits under the law where medical malpractice payouts are restricted & limited.

Along the same lines Dr. Burt in Chicago performs HSCT for a multitude of autoimmune diseases outside of FDA clinical trials without Government restriction for the same reason. Adding that he beleives the procedure to be so very safe that it is unlikely anyone will be harmed or die from the treatment (and indeed, no one has died from HSCT for MS). So probably he doesn't fear excessive tort judgements if something goes wrong and is willing to perform the procedure, although not specifically indicated in a mainstream way in the USA for autoimmune disorders. It also probably doesn't hurt his practice in charging more than $150K for the procedure.

The case of colony-expanded MSC therapy in the USA is not comparable because such MSC therapy is not FDA approved for any use. So an "off label" use is not an option (because it's not specifically labelled for anything). If it were approved for some use (any use), any hospital or doctor in the USA could legally perform it for MS treatment off label without concern for FDA limitation or sanction.

The law works in a funny way, rarely following the science.
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