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Comment by jessriedel | Hacker News Reader

> and scandalously the FDA is slowing progress in the field by seeking to prevent doctors from harvesting and reintroducing one's own stem cells back into the body.

According to this article, what you're referring to is just the FDA putting stem cells under the same regulatory burden as most drugs.

https://www.statnews.com/2016/02/08/fda-crackdown-stem-cell-...

They have escaped this previously because the stem cells came from the patient, and not much was done to the cells before re-injection, so it's closer to plastic surgery.

I happen to think that that FDA is probably way too conservative (both on stem cells and drugs) and seriously inhibits progress, but I think it's misleading to suggest that they are slowing progress in a way specific to stem cells. The FDA has always had a mission to not just protect patients from harm, but also from being fleeced by useless sham therapies.

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In this case the therapy is not useless or a sham, and it is autologous which has traditionally been an exempt area in this respect.

That the FDA has overturned its own history and precedent is the scandal, imho.

A benefit has been shown, to what degree and in which circumstances is being ironed out.

There is some hope, the FDA has liberalized to some degree in recent years and biotech has been a top performing sector. We live in miraculous times.

I don't think you disputed my point.

> In this case the therapy is not useless or a sham

More precisely, in this case you believe there is enough evidence that the therapy is effective, but the FDA does not yet agree that has been established. Then, in congruence with its policy on unproven medical procedures, the FDA has severely constrained stem cell procedures.

> and it is autologous which has traditionally been an exempt area in this respect.

It's clear that there was little/no enforcement in this area previously, but now they have announced clarification that it is to be enforced. You may call that a change in the regulatory environment, but it doesn't appear to be a change in general policy.

The situation is very similar to 23andMe. 23andMe was flying under the radar and, when the FDA cracked down on them, they experienced a changed in their effective regulatory environment, but this is not reasonably interpreted as the FDA changing its tune (or overturning history or precedent or whatever).

Again, I wish the FDA allowed more of these things to proceed (including 23andMe and stem cells) but I don't think this is change.

The FDA is cautious in this area because historically a number of stem cell injection therapies have led to tumor formations in the CNS.

That said they were not autologous mesenchymal stem cells. This study gives hope.

Refs: http://www.nature.com/stemcells/2009/0902/090226/full/stemce...

http://journals.plos.org/plosmedicine/article?id=10.1371/jou...

Old review from early 2000s http://onlinelibrary.wiley.com/doi/10.1002/ana.60000/full

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