4 ms·

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 overturne

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.

jessriedel 10y ago
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.
danielmorozoff 10y ago
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/stemcells.2009.32.html http://www.nature.com/stemcells/2009/0902/090226/full/stemce... http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000029 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 http://onlinelibrary.wiley.com/doi/10.1002/ana.60000/full

jessriedel 10y ago

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.

danielmorozoff 10y ago

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/stemcells.2009.32.html http://www.nature.com/stemcells/2009/0902/090226/full/stemce... http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000029 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 http://onlinelibrary.wiley.com/doi/10.1002/ana.60000/full