DAVID GRANOVSKY

WHY NO STEM CELLS IN THE USA?

A friend asked:

when are they going to allow us to use stem cells for autism in this country??? I am getting impatient evry treatment center I’ve called here (in the US) says they wont do it! I am having a baby in feb and want to use the cord blood for my son but when will I ever be able to? anyone know?

My response:

I expect that it will be at least 10 years and they will not be in the form you are expecting…the form that is so successful all over the world. Here’s why:

1.  The US medical and pharmacological system is based upon the production and patenting of drugs for the treatment of symptoms.

2.  The FDA has declared that stem cells are a regulated drug – https://repairstemcell.wordpress.com/2009/03/24/fda-part-2-adult-stem-cells-found-in-everyones-body-are-drugs-subject-to-regulation-and-monitoring/

and

https://repairstemcell.wordpress.com/2009/03/27/fda-part-5-adult-stem-cells-are-a-drug/

3.  Clinical trials for bringing a drug to market take 7-12 years and 250-900 million dollars to develop, market and patent.

4.  The US is JUST starting this process after being entirely focused on embryonic stem cells (that are currently irrelevant because they have produced zero treatments).  https://repairstemcell.wordpress.com/screw-the-embryos-they%e2%80%99re-irrelevant/

5.  The beauty of stem cells, besides that they work so well, is that they are in so many forms, from so many parts of the body. Stem cell treatment is essentially a procedure, not a drug IMO.  Patenting a drug means you have exclusive rights to sell it and you have no competitors.  No competition for a new drug is the desire of the pharma industry.  With new treatments coming out all the time, by the time a patent goes through (~6 months), there are probably going to be new treatments that match or exceed the patented one.

End result: Pharma company spends 7-12 years and 250-900 million dollars to develop, market and patent a new drug only to find that something better has already come along to replace it.  A terrible business model for them…a terrible travesty for those who are literally “dying for stem cells to become available!”

I hope all of that is clear.  So as it stands, the hope for treatment over the next decade at least still lies only outside the US.  Does it work?

.

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