DRIVING THE FDA DUNE BUGGY INTO THE STEM CELL OCEAN
“Give a small boy a hammer,
and he will find that everything he encounters
I have been following a linkedin dialogue about the utilization of the standard FDA clinical trial process to regulate the stem cell treatments. I put a small amount of thought into this issue since 2009 and come to the conclusion:
The clinical trial process is NOT the right process
for dictating stem cell treatments.
I wrote a brief breakdown of this process in 2009, covering the Billion dollar R+D paybacks, 7-12 years trials, patents required, non compete due to patents, economy of scale to sell drugs for dollars which cost pennies to make. I recommend reading it briefly before going on here: https://repairstemcell.wordpress.com/why-no-stem-cells-in-the-us/
BTW, pharma companies will tell you they need earnings of 2,800% to 570,000% higher over the cost of the drugs in order to recoup the cost of R+D (250 million to 900 million, averaging 500 million) but the truth is….pharma companies spend twice as much money on marketing and advertising than they do on R+D.
Back to the dune buggy…
The standard FDA clinical trial process is a system of regulation but it is only a system of regulating how drugs are brought to market. This system has nothing to do with adult stem cell treatment.
Assuming the FDA clinical trial process is the right vehicle to bring drugs to market; I firmly believe they are not the right vehicle to bring adult stem cell treatments to public. Adult stem cell treatments are a…treatment, a procedure, a protocol…like PRPs.
Platelet-rich plasma (PRP) is blood plasma that has been removed from the body, enriched with platelets and other chemicals and then injected back into the body. Sounds similar to adult stem cells, doesn’t it. (For a more detailed description, see the links and comment below.)
So…why aren’t PRPs likewise under this scrutiny?
The main problem I see with those whom embrace the standard FDA clinical trial process as the only method for the regulation of treatments, is they are embracing the rigors of FDA clinical trials regardless of whether or not they are the appropriate paradigm or methodology for the task at hand.
A case of: Abraham Kaplan‘s, 1964: “I call it the law of the instrument, and it may be formulated as follows:
Give a small boy a hammer,
and he will find that everything he encounters needs pounding.”
They are blinded by a faith in a system that demands the mandatory adherence to
“one size fits all”
“one size fits drugs”
“drugs fit all”
This system does not take into consideration the individuality of any product or service that is not expressly and specifically partaken with the intention of generating a drug treatment.
Clinical trials are not the right vehicle to bring ASC to public. Those who see the world as a desert can not separate themselves from their dune buggy and when they suddenly find themselves face to face with the ocean, they can do nothing else but try to ride their dune buggy right into the waters regardless of how inappropriate it is.
The standard FDA regulated clinical trial process is not the right procedure for dictating stem cell treatments. It is an inappropriate vehicle.
Please stop trying to ride your dune buggy into my ocean.
And btw, that dune buggy sucks…and that’s not me saying it:
From arsenic in apple juice to Aspartame’s political history of rejection to the Vioxx scandal, the FDA is not doing it’s job nearly well enough to protect the public from the drugs it presumes to regulate. Perhaps they can’t and it is the fault of the pharmaceutical companies and doctors:
Marcia Angell is a Senior Lecturer in Social Medicine at Harvard Medical School and former Editor in Chief of The New England Journal of Medicine. Her books are: