The fda is a destructive force

[barbara]

Fight Aging! Newsletter, April 30th 2012

We would be so much further along in applied biotechnology if not for
the perverse engines of regulation that hold back progress in much of
the world:

"The employees and appointees of the US Food and Drug Administration
have caused an incredible destruction of value and progress over the
time that the agency has existed. Their regulatory policies become
ever more onerous with each passing year, as unaccountable bureaucrats
follow their incentives: nothing good can happen to their careers as a
result of approving new technologies, and nothing bad tends to happen
to their careers as a result of making it really, really hard to bring
new medicine to the clinic. So of course you wind up with an
organization whose members collectively pay nothing more than lip
service to their declared mission, while working to make sure that
medicine stays moribund in a slow-motion stasis. This is most evident
in the cancer research community, largely because of its size, but it
applies just as evenly across all forms of medicine:

"A 2010 study in the Journal of Clinical Oncology by researchers from
the M.D. Anderson Cancer Center in Houston, Texas found that the time
from drug discovery to marketing increased from eight years in 1960 to
12 to 15 years in 2010. Five years of this increase results from new
regulations boosting the lengths and costs of clinical trials. The
regulators aim to prevent cancer patients from dying from toxic new
drugs. However, the cancer researchers calculate that the delays
caused by requirements for lengthier trials have instead resulted in
the loss of 300,000 patient life-years while saving only 16
life-years.

"To add to this picture, you must also see incumbent Big Pharma
entities and their executives and lobbyists - a deeply enmeshed
network of regulatory capture. They are far more willing to use the
current system as a weapon to suppress disruptive innovation in their
industry than to be a source of innovation themselves. So it goes,
just as in any other heavily regulated market. The strategic goals of
the major players wind up having very little to do with creating
beneficial change, and everything to do with keeping things the same
as they are now.

"Though the United States urgently needs new treatments for common
illnesses such as heart disease, stroke, and diabetes, the nation's
system for drug approval discourages innovation and investment,
especially for our most pressing public health challenges. In this
paper, we find that the main culprit is the high cost of Phase III
clinical trials, which are required for FDA approval of most drugs. We
examined drug development in four major public health areas and
discovered that for any given drug on the market, typically 90 percent
or more of that drug's development costs are incurred in Phase III
trials. These costs have skyrocketed in recent years, exacerbating an
already serious problem."

[LLL6521]

Besides the obvious absurd bureaucratic regulations that shut down children’s lemonade stands or confiscate raw milk from health food stores, we all need to worry more about those regulations that seem to be reasonable on the surface, but at the end, they ultimately impose a huge burden collectively like the FDA regulating SCT as a drug.

I have a few questions for the FDA:
How many have to suffer and die on the sidelines, because they can't receive treatments from their own stem cells? How many years are you willing to put your own children at risk in having a future without life-saving treatments or having the treatments delayed? How long FDA, because it is really crystal clear - your actions in delaying "medical research" and viable "medical treatments" is condemning a future for millions.