Asking the Government for Permission to Live
The Food and Drug Administration (FDA) has gone to court to
prevent the Colorado-based firm Regenerative Sciences from using stem
cells developed in one part of your body (bone marrow) to repair damage
in other parts of your body, such as joints. The FDA objects to the fact
that these cells are chemicals, the use of which they have the power to
regulate even though the cells are taken from your body to later be
injected back into your body.
The FDA is accustomed to the process by which it requires that many
years and millions of dollars be spent to approve drugs developed in a
laboratory before anyone is allowed to use them. Regardless of clinical
results that show use of stem cells to be highly effective, the FDA
finds it intolerable to let you use the cells in your own body without
prior approval by a vast and expensive bureaucracy.
It is a shame that no one told all of those who would benefit from
stem cell research that the benefits of such research would not actually
be available to patients. Treatment of individuals does not comply with
the FDA’s regulatory paradigm. Personalized medicine may work new
miracles, but care for the individual must be subordinated to
supervision by a multitude of administrators.
Growing government involvement in medicine, over generations, has
resulted in control for the controller’s sake. The most extreme example
of this is the refusal of the FDA, in many cases, to forbid access by
terminally ill patients to drugs that have passed the first phase of
testing, which establishes safety.
The FDA insists on protecting these patients from these drugs that
have not been conclusively proven effective, taking pride in this
perverse method of protecting the dead. As documented by the courageous
Abigail Foundation, hundreds of thousands of these patients have died
waiting for drugs already known to be safe–and which the FDA ultimately
The use of stem cells, should the FDA eventually give its approval,
may still have to pass many other obstacles, thanks to the wonders
enacted by Congress.
In 2009, Congress created the Federal Coordinating Council for
Comparative Effectiveness Research and handed it $400 million as a part
of the Stimulus Act.
(Don’t ask what that had to do with economic stimulus.) Now anything
that the FDA decides is safe and effective must run an additional
gauntlet of effectiveness. It will not make a difference whether a drug
is effective for some people or most people–it must be effective for
So much for personalized medicine.
In 2010, another hurdle was created with the passage of Obamacare.
The Independent Payment Advisory Board (IPAB)–”independent” because it
is appointed by the President–decides whether it will allow payment for
any care, including use of your stem cells. If you are on Medicare and
your physician accepts Medicare patients, you may not even use your own
money for treatment with your own stem cells. No physician in Medicare
is allowed to accept payment for anything not covered by Medicare.
Thomas Sowell lamented last year that in such situations “you are not free to use your life’s savings to save your life.”
All this from a loving government that claims it only wants you to
place your medical care and ultimately all of your decisions and freedom
in its hands so it can take care of you.
And if that makes your joints ache, you may not be able to use your own money or your own stems cells to do anything about it.
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