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 approved.
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 everyone.
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.
Richard E. Ralston
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