Must read about what the FDA is up to with autologous stem cell therapy


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Jeannine posted this link in another area, but I think it is important and that everyone should take a few minutes to read it.

Why Libertarians should Care about Autologous Stem Cells
Posted on March 14th, 2011 by A. Rahman Ford in Bureaucrash HQ

I don’t make a habit of publishing unsolicited submissions, but I’m making an exception today because I found Mr. Ford’s piece interesting. That said, the opinions expressed by the author are his and should not be understood to be the opinions of CEI or Bureaucrash. I add the disclaimer not to distance myself from the sentiments expressed here, but because stem cell therapy is something I know very little about. -Ed.

Much of the recent public discussion about stem cells has focused myopically on embryonic stem cells. Stated succinctly, these discussions are often rife with fundamental moral disagreements over whether an embryo is a “life” entitled to legal protection. Although these disagreements are not inconsequential, they can obscure the ultimate objective of regenerative medicine, generally, and stem cell research, specifically – to heal sick Americans. What we have seen is that argument over embryonic stem cells has monopolized the media marketplace, to the detriment of alternative varieties of stem cells that are safe, effective, non-controversial and immediately viable. Autologous stem cells are one such variety and libertarians should seize upon the opportunity to advocate for the immediate availability of autologous stem cell therapy to all Americans.
Autologous simply means “from one’s own body.” Autologous stem cells can be extracted from a person’s bone marrow, expanded in culture, and then injected back into the same person. Using a sub-population of stem cells called mesenchymal stem cells, autologous therapies have been used to treat a variety of ailments such as heart disease and neurological conditions. For example, Dr. Christopher Centeno has been using autologous therapy to treat orthopedic injuries at his clinic in Colorado. Dr. Richard Burt of Northwestern University has successfully treated patients with Multiple Scleroses, CIDP and Type 2 Diabetes using. This therapy is safe and effective and should be healing millions of Americans now.

Unfortunately, autologous stem cell treatment is not available in the U.S. because Food and Drug Administration (FDA) regulations have been interpreted to define autologous stem cells as “drugs,” which subjects them to a long, expensive clinical trial process. The issue is currently being litigated in federal court between Dr. Christopher Centeno and the FDA. However, there are many who cannot wait years for a judicial disposition or clinical trial approval for their specific condition. Americans are suffering now. Immediate action by the Obama administration could moot the litigation and obviate the need for costly, lengthy and, in this case, unnecessary clinical trials. Pres. Obama should direct the FDA to review its regulations that restrict availability of autologous stem cell therapy. Those regulations are ultra vires and must be changed immediately.

Make no mistake - fighting to change the federal regulations that restrict the use of one’s own stem cells is an issue that libertarians should be deeply concerned with. There are at least five reasons why. First, the FDA regulations constitute an unlawful infringement upon the fundamental individual liberty of the person. The Preamble to the U.S. Constitution makes it clear that the document was ordained and established, in part, to “secure the Blessings of Liberty to ourselves….” No aspect of liberty is more fundamental than our right to control our “selves” or, stated more plainly, our bodies. For the federal government to define our own stem cells as “drugs” is to impose a tyranny on the human body that is tantamount to commodification. As we all know, human commodification in the U.S. was abolished in 1865. The federal government has no authority to control derivations of a person’s body when used to heal that same person. I am not a “drug.”

Second, the FDA regulations interfere with the constitutional authority granted to the states under the Tenth Amendment because they compromise the state-supervised doctor-patient relationship. Under the Tenth Amendment, the powers not delegated to the federal government and not prohibited by the states, are reserved to the states or to the people. Ratification of the Tenth Amendment was intended to memorialize the basic idea of limited government and to provide the states a legal bulwark against unconstitutional intrusion into policy domains traditionally supervised by the states. The practice of medicine and the fiduciary relationship between a doctor and patient have always come under the authority of state law. Decisions as to what treatment is best for a patient, particularly when that treatment concerns a person’s own stem cells, are retained by the states and the federal government has no business micro-managing that practice.

Third, the FDA regulations ostensibly increase health care costs because they prevent sick people from receiving therapy that is relatively inexpensive. If autologous therapy were released from FDA control, we might see people with painful, crippling conditions undergo a simple procedure to replenish health and strength, thus allowing them to feel better about themselves, re-enter the workforce and reclaim their identities as productive citizens. Consequently, fewer Americans would have to purchase expensive drugs that may have limited effectiveness and debilitating side-effects, and fewer Americans would have to rely on federal assistance because they will be able to work. Under the current regulatory scheme, sick people are forced to endure a life of expensive medications and physician’s visits because conventional treatments have failed. The federal regulations inhibit health care cost-effectiveness and they need to change.

Fourth, the FDA regulations stifle U.S. competitiveness in the field of regenerative medicine and the bio-technology sector, while rising global competitors like China and India surge ahead and reap vast profits from American and European stem cell tourists. There is broad agreement among scientists that regenerative medicine is the medical technology of the future and will be the catalyst for the advanced therapeutic approaches that will treat maladies that were once thought untreatable. Current regulations are inefficient because they essentially cede control of the autologous mesenchymal stem cell industry to one company. Such a concentration of control is facially anathema to the core free market principles that nurture technological innovation and medical advancement. There is absolutely no reason why the U.S. should allow other countries to take the lead in autologous stem cell therapy. The present course is economically dangerous and must be corrected. The U.S. needs a reasonable, forward-thinking policy on autologous stem cells.

Fifth, and finally, advocating for a change in the FDA regulations would demonstrate to those with political affiliations other than libertarian that smaller government and less regulation can be beneficial to people who need help. For many non-libertarians, overtures of “smaller government” are met with apprehension, if not outright disdain, because they are interpreted as an attempt to eliminate programs that benefit the most vulnerable Americans. The autologous stem cell issue is an opportunity for libertarians to demonstrate that less regulation can, in fact, help those among us who are physically vulnerable. It can likewise help convince skeptics that limited government need not be inimical to achieving compassionate outcomes, and that access to health care in particular is not an abstraction, but an integral part of the libertarian platform.

In sum, libertarians of all orientations should care about making autologous stem cell therapy available to all Americans. Stagnant partisan debates that do little to help bring healing to countless Americans must give way to constructive deliberations over how government can best serve Americans. With a cumbersome, intrusive and backward regulatory framework, the U.S. is now implicitly relinquishing the power of innovation in the regenerative medicine field by curtailing research and severely delimiting clinical application. We must alert our local, state and federal lawmakers to this important issue. Personal liberty, economic competitiveness and human compassion dictate that autologous stem cell therapy be made available to all Americans now.

A. Rahman Ford is a Ph.D. Candidate in the Department of Political Science at the University of Pennsylvania. He earned his B.A. from Rutgers University and his J.D. from the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal. He can be reached via email at or through