An adult stem cell therapy that Texas Gov. Rick Perry, a candidate for president, has undergone has highlighted a debate concerning the role of the FDA in the regulation of therapies that use a patient’s own stem cells.
The procedure Perry underwent involved the injection of his own stem cells into his spinal cord after a spinal fusion and nerve decompression procedure to aid in tissue healing and regeneration. The procedure was apparently successful, but has raised questions about the procedure’s legality. The FDA has not approved the procedure for regular therapeutic use. Yet there are clinics that offer adult stem cell therapies.
According to an article in Humanity Plus, the question revolves on how the use of a patient’s own stem cells should be regarded. Is it like fertility treatment, in which a woman’s fertilized eggs are cultured outside her body before being reinserted and is outside the purview of the FDA, or is stem cell therapy like a prescription drug, and therefore subject to FDA regulation. The FDA says it is the latter. A number of doctors and researchers, along with Gov. Perry, says it is the former and subject only to state and medical guidance.
The reason Perry and his allies believe that using a patient’s own adult stem cells is not covered by FDA regulation is that it does not inject foreign genetic material, even when the cells are altered for specific therapies such as repairing damaged spinal cords, outside the body. Proponents of regulation maintain that some independent oversight is needed to insure safety and efficacy.
In an attempt to directly confront the FDA’s attempt to regulate the sort of adult stem cell therapy that he underwent, Perry is developing legislation that would create a commercial adult stem cell industry in Texas. The legislation faces a hurdle from the Texas Medical Board which proposes to establish rules that provide an independent review of proposed adult stem cell therapies, something that so far does not exist. Perry and his allies are resisting this policy, however review by independent committees of medical experts would be one way to head off interference by the FDA, according to a piece in the Houston Chronicle.
At stake is the development of cutting edge medical procedures that would not only treat a number of debilitating conditions, ranging from Lou Gehrig’s Disease to Alzheimer’s, but would also lower the cost of traditional therapies. The potential could be that drug based therapies costing $60 billion per year would be replaced by adult stem cell therapies costing about a tenth of that amount, according to a researcher quoted in the Humanity Plus article.
That prospect strikes at the heart of the pharmaceutical industry. If adult stem cell therapy became common practice, doctors would not have to prescribe expensive drugs, but would culture adult stem cells in their own laboratory. Thus the controversy is just as much about money as it is about patient safety.
Can a balance be struck between the need to ensure patient safety and the desire to bring a revolutionary therapy into common practice? Will private insurance pay for such procedures, even if they are cheaper than conventional therapies, if the FDA continue to resist their implementation? The answers to these and other questions will shape the nature of medicine and determine life and death and the quality of life of millions for decades to come.
Texas resident Mark Whittington writes about state issues for the Yahoo! Contributor Network.