Asking the Government for Permission to Live
Richard E. Ralston
May 10, 2012
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.