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 federal government, in general, and the Food and Drug Administration, in particular, increasingly inject themselves into direct control of every medical practice. The FDA is aggressively moving past its lock on the approval of every medication and all medical equipment. It now seeks control of every procedure and treatment that your physician recommends.
The FDA issued a warning (i.e., threat) about the use of venal catheters as a result of a physician conducting a clinical trial for treatment of multiple sclerosis. After approving the safety and efficacy of the device, the FDA now demands that it approve every use by individual physicians.
Michael Phelan is the CEO of SevOne. My Forbes colleague Tomio Geron recently wrote about his fast-growing IT company and Phelan contributed a guest post earlier this year at Eric Savitz’s CIO Network.
Phelan also has multiple sclerosis. Frustrated by the limited effectiveness of standard drugs for MS, he decided to try something more radical.
He traveled to a clinic in Panama and had infusions of adult stem cells generated from his own body fat.
It worked so well, he’s going back for another treatment.