I was recently asked to comment on a case between the FDA and two physicians vying for a new stem cell procedure. The orthopedists posit that they are using a procedure that implements host stem cells to repair orthopedic conditions. Their opponent, the FDA, argues that when these cells are returned to the patient's body they are considered a drug and not part of the patient's body. If the cells are to be classified as therapeutic drugs, a different set of guidelines is to be followed and FDA approval must be obtained for patient safety.
The physicians claim that the procedure is safe and has no place in the courts as the cells are simply being returned to their original host, but they are willing to fight the FDA to prove their point. Dr's Centeno and Schultz issued this press release about Regenerative and the FDA. If you knew there was a procedure that was safe and used your body to bring optimal recovery, would you be willing to take part even if it was new medical therapy? The thought of not enduring surgery to get results may actually be very comforting to some. To learn more about how patients can still avoid the need for invasive orthopedic surgery, see Regenexx SD link.
We commonly look to the FDA to recommend and ensure product safety and tend to trust their judgment both as patients and providers. In this particular case, however, their control might be infringing upon the rights patients have concerning their own body parts. Is this patient safety or medicinal dictatorship?
Question of the Week
A physician-scientist is conducting an experiment in which she tries to stimulate growth of cartilage in vitro. She wishes to use a substance to stimulate histogenesis. Which substance would be best suited to her purposes based on its stimulation of cartilage growth in vivo?
D. Vitamin A
E. Vitamin D