Comment upon an article appearing in NatureThere is a problem with the phrase "unproven stem-cell therapies". Outside of sterile mathematical/logical equality, nothing is proven. In science there are just degrees of knowing. "Unproven" is a loaded word that really boils down to a matter of opinion. For example, I can point to two studies indicating safety of autologus MSC therapies in humans 1 and 2. Presumably, for the FDA, such studies (and others) are not sufficient evidence. But strangely, the FDA seems happy to bless alternative therapies which have what I consider to be relatively high complication/death rates and/or frequently fail to relieve pain.
Of course, individuals weigh risk and benefit differently according to their inclinations and circumstances. My point is, that we should be sceptical about government bureaucracies that assume too much control over our decision making.
In a memorandum opinion we are treated the the legal basis for ruling that an autologous MSC therapy is a drug:The Federal Food, Drug, and Cosmetic Act defines "drug" to mean "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" or "articles (other than food) intended to affect the structure or any function of the body of man or other animals."There is some evidence that dogs confer health benefits to their owners and so I wonder how much longer before the FDA declares my pet to be a drug? In view of recent research, it seems that eminent lawyers also wonder about your dog as a medical device.