There’s trouble brewing over stem cells in Texas, and it raises a big question for the future of medicine. How should we regulate treatments that use cells taken from a patient’s own body?
If the cells are grown in culture, then the US Food and Drug Administration (FDA) views them as “drugs”, which must undergo a lengthy approval process. That has enraged clients of a company in Houston called Celltex, who argue that the government has no business telling them what they can and can’t do with their own body parts (see “Fight for the right to stem cells”).
However, there is minimal oversight of clinics that don’t culture cells, because simple transplants are a “practice of medicine”, which the FDA doesn’t control. That is a concern, given anecdotal reports of problems, such as a woman who had shards of bone growing in her eyelid after stem cell injections.
This incoherent situation arises from trying to shoehorn stem cells into a regulatory system designed for conventional drugs. One solution would be to create a new body to regulate all therapies that use a patient’s own cells.
Obvious as this sounds, it is unlikely to happen in a political climate that has little enthusiasm for costly new bureaucracy.
A sensible alternative would be to adapt the existing system to bring it in line with modern realities. Strict drug-style regulation seems appropriate for extensively manipulated cells. But if a person’s cells are merely grown in culture for a short while, as happens at Celltex, a different approach might be better.
The problem, then, is who would oversee clinics that fall outside FDA jurisdiction.
Whoever ends up doing it must balance the best scientific evidence with the needs of patients. The International Society for Stem Cell Research has written guidelines for moving therapies into the clinic. What’s missing from these is genuine engagement with the people whose interests they are supposed to serve.
That must change. If people desperate for therapies are simply told what is best for them, it should come as no surprise if they ignore the official advice and flock to snake-oil merchants flogging easy “cures”.