Bioethics Blogs

The Direct-to-Consumer Stem Cell Industry in the US

Stem-cell clinics can be found around the world: Mexico, South Korea, the Philippines, China and many other countries. Several have been exposed as scams, and others are suspect, while several high-profile patients (not all) have claimed to have been cured, or at least helped, by them. Two competing storylines have become standard. One is that desperate Americans go abroad for treatments because they were conned; the other is that the FDA is over-cautious and withholding life-saving treatments.

Both narratives assume that few, if any, of these clinics are in the US. That may have been true some years ago: 60 Minutes ran an exposé in 2010 that eventually led to arrests, and another in 2012. Introducing the second one, Scott Pelley made it clear that these were meant as examples, that their team had found “hundreds of credible-looking websites offering stem-cell cures at overseas clinics.”

It seems fair to suggest that up till now many Americans have assumed that the FDA was keeping us safe. That is now in serious question.

Leigh Turner and Paul Knoepfler recently published an important paper in Cell Stem Cell on stem cell clinics in the US. Turner is a University of Minnesota bioethicist and expert on medical tourism; Knoepfler is a stem cell professor at UC Davis who also runs a very well-regarded blog about stem cell research.

They identified 351 businesses, operating 570 clinics, all over the country (see map above, which is a reduced version of Figure 1 in their article). Some of these clinics may be offering services that do not require FDA approval, but in many cases, Knoepfler explained on his blog,

… there is a strong likelihood that FDA pre-approval would be needed because of issues such as non-homologous use and/or more than minimal manipulation.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.