Pain News Network Piece on Recent Pew Stem Cell Article

By A. Rahman Ford, PNN Columnist

As a self-professed vehicle for public policy-making, the Pew Charitable Trusts has released a new report that aims to protect Americans from the harms of “unapproved” stem cell therapy.

Regrettably, the 34-page report relies on cherry-picking of patient cases, supports an aggressive crackdown on stem cell clinics by the FDA, and curiously take the undemocratic position of supporting online censorship.

Like a similar report in 2019, Pew’s stated intent is a noble and valuable one: to protect patient health. The new report correctly asserts that “stem cell products and other regenerative therapies have significant potential to treat traumatic injuries and serious diseases.” Unfortunately, what follows is a porous analysis that includes woefully unsubstantiated assumptions and misdirected conclusions.

To support its claims of an ever-increasing number of harmful “adverse events” resulting from unapproved stem cell treatments, Pew researchers looked at peer-reviewed journals, government and news media reports, the FDA’s adverse event reporting system, and online consumer reviews of stem cell businesses from 2004 to 2020.

Over this 17-year period, Pew identified 360 people who had adverse events involving stem cells. Most of the adverse events (AEs) were relatively minor, such as bacterial infections, but some were serious enough to result in blindness, organ damage or even death. While each case is regrettable, keep in mind that over 250,000 people in the U.S. die every year from medical errors.

The Pew report assumes that adverse events from stem cells are under-reported, but provides no evidence for this claim. On the basis of the cases found, Pew concludes that “increased FDA enforcement action” against stem cell clinics is needed. The report also calls on state agencies, state legislatures and professional organizations to get involved.