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.

Less Than Definitive Definitions

On its face, Pew’s evidence against stem cells seems somewhat convincing. But upon closer inspection, it has serious and alarming methodological flaws.

First, the report’s definitions are problematic. For example, Pew defines an adverse event as “any undesirable experience associated with the use of a medical product in a patient.” This definition is so broad it can encompass almost anything. Furthermore, it’s conceptually clumsy to equate “adverse” with “undesirable” – the two are simply not the same in medicine, academia, policy, or in simple common sense.

To make matters worse, Pew conflates “unproven” therapies with “unapproved” therapies, when the two are very different. “Unapproved” means it’s not FDA-approved, which covers most products offered by stem cell clinics. Thai’s fine. But Pew then asserts that the stem cell products are also “unproven” because they lack “definitive, high quality evidence of safety and efficacy.”

To assert that stem cells products such as stromal vascular fraction (SVF) and autologous mesenchymal stem cells are all “unproven” simply defies the reams of published studies to the contrary. There are many examples where stem cell therapies were “proven” to safely and effectively help people, even when they are not FDA-approved.

And the “safe and effective” products the FDA has approved harm people all the time. Thus, the question remains, if “unproven” and “unapproved” are going to be used interchangeably, as the Pew report admits, then what is the point of having definitions in the first place?

Cherry-Picked Cases

Second, the Pew report wrongly assigns all cases equal evidentiary weight, regardless of the source from which they were collected.

Is it methodologically honest to give a case from a peer-reviewed academic journal the same scientific and evidentiary value as a case found on Yelp, a website where people go for reviews of Philly cheesesteaks and fish tacos? And how exactly did Pew investigate the veracity of posts it found on Facebook and Google? It didn’t.

Pew concedes that its social media analysis did not find “many new serious or life-threatening” adverse events. It also acknowledges that not all the consumer reviews about stem cells were negative, stating that “many, in fact, were positive.” Pew’s analysis excluded the positive reviews because it didn’t consider them reliable, but inexplicably included the negative ones. Why?    

Could it be that Pew was only looking for data that supported a conclusion that it had already arrived at?  If so, that would be unprofessional, unscientific and very, very troubling.

To cherry-pick some opinions over others is also undemocratic. This would be ironic because on its website, Pew purports to “invigorate civic life by encouraging democratic participation and strong communities.” Pew also maintains that it is inspired by America’s Founding Fathers and their belief in “the importance of an informed democracy.”

Given the report’s skewing of data, perhaps for Pew it’s only democracy for some.

This conclusion would coincide with Pew’s continued urging of online media platforms to censor stem cell information it finds disagreeable. In its report, Pew implores “companies that manage online platforms [to] do more to limit the spread of misinformation, and prevent clinics from advertising their products on their platforms.”

Pew would do well to realize that speech – online or otherwise – is a constitutionally protected freedom, and the perimeter of the public square should not be circumscribed so as to serve unspoken agendas.

All in all, the Pew report’s lack of methodological rigor undermines much of its credibility. To be sure, when any American is harmed by any medical procedure it should be taken seriously. And most stakeholders agree that reasonable regulations and enhanced data collection are welcome.

But the Pew report ignores the critical point that the current FDA regulatory scheme for stem cells is unduly burdensome and in desperate need of change. Cracking down on stem cell clinics won’t solve the problem of chronic pain, and it won’t solve the problem of pills and surgeries that don’t work, harm or kill. All it will do is discriminate against persons with disabilities and poor people. It doesn’t get more undemocratic than that.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.