I’ve been concerned that the journal Stem Cells Translational Medicine has been publishing some iffy papers from unproven stem cell clinics recently including from a Panama stem cell clinic called the Stem Cell Institute.
Back in 2019, I took the unusual step of raising the question of whether a Stem Cells Translational Medicine paper from Neil Riordan, et al. of the Stem Cell Institute should be retracted shortly after it was published.
In that post, I even politely criticized the journal for publishing it. In my view, the paper was that concerning.
Stem cell clinic paper retraction
Now the journal has retracted that same paper.
What’s the back story here?
In May of this year, Leigh Turner and Jeremy Snyder published a piece in Stem Cells Translational Medicine also raising issues on the now-retracted paper from the same journal.
Oddly, accompanying their piece was an editorial on the part of the journal written by section editors Karen Ballen and Joanne Kurtzberg in a sense defending the decision to publish the Riordan paper. Also, I’d say they were defending the field of cord blood for autism more broadly.
Pay for play in pubs
So why did the journal ultimately now retract the clinic paper? The decision seems focused on the participants (or their parents) having to pay for access to the trial, which was not disclosed.
Here’s the retraction notice (emphasis mine):
Retraction: Riordan, N.H., Hincapié, M.L., Morales, I., Fernández, G., Allen, N., Leu, C., Madrigal, M., Paz Rodríguez, J. and Novarro, N. (2019), Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of Autism Spectrum Disorder in Children: Safety Profile and Effect on Cytokine Levels. STEM CELLS Translational Medicine, 8: 1008-1016. https://doi.org/10.1002/sctm.19-0010. The above article (“the Article”), published online on 11 June 2019 in Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the journal’s Editors, AlphaMed Press, and Wiley Periodicals LLC. In May 2021, the journal published an article by Turner & Snyder (2021) (1) outlining concerns that participants were charged to participate in the clinical trial reported in the Article. The Article’s authors then published a Letter to the Editor (2) responding to those concerns, followed by an Editor’s Note (3) supporting the initial decision to publish the Article. Following publication of (1), (2), and (3), the journal reopened the investigation upon receipt of newly acquired information pertaining to the clinical trial and participants’ requirement to pay to participate. The journal has determined that participants were charged to participate and that these charges were not disclosed to the journal, which violates the journal’s guidelines on the disclosure of funding sources for clinical trials. As a result, the journal has made the decision to retract the article.
Stem Cells Translational Medicine and clinic pubs
It’s worth noting that when I posted here on The Niche in 2019 about my concerns about this paper they included the firm possibly charging participants. Just a blog post?
However, around the same time, I emailed the journal editors to also raise my concerns including about the charging issue.
Why no action until now?
On one level it’s again encouraging that the journal investigated this eventually but the whole process wasn’t ideal.
It seems that the journal should now look back at other papers it has published from such unproven stem cell clinics. Did those authors also charge participants? How often are clinics not charging what are essentially their customers in many cases? Probably rarely.
As to the Riordan piece, I believe they never should have published this paper in the first place. How did that review and editorial process unfold before publication? Weren’t those involved aware of the stem cell clinic problem more generally?
Looking ahead, maybe it’d be wise to reconsider the journal’s philosophy on publishing papers from stem cell clinics more generally? These papers also tend to be weak in design and I’d say they have results that don’t really add to the field positively. On the other hand, such papers are sometimes used by the clinics as promotional material to lure in more customers.
Hello,
I was treated at the Neil Riordan Medical Institute in Dallas. Although my condition did not improve, the staff and doctor was upfront with me that the umbilical cord stem cells and umbilical cord tissue they giving me may not work and treatment failures exist with even the best therapies. The facility is beautiful and first class all the way. I did not see any retraction on retractionwatch.com for this article of Neil’s that you mentioned. So it must not be a very big deal at all otherwise it would of been on retractionwatch.com.
Notice that this blog post doesn’t mention anything about the response from Riordan. Let’s face it. There is a narrative here that cannot be violated. Would love to follow the money if I could.
Can be “ethical” if one fully explains the fact that the treatment is not considered standard of care and is not covered by insurance.
I and millions of patients have had Lasix surgery: paid by me, not covered by insurance companies, no randomized controlled studies BUT it works !!!
If a patient pays money out of pocket for a treatment they may be more likely to report positive results. This effect has been shown to increases with the amount paid. You are more likely to try to find reasons that your costly financial decision was worth it than to accurately assess the decision in a way that makes you feel foolish.
FDA also allows for studies where the patients pay for their treatment. Please check their website regarding this.
Much of the published Orthopedic literature is based upon treatment paid by insurance companies so an even greater potential for a placebo effect.
Charging patients for treatment in a clinical trial increases the inherent bias in the trial significantly. Patient who pay for a treatment have an enormous placebo effect and the bias generated by such affect completely invalidates any data presented by the authors
How does charging participants change the results ???
Well, is charging them ethical in the 1st place? Also, if a journal requires disclosures of such COIs you should include the info. Finally, charging in an open-label study can actually change the apparent results.