Company’s Alzheimer’s treatment study earns a flag

A journal has issued an expression of concern for a federally-funded paper on Alzheimer’s disease after a sleuth on PubPeer noted potentially duplicated figures in the article. 

We shouldn’t forget to mention, as the paper did, that one of the authors – a prominent scientist who happens also to be a co-editor in chief of the journal – has financial ties to a company with interest in the work. That author said the fault lies with the corresponding author.   

Oh, what a tangled web we weave, it seems, when it comes to neurofibrillary tangles. And we’ve seen at least one other case of a paper failing to disclose conflicts of interest in a paper he’d published in his own journal. (This is a subject that has been taken up elsewhere.)

The article in this case, “Human Umbilical Cord Blood-Derived Monocytes Improve Cognitive Deficits and Reduce Amyloid-β Pathology in PSAPP Mice,” appeared in Cell Transplantation, a SAGE title, in November 2015. 

At the time, the University of South Florida (USF), in Tampa, where some of the authors were based, trumpeted the findings in a press release. 

Among the authors was Paul Sanberg, co-editor in chief of the journal and a co-founder of Saneron CCEL Therapeutics, a Florida-based “biotechnology R&D company, focused on neurological and cardiac cell therapy for the early intervention and treatment of several devastating or deadly diseases, which lack adequate treatment options.”

In 2010, Saneron and USF, where Sanberg has held high profile positions, received a $2.6 million grant  from the National Institutes of Health to study the role of blood from human umbilical cords in the treatment of Alzheimer’s disease. That money appears to have helped pay for the study in question. Meanwhile, Saneron has received nearly $6 million in federal funding across 16 grants. 

Saneron’s website includes a list of 11 papers stemming from its research efforts, two of which – but not the one with the expression of concern – appeared in Cell Transplantation. 

According to the expression of concern for the paper, which has been cited 20 times, according to Clarivate’s Web of Science: 

Following concerns posted on Pub Peer, SAGE would like to alert readers to a potential image manipulation with duplicated elements within the Figure 5B panels. We would also like to acknowledge that Dr. Paul Sanberg, the Co-Editor in Chief of Cell Transplantation, is a co-founder of Saneron and this should have been noted in a Conflict-of-Interest statement. The corresponding author did not respond to publisher requests for comment.

The remaining authors noted that the corresponding author has access to all of the data underlying the findings in this article and were unable to comment on the concerns raised.

The Editors and SAGE strive to uphold the very highest standards of publication ethics and are committed to supporting the high standards of integrity of Cell Transplantation. Authors, reviewers, editors and interested readers should consult the ethics section of SAGE and the Committee on Publication Ethics (COPE) website for guidelines on publication ethics.

We were unable to reach the following authors: Li S, Tian J, Tan J.

The co-author, Donna Darlington, has left academia for a career as a motivational author and speaker, charging between $300 and (aspirationally, we’re guessing) $20,000 an appearance:

Rev. Dr. Donna Darlington is South Carolina State, USF Morsani College of Medicine and Yale trained—and still in training. A certified coach, an “Above and Beyond” Award-winning Pastor, an award-winning bestselling author and coauthor with Brian Tracy of the Amazon Bestseller, “The Secret to Winning Big “, and also referred to as “The Empowerment Conduit” by colleagues, Donna is known for her service to God and to others. coauthor with Brian Tracy of the Amazon Bestseller, “The Secret to Winning Big”.

We tried to email Darlington at her speaker’s contact, but the message came back as undelivered. 

Our email to Saneron went unanswered.  

Sanberg told us that he thinks the figures don’t look right but an outside review could not determine if misconduct occurred: 

I think the two upper right panels in Figure 5b appear to have duplicated portions. However, the independent review conducted by the publisher was not able to confirm intentional manipulation and the related data did not affect the overall findings of the article. Based on this information, which did not constitute clear evidence that the findings were unreliable, it was determined by the publisher that an Expression of Concern would be more appropriate.

As for the conflict of interest, Sanberg said Darlington – with whom he has not spoken since 2015 – had neglected to include that information:  

I disclosed the company affiliation fully to the corresponding author of this paper, but it was not put in the final version of the publication. This has now been corrected as part of the Expression of Concern.

As in accordance with COPE guidelines and the publisher’s guidance, I do think it is fine for editors to publish in journals they are affiliated with as long as the peer review and decision processes are made without their involvement.

Sanberg said that to avoid similar problems in the future: 

It would be very useful if all authors had a chance to review galley proofs and sign off prior to publication.   

Camille Gamboa, a spokesperson for SAGE, told us that the publisher had no plans to discipline Sanberg or retract the paper: 

Currently, we are not planning to retract the article because we are unable to confirm that image manipulation did indeed take place.

We have noted elsewhere that failure to disclose conflicts of interest, on its own, is not typically used as a justification for retraction, although guidelines from the Committee on Publication Ethics include that criterion.

Gamboa added: 

The journal did not retract this paper on those grounds given the submission, review, and publication of the article took place independent of Dr. Sanberg. Additionally, Dr. Sanberg informed us that he made the corresponding author aware of his connection with Saneron and it was due to error that the conflict of interest statement was not included. We have no information suggesting the failure to include the COI statement was intentional.

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