Crow’s feet filler study omitted pharma funding, gets retracted

JKMSA paper on a filler for eye wrinkles did not disclose that it was funded by a pharmaceutical company that produces the cosmetic.

The paper explicitly noted that the authors do not have any financial conflicts of interest, and that a government program supported the study. According to the journal, a reader alerted them to the conflict of interest.

The cooperate tie wasn’t a secret, though — one of the authors was listed as affiliated with the  company, Pharma Research Products, based in Korea.

Here’s the retraction notice for “A Phase III, Randomized, Double-Blind, Matched-Pairs, Active-Controlled Clinical Trial and Preclinical Animal Study to Compare the Durability, Efficacy and Safety between Polynucleotide Filler and Hyaluronic Acid Filler in the Correction of Crow’s Feet: A New Concept of Regenerative Filler:”

A reader of the Journal of Korean Medical Science (JKMS) raised concerns regarding the above entitled article violating conflict of interest disclosure (1). The article described the conflict of interest as “We certify that all authors of this manuscript have had no financial involvement (e.g. employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, and royalties) within the past five years, or will have in the foreseeable future, with any organization or entity with a financial interest in, or financial conflict with, the subject matter or materials discussed in the manuscript.”The funding record of the article was “This study was supported by the regional innovation center program of the Ministry of Trade, Industry and Energy at the Skin Biotechnology Center of Kyung Hee University, Korea.”

The corresponding author, Dr. Chan Yeong Heo, later reported that the study was a clinical trial of a new filler and the trial expense was supported by a pharmaceutical company which was producing the filler. One of the coauthors, Dr. Iksoo Kim, was a researcher in the R&D Center of the company, and his written affiliation was the company. The corresponding author reported that the coauthor performed the animal experiment but the research integrity was kept unimpaired without any influence by the company’s funding and Dr. Kim’s involvement.

However, the journal decided the undisclosed conflict had to be addressed, as the retraction notice states:

The executive board for publication of the Korean Academy of Medical Sciences seriously discussed the matter on January 22, 2016. The board concluded that the article was an impaired publication of conflict of interest by wrong disclosure and incorrect notification of funding sponsor. The corresponding author of the article accepted the allegation of the publication board. The editor retracts the above article based on the decision of the board.

The article, published in 2014, has been cited once, by the retraction notice, according to Thomson Reuters Web of Science.

We should note that while the Committee on Publication Ethics’ retraction guidelines say that “failure to disclose a major competing interest likely to influence interpretations or recommendations” is one reason to retract, most of the time when we see conflict of interest mentioned in a retraction notice, it’s not the main reason for the move.

We asked Heo, the corresponding and last author — and chairman of plastic surgery at Seoul National University — why the authors didn’t initially disclose the corporate funding source. He said he “did not fully agree” with the journal’s decision to retract the paper:

The research was carried out with collaboration SNUBH and Pharmaresearch Product(R)…At this reason, I assigned and named the all members, who dedicated to this research.

Iksoo Kim’s affiliation on the paper is listed as the “Pharmaresearch Products R&D Center, Seoul, Korea.” The Pharma Research Products website lists Seoul National University as a collaborator.

We could not find contact information for Kim.

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