An influential osteoporosis study is “likely fraudulent” — but not retracted

Alison Avenell first came across The Yamaguchi Osteoporosis Study (YOPS) when she was working on a 2014 Cochrane Review on bone fractures.

She cited the study but felt something was off about it. “I suppose, together with my collaborators over the years, we developed sort of antennae for rather suspicious looking studies,” Avenell, of the University of Aberdeen in Scotland, told Retraction Watch. “And when you see a relatively large trial with just two authors, you think to yourself, that’s not possible.”

Avenell and her colleagues, whose work we’ve written about before, were critical to the retraction of fraudulent research by the late Yoshihiro Sato and his collaborator Jun Iwamoto, who rank third and fourth, respectively, on our retraction leaderboard.

This time the study in question was called “Comparative efficacy of hormone replacement therapy, etidronate, calcitonin, alfacalcidol, and vitamin K in postmenopausal women with osteoporosis: The Yamaguchi Osteoporosis Prevention Study.” The paper, which did not include Sato as an author, had a large scope, claiming to include nearly 400 postmenopausal women and comparing multiple treatment methods. It was published in the American Journal of Medicine (AJM), an Elsevier journal, in 2004.

The study was co-authored by Yoichiro Ishida and Shinya Kawai while they were at Yamaguchi University in Japan. Since then it has been cited 83 times according to Clarivate Analytics Web of Science. It has also been cited in five clinical practice guidelines, Avenell says. 

Several of Sato and Iwamoto’s retracted papers cited the study as well.

Avenell and her collaborators began digging into the study in earnest the summer of 2019. “And so when we started to look at this particular trial approach, there are many what we call red flags, about the conduct of the trial, improbable data, authorship that varied, impossible workload in terms of recruitment, lots of numbers that doesn’t add up at all, and data that were completely impossible,” she says.

Avenell and her team initially wrote to AJM about their concerns just under a year ago. 

That’s when things got a bit weird.

First, Joseph Alpert, the editor of AJM, invited the team to write about their concerns in the form of a published letter to the editor, which Avenell found an “unusual approach.”

But they went along with it. The critique was published in the June, 2020 issue of the AJM along with the editor’s response. That response, from chief editor Joseph Alpert, reads, “The Editor-in-Chief and the editorial staff of The American Journal of Medicine (AJM) have carefully reviewed the information sent to us by Bolland, Grey, and Avenell from New Zealand. We have attempted without success to contact Dr. Ishida in Japan. These articles were accepted for publication by the previous editor and editorial board of the AJM at a time when all submissions were in paper form.”

Alpert explained that because of how long ago the paper was published, the journal couldn’t access the notes from the original peer review process. He continued: “The allegations of Bolland, Grey, and Avenell seem valid, and the AJM and Elsevier are currently in a final review phase prior to retracting these articles. In my personal opinion, given the documentation of Bolland, Grey, and Avenell, these articles should be considered as likely fraudulent and should not be cited in the scientific literature.”

So far, so good, right? Well, maybe.

A fact-check, first: Avenell is in fact still in Scotland, not New Zealand, as the editor implied. But more important, Avenell is concerned that the article shows up on indexing sites without context — typically without a link to her critique or the editor’s expression of concern.

“The letter from the editor at American Journal of Medicine… indicates that hopefully a retraction will happen eventually,” says Avenell, “although it’s somewhat puzzling to us that, given the information that we’ve provided it hasn’t yet happened.”

When Retraction Watch contacted Alpert to find out more, he responded, “Not my area of expertise.” That was puzzling, given that he is the editor, but he responded the same way to follow-up questions.

Retraction Watch’s emails to Ishida and Kawai produced “delivery incomplete” warnings. The researchers don’t appear to be in Yamaguchi University’s faculty database. Yamaguchi University did not reply to an email request for comment, and both authors apparently ceased publishing in 2009.

Avenell was concerned not just by the slowness of the journal’s response, but by the manner of it. In her case, she and collaborators had little to risk as whistleblowers, but she wonders how the journal would have handled a case where the investigating authors felt at risk and wished to avoid identifying themselves publicly. 

“If the authors had said, I’m sorry, we’re not prepared to write a letter because… we don’t want to display our identity, particularly if it turned out that they were writing about people who knew them or even worked at the same institution,” she says.

“So, it is a rather unusual approach to adopt,” says Avenell. “And not really… following the best practice as recommended by” the Committee on Publication Ethics (COPE).

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