Last year, a researcher cast doubt on a bone scientist’s clinical trials, suggesting some of the findings may not be legitimate. So what’s happened since?
Since 2015, journals have retracted 14 papers by bone researcher Yoshihiro Sato, based at Mitate Hospital in Japan, for issues ranging from self-plagiarism, to problems with data, to including co-authors without their consent. (We covered the latest two retractions this week.) Last year’s analysis identified patterns in more than 30 of Sato’s clinical trials that suggest systematic problems with the results. (Sato has defended his research.)
With doubts cast on Sato’s body of work, we contacted the journals that have published his papers involving human trials, to see if any taken another look at Sato’s work; several responded. While most believe there is little reason to take further action at this time, some told us they are investigating.
Journal of the Neurological Sciences
Nicole Villemarette-Pittman, the managing editor for the Journal of the Neurological Sciences, told us she believes something will be done regarding the two papers Sato published in the journal:
I forwarded this to Elsevier administration when you first alerted us (JNS). It is in their hands at this time but I do expect some action.
The two papers are:
- “Hyperhomocysteinemia in Japanese patients with convalescent stage ischemic stroke: effect of combined therapy with folic acid and mecobalamine,” published 2002. (cited 14 times, according to Clarivate Analytics’ Web of Science, formerly part of Thomson Reuters)
- “Amelioration by mecobalamin of subclinical carpal tunnel syndrome involving unaffected limbs in stroke patients,” published in 2005. (cited 7 times)
Regarding a 1997 paper in Stroke, a spokesperson told us:
The American Heart Association journals do not investigate issues of misconduct. Questions such as these should be directed to the researcher’s institution.
The paper, “Amelioration of hemiplegia-associated osteopenia more than 4 years after stroke by 1 alpha-hydroxyvitamin D3 and calcium supplementation,” has been cited 57 times.
A spokesperson at Elsevier, which publishes the journal Bone, told us:
On behalf of the Editor and the Publisher, I wanted to drop you a quick note to let you know that at the moment I don’t have any comment on the inquiry below but I will be sure to alert you if we decide to take any action on these publications.
The three papers are:
- “Menatetrenone ameliorates osteopenia in disuse-affected limbs of vitamin D- and K-deficient stroke patients” (cited 65 times)
- “Menatetrenone and vitamin D2 with calcium supplements prevent nonvertebral fracture in elderly women with Alzheimer’s disease” (cited 32 times)
- “Etidronate for fracture prevention in amyotrophic lateral sclerosis: a randomized controlled trial” (cited 11 times)
Aging and Clinical and Experimental Research
The editorial office of Aging Clinical and Experimental Research informed us that given previous conversations with the executive editor of Neurology — the journal that originally published the analysis of 33 of Sato’s papers — the journal had no reason to retract Sato’s paper:
I have personally checked the article published in Aging Clinical and Experimental Research and had an intensive correspondence with Patricia K Baskin, Executive Editor, Neurology Journals, back in September 2016. Dr. Baskin guaranteed to me that after a final check of the paper, whose lead author was Dr. Iwamoto, would have not ended up in the final appendix, because all information collected indicated that the work was correctly done.
The paper in question is “Effect of whole-body vibration exercise on lumbar bone mineral density, bone turnover, and chronic back pain in post-menopausal osteoporotic women treated with alendronate.” (Cited 82 times)
Kurume Medical Journal
The Kurume Medical Journal recently retracted the paper that Sato had published in the journal:
We received an inquiry from The Neurology® editorial office in the fall of 2016, expressing concerns about the validity of paper written by Dr. Sato et al. Members of the Editorial Board met several times to discuss the issue, and the paper has been retracted as of December, 2016.
Technical process of the retraction is underway both on printed and online versions of the Kurume Medical Journal. The Retraction notice just appeared on Vol.63, 1&2, the most recently published journal. https://www.jstage.jst.go.jp/article/kurumemedj/57/4/57_4_117/_article
The paper is “The prevention of hip fracture with menatetrenone and risedronate plus calcium supplementation in elderly patients with Alzheimer disease: a randomized controlled trial.” (Kurume Medical Journal is not indexed by Web of Science)
Two papers by Sato were published in Osteoporosis International, and a spokesperson for the publisher, Springer, said they had investigated:
We have looked into this issue and can confirm that the editors of the journal Osteoproosis International have extensively reviewed the papers where Dr. Yoshihiro Sato appears in the authorship. No evidence of fraud was found as a result of the investigation and the editors now consider this case closed.
The two papers are:
- “Preventative effect of exercise against falls in the elderly: a randomized controlled trial” (Cited 38 times)
- “Alendronate is more effective than elcatonin in improving pain and quality of life in postmenopausal women with osteoporosis” (Cited 12 times)
Yonsei Medical Journal
The editor-in-chief of Yonsei Medical Journal, Jung-Won Park, said the editorial committee reached out to the corresponding author on the three papers Sato co-authored in the journal:
In regards to the suspected fabrication of data found in the following articles, the YMJ editorial committee requested a corresponding author’s reply at the end of September last year.
So, we received the reply from the corresponding author(Dr. Jun Iwamoto).
After reviewing Dr. Iwamoto’s explanation, we found that his reply was clear, therefore, we decided not to take any actions regarding the statuses of these manuscripts at that time.
However, our editorial committee will continue to monitor this issue.
The three papers are:
- “Comparison of effect of treatment with etidronate and alendronate on lumbar bone mineral density in elderly women with osteoporosis” (Cited eight times)
- “Comparison of effects of alendronate and raloxifene on lumbar bone mineral density, bone turnover, and lipid metabolism in elderly women with osteoporosis” (Cited 12 times)
- “Comparison of the effects of alendronate and alfacalcidol on hip bone mineral density and bone turnover in Japanese men having osteoporosis or osteopenia with clinical risk factors for fractures” (Cited five times)
We’ve contacted the other journals published the remaining 33 papers included in Bolland’s analysis, and will update if any respond.
The recent analysis of Sato’s work alleged that the treatment groups may not have been truly randomized, raised concerns over how quickly the researchers were able to recruit patients (33 trials in 15 years), and were suspicious about how many agents achieved consistent results in hip fracture rates.
Sato has defended his work, including his group’s ability to recruit patients, debated the statistics underlying the authors’ conclusions about randomization, and argued that the patient population he examined may have been predisposed to responding better to treatment. Click here to read his entire response.
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