Bone Studies Rife With Scientific Misconduct

A researcher from New Zealand has completed a study indicating the strong probability of scientific misconduct in a number of bone health studies. The new research, led by Mark J. Bolland, MBChB, Ph.D., of the University of Auckland in New Zealand, involved 33 studies, three of which were published in Neurology and retracted in summer 2016 after the author, Yoshihiro Sato, M.D., of Mitate Hospital in Tagawa, Japan, admitted to scientific misconduct.

According to the November 9, 2016 news release, the research, published in the November 9, 2016, online issue of Neurology, reported results that differed markedly from what could be expected statistically; further, the results were remarkably positive.

“Sato accepted full responsibility, admitting fabrication of the fraudulent Neurology papers, which reported on the effects of therapies to reduce hip fractures both after stroke and in Parkinson’s disease patients. Sato stated that none of the co-authors participated in any misconduct and were named as authors on an honorary basis only. Sato requested retraction of the three studies.”

“The researchers were remarkably productive, conducting 33 randomized controlled trials within 15 years, the outcomes of each being remarkably positive, ” said Dr. Bolland. “Our analysis suggests that the results of at least some of these trials are not reliable. In addition, results from these trials were not consistent with results found in similar studies by other researchers.”

Dr. Bolland told OTW, “That trials specifically carried out by a Japanese research group in the area of osteoporosis, particularly in patients with Alzheimer’s disease, Parkinson’s disease or stroke, may be unreliable. These trials constitute the majority of the evidence base for agents used to treat osteoporosis in these particular population groups.”

“The strength and consistency of the different statistical analyses, which showed that the baseline data for the randomised treatment groups presented in the papers were strikingly similar, and not consistent with the treatment groups being formed by chance (i.e., that randomisation took place). But there were a large number of red flags in the studies (the remarkable productivity of the small research group, their very high recruitment and retention rates of frail elderly patients with high rates of comorbidities, the consistently large reductions in hip fracture rates from many different agents in their trials that were inconsistent with results from trials for the same agents conducted by other groups, and the concerns identified about ethical oversight, plagiarism, and logical and other errors in the papers).”

“We presume that the authors’ institutions are carrying out investigations into the reliability of the trials. To date, 12 articles and letters have been retracted. We think it very important that the integrity of each of the remaining unretracted trials in the dataset is investigated. In addition, there are also 32 animal trials where Dr. Sato is a co-author, and numerous publications of other study designs such as cohort and cross-sectional studies of modest size, where Dr. Sato is first author. We think it is also important to know whether the data in these papers are reliable, and whether honorary authorship also occurred in these studies, as mentioned in all the retraction notices to date. We are waiting to hear the outcome of the institutional investigations.”