Evidence of Fraud Discovered in 33 Medical Studies

Researchers discovered evidence of scientific misconduct in 33 published papers related to bone health using statistical analysis, according to a new paper published in the Journal Neurology.

Mark Bolland, an associate professor at the University of Auckland, led the team that made the findings.

"Our use of statistical methods to examine the integrity of the data in 33 randomized controlled trials raises serious concerns about the reported results in those trials," he said.

Most of the studies, 26 in total, came from a single researcher: Yoshihiro Sato from Mitate Hospital in Tagawa, Japan. Three of the studies analyzed were retracted from the journal this summer, when Sato acknowledged that he had committed scientific misconduct, according to a press release about the paper.

Bolland and his team decided to exam 23 other papers on which Sato was the lead author, as well as an additional seven studies related to bone health and fractures.

They found that the results diverged starkly from statistical norms. What made the results even more suspicious, however, is that they were all strongly positive.

Since there's an incentive for scientists to produce and publish impressive findings, the combination of highly significant results along with dubious statistical indicators suggests malfeasance.

"The researchers were remarkably productive, conducting 33 randomized controlled trials within 15 years, the outcomes of each being remarkably positive," Bolland said. "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."

There were several problems that the researchers found in the studies:

• The study groups were much more homogeneous than is likely to happen by chance.
• Large reductions in hip fractures were reported for every treatment.
• The results were consistently more impressive than similar studies.
• Text and data was duplicated in multiple trials.
• It's unclear there was ethical oversight of the studies.
• There were errors and inconsistencies in the data.

"This statistical analysis demonstrates probable scientific misconduct on a large scale," the journal's editor-in-chief, Robert Glass, explained in an editorial.

"Fraud in an individual paper may be difficult to detect. One cannot conclude that any one study in the analysis is, or is not, fraudulent," he said. "As part of our due process, we have notified other editors of journals that published papers by Sato and colleagues communicated with Sato's institution, and published retractions of the three papers and a letter published in Neurology."

Sato himself accepted responsibility for the first three papers retracted from the journal. He also said that his co-authors were only named in an honorary capacity and deserved no blame for his misconduct. Retraction Watch, a blog that examines related issues in academia and the research world, reported in July that Sato had a total of 10 retractions to his name at the point.

Bolland told Patch that his team's investigation began with a conversation in 2012 with his colleague Alison Avenell, who had previously found suspicious results in Sato's publications of clinical trials.

"Even a superficial viewing of several of the trials in 2012 raised a number of questions, so we decided to investigate further by systematically reviewing all the published trials of this group," he explained.

The team unearthed many more troubling features of the study in its research.

It's not clear entirely why Sato carried out scientific misconduct, if indeed he did, as Bolland and his team believe.

"We haven't had any contact with the authors, and the results of any investigations undertaken by the journals involved or the authors' institutions have not been shared with us," Bolland said. "So we do not know what the authors' explanation is. Apart from the academic prestige of publishing in high-impact international medical journals, we don't know of any conflicts of interest."

Patch reached out to Sato for comment, but he did not respond. This story will be updated with any response.

With the publication of the team's findings showing misconduct in many studies in addition to those published in Neurology, it's likely other journals will retract more of his papers.

Read the full study>>

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