CANTON, MA--(Marketwire - Oct 9, 2012) - An unprecedented "Expression of Concern" editorial by The Journal of the American Medical Association (JAMA) cites Harvard Professor Douglas P. Kiel for nondisclosure of important information during the peer review process for an article on hip protectors that JAMA published in 2007. In the editorial, JAMA Editor in Chief Howard Bauchner details the findings of the United States Office of Human Research Protection (OHRP), which cited Kiel and other researchers for failure to disclose potential harm to subjects that came to light during the hip protector study. Despite these findings and additional information offered to JAMA about conflict of interest and fraud, JAMA states that it is taking no further action at this time.
Hip protectors are underwear with pads covering both hips designed to prevent fall-related hip fractures. Numerous studies indicate that hip protectors can be highly effective in reducing hip fractures in nursing home residents. Kiel studied a hip protector that padded only one hip in the hope of seeing fewer fractures on the side with the pad in this federally funded $8.5 million study of over 2000 nursing home residents. The operating hypothesis of the study was that people fall with equal frequency to the right or left side. Early in the study, data was developing showing that residents were falling to and fracturing the padded hip side with twice the frequency of the non-padded side. Halfway through the five-year study, several data sets of statistical significance confirmed that the single pad was causing an unsteady gait in these frail elders, contributing to the lopsided falls to the padded side: Yet Kiel suppressed this data and did not disclose it to the study safety oversight boards or the nursing home residents in the study.
During the JAMA peer review process, the foremost concern of the JAMA editor was the possibility that the single padded undergarments were altering the gait of the residents. Despite having several statistically significantly data sets that confirm the lopsided falls, Kiel responded that they had no information on this issue. The article was published in 2007 with the conclusion that all hip protectors are ineffective.
In 2008 HipSaver Inc., a hip protector manufacturer, sued lead author Douglas Kiel for product disparagement because of this over-generalized conclusion. During court-ordered discovery, numerous documents came to light that revealed that the study was plagued with fraud, conflict of interest, data manipulation and deliberately suppressed information. Ed Goodwin, president of HipSaver Inc. provided the documents relating to risk of harm to OHRP and requested an investigation. Goodwin assisted OHRP at points during their investigation. Goodwin's request resulted in the OHRP's finding of noncompliance with federal regulations which forms the basis of JAMA's "expression of concern."
"OHRP did a thorough investigation on this case and acknowledged that my input was critical in reaching their conclusions," states Ed Goodwin. "I extended to JAMA editor Dr. Bauchner the same assistance I gave to OHRP but on the issues of conflict of interest and fraud that are more pertinent to a retraction of the article. Dr. Bauchner did not respond to me. Instead, JAMA has whitewashed the OHRP findings with this watered-down and inadequate 'expression of concern.' JAMA's decision not to retract this study flies in the face of their much touted vetting and rigorous peer review claims."