Saturday, March 20, 2010
ORI Declines to Investigate Claims against Xiao Procedure
The Office of Research Integrity of Department of Health and Human Services responded to the open letter concerning Xiao Procedure. It declines to investigate citing lack of jurisdiction and absence of specific allegations. Here is the response letter in its entirely, dated March 15, 2010:
The Division of Investigative Oversight (DIO) of the Office of Research Integrity (ORI) has received your letter of March 1, 2010, and additional documentation describing concerns over a controversial procedure first described by Dr. Chuan-Guo Xiao to treat neurologenic bladder in subjects with spinal cord injury (SCI) or spina bifida. The material you provide raises concerns about the extent and quality of long-term followup of the many subjects that Dr. Xiao and his colleagues have operated on in China and suggests that the high success rate that he and others have claimed of this procedure (the "Xiao Procedure") has been overstated. This material also notes that Dr. Xiao, while working at New York University prior to his return to China, and others at the William Beaumont Hospital Research Institute, have received funds from the National Institutes of Health to conduct clinical trials to test the safety and efficacy of similar nerve re-routing procedures in children with spina bifida.
After reviewing your concerns, DIO has determined that this office cannot assist you. There are several reasons for this determination. Nearly all of the patients who have received this surgical procedure are in China and ORI does not have jurisdictional authority to intervene.[footnote] The procedure as practiced in the United States has to some extent been funded by PHS funds at NYU and the Beaumont Hospital Research Institute. However, these grant applications clearly identify the procedure as experimental and high risk, and as safety and efficacy trials. The preliminary results of the pilot studies described in the applications are described as providing some benefit for otherwise extremely compromised patients, and the risks and benefits are adequately described. Long term follow-up results will have an impact, when available, on determining the viability of the procedure for more patients.
More important for this office is the absence of specific allegations of possible research misconduct in NIH funded research that are suitably specific to claims that could be shown to be significant and intentional falsification or fabrications of data that could be ascribed to specific individuals. Broad claims that the procedure has been shown to not work in China are not sufficient to establish that appropriate care has been taken in NIH funded research to ensure appropriate care of subjects, and that the risks and possible benefits have been appropriately explained to patients. I also wish to point out that it seems likely that the conflicting opinions on the efficacy of this procedure may, at least in part, be due to honest differences of opinion in what constitutes therapeutic success.
Thank you for raising your concerns with ORI. However, as noted, we are unable to assist you at this time.
John E. Dahlberg, Ph.D.
Division of Investigation Oversight
Office of Research Integrity
[footnote] For ORI to have jurisdiction, allegations must meet the definition of research misconduct at 42 C.F.R. 93.103 and the questioned research must be supported by funds from Public Health Services agencies such as the National Institutes of Health.