美國官方拒絕調查方舟子對肖氏手術的質疑

弱明　刊發時間：2010-10-20  　光明網

http://topics.gmw.cn/2010-10/20/content_1323371.htm

    日前，幾位網友在互聯網上發帖指出，美國健康和人力資源部（NIH）的科研誠信辦公室（ORI）曾于2010年3月15日拒絕對方舟子有關肖氏手術的置疑進行調查，原因是舉報信中缺少材料證明肖氏手術研究中存在學術不端行為、手術對病人的處理有違規之處，以及超出美國健康和人力資源部（NIH）管轄權限等原因。

    附：以下是網友公布的美國健康和人力資源部（NIH）給予的英文回復信函原文及其中文譯文。

原文

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.

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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. Director 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.

美國健康和人力資源部的科研誠信辦公室拒絕對方舟子有關肖氏手術的置疑進行調查

美國的健康和人力資源部的科研誠信辦公室 (以下稱ORI) 對一封質疑肖氏手術的公開信做出了答復。ORI拒絕對此質疑作調查的原因是缺乏特定的指控和管轄權。下面是落款于2010年３月15日的答復信的全部內容。

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美國健康和人力資源部的科研誠信辦公室(ORI) 的調查科 (DIO) 于2010年３月１日收到了你們的來信和附帶的材料。在信中你們對于一個由肖傳國醫生首先描述的用于治療脊髓損傷和脊柱裂病人神經源性膀胱的手術表達了擔心。你們提供的材料質疑了肖醫生及其同事所開展的手術的程度和對很多病人進行長期隨訪的質量同時認為他們夸大了該手術的成功率。你們的材料也注意到了肖醫生在回到中國前也就是在紐約大學任職期間和William Beaumont 醫院研究所的醫生得到了美國國立衛生研究院（以下稱NIH) 的資助用以為脊柱裂 (spina bifida) 患兒開展類似的神經通路重建手術從而評估該手術的有效性和安全性。

在審閱了你們的材料后，DIO決定無法幫助你們。有幾個原因使我們做出這樣的決定。　首先幾乎所有接受該手術的病人都在中國，美國的ORI沒有管轄權去介入調查[腳注]。是的這個在美國紐約大學和William Beaumont 醫院研究所開展的手術在一定程度上接受了NIH的資助。但是在他們的基金申請書中點明了這個實驗性手術存在的高風險。該臨床研究的目的就是為了對該手術的安全性和有效性作出評估。在所提供的預實驗的結果中證明他們的手術可以為一些極端危重的病人提供幫助－利遠大于弊同時他們也按要求恰當的討論了該手術的風險和益處。而長期隨訪的結果將會有助于決定在更多病人開展此類手術的可行性。

更重要的是對我們辦公室來說你們提供的材料缺乏特定的指控來證明他們在NIH資助的科研活動中存在不端行為，也就是說證明某個人存在明顯的有意的剽竊或數據造假行為。只是空泛的說這個手術在中國看起來無效并不足以證明他們在NIH資助的課題中沒有給病人提供適當的看護也不足以證明他們術前沒有給病人適當的解釋這一手術的益處和潛在的風險。我也希望指出看起來對這一手術的有效性的爭議起碼部分基于對構成成功的要素所持的誠實的不同看法。

感謝你向ORI表示你的關心。但是基于上述原因我們目前無法幫助你。

John E. Dahlberg, Ph.D. 科研誠信辦事室調查科主任

[腳注] 要ORI 具有管轄權指控必須滿足在42C.F.R.93.103中對科研行為不端下的定義并且所質疑的研究必須是由公共健康服務下屬機構（如NIH）資助的。

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