NIH Stops or Continues to Fund Xiao Procedure Trial?

By xysergroup | 8月 4, 2013

According to the recent update made by Beaumont Hospitals on Aug. 1, 2013, the NIH funded clinic trial “Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida” “has been withdrawn prior to enrollment” for the reason that “protocol as presented by investigator was not approved by the NIDDK”. Here we record the reactions from Fang Zhouzi and Xiao Chuanguo.

[1] Translation of Fang Zhouzi’s micro blog.

2013-8-3 09:00

The U.S. National Institutes of Health (NIH) has withdrawn the “Xiao Procedure” clinic trial, the reason is that “protocol as presented by investigator was not approved by the NIDDK (the funding agency)” http://t.itc.cn/mghCq. The Xiao Procedure trial in the U.S. comes to a dead end. Not long ago, Xiao Chuanguo still bragged on Southern Metropolis Daily that “the Xiao Procedure has been carried out in several universities in the U.S., with very good results. this is the only one surgery learned by U.S. from China.”

[2] Translation of Xu Peiyang’s blog (deleted under the pressure from Xiao Chuanguo)
National Institutes of Health (NIH) Withdrew “Xiao Procedure” Clinic Study

2013-8-3 09:23
On Aug. 1, 2013, National Institutes of Health (NIH) Withdrew the “Xiao Procedure” clinic study. The reason is “protocol as presented by investigator was not approved by the NIDDK.”
http://clinicaltrials.gov/archive/NCT01096459/2013_08_01/changes

[3] Translation of Xiao Chuanguo’s blog (ranked the top most of the Hottest ScienceNet Blogs, recommended by 44 persons)

The NIH Extends the Inclusion Criteria to Further Assess the Effectiveness of Xiao Procedure, Continues to Fund the Xiao Procedure Study

2013-8-3 13:54

Thanks Xu Peiyang for removing the blog post containing misleading information. I was at first reluctant to waste time to talk about it before the US results being officially published.

The truth is:

http://www.clinicaltrials.gov/ct2/results?term=rerouting

1. The NIH has determined that Xiao Procedure is safe, therefore the safety assessment of the original study [translator’s note: from the context, “the original study” refers to NIH sponsored NCT01096459] would no longer be needed.

2. The NIH has determined that, so far the amount of SB cases and the results of Xiao Procedure can sufficiently draw statistical conclusions, so that this study does not need to increase the number of cases (otherwise there would be another 3 years of delay to complete the study). Therefore, the NIH has withdrawn the original plan funding 15 more cases, but instead continues to proceed and to fund the study in the name of the current title and contents [translator’s note: from the context, “the current title and contents” refers to that of 2006 study NCT00378664].

3. The NIH has determined in principle the efficacy of Xiao Procedure on the bowel and bladder disorders caused by spina bifida, and requires the new study [translator’s note: from the context, “the new study” refers to NCT00378664] to add research to further assess the level of improvement of Xiao Procedure on urinary incontinence caused by SCI and other diseases. (level of improvement, note: not to assess whether or not effective, but the level of improvement)

It’s realy funny to look at those clowns and Fang Zhouzi barking on the “withdraw”. After I first saw this on the microblog this morning, I deliberately waited for and finally saw Fang Zhouzi jumped into the mud :-) This Dr. Plagiarism who lives on Baidu [translator’s note: the predominate Chinese search engine], actually too stupid to understand even basic medical search.

[translator’s note: omitted the following the screen shot of the NCT00378664 web page http://clinicaltrials.gov/ct2/show/NCT00378664]

Topics: Xiao Chuanguo, Nerve rerouting | No Comments »

Xiao Chuanguo Fabricates and Falsifies Clinical Data

By xysergroup | 11月 15, 2010

Xiao Chuanguo published two papers on his clinical trials of his procedure in the Journal of Urology. Before the papers published, he also published related results in conference abstracts, articles in Chinese and other reports in Chinese. By comparing the results in the two papers with that from other sources, we demonstrate that Xiao fabricated and falsified his data.

Read the rest of this entry »

Topics: Xiao Chuanguo | No Comments »

Science: Questions from China Snag U.S. Trial of Nerve-Rerouting Procedure

By xysergroup | 11月 4, 2010

The following is a Science report in “Research Ethics,” published on it’s 11/5 edition. A Chinese version is also available here.

Questions From China Snag U.S. Trial Of Nerve-Rerouting Procedure

HAO XIN
SCIENCE VOL 330 5 NOVEMBER 2010 Published by AAAS

(Photo) Under fire. Xiao Chuan-Guo’s reports of success in treating spina bifida patients have been challenged by Chinese critics.

A running 5-year medical brawl in China has spilled over into Michigan, where it has delayed a clinical trial about to enroll patients. The trial, based at the William Beaumont Hospital in Royal Oak, Michigan, aims to surgically reroute the nerves of spina bifida patients to give them control of their bladder. Principal investigator Kenneth Peters confirmed last week that the U.S. National Institutes of Health (NIH)—which is funding the work—has asked for a review.

Read the rest of this entry »

Topics: Xiao Chuanguo | No Comments »

OHRP Responds to Open Letter on Xiao’s Procedure

By xysergroup | 10月 22, 2010

Back in March, we sent an open letter on Xiao’s Procedure, with supporting material, to several government offices and related hospitals. Of them, the Office of Research Integrity of Department of Health and Human Services, had previously responded to decline an investigation.

Today, an email arrived from a different office, the Office for Human Research Protections, indicating that they are taking actions on this issue:

Read the rest of this entry »

Topics: Xiao Chuanguo | 1 Comment »

Beaumont Hospital’s Results of Xiao Procedure Questioned by Peer Experts

By xysergroup | 8月 18, 2010

The Beaumont Hospital in Michigan is one of the first American institutes that took up clinical trials of the controversial Xiao Procedure. We have previously questioned their clinical outcomes and their misleading propaganda in our Open Letter of Complaint against the Xiao Procedure.

More recently, the hospital has also become the first institute to publish clinical results of Xiao Procedure in an established scientific journal. Dr. Kenneth Peters and his coauthors wrote in the Journal of Urology of their results:

Read the rest of this entry »

Topics: Xiao Chuanguo, Nerve rerouting | 12 Comments »

Experts’ Opinions on Xiao Procedure

By xysergroup | 8月 18, 2010

The Xiao Procedure has been questioned by top experts in China. Below are the experts’ opinions excerpted and translated from Chinese media reports.

Read the rest of this entry »

Topics: Xiao Chuanguo, Nerve rerouting | 1 Comment »

ORI Declines to Investigate Claims against Xiao Procedure

By xysergroup | 3月 20, 2010

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.

Read the rest of this entry »

Topics: Xiao Chuanguo | No Comments »

Xiao Procedure Trials in SCI outside China

By xysergroup | 3月 13, 2010

Listed below we summarize the facts regarding the clinical trials of the Xiao Procedure in patients with spinal cord injury (SCI) in the US and Germany. Some of the facts have already been included in the Open Letter of Complaint against the Xiao Procedure, others were recently found. We note that the SCI cases conducted by third parties all failed.

Read the rest of this entry »

Topics: Xiao Chuanguo | 2 Comments »

The Story of First Patient of Xiao Procedure Trial at Beaumont Hospitals

By xysergroup | 3月 9, 2010

The following are the story of one of the first patients of the Xiao Procedure trial conducted at  Beaumont Hospitals in December 2006, told by media reports, TV show, and mostly the patient and his mother’s web posts on the CareCure Forums. According to Beaumont, and indeed, ”the first procedure garnered national attention and appeared in more than 160 news outlets”.

For the situations of other SCI patients of the clinical trials outside China, please see the Open Letter against Xiao Procedure, or see Slide 80 of Xiao Chuanguo’s presentation at SIU 2009 and the report from St. Petersburg Times.

Read the rest of this entry »

Topics: Xiao Chuanguo | 2 Comments »

Daily Kos Reviews History of Xiao Procedure

By xysergroup | 3月 4, 2010

Daily Kos recently published a run-down on the history of Xiao Procedure with the alarming title “What unregulated medicine looks like“.

Drawing directly from media sources in Chinese, notably the Science News reports (sn1 and sn2) previously translated by the New Threads Volunteers, the article’s author xgz recounted the case and asked “Do we want that kind of health care in the US?”

 

Topics: Xiao Chuanguo | 1 Comment »

« Previous Entries