I will be commenting all in English in brackets (“[]”) throughout the daft, to avoid the hassles to switch back and forth between the language settings.

An Open Letter to Patients, NIH, PIs, and IRBs – “Xiao Procedure” is unsafe and inefficacious (Draft) [The word “complaint” would be more forceful only when the ones who complain have been directly at the receiving end. Otherwise, it’s equivalent to “whining”.]
We are concerned [write either “are concerned” or “have been concerned”. This illiterate procedure “concerns” reasonably well-informed patients and people with proper academic trainings. The latter “are concerned”. You do not have intention to “have concerned” somebody.] about the so called "Xiao Procedure" [This procedure has been defined and unique, therefore the word “procedure” should be initial capitalized.] and have been paying close attention to this procedure since it was initially touted by Dr. Xiao Chuanguo himself on the internet incognito in XXXX. We are concerned about the safety and wellbeing of the potential subjects.
We are united by the New Threads website (xys.org) founded by Dr. Fang Shimin, better known by his penname Fang Zhouzi in China and overseas Chinese communities. Dr. Fang and the New Threads [New Threads is a domain name. An article is called for whenever it is mentioned.] are committed to fighting against China's academic corruption, plagiarism, and misconducts for a decade (see the enclosed list of reports from well-known English media, [I still don’t get it. Fang’s contribution to human beings is not defined by this single article titled “Lie Detector” with a catchy title.). Among nearly 1,000 cases that the New Threads has exposed is Dr. Xiao Chuanguo's academic misconducts, his questionable surgical procedure, which recently drew the attention of Chinese lawyers and media (see the enclosed English translation of the reports), whose investigations further discovered even more startling facts about the "Xiao Procedure" ("artificial somatic-autonomic reflex arc", or "nerve rerouting procedure”).
We summarize as follows what the New Threads, the lawyers and the reporters have discovered about Dr. Xiao, his procedure, the implementation of the procedure in China, and the clinical trials in the United States, to bring to the attention of the National Institutes of Health (NIH) who funds the trials, the principal investigators, the institutional review boards (IRBs) of the hospitals where the trial will be conducted, as well as patients who may be lured into this highly questionable procedure.
1. An independent investigation by pro bono lawyers has not been able to identify or confirm a single success case of the “Xiao Procedure”. Instead, the investigation has discovered numerous cases of severe side effects. The lawyers have collected a contact list of 110 patients who were put through the “Xiao Procedure” at Shenyuan Hospital in China between August 2006 and March 2007 [the shorter the better] (note that the number of patients at the Shenyuan Hospital in 2006 was around 100, according to the official source of the hospital), and managed to interview 74 of them by telephone. The lawyers found that 73% of the patients who were through the procedure to be of no effect, and 39% of the patients developed various degrees of complications after surgery, including weakness, atrophy, deformity and lameness in lower limbs.
2. These patients themselves eventually realized that none of them was cured by the Xiao procedure as advertised by Dr. Xiao, by contacting each other who were hospitalized over the same period. Two patients have launched lawsuits against Shenyuan Hospital, and more will follow. The patients complained that they had been misled by the "85% success rate" advertised by Dr. Xiao at various occasions, without knowing that the procedure had caused serious side effects. The local private for-profit hospital, Shenyuan, of which Dr. Xiao owns 30% of its shares, has been dissolved as per Dr. Xiao's instruction, shortly before the litigation started.
3. The exemplary case frequently cited by Shenyuan Hospital and Dr. Xiao as proof of the success has turned out to be orchistrated hype. Little Shanshan, the very first patient Dr. Xiao “cured” at Shenyuan Hospital, has been widely propagated as a smashing success over the years by Dr. Xiao and some news media, inspiring hundreds of patients for this procedure. However, Little Shanshan, who was frequently reported of having "gotten rid of diapers and catheters", was finally found to have never gained the ability of voluntary voiding, other than developed a limping gait. His mother further revealed that doctors had him drink excessive amount of water whenever there were media coming to visit, and used electric stimulus to help him urinate.
4. An official document claiming an 85% success rate [please note, this Xiao-friendly-media-touted percentage is even higher than the 80% success rate touted by Dr Xiao’s self-claimed 80% success rate] was proven to be a complete fabrication. Shenyuan Hospital signed off on a certificate of cure rate for Dr. Xiao for his application for a seat in the most prestigious Chinese Academy of Sciences (CAS), claiming that the hospital had applied this procedure to 117 patients since January 2006, "sixty cases were followed up for more than 8 months, 85% of the patients have recovered normal bladder and bowel functions." However, the hospital did not come into existence till August 2006 and conducted its first operation on Little Shanshan on August 13, 2006. Less than 7 months later on February 28, 2007, the hospital fabricated document claiming "more than 8 months" follow-ups.
5. Members of an expert panel revealed the true story behind the initial evaluation of the “Xiao Procedure”. The panel, organized by the Ministry of Health of China, practically rubber-stamped on the decision based on the partial information selectively presented to them, the name-recognition of Xiao's adviser, Xiao's self-claimed fame abroad, and Xiao's self-claimed success rate alone. The evaluation panel eventually determined the procedure to be "world advanced", which was frequently advertised by Shenyuan Hospital later on. On the other hand, another critical opinion from the panel has never been disclosed to the public and potential subjects:"(this procedure) carries very high risks."
6. Top experts in China have expressed their concerns over the lack of scientific basis of the procedure and the unethical practice without adequate and proper clinical trials. One of the experts examined the urodynamic diagrams presented in Dr. Xiao's publications and found that the urination of some “successful” patients actually have benefited from the intra-abdominal pressure instead of the detrusor pressure, suggesting the failure of recovery of neurological function of the bladder after surgery. The experts also suspected that the improvement of voiding functions in some patients might be the effects of conventional surgeries conducted simultaneously or subsequently, such as detethering, selective sacral rhizotomy or electric stimulus, rather than that of the Xiao Procedure itself. For example, the girl who was reported by Dr. Xiao at SIU 2009 "gained complete bladder control in 5 months" after surgery, reportedly had very severe scar tissue in her gunshot wound, which is exactly the indication of detethering. Unfortunately, there is so far no controlled study, either by Dr. Xiao or a third-party, after the procedure has long been implemented by Dr. Xiao in his associated hospitals, for a profit of 30,000 RMB (4,400 USD) per patient.
7. Dr. Xiao has long been untruthful about or exaggerating his works. Just to mention a few: He had lied about winning the America Urological Association (AUA) Achievement Award in his resume, which was exposed by Dr. Fang along with Dr. Xiao's other misconducts. Dr. Xiao subsequently sued Dr. Fang for libel nearly 10 times, using his vast fortune that he earned from the above mentioned “worldly novel procedures” and “prestigious overseas awards”. Dr. Xiao won one of the 10 cases in his hometown, Wuhan, and the court ruling was based on the following findings, which became a joke teeming Chinese internet forums: "The fact that the defendant Fang could not find the plaintiff's name on the list of award winners can not deny the fact that the plaintiff won the award. Therefore, it is an established fact that the plaintiff has won the AUA Award." Another example is that the expert panel who once evaluated the “Xiao Procedure” were told that the procedure had been well recognized internationally. What they were not told was that Dr. Xiao's publications were seldom cited by peers; and at time, his procedure was not recognized even by his employer, who "discriminated against him ... by terminating his employment as a research director; by forcing him to work in a laboratory that was used for the storage of paint, tiles, and windows", as disclosed in a summary order from a U.S. Court of Appeals.
8. The clinical trials in the U.S. are based on dubious information. The key data were all originated from Dr. Xiao's claims at a conference, which have never been published on any peer-reviewed journals. This nonexistent report was cited in his review article in European Urology, and the latter became the major reference of the U.S. trials. Comparing to the information from other sources, the success rate and the number of patients in the report are suspicious. Moreover, in a press release, William Beaumont Hospitals, who started the clinical trial in the U.S. in December 2006 (Identifier: NCT00378664) and obtained a grant from the NIH in December 2009 (Project Number: 1R01DK084034-01), reiterated Dr. Xiao's "almost 90-percent success rate" and the understated risks, indicating that the trial at Beaumont was solely based on Dr. Xiao's own assertion without any independent verification. Furthermore, doctors at the All Children's Hospital (ACH) mis-labled the trial as "double-blind", indicating either that they lacked the understanding of the basic principle of clinical trials, or they (or Dr. Xiao himself) had no knowledge of the indications of the “Xiao Procedure”, and the special pre-, intra- and post-operative care of the patients who receive the procedure, at least until the trial began in March 2009.
9. The outcomes of clinical trials outside China have not been nearly as "promising" as Beaumont Hospitals claimed. First, the NIH sponsored trial (Grant Number: 5R01DK053063) on spinal cord injury (SCI) conducted by New York University (NYU) from 1999 to 2006 has so far no official outcomes published, except for a conference abstract that reported 2 cases with much worse result comparing to Dr. Xiao's own (mean PVR=200 cc in NYU's report vs. 31 cc in Dr. Xiao's first 15 SCI patients, for example). We have noticed that the number of patients that should have been recruited was said to be 40. Second, the information presented in Beaumont's 1- year report on spina bifida (SB) cases were selective and rather vague. There was no mention of the SCI cases, although the purpose of the trial was initially for both SCI and SB (see ClinicalTrials.gov registry), and its first procedure was for SCI, which "garnered national attention and appeared in more than 160 news outlets" (see Beaumont's website). There was no pre- and post-operative comparison, which is essential to and mandated for a clinical study report. The mean and standard deviation of postoperative urodynamic data were much worse than what Dr. Xiao has claimed ( mean PVR=119 cc in Beaumont's report vs. 23.67 cc in Dr. Xiao's first 20 SB patients, for example), which invalidated his claims to some extent. The side effect data were also understated. Third, according to Dr. Xiao's presentation at SIU 2009, 6 cases of SCI in Germany all failed ("only 2 showed some improvement"). Meanwhile, according to the media, all 3 patients with SCI at Beaumont were also "not helped by the procedure". Statistically, the failure of all third-party SCI cases may proclaim the failure of the principle of the Xiao procedure, especially considering that the "success" of Dr. Xiao's very first human trials and animal studies were published on SCI journals, for which Dr. Xiao have been rewarded. The recent NIH-funded trial was entitled "Safety and Efficacy of Nerve Rerouting for Treating Neurogenic Bladder in Spina Bifida" without mentioning SCI, which may speak for itself. [Yush you may want to work on this. I don’t see how SCI played into the plot so far.] Finally, Dr. Xiao blamed the failure of SCI cases to "incorrect patient selection" and "inappropriate postoperative care". The former indicates, at least in part, the "success" of Beaumont's SB patients was due to "extensive preoperative evaluation" (see Beaumont's one year report); the latter contradicts the "success" of Beaumont's SB patients who should have received the same postoperative care.
10. Beaumont Hospitals propagated the myth of the “Xiao Procedure” to potential patients. In response to patients' inquiries, Beaumont repeatedly gave false information, apparently from Dr. Xiao, that the procedure is "now standard of care" in China and is "done everyday in hospitals in China". The fact is that the procedure has never become standard of care in China, whereas Shenyuan Hospital was the only hospital who had performed the surgery in recent years, and Dr. Xiao's team is the only one who has the ability to perform the surgery. Furthermore, Beaumont suggested the patients going to China for the surgery, in spite of that fact that the surgery is still under trial in the U.S. and the "results are too immature". Beaumont's indiscreet reference might have resulted in serious consequence: more than 90 U.S. patients had been "successfully treated" by the procedure, as announced by the website of Dr. Xiao's Chinese Journal of Clinical Urology; and each foreign patient was charged about 20,000 USD, as disclosed online by a patient.
Based on the aforementioned facts, we hereinafter provide our suggestions to the NIH, the IRBs and the releated hospitals, as well as to patients and the media.
1. We demand that the NIH and the IRBs review their determinations regarding the clinical trials of the “Xiao Procedure”, by independently re-investigating the 15 SCI and 20 SB cases published in the Journal of Urology 2003 and 2005, the unpublished 92 SCI and 110 SB cases cited in European Urology 2006, and the 1406 cases since 2006 at Shenyuan Hospital presented at SIU 2009, all by Dr. Xiao, along with the more than 90 U.S. cases treated by Dr. Xiao, the 6 cases in Germany, as well as the 12 cases at Beaumont and the 8 cases at ACH. Dr. Xiao should have the obligation to present detailed original clinical data of his cases, and the lawyers in China would be more than willing to provide their detailed investigation report of 110 (and more now) patients.
2. We urge that the related hospitals terminate the trials. Instead of recruiting new patients, we suggest that the hospitals thoroughly examine the cases already conducted by themselves and Dr. Xiao. Considering the following claims "in China rigorous follow up is challenging" (see Beaumont's project description at the NIH website), we particularly suggest that Beaumont Hospitals help Dr. Xiao conduct the follow-ups of his 90 US. patients, rather than conduct further trials. The follow-ups should be funded by Dr. Xiao himself instead of the NIH. For Beaumont's effort of referring patients to Dr. Xiao, Beaumont deserves to take a percentage of nearly two million dollars that Dr. Xiao colleted from those patients, for the follow-ups.
3. We remind the NIH and the related hospitals that the undergoing clinical trials in the US. has been distorted by Dr. Xiao in China as the "success of the NIH approved clinical implementation", which may lure more patients into a devastating uncertainty of their safety and wellbing.
4. We advise patients to think it over when considering participating in this clinical trial or to go for the claimed cure in China. We encourage patients who already received this procedure to come forward just like the patients in China, to tell how they fare, for the wellbeing of themselves and of others. Meanwhile, we suggest that the media listen to patients, instead of solely listening to Dr. Xiao's propaganda and the sale pitches by the hospitals that Dr. Xiao has vested interests in.

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