改的地方用*标了一下。供参考。

An Open Letter Concerning the Safety and Wellbeing of Patients Involved in the “Xiao Procedure” and Its Clinical Trials(Draft)
We are a group of volunteers concerned about the safety and wellbeing of future potential subjects involved in the “Xiao Procedure” and its clinical trials. We are united by the New Threads website (xys.org), founded by Dr. Fang Shimin, more well known by his penname Fang Zhouzi. Dr. Fang and the New Threads are* committed to fighting against China's academic corruption, plagiarism, and frauds, and have been doing so* for a decade (please refer to the attached reports published in English). Among nearly 1,000 cases that the New Threads has exposed is Dr. Xiao Chuanguo's academic misconducts and his questionable surgical procedure, which recently drew attention from Chinese lawyers and the* media (please refer to the attached reports), whose investigations discovered even* more startling facts about the consequences that (cancelled) *patients have suffered from the so called “Xiao Procedure” ("artificial somatic-autonomic reflex arc", or "nerve rerouting" procedure).

We have summarized as follows what the New Threads, lawyers, and reporters have discovered about Dr. Xiao, his procedure and the human tests he has conducted in Chinese patients without their *properly-*informed consents, to bring to the attention of the National Institutes of Health (NIH), and the Institutional Review Boards (IRBs).
1. An independent investigation by pro bono lawyers has confirmed that the so called “Xiao Procedure” has not generated a single case of “success” as Dr. Xiao has* claimed to Chinese and overseas media. Instead, the investigation has revealed* numerous cases of severe side effects. The lawyers contacted 110 patients who underwent “Xiao Procedure” at Shenyuan Hospital between August 2006 and March 2007, and interviewed 74 of them by telephone. The lawyers found that 73% of patients considered the procedure to be of no effect, and 39% of patients developed various degrees of complications after this procedure, including weakness, atrophy, deformity and lameness in lower limbs.
2. Patients themselves eventually realized that none of them was cured by “Xiao Procedure”, by contacting others* who were hospitalized over the same period. Two patients have launched lawsuits against Shenyuan Hospital, and more may follow. The patients claimed that they were misled by the widely advertised "85% success rate", while* the procedure proved to be ineffective, *and also leading to* serious side effects. The local private for-profit hospital, Shenyuan Hospital, *of shares* which Dr. Xiao owns 30%, 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 the poster child of this procedure, has turned out to be a scam. Little Shanshan, the very first patient underwent the knife by Dr. Xiao himself at Shenyuan Hospital, has been widely propagated as a smashing success over the years, inspiring hundreds of patients to sell much of everything in their possession for the money for this procedure. However, Little (shanshan or shanhan?)Shans*han, who has been frequently reported of *having gotten rid of diapers and catheters, was finally found to have never gained the ability to urinate on his own, 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 that he was under electric stimulus to urinate for the cameras.
4. An official document frequently cited by Dr. Xiao and his camp claims the 85% success rate was proven a complete* fraud. Shenyuan Hospital signed a certificate of the* cure rate for Dr. Xiao for his application for the prestigious Chinese Academy of Sciences (CAS) grant, claiming that the hospital had applied the procedure to 117 patients since January 2006,. Apparently*,"Sixty cases were followed up for more than 8 months, and* 85% of the patients have recovered normal bladder and bowel functions." However, this hospital did not come into existence until August 2006 and did not conduct its first operation (on Little Shanshan) until the 13th [which month?]. Less than 7 months later, on February 28, 2007, the hospital fabricated the document stating "more than 8 months" follow-ups.
5. Members of an expert panel revealed the true story behind the initial evaluation of “Xiao Procedure”. The panel, organized by the Ministry of Health of China, practically rubber-stamped and endorsed the cherry-picked information, based on 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 that* has never been disclosed to the public reveals*: "(the 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 such expert* examined the urodynamic diagrams presented in Dr. Xiao's publication* and found that the urination of some successful patients were* actually caused by benefits* 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 suspect* that the improvement of voiding functions in some patients might be the effects of detethering, selective sacral rhizotomy or electric stimulus, rather than that of “Xiao Procedure”. For example, as reported by Dr. Xiao at SIU 2009, the girl who "gained complete bladder control in 5 months" after surgery had very severe scar tissue in her gunshot wound, the exact* indication of detethering. Unfortunately, there is no controlled study as of yet, both* by Dr. Xiao or a third-party, after the procedure has long been implemented by Dr. Xiao in his vested 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 Achievement (AUA) Award in his resume, which was exposed by Dr. Fang along with Dr. Xiao's other misconducts. Dr. Xiao has sued Dr. Fang repeatedly for libel for 10 times, and won one case in a local court, based on the following court findings, which became a source of humour teeming* Chinese internet forums: "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 “Xiao Procedure” were told that the procedure was well-recognized internationally. What they were not told was that Dr. Xiao's publications were seldom cited by peers; and at the time, his procedure was not recognized even by his employers, who disapproved of* him ... by terminating his employment as a research director; (cancelled) 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 (cancelled) all originated from Dr. Xiao's conference report, which* has never been published. This* nonexistent report was cited in his review article in European Urology, and the latter became the major reference of the U.S. trials. After* comparing (cancelled) the information with* other sources, the success rate and the number of patients mentioned* in the report become* suspicious. Moreover, in a press release, William Beaumont Hospital, which conducted the first clinical trial in the U.S. in December 2006 and obtained research grant from the NIH in December 2009, reiterated* Dr. Xiao's "almost 90% success rate" and the understated risks, indicating* that the trial at Beaumont was solely based on Dr. Xiao's own claims. Furthermore, doctors at the All Children's Hospital (ACH) mislabeled 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 about the indications of “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 as "promising" as Beaumont claimed to the media. Firstly*, the information presented in Beaumont's 1-year report on spina bifida (SB) cases were selective and rather vague. There were* no mentions* of the spinal cord injury (SCI) cases, although the purpose of the trial was initially conducted* 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 were no pre- and post-operative comparisons, essentials* to a clinical report. The mean and standard deviation of postoperative urodynamic data were much worse than what Dr. Xiao has reported, invalidating* his claims. The side effects were also understated. Secondly*, according* to Dr. Xiao's presentation at SIU 2009, 6 cases of SCI in Germany (cancelled) 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 “Xiao Procedure”, especially considering that the "success" of Dr. Xiao's very first human trials and animal studies were all of SCI'e*. The recent NIH-funded trial (cancelled) entitled "Safety and Efficacy of Nerve Rerouting for Treating Neurogenic Bladder in Spina Bifida", did not mention that* SCI may speak for itself. Thirdly*, Dr. Xiao had* 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 1-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 “Xiao Procedure”. 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 has 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 that the patients go to China for the surgery, in spite of the fact* that the surgery is still under trial in the U.S. and that 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 related hospitals, as well as to patients and the* media.
1. We demand that the NIH and the IRBs revisit their decisions regarding the clinical trials of “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 is obliged 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 patients (more pending).
2. We also* urge that the involved hospitals terminate the trials. Instead of recruiting new patients, we suggest that the hospitals thoroughly examine the cases of patients already performed by Dr. Xiao and others. Considering "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 perform the follow-ups of his 90 U.S. patients rather than operating on more cases. 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 Hospitals deserve* to take a percentage of nearly two million dollars that Dr. Xiao collected from those patients, for the follow-ups.
3. We advise that patients should think it over properly* when considering participation* in the clinical trials or to go for the treatment in China. We encourage patients who already received the procedure to come forward just like patients in China, to tell how they fare, for the well-beings of themselves and of others. Meanwhile, we suggest that the media should listen to patients as well, instead of solely listening to Dr. Xiao's self-benefitting* propaganda.
Volunteers from New Threads
P.S.
We are sending this letter to the NIH and IRBs. Meanwhile, we send the letter through email to the researchers and doctors that are involved or concerned, as well as the media who have reported related issues based on the misleading or false information provided by Dr. Xiao or his associated hospitals. We welcome for* the letter to be posted on the internet, especially where the misleading or false information appears, so as to prevent patients from being taken advantage* of and cheated.
We do not disclose our identities to the public, in order to protect ourselves* from potential spite* from Dr. Xiao, who declared his "life goals being living-large, money, and revenge" in his recent talk at Tsinghua University. Dr. Xiao has explicitly threatened some of us on* various occasions before, and more recently, asserted in one of his internet posts that "I would not hesitate to avenge Fang Zhouzi in the most treacherous way".
This* letter and the enclosed documents are* publicly available at: