An Open Letter of Complaint against the Xiao Procedure
February 25, 2010
We are a group of volunteers who are alarmed by the ongoing public misrepresentation and misinformation on an experimental surgical procedure invented by Xiao Chuanguo, M.D., from China. The procedure, sometimes referred to as "Xiao Procedure", is designed to treat neurogenic bladder due to spina bifida or spinal cord injury and has been undergoing clinical trials in China, United States, and a few other countries.
We initially learned about this procedure when Dr. Xiao was exposed for committing several academic misconducts on the New Threads (www.xys.org), a website that is committed to fighting against China's academic corruption, plagiarism, and fraud. In the last five years, we have been closely following the case and have become seriously concerned about the effectiveness of the Xiao procedure and the risks associated with it. Indeed, the problems of the procedure have recently drawn the attention of Chinese media, and extremely shocking findings have been published after investigations.
In this Letter, we summarize a few facts about the procedure below. We hope to bring them to the attention of the National Institutes of Health (NIH) who funds the trials, and the institutional review boards (IRBs) of the hospitals where the trials are currently undergoing, and any current or potential patients of the trials.
1. In China, an independent investigation by pro-bono lawyers has so far not been able to identify or confirm a single successful case of the Xiao Procedure. Instead, the investigation has discovered numerous cases of severe side effects. The lawyers collected a list of 110 patients who had undergone the procedure at Shenyuan Hospital in Zhengzhou, China, between September, 2006, and March, 2007, and interviewed 74 of them by telephone. They found that 73% of the patients reported that the procedure had produced no effect and 39% of the patients experienced various degrees of complications after surgery, including weakness, atrophy, deformity and lameness in lower limbs. Before the investigation, some of the patients who received the treatment together had already gotten in touch among themselves, and realized that there was no successful case among them.
2. Two victims of the Xiao Procedure have recently filed lawsuits against Shenyuan Hospital. We expect that more patients will follow. The patients claimed that they were misled by the widely advertised "85% success rate" of the procedure. Shortly before the litigation started, Shenyuan Hospital, a local, private and for-profit entity, of which Dr. Xiao owns 30% of the shares himself, was dissolved under Dr. Xiao's order.
3. Dr. Xiao's most famous case has since turned out to be all a hype. A boy by the nickname Little Shanshan was the very first patient treated by Dr. Xiao at Shenyuan Hospital. His "cure" was widely hailed in Chinese media and frequently cited by Shenyuan Hospital and Dr. Xiao himself as the proof of the success, inspiring hundreds of patients for the procedure. When investigators finally reached Little Shanshan, they found that he had never gained the ability of voluntary voiding but developed a limping gait. His mother revealed that Shenyuan doctors used to have him drink a lot of water and apply electric stimulus to help him urinate during demonstrations.
4. An official document testifying the "85% success rate" was discovered to be a fraud. On February 28, 2007, Shenyuan Hospital issued a certificate of cure rate when Dr. Xiao Chuanguo was applying to become a member of the prestigious Chinese Academy of Sciences (CAS). It claimed that the hospital had applied the 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 itself did not come into existence until August 2006 and only conducted its first operation on Little Shanshan on August 13 of that year. There was simply not enough time for it to have conducted a "more than 8 month" follow-up study.
5. The official appraisal of the Xiao Procedure in China was just a formality. A few members of an expert panel that evaluated the Xiao Procedure have since spoken out that they practically rubber-stamped their appraisal based on partial information selectively presented to them including the name-recognition of Dr. Xiao's advisor, Dr. Xiao's self-claimed fame abroad, and Dr. Xiao's self-claimed success rate. The panel determined the procedure to be "world advanced," which was frequently advertised by Shenyuan Hospital. On the other hand, another critical opinion from the panel has never been disclosed to the public: "(the procedure) carries very high risks."
6. The fundamentals of the Xiao Procedure is still in doubt. Top experts in China have expressed their concerns over the lack of scientific basis of the procedure and the unethical practices 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 patients was actually due to the 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 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 fee of 30,000 RMB (4,400 USD) per patient.
7. Dr. Xiao has long been untruthful about or exaggerating his works. In one instance, he lied about winning the America Urological Association (AUA) Achievement Award in his resume. He also claimed his work was well recognized internationally, despite the fact that his publications were seldomly cited by his peers. After such facts had been exposed on the New Threads, he filed about 10 lawsuits for libel against Dr. Fang Zhouzi, the owner of the website. Dr. Xiao also has a spotty personal record. For example, his employment at a research institute was once terminated prematurely, leading to a legal dispute in a U. S. Court of Appeals, which he lost. Another case in a civil court that involved a warden suggested that Dr. Xiao was once put in jail. He lost that case as well.
8. The current clinical trials in the United States are based on dubious data. The key data that these trials are based appears to be from a conference report by Dr. Xiao, which was cited by a review article by Dr. Xiao published in European Urology. However, this important conference report is in fact non-existent in the literature. Nevertheless, the review article became the major reference of the U.S. trials. Comparing to the information from other sources, the success rate and the number of patients cited in Dr. Xiao's article are very 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 claim of "almost 90-percent success rate," indicating that the trial at Beaumont was solely based on Dr. Xiao's own assertion without any qualification. Furthermore, doctors at the All Children's Hospital (ACH) mislabeled its trial as "double-blind", indicating that either they lacked the understanding of the basic principle of clinical trials, or they (or Dr. Xiao himself) had no knowledge about the indications of the Xiao Procedure and the special pre-, intra- and postoperative 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 were not "promising" as claimed by Beaumont Hospitals. Firstly, the NIH sponsored multi-million-dollar trial (Grant Number: 5R01DK053063) on spinal cord injury (SCI) conducted by New York University (NYU) from 1999 to 2006 has so far produced no official result, except for a conference abstract that reported two cases with results that are much worse than Dr. Xiao's (mean PVR=200 cc in NYU's report vs. 31 cc in Dr. Xiao's first 15 SCI patients, for example). Secondly, the information presented in Beaumont's one-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 should be essential for a clinical report. The mean and standard deviation of postoperative urodynamic data were much worse than what Dr. Xiao had reported (mean PVR=119 cc in Beaumont's report vs. 23.67 cc in Dr. Xiao's first 20 SB patients, for example), which should invalidate his claims to some extent. The side effects were also understated. Thirdly, according to Dr. Xiao's presentation at SIU 2009, all of the 6 SCI cases in Germany had 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 all of SCI. 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. 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 patients. In response to patients' inquiries, Beaumont repeatedly provided false information 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. In the more recent years, the now-closed Shenyuan Hospital was the only institute that performed this surgery. Dr. Xiao's team is so far the only one that performs it. Furthermore, Beaumont suggested patients going to China for the surgery, in spite of 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 consequences: 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 above facts, we wish to provide our following suggestions to the NIH, the IRBs of the related hospitals, as well as to patients and the media.
1. We appeal to the NIH and the IRBs to review their decision on clinical trials of the Xiao Procedure by independently and comprehensively 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 2 cases at NYU, 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.
2. We appeal the related hospitals to suspend the trials immediately, pending the review. We suggest that the hospitals thoroughly examine the cases already conducted by themselves and Dr. Xiao. Considering that "in China rigorous follow up is challenging" (see Beaumont's project description at the NIH website), we particularly urge Beaumont Hospitals to help Dr. Xiao conduct follow-ups of his 90 U.S. patients.
3. We caution the NIH and the related hospitals that the ongoing clinical trials in the United States have been distorted by Dr. Xiao in China as "the success of the NIH approved clinical implementation," and "all surgeries completely succeeded, astonishing the international medical communities," which may mislead more patients.
4. We advise patients to think twice when considering to participate in the clinical trials or to go for the treatment in China. We encourage patients who already received the procedure to come forward and report their status for the well-being of themselves and of others. Meanwhile, we suggest that the media should listen to patients as well, instead of relying solely on the stories put forward by Dr. Xiao and a few hospitals.
New Threads Volunteers
We send this letter to the NIH and the IRBs or the overseeing authorities through postal mail by our representative. 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. 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 misled or cheated when they eagerly search the web for a cure.
We do not disclose our identities to the public, in order to protect ourselves from retaliation from Dr. Xiao, who declared that his "life goals are welldoing, money and revenge" in his recent talk in Tsinghua University. Dr. Xiao has explicitly threatened some of us in various occasions before, and recently asserted in one of his internet posts that "I would not hesitate to avenge Fan Zhouzi in the most treacherous way".
To provide background information, we enclose a list of reports from prestigious English media, for a better understanding of the activities of the New Threads and Dr. Fang Zhouzi. We also enclose the English translation of reports regarding the Xiao Procedure from Chinese media and lawyers.
This letter and the enclosed documents are publicly available at:
http://xysblogs.org/wp-content/blogs/107/uploads/xpletter.html
For public and media inquiries, please send your emails to:
xysergroup @ gmail.com
or leave your comments on our blog at:
http://xysblogs.org/xysergroup/The Chinese translation of this letter and the original Chinese reports can be found at:
http://xysblogs.org/wp-content/blogs/107/uploads/xpletterc.htmlThis letter was drafted by Eddie and Yush. The following New Threads volunteers participated in the translation and proofreading of the enclosed documents: blobfish, Eddie, fuzzify, gadfly, james_hussein_bond, lightman, PoohHunny2, Sanjiaomao, whoami and Yush. Numerous volunteers provided their comments and suggestions on the writing or the translation.
1. List of reports on New Threads and Fang Zhouzi, from English media.
2. The lie detector. South China Morning Post. Jan 31, 2010
3. English translations of reports from lawyers, media and New Threads.
3.1 Investigation report on effects of Xiao Procedure. New Threads. Nov 12, 2009.
3.2 Who will evaluate Xiao Chuanguo? Science News. Oct 28, 2009.
3.3 An investigation of Xiao's Reflex Arc Procedure. China News Weekly. Nov 11, 2009.
3.4 A lawsuit strikes a nerve. China News Weekly. Nov 11, 2009.
3.5 "Artificial Reflex Arc", Who can explain it? China News Weekly. Nov 11, 2009.
3.6 The cure rate of "Xiao Procedure": 85% or 0%? Science News. Nov 23, 2009.
3.7 "Xiao Procedure": Patient follow-ups shock volunteers. Science News. Nov 23, 2009.
3.8 An investigation of Shenyuan Hospital. Beijing Sci-Tech Weekly. Dec 08, 2009.
3.9 How Xiao Procedure trials started in U.S.. New Threads. Feb 25, 2010
List of reports on New Threads and Fang Zhouzi, from English media.
1. The lie detector. South China Morning Post. Jan 31, 2010.
2. Lifting the veil on traditional Chinese medicine. Science. Feb 8, 2008: 319, 709-710.
3. China special: exposing the science charlatans. New Scientist. Nov 7, 2007.
4. "Science cop" faces backlash. China Daily. Dec 14, 2006.
5. China's fraud buster hit by libel judgments; defenders rally around. Science. Dec 1, 2006: 314, 1366-1367.
6. China's phony dcience - exposing corruption, plagiarism, and fraud. The New Atlantis. Summer 2006: 13, 103-106.
7. Special report: named and shamed. Nature. May 25, 2006: 441, 392-393.
8. Plagued by plagiarism. Chronicle of Higher Education. May 19, 2006.
9. Research fraud rampant in China. Christian Science Monitor. May 16, 2006.
10. Out to debunk: China's "science police". SciDevNet. Feb 3, 2006.
11. From scientist to "science policeman". China Daily. Aug 18, 2005.
12. Waging war Fang. China Daily. Nov 19 2004.
13. China: biochemist wages online war against ethical lapses. Science. Aug 10, 2001: 293, 1039.
South China Morning Post. Jan 31, 2010
Widespread corruption among some of the mainland's most ambitious academics has undermined the country's scientific community but one man has made it his mission to expose the culprits and clean up the system.
Paul Mooney
On January 16, Fang Shimin kicked off the new year with a recap of his top 10 news items of 2009. On his popular New Threads blog (www.xys.org), Fang, both respected and hated as the mainland's self-appointed "science cop", revisited a string of startling allegations: 12 university presidents and vice-presidents accused of plagiarism; a university president who claimed a leading scientific prize that was not rightfully his; two professors caught faking research results in an international journal; and a medical doctor who distorted the success rate for a new surgical procedure, which could have had serious health implications.
Fang's rogue's gallery made it seem like every time a light bulb goes on in the head of a genuine genius, there's a mainland scientist at hand to steal the idea and bask in the illicit glory, but the list came as no surprise to followers of the blog. For close to a decade, Fang, who goes by the pen name Fang Zhouzi, has been using the site to battle academic corruption, which, some say, has become so endemic on the mainland, it poses a threat to the country's development.
Fang, who earned a PhD in biochemistry from Michigan State University, in the United States, in 1995, became concerned about the phenomenon in 2000, when he started to see an increase in reports of academic cheating on the internet and in the print media. A fan of literature, Fang had a literary website called New Threads, which he has since employed to expose academic fraud.
"I care about science in China," he says, sitting in a Beijing cafe. "I want to see it go somewhere. [Academic fraud] is more common [here] than in any other country and more common than in any other period in Chinese history."
A survey conducted by the China Association for Science and Technology showed more than half of the scientists contacted said they were personally familiar with cases of scientific misconduct. However, few of the guilty parties are punished and that's what irks Fang, whose training in the US exposed him to a system in which plagiarism is rare and, when it does occur, is severely punished.
Shen Yang, an associate professor at the Information Management School of Wuhan University, pioneered software that detects plagiarism in university papers, but the will to implement such innovation has yet to surface.
Fang says that out of the more than 900 cases of academic corruption he has exposed only 20 have resulted in punishment - and the majority of those involved students.
New Threads receives about 100,000 hits a week, with close to 16 million people - academics and students primarily but also journalists - having visited it during the past nine years. The government occasionally blocks access, forcing users to reach it via mirror sites.
"New Threads is the news source for the vast majority of science journalists in China, including myself," says Fang Xuanchang (no relation to Fang Shimin), a reporter with Science News. "Actually, the vast majority of the cases of academic corruption that were brought to light by the media in recent years were originally exposed by contributors to the New Threads blog," says the journalist, who calls the site the "New Threads deep throat", in reference to the informant in the US' Watergate scandal.
Fang Shimin says he gets more than 20 e-mails a day reporting academic corruption and he spends an average of four hours following up on the claims. He says he applies strict criteria in handling reports: accusers must provide their name - many decline to do this out of fear of retribution; concrete evidence must be provided; and the case must be relevant. Fang often does his own research, sometimes consulting with experts in fields he is less familiar with.
Academic corruption runs the gamut from false claims about international awards to outright intellectual-property theft. No less than 16 Chinese scholars have claimed to have won the prestigious Albert Einstein World Award of Science since it was launched in 1984. For some years, more than one mainland scientist has claimed the award, despite that fact that it is given to only to one person a year. A search of the recipients list on the website of the World Cultural Council - the body that bestows the honour - yields not one Chinese name.
In 2006, when Fang, acting on a tip, pored over the online resume of the new assistant dean of Tsinghua University's medical school, he became suspicious when he noticed that one of the research papers it listed was about the molecular biology of HIV - a subject not related to the dean's speciality: surgery. Fang dug a bit further and discovered that the paper had been written by a Chinese scientist in the US with the same family name and first initial. He also discovered the professor had lied about his work experience.
Fang argued that Xiao Chuanguo, professor of urology at Huazhong University of Science and Technology, had lied about winning a major award given by the American Urological Association and questioned the success rate of a new surgical procedure being touted by Xiao. The doctor failed in two attempts to be appointed to the prestigious Chinese Academy of Sciences (CAS) and scholars credit New Threads for this.
Fang says that prior to the 1990s, the government had tight control on science and research and managed to keep a lid on cheating.
"After reform and opening, the controls were relaxed, and that was a good thing," he says. "We don't want the government controlling everything. But the side effect was that corruption and misconduct emerged."
Critics say government efforts to modernise the higher-education system are exacerbating the problem. The Ministry of Education and universities put pressure on academics to publish in journals catalogued by the Science Citation Index. School rankings, funding and monetary rewards are often based on such results.
A PhD candidate has to publish at least three papers before he can graduate, says Fang, and many graduate students are also required to publish. "That's huge, particularly for someone in biology or medicine," says Fang.
The publish-or-perish phenomenon has even extended to people teaching at junior colleges and high schools. But as more papers need to be published than can be accommodated by the country's key journals - the numbers run close to 500,000 per year - the trend has spawned a raft of low-quality "black journals", in which people pay to have their papers published.
"It's become a huge industry," says Fang. "And no one trusts the papers published in this kind of journal. It's just for promotion."
The pressure to publish has meant scholars churn out papers, often paying little attention to the quality of research or even lifting information from other sources without giving attribution. In many cases, professors allow their graduate students to do their research. If the student plagiarises, the professor pleads ignorance.
One of the problems, as Fang sees it, is that the fear of being caught is no disincentive.
"No one cares because the majority of scientists are involved in misconduct," he says. "So they don't think it's a big deal. You don't need to worry about being caught or punished."
Officials bear some of the blame, too, says Fang.
"The officials who have the power to distribute funding for research know nothing about science," he says. "They only know how to count the number of academic papers one has published. You only have to copy other peoples' papers and they say, `You've done a good job, here's your funding.'"
Universities and the government are often reluctant to punish cheaters, especially high-level scientists or someone who has Communist Party connections, which means just about any senior academic official.
"Government officials don't want to investigate and punish a vice-president or a president of a university because there's nothing in it for them," says Fang.
Universities will usually try to cover up such behaviour to protect the reputation of the institution. CAS members bring in large amounts of funding for their universities, Fang says. His website has exposed the misdeeds of about 20 members of the academy but none has been officially investigated or punished, he says.
He Shigang, of the CAS' Institute of Biophysics and a supporter of Fang, says: "Everything boils down to the political system. If the political system is corrupted you can't have a clean environment for anything."
"[Although the number is rising slightly] what appears in the media is a very small minority of the cases," says Fang Xuanchang. "Journalists have to consider whether or not there's a risk in reporting something. As a result, many cases go unreported."
There's a long history of scholarly cheating in China. During the Qing dynasty (1644-1911), scholars taking the rigorous imperial exam, to win coveted positions in the civil service, resorted to all sorts of tricks, including smuggling in miniature books, cheat sheets the size of a fingernail and even undershirts covered with relevant information.
In 1964, Mao Zedong went so far as to endorse cheating during a speech in which he criticised the staid education system and its emphasis on exams.
"At examinations, whispering into each other's ears and taking other people's places ought to be allowed," he declared. "If your answer is good and I copy it, then mine should be counted as good."
Cheating is also rampant among students. In recent years, qiangshou, or "hired guns", have been employed to take exams. Their services can be retained for just about any test on the mainland, including English language exams. One now-defunct website offered three options: a hired gun for 2,000 yuan (HK$2,275), answers in advance for 4,000 yuan or, for 1,200 yuan, answers provided during the test via a wireless device described as an imported "satellite receiver" no bigger than a thumbnail.
Fang says he makes no money from his blog, relying instead on the popular science books he writes to earn a living.
Eleven lawsuits have been brought against the crusader: courts ruled against him in three cases and dismissed five, while three are pending.
Xiao sued Fang for libel in a local court in Wuhan, Hubei province, where he teaches, winning the case and an appeal. Fang ignored the ruling and, last year, the court deducted 40,763 yuan from his wife's bank account.
Some of the legal cases have bordered on the absurd. In November 2006, the family of scholar Liu Zihua sued Fang for libel. In the 30s, Liu argued that he had used the Eight Diagrams theory - from ancient Chinese philosophy - to discover a 10th planet in the solar system, a claim Fang labelled "pseudoscience". The No 2 Beijing Intermediary Court ruled against Fang, fining him 20,000 yuan - despite the fact that Liu had passed away 14 years earlier.
Fang's legal setbacks are the result of politics, local cronyism and a flawed legal system, claims He. "I think he does his homework very carefully. That's the reason I respect him so much."
Supporters have set up a legal defence fund to defray his court costs as well as another website to fight his detractors.
Meanwhile, there is growing concern that academic cheating could adversely affect the development of education and science on the mainland. Fang says international academic journals are now reluctant to accept submissions from Chinese scholars, a problem that was highlighted last month when scientific journal Acta Crystallographica Sections E published an editorial announcing that some 70 crystal structures submitted by two scientists from Jinggangshan University, in Jiangxi, in 2007, had been faked.
Cao Cong, a senior research associate with the Neil D Levin Graduate Institute of International Relations and Commerce at the State University of New York, wrote this month that the peer-reviewed journal had been flooded with Chinese papers, ostensibly because it's just a database of crystal structures in which articles are usually one page long and go through a less-than-vigorous review process. Cao wrote that one chemistry professor at Heilongjiang University had submitted 297 papers to Acta Crystallographica over the past five years.
The incident attracted the attention of Richard Horton, editor-in-chief of medical journal The Lancet, who wrote that rewarding Chinese scholars for being prolific publishers was creating problems.
"In China, unfortunately, there are great incentives to commit fraud," he wrote on The Lancet's website. "When you make prestigious jobs and large amounts of money closely tied to publication, that creates conditions for fraud.
"The concern is if science in China cannot be trusted in certain areas, that undermines China's economic growth."
"Academic corruption is an incredible waste of taxpayer money," says Fang Xuanchang. "Furthermore, this general trend of corruption in scholarly circles will lead to a decline in the efficacy of scientific research and seriously obstruct China's dream of internationalising."
While on the surface it appears New Threads has had limited success, "without Fang Shimin, academic corruption in China would have been worse", says Rao Yi, dean of the School of Life Sciences at Peking University.
"Fang's goal of fighting academic misconduct should not be simply reduced to the number of people who are punished," says Fang Xuanchang. "The more important thing is making those potential cheaters afraid, which has resulted in reducing the emergence of this phenomenon within the academic world."
Fang Shimin says the Ministry of Education and the Ministry of Science and Technology (MoST) have both laid down guidelines for dealing with academic misconduct but he doubts they will be enforced. MoST set up the Office of Scientific Research Integrity in 2007, he says, but he's not heard of the office investigating a single case. He also contends that some MoST officials are corrupt and accept kickbacks for handing out research funding.
"There's an office at least," he says, optimistically. "The government now recognises that it's a problem - and although it hasn't done anything, I think that's progress."
Investigation report on effects of Xiao Procedure
The patients of the "Xiao proceure" started to roll in to seek help from Peng Jian in 2006. Since then, the lawyer has collected contact informations of more than 100 patients who received the Xiao procedure at Shenyuan Hospital, including 110 patients who underwent the surgery between the end of August 2006 and the end of March 2007. Four lawyers and two interns managed to contact the above-mentioned 110 patients and have reached and interviewed 74 patients or their parents by telephone.
Thereinafter we list the effects of the procedure on 74 patients who underwent the surgery between the end of August 2006 and the end of March 2007.
Efficacy and number of patients
Cured without adverse side-effect: 0
Complete recovery of normal bladder and bowel functions: 0
Recovery of basically normal bladder and bowel functions: 0
Significant improvement in bladder and bowel functions, nearly returned to baseline: 1
Considerable improvement in bladder and bowel functions: 4
Recovery of basically normal bowel function, some improvement in bladder function: 1
Slight improvement in bladder and bowel functions: 1
No noticeable improvement in bowel function, considerable improvement in bladder function: 1
No noticeable improvement in bladder function, some improvement in bowel function: 2
No noticeable improvement in bladder and bowel functions, slightly sensible better bowel function: 2
No noticeable improvement in bladder and bowel functions, slightly sensible better bladder function: 8
Basically no any noticeable effect: 32
No any effect: 22Disability (or side-effect) and number of patients
Weakness and atrophy in leg and foot: 1
Deformity in foot: 1
Atrophy in leg and foot, with slightly abnormal gait: 7
Deformity in leg and foot, with lameness or obvious abnormal gait: 21Therefore, the telephone interviews reveal that, the rate of ineffectiveness of the Xiao procedure is as high 73%, whereas the rate of disability is as high as 39%.
The lawyers suspect that "some improvement" or "slight improvement" in some patients might not be the result of the Xiao procedure. The effectiveness of the procedure has no solid scientific ground except the self-claims from Xiao Chuanguo, Shenyuan Hospital and interest-related parties.
Defining "success of the procedure" as "cured, complete recovery of normal functions without disability or side-effect", then, the investigation reveals no single successful case, or 0% success rate.
There are worlds apart between this investigation result and the "85% success rate" self-claimed by Shenyuan Hospital.
Face to face interviews of 11 parents conducted by Peng Jian suggest that the rate of ineffectiveness of the procedure might be higher than that obtained by telephone interviews.
The lawyers and interns that conducted the investigation has kept the telephone interview records for future reference. We welcome the inquiries from judiciary and administration authorities, as well as from representative netters.
Who will evaluate Xiao Chuanguo?
Reporter: Di Lihui
With the help from her parents, Little Fang (pseudonym) comes into the room with her crippled legs.
She is one of the patients who have had the surgeries of "Xiao's Artificial Reflex Arc Procedure". Her situation was not improved even got worse after she received this procedure one and a half years ago. Thus now, she came to Beijing and is looking for further treatment.
Little Fang is not the only victim of the Xiao procedure. On October 16, the mothers of other two children with spina bifida filed lawsuits against Henan Shenyuan Urological Surgery Hospital. They complained that the incontinence of their children was not improved three years after the Xiao procedure. Moreover, none of the patients who underwent the same surgery during the same period were cured either, which is much different to the success rate of 85% claimed by the hospital in their propaganda. The worst is that the procedure resulted in serious complications: the two children got atrophy and deformity in the left legs.
Suffering of the patients
The doctor who is treating Little Fang told the Science News that he is reluctant to comment on his own colleague Dr. Xiao, but suggests that we could hear the voices from the patients.
At the end of 2007, Little Fang's mother first learned the Xiao procedure and its effectiveness on TV. Little Fang had received five operations before 2007 with little improvement to her spina bifida. Her mother couldn't give up any chance and wanted to have a try again.
"I consulted doctors at that time," Fang's father told the Science News, "The doctors suggested not having this operation. But her mother was too impatient to give up this glimmer of hope."
From TV and the Internet, the father leaned that the Xiao procedure could be done in Zhengzhou. He paid a visit there, but he was disappointed and could not even believe how operations could be done in such a hospital with so poor conditions. He inquired several times, and finally was told that the inventor of this procedure, Xiao Chuanguo, was actually in Xiehe Hospital in Wuhan.
In March 2008, the Lital Fang's family came to Wuhan in haste to meet with Xiao Chuanguo at an international seminar there. "There were some foreign journalists and scholars at the seminar as well as we patient families. Some patients came from Vietnam and Taiwan." The father said, "A dozen of patients took the procedure at that time. We have kept in touch with each other, and so far I still have contacts with seven or so of them. I never heard any of us were cured, but we were told a cure rate of at least 60% at that time."
The father said, it was promised that the situation of Little Fang could be improved obviously in a half to one year. But now, one and a half years have past, nothing has been improved. They were told by doctors that to perform the Xiao procedure to her, it was necessary to use the nerve from a leg to connect another nerve system of her bladder and it was better to use the nerve of her healthy right leg rather than the one from her left leg with varus deformity. They were also told that her right leg would be a little sluggish but could recover in three or four months, at most in half a year. But so far, more than one year has past, both of her legs are still sick, and meanwhile, the voiding function of her bladder has not recovered.
"When I visited in Zhengzhou, I felt it is too hard for those farmers in poorness to have their kids treated. They need to raise enough money (around 30,000 RMB) by hard working and borrowing from others. I thought it would be a tragedy if the operations in Zhengzhou also failed like ours. For those poor families, it means life and death." The father said.
Nowadays, Little Fang stays at home after she dropped out of school. Her father believes going school is no longer useful. He said, "Lawsuit is not important either. Nothing is important except my kid could get recovered, living as a normal person."
"We will try again at any cost to have her treated, as long as there exists a ray of hope," Her mother said.
An evaluation
The operation Little Fang received was based on the theory of artificial reflex arc, invented by Professor Xiao Chuanguo of Xiehe Hospital in Wuhan.
In the opinion of Ji Xiaolong, director of the Pathology Department of the Armed Police General Hospital, the fact that Xiao could launch propaganda hypes for his theory and got the chances to perform the operation in some hospitals, owes very much to an evaluation in 2004.
In August 2004, a panel was formed by seven academicians and a professor, including top experts Qiu Fazu from Tongji Medical College and Han Jisheng from Beijing University Medical School. The panel concluded that Xiao's achievement had "important implications and outstanding novelty" on solving the urinary and fecal incontinence caused by congenital spinal meningocele。
According to the recollection of the panel member Wang Zhengguo, an academician at the Third Military Medical University, the procedure was first recommended for the evaluation by Ye Xinsheng, then vice director of the Life Science Department of the National Natural Science Foundation of China (NSFC). Some documents presented for the evaluation also described that the procedure has received very good response from overseas; it was highlighted on a number of world conferences in this field, and was well recognized internationally.
The composition of the panel, however, was flawed. Han Jisheng, the chairman of the panel, Gong Ju, from the Fourth Military Medical University in Xi'an, and several others excelled in the fundamental research in neuro-science, but were not specialized in clinical practice. Among all the experts, only Professor Jin Xiyu of the Third Military Medical University in Chong Qing was a specialist in urological surgery. Moreover, Guo Yinglu, the only academician of the Chinese Academy of Engineering in the field of urological surgery in China, was not even invited to join the panel. As a matter of fact, on the occasions when Xiao's result was under consideration for the National Prize for Progress in Science and Technology and when Xiao applied for the academianship of the Chinese Academy of Sciences, Guo Yinglu had made some comments: the effectiveness of the procedure were not as solid as expected.
"I'm not a specialist in urological surgery. At that time, the expert from the NSFC recommended him. Besides, Qiu Fazu had very good opinions on him. I have great respect for Professor Qiu. Normally he is a person with strong scientific spirit, and has always been exemplary in medical ethics. So I had had a favorable impression on the procedure, even before I came to know the details." Zheng_Guo Wang said.
During the evaluation, Xiao Chuanguo specially brought several patients to the panel to show the effects of the procedure. A non-specialist would see that the patients started to urinate normally after their lower abdomens being slightly pressed. But Jin Xiyu, being an expert in urodynamics, suggested that it could imply that the urination was caused mainly by the pressure, rather than the recovery of neurological functions.
"At that time, this young man was recommended by the NSFC expert, and strongly recommended by Qiu Fazu. Particularly, the opinions from overseas were very good. So I thought it was a very good thing, because there were few procedures were invented in Chin and were appreciated overseas. Trying to learn and to be encouraging, I felt it was quite good at that time. I did not talk much either, because I did very little clinical work." Wang Zhengguo said frankly.
In the meantime, the experts also commented that, although it was believed that the procedure had solved the practical problem in clinical practice, the analysis of its principle needed further refinement. Besides, the academic papers related to the research should also be substantiated. Nevertheless, the experts still rated the research as "advanced", although most of the invited experts worked on fundamental research, with an extremely small number of clinical doctors.
"It might involve human feelings. Jin Xiyu was lower than others in both rank and authority. The others were all academicians and senior. In Chinese tradition, whenever you do not agree, it is often too difficult to say no, especially to the reputed persons." Wang Zhengguo told Science News.
Considering that Xiao Chuanguo "did beautiful operations, and the outcomes were also very good", and that Qiu Fazu recommended the procedure, Gong Ju, the academician from the Fourth Military Medical University in Xi'an, would not believe the results were "fake". "Because, Teacher Qiu is very serious and very strict; he went to Pingdingshan to check the results. I believe in Teacher Qiu." Gong Ju conceded that Xiao's result was of value in clinical practice, although improvement in theory was still needed.
Troubles from CAS member election?
The approval in the evaluation seemed to have settled the basis for Xiao Chuanguo for the membership election of the Chinese Academy of Sciences (CAS). But on September 14, 2005, Fang Zhouzi was invited by Sohu Corporation and the Publishing Press of Peking Union Medical College to address on "the Academic Regulations in Biology and Medicine" at Sohu Health Channel. The academic status of "Xiao's Reflex Arc" was questioned. On September 21, 2005, Fang Zhouzi published an article "A Foot in Two Camps: the Chaos of Academician Election" at the Sohu News Channel. Fang further pointed out that Xiao Chuanguo had no international influence at all, and "Xiao's Reflex Arc" had never been accepted by medical communities in China either.
Xiao Chuanguo considered these as untrue reports and slanders; especially all the accusation on his academic works and their international acceptance deviated totally from the facts, and seriously damaged his reputation. Therefore, Xiao Chuanguo brought a suit before the people's court of law.
Since October 8, 2006, when Xiao Chuanguo formally launched his first case to the Jianghan Disctrict Court in Wuhan, till November 30, 2007, when the Beijing High People's Court pronounced a final adjudication, Xiao had filed nearly ten lawsuits one after another in Wuhan, in the U.S., and in Beijing for basically identical appeal against the key person, Fang Zhouzi, for his tort.
On July 25, 2006, the Jianghan District Court in Wuhan pronounced the sentence of the first instance, and Fang Zhouzi lost the lawsuit. Soon afterwards, more than 600 people signed "an Open Letter by Scholars in China and Abroad on the Lawsuit of Xiao Chuanguo vs. Fang Zhouzi", to protest the injustice of the court. The letter says, it is legitimate for Fang to criticize and question the qualifications of Xiao as a CAS candidate; it is purely academic criticism and media supervision; it totally accords with the purpose of the CAS to encourage the public to supervise its membership election process by publishing the candidate list; it is also a fundamental right for a citizen to express his opinions on public issues.
"I don't think lawsuit interesting either," said Gong Ju, "Other people can criticize you however they like; but you are what you are. There is no need for you to take it seriously. Probably nobody can afford to accompany him with the lawsuit. A lawsuits is expensive; if it lasts too long, other people cannot afford. "
On November 30, 2007, the judgment by the Beijing High People's Court described the obvious controversies over the academic status of Xiao Chuanguo and the international influence of "Xiao's Reflex Arc". The Court found, "the controversies are in the nature of academics, and thus should be appropriately solved by academics based on academic autonomy; the Court ought not, and is not able to make a judgment by the law."
Peers in awkward position
Now that lawsuit cannot solve the academic debating, then who should be appointed to evaluate Xiao Chuanguo and his "Xiao's Procedure"? Somehow frustratingly, none of peer experts in urologic surgery is willing to give comments on the procedure outcomes after the lawsuits.
A urinary surgery expert in a hospital in Beijing told the Science News: "It is currently impossible to rely on peer-review; I can assure that none of the experts is willing to comment on it. No matter whatever I would say in a peer-review, Xiao would always have many excuses to say my incorrectness." Meanwhile, he thought that the method proposed by Xiao is nevertheless in a worthy research direction; but there are more to concern how to bring the results from animal experiments to clinical trials. As to Xiao himself, it is better not to "antagonize" him as much as possible, "I have a lot to do," said him.
Gong Ju, who is engaged in basic neurology research, said frankly on the other hand that the basic research done by Xiao Chuanguo at the very beginning was not convincing enough, for example the tissue slice performed by using an electronic microscope; moreover, Xiao had drawn a scheme of reflex, but the middle part is not correct in neuroanatomy. "The reason is, the nerve reflections stimulated by scratching skin cannot reach motoneurons directly to form a reflex arc, as he had drawn. Such kind of reflex arc reaches muscle directly, which is only possible to reach the anterior horn of the spinal cord through an interneuron instead of to reach by skin-sense. He missed a connection, but he just drew in his way; he never concerned other's arguments, but insisted that it is very correct", said Gong Ju, "I don't like such kind of things."
In the 42th International Conference on Spinal Cord of Beijing, Zhang Shimin from Shanghai Tongji Hospital and Xiao Chuanguo reported in this field one after the other. "I had read previously all these papers by Xiao. We also had performed experimental research in this field; in the last slide of my presentation, I proposed that many questions were still open in this reflex arc and needed further research. After the presentation we have also discussed with Prof. Xiao about these open problems." Zhang Shimin told Science News.
Afterwards, Zhang Shimin wrote a 500-word comment on the "artificial reflex arc", and published it on the Journal of Urology in 2004.
As a peer expert, Yang Yong, the director of the Urology Department of Beijing Chaoyang Hospital declined to address any comment; and Guo Yinglu, the only academician in this field, excused himself from the reporter's interview for "health reason".
Since no authorized clinical trial has been carried out, there have been no third party statistical results about the detailed cure rate regarding this procedure; meanwhile, the hospital in Zhengzhou already stopped performing this procedure.
An investigation of Xiao's Reflex Arc Procedure
Cover Story: Who will tackle the medical gray area?
China News Weekly. Nov 11, 2009
On the one hand, it is a research project of the "National Programs for Fundamental Research and Development"; on the other hand, it is a promotional marketing strategy pursued by a private hospital. A panel of experts, including several academicians, concluded that the research has reached "the world advanced level". However, it has received vague feedback from other peers, who remain unwilling to adopt the surgical technique. In contrast with the 85% success rate claimed by the hospital, the majority of patients complained of the ineffectiveness of the treatment, some even brought up lawsuits. As a new medical theory and a new clinical technique, over the years the theory of "Xiao's Reflex Arc" and its clinical implementation have been treading in the gray areas of medical treatments, with little acceptance among clinicians in the country. In the era of rapid commercialization of new medical techniques, the embarrassment it's now facing reflects the urgency of enacting laws that regulate exploratory medical practices in China.
China News Weekly. Nov 11, 2009
The dissolved private hospital is now being taken to court, which raises the question for the inventor of this surgery, a self-claimed "would-be Nobel Prize Winner".
Reporter: Cai Rupeng
On November 10, 2009, Henan Erqi District Court formally accepted the case against Shenyuan Urological Surgery Hospital of Henan , filed by the mothers of two children with spina bifida. In the complaints, they said that their children underwent surgeries at the hospital for the treatment of incontinence, but their conditions have never improved. From what they have learned, among the children who were hospitalized over the same period, no single case was cured. Nevertheless, the hospital had been advertising "85% of success rate" for the treatment. What makes it even harder to accept is that the surgery leads to serious complications: the atrophy and deformation of their left legs.
So far, about 1,500 patients had received this surgery at Shenyuan Hospital.
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Zou Yingli of Jiaozuo, Henan, said that in 2006 she watched on television and learned in newspapers that "there was a hospital in Zhengzhou specialized in this disease. As soon as I heard their breakthrough, I came to them immediately."
At Shenyuan Hospital, President Gao Xiaoqun told her that this operation is called the "artificial somatic-autonomic reflex arc", specifically designed for the treatment of incontinence due to spina bifida". "I was told that the situation will improve after a few months. One or two years later, my child will be able to gain voluntary bladder and bowel control. The success rate is 85% or higher. I was so happy to hear that", Zou Yingli said. She recalled Gao Xiaoqun specifically cited the success story of Little Shanshan of Hainan, which had been widely reported by the media, "I was thinking, since it had been on TV and in the news, how could this be fake?"
On November 17, 2006, Her son Guo Zilong received the same surgery as Little Shanshan.
After the surgery, Guo's condition has not improved. Zou Yingli said that she called the hospital many times, "At the beginning, they asked me to be patient becasue the nerve grows slowly. Later they let me bring my child for an examination. After the examination, they said, 'yes, yes, your child has recovered very well. The nerves have grown together, just wait for a few more months'. Now three years have passed, there is still no effect at all."
Zou Yingli had asked Gao Xiaoqun, "Why is it not effective?" Gao answered, "A lot of people are cured. I am sorry it has no effect on you son." At first, she just choose to believe that "my son had a bad luck to be in the group of the unsuccessful 15%". Only after contacting more patients did she realize, "there is not a single case of cure."
In Henan, reporters have also located the parents of eight more children, who also had operations in Shenyuan in 2006. None of them has seen any improvement. Some parents complained that the legs of the children appeared abnormal after the surgery. Liu Chunhong (pseudonym), who lives in Zhoukou, Henan, said that her brother's legs were normal before, but his left leg began to shrink after the surgery and it's now significantly smaller than the right one, "He used to be a fast runner. Now you can see his lame walk from afar. The limping will be more obvious if he runs. His classmates all laugh at him."
A procedure to "win Nobel Prize"
Founded in August 2006, Shenyuan was a private specialist hospital. On its website, it was introduced as a hospital "intented mainly for the promotion of the 'artificial somatic-autonomic reflex arc' technique and its clinical implementations."
Before the National Day, China News Weekly reporter went to Shenyuan, only to find the hospital empty. A notice at the door wrote, "The hospital was dissolved on August 17, 2009. No more admissions of patients".
After several attempts, the reporter finally got contact with Lü Shaojie, the director of Liaison Office of Shenyuan Hospital. He told the reporter, "Our hospital is undergoing a reform; there is no any problem about the operation itself. By the end of October, the whole hospital will be annexed to the Fourth Affiliated Hospital of Zhengzhou University, and the operations will resume."
After Lü Shaojie's contact, the reporter met He Zhaohong, who is in charge of implementing the operation.
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"Whether from basic research or from clinical application, (the artificial reflex arc) is proven to be effective." He Zhaohong told the reporter, in the recent 3 years, Shenyuan had carried out about 1500 artificial reflex arc operations (approximately 100 in 2006, 300 in 2007, 800 in 2008, and 300 in 2009), "the results are very good, with success rate is 85%."
How "85% success rate" was obtained
So, how the success rate was obtained? Shenyuan Hospital said that they had two channels, one is the telephone follow-up after operations, and the other is the urine dynamic tests during reexamination of the patients.
Soon afterwards, the reporter of Chinese News Weekly interviewed Jia Bin, who is in charge of the follow-up in the hospital. He told the reporter, the current success rate came mainly from the follow-up results of over 400 operations before 2008, the reason is "operation would have the desired effect generally after one year". Jia Bin said, among the 400 patients, they followed up over 280 in effect; "in principle, we need to follow up each patient for two years, but some of them are out of touch so we had to give up."
During the interview with Jia Bin, the reporter proposed to have a look at the statistical data of the follow-ups. He said "now the hospital is in a mess due to relocation and it is not so easy to find". The reporter then proposed whether he could provide contacts of a couple of patients with successful operations for interview. He replied "sure"; but needed to have a search after going back to the hospital, and would send message to the reporter after finding it. But he never contacted the reporter afterwards.
The reporter also asked especially to contact patient Little Shanshan, the child from Hainan Province. Among all the parents of child patients whom the reporter contacted, many decided to come to the hospital just because they had seen the news reports on the success of Little Shanshan's operation. Jia Bin replied, however, "His home phone was reachable until two years ago; but now even I cannot get through to them and don't know why."
Dong Hongqi, the parent of a child patient from Luoyang, told the reporter that, before the operation, he once asked the hospital to provide phone numbers of any successful cases "just to ask about what the situation really is", but the response is that "the phone numbers are patients' privacy that should be kept secret, and cannot be disclosed". Dong said, he spent 30 thousands Yuan, "most of the money was borrowed", for his child's medical expenses, excluding meals and transportation.
"Among the 400 patients that had undergone operations before 2008, over 220 had urodynamic tests," said He Zhaohong. "The success ratio is also 85%." The main purpose of a urodynamic test is to measure the bladder contraction. Comparing to telephone follow-up, He Zhaohong believed that this is more convincing, "Symptoms are objective though, there is always subjective inside. We just looking at the urodynamic diagrams; if the bladders (of the patients) can contract after the operation which cannot previously, then we believe that it is effective."
"Artificial Reflex Arc", Who can explain it?
China News Weekly. Nov 11, 2009
"Such a good procedure, why can't it be accepted?"
"If he believe it works, let time prove it. We must respect facts."Reporter: Cai Rupeng
The surgical procedure performed in Shenyuan Hospital is based on the theory of "artificial somatic-autonomic reflex arc" proposed by Professor Xiao of Xiehe Hospital in Wuhan. This theory was also named "Xiao's reflex arc" after its inventor. The head of Shenyuan Hospital Gao Xiaoqun, and the people in charge of carrying out the surgeries, Du Maoxin and He Chaohong, all called themselves the "implementers and popularizers" of this theory.
Xiao is 54 years old today. He graduated from Hubei Medical College (now Wuhan University Medical School) in 1975. After graduation he was admitted to Tongji Medical University (now Tongji Medical School of Huazhong University of Science and Technology) and obtained his Master of Medicine in 1981. Xiao left the country at the end of the 1980's, and worked in London University in England, East Virginia Medical School in the US, and New York University in the US. Since his return in 1997, he has been the head of the Urology Department of Xiehe Hospital which is affiliated to the Tongji Medical School.
In Xiao's office, the reporter saw a wall filled with certificates and award plaques. The awards include Ho Leung Ho Lee Foundation Prize for Promoting Progress in Science and Technology (2002), the second prize of the National Prize for Progress in Science and Technology (2001), and Wu Jieping Medical Fund for Urological Research (2000). He said that these awards are all related to his proposal and verification of the "artificial reflex arc" theory.
Birth of "Artificial Reflex Arc" theory
Xiao said, his first idea of the artificial reflex arc, was after the big Tangshan earthquake in 1976. "I was a first year resident doctor. The hospital was filled with injured from the earthquake. Among them, the most miserable were those paralyzed. They couldn't move, and worse, they couldn't control their bowel movement and urination. It was heart wrenching.
Urination is a complicated process, "but the key is in the last step, a signal for the bladder to empty." Xiao said, "Because the spinal cords of paralyzed patients are broken, the signal from the top cannot reach the bottom, so they cannot control urination. But their nerves below are still good. For example they still have the knee tendon reflex, if you strike the knee the leg still comes up. So I thought, can we use these nerves to control the bladder? If we connect the nerve to the bladder, then stimulate it from the outside, would that be the signal we need?"
"Put it simply, my idea is to connect one of somatic nerves to the autonomic nerve that controls the bladder, to form an artificial reflex arc. This will allow patients to control their urination.
In 1978, Xiao was admitted to the graduate school. He remembers, "My decision to choose urology was to realize my dream of solving the continence problem of paralyzed patients. But at that time, our research conditions were very poor, we couldn't do it. Not until when I went abroad, I was able to gradually implement my ideas."
While in the US, Xiao took advantage of the better conditions, "applied for a research grant, and experimented on mice, cats, and dogs. Through animal experiments, I had the preliminary proof of my idea. In 1990, I reported for the first time this work on the US urology conference in the form of a conference proceeding."
In 1995, Xiao began the clinical research. His first choice was the Pingdingshan Coal Mine Hospital in Henan province. The reason that he did not first do the trial in the US, was because that "in the US application for grants is very slow, at least one and a half to two years. In addition, the US has much stricter approval process for clinical trials. Even for oral drugs you would need truckloads of paperwork. It's much harder for surgical procedures. Further, I am a foreigner, it would be even more difficult."
"At that time, the head of Pingdingshan Coal Mine Health Bureau was visiting the US. He heard that I was working on this, so invited me to their hospital. I went and visited them. The biggest advantage the hospital offered was that all the patients were miners so we could keep long term follow-up on them."
According to Xiao, the clinical study at Pingdingshan Hospital "did not require approval from the Ministry of Health, only needed approval from the hospital's ethics committee."
The first evaluation: treatment in paralysis
"At Pindingshan Hospital, we performed the surgery for two years. Then we did follow-ups for 4 years, until 2003 when we published our first paper." Xiao took out a copy of that article, pointed to a paragraph and said to the reporter, " Look, we operated on total 15 paralyzed patients. One and a half years later, 10 of them improved completely, with very good control of urination; Two improved partially, but needed strong stimulation or couldn't empty the bladder completely; One lost contact; Two had no effect. The success rate was 80%."
In March of 1999, before this paper was published, the Ministry of Health organized an expert panel to evaluate Xiao's clinical study.
The reporter found the evaluation report. The number of cases described in the report is not the same as in the paper. The report said, "(Artificial reflex arc procedure) began clinical applications in 1995. Treated 14 paralyzed patients, post-operation follow-up 2.5 to 3.5 years, except for one lost contact and two failures, 11 patients were all restored controllable urination. All urodynamic parameters either basically returned to normal or improved significantly."
Before the evaluation meeting, one of the experts, Qiu Fazu, who was a professor at Tongji Medical School (Qiu, honored as "the Father of Chinese Sugical Medicine", and an Academician of the Chinese Academy of Sciences, was the graduate advisor of Xiao. He passed away in 2008), went to Pingdingshan Hospital purposefully to see firsthand the effect of the procedure. Ye Xinsheng, then vice director of the Life Science Department of the National Natural Science Foundation of China (NSFC), went together on the trip. "At that time, Xiao had just returned from abroad. He applied for a grant to study the artificial reflex arc. But when we discussed the application, we were doubtful. We wanted to see firsthand how it worked, and I was asked to go." Ye told the reporter, other than himself, there were also people from Xiehe Hospital and from Tongji Medical University, who went as Prof. Qiu's aides.
"When we got there, he prepared four patients. These patients were able to urinate by stimulating their skin on the leg." Ye said, "Of course, some of them also needed to press the stomach to help with the urination. Prof. Qiu saw the results and was quite satisfied."
Finally, the evaluation panel gave a "World Leading" opinion. According to one of the experts on the panel, he believed that the artificial reflex arc procedure was indeed innovative, "theoretically it was believable. Furthermore, Prof. Qiu was so senior, and he went to see the patients in person. I respected him very much. He never made false claims."
With Ye's report, the NSFC agreed to support Xiao's study of the artificial reflex arc. Later, he obtained another grant from the NSFC. Two grants totaled nearly 3 million. Ye said, "Afterwards, the Ministry of Science and Technology also liked his project, and gave him support in the form of a National 973 Project."
The second evaluation: treatment in spina bifida
After passed the evaluation of the clinical study conducted at Pingdingshan Hospital, Xiao Chuanguo started applying the procedure on the patients in Xiehe Hospital in Wuhan. At the mean time, he started an attempt to apply this surgery technique to another type of patients, children suffering spina bifida.
"The medical causes for the urinary difficulties of these two types of patients are basically the same." Xiao said, "We performed the surgery on 20 children at the beginning. After the surgery, we did follow-ups once every three months after the operation. 17 of them gained voluntary bladder control within one year, which means a success rate of 85%. In 2004, the Ministry of Health organized an evaluation on this clinical study as well."
In August 2004, an expert panel consisting of seven academicians and one professor, including Qiu Fazu from Tongji Medical School and Han Jisheng from the Medical School of Beijing University, concluded that Xiao's study was "important and outstandingly innovative" to the cure for the incontinence of children with spina bifida.
The reporter interviewed several experts who participated in the evaluation. Academician Ju Gong recalls that the panel initially wanted to give the highest evaluation of "world leading". But many questions were brought up during the discussions. However, it was considered an invention, which nobody had done before either domestically or internationally, and it was clinically effective. Eventually it was determined to be "world advanced".
As to the success rate, an expert of the panel said, "The panel experts reviewed some cases performed by Xiao, and accepted the diagram of bladder pressure. But he only provided partial information of his cases to the panel, instead of providing everything. He did it selectively. He also brought 7 or 8 patients in to demonstrate their urination to us. He said he performed 20 cases at the beginning, but the experts did not see any information of those 20 patients."
The expert commented that any medical results must be verified by multiple-center trials in large- or medium-sized hospitals. For example, 100 to 200 cases should be done by 20 to 30 hospitals. Additionally, we need to see the long-term effectiveness, not only the short-term effectiveness.
He further suggested those patients who underwent the operation should be examined by some other hospitals with urodynamics facilities by experts in urodynamics. All those cases need to be analyzed and summarized to give an objective clinical evidence.
In the evaluation report, the reporter noticed it also mentioned, "The spinal continuity of this type of children patients is not broken. A functioning healthy somatic motor nerve bundle must be sacrificed in order to construct an artificial reflex arc to control the bladder, which carries very high risks."
About this potential risk, Xiao provided an explanation, "There were indeed 4 or 5 children having some problems among the initial 20 cases. This is like 'robbing Peter to pay Paul'. There is very little side effect to lower limbs, which may have a little weakness. But now we have solved it. Only a third of the nerve bundle, at most a half, is used, and it will fully recover after a year. So this is not a problem any more."
This explanation does not agree with the situations of some patients including Guo Zilong that the reporter has observed.
"We also state it clearly on the surgery consent form." Xiao added, "I once explained it to a patient's parent when I was in the US. The parent said it was worth it! This is to exchange a small loss for the voiding function."
Why difficult to popularize the procedure?
The reporter found that, only very few hospitals in the contry, including Xiehe Hospital in Wuhan and Shenyuan Hospital in Zhengzhou, are or have been performing the artificial reflex arc procedure, while China has millions of people suffering from spinal cord injury and spina bifida. If the Xiao procedure has 85% success rate, why cannot it be popularized in any major hospitals?
Ye Xinsheng was also puzzled by the situation, "Why such a good procedure cannot be put into more extensive clinical practice?"
To find out the answer, we interviewed several experts in urological surgery. "We also have this concern!", said Guo Yinglu, the honorary director of the Institute of Urological Surgery at Peking University and the only Academician in urological surgery in Chinese Academy of Engineering. Guo said, "It makes some sense in the theory of the Xiao procedure. But not for all the patients can it achieve nerve reconnection". He then took the case of SCI patients as an example. "The injury of spinal cord happens at different levels. Only for those at lower levels, their bladder nerve may be reconnected, and you can only do this when you are able to find the nerve". Guo continued to say, "So, it means that even if he (Xiao) is correct, the effectiveness (of the procedure) is limited". Guo said that he was not aware of the situation of implementing the Xiao procedure to spina bifida, and he did not have much contact with Xiao in person.
Most of the urosurgical experts interviewed were not willing to talk much about Xiao's reflex arc procedure. They all said that this technique needs to face the evaluation along the time. "If it is proven to be effective, it would gain extensive clinical implementation, because the needs from the affected patient population are overwhelming."
But there are doctors expressed doubt on the Xiao procedure. Dr. Ji Xiaolong, director of the Pathology Department of the Armed Police General Hospital, said that the healing of nerves remains a big challenge in medical field. "It's hard (for nerve) to grow into one piece. Imagine that each nerve is like a telephone cable with many contacts in it. Only when every contact is connected, can we say it is healed. No current technique in any microscopic surgery can achieve this. Leaving the two nerve stumps searching for each other (for reconnecting), it involves uncertainty".
Regarding Xiao's own opinion on the difficulties on promoting more clinical implementation of his procedure, he thought that the primary hinder is the complexity of the operation. "This operation requires opening of the spinal canal, and needs to sort out the one nerve root from a bunch of them to do the re-routing. No urosurgeon, except those Ph.D.s I supervised, knows how to do it, because they don't know how to pick up the nerve from inside the bones. On the other hand, neurosurgeons don't know urology, they have no idea which nerve root is for the bladder, neither do they know the preoperational condition of the bladder of the patient".
"We hosted some training courses, and invited doctors from all over the country to participate. But those came to the training were all urosurgeons, not neurosurgeons. They couldn't team up, so even if they came for the training, they can't perform the surgery. Now, we plan to train more Ph.D. students. When they graduate, they can go more places to establish more centers to perform the procedure".
Regarding the claim that the difficulty of the procedure hinders its application, Guo Yinglu thinks that, if there is no intrinsic problem in the technique itself, or there is no intention to keep the technical secret, it should be brought to extensive clinical implementation by training more surgeons to perform the procedure.
According to Xiao, the establishment of the Shenyuan Hospital has something to do with one of his Ph.D. students, but Xiao himself did not take one cent from the hospital. "The hospital is a joint-investment. They offered me some shares but I didn't take it. Finally they gave me about 30% of shares. I told them that if there is any profit, I don't want my part but re-invest to the hospital for further development. Anytime now I am there for performing the surgery, I buy the train ticket by my own."
The cure rate of "Xiao procedure": 85% or 0%?
Scinece News Editor: In Vol. 20, Oct. 28, this magazine reported the "Xiao reflex arc", the controversial surgical procedure, in article "Who will evaluate Xiao Chuanguo?" After the article was published, our reporters have learned more information about this procedure.
Reporter: Di Lihui
Peng Jian, a pro bono lawyer, continues his busy work of collecting and collating evidence from different sources. Previously on Oct. 16, the mothers of the two children with spina bifida filed lawsuits against Henan Shenyuan Urological Surgery Hospital. At present, the court has set the date for hearing on Oct. 28. Peng Jian revealed that, before the end of the year, it was expected that about twenty more patients (or their kins) would bring their cases to the court.
Investigation restarted
"I realized, for this case, the only effective way was for many patients to come forwards together, especially those who took the operation during the same period." Peng Jian told Science News that he started the effort to collect the names of the patients since 2006 -- in this year, Fang Zhouzi lost a case that was brought forward by Xiao Chuanguo, for Fang's harsh questioning on the validity of the theory of "Xiao's reflex arc", as well as the academic credentials of Xiao, the inventor of the theory.
In the summer of 2007, when the names on his list had totaled a few dozens, Peng Jian arranged interns to start interviewing the patients over the phone. "At that time, we successfully got through to more than forty people, and learned that the outcomes of their operations were very bad. In most cases there was virtually no improvement. Some (operations) even led to disability." Liu Lin, who took part in the phone interviews, told Science News.
Further investigation, however, was hindered by difficulties. The main one was the lack of financial support. Although several non-profit organizations expressed the intention to provide supports, none materialized in the end. Yet in the meantime, patients continuously visited the law firm where Peng Jian works, hoping to "accelerate the process of legal aid".
In September 2009, when financial resources became less of a constraint, the investigation was started again. This time, among the 150 plus contacts obtained through the exchanges between the patients, more than eighty successful phone interviews were made, and fifteen were interviewed in person. Peng Jian said, "Now the 'number' is still increasing; we receive at least two, even as many as three or four calls each day, that provide supporting evidence for the case."
Among the patients who have received the "Xiao procedure" and have been contacted so far, the survey finds no example of complete success. The percentage of patients with evident improvements is also low -- This is in sheer contrast with the "85% cure rate" advertised by the hospital.
More contradictions
Peng Jian, the lawyer, also found another inexplicable contradiction.
The Neuro-urologic Surgery Research Center at Zhengzhou University issued a certificate to Xiao Chuanguo on Feb. 28, 2007, for his application to academician. The certificate claimed: Starting from Jan. of 2006, the Neuro-urological Surgery Research Center at Zhengzhou University had applied the "artificial somatic-autonomic reflex arc" technique invented by Professor Xiao Chuanguo to 117 patients with neurogenic bladder caused by spina bifida or meningomyelocele. Sixty cases were followed up for more than eight months. 85% of the patients have recovered normal bladder and bowel functions.
Peng Jian found out, however, that it was reported on Aug. 14 of 2006 by Dahe Newspaper, "Yesterday, Little Shanshan received the operation at Zhengzhou Shenyuan Urological Surgery Hospital ...... the operation for Little Shanshan was the first case in Henan ...... Dong Ziming, from Zhengzhou University and the dean of Fundamental Medical School, said: Shanshan's operation made a Henan record -- the first 'artificial reflex arc' in Henan. And Zhengzhou Shenyuan Hospital made a national record -- this was the first, in our nation, interdisciplinary neuro-urological surgery hospital. It was a creation resulted from the effort to integrate research and clinical practice in Zhengzhou University."
In other words, the center conducted the first "Xiao reflex arc" operation as late as Aug. 13, 2006. It was merely six and a half months away from the time when the center provided the certificate of cure rate for Xiao Chuanguo, which evidently contradicted with its claim that "Sixty cases were followed up for more than eight months".
Peng Jian and others sought out and visited more than a hundred patients who took the "Xiao reflex arc" operation at Zhengzhou Shenyuan Urological Surgery Hospital between Aug. 2006 and the first six months of 2007. They found no case regained the bladder and bowel control. Instead, the conditions of many patients deteriorated after the operation. Judging from the times of their operations, these patients should at least count for a considerable portion of the "117 cases" mentioned in the certificate issued by the center. This calls into serious question the hospital's claim that "85% of the patients have recovered the bladder and bowel control".
"Let the patients speak out"
It is perhaps too shocking to believe the conclusion of the investigation that the cure rate is close to 0% -- is it related to the bias caused by the questions designed by people who are not medical professionals, such as Peng Jian?
"The statistical results obtained through amateur methods, although reviewing is needed prior to official publication, have already shed light on some issues." Professor Liao Limin at Beijing Boai Hospital commented in this way, "At present, only when the patients speak out can we expose the problems. Justice can be served only through the patients. If the operation succeeds, the patients are the biggest beneficiaries; if it fails, the patients are the hardest-hit victims. Let the patients speak out -- it is the most objective way."
To Peng Jian, spending money and man-power to interview the patients one by one is the most direct and, perhaps, the only viable way to collect evidence. "Peer review, is possible in theory, but impossible in reality. The current evaluation of the procedure was all made by the 'authorities', including the evaluation of some scientific achievements. Isn't it very difficult to find other experts to draw a different conclusion? Moreover, I find that, the experts in the field are trying to stay away," Peng Jian said.
What Peng Jian said was acknowledged by experts in the field. "We experts don't want to get involved, although we do not like to see what the patients have turned out to be." A well-known expert in urological surgery told Science News, "It is not that we are not willing to (speak out), but that what we say probably won't have any effects. He can say we know nothing. So-called experts and colleagues, or anybody, in his eyes, can be dismissed as worthless."
Comments from peers
Nevertheless, there are experts who, in the end, are brave enough to speak out.
"I use two sentences to describe (my opinion): first, this procedure is absolutely not like what he described, that it has solved the problem of neurogenic bladder; second, the procedure may be effective for some patients, because there are some pertinent indications. Some patients can be treated with this procedure, but absolutely not all." Professor Song Bo at the Third Military Medical University in Chongqing held this opinion.
Song Bo indicated that he did not agree to blindly gloss over or promote this type of procedures, because, after all, it was not a business activity. "I am all against the statement that it has solved the problem of neurogenic bladder; I did not really agree with its application for the National Prize for Progress in Science and Technology either." In the meantime, he believes there has not enough evidence so far to assert that the procedure is completely useless. "But his research is not finished yet. What are the indications for the procedure, ultimately, is not even clear. It is unfounded at this stage to say things like a grand problem has been solved." Song Bo said.
"He applied the (neuro-surgical) techniques to urological surgery. We could see very few clinical patients, and we did not observe his operations either. We simply were not able to make any comments. They brought the patients in. I did not watch the operation. He had no publication at that time. We knew even less about the international evaluation on his procedure. Everything was based on his own words. We could not see any comments from other countries. He said we would not be able to conduct the operation, but why they themselves were not able to popularize it either? We are also wondering." Guo Yinglu, a professor at the Beijing Medical University and an academician of China Engineering Academy, told Science News.
"When doing science, we should allow mistakes, exploration, and all kinds of efforts. But we should not allow claims such as what has been solved and what has been created, when there is no complete scientific evidence, nor a large amount of evidence-based medical data. They are not scientific statements. I oppose these statements." Song Bo summed up.
"Xiao procedure": Patient follow-ups shock volunteers
Reporter: Di Lihui
One of the volunteers, Liu Lin, took part in a survey on the effectiveness of the "Xiao procedure", which was claimed by the inventor, Dr. Chuanguo Xiao, to have an overall success rate of 85% for treating spinal bifida. Liu was shocked by the post-surgery results in the patients who she visited. During the week of November 10, she visited several patients who underwent the Xiao procedure. Because the patients lived in different places, Liu Lin had to travel through a number of provinces, from Chengdu to Meishan, Deyang, Guangyuan in Sichuan and then from Linfen to Gaoping in Shanxi province, braving the cold weather and heavy snow. Upon her return on Nov. 18, Liu granted an interview to Science News.
"No patient was cured by the Xiao procedure at all" she said, "On the contrary, the surgery did cause disabilities."
Liu Lin told the News that she felt the patients looked spiritless and were living in pain. They were told that their diseases could not be cured even at the best hospitals in Beijing. In their hopeless waiting, they saw the propaganda (the Xiao procedure) from the official and most authoritative Chinese medium -- the China Central Television (CCTV). They would trust the reputation of Zhengzhou University Medical School and their experts too.
Liu Lin has visited four patients in total. None of them has been cured by the so-called the Xiao procedure and some of them were even permanently disabled by the surgeries. Two of the patients are still minors. The other two are 19 years old but they were also minors when they underwent the spinal surgeries.
The boy patient in Meishan County could still walk by himself and even climbed stairs in the hospital before his surgery, in spite of a bit of deformity in his legs. But after having the Xiao procedure in Sep. 2007, his legs with parts of nerves cut off started to fester. Two years later, both of his legs had to be amputated at a local hospital of Meishan.
The parents of this boy cherished great hope before the surgery because the hospital had promised them a success rate of 85%, which means most of the patients could get cured. They trusted the doctors because the doctors were kind and looked very trustful. After the boy was already on the operation bed, the parents were asked to sign a consent form right before the surgery, as if it were just a routine procedure. No explanation was offered, so they signed the form without understanding the risk of serious complications at all.
The second child in Shanxi province could walk as well before the surgery, but is disabled now. After the surgery, the muscles of his feet and legs started to atrophy and now his lower extremities are apparently deformed. One year ago before the surgery, it costed 1000 Chinese Yuan a year to buy diapers for his incontinence. But now, not only his legs are disabled, but also his previous incontinence gets more severe. In 2008, he had a medical examination in Jishuitan hospital in Beijing, and was told by the doctor that it was impossible to restore to the same status as before by performing any further surgery on his legs.
The third kid in Deyang County was thought being lucky by his mother initially after the Xiao procedure. The kid was still very young and the case was not very severe before surgery. She was happy that the disease seemed to be cured a little and at least did not get worse as others after surgeries. But half a year later, the leg which was operated started to atrophy and became thinner.
"The whole journey was very depressing," Liu Lin said, "It was cruel to ask the patients any questions."
According to Liu, these kids who were harmed by the Xiao procedure were less naughty or active, and were not curious about strangers, but kept silence to themselves. Their parents cannot help weeping as telling others their miserable stories after the surgery. "They were waiting with hopes for the surgery, but now their hopes were broken, and eventually they fall in despair. I could feel their pain." Liu said to the News.
All the kids dropped out of schools and they don't want to go back. One was in the middle school before the Xiao procedure and gave up school later. He is just a small boy, but he can neither walk nor play as other kids, which is not convenient to him.
Liu Lin also said to News that she would follow up with more patients having the Xiao procedure. She is collecting more evidences to refute the possible argument in court from the advocators of the Xiao procedure, which are insisting that these are only individual cases of unsuccessful surgeries. One patient by the name of Little Shanshan advertised by the doctors as a special case is actually a failure too after the Xiao procedure. "We have been trying our best to find a successful case, but we can't." she said.
As for financial situation of the patient family, Liu Lin told the News, the one in Meishan County is able to pay the operation fee, but the parents are very angry at the hospital, because they were cheated and harmed. They want to sue the hospital not just for recouping their expenses. The kid in Deyang, his family has several kids and his operation fee was paid by his relatives. The one in Guangyuan also told her that they want to sue the hospital not just to recover the operation fee of the Xiao procedure, but they want the justice to be done.
The last one in Shanxi province, his father was a coal miner and is laid-off now. This family is living in the cave of a mountain and has no heating in this cold winter. His father raises 30 pigs and needs to save the heating for the piggy cubs, otherwise they will get sick in the cold. He has finished high school and wanted to make the justice to be done as well. These patients are preparing for suing the hospital who misleads them for the Xiao procedure with misleading and false statements on the surgical risks and effectiveness.
An investigation of Shenyuan Hospital (summary)
Beijing Sci-Tech Weekly. Dec 08, 2009
Reporters: Cai Hong and Tan Na
Beijing Sci-Tech Weekly joined the rank of official media questioning the effectiveness of the so-called the "Xiao procedure". On December 8, the paper carried a lengthy report on the upcoming litigation case brought on by two patients against Dr. Xiao Chuanguo and his hospital in a local court.
The report cited that the two patients, children with spinal bifida, were misled by the widely reported "85% success rate" and received the procedure three years ago. The procedure proved to be ineffective and they both suffered from serious side effects in their legs.
More significantly, the reporters found the very first patient of the Xiao procedure, a boy named Little Shanshan. In 2006, Little Shanshan underwent the Xiao procedure and was claimed to a complete success. His case was reported in many newspapers, inspiring hundreds of spinal bifida patients for the procedure. Dr. Xiao Chuanguo himself has also frequently cited these reports as proof of his success.
The reporters got contact with Little Shanshan's mother, who unequivocally stated that Little Shanshan's surgery has been a failure. The boy is still wearing diapers today. His mother further claimed that, during the time immediately after the surgery, doctors had Little Shanshan drink a lot of water whenever there were media coming to visit. They then used electric stimulus to help Little Shanshan pee. After they returned home, Little Shanshan never gained the ability to pee on his own. The only thing doctors tell them is that things may get better as the boy grows older.
That has obviously not happened yet.
How Xiao Procedure trials started in U.S.
By Yush
The clinical trials on the so called "Xiao Procedure" are currently undergoing in the U.S. [a, b], despite of the fact that the procedure has long been questioned in China and recently found by Chinese lawyers and reporters to be ineffective and risky. We thus raise the question: how could the clinical trials have started in the U.S.? We find the answer after thoroughly examining the information from different sources: Dr. Xiao Chuanguo provided false or dubious information regarding his procedure, and some hospitals in the U.S. accepted Dr. Xiao's self-claim without discrimination.
Dr. Xiao published a review article [c] in the European Urology, in which he claims by citing his conference report [25]
By the end of 2004, a total of 92 SCI patients with hyper reflexic or acontractile bladder in our hospital have been treated with the somatic and autonomic reflex arc procedure and 81 of them regained bladder control one year postoperatively [25].
...Up to date, we have performed the procedure for bladder and bowel control safely on 110 children with spina bifida [25]. The rate of success at the one year follow-up is 87%, compared to the 85% for the first 20 cases reported.
...Occurrence rate of partial loss of the left L4 or L5 motor function after surgery, the only complication for 25% of the first 20 cases, has been dramatically reduced to 5% with only slighter and recoverable muscular weakness by using only half of the lumbar ventral root [25].
Dr. Xiao's report [25] cited by the review [c] provides so far the best rate of success, the least rate of risk, and the largest number of patients among his publications. These data have logically become the major reference of the U.S. trials (see the ClinicalTrials.gov registry [a] and the project description at the NIH grant website [b]), and have been frequently cited by William Beaumont Hospitals in various occasions, such as its press release [d], the department description [e], and the one-year clinical report [f].
Unfortunately, these critical data are very suspicious.
A piece of material [g] dated on August 28, 2004 from the Propaganda Department of Dr. Xiao's hospital reveals: "since 2000 ... 62 patients with spina bifida have been treated in Xiehe Hospital," including Dr. Xiao's very first 20 patients who were followed up "over two years". In contrast, the report [25] dated on July 2-4, 2005 gives a total of 110 children with spina bifida who had been followed up for one year with 87% success rate, excluding the first 20 patients.
Another piece of news of March 2006 [h] from Dr. Xiao's university says: "up to date, 218 "artificial reflex arc" operations have been carried out in China; the rate of effectiveness is as high as 80%." However, there are total 237 cases reviewed in the article [c] (92 SCI and 110 spina bifida in the report [25], and 15 SCI and 20 spina bifida cases in Xiao's previous papers), and all these cases should have been followed up for one year by the end of 2004. By doing a simple math, we can find that there are 174 effective cases in the 2006 news [h], whereas there are total 206 successful cases in the 2005 review article [c] (81 + 110x87% in the report [25] and 15x80% + 20x85% in the previous papers).
Dr. Xiao's institute has no reason to play down its professor's achievement. The contradiction in the number of patients and success or effective rate can only be explained in such a way that the data in Dr. Xiao's article were either exaggerated or fabricated.
In fact, even the data from Dr. Xiao himself are also inconsistent. In a TV program [i] on March 29, 2009, Dr. Xiao admitted "the success rate is nearly 80%". Several months later in his presentation [j] at the SIU 2009 Congress, the rate dramatically increased to 86.2%. Moreover, in his presentation, he claimed that 506 cases were followed up for 12 months at Shenyuan Hospital, and presented the statistics of the urodynamic data of the 506 cases. Several days later, he said a slip of the tongue in his web post [k] that "only about 400 of the patients were followed up with urodynamic study".
Finally, the conference report [25] does not exist in the literature. There indeed exists an International Conference of Urology in Shanghai on July 2-4, 2005, which was solely sponsored by the Chinese Journal of Clinical Urology, Dr. Xiao being the Editor-in-Chief; there indeed exists a proceeding of the conference in the literature database, but Xiao's report disappeared.
Unfortunately, this is not the only case that Dr. Xiao manipulated clinical data.
On February 28, 2007, the Neuro-Urologic Surgery Research Center (a.k.a Shenyuan Hospital) at Zhengzhou University signed an official document [l] for Dr. Xiao, the Director of the Center, for his bid for the membership of the Chinese Academy of Sciences (CAS). The Academician is the most honorable title for a scientist in China to pursue. In this supporting document, it was claimed that, starting from January 2006, the Center had applied the procedure to 117 patients, "Sixty cases were followed up for more than eight months. 85% of the patients have regained normal bladder and bowel functions."
What was claimed in the supporting document is anything but truth. The Center did not come into existence until August 2006 and conducted its first operation on August 13. Ridiculously, less than 7 months later, the Center produced the document for its Director stating that they have conducted "more than 8 months" follow-ups on 60 patients. This ridiculous incident could not be the result of mistakenly dating the document, because the deadline for submitting application package was April 30, 2007 as required by the CAS.
In fact, Dr. Xiao has a long history of telling lies. Just to mention a few. He lied about winning the America Urological Association (AUA) Achievement Award in his resume [m]. The original copy of the resume disappeared from the internet after Dr. Fang Zhouzi exposed the fact along with Dr. Xiao's other misconducts, but the claim of winning the award can still be found on the internet, such as at Ho Leung Ho Lee Foundation's website [n]. Another example is that the expert panel who once evaluated the 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 work 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 [o].
Now that Dr. Xiao dared to fabricate an official document for the most honorable academic title in China, lie about his award and his work, why could not he play the same trick in his paper for it to be published in a prestigious urology journal in Europe, and in turn to deceive the top institutions in the U.S.?
Dr. Xiao failed in his application for the Academician in China, three times in row every two years. His procedure was not recognized at all in China. Ironically, clinical trials of his procedure have started in the U.S..
The question is: could the top institutions in the U.S., such as the National Institutes of Health, Beaumont Hospitals and All Children's Hospital, be so naive to be deceived and rashly start clinical trials based on suspicious data?
The answer is definitely YES.
"The procedure has not gained widespread acceptance outside of China," Beaumont's one year clinical report [f] implies the Xiao Procedure's widespread acceptance "inside" of China. In at least three responses [p, q, r] to patients' inquiries, Beaumont team said explicitly:
In China, this procedure is now standard of care. Dr. Xiao has taught this procedure to surgeon's at all the major hospitals in China.
......
>> This surgery is now standard of care in China. Dr. Xiao has taught this procedure to surgeons all over China. It is done everyday in hospitals in China. If you really want to have this procedure done on your son, we would suggest going to China. ... If you are at all interested in going to China, I would be happy to forward your information to Dr. Xiao. I have done this with other families.Beaumont's words regarding the acceptance of the procedure are absolutely not reflecting the truth, whose source apparently can be traced back to Dr. Xiao.
Xiao Procedure is not standard of care in China. Dr. Xiao has failed to teach this procedure to surgeons in China, as he admitted in an interview with China News Weekly, and his team is the only one who has the ability to perform this procedure. Moreover, no major hospital except a couple of affiliated hospitals of the university, where Dr. Xiao is the director of Urology Department, did it before mid-2006, and only one local private for-profit hospital, Shenyuan, where Dr. Xiao owns 30% of its shares, did it after August 2006.
The procedure has never been performed by surgeons in China other than Dr. Xiao's team, let alone being widely accepted in China, either by critics, or by doctors and patients. It has been questioned by Dr. Fang and the readers of the New Threads since 2005. Dr. Fang hereby faced nearly 10 libel lawsuits filed by Dr. Xiao and lost one case in a local court in Dr. Xiao's hometown, based on the following court findings, which became a joke teeming Chinese internet forums: "the defendant Fang could not find the plaintiff's name on the list of award winners cannot deny the fact that the plaintiff won the award. Therefore, it is an established fact that the plaintiff has won the AUA Award." Recently, some top experts, in defiance of Dr. Xiao's potential legal action, finally expressed their concerns over the lack of scientific basis of the Xiao Procedure and unethical for-profit practice of this questionable procedure without adequate and proper clinical trials. Those experts include the one and only Academician in urologic surgery, directors from departments of urology in major hospitals, and even members of the expert panel who once evaluated this procedure. In addition, the procedure has long been infamous across Chinese internet forums where there are full of complaints from patients who received this procedure; no single success case can be found from patients' posts. The only places where the procedure gets popular are the more than 50 (by the end of 2007) online advertising websites, where spamming posts from Shenyuan Hospital flood along with those of cures for cancer and diabetes.
Beaumont team took and further propagated the lie of so called widespread acceptance. What's worse, they based their trial at least partially on this lie, citing the lie in their one year report as the evidence. What's the worst, in at least two of their responses, they suggested the patients (and they "have done this with other families") to go to China for the surgery, in spite of the fact that the surgery "much is still unknown" [b] to them and the "results are too immature to report yet" [q].
Because of the unknowns, "if a parent walked into my office and stuck $50,000 in my face, I'd have to say no." Dr. Kenneth Peters, Chairman of Urology Department who leads the trial at Beaumont, once told St. Petersburg Times [s] before he would "emphasize caution" at the First World Conference on Spina Bifida Research, "Do the benefits outweigh the risks? I'm not ready to say that."
But, what has Beaumont team actually already done with patients who are "desperate for help [s]" from them?
Thanks to Beaumont's effort of spreading the lie, there were more than 90 U.S. patients that had been "successfully treated" by the procedure, as announced by the website of Dr. Xiao's Chinese Journal of Clinical Urology, after Dr. Xiao was interviewed by CNN [t]. We have noticed that each foreign patient is charged about 20,000 USD, whereas each local patient 30,000 CNY (4,400 USD).
What would be the destinies of the 90 U.S. patients, along with 9 patients with SB and 3 patients with SCI ("were not helped by the procedure" [s]) at Beaumont, 8 children at All Children's Hospital ("may eventually involve 100 children" [s]), as well as 6 SCI patients ("only 2 showed some improvement" [j]) in Germany?
On the same occasion, Dr. Peters told St. Petersburg Times: "I was wowed in China when I saw Dr. Xiao's data." [s]
Thus, the final question is: what data did Dr. Peters really see, or in other words, what data was Beaumont's trial based on? the suspicious data from the non-existent report [25]? or the data similar to what Dr. Xiao created out of thin air then presented to the CAS? the widespread acceptance of the Xiao Procedure in China where it has never been accepted? the so called international recognition that Dr. Xiao told the expert panel while at the time he was fired by his U.S. employer? or the lightly mentioned "dramatically decreased incidence of these complications" [c, d], "small risk of some foot weakness" [u] or the later "cautious findings in Beaumont" that need to be "emphasized" and "prompted intense debate at All Children's" [s]?
The answer to this final question is exactly to the very first question: how could the clinical trials have started in the U.S.?
REFERENCES
[a] Lumbar to Sacral Ventral Nerve Re-Routing.
Identifier: NCT00378664
http://www.clinicaltrials.gov/ct/show/NCT00378664[b] Safety and Efficacy of Nerve Rerouting for Treating Neurogenic Bladder in Spina Bifida.
Project Number: 1R01DK084034-01
http://projectreporter.nih.gov/project_info_description.cfm?aid=7696321
He has reported that in 92 SCI patients, 88% regained bladder control within one year after the nerve rerouting surgery and in 110 children with spina bifida, reported success in 87% at one year. However, in China rigorous follow up is challenging....[c] Xiao CG. Reinnervation for neurogenic bladder: historic review and introduction of a somatic-autonomic reflex pathway procedure for patients with spinal cord injury or spina bifida. Eur Urol. 2006 Jan;49(1):22-8; discussion 28-9. Epub 2005 Nov 2.
http://www.ncbi.nlm.nih.gov/pubmed/16314037
[25] Xiao CG. A somatic-autonomic reflex pathway procedure for neurogenic bladder and bowel: results on 92 patients with SCI and 110 children with spina bifida. . In: Proceedings of the International Conference of Urology; Shanghai, July 2-4, Shanghai, China; 2005.[d] Beaumont Hospitals' press release.
Beaumont sees results in nation's 1st urinary nerve rewiring surgeries for spina bifida patients. 04/17/2008.
https://www.beaumonthospitals.com/news-story-beaumont-results-urinary-nerve-rewiring-surgeries-spina-bifida-patients
Chuan-Guo Xiao, M.D., reports an almost 90-percent success rate....Possible side effects of the surgery include mild postoperative spinal fluid leakage, lower extremity weakness and headache. Recent changes in the surgical technique have dramatically decreased the incidence of these complications. Standard risks associated with any surgery may include bleeding and infection.[e] Beaumont Hospitals' Research by Department, Urology.
https://www.beaumonthospitals.com/research-institute-research-by-department-urology
Beaumont Hospitals launched a research study to "rewire" nerves in the spinal cord in the hope of giving bladder control to people with spinal cord injury or spina bifida who otherwise depend on self-catheterization to urinate. The first procedure garnered national attention and appeared in more than 160 news outlets including U.S. News & World Report, The Washington Post and Forbes.
...Chuan-Guo Xiao, M.D., reports an almost 90-percent success rate.[f] Beaumont Hospitals' one-year clinical report.
http://linkinghub.elsevier.com/retrieve/pii/S0022534709608843
Despite a reported success rate as high as 87% at one year, the procedure has not gained widespread acceptance outside of China.[g] New Technique Helps Children with Spina Bifida.
Propaganda Department of the Party Committee of Wuhan Xiehe Hospital, August 28, 2004
http://www.xys.org/forum/db/176/44.html
http://www.cnhan.com/gb/content/2004-08/29/content_380330.htm
Since 2000, 62 patients with spina bifida have been treated in Xiehe Hospital, most of them have obtained remarkable effects. Among the 20 patients who were followed up systematically over two years after surgery, 17 patients obtained bladder control and voluntary voiding functions in 8-12 months after surgery.... Among the rest 42 patients, the bladder functions of 71% of 21 patients who underwent urodynamics examination (6-12 months after surgery) have improved; the other 21 patients are still to recover, since it is less than 6 months after surgery.[h] Wuhan Xiehe Hospital "Exports" Surgery Technique.
Huazhong University of Science and Technology Weekly, Issue 205, March 2006
http://weekly.hustnews.com/text/show.aspx?id=6428
In 1995, Xiao Chuanguo, who invented "artificial reflex arc" after over 10 years of concentration, returned to China, and successfully performed the magic "artificial reflex arc" operation on a group of paraplegic patients for the first time. The patients obtained voluntary voiding function in about one year after operation. ???? Up to date, 218 "artificial reflex arc" operations have been carried out in China; the rate of effectiveness is as high as 80%.[i] The Wonder of "Magic Reflex Arc": Scratching Thigh to Cure Incontinence.
Hubei Provincial Broadcast and Television, News Channel, News at Six, March 29, 2009
http://news.hbtv.com.cn/content/2009-03/29/content_1614131.htm
Xiao Chuanguo: "We have solved the big problem that has not been solved in hundreds of years. We have done 1500 cases, the success rate is nearly 80%."
At first, foreign experts were skeptical that how the problem for hundreds of years could be so easily solved by Xiao Chuanguo. Xiao did not argue, instead he went to the U.S. himself last year, and did 12 around-the-clock surgeries in the presence of experts from the world. All surgeries completely succeeded, astonishing the international medical communities. Experts around the world began to come to Wuhan on their own expense to learn the Xiao Procedure.[j] Xiao Chuanguo's presentation at the 30th Congress of SIU (SIU 2009)
Shanghai, China, November 1-5, 2009.
http://webcasts.prous.com/netadmin/webcast_viewer/Preview.aspx?type=0&lid=10196&pv=2
Slide 56: Xiao Procedure for Spina bifida
1406 cases since 2006 in Henan Center, of the 506 follow-up at 12 month post-surgery, 435 gained bladder control
Slide 57: Comparison of urodynamic data in spina bifida patients
Effective Rate: 435/506=85.9% Pre & Post Surgery(1yr)
Slide 80: Tubingen Experience, Germany
6 SCI patients, only 2 showed some improvement. Possible causes: incorrect patient selection? inappropriate postoperative care?[k] Xiao Chuanguo's web post.
http://www.rainbowplan.org/bbs/topic.php?topic=103290
Posted by: WWWW 2009-11-15 01:22:52
The intention to support to set up the (Shenyuan) Hospital was more effectively doing follow-up and scientific research, but (the doctors) were all busy doing surgeries. So nearly 1500 cases have been done in more than 2 years, but only about 400 of the patients were followed up with urodynamic study.[l] Certificate for Xiao Chuanguo's CAS application
http://xysblogs.org/wp-content/blogs/107/uploads/shenyuan.jpg
Neuro-Urologic Surgery Research Center (a.k.a Shenyuan Hospital) at Zhengzhou University, February 28, 2007
Starting from Jan. of 2006, the Neuro-urological Surgery Research Center at Zhengzhou University has applied the "artificial somatic-autonomic reflex arc" technique invented by Professor Xiao Chuanguo to 117 patients with neurogenic bladder caused by spina bifida or meningomyelocele. Sixty cases were followed up for more than eight months. 85% of the patients have regained normal bladder and bowel functions.[m] Xiao Chuanguo's resume claiming he won AUA Achievement Award
http://xysblogs.org/wp-content/blogs/107/uploads/041210_cgxiao_cv.doc[n] Ho Leung Ho Lee Foundation's website showing Xiao Chuanguo won AUA Achievement Award
http://www.hlhl.org.cn/english/showsub.asp?id=476
Dr. Xiao has been awarded ... America Urological Association Achievement Award (2000)[o] Summary order from US Court of Appeals for the Second Circuit
http://vlex.com/vid/chuan-guo-xiao-continuum-18536135[p] Patients' posts regarding Beaumont Hospitals' responses.
http://webcache.googleusercontent.com/search?q=cache:qlNsld4U63UJ:spinabifidaconnection.com/showthread.php%3Fp%3D3209[q] Patients' post regarding Beaumont Hospitals' responses.
http://sci.rutgers.edu/forum/showpost.php?p=878421&postcount=44
our results are too immature to report yet in the spinal cord injury, ...Dr. Xiao in China who developed the surgery may be able to perform this on you there.[r] Letter from Beaumont Hospital on Xiao Procedure.
http://ronandmelissa.com/wp/?p=52
http://www.facebook.com/topic.php?uid=6743851747&topic=6088[s] Experimental Surgery Helps Relieve Kids with Spina Bifida and Spinal Injuries
By John Barry, Times Staff Writer, March 15, 2009
http://www.tampabay.com/features/humaninterest/article984049.ece[t] CNN Interviews "Xiao Reflex Arc"
Chinese Journal of Clinical Urology, June 12, 2009
http://www.cjcu.com.cn/showart.aspx?artid=3187
In the U.S. Professor Xiao Chuanguo has conducted the clinical implementation of this technique, and so far has successfully treated more than 90 cases of incontinence caused by spinal cord injury, spina bifida and other spinal cord diseases.[u] Surgery Might Aid Bladder Control after Spine Surgery
http://www.nctimes.com/lifestyles/health-med-fit/article_8b6c668a-94bb-59fc-b7d3-266bef6ecbe3.html
Lauran Neergaard, Associated Press, February 18, 2007
There are some risks, Peters cautioned, including general anesthesia and wound infections. For children with spina bifida who can walk, rerouting the thigh nerve causes a small risk of some foot weakness.
