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03-09-2010, 01:00 AM   #1
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Be aware of Xiao Procedure: an open letter of complaint against it

We, New Threads Volunteers, have formally filed the complaint to the IRBs of two hospitals and several federal oversight agencies against the clinical trials on the Xiao Procedure, which, according to our evidence, we believe to be primarily based on misinformation regarding the Xiao Procedure, including the untrue implementation status in China, distorted success rate, and understated risks.

Most of the facts presented in the Open Letter of Complaint against the Xiao Procedure are summarized from reports from Chinese lawyers and media. The evidence supporting all allegations can be found in the enclosed material, which consists of:

1. A list of reports on the activities of the New Threads and Dr. Fang Zhouzi from prestigious English media, such as Science, Nature, New Scientist and Chronicle of Higher Education. Some of which have reported the Xiao vs. Fang legal case.

2. The English translation of the report from Chinese pro-bono lawyers who support Dr. Fang, victims of scientific frauds, and victims of public incidents, such as those of the infamous scandal of melamine-tainted milk.

3. The English translation of the recent reports regarding the Xiao Procedure from major Chinese media, including Science News (China's first professional news magazine serving scientist communities), China News Weekly (published by China's second largest news agency), and Beijing Sci-Tech Weekly (China's first specialized newspaper in science and technology serving the public).

4. A blog article by one of the Volunteers, trying to answer the question "how Xiao Procedure trials started in U.S.", and providing additional evidence supplementing the lawyers and media's reports.

For more information about the Xiao Procedure and Dr. Xiao Chuanguo, please visit our blog at

http://xysblogs.org/xysergroup/


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

P.S.

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.../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...xpletterc.html

This 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.

Enclosures.

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
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03-09-2010, 05:42 AM   #2
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Previous Xiao discussion: forum/showthread.php?t=126166
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03-09-2010, 05:25 PM   #3
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xyusergroup,

I suggest that you append your real name(s) and credentials to the letter of complaint that you just posted on CareCure. You appear to be anonymously making very serious allegations of misconduct against a well-known clinician. While this may be customary in China, this is not acceptable behavior in the United States.

According to a link in your post, Dr. Xiao Chuan-Guo filed a defamation lawsuit against Sohu Information Technology Inc., the University Press of Peking Union Medical College, and Fang Shi-min in 2006. Are you one of the party that he filed the lawsuit against, i.e. Fang Shi-min (pen-name Fang Zhou-zhi)?

Or are you representing the "intellectuals in China" who are listed as signatories of a letter protesting the 2006 judgment by the Jianghan District Court of Wuhan City against the Fang Shi-min, ordering him to apologize publicly and compensate Dr. Xiao?

Who are the "New Threads Volunteers"? Whoever you are, please do not involve CareCure in the acrimonious personal exchanges between you and Dr. Xiao. If you are interested in discussing the merits of Dr. Xiao's method and whether or not people with spinal cord injury can benefit from the treatment, you are of course very welcome to post and discuss the method although your credibility would be much enhanced if we knew who you are.

One of the rules of this site is that members must not attack another member of CareCure. The complaint letter that you have posted is a personal attack of Dr. Xiao. Since Dr. Xiao may very well be a member of CareCure, I suggest that you avoid further personal attacks of him. Since the letter of complaint has been published elsewhere, I will allow the letter to remain on this site but please confine futher discussion to the surgical method.

In another thread, I had summarized the published works of Dr. Xiao reporting his scientific and clinical findings. I had also described what I have seen at Dr. Xiao's presentations at public symposia. Incidentally, the first presentation that I saw Dr. Xiao make was at the First International Spinal Cord Injury Treatment and Trials Symposium (ISCITT) held in December 2005 and sponsored by ChinaSCINet. I think that ChinaSCINet may have had some DVD's of that symposium for sale and there may be some left.

Wise.

Last edited by Wise Young; 03-09-2010 at 05:36 PM.
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03-10-2010, 12:49 AM   #4
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Dr. Young,

Firstly, we thank you for allowing the letter to remain here. We also thank you for frequently alerting the members of CareCure forums, such as that "people should not be thinking that this procedure is 85% successful", and especially for having confirmed one of our 10 allegations regarding the acceptance of the Xiao Procedure in China. We believe these are all for the best interest of CC members, as well as of the public.

Secondly, we understand your feeling being personally knowing Dr. Xiao and amazed by his presentation, but we do not agree that this letter is a personal attack. We have replied to one of the readers of our blog on this issue, please see here.

Thirdly, we want to clarify that we are the volunteers who wrote the open letter or translated the supporting material. We collectively answer the questions from the readers of the letter, either on our blog, by email or on the forums. Most of us are professionals or Ph.D. students in various areas, and among the signatories of the open letter protesting the 2006 judgment. We of course are supporters of Dr. Fang Zhouzi, the person who lost one of nine lawsuits filed by Dr. Xiao for one same reason. We have posted the details of the cases on our blog, which you have noticed. You may further read the story of the case appearing in the reports by Science Magazine ("China's fraud buster hit by libel judgments; defenders rally around") and South China Morning Post ("the lie detector").

Moreover, the facts in the open letter are regardless of our own credibility, since most part of the letter is simply the summary of the reports from Chinese lawyers and media, while the other small part is based on the evidence from various sources, such as from Dr. Xiao, Beaumont Hospitals, US media, and the internet forums like CareCure.

Finally, we have stated in the open letter why we do not disclose our identities to the public. We have filed a formal complaint to authorities endorsed by our representative, so that this letter is essentially not an anonymous one. Considering the lengthy investigation processing and the emergency that new trials in many US hospitals are right on the way, we have to post this letter on the internet as early as possible. This, again, is for the interest of the public.

New Threads Volunteers
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03-10-2010, 06:10 AM   #5
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xyusergroup,

I am disappointed that you are not admitting to who you are. By hiding behind a name such as xyusergroup and claiming that you are a group of anonymous individuals, you are keeping your identity hidden. You are criticizing another man's integrity and claiming that he is lying about the success rate of his surgical procedure but yet you are unwilling to say who you are. I understand your fear of being sued but that fear is precisely why it is important that people identify themselves when criticizing others. In the United States, anonymous character assassination is not acceptable and seriously detracts from your credibility.

Regardless of whether you agree your letter is personally attacking Dr. Xiao, I ask you to please refrain from attacks of him in the future on this site. Many parts of your letter go well beyond the facts and represent your personal subjective interpretations concerning Dr. Xiao's integrity. You should understand that "investigations" by lawyers are not highly regarded as sources of unbiased assessments because lawyers are traditionally expected in the United States to take sides in cases, regardless of truth. If you refer to so-called "experts", please identify them by name and credentials. For example, you are saying that certain "experts" disagree with Dr. Xiao's scientific explanations of the mechanisms of bladder reinnervation. Who are they? What makes them experts? The failure to identify them and the source of their authority makes your claims less credible.

Clinical trials by unbiased third party doctors is what is required to ascertain whether this procedure is safe and effective. In a news report (Source), Dr. Kenneth Peters of the William Beaumont Hospitals was appropriately cautious in his assessment of the efficacy of the Xiao procedure in patients, calling the results "mixed". He pointed out that the treatment was "unsuccessful" in three spinal cord injury patients out of 12 operated patients. What you omitted in your description of that study is Dr. Peters statement that 7 of 9 patients with spina bifida showed "marked improvement", including one girl that was considered a "home run" and recovered "complete continence". Also, according to the news report, the study was a blinded one, i.e. comparing patients who had only untethering and those that had the peripheral nerve bridging. It would be very interesting to see the publication of these results in a peer-reviewed journal.

Wise.
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03-10-2010, 06:31 AM   #6
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xyusergroup,

Thank you for posting http://webcasts.prous.com/netadmin/w...lid=10196&pv=2

This is a video of Dr. Xiao's presentation at SIU. It includes details of his preclinical animal work supporting the clinical procedure. It describes his results and his claim of 80% success rate. It showed videos of adult patients micturating when scratching themselves on the dermatome of the bridged nerves.

Wise.
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03-11-2010, 01:54 AM   #7
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Dr. Young,

You underestimated the retaliation that Dr. Xiao might apply to us. If the retaliation were restricted to legal actions only, we perhaps would be brave enough to face it. But it is towards our personal safety and career. One of the experts was excluded from the editorial board of the Chinese Journal of Clinical Urology (Dr. Xiao is the editor-in-chief), shortly after he expressed his opinion on the Xiao Procedure to the media. His name is Song Bo, the leader of the Continence and Female Urology Group of the Chinese Urological Association. Dr. Xiao once offered a reward for the identity of one of the volunteers, and threatened to "take any action". Dr. Xiao once had button men to tail and blackmail Dr. Fang Zhouzi. His most recent threat to Dr. Fang is "I would not hesitate to avenge Fan Zhouzi in the most treacherous way". Dr. Young, how would you interpret "the most treacherous way" after Dr. Xiao launched 9 lawsuits against Dr. Fang several years ago and only won once?

In spite of that, our representative has personally signed the complaint letter to the US authorities, and if necessary, most of us would like to present our identities to the authorities, along with the contact information of Chinese lawyers, reporters and experts.

Those experts' include the one and only member of Chinese Academy of Engineering in the area of urologic surgery, the directors of departments of urology in major hospitals or institutes, and the members of the expert panel who once evaluated the procedure. You can find their names and titles, along with their opinions in the news reports attached to the open letter.

As for the pro-bono lawyers who conducted the independent investigation and help the patients' cases, we would like to emphasize that they are also volunteers without any personal benefits from the investigation and the cases, which are for the interests of the public.

We dare to bluntly accuse Dr. Xiao of lying about the success rate, the only reason is that we have pure and simple evidence. Please take a look at the certificate for his CAS member application testifying the "85% success rate", obtained by the reporters, and compare the date on the certificate to the date when the hospital (or the center) conducted its first surgery in this news report. We hope your Chinese is good enough to read those, so that you can tell yourself and the members of this forum how strong our evidence is.

We also accused Dr. Xiao's data of being dubious, which you can as well verify by yourself by searching the literature for his non-existent report[25], which forms the base of his 2006 review article and subsequently the US trials.

Almost all of the evidence can be found in the supporting material of our open letter. Our volunteers are translating few other Chinese reports that we had no enough time to do before.

Nobody can be free of personal subjective interpretations, just like you, Dr. Young. When you described the Xiao vs. Fang cases in your previous post, you only mentioned the defamation lawsuit in Wuhan where Dr. Fang was ordered "to apologize publicly and compensate Dr. Xiao", what you omitted are that the presiding judge was disciplined, and that this was the only case that Dr. Xiao won among 9 cases, all other cases, either Dr. Xiao lost, or were dismissed or ended up with nothing.

Nevertheless, we have provided the links to Beaumont's clinical report, its web pages, and the related news reports, and we describe its study as "the 'success' of Beaumont's SB patients", although we pointed out its problems, for example, mean PVR = 119 +/- 125 cc, the standard deviation of the post-void residua is larger than the mean, how "mixed" of the "marked improvement" could it be. How much are Dr. Xiao's own data? Mean PVR=23.67 ml in his 2005 paper, and 56.3+/-21.6 ml in his SIU 2009 presentation.

We believe Beaumont is much more cautious now, after they saw their results. But what they said before? "almost 90-percent success rate", "small risk of some foot weakness".

The study at All Children's Hospital (ACH) can no way be "double-blind". It can only be "controlled". Dr. Xiao blamed the failure of SCI cases to "incorrect patient selection" and "inappropriate postoperative care", which implies that patients who undergo the surgery need special cares, so that patients know who get the procedure.
Their parents were told that the All Children's study is a blinded one. That means there is a control group that gets the detethering, but does not get the Xiao procedure. The parents won't know who got what until the study is over.

Finally, we thank you very much for your suggestion on the "experts" issue. We would like to collect experts' opinions, and will post them on our blog in the coming couple of days.

New Threads Volunteers
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Unread 03-11-2010, 02:24 AM   #8
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See the Danish SCI magazine RYK page 26 to 27 http://ryk.dk/magasin/ipaper/ryk!4-2009 as for the Xiao procedure. The Danes are planning for clinical trials for the Xiao procedure, not limited only to that but use it as is. Denmark national SCI website. http://ryk.dk/
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Unread 03-11-2010, 06:38 AM   #9
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Quote:
Originally Posted by xysergroup View Post
Dr. Young,

You underestimated the retaliation that Dr. Xiao might apply to us. If the retaliation were restricted to legal actions only, we perhaps would be brave enough to face it. But it is towards our personal safety and career. One of the experts was excluded from the editorial board of the Chinese Journal of Clinical Urology (Dr. Xiao is the editor-in-chief), shortly after he expressed his opinion on the Xiao Procedure to the media. His name is Song Bo, the leader of the Continence and Female Urology Group of the Chinese Urological Association. Dr. Xiao once offered a reward for the identity of one of the volunteers, and threatened to "take any action". Dr. Xiao once had button men to tail and blackmail Dr. Fang Zhouzi. His most recent threat to Dr. Fang is "I would not hesitate to avenge Fan Zhouzi in the most treacherous way". Dr. Young, how would you interpret "the most treacherous way" after Dr. Xiao launched 9 lawsuits against Dr. Fang several years ago and only won once?

In spite of that, our representative has personally signed the complaint letter to the US authorities, and if necessary, most of us would like to present our identities to the authorities, along with the contact information of Chinese lawyers, reporters and experts.

Those experts' include the one and only member of Chinese Academy of Engineering in the area of urologic surgery, the directors of departments of urology in major hospitals or institutes, and the members of the expert panel who once evaluated the procedure. You can find their names and titles, along with their opinions in the news reports attached to the open letter.

As for the pro-bono lawyers who conducted the independent investigation and help the patients' cases, we would like to emphasize that they are also volunteers without any personal benefits from the investigation and the cases, which are for the interests of the public.

We dare to bluntly accuse Dr. Xiao of lying about the success rate, the only reason is that we have pure and simple evidence. Please take a look at the certificate for his CAS member application testifying the "85% success rate", obtained by the reporters, and compare the date on the certificate to the date when the hospital (or the center) conducted its first surgery in this news report. We hope your Chinese is good enough to read those, so that you can tell yourself and the members of this forum how strong our evidence is.

We also accused Dr. Xiao's data of being dubious, which you can as well verify by yourself by searching the literature for his non-existent report[25], which forms the base of his 2006 review article and subsequently the US trials.

Almost all of the evidence can be found in the supporting material of our open letter. Our volunteers are translating few other Chinese reports that we had no enough time to do before.

Nobody can be free of personal subjective interpretations, just like you, Dr. Young. When you described the Xiao vs. Fang cases in your previous post, you only mentioned the defamation lawsuit in Wuhan where Dr. Fang was ordered "to apologize publicly and compensate Dr. Xiao", what you omitted are that the presiding judge was disciplined, and that this was the only case that Dr. Xiao won among 9 cases, all other cases, either Dr. Xiao lost, or were dismissed or ended up with nothing.

Nevertheless, we have provided the links to Beaumont's clinical report, its web pages, and the related news reports, and we describe its study as "the 'success' of Beaumont's SB patients", although we pointed out its problems, for example, mean PVR = 119 +/- 125 cc, the standard deviation of the post-void residua is larger than the mean, how "mixed" of the "marked improvement" could it be. How much are Dr. Xiao's own data? Mean PVR=23.67 ml in his 2005 paper, and 56.3+/-21.6 ml in his SIU 2009 presentation.

We believe Beaumont is much more cautious now, after they saw their results. But what they said before? "almost 90-percent success rate", "small risk of some foot weakness".

The study at All Children's Hospital (ACH) can no way be "double-blind". It can only be "controlled". Dr. Xiao blamed the failure of SCI cases to "incorrect patient selection" and "inappropriate postoperative care", which implies that patients who undergo the surgery need special cares, so that patients know who get the procedure.
Their parents were told that the All Children's study is a blinded one. That means there is a control group that gets the detethering, but does not get the Xiao procedure. The parents won't know who got what until the study is over.

Finally, we thank you very much for your suggestion on the "experts" issue. We would like to collect experts' opinions, and will post them on our blog in the coming couple of days.

New Threads Volunteers
xyusergroup,

I have asked you to confine your statements to Dr. Xiao's procedure and to refrain from personal attacks. You say that you are afraid of personal retaliation and yet you are again making personal attacks of Dr. Xiao on this public forum. In case you do not understand what I mean by personal attack, I refer to your repeated claims that Dr. Xiao is dishonest and that he has made threats against you. Please do not bring your acrimonious personal vendetta onto CareCure. It is clearly a vendetta, a campaign to discredit Dr. Xiao. It is not welcome on this site. I am consequently moving this thread into the Members Only Forum. If you make another attack post, I will remove this thread and ban you.

Wise.

Last edited by Wise Young; Today at 07:49 AM.
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Unread 03-11-2010, 06:40 AM   #10
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Looks interesting. - very encouraging that at least something is happening..
I'd much rather see attempts to 'bridge the gap' in the spinal cord, but this is a start of some kind..

Edit: This is a respons to Leifs comment.
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nerve rerouting, xiao chuanguo, xiao procedure <