The words in【】are suggested revisions for your reference.

The clinical trials on the so called “Xiao Procedure” are currently undergoing 【being implemented】in the U.S. [a,b], despite of 【despite the fact that】the procedure has long been questioned in China and 【was】recently found by Chinese layers 【laywers】and reporters to be ineffective and risky. We thus raise the question: how could the clinical trials start 【have started】in the U.S.? We find the answer after thoroughly examined 【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 【sufficient 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 success rate, the least rate of risk, and the most 【largest or highest】number of patients among his publications. These data logically became 【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 【and the】one-year clinical report [f].

Unfortunately, these critical data are suspicious.

A 【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”. In contrast, the report [25] gives a total of 110 children with spina bifida who should have been treated before the end of 2003 (one year follow-up by the end of 2004 in [25]).

Another 【Another piece of】news of March 2006 [h] from Dr. Xiao’s university says: “up to date, 218 cases of the 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 【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 found 【find】that there are 174 cases of effectiveness 【effective cases】in the 2006 news [h], whereas there are total 206 cases of success 【successful cases】in the 2005 review article [c] (92×88% + 110×87% in the report [25] and 15×80% + 20×85% in the previous papers).

Dr. Xiao’s institute has no reason to play down it 【its or the】professor’s achievement. The inconsistence in the number of patients and success or effective rate can only be explained that 【in such a way that】the data in Dr. Xiao’s article were either exaggerated or fabricated.

In fact, the data from Dr. Xiao him own 【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 became 86.2%. Moreover, in his presentation, he claimed 【claimed that】506 cases were followed up for 12 months at Shenyuan Hospital. 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 【existed】an International Conference of Urology in Shanghai on July 2-4, 2005, which was solely 【exclusively】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.

This could not be 【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 scholar 【a scientist】in China to pursue. In this supporting document, it 【he】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 recovered 【regained】normal bladder and bowel functions.”

What claimed 【were claimed】in the supporting document are 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 【stating that】they have conducted “more than 8 months” follow-ups on 60 patients. This ridiculousness 【ridiculous incident】could not have occurred due to 【without?】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 lying 【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 one 【in】the internet, such as 【such as in】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 could 【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 in order to 【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 turn 【in row】every two years. Ironically, clinical trials started 【have started】in the U.S..

The question is: could the top institutions in the U.S., such 【such as】Beaumont Hospitals and All Children’s Hospital, be so naive to be deceived and rashly start clinical trials based on fabricated 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 【surgeons ?】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 saying 【words】regarding the acceptance of the procedure is【are】absolutely a lie 【not reflecting the truth】, whose source apparently can be tracked back 【traced back】to Dr. Xiao.

Xiao Procedure is not standard of care in China. First, 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. Second, No major hospital 【hospitals】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, doctors or 【or by】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 【That the】 defendant Fang could not find the plaintiff’s name on the list of award winners can not 【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 that has been taken 【"that has been taken" can be removed?】against Dr. Fang, 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 【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 being the 【as】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 that 【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” from them?

Thanks to Beaumont’s effort of spreading the lie, there were 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, after Dr. Xiao being 【was】interviewed by CNN [t]. We have noticed that each foreign patient is charged about 20,000 USD, whereas 【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 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 “dramatically decreased incidence of these complications” [d], “small risk of some foot weakness” [t] 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 start 【have started】in the U.S.?