We, the New Thread volunteers, previously published an Open Letter of Complaint against the Xiao Procesure on February 25, 2010, and sent it to some U. S. authorities via a representative []. Since then, the Office of Research Integrity (ORI) of Department of Health and Human Services had replied and declined to investigate, citing without jurisdiction and lack of specific allegations. On the other hand, the Office for Human Research Protections (OHRP) recently have decided to take actions, and have initiated an evaluation on the ongoing clinical trials in the US.

In this letter, we intend to give an update on more recent developments related to Dr. Xiao Chuanguo and his procedure. We will also present newly-uncovered evidence that would have precluded the clinical trials and the practising of the procedure. We call for a serious investigation into the Xiao's procedure and the misconducts that might have occurred during its research and implementation in the US and elsewhere in the world.

[b]Section 1: Litigations and cristisms against Dr. Xiao and his procedure in China, and an "open letter"
Section 2: Newly-uncovered materials and new evidence questioning the effectiveness of the procedure
Seciont 3: Serious concerns about ethical violations
Section 4: Our recommendations[/b]

[b]Section 1: Litigations and cristisms against Dr. Xiao and his procedure in China, and an "open letter"[/b]

1.1 Dr. Xiao has been convicted of masterminding two violent attacks on his critics, and has been sentenced to a five-and-a-half-month term in jail.

Police investigation revealed that Xiao paid one of his relatives to hire thugs to attack Mr. Fang Xuanchang and Dr. Fang Zhouzi in revenge of their reports on his fraudulent procedure. Three thugs staged a deadly attack to Mr. Fang Xuanchang, the journalist who published a series of investigative reports on Xiao′s procedure. The same group of mobs ambushed Dr. Fang zhouzi in daylight with chemical spray, hammer and metal pipe, after months of spying and stalking. Dr. Fang narrowly escaped with minor injuries.

The ugly episode has shocked the public, the scientfic community, the media and some Chinese authorities. The Ministry of Science and Technology condemned Xiao's "vicious misconduct and lack of integrity". The Chinese Association for Science and Technology declared their firm support for Dr. Fang. The scandal has also gained world-wide attention and featured in major international media [].

1.2 A growing number of victims of Xiao's procedure are planning lawsuits against Dr. Xiao and his private hospital where he and others had performed the operations.

The number now tops three hundred. The patients′ efforts are being helped by public donation and human right lawyers. Dr. Xiao owned 30% of the shares of the private hospital and was its legal representative. The hospital had been dismantled a few months ago under the instructions of Xiao.

As was reported in our previous open letter, most of the patients had been lured into taking the operation by false information presented by Xiao and his associates in the hospital. Recent developments further revealed that the three much-boasted ¨successful¨ cases, Little ShanShan, the ¨crawling girl¨ and the ¨earthquake hero, were fake as well.

1.3 In the wake of the attacks, the Chinese Medical Association had convened the a group of experts in related fields for a meeting to re-evaluate the procedure. Six top urologists in China have urged publically an immediate ban on the unapproved practice. An investigation overseen by the Ministry of Health of China is underway.

1.4 In the name of "International Academic Community", thirty-four scientists, most of them urologists involved in the clinical trials of the procedure, issued an open letter in support of Xiao, addressed to the Minister of Health and the president of Xiao's university. The letter appeared online at the time when the video of Dr. Xiao's confession was released by the police in response to the rumor that he might be framed.

In the letter, the authors urged "the Chinese government and authorities to treat Dr. Xiao fairly and to protect his human rights", which is fair, except for the doubtful reasons: the "scientific and humanitarian contributions" of Dr. Xiao. They disregarded the substantial evidence that Dr. Xiao, a "compassionate man" in their eyes, had treated hundreds of innocent patients as lab rats, the evidence that should have been utmostly apparent to them being well-trained scientists. They disregarded the fact that Dr. Xiao, the "incredible gentleman []", had been endlessly slandering, cursing, threatening his critics in the past 10 years []. In the letter, they showed not the slightest sympathy to the victims, nor did they spare a word to condemn the criminals. Yet, they were cavalier enough to maliciously accuse the victims of "self-directing-and-self-acting" the crime [].

In our opinion, the letter was extremely irresponsible, and has been motivated by self-interests, despite poising to represent the ¨international academic community¨. Furthermore, the open letter also deliberately tried to misguide the public's opinions about the Xiao's procedure, as we will point out below.

[b]Section 2: Newly-uncovered materials and new evidence questioning the effectiveness of the procedure[/b]

2.1 Beaumont Hospital's preliminary results have recently been published in the Journal of Urology. However, in the same issue of the journal, peer experts have made harsh critical comments as to the usefulness of the procedure. It was pointed out that there is stark contradiction between Beaumont's results and those of Xiao. There is also discrepancy between urodynamic data and subjective reporting. The critics commented that the improvement may not be statistically significant, and that the improvement might be the result of unilateral denervation or intra-abdominal pressure generation. It was also remarked that, with all the uncertainties in the benefits, the great danger of the procedure was particularly worrying.

2.2 There is huge discrepancy between Xiao's 2003 paper and his earlier 1998 abstract on his first human trials of 14 or 15 SCI patients [], indicating that he might have fabricated or falsified at least part of his results.

2.3 The objective and subjective results obtained at Beaumont are much worse than Dr. Xiao's, which suggests that Dr. Xiao may have manipulated his data.

2.4 In the report published by the Beaumont team, there is no correlation between the establisment of reflex arc and the improvement of bladder capacity and voiding, shown in Table 2 of the report. This might have announced the fundamental failure of the procedure.

2.5 It is clear that it is the intra-abdominal pressure that plays the main role in some patients' voiding, rather than the detrusor contraction. This suggests the failure of the recovery of neurological function.

The observation has been made by the editoral comments on Beaumont's reprort, and also by a top Chinese expert who evaluated the procedure and witnessed the patients. Several figures in Dr. Xiao's paper on spina bifida cases and in a review article citing the paper also indicate that the detrusor pressure is almost zero and voiding happens only when the intra-abdominal pressure exists.

We note that even Dr. Xiao himself had once admited in one of his earlier articles that "most of patients need the help of different level of abdominal pressure in order to completely empty bladders" [], although he never mentioned that again later on.

2.6 The previous NIH projects on the research of the procedure were finished with very poor outcomes. One can hardly say the proposed research had been fufilled. The funding might have been misused.

The first grant awarded to Dr. Xiao (R01DK44877, $357,067 []) was initially proposed for the canine model, but the final result turned out to be merely a journal paper on 6 cat models [], while the preliminary result of 5 cat models had already been reported by Dr. Xiao [] far before the grant awarded.

The second grant awarded to Dr. Xiao (R01DK053063, $2,423,082 []) had been used to supported only a clinical trial with merely 2 patients and resulted in only one conference abstract [] cited by a review article [].

NIH has the responsibility to investigate how tax-payer's multi-million dollars were spent in these cases.

[b]Seciont 3: Serious concerns about ethical violations[/b]

3.1 Dr. Xiao' human trials started in China only one year after his rat results were published in a peer-reviewed journal and six months after the NIH grant (R01DK44877) was awarded for the canine model. Even worse, it is four years after human trials started did he publish cat results in a peer-reviewed journal (supported by R01DK44877). The timeline shows clearly that Xiao had committed serious ethical violations by applying experimental techniques on human bodies (Besides, in later years, he charged the patients tens of thousands Chinese dollars for the operation).

As an example of blatant disrespect of scientific standards, we point out that, Dr. Xiao wrote in his cat paper that if his technique "can be further perfected in larger animals, it may eventually be applied to patients", even though his preliminary human results were already reported two years ago. Also, no result on the canine model or higher taxonomic species have ever been published so far.

If the NIH grants (see above) were used to support Dr. Xiao's "clinical trials" in China, the OHRP should have the responsibility to investigate Dr. Xiao's unethical practice within the time frame of the funding being awarded (1999-2007).

3.2 In relation to the last point, we note that in the open letter in support of Xiao, whose co-signers in large part consist of the doctors involved in the clinical trials, it was claimed that "Dr. Xiao eventually took the courageous step of moving from animal research to human studies" after the results of his animal studies were published in peer-reviewed journals and replicated and confirmed by other scientists. This shows that the authors were either trying to gross over Xiao's violations, or were unacceptably unfamiliar with the history of the development of the procedure. The claim reflects poorly on the authors' ethical standards and scientific credentials.

3.3 Doctors at Beaumont started the clinical trial based on dubious information and hearsays from Dr. Xiao, without proper discrimination and investigation. They also provided mileading information to patients and the public, as is shown in the following long list of examples. These conducts represent colossal scientific misjudgement on their part, to the extent that one may question their scholastic honesty.

They misled potential patients by claiming that the procedure was "standard of care" and "done everyday in hospitals in China", and suggesting patients go to China for the surgery []. The misinformation could have been easily proved to be false should they have spent the least effect to cross-check.

They exaggerated the number of patients of the NIH sponsored trial at New York University in their publication [] and news release [].

They had constantly understated the risks of the procedure on their website and to the media, claiming that, for example, there was "a small risk of some foot weakness" [] and that "recent changes in the surgical technique have dramatically decreased the incidence of these complications" []. Only in a recent interview did they tell the media that "the surgery ... carries serious risks" [].

The misleading information may have had serious consquences. According to the website of Dr. Xiao's Chinese Journal of Clinical Urology, more than 90 U.S. patients had been "successfully treated". These patients may have made the decision to take the operation based on the misleading information.

In the open letter alluded to above, the authors claimed that Beaumont Hospital's "pilot data was supportive of Dr. Xiao's procedure", without even mentioning the critical comments from their peers. To wit, it was commented that Beaumont's results "challenge the excellent, previously published results" by Dr. Xiao, and that "the clinical benefit of the procedure is not at all similar to previous (Dr. Xiao's) reports".

Doctors at Beaumont have consistently avoided to report their three patients with spinal cord injury, neither in their conference abstract nor journal paper, not even in their review article on bladder reinnervation of both spinal cord injury and spina bifida. The truth is, the patients were "not helped by the procedure", as was discovered by the media.

When the trials at Beaumont failed to replicate the kind of Dr. Xiao's results, they tried to distort the definition of success by saying that "a difficult aspect of this study is how success should be defined" in their paper, turning a blind eye to the fact that the definition of success had already been clearly described by the objective and subjective measures in Dr. Xiao's reports. For example:

They stated that "one cannot expect normalization of bladder and bowel function to be the definition of success" in their open letter, totally ignoring the fact that Xiao had described his successes with words like:

"complete bladder function restoration ... regained total control of the bladder", "successful recovery of bladder function ... relatively normal", "almost normal storage and synergic voiding", and "gained satisfactory bladder control and continence", "regained bladder control".

In particular, in the falsified certificate of the cure rate of the procedure (issued to support Dr. Xiao′s bid to the membership of Academician), it was stated "regained normal bladder and bowel functions". Phrases such as "completely resolve the problem of incontinence", "voluntary control of bladder and bowel after surgery with no difference to normal people" have also been used in the advertisements of Xiao's private hospital.

Furthermore, the doctors at Beaumont apparently had also forgotten what they said in their news release on their one-year results: "in most patients the brain was able to take over and control urination normally."

3.4 Shortly after Dr. Xiao's arrest, Dr. Evan Kass started to attack one of Xiao's victims in his comments at Science website, publicly accusing Dr. Fang of plagiarism and conspiracy. Even worse, he repeated the same baseless charges after he was challenged on its factual basis.

[b]Section 4: Our recommendations[/b]

Based on the forceful information presented above, we suggest that the current NIH grant awarded to Beaumont Hospital was questionable in its approval.

It is clearly indicated in the project information [] that the grant application was based on the data from Dr. Xiao [], as well as on "very promising"[] one-year result of the pilot study. As we have strongly argued above, the former was unpublished and more importantly unverified, whereas the latter has been pointed out to be "not at all similar"[] to Dr. Xiao's.

In one of the news reports, an expert in the field commented that "nobody ever believed there was an 85 percent success rate"[]. Given that the same one-year result of the pilot study is now receiving so serious criticisms, one has every reason to question how the grant application could have been approved in the first place.

We believe that, if the current study is not meant to "challenge the excellent, previously published results" [] by Dr. Xiao, or to prove the obvious, that the procedure "carries serious risks" [], then the study should be stopped and the grant revoked, and the process of the grant approval should be investigated.

We decide to publish this letter online, partly in response to the open letter in support of Dr. Xiao, so that the public could be properly informed rather than be manipulated or fooled by the so-called "International Academic Community".

Most importantly, we continue to present this letter to relevant U.S. authorities in the hope that they would take further actions. The many patients who have been put in a disastrous situation by the Xiao′s procedure are embarking on the difficult road to seek their justice. They will welcome, and deserve, the immediate actions from the U.S. authorities and the scientific community. We urge the NIH, OHRP, ORI, the related institutes, and the journals that publish Dr. Xiao's results, to investigate the misuse and the mis-approval of the research fundings, the breach of medical ethics of the clinical trials, the fabrication and falsification of research data in Dr. Xiao's publications, as well as the moral and academic misconducts of related parties.