Section 2: New evidence questioning the effectiveness of the procedure

2.1 Beaumont Hospital's preliminary results have 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 mentioned that, with all the uncertainties in the results, 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. Even Dr. Xiao himself 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 have never been fulfilled. 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 []) supported a clinical trial with only 2 patients and resulted in only one conference abstract [] cited by a review article [].

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

Seciont 3: Serious concerns about ethical violations

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).

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 reflects 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 awareness and scientific excellency.

As an example of blatant negligence 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, with no result on the canine model or higher taxonomic species had ever been published.

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 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. This conducts represent colossal scientific misjudgement, to the extent that one may question their scholastic honesty.

They misled potential patients by claiming that the procedure is "standard of care" and "done everyday in hospitals in China", and suggesting patients go to China for the surgery [].

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

They had 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, potentially, had taken the operation under the influence of the misleading information.

In their open letter, the authors claim that Beaumont Hospital's "pilot data was supportive of Dr. Xiao's procedure", without even mentioning their peers' critical comments. 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 has never reported on their three patients with spinal cord injury who were revealed by media "not helped by the procedure", 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.

When the trials at Beaumont failed to replicate the kind of Dr. Xiao's results, they try 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 has already been clearly described by the objective and subjective measures in Dr. Xiao's reports.

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, 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."

3.3 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.

Section 4: Conclusions

Based on the above information, 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 has 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 inquire 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. 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.