An Open Letter Calling for Investigations on the Xiao Procedure

An Open Letter Calling for Investigations on the Xiao Procedure (Draft)

( Keep updating. References and Appendix will be added later on. Please post your comments on XYS forum or email to xysergroup at gmail dot com. )

Original Version

We, New Thread Volunteers, published an Open Letter of Complaint against the Xiao Procedure on February 25, 2010, and sent the Open Letter to some U.S. authorities through our representative []. The Office of Research Integrity (ORI) of Department of Health and Human Services declined to investigate the case, citing lack of jurisdiction and absence of specific allegations, whereas the Office for Human Research Protections (OHRP) recently decided to take actions by initiating an evaluation on the ongoing clinical trials in the US.

In this letter, we update more recent developments related to Dr. Xiao Chuanguo and his procedure, and present new evidence against the clinical trials or practice of the procedure and the doctors (hereinafter "doctors being concerned") who are involved in the clinical trials of the procedure in the US and elsewhere of the world.

1. More and more victims of Dr. Xiao's unethical practice of the procedure have been emerging and drawn the attention of Chinese authorities.

Patients united through online community. With the help of public donation and human right lawyers' support, more than three hundreds of them are planning to launch more lawsuits against Dr. Xiao and his private hospital, of which Dr. Xiao owns 30% of the shares and is the legal representative. Three mostly advertised "successfull" cases, Little Shanshan, the "crawling girl" and the "earthquake hero", have all been discovered to be hoax.

The Chinese Medical Association called for experts to evaluate the procedure, and six top urologists urged an immediate stop of the unapproved practice. An investigation by the Ministry of Health of China is under way.

2. Dr. Xiao has been sentenced to five and half months in jail for masterminding two violent attacks on his critics.

After his fraud was exposed and while the litigation against his hospital was on its way, Dr. Xiao hired three thugs through a cousin of his brother-in-law to brutally assault Mr. Fang Xuanchang, the journalist who investigated Xiao’s medical fraud last year. After months of tracking and monitoring, in daylight and armed with chemical spay, hammer and metal pipe, they finally ambushed Dr. Fang Zhouzi who have been exposing Xiao's academic misconducts and fraud since 2005.

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

3. Beaumont Hospital's preliminary results have been published in the Journal of Urology and received sharply critical comments [].

In the same issue of the journal, peer experts raised serious questions, such as the contradiction between Beaumont's results and Xiao's own, the discrepancy between urodynamic data and subjective reporting, the statistical insignificance of the improvement, the speculation that the improvement might be the result of unilateral denervation or intra-abdominal pressure generation, as well as the great danger of the procedure.

4. Doctors being concerned have a problematic moral standard.

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.

After the video of Dr. Xiao's confession was released by the police in response to the rumor that he might be framed, 34 scientists, in the name of "International Academic Community" but in fact mostly urologists involved in the clinical trials of the procedure, issued an open letter in support of Xiao, addressed to Minister of Health and the president of Xiao's university.

In their letter, they show no sympathy to the victims and no condemnation to the criminals at all. Instead, they pressure "the Chinese government and authorities to treat Dr. Xiao fairly and to protect his human rights" for his "scientific and humanitarian contributions", regardless of the fact that this "compassionate man" has harmed hundreds of innocent patients who were treated as voluntary lab rats, and the fact that this "incredible gentleman []" has been endlessly slandering, cursing, threatening his critics in the past 10 years [], and eventually committed the hideous crime, then impudently falsely accused his victim of "self-directing-and-self-acting" the crime []. Thanks to this open letter, Dr. Xiao has received a lesser sentence for a lesser charge of "causing disturbance" that should have been attempted murder or at least intentional harm.

5. Doctors being concerned provided false information to patients and the public.

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 lightly mentioned the risks of the procedure on their website and to the media, claiming that, for example, there is "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 false information may have enticed many patients to go to China for the surgery (more than 90 U.S. patients had been "successfully treated", according to the website of Dr. Xiao's Chinese Journal of Clinical Urology), or to participate in the clinical trials. Among 9 patients in Beaumont's clinical trial, one child has persistent drop foot, others developed "significant lower extremity complications that largely improve with physical therapy and time" [1year abstract].

We note that Chinese patients are not so lucky to receive "intense physical therapy" []: most patients were even lost to followup, and Dr. Xiao recently even claimed in his blog that "patients with spina bifida do not need physical therapy" after the surgery. Lack of post-op cares has resulted in that 39% of Chinese patients suffer much severer side effects, according to lawyers' initial investigation [].

6. Doctors being concerned try to cover up the ethical lapse of the clinical trials on the procedure.

They claim in their open letter 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, ignoring that Dr. Xiao's research has seriously breached the basic medical ethics. The fact is that 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).

Ironically, Dr. Xiao expected in his cat paper that if his technique "can be further perfected in larger animals, it may eventually be applied to patients", after his preliminary human results were already reported two years ago, with no result on the canine model or higher taxonomic species has ever been published.

7. Doctors being concerned show a lack of scholastic honesty.

In their open letter, they claim that Beaumont Hospital's "pilot data was supportive of Dr. Xiao's procedure", without even a mention of their peers' critical comments such as 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".

Moreover, 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.

Furthermore, after many years they started the clinical trial but failed to replicate the kind of Dr. Xiao's results, now 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, regardless of fact that the definition of success has already been clearly described by objective and subjective measures in Dr. Xiao's reports.

They also state 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 wordings 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" all appear in Dr. Xiao's reports, "regained normal bladder and bowel functions" in his falsified certificate of cure rate, and "completely resolve the problem of incontinence", "voluntary control of bladder and bowel after surgery with no difference to normal people" in the advertisements of his hospital. Apparently, they also forgot what they have said in their news release on their one-year results: "in most patients the brain was able to take over and control urination normally."

8. Doctors being concerned exhibit a lack of scientific judgement.

Doctors at Beaumont imprudently started the clinical trial based on dubious information and hear-says from Dr. Xiao, without proper discrimination and investigation. Otherwise, they would have found that the so-called wide acceptance and the success rate of the procedure are all questionable. They would have also found that there are 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 fabricated or falsified at least part of his results.

They failed to explain the fact that their objective and subjective results are much worse than Dr. Xiao's, which suggests that Dr. Xiao may have manipulated his data.

They failed to explain that there is no correlation between the establisment of reflex arc and the improvement of bladder capacity and voiding, as shown in Table 2 of their report, which may announce the fundamental failure of the procedure.

They failed to do a historic review on the closely related conventional treatments of neurogenic bladders, which may reveal the truth that the effects of Xiao's procedure are actually that of detethering and denervation, other than the procedure itself.

They failed to explain the so-called new sensory function and post-operative voluntary voiding which they believe it "challenges our current understanding of neurourology". They propose a absurd supposition of the remodeling of the micturition center of the brain, but in fact, the phenomenon can be simply explained by the improvement of the continuity between spinal cord and brain, as suggested in Dr. Xiao's earliest report on spina bifida cases (in Chinese) [].

They failed to observe that it is the intra-abdominal pressure that plays the main role in some patients' voiding, rather than the detrusor contraction, which suggests the failure of the recovery of neurological function. The fact has been pointed out by the editoral comments on Beaumont's reprort, and has already revealed by a top Chinese expert who once evaluated the procedure and witnessed the patients. Some figures in Dr. Xiao's paper on spina bifida cases and the 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 his earlier article that "most of patients need the help of different level of abdominal pressure in order to completely empty bladders" [], but he never mentioned that again later on.

9. The previous NIH projects on the research of the procedure have never been fulfilled and 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. We note that this journal paper was co-authored by Dr. Xiao's sister and brother-in-law, and the corresponding experiment was supposed to be carried out in "a laboratory that was used for the storage of paint, tiles, and windows" in "a building that was closed by LICH" []. We also note that in Dr. Xiao's 1998 abstract on his first 14 SCI patients [], it is indicated that NIH is one of the sourcecs of funding.

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 should have the responsibility to investigate how tax-payer's multi-million dollars were spent. On the other hand, if the NIH grants were also used to support Dr. Xiao's "clinical trials" in China, then the OHRP should have the responsibility to investigate Dr. Xiao's unethical practice within the time frame of the funding being awarded (1999-2007).

10. The current NIH grant awarded to Beaumont Hospital is questionable in its approval.

It is clearly indicated in the project information [] that the grant application was based on unverified and unpublished data from Dr. Xiao [], as well as on "very promising"[] one-year result of the pilot study which was pointed out to be "not at all similar"[] to Dr. Xiao's.

Now that "nobody ever believed there was an 85 percent success rate"[], and the same one-year result of the pilot study now received so serious criticism, then, one has to wonder 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 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 U.S. authorities in the hope that they could 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 the doctors being concerned.

lightman's version
http://www.xys.org/forum/db/7/218/115.html

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.

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 question the effectiveness of the procedure

Section 3: Serious concerns about ethical violations

Section 4: Our recommendations

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

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 the cousin of his brother-in-law 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 ¨successes¨, the cases of 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 showed not the slightest sympathy to the victims, nor did they spare a word to condemn the crimes. Instead, the authors urged "the Chinese government and authorities to treat Dr. Xiao fairly and to protect his human rights". The petition is fair, except for their doubtful reason: the "scientific and humanitarian contributions" of Dr. Xiao. As we will show below with ample evidence, it is clear

- that the authors tried to inflate the credential of Xiao with their clinical trials, while conveniently forgot to mention the sharp criticisms that point out the sheer contradition between their results and those of Xiao;

- and that the authors disregarded the substantial evidence that Dr. Xiao had treated hundreds of innocent patients as lab rats, the evidence that should have been utmostly apparent to them being well-trained scientists.

Many of these ¨lab rats¨, by the way, paid Dr. Xiao with life-time savings in order to take the operation.

Thus, in our opinion, the letter was intended to deliberately misguide the public′s opinions about Xiao′s procedure. It was motivated by self-interests, despite being purported to represent the ¨international academic community¨.

Finally, one can hardly not find it ironic, when it is discovered that this Dr. Xiao, a ¨compassionate man¨ and an ¨incredible gentleman" according to the authors of the open letter, had repeatedly slandered, cursed and threatened his critics in the past ten years []. About the integrity of this ¨incredible man¨, nothing is more telling than the fact that, only a few days before he was arrested and later confessed to be the mastermind of the attacks, he still publically accused the victims of "self-directing-and-self-acting" the attacks in his postings on the web.

Section 2: Newly-uncovered materials and new evidence question the effectiveness of the procedure

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. It is even difficult to say the proposed research had been fufilled. The funding might have been misused.

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 [].

We note that in Dr. Xiao's 1998 abstract on his first 14 SCI patients [], it was indicated that NIH was one of the sourcecs of funding. NIH has the responsibility to investigate how tax-payer's multi-million dollars were spent in these cases.

Section 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). 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 values, 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 has been published ever since.

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. They appeared to have no knowledge of the fact that Dr. Xiao's research had seriously breached the basic medical ethics. This shows that the authors were either trying to gloss 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 The Beaumont team 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 actively repeating the false claim that the procedure was "standard of care" and "done everyday in hospitals in China", and suggesting patients go to China for the surgery []. The information could have been easily proved to be false should they have spent the least effort to cross-check.

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

On the other hand, 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.

These patients are exposed to the serious risks of the operation. To give concrete examples of the risks, we note that, among the 9 patients in Beaumont's clinical trial, one child has had persistent drop foot, others developed "significant lower extremity complications that largely improve with physical therapy and time" [1year abstract], although how much improvement was obtained was not specified.

As a side note, we note that Chinese patients are not so lucky to receive "intense physical therapy" []: most patients lost contact without followup. Dr. Xiao recently even claimed in his blog that "patients with spina bifida do not need physical therapy" after the surgery. Due to lack of post-op care, 39% of Chinese patients suffer much severer side effects, according to lawyers' initial investigation[].

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".

The Beaumont team has consistently avoided to report the three patients of theirs with spinal cord injury. They were not reported 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 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". In the advertisements of Xiao's private hospital, 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.

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.

Section 4: Our recommendations

Based on the 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.

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, related institutions, 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.

Eddie's version
http://www.xys.org/forum/db/7/218/150.html

On February 25, 2010, we, the New Thread volunteers, had published an Open Letter of Complaints against the Xiao Procesure. Our appeal had caught the attention of the Office for Human Research Protections (OHRP), which recently initiated an evaluation of the ongoing clinical trials on the procedure in the US.

In this letter, we wish to provide an update on more recent developments related to Dr. Xiao Chuanguo and his procedure, including newly-uncovered evidences that, had it been revealed earlier, might have disqualified the clinical trials and the practicing 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.

In the past months, an unexpected and dramatic event put Dr. Xiao Chuanguo into the spotlight in China. He was convicted of masterminding two violent attacks on his

critics and is currently serving a five-and-a-half-month sentence. This vicious act drew condemation from many organizations in China. The scandal was well covered in

all major international media.

Also in China, more than 300 patients who had received Xiao's procedure are planning lawsuits against Dr. Xiao and hospitals, claiming ineffectiveness, serious side

effects, and deception. Several of Dr. Xiao's "success stories" have now been revealed as actual failures. The procedure is now under review by China's Ministry of Health.

Outside of China, Beaumont Hospital's preliminary results was published in the Journal of Urology. It received harsh critical comments in the same issue.

Meanwhile, new findings are emerging from the muddied history of Xiao's procedure:

1. There is a huge discrepancy between Xiao's 2003 paper and his earlier 1998 abstract on his first human trials of 14 or 15 SCI patients [] {What exactly is the discrepancy?}

2. The success rate of Beaumont team, measured by either the objective or subjective results, is not comparable to Dr. Xiao's earlier claim.

3. In the report published by the Beaumont team, there is no correlation between the establishment of reflex arc and the improvement of bladder capacity and voiding, shown in Table 2 of the report, undermining the very premise of the procedure.

4. Independent experts both inside and outside of China are able to attribute some patients' voiding ability to intra-abodminal pressure rather than the detrusor contraction.

5. Previous NIH projects on the research of the procedure were completed with very poor outcomes:

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

We note that in Dr. Xiao's 1998 abstract on his first 14 SCI patients [], it was indicated that NIH was one of the sources of funding. NIH has the responsibility to investigate how tax-payer's multi-million dollars were spent in these cases.

Our investigation also led us to several concerns about possible ethical violations:

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 was four years after human trials started did he publish cat results in a peer-reviewed journal (supported by R01DK44877). In his paper on cat, Dr. Xiao wrote 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.

2. Doctors at Beaumont started their clinical trial on the sole basis of dubious data from Dr. Xiao, without due diligence. They also provided mileading information to patients and the public, claiming the procedure was "standard of care" and "done every day in hospitals in China." They have also exaggerated the number of patients of the NIH sponsored trial at New York University in their publication [] and news release [], while understating the risks of the procedure.[]

3. 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.

4. Shortly after Dr. Xiao's arrest for attacks, 34 international scientists, most of whom urologists involved in the clinical trials of the procedure, issued an open letter in support of Dr. Xiao. The letter showed no sympathy to the victims and did not bother to condemn the crimes. Instead, the authors trumpeted Xiao's achievements by citing the clinical trial results at Beaumont, while conveniently neglecting to mention the criticisms to that very results.

Based on the information presented above, we would like to raise questions about the current NIH grant awarded to Beaumont Hospital and its approval.

Specifically, 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. Of these, the former was unpublished and, more importantly, unverified while the latter has been pointed out to be "not at all similar"[] to Dr. Xiao's.

We urge the NIH, OHRP, ORI, related institutions, 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.

Breaking News

The Ministry of Health of China has convened authoritative experts to re-evaluate the procedure. The experts have found that the technique lacks sufficient validation of safety and efficacy in the sense of evidence-based medicine, and that the technique should not have been implemented in clinical practice before sound argument provided. Earlier, six top urologists in the expert panel urged an immediate ban on the unapproved practice of the procedure. More recently, the provincial health department eventually banned the practice.

http://www.tudou.com/programs/view/eEKE4FW5Cn4/
http://xysblogs.org/wp-content/blogs/20/uploads/cctv2xiao.jpg
CCTV2经济半小时 2010-11-10
节目结束前的全屏字幕：“节目播出前，记者接到郑州大学第四附属医院来电，该院的肖氏反射弧手术被河南省卫生厅叫停。”
"The Fourth Affiliated Hospital of Zhengzhou University notified the reporter that the Xiao reflex arc procedure at the hospital has been banned by Henan Department of Health."

http://www.china.com.cn/zhibo/2010-11/09/content_21298706.htm
卫生部11月9日新闻发布会
卫生部组织专家进行了多次研究，国内权威的专家们认为，……利用人工体神经—内脏神经吻合术解决这个难题是一项探索性的研究，目前，这个技术的安全性、有效性的循证医学证据尚不足，对这个技术是否适用于临床应用，还要进行充分的论证。
News Release
The Ministry of Health of China has convened experts to re-evaluate the procedure several times. Those domestic authoritative experts have concluded that ... the safety and efficacy of the technique still lacks validation in the sense of evidence-based medicine; further comprehensive validation is needed to determine whether this procedure can be implemented in clinical practice.

http://www.cnr.cn/china/gdgg/201011/t20101109_507294232.html
中广网北京11月9日
方舟子遇袭、患者代表请求卫生部禁止各地医疗机构实施“肖氏反射弧手术”，一系列事件使人们对于肖氏反射弧手术是否可以被运用于临床产生了很多的疑问。新闻发布会上，卫生部新闻发言人邓海华首次就此做出了明确回应：卫生部组织专家进行了多次研究，专家的意见是一致的，它还没有在临床使用的安全有效性的循证医学证据，就是说这个技术不应该在临床上使用。

http://news.sina.com.cn/c/2010-10-18/041718245542s.shtml
成都商报 2010年10月18日
6名评审组泌尿外科专家已达成一致意见，他们在18日的评审会上将代表泌尿外科领域提出4点建议：
1，立即停止实施肖氏反射弧。
2，对现有的实施过肖氏反射弧手术的病患实施观察随访，确定疗效和安全性。
3，组织专家团，对肖氏反射弧技术进行全面调查，确定该手术的有效性和安全性。
4，对实施了该手术失败导致不良后果的患者提供医疗帮助。