我按照前面说的自己的想法做了比较大的修改，主要是结构上的，copy and paste，文字还没太修饰，一些说法改得温和了一些。
现在分三个sections，最后可以加个conclusion，和论文八股比较象，但觉得比原来的清晰。
因为我觉得是被xysergroup代表的一员，所以强烈希望xysergroup考虑我的建议，采用这样的格式:-)
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 our 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 new evidence that would have raised serious objection against the ongoing clinical trials and the practising of the procedure. We call for an serious investigation into the Xiao's procedure and any misconducts that might have occurred during its research and implement in the US and elsewhere of the world.
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 been sentenced to five and a half months term in jail.
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1.2 A growing number of victims of Xiao's procedure are planing lawsuits against Dr. Xiao and his private hospital where he and others have performed the operations.
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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 [].
1.3 The Chinese Medical Association has called for an re-evaluation of the procedure. Six top urologists in China have urged an immediate ban on the unapproved practice. An investigation led by the Ministry of Health of China is underway.
1.4 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 showed 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". They disregarded the ample evidence that this "compassionate man" had harmed hundreds of innocent patients who were treated as voluntary lab rats, and that this "incredible gentleman []" had been endlessly slandering, cursing, threatening his critics in the past 10 years [], and eventually committed the hideous crime. They even maliciously accused the victims of Xiao 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.
The open letter also deliberately tried to misguide the public's opinions about the Xiao's procedure, as we will point out below.
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 Xiao's own is pointed out and 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. With all uncertainties in the results, the great danger of the procedure was also mentioned.
(a number of paragraph about the scientific judgement can be moved here, such as the following)
2.2 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.
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, 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 also by a top Chinese expert who 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.
2.6 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.
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 [].
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.
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 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 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, may have been misled into the procedure.
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, 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".
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 also 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 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". In particular, in the falsified certificate of the cure rate of the procedure, it was stated "regained normal bladder and bowel functions", and phrases such as "completely resolve the problem of incontinence", "voluntary control of bladder and bowel after surgery with no difference to normal people" have 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.