Wednesday, February 24, 2010

New Threads Volunteers Draft Open Letter against "Xiao Procedure"

Led by Yush, a group of New Threads volunteers have drafted the following open letter on the so-called "Xiao Procedure." The open letter, along with a collection of supporting material, will be delivered to related hospitals and institutions and hopefully reach concerned patients, both present and potential ones.

An Open Letter of Complaint against Xiao Procedure

We are a group of volunteers who are alarmed by the ongoing public misrepresentation and misinformation on an experimental surgical procedure invented by Xiao Chuanguo, M.D., from China. The procedure, sometimes referred to as "Xiao Procedure", is designed to treat neurogenic bladder due to spina bifida or spinal cord injury and has been undergoing clinical trials in China, United States, and a few other countries.

We initially learned about this procedure when Dr. Xiao was exposed for committing several academic misconducts on the web site New Threads, a site that is committed to fighting against China's academic corruption, plagiarism, and fraud. In the last five years, we have closely followed the case and become seriously concerned on the procedure's effectiveness and risk. Indeed, the problem has recently drawn the attention of Chinese media, which published investigative reports that are quite shocking.

In this Letter, we summarize a few facts about the procedure as follows. We hope to bring them to the attention of the National Institutes of Health (NIH) who funds the trials, and the institutional review boards (IRBs) of the hospitals where the trials are currently undergoing, and any current or potential patients of the trials.

1. In China, an independent investigation by pro-bono lawyers has so far not been able to identify or confirm a single success case of the Xiao Procedure. Instead, the investigation has discovered numerous cases of severe side effects. The lawyers collected a list of 110 patients who had undergone the procedure at Shenyuan Hospital in Zhengzhou, China, between September, 2006, and March, 2007, and interviewed 74 of them by telephone. They found that 73% of patients reported that the procedure had produced no effect and 39% of patients experienced various degrees of complications after surgery, including weakness, atrophy, deformity and lameness in lower limbs. Before the investigation, some of the patients who received the treatment together had already got in touch among themselves, through which they realized that there was no success case among them.

2. Two of those patients have recently filed lawsuits against Shenyuan Hospital. We expect that more will follow. The patients claimed that they were misled by the widely advertised "85% success rate" of the procedure. Shortly before the litigation started, Shenyuan Hospital, a local, private, and for-profit entity, of which Dr. Xiao owns 30% of shares himself, decided to dissolve itself under Dr. Xiao's order.

3. Dr. Xiao's most famous case has since turned out to be only hype. A boy by the nickname Little Shanshan was the very first patient treated by Dr. Xiao at Shenyuan Hospital. His "cure" was widely hailed in Chinese media and frequently cited by Shenyuan Hospital and Dr. Xiao himself as proof of the success, inspiring hundreds of patients for the procedure. When investigators finally reached Little Shanshan, they found that he had never gained the ability of voluntary voiding but developed a limping gait. His mother revealed that Shenyuan doctors used to have him drink a lot of water and apply electric stimulus to help him urinate during demonstrations.

4. An official document testifying the "85% success rate" was discovered to be a fraud. On February 28, 2007, Shenyuan Hospital issued a certificate of cure rate when Dr. Xiao Chuanguo was applying to become a member of the prestigious Chinese Academy of Sciences (CAS). It claimed that the hospital had applied the procedure to 117 patients since January 2006, "sixty cases were followed up for more than 8 months, 85% of the patients have recovered normal bladder and bowel functions." However, the hospital itself did not come into existence until August 2006 and only conducted its first operation on Little Shanshan on August 13 of that year. There was simply not enough time for it to have conducted a "more than 8 month" follow-up study.

5. The official approval of the Xiao Procedure in China might be less than what it seems. A few members of an expert panel that had evaluated the Xiao Procedure have since spoken out that they had practically rubber-stamped their approval based on partial information selectively presented to them including the name-recognition of Dr. Xiao's advisor, Dr. Xiao's self-claimed fame abroad, and Dr. Xiao's self-claimed success rate. The panel determined the procedure to be "world advanced," which was frequently advertised by Shenyuan Hospital. On the other hand, another critical opinion from the panel has never been disclosed to the public: "(the procedure) carries very high risks."

6. The fundamentals of the Xiao Procedure is still in doubt. Top experts in China have expressed their concerns over the lack of scientific basis of the procedure and the unethical practices without adequate and proper clinical trials. One of the experts examined the urodynamic diagrams presented in Dr. Xiao's publications and found that the urination of some patients was actually due to the benefits from the intra-abdominal pressure instead of the detrusor pressure, suggesting the failure of recovery of neurological function of the blader after surgery. The experts also suspect that the improvement of voiding functions in some patients might be the effects of conventional surgeries conducted simultaneously or subsequently, such as detethering, selective sacral rhizotomy, or electric stimulus, rather than that of the Xiao Procedure itself. For example, the girl who was reported by Dr. Xiao at SIU 2009 "gained complete bladder control in 5 months" after surgery, reportedly had very severe scar tissue in her gunshot wound, which is exactly the indication of detethering. Unfortunately, there is so far no controlled study, either by Dr. Xiao or a third-party, after the procedure has long been implemented by Dr. Xiao in his associated hospitals, for a profit of 30,000 RMB (4,400 USD) per patient.

7. Dr. Xiao has long been untruthful about or exaggerating his works. In one instance, he had lied about winning the America Urological Association (AUA) Achievement Award in his resume. He also claims his work as well recognized internationally, despite the fact that his publications were seldomly cited by his peers. After such facts were exposed on the New Thread web site, he sued Dr. Fang Zhouzi, the site's owner, for libel nearly 10 times. Dr. Xiao also has a spotty personal record. For example, his employment at a research institute was once terminated, leading to a legal dispute in a U. S. Court of Appeals, which he had lost. Another case in a civil court that involved a warden suggested that Dr. Xiao was once put in jail. He lost the case as well.

8. The current clinical trials in the United States are based on dubious data. It appears that these trials are based on some critical data in a conference report cited in Dr. Xiao's review article in the journal European Urology. However, that original report could not be located while the subsequent review article became the major reference of the U.S. trials. Comparing to the information from other sources, the success rate and the number of patients in that report are suspicious. Moreover, in a press release, William Beaumont Hospitals, who started the clinical trial in the U.S. in December, 2006 (Identifier: NCT00378664) and obtained a grant from the NIH in December 2009 (Project Number: 1R01DK084034-01), reiterated Dr. Xiao's "almost 90-percent success rate," indicating that the trial at Beaumont was solely based on Dr. Xiao's own assertion without any qualification. Furthermore, doctors at the All Children's Hospital (ACH) mis-labled its trial as "double-blind", indicating that either they lacked the understanding of the basic principle of clinical trials, or they (or Dr. Xiao himself) had no knowledge about the indications of the Xiao Procedure, and the special pre-, intra- and postoperative care of the patients who receive the procedure, at least until the trial began in March 2009.

9. The outcomes of clinical trials outside China have not been as "promising" as Beaumont Hospitals claimed. Firstly, the NIH sponsered multi-million-dollar trial (Grant Number: 5R01DK053063) on spinal cord injury (SCI) conducted by New York University (NYU) from 1999 to 2006 has so far produced no official result, except for a conference abstract that reported two cases with much worse result than Dr. Xiao's own (mean PVR=200 cc in NYU's report vs. 31 cc in Dr. Xiao's first 15 SCI patients, for example). Secondly, the information presented in Beaumont's one-year report on spina bifida (SB) cases were selective and rather vague. There was no mention of the SCI cases, although the purpose of the trial was initially for both SCI and SB (see registry), and its first procedure was for SCI, which "garnered national attention and appeared in more than 160 news outlets" (see Beaumont's website). There was no pre- and post-operative comparison, which should be essential for a clinical report. The mean and standard deviation of postoperative urodynamic data were much worse than what Dr. Xiao has reported (mean PVR=119 cc in Beaumont's report vs. 23.67 cc in Dr. Xiao's first 20 SB patients, for example), which should invalidate his claims to some extent. The side effects was also understated. Thirdly, according to Dr. Xiao's presentation at SIU 2009, 6 cases of SCI in Germany all failed ("only 2 showed some improvement"). Meanwhile, according to the media, all 3 patients with SCI at Beaumont were also "not helped by the procedure". Statistically, the failure of all third-party SCI cases may proclaim the failure of the principle of the Xiao Procedure, especially considering that the "success" of Dr. Xiao's very first human trials and animal studies were all of SCI. The recent NIH-funded trial was entitled "Safety and Efficacy of Nerve Rerouting for Treating Neurogenic Bladder in Spina Bifida" without mentioning SCI, which may speak for itself. Finally, Dr. Xiao blamed the failure of SCI cases to "incorrect patient selection" and "inappropriate postoperative care". The former indicates, at least in part, the "success" of Beaumont's SB patients was due to "extensive preoperative evaluation" (see Beaumont's one year report); the latter contradicts the "success" of Beaumont's SB patients who should have received the same postoperative care.

10. Beaumont Hospitals propagated the myth of Xiao Procedure to patients. In response to patients' inquiries, Beaumont repeatedly provided false information that the procedure is "now standard of care" in China and is "done everyday in hospitals in China". The fact is that the procedure has never become standard of care in China. In the more recenty years, the now-closed Shenyuan Hospital was the only institute that performed this surgery. Dr. Xiao's team is so far the only one that performs it. Furthermore, Beaumont suggested patients going to China for the surgery, in spite of that the surgery is still under trial in the U.S. and the "results are too immature." Beaumont's indiscreet reference might have resulted in serious consequences: 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; and each foreign patient was charged about 20,000 USD, as disclosed online by a patient.

Based on the above facts, we wish to provide our following suggestions to the NIH, the IRBs and the releated hospitals, as well as to patients and the media.

1. We appeal to the NIH and the IRBs to review their decision on clinical trials of the Xiao Procedure by independently and comprehensively re-investigating the 15 SCI and 20 SB cases published in the Journal of Urology 2003 and 2005, the unpublished 92 SCI and 110 SB cases cited in European Urology 2006, and the 1406 cases since 2006 at Shenyuan Hospital presented at SIU 2009, all by Dr. Xiao, along with the more than 90 U.S. cases treated by Dr. Xiao, the 2 cases at NYU, the 6 cases in Germany, as well as the 12 cases at Beaumont and the 8 cases at ACH. Dr. Xiao should have the obligation to present detailed original clinical data of his cases.

2. We appeal the related hospitals to suspend the trials immediately, pending the review. We suggest that the hospitals thoroughly examine the cases already conducted by themselves and Dr. Xiao. Considering that "in China rigorous follow up is challenging" (see Beaumont's project description at the NIH website), we particularly urge Beaumont Hospitals to help Dr. Xiao conduct follow-ups of his 90 U.S. patients.

3. We caution the NIH and the related hospitals that the ongoing clinical trials in the United States have been distorted by Dr. Xiao in China as the "success of the NIH approved clinical implementation," which may mislead more patients.

4. We advise patients to think twice when considering to participate in the clinical trials or to go for the treatment in China. We encourage patients who already received the procedure to come forward and report their status for the well-being of themselves and of others. Meanwhile, we suggest that the media should listen to patients as well, instead of relying solely on the stories put forward by Dr. Xiao and a few hospitals.

New Threads Volunteers

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