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 ClinicalTrials.gov 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

SciDev.net: Science Paper Trade Booms in China

On February 15, Science and Development Network published the following report on China's science paper trade. A Chinese translation is also available here.


Science paper trade booms in China   
Ding Jie   
15 February 2010  

[BEIJING] Researchers and lecturers desperate to succeed in China's 'publish or perish' system have driven a five-fold increase in the country's scientific 'paper trade', a researcher has found.
  
The business of scientists paying for publication — sometimes of ghostwritten material or publication in illegal journals — was worth one billion Chinese yuan (around US$146 million) in 2009, five times larger than in 2007.   

This was according to Shen Yang, a management studies researcher at Wuhan University, who released his assessment of the trade to the media last month (January).   

Shen described China's publishing process as "a massive and integrated production chain" in his research.   

He defined five questionable paper-publishing practices in China: charging exorbitant publication fees, where instead of a peer review systems authors pay hundreds or thousands of yuan for publication in a journal; the establishment of illegitimate journals; ghostwriting of papers; paper brokering, where authors pay agencies to get their papers published in particular journals; and the fabrication of awards by illegitimate journals.   

This trade is a product of the way Chinese universities and research institutions use rates of publication as a measure of performance and eligibility for promotion or graduation, wrote Shen. Many institutions, for example, stipulate that doctoral candidates cannot gain their PhD unless they have published one paper before graduation.   

As a result, researchers and academics — particularly those in lesser universities or institutes — plagiarise or buy papers.   

China has almost 9,500 academic publications that generate about 2.5 million papers per year, according to Shen's figures. But there are 30 million teachers, lecturers, students, technicians and researchers seeking publication.   

This shortfall has spawned many illegitimate journals, wrote Shen, which are usually larger than recognised journals but use a smaller font size to contain as many papers as possible.   

Fang Zhouzi, a critic who has been fighting academic fraud in China for years, told SciDev.Net that the country's current academic system makes researchers' fraud a profitable business.   Local governments are increasingly funding research, so there is more money available for economically-motivated researchers. And the pressure to publish, coupled with a lack of effective monitoring and penalty systems, has lead to the proliferation of fraudulent behavior, Fang explained.   

Fang is also concerned that Chinese academic supervisory organisations, such as the authority that provides publication licenses, turn a blind eye to fraud.   

Shen called for an end to the paper publishing burden on teachers, researchers and students. He also suggested the development of online publications to reduce printing costs.

Friday, February 12, 2010

Tuesday, February 9, 2010

A Few Examples of Recent Extractions Involving Chinese Authors

A New Threads netter, sicheng, did a simple search and found quite a few extractions of published research articles authored by Chinese scientists. The reasons for extraction are plagiarism and/or multiple submission. Below is what he found:

Journal of Molecular Diagnostics 2010, Vol. 12, No. 1

DOI: 10.2353/jmoldx.2010.090231
Retraction

Following correspondence from a concerned reader, an inquiry was initiated into the novelty of results reported in the article entitled "Quantification of mitochondrial DNA with the A1555G mutation in deaf patients using real time-amplification refractory mutation system-quantitative PCR," which appeared online December 3, 2009 in The Journal of Molecular Diagnostics as publish-ahead-of-print (doi: 10.2353/jmoldx.2010.090065). It was determined that four tables present in the JMD article had been previously published in the Chinese language journal National Medical Journal of China. After editorial communication with the corresponding author, Dr. Qi-shui, the Editors determined that the data represented redundant publication. The article is therefore being retracted from The Journal of Molecular Diagnostics by the American Society for Investigative Pathology and the Association for Molecular Pathology (the Publishers). All authors have been notified of this decision.


J Exp Clin Cancer Res. 2009; 28(1): 101.
Published online 2009 July 16. doi: 10.1186/1756-9966-28-101.

PMCID: PMC2717054
Copyright © 2009 Hao et al; licensee BioMed Central Ltd.

Retraction: siRNA directed against c-Myc inhibits proliferation and downregulates human telomerase reverse transcriptase in human colon cancer Colo 320 cells
Huang Hao,#1,2 Yu Nancai,1 Fu Lei,#1 Wei Xiong,3 Su Wen,1 Huang Guofu,1 Wu yanxia,1 Huang Hanju,2 Liu Qian,1 and Xiao Hongcorresponding author1

1 Center of Experimental Medicine, Wuhan No.1 Hospital, Wuhan, 430022, PR China
2 Department of Pathogentic Biology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, PR China
3 Brain Research Center, University of British Columbia, Vancouver, BC, Canada
corresponding authorCorresponding author.
#Contributed equally.

Retraction
The corresponding author submitted this article [1] to Journal of Experimental and Clinical Cancer Research although this article had been accepted and previously published by Cancer Biotherapy & Radiopharmaceuticals [2]. The article was also received and subsequently accepted and published by Nucleosides, Nucleotides and Nucleic Acids [3]. Since it has been brought to the attention of all authors that duplicate submission and publication have taken place the decision has been made to retract the article published in Journal of Experimental and Clinical Cancer Research. The authors are deeply sorry for any inconvenience this may have caused to the editorial staff and readers.


Brazilian Journal of Medical and Biological Research
Print version ISSN 0100-879X
Braz J Med Biol Res vol.41 no.5 Ribeirão Preto May 2008
doi: 10.1590/S0100-879X2008000500014

Braz J Med Biol Res, May 2008, Volume 41(5) 437 (Retraction)

Retraction

Retraction of the paper "Niemann-Pick type C1 protein influences the delivery of cholesterol to the SREBP:SCAP complex"

Yong-Jun Guo, Wei-Hua Li, Rong Wu, Qiang Xie, Zu-Huang Zhang and Lian-Qun Cui
Braz J Med Biol Res 2008; 41: 26-33

The Editors of the Brazilian Journal of Medical and Biological Research are retracting the paper "Niemann-Pick type C1 protein influences the delivery of cholesterol to the SREBP:SCAP complex". Yong-Jun Guo, Wei-Hua Li, Rong Wu, Qiang Xie, Zu-Huang Zhang, Lian-Qun Cui. Braz J Med Biol Res 2008; 41: 26-33 because of plagiarism. The person responsible, Y.J. Guo, Department of Cardiology, Shandong Provincial Hospital, Fujian Medical University, Xiamen, China, has admitted this breach of ethics, has stated that the other authors were not aware of the plagiarism, and sends his sincere apologies to all involved. The original work was published in an Honour Thesis by Julie Wood of the University of New South Wales, Sydney, Australia.


Retraction: Gong Z et al. Injuries after a Typhoon in China. N Engl J Med 2007;356:196-7.


To the Editor: I request that our letter to the editor, "Injuries after a Typhoon in China,"1 be retracted because much of it was previously published in Chinese journals.2,3


Zhenyu Gong, M.P.H.
Zhejiang Center for Disease Control and Prevention

References

1. Gong Z, Chai C, Tu C, Lin J, Gao Y, Qui Y. Injuries after a typhoon in China. N Engl J Med 2007;356:196-197. [free full text]
2. Gong Z, Chai C, Tu C, et al. Epidemiologic study of the present status of injury to the population caused by typhoon Yunna. Natl Med J China 2005;85:3007-9. (In Chinese.)
3. Gong Z, Chai C, Tu C, et al. A field epidemiological study on the risk factors of injury caused by typhoon. Chin J Epidemiol 2006;27:773-6. (In Chinese.)


Retraction: Correlation between DNA Repair Capacity in Lymphocytes and Acute Side Effects to Skin during Radiotherapy in Nasopharyngeal Cancer Patients

* Wei-Dong Wang,
* Zheng-tang Chen,
* De-zhi Li,
* Zheng-huai Cao,
* Ping Pu,
* Shi-liang Sun,
* and Xiao-pin Shen

Clin Cancer Res May 15, 2009 15:3642; Published OnlineFirst April 23, 2009, doi:10.1158/1078-0432.CCR-15-10-RET

Notzon's journal was alerted to such a case by Déjà vu. A group in China had, by Déjà vu's estimate, copied more than 95% of a paper on breast cancer first published in 2003 in the International Journal of Radiation Oncology, Biology, Physics. The Chinese group changed the focus from breast cancer to nasopharyngeal cancer, which is much more common in those of Asian ancestry, and reported data from their own patients. The lead author of the original paper, Odilia Popanda of the German Cancer Research Center in Heidelberg, notes that she was rather miffed that the Chinese work, published in 2005, appeared in a higher profile journal, Clinical Cancer Research.


RETRACTED: Tube domains on antisymmetric matrices and representations of minimal representations
Journal of Mathematical Analysis and Applications, Volume 352, Issue 2, 15 April 2009, Pages 846-855
Li Zhu

This article has been retracted at the request of the Editor-in-Chief. Please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy).

Reason: The author has plagiarized part of a paper that had already appeared in Int. J. Math., 19 (2008) 1247–1268, doi:10.1142/S0129167X08005114. One of the conditions of submission of a paper for publication is that authors declare explicitly that their work is original and has not appeared in a publication elsewhere. Re-use of any data should be appropriately cited. As such this article represents a severe abuse of the scientific publishing system. The scientific community takes a very strong view on this matter and we apologize to readers of the journal that this was not detected during the submission process.


RETRACTED: Pricing currency options based on fuzzy techniques
European Journal of Operational Research, Volume 193, Issue 2, 1 March 2009, Pages 530-540
Fan-Yong Liu

Reason: The author has plagiarized part of a paper that had already appeared in Comput. Oper. Res., 31 (2004) 1069–1081, doi:10.1016/S0305-0548(03)00065-0. One of the conditions of submission of a paper for publication is that authors declare explicitly that their work is original and has not appeared in a publication elsewhere. As such, this article represents a severe abuse of the scientific publishing system. The scientific community takes a very strong view on this matter and we apologize to readers of the journal that this was not detected during the submission process.


Separately, another netter, ASH, reported that an article published in New England Journal of Medicine has been subsequently published in Chinese journals by the same author. It has been used as an example of misconduct by NEJM's associate editor in his seminars.