- A report from the American Urology Association on the three-year results of Xiao's Procedure tests. It shows that the procedure can "improve the voiding functionality" of patients with spina bifida. [Blogger's Note: as far as we could tell, this must refer to the to-be-published results from Beaumont Hospital, which indicated that the so-called "Xiao's Reflective Arc" had disappeared from all but one patient after three years.]
- Some video clips of patients voiding by scratching their side or leg skins
- A couple of patients or their relatives making statements of their being cured by Xiao's Procedure.
- A picture of himself in prison uniform. Dr. Xiao Chuanguo claims that he has been mistreated by the media and will sue CCTV for slandering.
Sunday, April 24, 2011
Dr. Xiao Chuanguo, who was recently released from prison for his attacks, made his first public appearance in the form of a press conference today in Wuhan, China. The conference was announced a few days ago and had a touch of mystery, as reporters were required to sign a non-disclosure-agreement in the name of protecting patients' privacy.
News reports of the conference are just starting to show up in some small-scale media in China. According to them, Dr. Xiao Chuanguo presented:
When responding to questions from reporters, Dr. Xiao Chuanguo insisted that the procedure had not been officially halted in China. Although he has lost his medical licence due to his court trouble, he said that his students and assistants can still perform the procedure.
He also disclosed that he is considering to leave China for America.
Monday, March 28, 2011
Professor Xiao Chuanguo, who was previously sentenced to 5.5 month detention for masterminding brutal attacks on Fang Zhouzi and the journalist Fang Xuanchang, is recently released from prison after serving his term. The newspaper XinKuaiBao interviewed the unrepentant doctor, who continued to call Fang Zhouzi as a "mad dog."
Curiously, the reporters found Dr. Xiao Chuanguo at work in his old office at HUST, which had, supposedly, stripped all his administrative and teaching positions. The doctor did not directly answer reporter's questions on his work status, but he appeared to be busy at his work. He also disclosed that he is scheduled to travel abroad for his surgical work.
Despite a videotaped confession in which he admitted to the details of his involvement, Dr. Xiao Chuanguo now claims that he had never violated any law, nor admitted to such. He claimed that it was the media that were spreading rumors.
In response to complains of his patients, he appealed for calm and promised that he could reexamine and "fix" those who had failed to see effects of his procedure. He also blamed most doctors in China lacked sufficient expertise to understand his work.
Meanwhile, both Fang Zhouzi and Xiao Chuanguo are appealing to the highest court of China for a retrial of the attack case.
Tuesday, March 8, 2011
Fang Zhouzi and Fang Xuanchang, the two victims (no relation) of a vicious attack masterminded by the disgraced Dr. Xiao Chuanguo, made a formal appeal to the Supreme People's Court of the People's Republic of China yesterday, asking for a review of the previous lower court decisions which led to a five and half month detention for Xiao Chuanguo. They are appealing that the decisions contained mistakes in legal basis and that there are new evidences proving that the facts recognized by the earlier judges were in error.
The lengthy appeal document lists seven major issues:
- Obvious errors in the application of law and the crime. (The lower courts had settled with a minor "causing disturbance" charge while the attackers had clearly intended to kill or at least causing major injuries.)
- New evidences prove that previous court-recognized facts are in error. (The lower courts had accepted a hospital statement that Fang Xuanchang only suffered minor injuries while the involved doctor told a newspaper that Fang Xuanchang had lost a large amount blood and showing signs of shock and dizziness.)
- The lower courts made mistakes in recognizing key facts, missed important leads in the case, and confused a few facts.
- There are significant discrepancies in the motives of the defendant.
- The sentences given by the lower courts are too light for the crimes involved.
- On their appeal, the Intermediate Court did not factually record evidences provided by the prosecutors.
- The original court procedure was seriously fraud.
By the original sentence, Dr. Xiao Chuanguo is due to be released at the present time.
Thursday, November 25, 2010
In the aftermath of Dr. Xiao Chuanguo's conviction for attacks, the Huazhong University of Science and Technology decided to impose severe disciplinary actions on Dr. Xiao Chuanguo, who is an employee at the school and its affiliated Xiehe Hospital. The school announced today that they had decided on November 6 to strip all administrative and teaching positions Xiao Chuanguo held in the school and hospital.
But the school stopped short of expelling him altogether. Dr. Xiao Chuanguo also received an administrative censure and a one-year probation. It is unclear how the probation would carry out.
Thursday, November 4, 2010
The following is a Science report in "Research Ethics," published on it's 11/5 edition. A Chinese version is also available here.
Questions From China Snag U.S. Trial Of Nerve-Rerouting Procedure
SCIENCE VOL 330 5 NOVEMBER 2010 Published by AAAS
A running 5-year medical brawl in China has spilled over into Michigan, where it has delayed a clinical trial about to enroll patients. The trial, based at the William Beaumont Hospital in Royal Oak, Michigan, aims to surgically reroute the nerves of spina bifida patients to give them control of their bladder. Principal investigator Kenneth Peters confirmed last week that the U.S. National Institutes of Health (NIH)—which is funding the work—has asked for a review.
The urologist who invented the nerve-rerouting procedure, Xiao Chuan-Guo, has claimed phenomenal results in China—including an 87% success rate for 110 spina bifida patients at their 1-year follow-up visits. But the controversy surrounding his work is phenomenal, too. Earlier this year police charged Xiao, head of urology at the Union Hospital affiliated with Huazhong University of Science and Technology in Wuhan, with organizing street attacks on two of his critics. Those injured were Fang Shimin, who under the pen name Fang Zhouzi operates the Xin Yu Si or New Threads Web site (www.xys.org), and journalist Fang Xuanchang (no relation to Fang Shimin), who has edited magazine articles about Chinese patients who failed to benefit from Xiao’s procedure.
Xiao was convicted of “causing disturbance” and sentenced to 5.5 months of detention (http://scim.ag/doctor-sentenced-Beijing). He has appealed the verdict. Science sent a request for comment to Xiao’s lawyer by e-mail but did not receive a response by presstime.
Questions about the clinical trial in Michigan based on Xiao’s procedure reached the U.S. Department of Health and Human Services in March, when the so-called New Threads Volunteers, a watchdog group that tracks Xiao’s research, sent a letter to the Office of Research Integrity (ORI) and the Office for Human Research Protections (OHRP). The letter alleged, among other things, that “the current clinical trials in the United States are based on dubious data.”
ORI declined to take action, according to Eddie Cheng, a blogger, software engineer, and member of the Volunteers, who mailed letters about Xiao’s study to ORI and OHRP. Cheng says ORI wrote back in March that the allegations weren’t specific and that Xiao’s work in China was out of its jurisdiction. Last week, however, OHRP confirmed in an e-mail to Cheng that it had asked the funding agency to evaluate the allegations.
Xiao has many friends in the scientific community. Peters, head of urology at the Beaumont Hospital, and 30 researchers signed an open letter in support of Xiao in September urging China to “protect his human rights” and praising Xiao as “a compassionate man who is respected worldwide for his integrity and his innovative scientific contributions to society.”
Xiao developed a nerve-rerouting procedure to treat neurogenic bladder disorder in patients with spinal cord injury (SCI). Nerve crossover was first proposed by an Australian surgeon in 1907; medical literature holds a scattering of partial success stories. But Xiao’s approach—which he proposed in the late 1980s—bypasses the central nervous system by grafting a lower lumbar nerve to one or two sacral nerves below the spinal cord lesion, rerouting signals to bladder and urinary muscles. Xiao claims to have established a new pathway that can be used to initiate voluntary urination by scratching or squeezing skin on the thigh.
After testing the idea on rats and cats, Xiao applied for and received an NIH grant in 1994 to study dogs at the Long Island College Hospital in Brooklyn, New York. According to his own published account, Xiao began a trial of the procedure with Chinese SCI patients at a hospital affiliated with a coal mine in Henan Province in 1995 and published final results from the SCI patients in 2003 in The Journal of Urology. This peer-reviewed article reported that of 15 male SCI patients—all with hyperreflexic neurogenic bladder (involuntary voiding)— who had the surgery, 10 gained satisfactory bladder function, two had partial recovery, two failed, and one was lost to follow-up.
Critics see inconsistencies in the data. For example, in early reports (some in Chinese), Xiao described patients’ recovery taking place between 10 and 12 months post-op, but the 2003 final report says that patients gained bladder function 12 to 18 months post-op. In addition, the depiction of all 15 patients as hyperreflexic in the 2003 report seems at odds with Xiao’s previous reports, which described treating a mix of patients with hyperreflexic bladder and areflexic bladder (failure to void).
Eric Kurzrock, chief of pediatric urology at the University of California, Davis, Children’s Hospital in Sacramento, California, says Xiao’s study is “extremely flawed” because of “patient selection bias.” Kurzrock is particularly critical of the claimed high success rate, because it is not based on data from a randomized, controlled trial.
After treating SCI patients, Xiao began using nerve rerouting to treat bladder malfunction in children with spina bifida, whose spinal cords are generally not as damaged as those of SCI patients. The first privately funded trial at Beaumont Hospital, which took place in 2006 and 2007, included nine spina bifida patients and two SCI patients; Peters and co-authors reported preliminary results from spina bifida patients, but results on SCI patients have not been reported. The current NIH-funded trial aims to enroll about 16 spina bifida patients; the original design was not blind and had no control group. Peters says NIH has “created an oversight committee for our study. We met with them a few weeks ago and are addressing their comments. We will be submitting a revised protocol soon for their review.”
Friday, October 22, 2010
Back in March, we sent an open letter on Xiao's Procedure, with supporting material, to several government offices and related hospitals. Of them, the Office of Research Integrity of Department of Health and Human Services, had previously responded to decline an investigation.
Today, an email arrived from a different office, the Office for Human Research Protections, indicating that they are taking actions on this issue:
From: Borror, Kristina C (HHS/OASH)
To: Eddie Cheng
CC: Menikoff, Jerry (HHS/OASH)
Subject: "Xiao Procedure"
Dear Mr. Cheng:
The Office for Human Research Protections (OHRP) has received your letter concerning research conducted at William Beaumont Hospital. I apologize for the delay in responding to you.
OHRP has responsibility for oversight of compliance with the U.S. Department of Health and Human Services (HHS) regulations for the protection of human research subjects (see 45 CFR Part 46 at http://www.dhhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). In carrying out this responsibility, OHRP evaluates, at OHRP's discretion, substantive allegations of noncompliance involving human subject research projects conducted or supported by HHS or that are otherwise subject to the regulations (see OHRP memorandum dated October 14, 2009 at http://www.hhs.gov/ohrp/compliance/ohrpcomp.pdf for an explanation of OHRP's jurisdiction).
OHRP has initiated an evaluation of the matter referenced in your letter. We notified the funding agency of your allegations and they have stopped enrollment into the study. We will advise you when the evaluation has been completed.
OHRP appreciates your concern about the protection of human research subjects. Please do not hesitate to contact me at any time should you have any questions or wish to provide additional information.
Kristina C. Borror, Ph.D.
Division of Compliance Oversight
Office for Human Research Protections
1101 Wooton Parkway, Suite 200
The Tower Building
Rockville, MD 20852
(Note: email address and phone number are also included in the above email. Although they are public records, they are omitted here to limit spam.)
Wednesday, October 20, 2010
Nature joins the fray with an editorial of its own today:
A hammer blow to national ethics
Nature 467 , 884 (21 October 2010)
Published online 20 October 2010
China needs to act on broader science failures, not simply condemn an isolated case.
The trial of Chinese urologist Xiao Chuanguo for organizing beatings of two of his critics started on a Sunday. By Monday, the Beijing district judge had handed him a five-and-a-half- month sentence, and lesser or equal terms to other men involved. One of the victims, Fang Shimin, a self-styled science watchdog who investigates misconduct claims under the name Fang Zhouzi on his New Threads website, says the penalty is too light. But the judgment has already made Xiao persona non grata in China.
The attacks involved a hammer, steel rods and pepper spray (see Nature 467, 511; 2010). Xiao's supporters argue that the incident involving Fang Shimin followed a long-standing feud between the two men. The Chinese scientific establishment is right to condemn Xiao for his crime, but the authorities should not use this case to divert attention from wider failings in the research community.
The science ministry issued an online statement after the verdict, saying that Xiao “should be condemned for his vicious misconduct and lack of integrity”. The ministry wants nothing to do with Xiao, taking pains to disavow claims that he was chief scientist on a ministry-sponsored science project. The China Association for Science and Technology (CAST), the country's largest non-governmental organization of scientists and engineers, likewise welcomed the judgment. Meanwhile, the widespread and debilitating failures in China's scientific community go on largely uncontested, even though they have created fertile ground for this ugly episode.
Lack of monitoring and regulation in China means false CVs and scientific misconduct are rife there. The laxity can lead to a blurring of the lines between what is considered acceptable and unacceptable scientific behaviour, especially among young researchers. Channels of complaint about misconduct exist, but fear of identification and doubts over effectiveness drive many to launch unofficial, often anonymous attacks. Reasoned examination of facts and allegations gives way to vitriol and fear.
The impacts can be widespread. More than 250 patients in China are now threatening to sue hospitals, or Xiao directly, because they claim a surgical procedure he pioneered — which aims to restore bladder and bowel function in patients with spina bifida or spinal-cord injuries — doesn't work. The procedure has its critics, who say it should be considered experimental (K. M. Peters et al. J. Urol. 184, 702–708; 2010). But others back it, and last month 31 scientists (including 22 from the United States) posted a letter of support on the CareCure Community website, which is largely devoted to discussions of cutting-edge spinal therapies. The letter, signed by many who use Xiao's method, asks that his “scientific and humanitarian contributions to the world” are considered. With Xiao's conviction, will his technique get a fair trial?
Chinese government officials often promise to deal with scientific misconduct. This time they should do more than just punish hammer-wielding thugs and take steps to create a system that properly monitors fraud and plagiarism, checks reasonable allegations, prosecutes libellous ones and protects whistleblowers. The careers of scientists, the health of patients and the scientific future of the nation are at stake.
Tuesday, October 19, 2010
The following is an Associate Press report:
Patients protest Chinese doctor's risky surgery
By GILLIAN WONG, Associated Press Writer – Tue Oct 19, 5:53 am ET
BEIJING – At one moment, the Chinese urologist seemed to be at the height of his career: He had invented a surgical procedure to help patients overcome incontinence and was training doctors in America and elsewhere. The next, Dr. Xiao Chuanguo was in handcuffs, confessing that he'd hired thugs to attack two persistent critics who called him a fraud.
The scandal has shocked the public and prompted calls for better regulation of Chinese medical research. And while research fraud and misconduct is widespread in China, Xiao is no run-of-the-mill charlatan. More than 30 urologists from the United States, Canada, France, India and other countries issued a letter in support of the U.S.-trained surgeon after his arrest late last month.
In China, several former patients have complained about severe side effects, including a worsening of their mobility. The respected Southern Weekly newspaper said in an analysis that poor regulation led to Xiao "treating patients as if they were voluntary lab mice."
Last week, a Beijing court sentenced the 54-year-old doctor to five and a half months in detention for his role in the attacks. Xiao, in police custody, could not be reached for comment.
Some American doctors consider his technique experimental but promising, and two U.S. hospitals are carrying out trials on a small number of volunteers, mostly children. Others, though, are skeptical, particularly of his claims of an 85 percent success rate. The surgery is meant to help people who cannot control their bladders because of a paralyzing accident or a birth defect known as spina bifida.
"Most of the pediatric urologists in the United States were very cynical about his reports," said Dr. Eric Kurzrock, chief of pediatric urology at the UC Davis Children's Hospital in Sacramento, California. "Nobody ever believed there was an 85 percent success rate, you know, and when you looked at his reports they were very short on details."
In China, Xiao forged ahead with the surgery on hundreds of patients, according to media reports. Now, some are saying he exaggerated the chance of success and that the surgery left them worse off.
Whether or not he is guilty of fraud or an ethical lapse, his case highlights the unregulated nature of research in China, with few protections for patients.
"It's no secret that the Chinese medical space is the Wild West," said Cong Cao, a researcher at the State University of New York who has written two books on China's science and innovation.
One man, Fang Shimin, has emerged as an unofficial sheriff, unearthing examples of scientific fraud and posting them on his website.
He took on Xiao, and the two ended up in a long-running feud. Separately, investigative journalist Fang Xuanchang, no relation to the other Fang, also started writing critical pieces about Xiao.
The stakes are high for Xiao, who once told reporters his procedure should win him a Nobel Prize and has said that becoming a target of the two Fangs cost him a seat in the prestigious Chinese Academy of Sciences.
In June, two men attacked the journalist Fang with metal pipes, leaving a deep gash on his head. Two months later, the other Fang was attacked with a chemical spray and a hammer, escaping with minor injuries.
Police arrested Xiao after he returned from training doctors in Argentina. In a videotaped interrogation, the doctor said he paid a distant relative 100,000 yuan ($15,000) to hire two men "just to give them black eyes and swollen faces ... but not to do any permanent damage.
"Nothing else would solve the problem except beating him up," he said, referring to Fang Shimin, the muckraker.
Half a dozen patients and family members protested outside his trial, saying they represented 200 patients who were duped by Xiao into thinking the 30,000 yuan ($4,500) procedure had an 85 percent success rate.
"We need an explanation. We need justice," said Qu Binbin, a 29-year-old man in a wheelchair who said he was able to get around without crutches before having the surgery three years ago.
Supporters of the doctor also showed up. Guo Yuling, a 19-year-old college student, said he constantly wet his pants for the first 13 years of his life before Xiao's surgery.
Two former patients are suing Xiao for false advertisement, and more lawsuits are planned, said Peng Jian, a human rights lawyer who said he has documented 150 cases in which the surgery had no benefit or left patients worse off.
So far, the scandal has not derailed plans to continue studies in the U.S.
Researchers at William Beaumont Hospital in Royal Oak, Michigan, reported mixed results — and some side effects — from a pilot study of nine spina bifida patients.
By early next year, they plan to begin a 5-year clinical trial funded by $2.3 million from the National Institutes of Health.
Dr. Kenneth Peters, the hospital's head of urology, said he ensures that patients are fully aware the surgery is experimental and carries serious risks.
"Dr. Xiao has been nothing but in our experience an incredible gentleman, scientist and a very good colleague," said Peters, one of those who signed the letter in Xiao's support.
A separate 3-year study on eight children is under way at All Children's Hospital in St. Petersburg, Florida.
Associated Press researcher Xi Yue contributed to this report.
Thursday, October 14, 2010
The following is a translation of an essay written by Fang Zhouzi's wife, expressing her anger and frustration on how the Xiao Chuanguo case was handled. Fang Zhouzi posted the original in Chinese here.
by Fang Zhouzi's wife
Today I plan to take an act of rebellion forced by high officials.
I am a very good citizen. I live a normal life. In the subway, I offer my seat to those who are old, preganant, or very young. I am optimistic, always hoping for and pursuing a beautiful future. I live cleanly myself, and think about charity whenever I am able. I have never caused any trouble to society, never wanted to harm anyone. I am one of those who form the foundation of social stability, I am one of those for whom the ruling class is most at ease, never a need to worry or concern about.
However, Xiao Chuanguo spent 100,000 RMB to purchase an attack [on my family] -- considering that the perpetrators lived in a hotel across the street from my family for months and spent all day doing nothing but sitting on a stone bench or sidewalk in front of our building waiting for Fang Zhouzi, that was an expensive undertaking. Unless they are volunteers, this 100,000 sum is most likely only a down payment -- and planned [the attack] for half a year. When they took the action, Fang Zhouzi was lucky enough to be able to run away without serious harm only because of his quick reflexes, a result that led to the conspirator to claim as "impossible" on the Internet. Yet this very conspirator was only sentenced to 5.5 month of detention. This dramatic event became the last straw for me to live a silly and indignant life in this society.
I no longer want to use words like crazy, absurd, or emptiness. This rotten society does not deserve such emotion from me. I want to say it's buffoonery, for the ordinary people are slipping around in a giant, black and messy sauce jar, and splash, they are tripped and fell, and immediately submerged into the bottom. There is only a sound and everything will appear the same normal again. Life goes on. Only that too many people had drawned this way, the stench is unbearable.
"Social phenomena" much worse than this case of attacking Fang Zhouzi are happening every day. In the past, I have always hoped and believed that their exposure will lead to change. A net-friend had described me as "a woman desperately struggling in a sauce jar while her husband is making a great effort to smash it." Because of its symbolic importance, the attack has become national and even international news. But in the end, it is still able to be massaged and smoked into such a ball of mess without any true color. I congratulate the Political and Legal Committee of the city of Beijing.
You have successfully threatened a chivalrous fighter, encouraged criminals, and made obedient people desperate. You did a marvelous job.
Ever since that day of September 21, when Xiao Chuanguo was captured, a strong and mysterious power started to assert its force -- if this power had known it was Xiao Chuanguo's deed ahead of time, he would never have been arrested. So here I want to sincerely express my respect and gratitude to the Beijing police. Given the will and resource, you are able to recover all truth.
Guided by that mysterious power, in the short span of a dozen or so days, the investigation and questioning screeched to a halt. The case was sent to the prosecutors with a baffling charge. The prosecutors did not even take a break during the National Day holiday and forwarded it to the court with high efficiency. The court announced its verdict with lightning speed, without the presence of any "irrelvant" media. Xiao Chuanguo coorperated accordingly. Report shows that Xiao Chuanguo, who had been acting up "like a professional lawyer in questioning witnesses in court," behaved much unlike himself in the beginning, claiming that he did not understand the "causing disturbance" charge but if the court designates this charge to him, he would have no objections. Perhaps because all this had been planned too carefully and executed too smoothly, it actually led to a close call among themselves. When the defendant's side realized that the victim's side is helpless with the cover provided by the court, they wanted to enter a not-guilty plea instead. This sudden change must have not been planned ahead of time. At noon, the hungry judge had no choice but announced that he had to change the simplified proceeding back into a normal procedure. He announced an adjournment, the verdict would have to wait for another day.
The mysterious power realized that they could not afford to wait any longer and quickly took action to guide the events back into a preset track. So, the court was back to action in the same afternoon.
The defendants were then no longer making any troubles and an "intelligent" verdict was reached on time -- never mind that the victims' lawyer was not even present. Xiao Chuanguo said he would appeal. Yes, please continue your act, please continue to act diligently. The whole nation is watching with taste and excitement. They know what's at stake now. When the ruling class embraces sin, deception, and lies, the powerless has no choice but lowering their heads and accepting exploitation, cheating, and insults.
I can no longer trust the laws and courts of my motherland. I can not imagine what would be the result of the petition by more than a hundred victims of the surgical operation called "Xiao's Procedure". I can no longer believe that the Ministry of Science and Technology, Ministry of Education, Ministry of Health, or any other "relevant" power institutes could take their responsibilities. They always pretend to see nothing and hear nothing. Reports say that "the Minsitry of Health may publish its opinion on Xiao Chuanguo within a week." Is it so difficult to say that we need to launch an investigation on the "Xiao's Procedure"?
On the day after the verdict, an abusive and threatening message showed up on my cell phone. I couldn't help but laugh. Look how desperate you guys were, did you want the Beijing Policial and Legal Committee to take another action and arrest the entire family of Fang Zhouzi and kill them? Would that help to ease the hatred of Xiao Chuanguo and the like?
My little baby often makes up stories with me. Lately she has been naming her hero "Little Tear Drop". She also calls her most faviorate toy Little Tear Drop... Why are there so many tear drops in your little heart? I recall the confession from one of the attackers. He had followed Fang Zhouzi all the way as he was carrying our baby to supermarket. I tremble with fear. I have also been unknowingly taken pictures by the spies hired by Xiao Chuanguo. I have not seen those pictures myself. They were most likely taken around my neighborhood. For a Mom who dedicated all her spare time to her baby, the pictures must have been clandestinely taken when I was playing with her. I had even smiled at Xu Lichun, one of the would-be attackers. He was sitting on a stone bench with a funny expression and stared at me. I thought he was a relative of one of my neighbors. Then I turned away to chase my baby. She was calling for me.
China could not tolerate Fang Zhouzi. I open my eyes waiting for the time when the burning lava could break through the ground. There is no need for Fang Zhouzi to change himself. Let the time distill his sincerity and his value.
So, Ah Min, shall we run away?
Sunday, October 10, 2010
In an unusual move, a local court in Beijing took on the case of attacks on Fang Zhouzi and Fang Xuanchang on a Sunday. The proceedings was supposed to be open but few were able to obtain tickets. Fang Zhouzi did not attend it himself. His lawyer Peng Jian represented him. Fang Xuanchang was present.
Previously, the prosecutor of this case had adopted a lower charge against the accused, citing them only for "causing disturbance" (寻衅滋事). The court then used a "simplified procedure" (简易程序) to reach a speedy verdict without a jury.
In court, Xiao Chuanguo did not contest the prosecutor's charge of beating other people and causing disturbance. He said that he did not quite understand the term but "if the court thinks what I did fit this crime, I have no objections." But he denied that he had offered money to his relative Dai Jianxiang for the attacks, while Dai Jianxiang, a co-defendant in the case, insisted as true.
The court spent almost 5 hours cross-examining the evidences and then announced to take a break. However, after Fang Xuanchang, Peng Jian, and others had left the building, the court suddenly issued a callback and announced its decision.
The court found Xiao Chuanguo and his co-defendants guilty and sentenced Xiao Chuanguo and Dai Jianxiang for 5.5 month of detention (拘役), a lessor punishment than normal jail terms. Other co-defendants who participated in the attacks receives detention terms of 4, 3, and 1.5 months.
Even before the trial, Fang Zhouzi and Fang Xuanchang had already voiced their objection of the lessor charges. They believe the accused should be trialled for attempted murder. After the sentencing, Fang Zhouzi expressed his shock, claiming that the decision was even below his already lowered expectations.
Xiao Chuanguo indicated that he might appeal. Fang Zhouzi and Fang Xuanchang are also seeking other possible legal procedures.
Thursday, September 30, 2010
Exactly one year ago, Hollywood celebrities were busy writing appealing letters on behalf of Roman Polanski, a movie director who was convicted for child rape. A couple of years earlier, a world-renowned scientist, William French Anderson, might have his sentence for molestation reduced because of supporting letters from his colleagues, including a Nobel Laureate.
Today, 31 internationally-renowned scholars, most of whom are accepting fundings for experiments on Xiao's Procedure, issued an open letter supporting Dr. Xiao Chuanguo, who had confessed to the hideous crime of masterminding two brutal attacks on an investigative reporter and a free-lance writer who had worked to expose his fraud.
The common thread of these letters is that their authors pay little or no regards to the horrible injuries caused by the perpetrators, in the name that the criminals or suspects had previous made valuable contributions to the society and therefore somehow should be judged more than mere citizens. Where are the moral standards?
In addition, this particular letter once again states the Beaumont Hospital result has confirmed that "[nerve] rerouting does occur," without even a mention of the critical comments by their peers published in the same issue of the Journal of Urology. Where is scholastic honesty?
To those protected elites who never fail to protect one of their own, where is the shame?
Below is the open letter, in its entire glory:
Open letter in support of Chuan-Guo Xiao, M.D. from theInternational Academic CommunitySeptember 29, 2010To all,We have all had the pleasure of knowing Dr. Chuan-Guo Xiao for many years. He is an internationally respected surgeon-scientist who has made major advances in the development of neuroregeneration to restore voiding and bowel function. Dr. Xiao performed groundbreaking animal research in the United States, demonstrating that a motor nerve that innervates the leg can be used to reinnervate the bladder and bowel. This reinnervation allows for development of a reflex to initiate bladder function. The results of his studies were published in peer-reviewed journals and other scientists have replicated Xiao’s findings confirming these results.Dr. Xiao eventually took the courageous step of moving from animal research to human studies and began performing the rerouting procedure on patients with spinal cord injury and spina bifida in China. Neurogenic bladder is life threatening in China due to a lack of both antimuscarinics and intermittent catheterization, and lessening the complications of neurogenic bladder would be considered a lifesaving success. Patients with neurogenic bladder and bowel suffer greatly and endure a host of issues such as urinary retention, incontinence, recurrent infections, renal insufficiency, fecal incontinence, constipation, and poor quality of life. For a procedure as complicated as nerve rerouting requiring nerve regeneration, one cannot expect normalization of bladder and bowel function to be the definition of success. What is important is that the benefits outweigh the risks of the procedure.Dr. Xiao published his clinical results in peer-reviewed journals and was twice honored by the Jack Lapides Essay Contest, one of the most respected international awards given to scientists who make major contributions to the field of neurourology. In 2008, he was named the Kelm Hjalmas Memorial Lecturer from the International Children’s Continence Society for his scientific achievements. Many of us have traveled to China to examine patients treated by Dr. Xiao and/or have been trained by him in the nerve rerouting surgery he invented. Dr. Xiao is a very skilled surgeon who is passionate about patient care and works tirelessly to train physicians around the world in performing his nerve rerouting procedure.In the United States, an independent and very rigorous pilot research trial was performed to test the safety and efficacy of this procedure. The one-year results were recently published in the Journal of Urology. At the 12-month follow-up visit, a cutaneous to bladder reflex was found in 7 of 9 spina bifida patients, confirming that rerouting does occur. This finding by itself is remarkable and Dr. Xiao should be commended. In addition, a number of patients demonstrated improvement in bladder and bowel function, which has continued to improve with longer patient follow-up.The 36-month results are currently being analyzed and will be reported in the near future. The pilot data was supportive of Dr. Xiao’s procedure, and now an NIH sponsored clinical trial is being conducted to further study lumbar to sacral nerve rerouting in spina bifida patients. In addition, similar procedures have been done worldwide, with Dr. Xiao helping to mentor the surgeons at each site.The Chinese people and government should be proud of Dr. Xiao for his dedication to his patients, his scientific achievements, and his willingness to train doctors around the world how to perform his surgery. The International scientific community was shocked to hear of Dr. Xiao’s arrest. Those of us who know Dr. Xiao well find it difficult to believe that he is involved in these attacks.Dr. Xiao is a compassionate man who is respected worldwide for his integrity and his innovative scientific contributions to society. We implore the Chinese government and authorities to treat Dr. Xiao fairly and to protect his human rights as these charges are investigated. Please strongly consider Dr. Xiao’s scientific and humanitarian contributions to the world as facts are gathered in this case.Sincerely,Kenneth M. Peters, MDProfessor and Chairman of UrologyBeaumont HospitalRoyal Oak, Michigan USAJack S. Elder, M.D.Chief of Urology, Henry Ford Health SystemAssociate Director, Vattikuti Urology InstituteDepartment of Urology,Children's Hospital of MichiganDetroit, MI USAEdwin A. Smith M.D.Assistant Clinical Professor of UrologyEmory University School of MedicineAtlanta, Georgia USAKevin M. Feber, MD, FAAPBeaumont Children's HospitalRoyal Oak, MI USAAnanias C. Diokno, M.D., F.A.C.S.Executive Vice President & CMOBeaumont HospitalRoyal Oak, Michigan 48073 USAJuan José de BenitoUrologistHospital Nacional de ClínicasCórdoba, Argentina.William E. Nantau B.Sc., CNIMClinical ManagerClinical Neurophysiology DepartmentBeaumont Hospital Royal Oak, MI USAEvan J Kass MD,FACS,FAAPChief, Division of Pediatric UrologyBeaumont Childrens HospitalProfessor of Urology, Oakland University-WilliamBeaumont School of MedicineUSAJacques Corcos MD.Professor of Urology, McGill UniversityGeneral Secretary of the International ContinenceSocietyJewish General hospital3755 Cote Ste-CatherineMontreal, Quebec, Canada H3T 1E2Jose Gonzalez, M.D.Department of UrologyBeaumont HospitalRoyal Oak, Michigan USAChristopher Payne, MDAssociate Professor of UrologyStanford University Medical SchoolStanford, CA 94305-5118 USAKenneth I. Glassberg, MDDirector, Division of Pediatric UrologyMorgan Stanley Children's Hospital of New York-PresbyterianProfessor of Urology, Columbia UniversityCollege of Physicians and Surgeons3959 Broadway, CHN 1118 NY USAEarl Y. Cheng, MDAssociate Professor of UrologyChildren’s Memorial HospitalChicago, Illinois USADarius J. Bagli, MDCMProfessor of SurgerySenior Associate ScientistDirector of Urology ResearchDivisions of Urology andDevelopmental & Stem Cell BiologyThe Hospital For Sick ChildrenInstitute of Medical ScienceUniversity of TorontoHenri B. LOTTMANN, MD, FEBU, FEBPS,FRCS(england) FEBPUPaediatric urology unitHopital Necker-Enfants-Malades149, rue de Sèvres75015 Paris, FranceDr. Amrish Vaidya MS. MCh.Consultant Paediatric Surgeon,Kokilaben Dhirubhai Ambani Hospital,4 Bungalows, Andheri W, Mumbai, IndiaMarc Cendron, MDAssociate Professor in UrologyHarvard Medical SchoolChildren’s Hospital BostonBoston, MA USAStuart B. Bauer, MDAssociate Director, NeurourologyProfessor of UrologyHarvard Medical SchoolChildren’s Hospital BostonBoston, MA USAEdmond T. Gonzales, Jr., MDProfessor of UrologyBaylor College of MedicineHouston TX USARichard Macchia, MD FACSSUNY Distinguished Teaching ProfessorCleveland Clinic, FloridaBenjamin Girdler, MDUrology Center of the RockiesFort Collins, Colorado USAWilliam C. de Groat, Ph.D.Professor of PharmacologyUniversity of PittsburghPittsburgh, PA USAMichael R. Ruggieri, Sr., Ph.D.Director of Urologic ResearchTemple University School of MedicinePhiladelphia, PA USAStanley J Kogan MDChief, Pediatric UrologyChildren's Hospital at MontefioreBronx NY USAAnthony Caldamone, MDUniversity Urologic Associates, Inc.2 Dudley St Ste 185Providence, RI 02905 USAYves Homsy MD, FRCSC, FAAPClinical Professor of Urological Surgery andPediatricsUniversity of South FloridaChildren's Urology Group5507 E. Longboat BlvdTampa FL 33615 USADr. Enrique TurinaProfessor of urology of the National University ofBuenos AiresChief of section Urology of Instituto deRehabilitaciónGovernment of Buenos Aires, Argentina.Dr. Angel OzónUrologist of the Instituto de Rehabilitación of BuenosAiresDr. Daniel EkizianUrologist of Instituto de Rehabilitación.Professor Dr. med. Karl-Dietrich SievertVice ChairProf. of Urology, Director - Uro-oncology,Neurourology, Incontinence, & ReconstructiveUrologyDepartment of Urology University of TuebingenD72076 Tuebingen, GermanyHolly Gilmer, MDChief of Pediatric NeurosurgeryBeaumont HospitalRoyal Oak, Michigan USAYegappan Lakshmanan, MDChief, Pediatric UrologyChildren’s Hospital of MichiganDetroit, MI USA
Wednesday, September 29, 2010
The following is a news report by Nature on September 29, 2010.
The story incorrectly identified this blog as Dr. Fang Shimin's web site. The correct web site is at http://www.xys.org and is in Chinese. Dr. Fang is not personally involved in this blog.
Brawl in Beijing
Critics of Chinese researchers targeted in physical attacks
Science can be a rough game in China. On 29 August, on his way home from a tea house in Beijing, Fang Shimin was assaulted. The former biochemist — who for the past decade has run a website exposing scientific fraudsters — was chased by two men, caught and attacked with a hammer.
"I believe they planned to kill me," he says. "The only way to shut me up is to kill me." He escaped with only minor cuts and bruises. In June, Fang Xuanchang, a journalist who had reported on corruption in science in China, was left with more serious injuries after two men assaulted him with steel rods.
On 21 September, police arrested Xiao Chuanguo, a urologist at Tongji Medical College in Wuhan, on suspicion of master minding both plots. Xiao could not be reached for comment, but has confessed his involvement to Beijing's police. Fang Shimin says Xiao could face 3–10 years in prison — or more if the charges become attempted murder.
Xiao and Fang Shimin have never met or spoken, but their paths have crossed on the Internet — and in court. Xiao's clash with him, and with Fang Xuanchang, revolves around a surgical procedure devised by Xiao that aims to restore bladder and bowel function in patients with spina bifida or spinal-cord injuries. Xiao reported an impressive 87% success rate for the operation, which involves re-routing nerves[1,2]. In 2005, he was nominated for membership of the Chinese Academy of Sciences, the elite body of the Chinese scientific world.
Following his nomination, people started posting questions about Xiao's claims on Fang Shimin's website (http://fangzhouzi-xys.blogspot.com). Then in September 2005, Fang Shimin published an essay in Beijing Sci–Tech Report, which said that Xiao was not an associate professor at New York University as he states in his CV, but only an assistant professor. Furthermore, the article said that only 4 of the 26 English-language publications Xiao listed were journal articles — the rest being abstracts from conference proceedings.
It is not known if Fang Shimin's article affected the academy's decision, but Xiao was not made a member and has since sued Fang Shimin for libel five times. Fang Shimin, whose site has been criticized for giving contributors a platform for unjustified attacks on their enemies, lost one case and won two, with the other two undecided. Meanwhile, criticism of the 'Xiao procedure' has continued. Last year, Fang Xuanchang published a series of articles questioning its efficacy, which may have prompted the attacks on him.
Beijing-based lawyer Peng Jian says he has interviewed 20–30 patients who have experienced side effects after undergoing the Xiao procedure, and who are seeking compensation. This summer, the first US trial of the treatment reported ambiguous results in The Journal of Urology, and two journal editorials said it should be considered experimental.
Fang Shimin, meanwhile, is unfazed by the attack. "It won't stop me," he says. "I will continue to do what I am doing."
1. Xiao, C.-G. Proc. Int. Conf. Urol. Shanghai, 2–4 July (2005).
2. Xiao, C.-G. Eur. Urol. 49, 22-29 (2006).
3. Cyranoski, D. Nature 441, 392-393 (2006).
4. Peters, K. M. et al. J. Urol. 184, 702-708 (2010).
Monday, September 27, 2010
Professor Xiao Chuanguo first surfaced in the world internet forums some time near the turn of the centry. But nobody knew him then -- He was posting under a pseudonym "Confused Professor" (昏教授). Around the same time, Fang Zhouzi was starting his efforts in exposing scientific fraud in China. "Confused Professor" took an interest in Fang Zhouzi's actions and decided that he didn't like what he saw. He posted a few articles criticizing Fang Zhouzi.
In 2001, Fang Zhouzi published a popular science essay in a newspaper in China, introducing some recent research results to the general public. "Confused Professor" reported it to Science, which carried the original study, as a case of plagiarism. Science responded that it was not plagiarism because Fang Zhouzi "neither implied that the work was his own by writing in the first person nor directly copied the language in the Science paper." Nevertheless, "Confused Professor" and his followers continued to propagate the myth that Fang Zhouzi had committed plagiarism.
Fast forward to the fall of 2005, "Confused Professor" was revealed to be Professor Xiao Chuanguo, then in the process of moving back to China from his post in New York and applying to become a member of the prestigeous Chinese Academy of Science. Alerted netters wrote to New Threads suggesting that Xiao Chuanguo had been mispresenting his resume in his application. On September 21, 2005, Fang Zhouzi publised an essay in Beijing Science and Technology summarizing the charges, questioning Xiao Chuanguo's claims of his academic status, number of publications and that he had invented a world-famous "Xiao's Procedure" (At that time, the term "Xiao's Procedure" had only existed in Xiao Chuanguo's own tellings).
In October, Xiao Chuanguo sued Fang Zhouzi and the newspapers that carried the articles.
May, 2006, as Fang Zhouzi's efforts were exposing more scientific fraud in China, 120 Chinese scholars, mostly biologists based in US, published an open letter calling for a stop of such public investigation in the name of protecting scientists' reputations.
That June, Xiao Chuanguo also published an open letter of his own, attacking Fang Zhouzi personally and swore that "this must be revenged!" He followed that up by launching a series of libel suits against Fang Zhouzi.
On July 31, 2006, a local court in Wuhan reached verdict on the very first Xiao Chuanguo vs. Fang Zhouzi case. The court decided in favor of Xiao Chuanguo, employing some very convoluted logic. Fang Zhouzi denounced it as a practice of local protectionism and vowed to defy any penalty ruling.
That very same day, an open letter supporting Fang Zhouzi began circulating. Over a hundred people signed up right away. The number of signatures eventually reached over 600.
September 5, 2006, Xiao Chuanguo launched another lawsuit against Fang Zhouzi, this time in Beijing, challenging Fang Zhouzi's assertion of local protectionism in Wuhan, where Xiao Chuanguo lived and worked. Also in that September, Rao Yi, then a professor at Northwestern University in US, published a friend-of-court style essay criticizing Xiao Chuanguo. In China, Professor Qing Chenrui (the wife of Professor He Zuoxiu) also published an open letter supporting Fang Zhouzi.
By November that year, escalation continued. Xiao Chuanguo launched another round of lawsuits, this time in New York against Rao Yi, Fang Zhouzi, and New Threads. (Rao Yi's insurance company in US eventually settled on his behalf.)
In China, Professor He Zuoxiu and Fang Zhouzi's lawyer Peng Jian established a Fund in support Fang Zhouzi, who at that time was also facing several other lawsuits in addition to those by Xiao Chuanguo. Overseas, The Organization of Scientific and Academic Integrity in China was also formed to collect donations supporting Fang Zhouzi's cause. Science reported thusly, "China's Fraud Buster Hit by Libel Judgements; Defenders Rally Round"
March, 2007, Xiao Chuanguo, together with other plaintiffs against Fang Zhouzi, issued a public threat to all signatories of the open letter supporing Fang Zhouzi, vowing to sue every person who did not publicly rennounce their signatures. Within that month, Fang Zhouzi lost most of those cases in several courts. He once again pledged to defy the judgements.
But then on May 28, 2007, Beijing Intermediate Court reached a verdict in Fang Zhouzi's favor, a first court victory of its kind.
After that, the dispute seems to have died down for a couple of years until August 2009 when Xiao Chuanguo boasted on Internet that he had received a court-issued fine from Fang Zhouzi. It was news to the latter. It was then that Fang Zhouzi discovered that his wife's bank account had been raided by the Wuhan court without their knowledge. (Fang Zhouzi and his wife had a prenuptial agreement that separates their finances.) His appeal was denied by the court.
In the months of October through December of 2009, a couple of Chinese newspapers, led by science reporter Fang Xuanchang, published a series of investigative findings exposing the ineffectiveness of the Xiao's Procedure and its severe side effects. Lawyer Peng Jian announced lawsuits to seek damages from the surgery.
February, 2010, A group of volunteers of New Threads collected documented materials and published an open letter questioning the Xiao's Procedure. The letter was sent to several institions and hospitals involved in clinical trials of the procedure in US.
August, 2010, the first clinial trial result of Xiao's Procedure from Beaumont Hospital in Michigan, US, was published in Journal of Urology. The journal also published sharply critical comments.
June 24, 2010, reporter Fang Xuanchang was brutally attacked by two thugs on his way home. He suffered serious head injuries and barely escaped.
August 29, 2010, Fang Zhouzi was attacked in daylight in a similar mannar. Fortunately he was able to escape with only minor injuries.
September 20, 2010, Xiao Chuanguo was arrested and identified as the mastermind behind both attacks.
Thursday, September 23, 2010
The following is a report by Science on September 23, 2010.
Urologist Arrested for Attacks on Chinese Whistleblowers
by Hao Xin
BEIJING—The police bureau here announced Tuesday evening that they have detained the suspected mastermind behind assaults on China's science misconduct watchdog Fang Shimin (aka Fang Zhouzi) and journalist Fang Xuanchang. (The two Fangs are not related.)
Earlier on 21 September, police detained Xiao Chuanguo, chief urology surgeon at the Tongji Hospital affiliated with Huazhong University of Science and Technology (HUST) in Wuhan, after Xiao returned from a trip to Argentina. According to a Beijing police report published online, Xiao believed that the Fangs' muckraking investigation of his academic achievements resulted in his failure to be elected a member of the Chinese Academy of Sciences (CAS). Chinese media have reported that, according to a police briefing, Xiao paid about $15,000 to a distant relative, who allegedly arranged the assaults on Fang Xuanchang in June and Fang Zhouzi in August. Police took the relative and two accomplices into custody earlier this month.
The bone of contention between Xiao and the Fangs is a surgical procedure Xiao developed that he claimed can help patients with spinal cord injury and spina bifida to restore some control over bladder and bowl movements. After seeing material supporting Xiao's nomination as member of CAS in 2005, Fang Zhouzi asserted on his Web site, New Threads, that Xiao's procedure was not nearly as internationally famous as Xiao claimed and alleged that Xiao exploited the Chinese public's inability to access information in English to inflate his achievement. Xiao sued Fang for libel in a Wuhan court and won in 2006, but attempts to sue Fang in Beijing courts failed.
Last December, while working for the biweekly Chinese Science News, Fang Xuanchang edited a series of investigative reports on Xiao's procedure, which has been performed on thousands of Chinese patients, according to Xiao. Before the Ministry of Health in May 2009 issued regulations banning the clinical application of unproven and controversial medical procedures such as stem cell therapy, some Chinese hospitals peddled experimental procedures to make more money. It's not clear whether Xiao's procedure falls in the banned category, but no clinical trials have been conducted in China to prove its efficacy. Many prospective patients were enticed by the touted 85% success rate. Since publication of the investigative reports, however, "the number of patients seeking treatment has fallen sharply," says Jia Hepeng, editor-in-chief of Chinese Science News.
The procedure also caught the attention of Kenneth Peters, director of urology research at the William Beaumont Hospital in Royal Oak, Michigan, who launched a phase II clinical trial at his hospital (see also an Associated Press report). Trial results have not been published. Peters also obtained two grants from the National Institute of Health to study the safety and efficacy of the procedure for treating spina bifida patients. According to a description in his grant proposal, preliminary results show that seven out of nine patients who received the treatment have shown improvements. Peters did not respond to an e-mail request for comment.
Xiao could not be reached for comment. His employer, HUST, yesterday issued an online statement that said the university was shocked by the police investigation into Xiao's alleged crime of intentional injury to others. The statement says that the university will follow the case closely and take appropriate action once the judicial system renders its verdict.
Wednesday, September 22, 2010
A day after the Beijing police arrested Xiao Chuanguo, a few details of the case and its investigation started to emerge publicly.
After the attack on Fang Zhouzi gained much publicity, both local and city police allocated a large amount of resources to investigate the case. They interviewed close to a thousand people in the area and identified a couple of eyewitnesses. They were also able to retrieve a surveillance video footage showing a man following Fang Zhouzi right before the attack.
Within days from the attack, police was already able to identify the man in the video as 32-year-old Xu Lichun (许立春). Further surveillance on Xu Lichun then led police to his co-suspect Long Guangxing (龙光兴) and Dai Jianxiang (戴建湘). After they were comprehended, Dai Jianxiang, a distant relative of Xiao Chuanguo's, confessed that Xiao Chuanguo paid him 100,000 RMB (14,000 USD) to "teach Fang Zhouzi and Fang Xuanchang a lesson". Dai Jianxiang then offered half of that money to Xu Lichun and Long Guangxing to do the dirty work.
Xiao Chuanguo himself was abroad at the time of these arrests, so the crack of the case was kept secret for days, until police was able to arrest Xiao Chuanguo on his return at the Shanghai Airport yesterday.
The attack itself was more dangerous than it had previous thought. Fang Zhouzi escaped thanks in part to a comical error committed by the perpetrators. The attack was designed to have Xu Lichun confront Fang Zhouzi head on with pepper juice and an iron hammer while Long Guangxing hit with a steel rod behind Fang Zhouzi's back at the same time. Fortunately, Fang Zhouzi ducked quickly enough that the majority of the pepper juice landed on Long Guangxing's face instead, neutralizing that sneak attack. Fang Zhouzi was then able to run away. Xu Lichun chased and threw his hammer to him a couple of times. He managed to hit Fang Zhouzi on the back once but only caused minor injuries.
Various news reports indicate that all suspects, including the mastermind Xiao Chuanguo himself, had already confessed their criminal actions to police.
Tuesday, September 21, 2010
Beijing Police Bureau announced last night that they have cracked the case of Fang Zhouzi's assault. They identified Xiao Chuanguo, the professor who pioneered the controversial "Xiao's Procedure" and a long-time target of Fang Zhouzi's fraud exposure, as the mastermind behind the attack. Xiao Chuanguo and three other suspects are currently detained by the police.
Police also said that they had uncovered iron hammers and steel pipes, tools that were used in separate previous attacks on Fang Zhouzi and Fang Xuanchang.
Fang Zhouzi first exposed Xiao Chuanguo's misconducts in 2005 for lying about his resume. Xiao Chuanguo launched a series of law suits against Fang Zhouzi. Later, Fang Zhouzi further questioned the effectiveness of the "Xiao's Procedure," a charge that has also led to court cases in China and apparently supported by a recent clinical trial result.
The police will have further details as they continue their investigation.
Monday, August 9, 2010
The Beaumont Hospital in Michigan is one of the first American institutes that took up clinical trials of the controversial Xiao Procedure. We have previously reported on their misleading propaganda. More recently, the hospital has also become the first institute to publish clinical results of Xiao Procedure in an established scientific journal. Dr. Ken Peters and his coauthors wrote in Journal of Urology of their results:
At 1 year 7 patients (78%) had a reproducible increase in bladder pressure with stimulation of the dermatome. Two patients were able to stop catheterization and all safely stopped antimuscarinics. No patient achieved complete urinary continence. The majority of subjects reported improved bowel function. One patient was continent of stool at baseline and 4 were continent at 1 year. Of the patients 89% had variable weakness of lower extremity muscle group at 1 month. One child had persistent foot drop and the remainder returned to baseline by 12 months.
In their conclusion, they noted that "more patients and longer followup are needed to assess the risk/benefit ratio of this novel procedure."
The Journal, however, appears to be less than impressed. It published two pieces of editorial comments to accompany the paper, both are quite negative. In one, Dr. Eric Kurzrock of UC Davis Children's Hospital wrote:
The authors present the first North American experience with lumbar to sacral nerve rerouting for patients with spina bifida. The results from this study and previous animal and clinical studies by Xiao clearly demonstrate that nerve rerouting produces a somatic-autonomic or cutaneous/bladder reflex with stimulation of the lower extremity dermatome. What is also clear is that the clinical benefit of the procedure is not at all similar to previous reports.Although the authors did an excellent job of following the patients and characterizing their changes, the results are hard to validate without a control population going through the same rigorous surveillance regimen. In particular the improved bowel continence and minimal changes in bladder compliance may not be statistically significant. The fact that most patients were still on clean intermittent catheterization and none achieved complete urinary continence is troubling in light of the report of 87% success with 110 children with spina bifida presented by Xiao. One has to wonder if most of these children are not voiding volitionally or using the newly developed cutaneous reflex, and how much reinnervation has a role in this surgery. Is it possible that unilateral denervation of the S3 ventral motor nerve produced improved compliance and continence, as previously reported in numerous clinical series?I congratulate the authors for taking on this challenge. I hope this study leads to a rebirth or refocus regarding neurosurgical treatments of neuropathic bowel and bladder. I strongly agree with the authors that this procedure should remain on a research protocol only.
One of the most curious findings is the discrepancy between urodynamic data and subjective voiding. One patient exhibited a decrease in capacity and an absence of reflex arc, and yet he subjectively reported improved bladder and bowel function! I could not help but speculate that his voiding after the procedure could simply be the bladder emptying via intra-abdominal pressure generation against an open bladder neck, given his preoperative stress incontinence. Xiao reported that more than 87% of 110 patients gained sensation and continence within 1 year (reference 7 in article). In comparison, the current patients undergoing the identical procedure with the help of Xiao himself only showed a modest improvement in objective urodynamic studies and subjective reporting. Unless the innovators provide a sound argument and data for the validity of the procedure, there is a great danger of its improper and rapid adaptation by patients and the medical community at large.
Saturday, March 20, 2010
The Office of Research Integrity of Department of Health and Human Services responded to the open letter concerning Xiao Procedure. It declines to investigate citing lack of jurisdiction and absence of specific allegations. Here is the response letter in its entirely, dated March 15, 2010:
The Division of Investigative Oversight (DIO) of the Office of Research Integrity (ORI) has received your letter of March 1, 2010, and additional documentation describing concerns over a controversial procedure first described by Dr. Chuan-Guo Xiao to treat neurologenic bladder in subjects with spinal cord injury (SCI) or spina bifida. The material you provide raises concerns about the extent and quality of long-term followup of the many subjects that Dr. Xiao and his colleagues have operated on in China and suggests that the high success rate that he and others have claimed of this procedure (the "Xiao Procedure") has been overstated. This material also notes that Dr. Xiao, while working at New York University prior to his return to China, and others at the William Beaumont Hospital Research Institute, have received funds from the National Institutes of Health to conduct clinical trials to test the safety and efficacy of similar nerve re-routing procedures in children with spina bifida.
After reviewing your concerns, DIO has determined that this office cannot assist you. There are several reasons for this determination. Nearly all of the patients who have received this surgical procedure are in China and ORI does not have jurisdictional authority to intervene.[footnote] The procedure as practiced in the United States has to some extent been funded by PHS funds at NYU and the Beaumont Hospital Research Institute. However, these grant applications clearly identify the procedure as experimental and high risk, and as safety and efficacy trials. The preliminary results of the pilot studies described in the applications are described as providing some benefit for otherwise extremely compromised patients, and the risks and benefits are adequately described. Long term follow-up results will have an impact, when available, on determining the viability of the procedure for more patients.
More important for this office is the absence of specific allegations of possible research misconduct in NIH funded research that are suitably specific to claims that could be shown to be significant and intentional falsification or fabrications of data that could be ascribed to specific individuals. Broad claims that the procedure has been shown to not work in China are not sufficient to establish that appropriate care has been taken in NIH funded research to ensure appropriate care of subjects, and that the risks and possible benefits have been appropriately explained to patients. I also wish to point out that it seems likely that the conflicting opinions on the efficacy of this procedure may, at least in part, be due to honest differences of opinion in what constitutes therapeutic success.
Thank you for raising your concerns with ORI. However, as noted, we are unable to assist you at this time.
John E. Dahlberg, Ph.D.
Division of Investigation Oversight
Office of Research Integrity
[footnote] For ORI to have jurisdiction, allegations must meet the definition of research misconduct at 42 C.F.R. 93.103 and the questioned research must be supported by funds from Public Health Services agencies such as the National Institutes of Health.
Monday, March 1, 2010
Daily Kos recently published a run-down on the history of Xiao Procedure with the alarming title "What unregulated medicine looks like".
Wednesday, February 24, 2010
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.
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