Wednesday, November 25, 2009

“Xiao's Procedure”: Patient Follow-ups Shock Volunteers

A New Thread netter, "blobfish", has translated a report on the Chinese magazine Science News into English. With permission, here is the English version. The original Chinese version can be read here.

“Xiao Procedure”: Patient Follow-ups Shock Volunteers

Li-Hui Di, Science News (Chinese) Vol. 22, Nov. 23, 2009

One of the volunteers, Lin Liu, conducted a survey on the effectiveness of the “Xiao Procedure”, which was claimed by the inventor, Dr. Chuan-Guo Xiao, to have an overall success rate of 85% for treating the urology disease (spinal bifida) by surgery. Liu was shocked by the post-surgery results in the patients who she visited. During the week of November 10, she visited several patients who underwent the Xiao Procedure. Because the patients lived in different places, Lin Liu had to travel through a number of counties, from Chengdu to Meishan, Deyang, Guangyuan in Sichuan and then from Linfen to Gaoping in Shanxi province, braving the cold weather and heavy snow. Upon her return on November 18, Lin granted an interview to Science News.

“No patient was cured by the Xiao Procedure at all” she said, “On the contrary, the surgery did cause disabilities.”

Lin Liu told the News that she felt the patients looked spiritless and were living in pain. They were told that their diseases could not be cured even at the best hospitals in Beijing. In their hopeless waiting, they saw the propaganda (Xiao Procedure) from the official and most authoritative Chinese medium --- CCTV (the China Central Television). They would trust the reputation of Zhengzhou University Medical School and their experts too.

Lin Liu has visited four patients in total. None of them has been cured by the so-called Xiao Procedure and some of them were even permanently disabled by the surgeries. Two of the patients are still minors. The other two are 19 years old but they were also minors when they underwent spinal surgeries.

The boy patient in Meishan county could still walk by himself and even climbed stairs in the hospital before his surgery, in spite of a bit of deformity in his legs. But after having the Xiao Procedure in September 2007, his legs with parts of nerves cut off started to fester. Two years later, both of his legs had to be amputated at a local hospital of Meishan.

The parents of this boy cherished great hope before the surgery because the hospital had promised them a success rate of 85%, which means most of the patients could get cured. They trusted the doctors because the doctors were kind and looked very trustful. After the boy was already on the operation bed, the parents were asked to sign a consent form right before the surgery, as if it were just a routine procedure. No explanation was offered, so they signed the form without understanding the risk of serious complications at all.

The second child in Shanxi province could walk as well before the surgery, but is disabled now. After the surgery, the muscles of his feet and legs started to atrophy and now his lower extremities are apparently deformed. One year ago before the surgery, it costed 1000 Chinese Yuan a year to buy diapers for his incontinence. But now, not only his legs are disabled, but also his previous incontinence gets more severe. In 2008, he had a medical examination in Jishuitan hospital in Beijing, and was told by the doctor that it was impossible to restore to the same status as before by performing any further surgery on his legs.

The third kid in Deyang county was thought being lucky by his mother initially after the Xiao Procedure. Her kid was still very young and the case was not very severe before surgery. She was happy that the disease seemed to be cured a little and at least did not get worse as others after surgeries. But half a year later, the leg which was operated started to shrink and became thinner.

“The whole journey was very depressing,” Lin Liu said, “It was cruel to ask the patients any questions.”

According to Liu, these kids who were harmed by the Xiao Procedure were less naughty or active, and were not curious about strangers, but kept silence to themselves. Their parents cannot help weeping as telling others their miserable stories after the surgery. “They were waiting with hopes for the surgery, but now their hopes were broken, and eventually they fall in despair. I could feel their pain.” Liu said to the News.

All the kids dropped out of schools and they don’t want to go back. One was in the middle school before Xiao Procedure and gave up school later. He is just a small boy, but he can neither walk nor play as other kids, which is not convenient to him.

Lin Liu also said to News that she would follow up with more patients having the Xiao Procedure. She is collecting more evidences to refute the possible argument in court from the advocators of the Xiao Procedure, which are insisting that these are only individual cases of unsuccessful surgeries. One patient by the name of Little Shanshan advertised by the doctors as a special case is actually a failure too after the Xiao Procedure. “We have been trying our best to find a successful case, but we can’t.” she said.

As for financial situation of the patient family, Lin Liu told the News, the one in Meishan county is able to pay the operation fee, but the parents are very angry at the hospital, because they were cheated and harmed. They want to sue the hospital not just for recouping their expenses. The kid in Deyang, his family has several kids and his operation fee was paid by his relatives. The one in Guangyuan also told her that they want to sue the hospital not just to recover the operation fee of the Xiao Procedure, but they want the justice to be done.

The last one in Shanxi province, his father was a coal miner and is laid-off now. This family is living in the cave of a mountain and has no heating in this cold winter. His father raises 30 pigs and needs to save the heating for the piggy cubs, otherwise they will get sick in the cold. He has finished high school and wanted to make the justice to be done as well. These patients are preparing for suing the hospital who misleads them for the Xiao Procedure with misleading and false statements on the surgical risks and effectiveness.

The Cure Rate of "Xiao's Procedure": 85% or 0%?

A New Thread netter, "lightman", has translated a report on the Chinese magazine Science News into English. With permission, here is the English version. The original Chinese version can be read here.

The cure rate of "Xiao procedure": 85% or 0%?

Di Li-hui, Science News (Chinese) Vol. 22, Nov. 23, 2009

Scinece News Editor: In Volume 20, Oct. 28, this magazine reported the "Xiao reflex arc", the controversial surgical procedure, in article "Who will evaluate Xiao Chuan-guo?". After the article was published, our reporters have learned more information about this procedure.

Peng Jian, a pro bono lawyer, continues his busy work of collecting and collating evidence from different sources. Previously on Oct. 16, the mothers of the two children with spina bifida filed lawsuits against Henan Shen Yuan Urologic Surgery Hospital. At present, the court has set the date for hearing on Oct. 28. Peng Jian revealed that, before the end of the year, it was expected that about twenty more patients (or their kins) would bring their cases to the court.

Investigation restarted

"I realized, for this case, the only effective way was for many patients to come forwards together, especially those who took the operation during the same period." Peng Jian told Science News that he started the effort to collect the names of the patients since 2006 - in this year, Fang Zhou-zi lost a case that was brought forward by Xiao Chuan-guo, for his harsh questioning on the validity of the theory of "Xiao reflex arc", as well as the academic credentials of Xiao, its inventor.

In the summer of 2007, when the names on his list had totaled a few dozens, Peng Jian arranged interns to start interviewing the patients over the phone. "At that time, we successfully got through to more than forty people, and learned that the outcomes of their operations were very bad. In most cases there was virtually no improvement. Some (operations) even led to disability." Liu Lin, who took part in the phone interviews, told Science News.

Further investigation, however, was hindered by difficulties. The main one was the lack of financial support. Although several non-profit organizations expressed the intention to provide supports, none materialized in the end. Yet in the meantime, patients continuously visited the law firm where Peng Jian works, hoping to "accelerate the process of legal aid".

In September 2009, when financial resources became less of a constraint, the investigation was started again. This time, among the 150 plus contacts obtained through the exchanges between the patients, more than eighty successful phone interviews were made, and fifteen were interviewed in person. Peng Jian said, "Now the 'number' is still increasing; we receive at least two, even as many as three or four calls each day, that provide supporting evidence for the case."

Among the patients who have received the "Xiao procedure" and have been contacted so far, the survey finds no example of complete success. The percentage of patients with evident improvements is also low - This is in sheer contrast with the "85% cure rate" advertised by the hospital.

More contradictions

Peng Jian, the lawyer, also found another inexplicable contradiction.

The Neuro-urologic Surgery Research Center at Zhengzhou University issued a certificate to Xiao Chuan-guo on Feb. 28th, 2007, for his application to academian. The certificate claimed: Starting from Jan. of 2006, the Neuro-urological Surgery Research Center at Zhengzhou University had applied the "artificial somato-autonomic reflex arc" technique invented by Professor Xiao Chuan-guo to 117 patients with neurogenic bladder caused by spina bifida or meningomyelocele. Sixty cases were followed up for more than eight months. 85% of the patients have obtained bowel movement and urination completely continent.

Peng Jian found out, however, that it was reported on Aug. 14 of 2006 by Da He Bao:"Yesterday, little Shan-shan received the operation at Zhengzhou Shen Yuan Urological Surgery Hospital ...... the operation for little Shan-shan was the first case in Henan ...... Dong Zi-ming, from Zhengzhou University and the dean of Fundamental Medical College, said: Shan-shan's operation made a Henan record - the first 'Artificial reflex arc' in Henan. And Zhengzhou Shen Yuan Hospital made a national record - this was the first, in our nation, interdisciplinary, neuro-urological surgery, hospital. It was a creation resulted from the effort to integrate research and clinical practices in Zhengzhou University."

In other words, the center conducted the first "Xiao reflex arc" operation as late as Aug. 13th of 2006. It was merely six and a half months away from the time when the center provided the certificate of cure rate for Xiao Chuan-guo, which evidently contradicted with its claim that "Sixty cases were followed up for more than eight months".

Peng Jian and others sought out and visited more than a hundred patients who took the "Xiao reflex arc" operation at Zhengzhou Shen Yuan Urological Surgery Hospital between Aug. 2006 and the first six months of 2007. They found no case of bowel movement and urination completely continent. Instead, the conditions of many patients deteriorated after the operation. Judging from the times of their operations, these patients should at least count for a considerable portion of the "117 cases" mentioned in the certificate issued by the center. This calls into serious question the hospital's claim that "85% of the patients have obtained bowel movement and urination completely continent".

"Let the patients speak out - it is the most objective way"

It is perhaps too shocking to believe the conclusion of the investigation that the cure rate is close to 0% - Is it related to the bias caused by the questions designed by people who are not medical professionals, such as Peng Jian?

"The statistical results obtained through amateur methods, although reviewing is needed prior to official publication, have already shed light on some issues." Professor Liao Li-min at Beijing Bo Ai Hospital commented in this way, "At present, only when the patients speak out can we expose the problems. Justice can be served only through the patients. If the operation succeeds, the patients are the biggest beneficiary; if it fails, the patients are the hardest-hit victims. Let the patients speak out - it is the most objective way."

To Peng Jian, spending money and man-power to interview the patients one by one is the most direct and, perhaps, the only viable way to collect evidence. "Peer review, is possible in theory, but impossible in reality. The current evaluation of the procedure was all made by the 'authorities', including the evaluation of some scientific achievements. Isn't it very difficult to find other experts to draw a different conclusion? Moreover, I find that, the experts in the field are trying to stay away," Peng Jian said.

What Peng Jian said was acknowledged by experts in the field. "We experts don't want to get involved, although we do not like to see what the patients have turned out to be." A well-known expert in urological surgery told Science News, "It is not that we are not willing to (speak out), but that what we say probably won't have any effects. He can say we know nothing. So-called experts and colleagues, or anybody, in his eyes, can be dismissed as worthless."

Comments from peers

Nevertheless, there are experts who, in the end, are brave enough to speak out.

"I use two sentences to describe (my opinion): first, this procedure is absolutely not like what he described, that it has solved the problem of neurogenic bladder; second, the procedure may be effective for some patients, because there are some pertinent indications. Some patients can be treated with this (procedure), but absolutely not all." Professor Song Bo at the Chong Qing the Third Military Medical University held this opinion.

Song Bo indicated that he did not agree to blindly gloss over or promote this type of procedures, because, after all, it was not a business activity. "I am all against the statement that it has solved the problem of neurogenic bladder; I did not really agree with its application for the National Prize for Progress in Science and Technology either." In the meantime, he believes there has not enough evidence so far to assert that the procedure is completely useless. "But his research is not finished yet. What are the indications for the procedure, ultimately, is not even clear. It is unfounded at this stage to say things like a grand problem has been solved." Song Bo said.

"He applied the (neuro-surgical) techniques to urological surgeries. We could see very few clinical patients, and we did not observe his operations either. We simply were not able to make any comments. They brought the patients in. I did not watch the operation. He had no publication at that time. We knew even less about the international evaluation on his procedure. Everything was based on his own words. We could not see any comments from other countries. He said we would not be able to conduct the operation, but why they themselves were not able to popularize it either? We are also wondering." Guo Ying-lu, a professor at the Beijing Medical University and an academian of China Engineering Academy, told Science News.

"When doing science, we should allow mistakes, exploration, and all kinds of efforts. But we should not allow claims such as what has been solved and what has been created, when there is no complete scientific evidence, nor a large amount of evidence-based medical data. They are not scientific statements. I oppose these statements." Song Bo summed up.

Tuesday, November 24, 2009

Michigan Hospital Propagates Myth for "Xiao's Procedure"

The controversial "Xiao's Procedure" has been practiced in at least one hospital in the US on clinical trial basis. In April, 2008, Beaumont Hospitals in Michigan reported some of its initial success. In that press release from the hospital is the following passage:
The research at Beaumont uses a spinal surgery pioneered in China to redirect nerves from the leg to the bladder to gain better control of urination. Beaumont is the only U.S. hospital performing this surgery, and patients have traveled from as far as Utah and Pennsylvania to have it. The Chinese doctor who developed the surgery, Chuan-Guo Xiao, M.D., reports an almost 90-percent success rate and an average time for results of 12-24 months after surgery.
This "almost 90-percent success rate" is solely based on Dr. Xiao Chuanguo's own assertion and has now been seriously questioned in newspaper reports. An independent investigation has so far not been able to identify or confirm a single success case. Instead, it recovered numerous cases with severe side effects.

Separately, in an online forum on spina bifida conditions, a patient posted a letter from the same Beaumont Hospitals in response for his inquiry of the procedure. The letter repeated the same assertion from Dr. Xiao Chuanguo himself without any qualification. Furthermore, the letter states:
In China, this procedure is now standard of care. Dr. Xiao has taught this procedure to surgeon's at all the major hospitals in China.
This is totally a lie. As of now, there is only one local hospital in Zhengzhou, China, which performs this procedure routinely. It is far from being a "standard of care".

Friday, November 13, 2009

OSAIC Calls for Donation to Support Victims

Issues of academic integrity normally are confined within the elite community of academics and scholars, rarely affecting the common people. However, when an unproven surgical procedure is practiced on patients without proper disclosure of its risks, the results could be devastating.

Dr. Xiao Chuanguo's procedure is such an example. While Xiao Chuanguo and his hospital claim that the socalled "Xiao's Procedure" has a success rate of 85%, evidences are now emerging that the number is most likely a lie. A recent telephone survey of 74 former patients conducted by Fang Zhouzi's lawyer finds that in more than 73% of cases the procedure had no effect at all. Worse, 39% of them had severe and even crippling side effects.

Most of these patients are from poor families who had spent their life's savings for the procedure. Some of them intend to sue hospital for false advertisement, but are lacking resources to do so.

The Organization of Scientific and Academic Integrity in China
has established a new fund intended to help the innocent victims of academic fraud. The primary purpose of the fund is to provide financial aid in legal procedures to the families who can not afford it. OSAIC is calling for donations.

Sunday, November 8, 2009

"Xiao's Procedure" Questioned in China

The good doctor Xiao Chuanguo is in the news again, but this time it was all good for him. For the first time in years, a magazine in China reported that his famed "Xiao's Procedure" might not be what it was previously claimed to be.

The Science News (科学新闻) published an article titled "Who Can Evaluate Xiao Chuanguo?" on October 27. It reported that several families of the patients who had received Xiao's treatment a couple of years ago are now suing their hospital for false claims. A hospital in Henan Province had claimed that the success rate of the procedure is 85%. Yet these families could not find a single successful case within their ranks. Many patients are suffering from serious side effects from the operations.

The report also carried more damaging information. Through interviews to a few other doctors involved in the initial evaluation of Dr. Xiao's procedure, it revealed that none of them are qualified to provide a real, technical evaluation. They practically rubber-stamped on the decision based on the name-recognition of Xiao's adviser, Xiao's self-claimed fame abroad, and Xiao's self-claimed success rate alone. The magazine pointed out that there is so far no third-party study on the success rate.

The fact that Xiao Chuanguo had repeated sued Fang Zhouzi in court also played an important role. The magazine cited an unnamed surgeon from a Beijing hospital as saying that "there won't be a single expert who is willing to comment" Xiao's work. Everyone is scared of Xiao's bullying conduct. As if to underscore this point, the article listed two experts who had refused to be interviewed for this story.

After a period of staying low-profile, it is likely that the dispute surrounding the so called "Xiao's Procedure" will be heating up again in China.