In recent years, the domestic medical service market has continuously launched various "high-tech" projects with new names, leaving patients eager for treatment unable to distinguish between truth and falsehood, and at a loss. Among these, some technologies are not yet mature professionally, and procedurally have not undergone strict reviews, yet they have entered the medical market. China News Weekly Issue 2009042 Cover Story: Who Will Regulate "Gray Healthcare"? On one hand, it is a research project under the "National Key Basic Research Development Plan", while on the other, it is a marketing promotion by a private specialized hospital; on one hand, the hospital claims an 85% surgical success rate, while on the other, most patients express dissatisfaction or even file lawsuits due to ineffective treatment; on one hand, an expert group composed of multiple academicians evaluates it as "internationally advanced", while on the other, the technology faces difficulties in widespread promotion and vague evaluations from peers. As a new medical theory and medical technology, "Xiao's Reflex Arc" and its clinical techniques have walked in the gray area of medicine for many years, failing to gain widespread promotion and application. Its predicament reflects that in today's era of rapid commercialization of medical new technologies, establishing relevant laws and regulations for exploratory medical technologies in our country has become an urgent issue. A lawsuit triggered by a nerve. A dissolved private specialized hospital was sued, leading to questions about a surgery that was said to win a Nobel Prize. Reporter of this magazine/Cai Rupeng. On November 10th, the Erqi District People's Court of Zhengzhou City, Henan Province, officially accepted the litigation request of two mothers of children with spina bifida against Henan Shen Yuan Urology Hospital (hereinafter referred to as Shen Yuan Hospital). The complaint stated that three years ago, their children underwent surgery at this hospital to treat urinary and fecal incontinence, but their conditions have not improved to this day. According to their understanding, none of the patients who were hospitalized at the same time as their children were cured, while according to the hospital's publicity, this treatment had an "85% surgical success rate". What troubled them even more was that the surgery left serious side effects on their children: the left leg showed signs of atrophy and deformity. Up to now, approximately 1500 patients have received this surgery at Shen Yuan Hospital. Are the "unsuccessful" cases part of the remaining 15%? This reporter from China News Weekly met one of the mothers suing Shen Yuan Hospital, Zou Yingli (pseudonym), and her 9-year-old son Guo Zilong (pseudonym) in Henan. The reporter noticed that Guo Zilong's left leg was obviously lame, and he walked unsteadily. Zou Yingli said that after her child was born, he was diagnosed with congenital spina bifida and had undergone one surgery, but the problem of urinary and fecal incontinence remained unresolved. "We've been to many hospitals, and they all said there's no cure." Spina bifida is a common congenital disease, with a global average incidence rate of 1‰ in newborns, and as high as 5‰ in northern China. This disease is caused by incomplete closure of the spine during fetal development. The exact cause is still unclear, but some experts believe it may be related to folic acid deficiency in early pregnancy. One of the clinical manifestations of spina bifida patients is dysfunction in urination and defecation, difficulty in defecation (constipation), and urinary incontinence. Some patients are still dependent on diapers even in their twenties. Pathology Director Ji Xiaolong of the Armed Police General Hospital explained to the reporter of China News Weekly that this symptom is mainly due to damage to the nerves controlling the bladder, which prevents the bladder from contracting normally. "For such urinary dysfunction, the medical community has not yet developed satisfactory treatment methods," Ji Xiaolong said. "The common solutions currently available mainly include stoma creation and manual catheterization, but none can achieve self-controlled urination." However, the two mothers stated in their complaint that Shen Yuan Hospital promised them that the surgery could "enable patients to achieve self-controlled urination and completely solve the problem of urinary and fecal incontinence." Zou Yingli, who lives in Jiaozuo, Henan, said, "In 2006, I saw on TV and newspapers that there was a hospital in Zhengzhou specializing in treating this disease. I felt like an opportunity had come, so I came here immediately." At Shen Yuan Hospital, President Gao Xiaoqun told her that this surgery was called "artificial somatic nerve-visceral nerve anastomosis," specifically used to treat urinary and fecal incontinence caused by spina bifida. He said that symptoms would improve within a few months after the surgery, and the child would be able to control urination and defecation independently within one to two years, with a success rate of over 85%. "I was very happy when I heard that," Zou Yingli said. She remembered that Gao Xiaoqun also specifically mentioned the widely reported successful surgery case of a child named Xiao Shan from Hainan. "I thought if so many TV stations and newspapers reported it, it couldn't be fake." Xiao Shan's surgery was indeed one of the reasons many parents brought their children to Shen Yuan Hospital for treatment. According to a report by Dahan Daily on August 14, 2006, Xiao Shan's surgery was the first "artificial reflex arc" surgery in Henan, and Shen Yuan Hospital set a national precedent — it was the first interdisciplinary neuro-urology hospital in the country, a pioneering effort combining research and clinical practice with Zhengzhou University. On November 17, 2006, Guo Zilong underwent the same surgery treatment as Xiao Shan at Shen Yuan Hospital. After the surgery, Guo Zilong's condition did not improve. Zou Yingli said she called the hospital multiple times for inquiries. "At first, they said that nerves grow slowly, asking me to wait a bit longer. Later, they asked me to bring my child back for a follow-up examination. After the examination, they said it was good, the nerves had grown through, and it would be fine in a few months. But now three years have passed, and there's still no effect at all." Zou Yingli said she once asked Gao Xiaoqun why there was always no result, and he replied, "Many people have been cured, your son didn't get results, I'm sorry too." Initially, she believed that "it was just bad luck for my son, belonging to the unsuccessful 15%," but when she contacted more fellow patients, she realized that "none of them were good." The reporter also found eight other parents of children in Henan. Their children all underwent surgery at Shen Yuan Hospital in 2006 and have shown no improvement to this day. Some relatives also reported that the children's legs showed abnormalities after the surgery. Liu Chunhong (pseudonym) from Zhoukou, Henan, said her younger brother's legs were normal before the surgery, but his left leg started to shrink after the surgery, now clearly thinner than the right leg, "It's obvious from far away that he limps. He used to run very fast, but now he can't run anymore. If he runs, he limps severely, and classmates laugh at him." Established in August 2006, Shen Yuan Hospital is a private specialized hospital. The hospital's website introduces that it "mainly promotes and clinically applies the 'artificial somatic nerve-visceral nerve reflex arc' technology." Before the National Day holiday, this reporter interviewed Shen Yuan Hospital, but found it empty, with a notice posted at the entrance stating "the hospital announced dissolution on August 17, 2009, and will no longer accept patients." After much effort, the reporter contacted Lü Shaojie, the director of the external relations office of Shen Yuan Hospital. He told the reporter, "the hospital is undergoing adjustments, and there is absolutely no problem with the surgery itself. By the end of October, the entire hospital will merge into Zhengzhou University's Fourth Affiliated Hospital and continue conducting surgeries." Through Lü Shaojie's contact, the reporter met Dr. He Chaohong, who was responsible for performing the surgeries. According to him, the type of surgery they conduct is a brand-new neuro-microsurgery based on the "artificial somatic nerve-visceral nerve reflex arc" (hereafter referred to as artificial reflex arc) theory proposed by Professor Xiao Chuanguo, the chief of the urology department at Wuhan Union Hospital. He explained that the surgery involves cutting a normal somatic nerve that innervates the lower limbs of the patient and connecting it with the visceral nerve that controls the bladder, forming a new "reflex arc," "so that in the future, the patient only needs to scratch their thigh, stimulating the somatic nerve, to achieve self-controlled urination." "This is a remarkable achievement," He Chaohong said. "Because, no one before thought of integrating somatic nerves with visceral nerves to solve this problem." According to him, some experts predicted that this work "will win the Nobel Prize in five to six years." Somatic nerves and visceral nerves are two different types of nerves in the human body. The former innervates the movement of the body, while the latter controls the movement of internal organs. The biggest difference between the two is that somatic nerves are controlled by the brain, while visceral nerves are not. This is exactly why we can freely control the movement and sensation of our limbs, but cannot make the intestines and stomach stop moving. "Whether in basic research or clinical application, (the artificial reflex arc) has been proven to be effective," He Chaohong told the reporter. In the past three years, Shen Yuan Hospital has performed approximately 1500 artificial reflex arc surgeries (about 100 cases in 2006, about 300 cases in 2007, about 800 cases in 2008, and about 300 cases in 2009), "with very good results and an 85% success rate." (Source: China News Network)