/cysc/zyy/jrgx/200804/29/t20080429_15314357.shtml
This belongs to the very bad medical malpractice.
The full text is as follows:
China-Zhejiang, April 30
Unregistered medical devices are used time and time again in the treatment of patients;
The immature medical technology has been used repeatedly in a child's body
Is it a cure for the sick or a human experiment
Economy and the law reporter investigated the Shanghai Oriental Hospital The truth about the inside story of the "artificial heart" is shocking
First, why did the hospital waive the 400,000 yuan medical fee, but also put forward the "three disallowances"
CCTV.com News (Economy and Law): This thing on the screen is called an artificial heart. In the Shanghai Oriental Hospital promotional materials, it is a ventricular mechanical assist device, mainly for the treatment of serious heart disease, can provide many dying patients with a chance of survival.
But it was at this hospital that this artificial heart brought bad luck to one patient after another.
On July 15, 2005, a 13-year-old boy, Zhou Yiqing, received a heart transplant at Shanghai Oriental Hospital. The doctor in charge of the operation was Prof. Liu Zhongmin, the president of Shanghai Eastern Hospital, and Prof. Weng Yuguo, an expert from Germany, according to the hospital.
At 1:30 p.m., Zhou Yiqing was wheeled into the operating room.
The surgery lasted about 15 hours, until 5 a.m. the next morning. However, the surgery was unsuccessful, and Zhou Yiqing had to rely on a ventilator and pacemaker to stay alive.
Mother Guo Yongbei: I really can't take it ......
Zhou Yiqing has not been able to wake up since then, and 15 days later, Zhou Yiqing died of multiple organ failure after his heart transplant.
Guo Yongbei: he said mom I have no, I have nothing to leave you he said, I have three hundred dollars inside the savings jar, one hundred to you, one hundred to dad, one hundred dollars to grandparents he said, he is now the savings jar is still there.
Zhou Yiqing was admitted to the Oriental Hospital in April 2004, during which he received an artificial heart implantation, heart transplantation and other surgeries, the cost of up to more than 900,000 yuan. Zhou Zhenhua couple *** owe more than 400,000 yuan of medical fees. After his son left, the couple and the hospital to discuss, hoping to grace a little time to raise medical fees, did not expect this hospital unexpected tolerance: more than 400,000 yuan in arrears can be fully exempted, however, the premise is that the need to sign a special confidentiality consent form.
Mother Guo Yongbei: the media came, you can not go to say this thing. The second can not go to the public security organs to report to the police. The third can not go to the administrative department to appeal. We thought, what have you done to him?
Why did the Shanghai Oriental Hospital mention such a request? The first is that it is not possible to make a decision on what to do, but it is possible to make a decision on what to do, and what to do. Zhou Zhenhua more a mind, in and the hospital negotiation, quietly do a recording.
Zhou Zhenhua couple and Shanghai Oriental Hospital medical disputes office director Wang Zian negotiation: (Guo) shall not report to the judicial organs, I did not expect. (Wang) we are the first small man after the gentleman. (Guo) make a copy of this agreement, (Wang) this can not be copied.
Before the hospital asked to sign this agreement, Zhou Zhenhua and his wife have always been grateful to the Shanghai East Hospital, never had any doubt about the hospital's treatment. But after this incident, the couple began to have doubts, the hospital why to use this way to seal the mouth of the family, what they actually did to his son? Then Zhou Yiqing because of what disease hospitalized, and received what treatment?
Second, the 12-year-old boy Zhou Yiqing to the Oriental Hospital before and after treatment
April 19, 2004, 12-year-old Zhou Yiqing sudden chest tightness, hospitalized in the Pediatrics Hospital affiliated with Fudan University, was diagnosed with primary cardiomyopathy and cardiac insufficiency. the afternoon of April 22nd, the Shanghai Oriental Hospital Director Liu Zhongmin came to the Pediatrics Hospital consultation.
Guo Yongbei: Then he sat down with said, I tell you, the child is very sick, today can not pass, tonight is not pass, I said what, what do you mean can not pass, he said he has no sweat on him.
Before just listening to the pediatric hospital doctor said the child's disease is very serious, Professor Liu this conclusion let Guo Yongbei almost collapse. Just when she was in despair, Prof. Liu Zhongmin's words suddenly changed.
Guo Yongbei: You are now very lucky he said, we have an artificial heart here, I do not understand, I said artificial heart how can it, he said don't be afraid, we happen to be this time it in the opening of the International Center, the International Heart Center Conference in Shanghai, he said you don't be afraid of, we have the German side of the German side, he brought an artificial heart of the product to show he said. I said dangerous, how is your success rate, he said the success rate of 90% he told me.
The couple immediately transferred their son to Shanghai Eastern Hospital. That night, President Liu Zhongmin and German expert Weng Yuguo together to Zhou Yiqing did "artificial heart" surgery, that is, through the installation of the "artificial heart" this external device, temporarily replace the diseased heart to exercise the function. At that time, the Shanghai media quoted President Liu Zhongmin as saying that Zhou Yiqing was very lucky, and that it would not be long before he could remove the "Berlin Heart" artificial heart and go home to recuperate!
Zhou Yiqing was admitted to the ICU intensive care unit. At this time, Guo Yongbei still have a worry, installed artificial heart, what to do next?
Guo Yongbei: Stem cells, their own stem cells, his blood, he said to his blood drawn out, drawn out after he said that he separated, separated into stem cells and then played in, like a farmer planting seeds, spread this in his heart muscle above.
Two months later, the hospital gave Zhou Yiqing the stem cell repair heart surgery that Prof. Liu said. But the surgery failed.
Guo Yongbei: His father went to ask the doctor, now the stem cells do? He said, stem cells look bad, no effect he said.
After the failure of the stem cell repair treatment surgery, Dean Liu Zhongmin put forward a new treatment program - myocyte transplantation!
Guo Yongbei: We say what is called myoblast transplantation, he said that stem cells it is too fragile, myoblasts from the thigh, thigh above the digging a little muscle, muscle, and then put it in that bottle, to give it a culture, put the machine inside the culture, two weeks after the culture is good, the muscle after the muscle culture into the myoblasts, and then hit the heart muscle to him inside the heart, he said.
In October 2004, the Oriental Hospital for Zhou Yiqing implementation of myocyte transplantation, but the operation was still unsuccessful. After both surgeries failed, the Eastern Hospital decided to carry out a heart transplant for Zhou Yiqing, which was his fourth surgery, which ended in failure. 15 days later, he died. By this time, the artificial heart installed in Zhou Yiqing in the first operation had been installed in Zhou Yiqing for 15 months. Dr. Weng Yuguo, a German doctor, said in a statement on the Internet that this was "the longest and most successful cardiac assist device for children in the world". But in the 15 months of this so-called success, 13-year-old Zhou Yiqing has suffered a great deal of pain.
Guo Yongbei: son ah, I said in the inside how, he said mom do not say it he said, I do not want to remember this inside a paragraph of things he said, I said you how, he said you a few lifetimes did not see, have not endured he said.
Could it be that the patient and the family to bear the great pain behind, just to get an artificial heart device for the longest time data? The father of the deceased Zhou Zhenhua came to the Shanghai Municipal Health Bureau, inquired about the German doctor Weng Yuguo information.
Zhou Zhenhua: Health Bureau, the Shanghai Health Bureau also gave me a relevant reply, it shows that Weng Yuguo really does not have the qualifications, no medical practice, no medical license in China.
According to the Interim Measures for the Administration of Foreign Physicians in China issued by the Ministry of Health, the third provision, foreign doctors to China to practice short-term medicine, must be registered, to obtain a "foreign physician short-term medical license. However, the Shanghai Municipal Health Bureau has confirmed that it has never issued a license to Weng Yuguo to practice medicine.
Third, the parents wondered if their son Zhou Yiqing had been subjected to human experimentation.
By now, Mr. and Mrs. Zhou Zhenhua felt that there was a lot of confusion behind their son's death. In order to preserve the evidence, Zhou Zhenhua, with the help of lawyers, went through a lot of trouble to retrieve more than 1900 pages of medical records during Zhou Yiqing's hospitalization.
But a lot of the information he couldn't understand. Zhou Zhenhua asked around and finally found a professional who was willing to help him. It is the former Shanghai Drug Administration supervisor Chen Xiaolan, who was honored as one of the "CCTV 2007 Moving China" top ten figures for exposing the dark secrets of the healthcare system and promoting healthcare reform.
Chen Xiaolan searched the website of the State Drug Administration and did not find the registration number of the "berlinheart" artificial heart implanted in Zhou Yiqing's body. This is a bit of a surprise to her, and she made a special trip to the State Drug Administration to verify in person. The State Drug Administration confirmed that the German "berlinheart artificial heart assist machine and berlinheart artificial heart pump did not pass the national registration.
Shanghai Municipal Health Insurance Bureau Supervisor Chen Xiaolan: not a valid legal products, take over the implantation of the child's body inside the body, implanted in the body, this product is illegal, this surgery is even more illegal.
The hallowed second-class hospital - Oriental Hospital, even the use of foreign medical devices not registered by the state, Chen Xiaolan do not believe that there will be such a ridiculous thing.
Chen Xiaolan: do not respect the value of life, disregard for the preciousness of life, so let me be very angry, he is not to do experiments, he does not even know how to experiment, he does not have the ability to do this type of experiments, but also does not have the qualification to do experiments, to do experiments with all the things to be approved.
Since it is an illegal medical device, and how to enter from abroad to the regular Shanghai Oriental Hospital? It is how to declare customs? In this regard, Shanghai Customs replied, "in the import of cardiac assist devices, the Oriental Hospital in August of that year to the Shanghai Mechanical and Electrical Office to fill out the application form for the import of electromechanical products," is in accordance with the declaration of electromechanical products and obtain approval. At the same time, the Customs also confirmed that "the Oriental Hospital did have a foreign expert professor to carry the factory gift of medical equipment into the country without declaring to the Customs, should be a violation of customs supervision provisions of the behavior.
Chen Xiaolan: in foreign countries, too, foreign technology is only exploratory in the clinical limited, selective use, not like the Oriental Hospital, infarction patients also use, dilated heart patients also use, this technology should be a top technology. The first thing you need to do is to get your hands on a new pair of shoes or boots.
Zhou Zhenhua, deputy editor-in-chief of China's health legal system, Mr. and Mrs. Zhuo Xiaoqin, the agent: The artificial heart can indeed make the statement of the dying patient to continue. But it must be immediately in the shortest possible time, this do heart transplantation, because heart transplantation is the ultimate a treatment program.
So using an artificial heart plus stem cells, is this therapy mature?
Stem cells are in the experimental stage of clinical treatment, as I understand it in various countries.
And with the study of medical records and investigation step by step, a more serious situation was gradually discovered.
Chen Xiaolan: I began to read his medical history, and I felt more and more clearly that he did not treat this child as a patient, he treated him as an animal, like a mouse, they make full use of this animal. So for a whole year I was furious, this thing must be clarified, although very tired.
The East Hospital to Zhou Yi implementation of myoblast transplantation technology, at present even in the medical technology developed countries, is only in the experimental stage.
Chen Xiaolan: (myoblasts) This is even less (mature technology), more avant-garde than stem cells, in the international are still in the experimental stage. 2005 Oriental Hospital has a paper, said how many dogs to do myoblasts test, but in 2004 has been used in the myoblasts transplantation of four people.
Everything that happened to Zhou Yiqing was shocking. Was 13-year-old Zhou Yiqing treated as a patient at the Oriental Hospital or did he become a test subject? If these practices are really to save the life of the patient, do not do so Zhou Yiqing will die immediately, the Zhou family couple can still be relieved, but at that time Zhou Yiqing's disease is serious enough to have to do this kind of surgery?
The famous cardiovascular disease expert Gu Fusheng: there is no need to do artificial heart.
All kinds of irregularities in the treatment of one after another in a child, and things are not just so, in the East Hospital public brochure, there are such words, in 2001, Professor Liu Zhongmin in the country's first use of artificial heart treatment of end-stage heart failure patients have been successful, and so far has successfully completed nine cases of artificial heart surgery, is the domestic application of the artificial heart of the most units. So, these nine cases of surgery really successful? Economy and law column reporter investigated several of these patients.
Fourth, the so-called "artificial heart" behind the successful treatment
The old man named Deng Zhongxing, living in Pudong New Area, Shanghai, Jiajiaqiao Road, 2001, he was sent to the Oriental Hospital for sudden myocardial infarction.
Wife Ma Xiangmei: they did not rescue in time, delayed for more than ten hours, and then told us that there is really no way, can only install an artificial heart, then we do not understand what is called an artificial heart, can only rely on the hospital.
Ma Xiangmei accepted the hospital program, but soon, Deng Zhongxing had serious problems.
Wife Ma Xiangmei: installed after ten days of cerebral infarction, immediately cerebral infarction.
Is this directly related?
Of course there is a direct relationship, we are already the fourth (installed artificial heart), right, the first few have a Ding Xiaolan's death I personally saw.
Seeing her husband in critical condition, Ma Xiangmei insisted on removing the "artificial heart".
Wife Ma Xiangmei: This artificial heart is our request resolutely removed, why, after you installed, the heart and no good what, and all the people paralyzed, you still installed what, you are not to give him life, life dead you only heart dead ah.
Under the strong request of the family, the Eastern Hospital had to remove the artificial heart of Deng Zhongxing. After the removal of the artificial heart, Deng Zhongxing old man did not die, on the contrary, he lived for seven years. But in these seven years, his life was full of pain due to this treatment.
Wife Ma Xiangmei: you see a hand can not move, two hands are like this, see, a hand can not move, a foot can not move. I spent more than 200,000 yuan to replace a person like this. Whose family can live like this?
Deng Zhongxing later Eastern Hospital to the court, the conclusion of the medical malpractice appraisal is not constitute medical malpractice, but the court found that the status quo caused by Deng Zhongxing, "and the loading of the artificial heart has a certain causal relationship." In the court's mediation, the Oriental Hospital compensation Deng Zhongxing 160,000 yuan.
In addition to Deng Zhongxing, the reporter should try to find a patient called Dou Fangrong's family. 2002 Dou Fangrong also because of dilated heart disease into the Oriental Hospital, also installed an artificial heart. About six months after the operation, still in the intensive care unit of the Dou Fangrong was sent home by the hospital. On the evening of the day after returning home, Dou Fangrong suddenly spewed out a large amount of blood from his mouth, and was sent back to the Eastern Hospital by car, resulting in the death of the resuscitation.
Dr. Chen Xiaolan also launched an investigation in this regard, according to her investigation, Shanghai Oriental Hospital from 2001, has been installed for nine patients with artificial hearts, which nine people, seven people have died, alive only two people, one is Deng Zhongxing, another called Su Qin, and the two people are left with sequelae. In the face of all this, the Shanghai Oriental Hospital and how to explain it?
Unannounced: Shanghai Oriental Hospital Zhou Yiqing attending doctor Fan Huimin: all the questions can not answer you.
The Oriental Hospital has issued a public statement on this matter, the main point is that the artificial heart is legal, because at that time the State Food and Drug Administration did not have the provisions of the relevant equipment registration. In 2006, the European Heart Failure Association has included the artificial heart as one of the treatments in the guidelines for the treatment of heart failure.Beilinheart artificial heart has not been approved for registration by the U.S. Food and Drug Administration (FDA), but the FDA has allowed the product to be used in the U.S. under special circumstances. Is stem cell transplantation safe? Liu Zhongmin believes that stem cell transplantation is indeed a new technology, currently does belong to the stage of clinical trials, but there have been a large number of stem cell clinical trials at home and abroad published information, the relevant laws and regulations on stem cell transplantation is not prohibited. About whether it is an all-out rescue or human trials? The hospital's explanation is that there is no medical technology that can make a person immortal, they are in the case of respecting the family's right to know the operation.
"China's health legal system" deputy editor-in-chief Zhou Zhenhua couple agent: Zhuo Xiaoqin Shanghai in November 1, 2002, on the enactment of the "new medical technology clinical access management approach", where the new medical technology, medical institutions in the development of new medical technology, must be approved by the Shanghai Municipal Health Bureau, and as far as we know, the Shanghai Municipal Health Bureau has not been approved by the Oriental Hospital to use this The first thing you need to do is to get your hands on a new pair of shoes or boots, and then you'll be able to get your hands on a new pair of shoes or boots.
In this statement, the reporter also noted that the European Heart Failure Association used the artificial heart as one of the treatments for heart failure in 2006, and even though the Heart Failure Association is authoritative and the information is true, Zhou Yi-Qing did the surgery in 2004, and as early as 2001, Dongfang Hospital had already performed the first case, and the first patient, Ding Xiaolan, died ten months after the surgery.
Qiu Renzong, a researcher at the Applied Ethics Research Center of the Chinese Academy of Social Sciences: In foreign countries, such as in the United States, Germany, and some other countries, the general clinical application of this new technology and new drugs is very strict, he must go through a certain process, right, to achieve a certain this can be applied to the clinical body. Because the clinical application is equal to an entry into the market, large-scale production to earn a lot of money, then he can not do how to do it? He just avoided the strict review process in his own country, right, and then he went to developing countries to use it, and that berlinheart is a typical example.
May 1, 2007, China's "Human Organ Transplantation Regulations" officially implemented, the approval of organ transplants and hospital qualifications to make strict restrictions, the reporter investigated, the operation has been stopped in the Eastern Hospital. According to Chen Xiaolan introduced, after this incident, Shanghai Municipal Health and Drug Inspection Department have also gone to the Oriental Hospital to understand the situation, but so far there is no more in-depth investigation of the Oriental Hospital and Liu Zhongmin himself did not have any statement. 2007 April, Zhou Zhenhua to the Shanghai Municipal Public Security Bureau Pudong Branch of the Criminal Investigation Detachment, did not file a case; in June 2007, he sued the Shanghai Oriental Hospital to the court. But to this day, the medical malpractice appraisal is still inconclusive, the case trial has not progressed.
Illegal entry, unregistered medical products, in Shanghai Oriental Hospital, even a few years for a number of patients to implement surgical installation, is still in the experimental stage of the technology is applied to a child, this blatant, not only risky, the actual has been contrary to the medical ethics and even the basic human morality of the behavior, behind, but also what is hidden? And the relevant departments in this process, why did not find out in time, why so far has not been able to thoroughly investigate this matter? For some foreign immature medical treatment technology, in order to avoid the laws and regulations of their own countries to find ways to enter other countries to carry out experiments to promote, and how to regulate and respond to this one question mark, must, to be someone to answer!