/cysc/zyy/jrgx/200804/29/t 2008 04 29 _ 153 14357 . shtml

This is a very serious medical accident.

The full text is as follows:

Zhongxin Zhejiang Network April 30th

Using unregistered medical devices to treat patients again and again;

This immature medical technology has been repeatedly used on a child.

Is it to save lives or to conduct human experiments?

The investigation of "artificial heart" in Shanghai Oriental Hospital by economic and legal journalists is shocking.

First, why did the hospital waive 400,000 medical expenses and put forward the "three noes"?

CCTV.com News (Economics and Law): This thing on the screen is called an artificial heart. According to the propaganda materials of Shanghai Oriental Hospital, it is a ventricular mechanical auxiliary device, which is mainly used to treat patients with severe heart disease and can provide survival opportunities for many dying patients.

However, it is in this hospital that this artificial heart has brought bad luck to one patient after another.

On July 5th, 2005, a boy aged 13, Zhou Yiqing, received a heart transplant in Shanghai Oriental Hospital. On that day, Liu Jiaoshou, president of Shanghai Oriental Hospital, and Professor Weng Yuguo, a German expert introduced by the hospital were the main surgeons.

In the afternoon 1 30, Monday Qing was pushed into the operating room.

The operation lasted about 15 hours until five o'clock the next morning. However, the operation was unsuccessful, and on Monday, Qing could only rely on ventilators and pacemakers to maintain her life.

Mother Guo Yongbei: I really can't stand it. ...

After that, Monday Qing never woke up. 15 days later, she died of multiple organ failure after heart transplantation on Monday.

Guo Yongbei: He said, Mom, I have nothing left for you. He said, I have 300 yuan in my piggy bank, you 100 yuan, dad 100 yuan, grandparents 100 yuan. He said that he still has a piggy bank.

Zhou Yiqing was admitted to Dongfang Hospital in April, 2004, during which he underwent various operations such as artificial heart implantation and heart transplantation, and the cost was as high as 900,000 yuan. Mr. and Mrs. Zhou Zhenhua owe more than 400,000 yuan for medical expenses. After the son left, the couple discussed with the hospital, hoping to allow some time to raise medical expenses. Unexpectedly, the hospital was unexpectedly tolerant this time: more than 400,000 debts can be completely exempted, but only if a special confidentiality agreement is signed.

Mother Guo Yongbei: The media is coming. You can't talk about it. Second, you can't report the case to the public security organ. Third, you can't appeal to the administrative department. We thought, what did you do to him?

Why did Shanghai Oriental Hospital make such a request? Is there anything hidden behind the child's death? Zhou Zhenhua is more careful. When he was negotiating with the hospital, he quietly recorded it.

The couple negotiated with the director of the medical dispute office of Shanghai Oriental Hospital: (Guo) is not allowed to report the case to the judicial organs, which I didn't expect. (King) We are villains before gentlemen. (Guo) Copy this agreement. (Wang) This cannot be copied.

Before the hospital asked to sign this agreement, Mr. and Mrs. Zhou Zhenhua had been sincerely thanking Shanghai Oriental Hospital and had never had any doubts about the treatment of the hospital. But after this incident, the couple began to have doubts. Why did the hospital seal the mouths of family members in this way? What did they do to their son? So what disease was Zhou Yiqing hospitalized for and what treatment did he receive?

2. 12-year-old boy came to Dongfang Hospital for treatment on Monday.

On April 9, 2004, Zhou Yiqing, who was 12 years old, suddenly felt chest tightness and was admitted to the Pediatric Hospital affiliated to Fudan University. He was diagnosed with primary cardiomyopathy and cardiac insufficiency. On the afternoon of April 22nd, Liu, president of Shanghai Oriental Hospital, came to the Pediatric Hospital for consultation.

Guo Yongbei: Later, he sat down and said, I'm telling you, the child is very ill and can't come today, and he can't come tonight. What do you mean? He said he didn't sweat.

I just heard from the doctor in the pediatric hospital that the child was very ill. Liu Jiaoshou's conclusion made Guo Yongbei almost collapse. Just when she was desperate, Liu Jiaoshou suddenly turned the tables.

Guo Yongbei: You are very lucky now. He said, we have artificial hearts here. I don't understand. I said, how is an artificial heart possible? He said, don't be afraid. We are opening an international center at this time, and the International Heart Center Conference is held in Shanghai. He said, don't be afraid. On our German side, he brought an artificial heart product to show, he said. I said it was dangerous. What is your success rate? He said the success rate was 90%. He told me.

Anxious to save their son, the couple immediately transferred their son to Shanghai Oriental Hospital. That night, Dean Liu Zhong and German expert Weng Yuguo performed an "artificial heart" operation for Zhou Yiqing, and temporarily replaced the sick heart by installing an external device. At that time, the Shanghai media quoted Dean Liu as saying that the children on Monday were very lucky. It won't be long before they can take out the artificial heart of Berlin and go home to recuperate!

Zhou Yiqing has been admitted to ICU. At this time, Guo Yongbei had another worry. He has an artificial heart. What should he do next?

Guo Yongbei: Stem cells, his own stem cells, his blood. He said that the blood he gave him was drawn. After pulling it out, tell him that he separated it, separated it into stem cells, and then punched it in, just like a farmer sowing seeds on the ground, and sprinkled it on his heart muscle.

Two months later, the hospital gave Zhou Yiqing what Liu Jiaoshou called stem cell surgery to repair his heart. However, the operation failed.

Guo Yongbei: His father went to ask the doctor. What about stem cells now? He said that stem cells look bad and have no effect, he said.

After the failure of stem cell repair surgery, Dean Liu proposed a new treatment plan-muscle cell transplantation!

Guo Yongbei: What do we mean by muscle cell transplantation? He said that stem cells are too fragile. Muscle cells dig a little muscle from the thigh and above, then put the muscle in that bottle, cultivate it, and cultivate it in that machine. After two weeks of culture, this muscle will be cultured into muscle cells and then hit his myocardium, he said.

From June 5438 to October 2004 10, Dongfang Hospital performed a muscle cell transplant for Zhou Yiqing, but the operation was still unsuccessful. After these two operations failed, Oriental Hospital decided to perform a heart transplant on Monday, which was the fourth operation of Monday, and the operation ended in failure. /kloc-died after 0/5 days. At this time, the artificial heart installed for Zhou Yiqing in the first operation has been installed on Zhou Yiqing for 15 months. Afterwards, German doctor Weng Yuguo issued a statement through the Internet, calling it "the longest and most successful cardiac auxiliary device used in children in the world". However, in this so-called successful 15 months, 13-year-old Zhou Yiqing suffered great pain.

Guo Yongbei: Son, I said what's inside. He said that mom should stop talking. I don't want to recall part of it,' he said. He said, I said how are you. He said that you have never seen it in your life, and you have never suffered what he said.

Is it the great pain of patients and their families behind obtaining the longest data of an artificial heart device? Zhou Zhenhua, the father of the deceased, came to the Health Bureau to ask about the German doctor Weng Yuguo.

Zhou Zhenhua: The Health Bureau and the Shanghai Health Bureau also gave me relevant replies, which showed that Weng Yuguo was really unqualified, did not practice medicine, and did not have a license to practice medicine in China.

According to Article 3 of the Interim Measures for the Administration of Foreign Doctors' Short-term Medical Practice in China promulgated by the Ministry of Health, foreign doctors must be registered and obtain the Short-term Medical Practice License for Foreign Doctors. However, the Shanghai Municipal Health Bureau confirmed that Weng Yuguo had never been granted a medical license.

Third, parents wondered whether his son Zhou Yiqing had done experiments on people.

At this time, Zhou Zhenhua and his wife felt the fog behind their son's death. In order to preserve the evidence, Zhou Zhenhua, with the help of his lawyer, retrieved more than 65,438+0,900 pages of Zhouyi medical records in Seijuin.

However, he can't understand a lot of information. Zhou Zhenhua asked around and finally found a professional who was willing to help him. It was Chen Xiaolan, the former supervisor of the US Food and Drug Administration in Shanghai, who was named as one of the top ten people in "CCTV moved China in 2007" for his outstanding deeds of exposing medical shady and promoting medical reform.

Chen Xiaolan searched the website of the State Administration of Medical Products, but couldn't find the registration number of Berlin Hart artificial heart implanted in Monday. This made her a little surprised, and she made a special trip to the State Administration of Medical Supplies for face-to-face verification. The State Administration of Medical Products confirmed that the German Berlin Hart artificial heart auxiliary machine and Berlin Hart artificial heart pump failed to pass the national registration.

Chen Xiaolan, Chairman of the Board of Supervisors of medical insurance bureau: It is not an effective and legal product. It was taken out and implanted in the child. It's implanted in the body. This product is illegal, and this operation is even more illegal.

Dongfang Hospital, an old secondary hospital, actually uses foreign medical devices without national registration. Chen Xiaolan didn't believe such a ridiculous thing.

Chen Xiaolan: He doesn't respect the value of life and ignores the preciousness of life, which makes me very angry. He doesn't do experiments. He doesn't even understand the experiment. He has no ability to do this kind of experiment, nor is he qualified to do it. Everything he does needs to be approved.

Since it is illegal medical equipment, how can it enter the regular Shanghai Oriental Hospital from abroad? How is it declared? In this regard, Shanghai Customs replied that "Oriental Hospital filled out an application form for the import of mechanical and electrical products to Shanghai Electromechanical Office in August of that year before importing cardiac auxiliary devices", which was declared as mechanical and electrical products and approved. At the same time, the customs also confirmed that "foreign experts and professors did bring medical devices donated by the factory into the country without declaring them to the customs, which is a violation of customs supervision regulations."

Chen Xiaolan: The same is true in foreign countries. This technology is only used tentatively and selectively in clinical practice, instead of being used for patients with myocardial infarction and dilated heart disease like Dongfang Hospital. This technology should be the top technology. Dongfang Hospital is a secondary hospital. He is neither qualified nor capable.

Zhuo Qin Xiao, deputy editor-in-chief of China Health Law and agent of Zhou Zhenhua, said: Artificial heart can really make the declaration of dying patients continue. But it must be done immediately in the shortest time, because heart transplantation is the last treatment.

So using artificial heart and stem cells, is this therapy mature?

Stem cells are entering clinical treatment. As far as I know, all countries are in the experimental stage.

With the in-depth research and investigation of medical records, more serious situations have been gradually discovered.

Chen Xiaolan: I started reading his medical history, and it became more and more clear that he didn't treat the child as a patient. He treats him as an animal, just like a mouse. They made full use of this animal. So I have been angry for a whole year, and this matter must be clarified, even though I am very tired.

At present, the muscle cell transplantation technology implemented by Oriental Hospital for Zhouyi is only in the experimental stage, even in countries with developed medical technology.

Chen Xiaolan: (Muscle cells) This is not (mature technology), it is more advanced than stem cells, and it is still in the experimental stage internationally. In 2005, Oriental Hospital had a paper about how many dogs were used in the muscle cell experiment, but in 2004, four people were used in the muscle cell transplantation.

What happened on Monday was shocking. /kloc-Is Zhou Yiqing, 0/3 years old, treated as a patient or an experiment in Dongfang Hospital? ! If these measures are really to save the patient's life, Zhou Qing will die immediately if he doesn't do so on Monday, and the Zhou couple can rest assured. But was Qing's illness serious enough to have this operation on Monday?

Gu, a famous cardiovascular expert: there is no need for an artificial heart at all.

All kinds of illegal treatment happened to a child one after another, and things didn't stop there. In the brochure published by Dongfang Hospital, it is said that in 200 1 year, Liu Jiaoshou took the lead in using artificial heart to treat patients with end-stage heart failure in China and achieved success. Up to now, 9 cases of artificial heart surgery have been successfully completed, which is the most widely used unit in China. So, are these nine operations really successful? The reporter of "Economics and Law" column investigated several patients.

Fourth, the so-called "artificial heart" behind successful treatment.

The old man named Deng Zhongxing lives in Jujiaqiao Road, Pudong New Area, Shanghai. 200 1 sudden myocardial infarction, sent to Dongfang Hospital.

Wife Ma: There was no timely rescue, which dragged on for more than ten hours. Then they told us that there was no other way but to install an artificial heart. At that time, we didn't understand what artificial heart was, and we had to rely on hospitals.

Ma accepted the plan of the hospital, but before long, Deng Zhongxing had serious problems.

Wife Ma: I had a cerebral infarction ten days after I put it on, and I had a cerebral infarction immediately.

Is this directly related?

Of course it is directly related. Are we already the fourth (artificial heart)? I saw Ding Xiaolan's death with my own eyes.

Seeing that her husband was dying, Ma Xiangmei insisted on dismantling the "artificial heart".

Wife Ma: This artificial heart is what we demand to be resolutely dismantled. Why, after you pretend, nothing is good in your heart, and everyone is paralyzed. What else did you install? Are you going to kill him? When you die, your heart dies.

At the strong request of family members, Dongfang Hospital had to dismantle Deng Zhongxing's artificial heart. After the artificial heart was taken out, old Deng Man Zhongxing did not die. Instead, he lived for seven years. But in these seven years, his life was full of pain because of this treatment.

Wife Ma: You can't move a hand. Both hands are like this I can't move a hand or a foot when I see it. I spent more than 200 thousand for such a person. Who can live like this?

Deng Zhongxing later took Dongfang Hospital to court, but the conclusion of medical accident appraisal was that it did not constitute a medical accident, but the court found that Deng Zhongxing's current situation "has a certain causal relationship with artificial heart." Under the mediation of the court, Dongfang Hospital compensated Deng Zhongxing 1.6 million yuan.

Besides Deng Zhongxing, the reporter should also try his best to find the family of a patient named Dou. In 2002, Dou was admitted to Dongfang Hospital because of dilated heart disease, and an artificial heart was installed. About half a year after the operation, Dou, who was still in the intensive care unit, was sent home by the hospital. On the night after returning home, Dou suddenly spit out a lot of blood in his mouth and was sent back by the Oriental Hospital. Results He died after being rescued.

Dr Chen Xiaolan also launched a survey. According to her investigation, Shanghai Oriental Hospital has installed artificial hearts for 9 patients since 200 1. Of these nine patients, seven have died, and only two are still alive, one is Deng Zhongxing and the other is Sugar Singing, both of whom have left sequela. In the face of all this, how does Shanghai Oriental Hospital explain?

Unannounced visit: Fan Huimin, attending doctor of Shanghai Oriental Hospital on Monday: All questions can't be answered.

Oriental Hospital has made a public statement on this matter, the main point is that artificial hearts are legal, because at that time, the US Food and Drug Administration did not have regulations on the registration of related equipment. In 2006, the European Heart Failure Association has included artificial heart as one of the treatment methods and included it in the treatment guidelines for heart failure. Although Bellinghart artificial heart has not been registered by the US Food and Drug Administration (FDA), the FDA allows the product to be used in the United States under special circumstances. Is stem cell transplantation safe? Liu believes that stem cell transplantation is indeed a new technology, and it really belongs to the clinical trial stage at present. However, a large number of data of stem cell clinical trials have been published at home and abroad, and there is no prohibition of stem cell transplantation in relevant laws and regulations. About all-out rescue or human experiment? The hospital explained that there is no medical technology that can make people live forever. They respected their family's right to know when performing the operation.

Deputy editor-in-chief of China Health Law, and agent of the couple: Zhuo. In June 2002 1 65438+1October1,Shanghai promulgated the Administrative Measures for Clinical Access of New Medical Technologies. All new medical technologies and medical institutions must be approved by the Shanghai Municipal Health Bureau, but as far as we know, the Shanghai Municipal Health Bureau has not approved the Oriental Hospital to use this berlinheart artificial heart.

In this statement, the reporter also noticed that the European Heart Failure Association took artificial heart as one of the treatment methods of heart failure in 2006. Even though the Heart Failure Association is authoritative and the information is true, Zhou Yiqing had an operation as early as 2004, and the first case was carried out as early as 200 1 Oriental Hospital. The first patient, Ding Xiaolan, died ten months after the operation.

Qiu Renzong, a researcher at the Applied Ethics Research Center of China Academy of Social Sciences: In foreign countries, such as the United States and Germany, the clinical application of this new technology and new drug is generally very strict. He has to go through certain procedures, right? Only when he reaches a certain level can he be applied to clinic. Because clinical application is equal to entering the market and making big money in large-scale production, so what if he can't do it? He just escaped the strict censorship procedure in his own country, didn't he? Then he used it in developing countries, and Berlin Hart is a typical example.

On May 1 2007, China's "Regulations on Human Organ Transplantation" was officially implemented, which strictly restricted the approval of organ transplantation and the qualification of hospitals. According to the reporter's investigation, Dongfang Hospital has stopped this operation. According to reports, after the incident, Shanghai health, drug inspection and other departments also went to Dongfang Hospital to understand the situation, but so far there has been no further investigation, and Dongfang Hospital and Liu himself have not said anything. In April 2007, Zhou Zhenhua reported the case to the Criminal Investigation Detachment of Pudong Branch of Shanghai Public Security Bureau, but no case was filed; In June 2007, he took Shanghai Oriental Hospital to court. But so far, the medical malpractice appraisal has not reached a conclusion, and the trial of the case has not progressed.

Illegally entered and unregistered medical products have been surgically installed for several patients in Shanghai Oriental Hospital for several years, but the technology that is still in the experimental stage has been applied to a child. What is hidden behind this blatant behavior that is not only risky, but actually violates medical ethics and even basic human ethics? In this process, why did the relevant departments fail to find out in time, and why have they not been able to thoroughly find out this matter so far? For some immature diagnosis and treatment technologies abroad, how to supervise and deal with them, in order to avoid our laws and regulations and try to enter other countries for experimental promotion, someone must answer!