Monday, June 25, 2012

Protection - medicine people-

Protection - medicine people-
Do you want to make 3000 yuan within 4 days? It is believed that many people will all make the definite answer. Attend Beijing second foreign language university once little stamen ' Assumed name) No exception. However, she has hesitated when saw this inscription which is recruited the notice. This is an advertisement that a pharmaceuticals recruits experimenters, it is healthy university students to recruit the target. "What differences is this with looking for the little white mouse to have? " The once small stamen can't help saying. Lack protection of laws and regulations, participate in experimenter that clinical medicine test, may not protect the little white mouse organizing paying close attention to as the animal yet. Recently, the first experimenter's protection work system of our country is established in Peking University formally, include the data and monitor organizations such as committee, biological security council, interests conflict and scientific research sincere office,etc. safely. "Experimenter the intersection of protection work and system can respect and maintain the intersection of experimenter and fundamental right in people better. " Biomedical ethics committee's General Board, medical ethics professor Cong YaLi in Peking University say. 800 multi-type new medicines carry on human tail every year in our country, involve about 500,000 crowds "Everybody may become experimenters. " The clump is inferior and beautiful to explain the original intention of setting up experimenter's protection work system like this. Engaged in this the professor in the past 10 years of experimenter's protection work seems, so long as it is experimenters to participate in studying. Among them not only include participating in the volunteer of the clinical trial, also include because of pressures of doctors and patients, etc. joins the patients of experimenter's ranksing. The clump is inferior and beautiful to explain, many patients will think, if does not participate in the clinical trial that the doctor in charge presides over, " he is sure not to cure my disease carefully " . Generally speaking,whose name is new medicine must test basic research, animal and clinical trials human,etc. behind procedures fixed, could be listed. In the clinical trial, researchers, through the means to intervene voluntarily or not intervene at all, carry on new-type medicines, treat the way etc. to test, observe through data analysis, symptom on experimenter, obtain relevant information. In recent years, of our country the intersection of medicine and the intersection of clinical trial and project increase severely, one experimenter that research involve at least dozens of, as many as ten thousand at most. The data reveal, 800 multi-type new medicines carry on human tail every year in our country, involve about 500,000 crowds. About experimenters, there is a call of the image very much among the people - -" medicine people " . From the middle of last century, with the constant discoveries of a lot of problems in medical science and behaviouristics research, protect medical research experimenters and enter the public visual field gradually. Among them the most famous one is no more than U.S.A. " Taskey's lucky syphilis is tested " . Since 1932, American public National Health Administration regarded 500 totally ignorant African black persons as the test target in the name of treating syphilis free, danger to the human body of syphilis of secret research. In fact, these experimenters have not got any treatment. This project was not stopped until exposing by the media in 1972. At that time, already 28 people died of syphilis in the patient participating in testing directly, about 100 people died from syphilis complicationed, 40 people's wife is infected, 19 name women catch syphilis when born in. " hard base declaration in Hull " announced in 1964 is considered as the foundation stone of the code of ethic of the ethics of clinical research. Among them stipulate: "Medical research could go on when being tried the crowd and can profit from result studied only. " Clinical chief of institute of pharmacology Lu Yuan in Peking University tells reporters, in China, experimenter's protection work started just now since the 1990s last century, everything was not " ripe enough " . Before this, only the biological ethics committee undertakes the important task of experimenter's protection work. At present, medicine of a larger scale studies the universities and colleges, research institution and hospital of the first, second and third in our country, just set up the special biological ethics committee. According to regulation, before clinical trial begin, seminar must ahead of time until biological ethics committee in organization submit the research report. The research report includes research approach, purpose, experimenter's number,etc.. Every step of the test must carry on detailed planning, including the composition of medicines, change of product dosage of traditional Chinese medicine of the test,etc.. Only the biological ethics committee agrees after the research approach, the clinical trial can go on formally. "But the function that the biological ethics committee plays is very limited. " Cong YaLi says, " it is not merely far from enough to protect, even some fine starts and poor finishes. " She admits, because of lacking effective supervision, will present some questions in the clinical trial. For example some seminars will revise and study the step without authorization; The test data even has suspicion of making the fake; " letter of consent in the know " that experimenters signed with the seminar is unable to play a role in protecting experimenters at the point of key. Only less ethics committee member can insist on examining continuously, but still " unable " to studying the control of the course . Experimenters are just under the situation like uneven bars athlete without any protection, experimenters just as once little stamen likened, become uneven bars athletes, finish various stunts in case of not having any protective measure. A famous medicine person reveals to the media whether have a side effect to ask a doctor before test oneself, the other side comforts him " There are not any sequela and side effect " ,Can " rest assure of cooperating and testing " . Later on he finds one's own nose bleeds sometimes, and often cold insulation, move and gasp for breath, he knows the medicine to take by oneself resists and solidifies function. This is different to imagine under situation that experimenter's protection system is complete. For example, U.S.A. has strict regulations in checking experimenter's qualification. If the experimenters not up to standard appear in a seminar, this test result will not be acknowledged. It will be refused while listing to permit that new medicines are being applied for. There is a usable volunteer's list at any time in most research institutions. In addition, researchers can put up the notice in the drawing room of the clinic or operating room, but similar " Earn 3000 yuan of foot within 4 days " ,etc. jingle forbid. However, because experimenter's protection work system is imperfect, it is very complicated for the experimenters of China to form, professional experimenter, university students even medical staff members are all important components. Some businessmen smell the enormous commercial interest, a experimenter, the intermediary and food chain of testing the organization take shape progressively. According to once small the intersection of stamen and contact detail of offering, China Youth News reporter find, recruit university student go-between of experimenter Liu happy (assumed name) . He is one graduating student in Haidian District of Beijing. Liu happy to reveal some intermediary these by way of incorporated company privately, more one is still the personal behavior. Some " try the medicine intermediary " Itself have relation that is familiar with with hospital, director of seminar, they have steady experimenter resources, it can be each research project in a short time, find experimenters rapidly. Pass and " pull strings The bridge " ," try the medicine intermediary " Often collect certain deducting a percentage, it is generally 25%~30% of experimenter's remuneration, sometimes? Chuo's grain ji? 0%. According to estimating roughly, only in Beijing, when about 7000 professional experimenters shuttle between every large hospital. "Professional experimenters can't reflect the true curative effect of medicines. " A clinical expert of Peking Union Medical College Hospital insisting on anonymity says. He says, medical manufacturer, research institution incline to utilize the students of the university to carry on the medical experiment even more. Because university students do not mostly have bad hobby, but also fulfil requirements on cutural dynamics, healthy state even more. The clump is inferior and beautiful to tell reporters, the medical personnel is special experimenters too. They possess certain professional knowledge, can carry on effective control to symptom in the clinical trial. So, in the first stage of test of the new medicine, the medical personnel often joins in. In the first stage of test, the doctor is through changing the dosage of the medicine constantly, it is tested that the clinic on the human body of new medicines reacts, safety coefficient is relatively low, the harmfulness to the human body is relatively great. "The legitimate rights and interests which protect experimenters are very urgent systematically. " She says at once. In 10 new medicines which U.S.A. sanction in 2008, none of experimenters are Americans In 2003, 34 HIV-positive persons participated in a medicine test of Temple of Earth hospital, there are 4 people to die during this period in observation in 6 months. Two years later, these patients send out the open letter to a ethics examination board with unit project among them, require the committee to examine ethics and legal question involved in test of this medicine, and put forward the patient that tests to all participation medicines for the living cost, delay work the subsidy request of fee and nutrition fee. Passed the investigation of " Chinese Newsweek " later, this test had not got approval of national Bureau of Drugs Supervision. Such medicine from U.S.A. has just finished human tail in Bulgaria and Mexico. This incident has initiated and should try medicines to set up the dispute of the threshold in China for the transnational pharmaceutical factory. Released the report according to the intersection of U.S.A. and hygiene and the intersection of humanity and affairs department, 80% carry on human tail in 2008 abroad in the medicine which U.S.A. sanctions, 78% are recruited abroad in the experimenters of all participation human tail. Among them 10 new medicines sanctioned totally carry on the test abroad, none of experimenters are Americans. The expert thinks, the medical giant aims at Chinese base and tries the medicine risk extremely high because of America and Europe, even traced back to the clinical trial accident 20 years ago, compensation number reached several ten million dollars. By contrast, the compensation of HIV-positive person that preceding paragraphs mention requires it is only the delaying work and is subsidized of 10 yuan for one day, somebody proposes standards such as a hen or 0.5 kilograms of eggs,etc.. Worthy to be gratified, in recent years, degree is higher and higher for concerning by protection work of the persons who try at home. At the beginning of 2007, Ministry of Public Health printed and distributed <>,Aim at the norm and involve people's biomedical research and application of correlation technique, the guardian's life and health, the maintainer's dignity, respect and protect human experimenters' legitimate rights and interests. Since March of this year, the clump is inferior and beautiful and some researchers, put into the preparation of China's first experimenter's protection work system. "The protection work system of the experimenters in Peking University has drawn domestic and foreign advanced experience, design finishing on the basis of this. " Cong YaLi says, this working system is made up of nearly 50 staff members, they all have special experimenters who protect working experience. Peking University medical science portion the intersection of Deputy Director and square big hillock introduce, the protection work system of the experimenters in Peking University will pass and offer training to researcher, carry on ethics check to research approach, to study course carry on the intersection of ethics and supervision and clinic and the intersection of scientific research and leader carry on the intersection of ability and train, sincerity to maintain scientific research,etc. to future, provide all-round protection for experimenter. A staff member says privately, they hope to pass this experimenter's protection work system, really help " Those are in weak position " Experimenter. Perhaps in the near future, once small stamen would be met no longer in the propaganda column of the school those made, she " shocked" Advertisement. Recruit experimenters, does not " transact business " ,Not even " Look for the little white mouse " .

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