Ji'nan trial drug student is the main clothing anti AIDS medicine 3 days profit 40 thousand
the Ji'nan Times reporter
the "Jianghu"
thriller film "the immortal gardener", a multinational pharmaceutical company in Africa secretly uses the human body to test new drugs, a strange adventure story, a woman reporter To expose the truth, death in Africa. Behind the film, the big market of medical research and development is spawning a special "river and lake". Every new drug listing needs three stages of clinical trials. Who will try?
someone is for life. When the disease is killed, only the last hope is left, the unknown pill is swallowed, the birth or death, the last stroke of the money, a thousand yuan of trial subsidy, the body to make sure, with an ideal, with an ideal. Shennong tried the spirit of hundred herbs to promote medical progress.
these people are called "trial drug families". They form a special arena and experience is not known to outsiders.
lying in hospital bed, 42 year old Li Chenfang (alias) skinny. Turning over a page of calendar, she smiled inadvertently at her lips, because she was able to live another day. She is an advanced lung cancer patient. She should have lived for only two or three months. But she has passed the past year since she was diagnosed in February last year. The test drug, which most people sounded unthinkable, continued her life. "No worries. For life, I can only fight." She said. It seems to be her success.
written on the sick bed
outside the window haze, Li Chenfang hiding in the hospital oncology ward, slightly chest tightness. Weather like this, she must not go out, care for her lungs carefully.
Spring Festival is coming soon. She said that she never thought that she would be able to live another year. She was diagnosed with lung cancer last year after the Spring Festival. She had been coughing and chest pain for a long time. She persuaded her family and returned home. No money for treatment, she wanted to go home and wait for death, stay with her family for a few days.
Li Chenfang said it was painful at that time, on the one hand, she was suffering from chest pain, and she could not get up at all. On the other hand, the family is accompanying her every day, "the closer the death period is, the more reluctant family members will be." The feeling of lingering but incapable of redemption is very painful.
the body is going from bad to worse. When Li Chenfang is alone, he quietly writes his remains on the bed. "I write a piece of it. The child is only 14 years old. After I die, he can try to soothe the child and give the child a complete love... The remains are still at home now.
for the treatment of medicine
from February last year to now, nearly a year, Li Chenfang has experienced the process from "waiting for death" to "life continuity". Today, she is still thin, but there is no problem in action. Chest pain and cough are almost gone.
"is the reagent that keeps me alive. I don't want to let more people know. When listening to the word "reagent", they usually misunderstand. To tell the truth, I feel embarrassed myself. Li Chenfang said.
that was in March of last year, when Li Chenfang was discharged from hospital for more than 1 months, the chief physician who had been hospitalized in Ji'nan made a phone call to her. The doctor is her hometown, telling her that the hospital has an opportunity to test medicine, is a cancer chemotherapy combined with targeted clinical drugs, very suitable for her treatment, and all free.
listen to this news, Li Chenfang arrived in Ji'nan in second days. "At that time," Li Chenfang said, "at that time, there was a risk of taking the medicine into consideration. The risk was a little thing. I only thought I could make me live for a long time, and I wouldn't rely on the hospital."
tumor gradually reduced
examination, Li Chenfang's indicators met the test standard. After signing, she entered the group to start the 4 cycles of chemotherapy trial life.
every week, the doctor will give her a injection of chemotherapy, then do lung CT, observe the development of the tumor, and study the efficacy of the medicine. "When I saw the doctor treating me with care, he changed his mind at that time, no longer negative." Li Chenfang said.
hospitalization for 3 weeks, Li Chenfang's body recovered a lot, chest pain gradually disappeared, cough reduced. With the improvement of her condition, her whole state of mind changed from day to day. "I came to heal, not to wait for death."
finished the 4 week trial. Li Chenfang felt a lot of recovery. Her tumor was smaller after examination, and her previous symptoms almost disappeared. She said that if you do not participate in the trial drug, normal treatment, the 4 cycle of chemotherapy will cost more than 2 yuan, this money can not afford to take.
after discharge, the doctor will still ask Li Chenfang regularly about his physical condition. Two weeks ago, the doctor told her again that the hospital had to start the trial again, the same chemotherapy for three weeks. She promised to come down without thinking. "You don't understand that for those of us who have been sentenced to death, we must fight for even a chance." Li Chenfang said that the test should have more than ten blood collection processes, not only the reagent free, but also some subsidies.
not all drug users are patients, they are more healthy people. "Occupational testing" has become the most risky new occupation. In the vast network world, there is a special QQ group -- the reagent QQ group. The QQ group will publish drug test information from all the major hospitals in the country from time to time. Some QQ group members have reached more than 400 members. Most of them are distributed in Beijing and Shanghai.
, in fact, some QQ groups are hotbeds of underground processes, which hide many "occupational test people". In the past two years, nearly 20 trials of anti HIV drugs have been made, regardless of risk. The profit is 40 thousand yuan. What we see in these "career reagents" is insanity.
20 times
through the underground flow test. "A certain kind of calcium tablet in a hospital in Suzhou, 4 tablets for 4 weeks, 15 boys, 1600 yuan for nutrition." "a hospital in Shanghai is recruited, the test is two days, every Sunday test, 150 yuan every day..." When the reporter applied to join a test QQ group, the group owners released 2 test information. Subsequently, many members inquired about the trial.
the reporter was in contact with a "professional trial agent" as a "novice". He told reporters that he was a medical college student in Shanghai. He had never found a job after graduation. He had been working as a "professional drug test person" for 2 years. In the 2 years, he tested the drug nearly 20 times. "The longest time is 21 days, and there are drugs and injections."
according to the regulations, 3 months after the trial, the reagent can not be taken again, otherwise it will bring danger to the individual of the reagent. In this way, he can only test 8 times at most in two years. So, nearly 20 times, how did he do it?
"reagent has regular process and underground process". The regular process is the test plan first let the ethics committee approve through, the test hospital and then find the drug test person, sign the informed consent, after the trial, the hospital personally paid the cost of the trial drug. The underground process is the connection between some hospitals and referrals to find drug users, to introduce information and distribute phone numbers through QQ group. We then contacted the referee, the referee was taken to the trial base, and the agreement was signed. After the test is finished, the referee will take money from the hospital and other institutions, and then send the reagent to the drug user. So I can not strictly follow the 3 month trial. "
, he said, nearly 20 trials did not encounter any danger and felt relaxed. "Because China is generic, there will be no risk. In the trial group, the hospital will enjoy good food and drink, and finally get paid. I didn't test too high risk drugs, so I didn't pay much, every time about 2000 yuan, two years to do it, making tens of thousands of Yuan no problem. "
3 days' profit of AIDS drugs 40 thousand yuan
this year's 21 year old boy, Xiao Chen, who was just retired from the army, has not yet found a job. Because of curiosity, he joined the group of reagent users.
"one of my comrades in arms is a trial worker in Beijing. He is a professional. He has worked for 3 years and has tried many drugs. He told me that many large hospitals and military hospitals in Beijing have lots of risky clinical trials. Although the risks are great, they make more money. If you dare to take risks, it will be easy to earn money. " Xiao Chen said.
at present, Xiao Chen's comrades in arms have not been in danger in the process of testing drugs. He encouraged Xiao Chen to go to Beijing to be a "career reagents". Xiao Chen said, "I didn't dare to go because I was not short of money. I had a retirement fee at hand, and I wanted to test it just because I was curious. But it is not worth it to sacrifice oneself for curiosity.
let Xiao Chen retreat for another reason. He thinks that the "career reagents" are a little crazy. "My comrade in arms told me that he had known a" professional reagent "who had made an anti HIV drug tolerance test a few days ago, and that he got 40 thousand yuan in 3 days. The income is very attractive, but I do not envy at all, before I had an understanding of the drug test, antitumor drugs, AIDS drugs, psychotropic drugs have great impact on the human body, I will not do anything for money. Some friends said that the risk of experimental drugs in Ji'nan is not high and relatively standardized, which is more insurance.
experts say
there are hundreds of "healthy drug users" in Ji'nan each year,
the library of drug subjects is building
it is understood that there are 370 new drugs in our country on average, and each new drug is generally in the period of 1 to 3 clinical trials before the launch of the market. The first phase is Zai Jian. The two phase of the validity of Kang's body is for the patients, to understand the toxic and side effects of the three phase, to further expand the number of cases, to determine the dosage and to definite the curative effect. The director of clinical pharmacy of a three a hospital in Ji'nan, the director of clinical pharmacy, has strict admittance standards for the medical institutions engaged in clinical trials of drugs. Clinical trials need to be carried out in the clinical pharmacological bases confirmed by the state. At present, most of the three A hospitals in Ji'nan have a clinical pharmacological base.
there are only two in Ji'nan that can carry out clinical trials of healthy people. Each hospital has more than 10 new phase clinical trials in one year. Each person needs 20 to 30 subjects each time. According to this calculation, hundreds of people are supposed to be "healthy drug testing people" in Ji'nan each year. In phase two and phase three clinical pharmacology trials, there are many "patient trial people". It is understood that hospitals usually post notices in their own outpatient advertising columns, and patients who are recruited to see the doctor try the medicine. The patients are generally new drugs that can be symptomatic treatment. They do not have the corresponding remuneration, only about 100 yuan of transportation subsidy. Their medicine is mainly for the free test of the latest drug, free of charge to do some examination, can get more attention of the doctor, doctors can make a variety of treatment programs for them.
it is understood that overseas recruitment of drug users is very common. In our country, because of the limitations of various conditions and ethical and moral factors, this topic has always maintained a low profile in public. The researchers of the drug trial, the trial drug person or the clinical trial itself have been covered with a mysterious veil for decades.
there are experts saying that at present there is no special law on human testing in China. There is still a certain degree of nonstandard in the domestic trial market. This is also a opportunity for "professional trial drug people". At present, the country is building the subject library, and the trial hospital is able to share the test drug delivery system. It is guaranteed that the drug can not be retested within 3 months.
there is only one standard for the quality management of drug clinical trials at present, which does not have a mandatory role, and there is no clear standard for the amount of economic compensation. This has made clinical trials in China for decades, but sometimes the test agents are still in a weak position.
"Shennong tastes all kinds of herbs, and is poisoned seventy times a day". Is the drug three detoxification, the health of the body test, does it cause harm to itself? Why do they do this, is it for money or ideal? How is the current state of the group in Ji'nan? We know that Qilu Hospital will have a healthy drug test, reporters come to the scene, and explore the whole process of trial.
20 people, one group, 18 students,
new drugs should undergo 3 strict human trials before being approved. The 1 phase test subjects were healthy persons, while the latter two were clinical patients. In view of the stricter clinical conditions for healthy people, only a few hospitals in Ji'nan are qualified for 1 stages of clinical trial, and Qilu Hospital is one of them.
more than 6 o'clock in the morning in January 7th, and the night was not dispersed. Some young men rushed to the 1 phase clinical trial ward of Qilu Hospital drug testing center. They look very young. Five or six central medical staff each division of labor, each responsible for carrying out preparations before the trial. On the
table, there is a "screening / signing table for the subjects of the Qilu Hospital," showing that the drug was a spray for asthma treatment, and the applicant was a pharmaceutical company in Shandong. The participants in the trial were 20 healthy people, all male. From the register address column, 18 of them were college students in a medical college, and the rest 2 were social workers.
"Ji'nan's health test drug users are mainly in Colleges and universities, especially in medical colleges, and the senior grade is more than the lower grade. This is because medical students have certain knowledge of medicine or pharmacy, and it is easier to understand the pharmacological effects and possible side effects of experimental drugs. Unless there are special requirements for special drugs, such as women after marriage or after birth, they generally do not recruit social workers, so there is no occupational test person in Ji'nan. The doctor said.
Mastery of pharmacological knowledge does not worry about the risk of drug testing
in the trial of drug trial, Xiao Liu is one of the most frequently tested drugs, and he has participated in 3 trials in two years. Xiao Liu said, initially knowing that the drug test was posted on the university campus, and then he knew that many students from different grades participated in the trial, and most of the students had no danger except for a student's hypoglycemic fainting. "You look at the medicine today, medical college, medicine college, public health college students all have, there are undergraduate students, and a dorm roommate." Xiao Liu pointed to other drug users. Surprisingly, he was not at all worried about the risk of drug testing. This is also the attitude of most of the test people in this trial. "All of us have had pharmacology lessons. We know that this experiment is a hormone drug, and it is partly administered. It has little effect on the human body. Most of the Chinese medicines are generic drugs, which have been listed in foreign countries. Ignorance will fear. " "It was all done with white mice before, and this time they became white mice themselves." Xiao Liu laughs, but he has received a reward of nearly 6000 yuan through 3 previous tests. "What is the purpose of the test?" when he heard the question, he smiled. "I know you want to say that I do not deny it for money. But it is also for a little medical ideal to contribute to the development of medicine. "
two times a day, 11 times a day,
, and Liu was asked to take his blood pressure. In order to ensure the safety of drug users, the heart rate and blood pressure should be monitored continuously in the course of drug testing. If these two indicators are abnormal, they will be dealt with urgently. This is the first test to be taken when the reagent arrives.
the reagent was numbered and the blood pressure and heart rate were measured according to the serial number. Such monitoring was performed 1 hours and 4 hours before and after taking the medicine. According to the pharmacological properties and risks of experimental drugs, monitoring indexes and monitoring frequencies are also different.
the effect of the drug is mainly based on the blood concentration of the reagent, so before taking the medicine, it is necessary to draw blood for them before taking the medicine. Each person pumping 6 milliliter of blood each time, from 7 points to take medicine, at 7 o'clock in the evening, they need to be pumped 11 times, 24 days to smoke two times, the 25 need to draw again, in order to monitor the efficacy. A week later, they will repeat the whole trial process for second cycles.
according to the serial number, the blood test personnel began to draw blood one by one, and strictly recorded the time of blood collection, and the interval between the 11 intervals was also strict. The process of drawing blood is also the process of embedding the needle. The method of collecting blood by using a buried needle can reduce the discomfort or pain of the needles.
each person is sprayed 500 micrograms and can not leave the hospital
7 o'clock a.m. The monitoring center is responsible for explaining the matters for the drug reagents, and the reagent person enters the reagent room with 4 persons in one group. Later, the doctor took a pile of experimental drugs into the reagent room.
test drugs can be divided into two categories, one is the new drug that has not yet been listed, that is, the newly developed test drug commissioned by the company. The other is the original research drug that has been listed abroad, which is called reference preparation. The reagent group will take the test group in the first cycle and take the reference preparation in the second cycle. By comparing with the listed drugs, it is evaluated whether the drug has reached the same standard as the listed drug, and is the basis for the approval of the registration and approval of the listing by the drug review department.
doctors have two consecutive times of spraying drugs for trial drug users and 500 micrograms of spray. This is also a regular dose for clinical use. "You have to wrap the nozzle on your lips. When I spray, you breathe in and hold your breath for 30 seconds. Then repeat the spray once and rinse the mouth after it is finished. The doctor told each of the trial agents. In order to ensure the accuracy of the dosage, the research doctors have repeatedly drilled the operation norm. After spraying, the doctor records the test time of each reagent, so as to grasp the time of drawing blood. "It doesn't feel like that. It's a little cool in the mouth." Xiao Liu said after the trial. After taking all the medicine, the 20 drug users returned to the activity room and waited for the next 10 blood tests. "For their safety consideration, they can't leave the hospital all day." The doctor said, "after the end of all the tests, we will give the test reagents certain financial compensation."
legal trial medicine must be approved by the Ethics Committee for the
the people are kept confidential
the screening standard is introduced by a series of strict physical examination
doctors, in fact, the people do not want to be able to be able to be used, and have strict screening criteria, such as no other new drugs in bed test within 3 months, no contribution within 3 months. No history of drinking and smoking, no family history. Before the test, they undergo a series of strict physical examination, including blood routine, liver function, kidney function, urine routine and so on. Only after the physical examination is completely qualified can we enter the group test.
consent to participate in the voluntary withdrawal at any time
the day of physical examination, the hospital will also be signed with the reagent "informed consent". The reporter sees that the informed consent lists 11 items including research names, research profiles, research procedures, possible adverse reactions (events), your safety and assurance, your rights and interests, matters that require you to cooperate, voluntary participation, reasons for terminating your participation in the experiment, consultations on research, and confidentiality. The consent of
indicates that the trial procedure has strict clinical trial plan and approved by the medical ethics committee of Shandong University. Although the drug has been used for many years at home and abroad, it has proved safe and effective, but, like any other drug, there are individual differences and unpredictability, which may cause discomfort and adverse reactions to varying degrees.
in addition, the consent form also indicates that the hospital will contact the bidding unit and give reasonable and necessary medical care and compensation in accordance with the contract agreement, if the damage caused by the trial drug occurs. It will also be reported to the ethics committee and the State Food and drug administration. The experiment will follow the principle of voluntariness and withdraw at any time. The reagent can get a free medical examination and give some financial compensation after the test is finished.
do not disclose the identity of the identity
with a special list of "confidentiality", indicating that it is not leaked to any organization or individual except for the research unit, the test organizer, the participant and the Department of pharmacy administration. Qilu Hospital and the State Administration of drug administration will keep the records of trial reagents in this study.
indeed, in contact with Xiao Liu, he repeatedly asked not to reveal his identity. He said that although he knew it was not dishonorable, he did not want others, especially his family, to know that he had tried the medicine. In addition to fear of family members who fear no medical knowledge, there is also "because of traditional concepts, the test and selling kidneys are now outside the scope of moral tolerance".