Back To The Age Of The 80s
Chapter 191:
Li Zheng made an appointment with Lao Yang the day after he returned from Jinjiang.
"When will Professor Li have time to make an appointment with this old man of me? Let me talk about it first, I am retired, don't ask me for things like patting the table with the leader." Yang Lao laughed as soon as he walked into Li Zheng's laboratory. Hehe took out a blue-skinned retirement card and shook it in front of him.
Li Zheng touched his nose, got up and made a cup of tea for Lao Yang himself, "Lao Yang, I am such a person in your eyes."
"No, everything is not going to the Three Treasures Hall." Yang Laosi gave no face to Li Zheng.
Li Zheng...
But Mr. Yang was right. He asked someone to come over, and it was really something.
"I hope that the HPV virus vaccine will be used for the first clinical trial in China."
Yang Laocha drank half of it, and a sip of tea stuck in his throat, and a cough broke out instantly.
He coughed for a while, and said dryly: "Oh, this is a good thing, a good thing."
Promoting the clinical work of HPV virus vaccines and promoting the reform of the national drug approval system are two different things. The latter has many disadvantages and has to be changed. In the former, Yang Lao has also read papers on the carcinogenicity of HPV, and he still has no idea about the relationship between HPV and cervical cancer. Skeptical.
Fortunately, the clinical trial is successful. If something goes wrong, it is a vaccine clinic after all. This means that the volunteers are not dying patients, but healthy people. After being vaccinated, healthy people are exposed to the virus to observe the effect of the vaccine. If this one is not dealt with, it will be criticized by the population.
Old Yang also knows that if the vaccine is successfully developed, this anti-cancer vaccine will bring great prestige and glory to China, just like the previous hepatitis B vaccine, but when he gets older, older people will unconsciously be conservative. Don't like risk.
Li Zheng could see the embarrassment on Old Yang’s face, he sighed in his heart, "Old Yang, I am not asking you to support me, but I hope to convene a drug review committee meeting in your name, at least once. An opportunity to present to you seniors."
The drug review committee meeting is equivalent to the highest authority of the drug control department. Once a month, it conducts concentrated discussions on difficult drug approval issues in the month. Although Yang Lao and others have retired in their positions, they are still participating in January A drug review meeting.
It’s just that the drug review meeting is usually held at fixed times and in the drug control building. In addition to a group of experts, there are also officials from the drug control department. The newly appointed officials after the reform of the drug review system are indeed good and will do practical things, but It is the nature of officials to be conservative, and what Li Zheng has to do is to let the risk assessment department of future generations evaluate it, and that will not be passed.
Since Mr. Yang took a table and photographed a reform of the drug review system three years ago, he has almost been responsive in the drug review committee. His elderly people have a golden mouth, and more than half of the key management committee members will participate.
As long as Li Zheng can take advantage of the opportunity to persuade them, then his HPV vaccine clinically will be half the battle.
Old Yang looked at Li Zheng with a complicated expression, "Little Li, are you really so sure? This is not a joke. The domestic clinical norms were established too late. The masses' clinical understanding of this drug The acceptance level is not as good as in the West, and some people even treat this as a human experiment. If something goes wrong, no matter what genius you are, the people can drown you with every spit."
Of course, Li Zheng is sure that the localization of the HPV virus vaccine was promoted by him alone, but because of the constraints in 1990, he was unable to explain all this with rigorous data.
"Lao Yang, the HPV vaccine is not a biological vaccine. It is neither a live vaccine nor an attenuated vaccine, so it has a high degree of safety! Moreover, the HPV virus itself is not fatal, and its carcinogenicity is also a chronic process, so this time The clinical risk is far lower than you think."
"We know what's the use. The people only know that the virus is terrible and the cancer is terrible!" Old Yang said loudly.
There was silence in the room. After a long time, Lao Yang said again: "Tell me the truth, how sure are you."
"Ninety percent."
"Jiucheng? Don't fool me!" Old Yang suddenly widened his eyes. He still admired Li Zheng, knowing that this biological genius was not a reckless person, so he thought to himself, if Li Zheng had With more than 70% certainty, he will spare his face and help him.
But when the word "90%" came out of Li Zheng, Old Yang hesitated instead.
Where are you confident? The international community has not yet recognized the carcinogenicity of HPV. Tell me now that you are 90% sure of the clinical medicine? Unless the drug has undergone a clinical trial, it is almost impossible.
This medicine has really undergone clinical trials, more than once, but Li Zheng can't tell Old Yang like that, he can only express his seriousness and seriousness with a sullen face.
Old Yang stared at him for a long time, "Yes, I will call for you, but I will stick to my point of view for the time being. I suggest that the clinical trial be suspended."
When Li Zheng heard the words, he was more touched while delighted. He felt that he was very lucky. In his previous life or in this life, the senior scholars he met had spared no effort in supporting the younger generation.
An old man in the scientific research community in China said that the greatest feature of science is exploration and inheritance, and generations of scientists in China have also done this.
On the evening of April 28, 1990, this was an important day in the history of the changes in the Huaguo drug review system. On that night, more than half of the Huaguo drug review committee gathered in the meeting room of the Yanjing Hotel.
The Huajing night in April was already two minutes of sultry heat, and the big electric fan was rustling. The Yanjing Hotel was rebuilt from the old Huajing guesthouse. This old brand means that the facilities are outdated. A group of bigwigs who are important in the Chinese medicine industry sat together in twos and threes, discussing what Mr Yang would come to them tonight.
When Lao Yang and Li Zheng arrived together, they were almost there.
"Lao Yang, Professor Li, you are here." The one who was talking was a slightly fat man, in his early forties, wearing a pair of black-rimmed glasses, and smiling very kindly. A person next to him also smiled and looked up to the two of them, it was Guo Kezhen.
"Lao Yang, Professor Li." Guo Keping said.
"I'm sorry to call you in such a hurry. However, if you are wronged, you have a debtor. If you delay your affairs, you should find him." Old Yang pointed at Li Zheng, "It is Professor Li who is looking for you. "Old Yang said with a smile.
On the face of Yang Laoming, Li Zheng was pushed out, but the intimacy of the words meant that everyone present could understand as long as they were not fools.
Everyone naturally laughed at the face, and didn't even delay.
After a few greetings, Li Zheng didn't waste time, waved his hand to let Zhang Chao send the information.
The HPV vaccine project was led by Li Zheng, and Liu Sichao and Zhang Chao assisted. Li Zheng called Zhang Chao to participate in this meeting.
Some people in the Drug Approval Committee have heard of this HPV vaccine project. After all, Li Zheng has talked to the drug control department more than once about clinical medicine, and the officials of the drug control department have naturally solicited the opinions of several experts.
However, these detailed information is the first time I have seen it.
They turned it over, and they started talking in twos and threes.
"The hepatitis B vaccine is clearly stated in the drug guide that it is to prevent acute hepatitis. In this way, if Professor Li's HPV vaccine is really successful, it is really worthy of the name if it is the first anti-cancer vaccine."
"Cancer, just like our ancient people looked at smallpox, and the smell changed. Even if it is clear that it is a vaccine, it is very difficult to carry out clinical work."
"But if it is really made out by Professor Li, Huaguo will be the first to be listed on the clinical market. This name may have a reputation in the world."
"Cancer is the enemy of mankind as a whole. If Chinese people can take the first step to defeat cancer, it will be of great significance."
"Who doesn't know, but we have to be practical, how to carry out clinical trials, and what if it fails? Although this HPV vaccine is not a biological vaccine, nor is it an attenuated vaccine, to test whether it is effective, volunteers must be asked Contact with the virus, HPV virus can also cause cancer, how can this work?"
Everyone talked a lot, and Li Zheng heard clearly beside him.
He coughed twice, and the sound reinforcement effect of the microphone made it clear to everyone present.
The meeting room gradually became quiet, and Li Zheng turned on the projector.
"This is the preparation data for the three-point project. The first is the data demonstration on the relationship between the HPV virus and cervical cancer that can be found in the international shared data; the second is the data from the Hong Kong Mary Hospital. During the three years from 1987 to 1990, Analysis of blood test reports of cancer patients; third, during the three-year project period, Li Zheng’s laboratory randomly selected 100 blood samples of cervical cancer patients of different ages, genders, and races."
"In the first data, data from papers that recognized the carcinogenicity of HPV show that 70%-90% of cervical cancer patients have HPV subtypes in their blood samples. The second data is more accurate, with 6,729 cervical cancer patients in Queen Mary Hospital in three years. HPV16 or HPV18 virus was found in 5621 patients’ blood samples. The third piece of information was made by our laboratory in three years. Of 100 cervical cancer patients, HPV subtype virus was found in 76 blood samples. ."
"Therefore, I personally have no doubts about the carcinogenicity of the HPV virus."
"Then the next step is the HPV vaccine. The principle of the HPV vaccine is to use a special protein antibody on cancer cells to trigger the body's immunity. Therefore, the HPV vaccine itself is a protein, not a virus. Simple injection of HPV vaccine It will not be infected with the virus."
When Li Zheng said this, he paused and looked around and saw that everyone was listening to them.
"In this clinical trial, the staff of Li Zheng's laboratory, including me, and the management of Zhenzhe Laboratory said that we are willing to be the first batch of clinical drug volunteers."
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