New drug data involved in fraud, the regulatory link failed, and the corruption case of pharmaceutical companies uncovered layers of shady scenes.

After completing the resignation formalities, Li Li walked out of the medicine building, and while waiting for the bus on the roadside, she was suddenly hit by a car … Because of this accident, Li Li was seriously injured, became a vegetable, and lay in the hospital for three years.

Three years later, she woke up unexpectedly, but she forgot her identity and even her name.

After leaving the hospital, Liu Cong, the first person Zhu Li woke up to know, became the only person she could rely on.

Occasionally, Zhu Li found herself unusually familiar with drugs. When she saw a bottle of medicine, she could accurately tell the ingredients of this medicine. Therefore, she speculated that she was probably engaged in pharmaceutical-related work before. With the medical knowledge in her memory, Zhu Li successfully entered Fangchen Pharmaceutical, the largest local pharmaceutical company, and her life seemed to start again.

At that time, Fangchen Pharmaceutical had the same scenery and was ready to go public with its climbing performance.

During the process of raising new drug approval materials, Zhu Li went to the hospital to verify the signature of the experimental doctor, but was surprised to learn that the company had forged drug experimental data. It was also on this day that Zhu Li met Xiao Yun’s parents in the hospital.

Xiao Yun, a ten-year-old girl, became a vegetable after the operation. According to the doctor, Xiao Yun’s coma was suspected to be related to the use of narcotic drugs, which was produced by Fangchen Pharmaceutical. Zhu Li thought that she was in a coma for three years because of surgery. She found her own medical record and found that the anesthetic she used at the beginning was because of methamphetamine.

Zhu Li decided to pursue the truth.

During the chat with colleagues, Zhu Li learned that the company had destroyed all the amphetamine and the files about this drug were sealed. She found the application materials at that time, but found that there was no file record in the column of production experiment. That is to say, because of phenanthrene, it is very likely that it has rushed into the market without clinical trials at all. But without clinical trials, how can it pass the examination and approval?

With the deepening of the investigation, Zhu Li found the intermediary company that had originally declared the life of Infineon. As long as it is proved that the intermediary is cheating in the declaration, it can be proved that there is a problem with methamphetamine.

The closer she got, the more familiar she felt, and the truth was slowly emerging. It turns out that her name is Lin Li instead of Zhu Li. This medical agency is where she used to work. Before becoming a vegetable, she was also one of the participants in counterfeit drugs, and the agent who signed on the intermediary company was herself.

Perhaps, somehow, it was God’s will, and Zhu Li happened to be planted on the medicine she had represented.

In order to calm this matter down, Fangchen Pharmaceutical took money as a temptation and threatened Zhu Li not to tell anything. Under the torture of conscience, she finally chose to surrender, and all the leaders of Fangchen Pharmaceutical and the participants in the counterfeit drug incident were arrested by the police.

From car accident, amnesia, tracing to prosecution, Zhu Li completed a self-salvation and got the punishment she deserved.

This seemingly perfect ending did not happen in reality, but the ending of the movie "I am a vegetable".

　

The film was released on October 15th, 2010, which happened to be in the chaotic period of China’s drug administration system reform. Tens of thousands of backlogged drug applications and the list of pharmaceutical companies waiting for approval for many years all pointed to a loophole in the industry at that time-drug approval.

In 1984, the National People’s Congress passed the Drug Administration Law, which clearly stipulated the market access system and administrative punishment measures for drugs. At the same time, drugs will be subject to two standards: national standards and local standards.

In the next 10 years, the management of the drug market is still chaotic, and it is urgent for someone to take charge of drug supervision. It was in this year that Zheng Xiaoyu entered Beijing as the director of the State Administration of Medicine, and was elected as the first director of the Food and Drug Administration four years later.

By December 1st, 2001, Article 29 of the Drug Administration Law, which was deliberated and passed by the National People’s Congress Standing Committee (NPCSC), clearly stipulated that clinical trials can be conducted only after the approval of the drug supervision and administration department of the State Council. This means that local standards can only continue to circulate after being reviewed and upgraded to national standards, otherwise they must be eliminated.

Therefore, the promotion of "landmark" to "national standard" became a major purge of the survival of the fittest in the pharmaceutical industry at that time, and it was also a game for pharmaceutical companies to enter the market and grab profits. Originally, we could use this opportunity to implement a thorough regulatory reform, but Zheng Xiaoyu, together with the drug supervision system, made a drastic rectification of drug production and circulation enterprises on the surface, secretly took bribes crazily, and passed a large number of drug approvals in a short time, making "supervision" a dead letter.

The so-called new drug approval is just a change of "skin", such as changing capsules into tablets, adding additional ingredients, and then spending tens of thousands of yuan to collect registration materials. After sending fake samples for review, you can enter the approval process for similar new drugs and register them as new drugs.

Such a simple and rude procedure has undoubtedly become a shortcut to the registration of new drugs, and it has also become the source of the falsification of experimental data of new drugs at that time.

In 2004 alone, the Food and Drug Administration accepted 10,009 applications for "new drugs". According to 250 working days per year, on average, 40 new drugs were approved every day, while the US Food and Drug Administration only accepted 148 in the same period. In such a rapid audit, fraud seems to have become an ordinary means.

One of the lines poked at the reality of drug supervision: "They are related, so they should be approved first and then supplemented …"

The crazy surge in approvals also gave birth to another freak-an intermediary company that appeared as a medical consulting company. As long as things related to drug production and operation, whether legal or illegal, can be handled by intermediary companies. And there are such magical intermediary companies, each of which is actually inextricably linked with the Food and Drug Administration, and the flow of each sum of money is self-evident.

Rome was not built in a day. In the seven years since he was in charge of National Medical Products Administration, it was Zheng Xiaoyu’s proud stroke that "landmark" rose to "national standard", and these "rent-seeking achievements" finally sent him to his grave. On May 29th, 2007, Zheng Xiaoyu was executed for accepting bribes and dereliction of duty.

Zhu Li, on the other hand, "came back from the dead" and made the right choice between conscience and interests.

Through a story of the cycle of injury and being injured, the film reveals the benefit loopholes and chaotic examination and approval phenomenon of China pharmaceutical industry in using the drug supervision system.

However, in real life, many people have given up the opportunity to re-choose their conscience for self-interest and become "vegetative" at the mercy of others.

Through a seemingly incredible coincidence, the film finally exposed the shady situation of China’s medical system like peeling onions, and deeply tortured the society’s indulgence in power and money trading.

Don’t think about the past and the present, don’t look forward and backward. The voice of the people and the torrent of reform have already waited for no time. With the passage of time, the pros and cons of the reform of the medical and health system will eventually become clear. The problem is that the cost of time is too great.

Reference article:

[1] China. com: Crazy at the End: Zheng Xiaoyu and his drug dealers.

[2] Netease News: "The Legacy of the Greedy Zheng Xiaoyu"

Source: Si Qi Club.

Author: Janessa

Typesetting: Joyce

Editor: Adam