The film tells the story of an unexpected visit by an uninvited guest, which breaks the ordinary life of Shen You store owner Yong Cheng. He jumped from a male health care product vendor who couldn't afford the rent to the exclusive agent of Indian generic drug "Glenin". He has made huge profits and his life has undergone earth-shaking changes, so he was named the "drug god" by his patients. However, a tug-of-war about redemption is slowly unfolding in the undercurrent of waves ... In order to avoid spoilers, we have to quote a plot description on the Internet. In fact, this film has a prototype. Let's extend the content with the prototype experience.
In 2004, Lu Yong discovered an Indian-made generic drug, which was much cheaper and had almost the same effect as the original drug. Lu Yong directly contacted the Indian distribution company and began to buy anticancer drugs directly from India. Since then, he has recommended them to his patients through online QQ groups. With the spread among patients, the number of domestic leukemia patients who bought the anticancer drug from India Sino Company gradually increased, and the price of the drug gradually decreased until it was more than 200 yuan per box.
In order to facilitate patients to remit money, Lu Yong bought three bank debit cards with other people's identity information. 20 13 In late August, Lu Yong, who had already bought a credit card, was arrested by Yuanjiang Public Security Bureau of Hunan Province when investigating a gang selling bank cards online. On July 2, 20654381,Yuanjiang City Procuratorate prosecuted Lu Yong for the crime of obstructing credit card management and selling counterfeit drugs.
After Lu Yong was arrested, hundreds of leukemia patients signed a letter, asking the judicial organs to exempt him from criminal punishment.
2065438+On February 27th, 2005, Yuanjiang City Procuratorate of Hunan Province made a final decision on the cases of Lu Yong's "crime of obstructing credit card management" and "crime of selling counterfeit drugs", confirming that "all the help provided by Lu Yong to patients is free". Although Lu Yong "violated the financial management laws and regulations, but its purpose and use is entirely for leukemia patients to pay for self-medication and buy anticancer drugs, the circumstances are obviously minor and the harm is not great", so he decided not to sue Lu Yong.
This case has aroused great concern in society. From 2065438 to February 2007, Gleevec, the main drug of CML, was included in the national medical insurance. Since May this year 1, the state has achieved zero tariff on all anticancer drugs actually imported from China.
In an interview with the reporter of Beiqing Daily on July 5th, Lu Yong said that with the promotion of new policies such as medical insurance, fewer people came to seek their own way to buy generic drugs. Speaking of popular movies, he said that many of them were experienced by himself and patients, and he shed tears for these clips in the movie.
Lu Yong told the reporter of Beiqing Daily that he was really "not a drug god". "I am just an ordinary leukemia patient, a real person."
So far, this movie has really earned enough eyeballs and tears, especially the part where the old lady pulls the police sleeve and cries. But after feeling it, I come back and think about it. Why does the price department ignore the tens of thousands of bottles and hundreds of thousands of medicines a year? After all, they still have a way to limit house prices, but it really doesn't matter, because the cost of medicine is so high, some people will say, you talk nonsense, why can people sell hundreds of dollars in India? This is what you mean by wrongly ignoring the cost. The expenses mentioned here are not just pills. However, we also need to see that behind this specific drug are its research and development costs, approval costs, patent costs and so on. Let me introduce you to the process of severe CAR-T therapy passed by FDA in the United States last year (this is also an effective way to treat cancer and even cancer):
In the United States, a new drug must go through the most stringent procedures in the world:
It is necessary to submit an application to the FDA (US Food and Drug Administration) before starting the first, second and third phase clinical trials.
In the first stage, solve the toxicity and dosage problems, and write a report and send it to the audit after completion;
Only after passing the audit can we enter the second stage. At this time, we will recruit dozens to 200 people to do efficacy tests, write reports and send them to the audit.
If it can still pass, it will enter the third stage. In the third stage, hundreds to thousands of people are recruited to do larger-scale efficacy trials and write reports for audit;
If it still passes, the drug can be listed.
From the initial application to the final passage of phase III clinical trials, the approximate ratio is: 100 new drug applications, and there are about 2-3 new drug applications that can finally be marketed. It takes about 10 years and costs about $2 billion.
Most drugs die in the third stage of clinical practice.
Whether the Phase III clinical trial is effective, safe and available is decided by the expert review team I just mentioned. In CAR-T therapy, more than half of the 65,438+00 experts can go public by voting.
Generally speaking, there are few all tickets, but CAR-T actually got the result of 10-0. With the unanimous consent of the expert group, the remaining administrative examination and approval work is to go through the process and approve the listing. This process took about a month and a half.
But why India can replicate Glennen almost perfectly, and the research and development of modern drugs is like this:
It is necessary to indicate what the active ingredient is, and not only the chemical molecular formula but also the chemical structure should be clearly written in words. You can look at the instructions, which are marked with various patterns, that is, its chemical structure. Because the same component can have different structures, different structures will have completely different functions.
Take a simple example, such as graphite for pencils, but diamonds are expensive. Their ingredients are the same. So this is the same chemical formula, but the structure and function are completely different.
In fact, when pharmaceutical companies label the chemical molecular formula and chemical structure of active ingredients, this drug has no secrets for any enterprise. The reason why these molecular structures can be effective for a certain disease is that they have been developed for more than 10 years and finally proved to be effective in a large number of experiments.
The regulations require labeling, and other manufacturers will know how to do it as soon as they see it. Why not directly synthesize this molecule?
Therefore, in order to prevent this unfairness, drugs have a patent protection period of 20 years, during which other manufacturers are not allowed to manufacture even if they know how to synthesize this small molecule. Only after the patent protection period expires can everyone produce. At this time, it has been sold for more than ten or twenty years, and the profit earned and the recovered R&D cost have also been recovered. Today, it usually takes 20 years of research and development time and 2 billion dollars of research funds from the publication of the most important paper of a new drug to the listing of a new drug. The first half of the time is basically animal experiments, and patents may be applied in the middle, most of which are applied before the start of clinical trials.
Therefore, when a new drug really comes on the market, it will only have a patent period of seven years on average. Pharmaceutical companies must earn back $2 billion in seven years, otherwise they can't continue to invest in the research of new drugs, which is also the reason why new drugs are expensive.
In other words, such a high price is only available during the patent protection period to ensure that R&D manufacturers can successfully recover huge investment and realize corresponding profits. After the protection period, everyone can produce it, and then the price of tablets will drop to the price of generic drugs. Then someone will definitely jump out to "uphold justice." During this protection period, how many patients will die because they can't afford medicine? This is putting the cart before the horse. On the other hand, think about it. Without this patent protection mechanism, how could a pharmaceutical company spend so much money on research and development, and how many patients would die prematurely without Glenin's successful research and development? Furthermore, without the cost recovered and the profit earned by Granin's sales, how can these pharmaceutical companies invest a lot of money to develop another 20-year patent and develop better drugs to save more people?
In fact, there is a mechanism in the United States that special patients can negotiate directly with pharmaceutical companies. I don't think we have such a mechanism so far. If you really can't afford it, you can go to a pharmaceutical factory. It's not very heartless. For special patients who can't afford it, there are actually special channels to apply for discounted genuine drugs. For example, Lipitor, a specific drug used by Pfizer to lower cholesterol, costs about $3,600 a year in the United States. If you really can't afford it and don't have health insurance, you can apply for a special price from Pfizer, which is $720 a year.
However, these pharmaceutical companies have a principle-if you have difficulties, I can help you solve them, but you must not use piracy. This explains why the representative of the film Chinese medicine company hates pirated drugs so much, but maybe this person doesn't know that there is such a mechanism in the United States, he just knows: you can't use pirated drugs. But I don't know that in order to prevent piracy, pharmaceutical companies still have their own means of appeasement.