Wang Ju PAIAN | Are there few adverse reactions to traditional Chinese medicine? What does “not yet clear” mean? | Text version

1. The contrast in drug instructions: Western medicine “terrified” versus traditional Chinese medicine “not yet clear”

Today I’m going to talk about a topic related to traditional Chinese medicine. If you take medicine in China, you might have this kind of contrast: when you take this chemical medicine, you look at the adverse reaction column, and you often get scared. Why? Generally, the adverse reactions of chemical drugs will list many items, some listing a dozen or twenty items, such as liver damage, skin allergies, or palpitations, insomnia, headaches, etc. So after reading it, many people feel whether they can take this medicine, and they feel hesitant.

But if you look at traditional Chinese medicine, some of the adverse reactions of traditional Chinese medicine are simply not written, and some write “not yet clear”. What does “not yet clear” mean? “Not yet clear” means I don’t know. The contraindications are just a note that pregnant women should not take it. Therefore, the Chinese people generally believe that traditional Chinese medicine has fewer adverse reactions and fewer toxic side effects, while Western medicine has greater toxic side effects. Why? You see, Western medicine lists a dozen or twenty adverse reactions, while traditional Chinese medicine just says “not yet clear”. What does “not yet clear” mean? “Not yet clear” means I don’t know. Why don’t they know? They don’t know because their toxic side effects are relatively small, and their medicine is safe to take. If the toxic side effects are relatively large, then, for example, if you take Longdan Xiegan Wan or Yunnan Baiyao, you will immediately faint, and you will immediately faint and go into shock, then the toxic side effects will be relatively large. It’s okay to take it, and you can walk normally, then it means that their toxic side effects are relatively small.

So you see, the Chinese people’s concept is shaped by these drug instructions. But is traditional Chinese medicine in China really less toxic and has fewer adverse reactions? Definitely not. In fact, “not yet clear”, on the one hand, means I don’t know, and on the other hand, it means that even if I know, I won’t tell you, I really won’t tell you.

2. Deadline of July 1, 2024: Farewell to the historical background of “not yet clear”

But recently, as everyone knows, the domestic media reported that by July 1st of this year, all traditional Chinese medicine in China will no longer be able to write “not yet clear” in the adverse reaction column. If you write “not yet clear” again, it will be taken off the shelves.

Why? Because in 2023, the National Medical Products Administration issued a regulation that when re-registering the already-marketed traditional Chinese medicine, it made requirements for your adverse reaction column. It says that if you write “not yet clear” again, you will not be able to re-register. If you can’t register, your drug can’t be sold anymore, and it has to be taken off the shelves. There is a three-year transition period, and this three-year transition period will end on July 1st of this year. Therefore, many people say “the big exam”, there are more than 9,000 kinds of traditional Chinese medicine in China, if you can’t meet this standard, you can’t be listed anymore. Look, it’s managed together with Western medicine and chemical drugs, with unified standards, so everyone cheers that this is a progressive decision.

Is that really the case? Or what is the background of the introduction of such a regulation? And what is its effect? Today we will talk about the story behind this news.

3. The logic of scientific supervision: Why can Western medicine clearly write adverse reactions?

First, let’s talk about why Western medicine can clearly write adverse reactions. That’s because we said that chemical drugs need to go through four phases of clinical trials when they are launched. Before the four phases of clinical trials, there are also pre-clinical studies. The so-called pre-clinical studies generally also include two stages: the first is the in vitro experiment stage, you think the drug itself is effective, first do in vitro experiments; after the in vitro experiments are done, do animal experiments, first do rat experiments, after the rat experiments are done, then do monkey experiments, and verify on monkeys whether the drug itself is effective.

After this is done, human experiments begin. There are a total of four phases of human experiments. The first phase is generally called the safety experiment, the so-called safety experiment is to verify whether the drug itself is safe, and what adverse reactions it has. When doing this experiment, a double-blind method should also be adopted. That is to say, some people take a placebo, and some people take this drug, and some even compare it with other drugs that are already used to treat this disease, and a control group can be used. Do this experiment to take this medicine, and then count what adverse reactions are in different groups, and measure these adverse reactions in detail.

Why do we need to measure the adverse reactions of this drug? The reason is actually very simple. When humans treat diseases, they must consider a benefit-cost ratio, that is, what disease you treat, and what price you are willing to pay. Adverse reactions are different. For example, we have chemotherapy when treating cancer, and everyone knows that chemotherapy has a very important adverse reaction, which is that the hair will fall out. That price is quite high, especially for girls, think about it, when you have chemotherapy, your hair will fall out all at once, which is very ugly. But we are willing to pay this price to treat cancer, because if you don’t treat cancer, it threatens human life, so for drugs that treat cancer, even if our hair falls out, this cost or this price is worth it. But if you treat a cold, and you lose your hair, it’s not worth it. Right? Because there are many other safe drugs to treat a cold, and on the other hand, a cold does not endanger human life, even if you don’t use drugs to treat it, you can lie at home for a few days, and in most cases, it will be fine, a self-limiting disease.

So for different drugs, the price we are willing to pay is different. So how do we measure the relationship between this price and the benefits? You must first figure out what adverse reactions your drug has. So the first phase of clinical trials is to measure what adverse reactions this drug has, and then the second and third phases are efficacy experiments. After the efficacy experiments are passed, the drug is launched. Generally, there is also a fourth phase after the launch, which is actually mainly to collect the adverse reactions after the drug is launched. Because in your first phase of clinical trials, you may not be able to measure all the adverse reactions of a drug, because some adverse reactions of the drug need enough time to react. You may be fine for a month, and you may be fine for two months, because some long-term drugs, like drugs to treat high blood pressure, you need to take them for life, and you may have significant adverse reactions after five years. So after the drug is launched, you still need to continue to monitor its adverse reactions, and if there are serious adverse reactions, after tracing back, some need to remind everyone to pay attention, and some may be directly taken off the shelves. Like the famous “thalidomide” incident, it was actually after the drug was launched that people found that this drug could cause birth defects in pregnant babies. So what can you see? For current chemical drugs, during the launch process, it has a complete set of testing, experiments, and statistical retrospective systems for adverse reactions. Because of this, the adverse reaction column of current chemical drugs can be written so detailed.

4. The historical baggage of traditional Chinese medicine: The crazy approval of Zheng Xiaoyu’s era

Then, in contrast, let’s talk about why traditional Chinese medicine writes “not yet clear”.

First of all, our country’s traditional Chinese medicine is profound, with Hua Tuo and Li Shizhen in the early days, who treated many diseases for the Chinese people. Right? Scraping the bone to cure poison, and many royal secrets were treated with traditional Chinese medicine. Of course, we don’t know if it can be cured. But in the past, we have indeed left behind so much traditional Chinese medicine in China, which has been used in the folk for a long time. So when our country’s drug regulatory system was re-established, what should we do with those traditional Chinese medicines that have been used for a long time?

So before 1998, in fact, these traditional Chinese medicines in our country did not undergo any double-blind experiments when they were launched. It’s similar to chemical drugs, and at that time, it was believed that you have used these medicines for thousands of years, and nothing has happened. Right? So there is no need to conduct double-blind experiments. And traditional Chinese medicine has a set of theories, and traditional Chinese medicine often says: you can’t use the standards of Western medicine to require traditional Chinese medicine. Why? Traditional Chinese medicine is based on syndrome differentiation and medication, and one person has one prescription. If you do this double-blind statistics, then you have to use the same standard for everyone, and you do statistics in the population, which is not right, which does not conform to the principles of traditional Chinese medicine, and these are two independent systems. So we can only require traditional Chinese medicine according to the standards of traditional Chinese medicine, and you Western medicine can require it according to the standards of Western medicine. So before 1998, there were thousands of traditional Chinese medicines in China that were launched, but none of them had done clinical trials.

Later, as everyone knows, Zheng Xiaoyu became the director of the State Drug Administration, and he “upgraded local standards to national standards”. When upgrading local standards to national standards, this was actually an opportunity to improve drug standards in China. But this person, Zheng Xiaoyu, not only did not seize the opportunity, but as long as the local areas gave him money, and which pharmaceutical factory gave him money, he would issue a batch number. What did this lead to? This led to the number of traditional Chinese medicine varieties in China, according to the batch numbers issued by the national pharmacopoeia? There are a total of more than 59,000. There are more than 9,000 proprietary Chinese medicines, and there are more than 2,800 enterprises that produce traditional Chinese medicine. This is as of 2018, and there were even more before. Then these drugs did not undergo double-blind experiments when upgrading local standards to national standards. Then I don’t know, so what should I write? I have to write “not yet clear”.

5. Two sets of regulatory systems: The “privileges” and historical hidden dangers of traditional Chinese medicine

Then, around 2000, our country required that all chemical drugs must clearly write their adverse reactions. But what should we do when we encounter proprietary Chinese medicines if we want to clearly write these adverse reactions? In 2006, the State Drug Administration specifically issued a document stating that for traditional Chinese medicine and natural drugs, when it involves their toxicology, adverse reactions, or contraindications, you can not write it, you can not know it, and you can launch it.

Why? There are two possibilities for the people in the national regulatory department: one possibility is that they think that traditional Chinese medicine may indeed have fewer toxic side effects; another possibility is that they have been bribed by the traditional Chinese medicine enterprises, and then they issued such a regulation. This regulation was officially legalized in 2008, which gave traditional Chinese medicine a privilege: traditional Chinese medicine does not need to do clinical double-blind experiments, and you do not need to clearly write it in the toxic side effects and adverse reactions column.

Then, the drug regulation in China has formed two independent systems. One independent system is the current chemical drugs, which strictly follow Western standards and worldwide standards, and the launch of these drugs, including the statistics of adverse reactions, are all carried out according to this standard. But traditional Chinese medicine is an independent system, and this independent system means that in the adverse reaction section, it writes “not yet clear”, and even when this traditional Chinese medicine is launched, it does not require any double-blind experiments.

6. “White mouse”-style verification: Why is toxicity always late?

Then the next question comes, you say that traditional Chinese medicine is not yet clear, does it have toxic side effects? Of course it does. We have done many programs in the past, the Longdan Xiegan Wan incident, right. That caused 100,000 people to have kidney problems, all over the world, and it was not discovered by the Chinese.

Then, regarding the toxic side effects of traditional Chinese medicine, in China, it is not completed through pre-clinical experiments of drugs, but through people taking a large amount of traditional Chinese medicine, and slowly discovering the problems. Because China has also established a drug adverse reaction center later. This drug adverse reaction monitoring center requires you to report after adverse reactions to drugs occur in each place, and then the state will count. If there are too many adverse reactions for a certain drug, then it may be the problem of this drug.

Then, after 2000 in China, a large number of drug adverse reactions were related to traditional Chinese medicine. I remember we talked about it in the past, for example, the Houttuynia cordata injection in traditional Chinese medicine injections. This Houttuynia cordata is in the Yunnan, Guizhou, and Sichuan areas of China, and many people like to eat that Zheergen. This Zheergen, the folk believe that it can treat colds. Later, to promote the traditional medicine of the motherland, this Zheergen was developed into a traditional Chinese medicine injection, called Houttuynia cordata injection. Of course, it was not called Zheergen injection. This Zheergen feels like food, not like medicine, so it is called Houttuynia cordata injection. I also had it when I was a child.

But this Houttuynia cordata injection, the serious adverse reaction during the injection is mainly shock. In fact, the adverse reactions of a large number of traditional Chinese medicine injections are shock. You see, what Xiyanping injection, various Danhong injections, most of their adverse reactions are shock. Why shock? Because it is difficult to purify traditional Chinese medicine injections, and there are many macromolecules, and these macromolecules are directly injected into your body, you think of it as injecting Zheergen into your blood. You usually eat Zheergen, right? You have to go through the stomach to digest it. Now you don’t need to digest it, and you inject it directly into your blood. This is equivalent to injecting dumplings directly into your blood. The principle is roughly the same. So it leads to a large number of children’s allergies, and the result of the allergy is what? There were a considerable number of deaths. So this matter, at first, when it was reported to the National Adverse Reaction Center, they didn’t pay attention, and as a result, this case was delayed for five or six years, and many children died all over the country, and finally a warning notice was issued. This is the Zheergen incident. The Zheergen incident, because it is an injection, its adverse reactions are still relatively timely, after the injection, the child may convulse, and then it will not work, and then rescue, because of the allergy.

But a large number of traditional Chinese medicines, in fact, their adverse reactions are not so clear and timely, so it is actually quite difficult to find them. A more typical one here is the hepatotoxicity of Polygonum multiflorum. Everyone knows that Polygonum multiflorum is also a very famous traditional Chinese medicine, and the Chinese people see this Polygonum multiflorum and think it looks like a human figure, black and ugly. Everyone thinks that this Polygonum multiflorum is not simple, it grows like a person underground, so it must be very magical. Among them, the black and ugly, the main theory of traditional Chinese medicine is basically “what is lacking is supplemented”. He sees this black and ugly, and he thinks it can treat hair loss and gray hair. For example, traditional Chinese medicine believes that eating black sesame paste can turn gray hair black, but now it seems very ridiculous. You may be able to turn your hair black by eating coal. Right? It’s not that your hair will turn black if you eat black, there is a whole set of growth mechanisms. But traditional Chinese medicine thinks so, and believes that Polygonum multiflorum can treat hair loss and gray hair, so many people in the folk use Polygonum multiflorum to stew chicken soup. And there are also a lot of Polygonum multiflorum drugs in our traditional Chinese medicine, which are mainly used to treat hair loss and gray hair. But around 2004, many liver disease hospitals received a large number of patients. These patients all had a common feature: they all took drugs containing Polygonum multiflorum, and on average, they developed obvious liver disease after taking it for nine weeks. Upon investigation, they all took Polygonum multiflorum. Many hospitals responded, saying that is Polygonum multiflorum hepatotoxic? So some hospitals did some retrospective analysis and found that the correlation was particularly strong. So they reported this information to the Adverse Reaction Center of the State Drug Administration. Later, it seemed that it was not until 2013 that the state officially issued a warning notice, saying that Polygonum multiflorum should not be eaten randomly, it is really hepatotoxic. Later, I read some academic papers in medicine and basically figured out which substance in Polygonum multiflorum caused this hepatotoxicity.

What does this case want to illustrate? A large number of traditional Chinese medicines, in fact, their toxicity is not immediate, but chronic and accumulative. Then this kind of accumulative toxic side effects or this kind of adverse reactions, it is difficult to find through the individual experience perception of ordinary people. And this can only be found through what? It is only found by accumulating a large number of adverse reaction monitoring cases. What I want to talk about here is that the drug of Polygonum multiflorum at that time caused not only hepatotoxicity, but also many death cases. What is the difference between this situation and that of Western medicine, that is, chemical drugs, before clinical trials and before being launched? The difference is: traditional Chinese medicine actually treats the whole people of the country, every person who takes traditional Chinese medicine, as a laboratory white mouse. Because I don’t know whether the drug itself is toxic, that is “not yet clear”. “Not yet clear” lets you eat it? If you eat it and die, I’m sorry, I will report this information to the relevant departments of the state. If enough people die, then the relevant departments of the state will issue an announcement. This announcement will say: oh, everyone should be careful when taking these drugs, and the dosage should be lower.

In the past one or two decades, the National Medical Products Administration has summarized a total of twenty-eight kinds of obviously toxic traditional Chinese medicines, and also issued warnings. What are these? Let me read them to you. For example, they are called: Aconite, Realgar, Arsenic, Mercury, Chuanxiong, Caowu, Pinellia. These twenty-eight kinds in total. These traditional Chinese medicines now have very clear evidence to prove that they are toxic, and the toxicity is quite high.

7. The secret behind the instructions: The enterprise knows, but doesn’t tell you

Then the problem comes next. So what do these highly toxic drugs write in their drug instructions now? I read a paper, and he made statistics on the traditional Chinese medicines warned by the China Adverse Reaction Center of Drugs more than ten years ago, and there were 410 kinds in total. Among these 410 kinds, three are traditional Chinese medicines from abroad (there are also traditional Chinese medicines abroad, and this traditional Chinese medicine is not called traditional Chinese medicine, but natural drugs), and there are 407 kinds in China. Among these 410 kinds of drugs, 302 kinds are written as “not yet clear”. You think so many adverse reactions have been reported, but in fact, 302 kinds are written as not yet clear, and this proportion is quite high. I read another paper that says: among the traditional Chinese medicines in China, the adverse reactions that are written as not yet clear account for about 90% to 95% on average.

Then this paper will say: among these 410 kinds of drugs, there are 20 kinds that clearly contain the 28 kinds of toxic traditional Chinese medicine materials that I just mentioned. The 20 kinds of traditional Chinese medicines clearly have the arsenic, mercury, Chuanxiong, and Aconite that I just mentioned in the drug material list. Then, among these 20 kinds of traditional Chinese medicines, the adverse reactions on their instructions, 13 kinds are still written as “not yet clear”. These 13 kinds of “not yet clear” include many famous drugs.

• For example, Liuwei Dihuang Wan, from Tongrentang. Tongrentang’s Liuwei Dihuang Wan contains Realgar. Realgar is now known to be toxic, and its chemical component seems to be arsenic trioxide.
• Also, for example, Huo Xiang Zheng Qi Shui. Many people have said that Huo Xiang Zheng Qi Shui can treat colds and fevers and also treat internal heat. Chinese people drink a cup when they are fine. Contains alcohol, contains alcohol. After you drink it, the police can test you for drunk driving. But the most important thing is that Huo Xiang Zheng Qi Shui contains a drug called Pinellia. This Pinellia drug is also clearly one of the 28 kinds of toxic traditional Chinese medicine materials clearly warned by the State Drug Administration. But the adverse reactions of Huo Xiang Zheng Qi Shui are also written as I don’t know, I don’t know, not yet clear.
• And for example, Yunnan Baiyao Paste. Yunnan Baiyao Paste contains a drug called Xue Shang Yi Zhi Hao. This drug also clearly contains toxic substances.
• And for example, Angong Niuhuang Wan. It also contains Realgar.

These drugs all clearly contain toxic medicinal materials, but their adverse reactions are all written as “not yet clear”. What does this mean? This means that the enterprise may already know that its drug is toxic, and its adverse reactions are also very serious, but it doesn’t tell you.

I’ll give you some data here: according to data from the China Adverse Reaction Monitoring Center, 99% of the adverse reactions of drugs in China come from doctors’ uploads, and only 1% come from the enterprises’ own reports. Doesn’t this proportion seem to be inconsistent with common sense? In theory, you, the enterprise, should know more about the drugs you manufacture, right? But the enterprise itself will not report it. Why? It is afraid that it will be unfavorable to itself after reporting. Some people say that doctors themselves may be more likely to find it in the process of using the drug. In fact, I tell you, doctors actually don’t have much incentive to report to the adverse reaction center. Why? Because once he reports it, it is often related to medical accidents. You say that you gave someone this medicine, and as a result, the person died, or was paralyzed, or had problems, and the person wants to find your hospital, right? So doctors are also unwilling to report. In the case that doctors are unwilling to report, you think that 99% comes from the hospital’s report, and only 1% comes from the pharmaceutical company.

Does the pharmaceutical company know and not report it? There are many. I read a paper that tells a story: it says that there is a kind of capsule for treating arthritis in China, which was launched in 2007. In 2007, it clearly contained a toxic drug. As a result, this drug was advertised on the Internet every day, and it sold very well after the advertising. When this drug was re-registered in 2012, it was still written as “not yet clear”. Then, in 2015, the State Drug Administration put pressure on it, saying that you must change it, and then it changed. The author of this paper did not dare to write the name of this drug. I looked it up, and the name of this drug is Cao Qinghua Capsule. Cao Qinghua Capsule claims to treat arthritis, and its drug contains Aconite. Aconite is highly toxic. Then he advertised every day, and it sold for a high price, and a box of medicine sold for seven or eight hundred yuan of traditional Chinese medicine. Of course, I estimate that it is mainly kickbacks. Then, after this drug was launched, the Adverse Reaction Center of the State Drug Administration monitored a large number of adverse reactions related to this drug, such as palpitations, high blood pressure, fever, abdominal pain, etc. As a result, when this drug was registered in 2012, it was still written as not yet clear. Later, in 2015, the State Drug Administration ordered it to be modified, and it finally changed it back. What does that mean? That means that the enterprise clearly knew that its drug had adverse reactions, and it was also unwilling to tell consumers. In fact, it is because it is worried that if it writes a long list of adverse reactions, people will not buy it. This is a very important background for the “not yet clear” adverse reactions of traditional Chinese medicine in China today.

8. Can the new regulations break the deadlock? The difference between mainstream drug varieties and “zombie drugs”

Then, in view of this situation, we will analyze it next: can this new document really play this role, so that the traditional Chinese medicine in China and the chemical drugs in China can completely achieve the same standard in the adverse reaction part?

In my opinion, it is very difficult. Why is it so difficult? In fact, this standard this time, to be frank, it is not aimed at the mainstream varieties that are already on the market. If you look at the State Drug Administration of China, from 2010 to 2022, in about 12 years, it has already made a large number of mainstream traditional Chinese medicine varieties modify their instructions. For example:

• Yunnan Baiyao: We have all talked about it, and its adverse reactions have now been changed.
• Pian Zai Huang: Pian Zai Huang is also one of the eight confidential formulas in our country. This Pian Zai Huang is also very famous and is known as the “Maotai of medicine”. In the past two years, during the epidemic in China, many people said that Pian Zai Huang could prevent the epidemic, so the price soared, and a box rose by 1,600 yuan, but now it has fallen, to four or five hundred yuan. You can take a look at Pian Zai Huang, and what is written on its instructions is not yet clear. But later, in 2021, the State Drug Administration asked Pian Zai Huang to quickly change it, and it had to be changed. Later, Pian Zai Huang changed its adverse reactions.
• Also, for example, Liuwei Dihuang Wan, which is also a large variety, has now been changed, and it was all not yet clear in the past.

So how many of these mainstream varieties have been changed now? More than a hundred have been changed. Then what about the rest? Didn’t I just say that there are 9,000 kinds of traditional Chinese medicine in China? In fact, not many are circulating on the market. So this reform is mainly aimed at those “zombie drugs” that have not been launched for a long time. Because for those pharmaceutical companies in China, they are desperately taking batch numbers for some drugs. I don’t produce it now, but I also take the batch number, so many traditional Chinese medicine companies are holding a large number of drug batch numbers, but these drugs themselves may not be circulating on the market. So this regulation may mainly target these zombie drugs. For the drugs of mainstream varieties, almost most of them have passed.

9. The huge gap in procedures: Traditional Chinese medicine still does not need double-blind experiments

In addition, you can take a look at the specific regulations. This regulation says: if these traditional Chinese medicine enterprises want to modify this adverse reaction column, the requirements for the procedure and the whole process are tens of thousands of miles away from our chemical drugs to modify the adverse reaction column.

If you want to modify the adverse reaction column of a chemical drug, you must redo the double-blind experiment. For example, the State Drug Administration supervises that your drug may have serious adverse reactions, and may take it off the shelves, and recall it. After that, if your drug is re-launched, you must redo the clinical safety experiment. After you have completed the clinical safety experiment, submit the report, and then you may be able to re-approve it. This is for chemical drugs.

But for traditional Chinese medicine, we can take a look. How does the already-marketed traditional Chinese medicine re-apply for the adverse reaction column? He says no need, no need to redo the double-blind experiment. He says there are several sources:

1. Data from the national database: Doesn’t the state have an adverse reaction monitoring center? It tells you what adverse reactions your drug has, and you write it down. Right.
2. Literature data: Literature means that the already-marketed drug, others may have done some research and said that your drug may have some adverse reactions.

For example, Pian Zai Huang. I see that some hospitals also do adverse reaction analysis of Pian Zai Huang. I see that its adverse reactions include abdominal pain (that is, after taking Pian Zai Huang, because it contains borneol, right?). There are also more exaggerated ones, saying that men can cause genital cracking after taking it, and the more serious one is causing eczema. So I tell you that you can’t take Pian Zai Huang randomly. You think about it, many male friends, if you take Pian Zai Huang, the effect is also quite terrible.

Then these literatures, if people have already listed them, then you can write it when you write the adverse reactions of Pian Zai Huang. You can say that this adverse reaction may cause male genital cracking and eczema. This is possible. This is you using the published literature, and then on this basis, you can also do your own data. Just do your own data, encourage you to do double-blind experiments, but it doesn’t matter if you don’t do it. And on this basis, you rewrite this report, and then hold an expert review. After the expert review, then you can be listed. You can take a look, this standard is much lower than the standard of chemical drugs, right? Chemical drugs only require you to redo clinical experiments, and redo double-blind experiments. But now this traditional Chinese medicine does not need to do double-blind experiments at all, and it still basically belongs to the scope of perceptual cognition. Are you still treating the whole people as white mice? So you know, this is actually far from the unified standard.

10. Missing safety experiments and drug interactions

I’ll give you another piece of information here: when doing this clinical safety experiment, in fact, you not only need to look at the adverse reactions of the drug itself. It also has a very important function, which is the possible reactions of different drugs interacting with each other. Because people now have diseases and take several different drugs. Is it safe to take these different drugs together? Will it produce new effects? These are all things that must be verified during the clinical experiments and safety experiments of drugs.

But our current so-called safety experiments of traditional Chinese medicine do not exist. You have no way to test what results will be caused by taking this drug with other drugs, and you can’t even talk about the effects and reactions between drugs. So you see how terrible this so-called adverse reaction of traditional Chinese medicine is under the regulatory system and institutional system in China.

After saying this, in fact, we can go one step further. Because China has its own special traditional Chinese medicine administration, although it theoretically belongs to the State Drug Administration, but because it is a self-contained system (because Xi Jinping himself believes in traditional Chinese medicine very much, and traditional Chinese medicine is the traditional treasure of the Chinese nation), this traditional treasure, ordinary people are not very dare to touch it. But this process has led to the fact that the regulatory system of traditional Chinese medicine is completely not included in the entire regulatory system of modern drugs. We just talked about this safety experiment or this adverse reaction, which is only a pre-requisite procedure before a drug is launched. We can’t do it at all on traditional Chinese medicine.

I have already said that the consequence is to make the whole people of the country guinea pigs, white mice, and monkeys, and then you personally measure whether you will die after taking it with your own body.

11. Conclusion: The efficacy should also be written as “not yet clear”

Of course, in fact, there are even more serious things. Does the medicine itself work? What do we rely on to verify it? For chemical drugs, it is through the second and third phases of clinical trials to verify its effectiveness. Traditional Chinese medicine still doesn’t have it, and it doesn’t have this step.

So we have now launched more than 9,000 traditional Chinese medicines, will it be effective after taking it? Can it cure diseases? We don’t know either. So in the “main function” part of the drug, I suggest that our traditional Chinese medicines should all write “not yet clear”. Because you haven’t done the experiment, how can you prove that you can cure this disease? You say that your toxic side effects are I don’t know, you should actually write “not yet clear” in the efficacy section. If you write “not yet clear” and I don’t know in the efficacy section, do you think anyone will buy it? No one will buy it, right? Then why didn’t he do clinical trials, and as a result, what is written in the efficacy section is to treat this, treat that, treat this, treat that, but when it comes to the toxic side effects, he says I don’t know?

So from the perspective of our future regulatory development, only by completely including our traditional Chinese medicine into the regulatory system of modern medicine: after you have completed your safety experiments, write out your toxic side effects; your efficacy is evaluated consistently through clinical trials, and you make a consistent evaluation with other drugs, and you can make a consistent evaluation, then you write out what diseases your drug can cure. If you can’t write it out, then you have to write “not yet clear”. Then I think that the traditional Chinese medicine in China can be included in our entire modern medicine regulatory system.

But anyway, we still have to say a few objective words for this policy. That is, the introduction of this policy has, after all, made our traditional Chinese medicine regulatory system take a step towards the modern medicine regulatory system. Although this step is very limited, this direction is worth encouraging. We hope that their steps will be bigger and their courage will be greater. Then, the Chinese people will not become the white mice of these traditional Chinese medicine enterprises, and will not become their experimental animals.

Okay, I’ll stop here today, thank you all.