Dr. Clove is here to answer that question.

On December 2, Dr. Clove tweeted, "Brainwashing medicine that sells 750 million dollars a year, please spare China's elderly".

December 6 SFDA Notice on Matters Related to Saproxil Eye Drops

Health is dependent on life, do not forget the original intention, move forward.

Thanks for the invite!

A few years ago, my fellow ophthalmologist mentioned that Saphris for cataracts was, basically, ineffective. But that's how it survived for almost 20 years, until the recent furor ......

About the approval of Saproxel for marketing

Saproxil is actually an official and officially approved drug, with the approval number H19980187, which is a chemical approved for marketing in 1998, according to the drug approval number. Because of its age, Dr. No Drugs No Drugs is currently unable to find pre-market data on the effectiveness of the drug.

But what was the state of marketing approval of drugs in China in 1998? At that time, there was no State Food and Drug Administration (SFDA), and drugs were approved for marketing after verification by local drug administration bureaus. For example, Saproxil was approved by the Zhejiang Provincial Food and Drug Administration. Later, around 1999-2000, the state, in order to unify the management, will be approved by the local drugs, unified for the issue of the document number, Saprox has the number of the State Drug Approval Character. Saproxil was then given a State Drug Approval number and successfully entered the national level of regulation of medicines.

When you give the State Drug Approval Number, it's a uniform exchange, and the process does not involve re-evaluation of the drugs, either because you believe in the approval of the various provincial drug regulatory bureaus, or because there are just too many drugs that need to have their numbers changed to re-evaluate them one by one. So for these drugs, honestly very uneven, some have been used in the clinic for decades, and for over-the-counter drugs like Saproxil, the regulation is even less strict. At present, it can only be verified by the State Food and Drug Administration when problems are found. If it is found that there are indeed problems with the clinical safety and efficacy of the drug, corresponding treatment will be made.

The treatment of Saproxil is accurate

After the above elaboration, the way the State Food and Drug Administration dealt with Saproxel, Dr. No Drugs No Drugs thinks it is very correct. A drug that has been approved for marketing and has no serious adverse reactions cannot just be suspended from production, operation and use. However, the State Administration has the right to request the manufacturer to provide clinical effectiveness data and re-evaluate the variety.

And this time, the National Bureau is serious when it asks the manufacturer of Saproxil to re-evaluate it. This step is carried out in accordance with China's drug management law and the relevant provisions of the consistency evaluation of the quality and efficacy of generic drugs. There is a legal basis and specific requirements. This is equivalent to the pre-market review and approval process for drugs. This process is currently standardized, strict and does not allow any speculation. If the safety and efficacy can meet the requirements after evaluation, it will continue to be marketed for sale and use. However, if it is found that the efficacy is not met at all, or if no data on effectiveness can be obtained within three years, then the consequence for Saproxel is that it will not be approved, and the approved symbol will be canceled, and the drug will no longer be available on the market.

Dr. No Drugs No Drugs has used his little experience in drug clinical trials to talk superficially about Saproxil, so feel free to leave a comment and discuss!

[No Drugs No Drugs] Introduction

D. from Tsinghua University, pharmacist-in-charge, senior nutritionist with 10 years of experience in medication guidance, nutritional counseling and health management. No drugs, no medicine, healthy life, no sickness, no medicine!

On December 2, an article by Dr. Clove, "Brainwashing "miracle drug" that sells 750 million dollars a year, please spare the elderly in China," caused a wide range of heated debates. The article cited the views of many domestic ophthalmologists and authoritative literature, questioning the familiar "Saproxil eye drops" can not treat cataracts, and its advertisements are suspected of exaggeration and false propaganda.

Although the content of the article is well-documented, but as a listed company Sharp Acres in the evening of December 3 or issued an announcement to respond to the questioning, said that its Bendazac Lysine eye drops on cataracts does have a delay in the development of the role of the advertisement is not exaggerated.

Saproxil advertisement

Image Source: Internet

Obviously, Sharp Ace's response did not play a role. on December 4, Sharp Ace (stock code: 603168) stock should be down, the total market value of a single day shrunk nearly 200 million yuan. In December 7 has been suspended.

Saproxel Stock Trend

Image Source: Internet

The authorities concerned certainly did not sit idly by. On December 6, the State Food and Drug Administration (SFDA) issued a notice requesting the Zhejiang Food and Drug Administration (FDA) to urge Sapphire to initiate clinical effectiveness trials as soon as possible.

It can be said that the State Food and Drug Administration can quickly take action after the release of the article is very recognizable, which reflects the power for the people, feelings for the people, and benefits for the people.

FDA Notice on Saproxil

Image source: Official website of the State Food and Drug Administration

Zhejiang Provincial Food and Drug Administration Notice on Saproxil

Image source: Zhejiang Food and Drug Administration official website

Historical legacy?

In 1997, Sapocephalus obtained the new drug certificate for Bendazac Lysine Eye Drops as well as for the API. China's State Drug Administration was established in March 1998, which means that the success of Sapocephalus eye drops was due to the fact that in the 90's, China's drug regulatory system for drug clinical trials were not yet so strict when the marketing authorization was obtained, and there is no mature mechanism for drug delisting.

In 2004, the State Drug Administration approved the conversion of Saproxil eye drops to OTC (over the counter) drugs, that is, non-prescription drugs, meaning that the public in the ordinary drugstore can be bought, without having to go through the doctor to prescribe this step, so many people buy their own Saproxil eye drops to treat their illnesses, delayed the condition.

It has been questioned for some time.

It's not as if Saphris hasn't been challenged in the media after this.

On June 3, 2011, the Food and Drug Administration of Guangdong Province announced the 4th issue of illegal drug advertisements in the province in 2011, and "Bendazac Lysine Eye Drops" produced by Saproxis was exposed 350 times for its illegal advertisement in March 2011 on Shenzhen TV City Channel.

In November 2012, the Changsha Drug Distribution Industry Association pointed out that Saproxel was suspected of violating the relevant provisions of the Measures for the Examination of Pharmaceutical Advertisements, containing unscientific assertions and assurances about the efficacy of medicines, and seriously deceiving and misleading consumers.

In 2014, as Sapocephalus Pharmaceuticals passed the SEC's listing audit, there were also media reports that the company had been dealt with several times for product quality issues and advertising violations.

Saproxil advertisement

Image Source: Internet

lock the stable door after the horse has bolted

Saproxil eye drops have been around for years. Since the eye drops have not been tested for clinical efficacy and have been questioned by the media many times, the State Drug Administration has not taken any relevant measures? This shows that there is still not enough regulation. This time, Dr. Clove's article reached millions of clicks, and the rapid response of the State Drug Administration can only be regarded as mending the fold.

Popularization of science should also be done well

It is believed that Sapphire is not the only company that does false advertising. When you turn on the TV, you can see a lot of TV shopping advertisements, publicizing that they can cure rheumatism, lumbar disc herniation, three high and so on. The advertisements are written with conviction, and there are many people who believe in them. Then the importance of popularization of medical knowledge is self-evident.

reach a verdict

In the future, it is necessary for the State to step up its efforts to regulate medicines, to make the mechanism for withdrawing medicines from the market more mature, and to popularize medical knowledge among the general public.

Pay attention to the "YiFuLai Senior Living" Wukong number, or WeChat follow the public number (YiFuLai Senior Living), to get the most professional knowledge of the elderly!

Recently, an article from a self media "brainwashing "miracle drug" sold 750 million a year, please spare the elderly in China" triggered widespread concern, and the protagonist of the article "Saproxil eye drops" pushed to the wind and waves.

Continuously questioned, Sapocephalus eye drops on cataract patients have no efficacy; its advertising is suspected of false propaganda, misleading consumers; its less R & D costs high advertising costs behind the business ethics is justified, etc., the foregoing are for the outside world's concerns about the core issues, have hustle and bustle, confusing a lot of cataract patients.

In the midst of the controversy, the media quoted Zhejiang Food and Drug Administration as responding to the matter, saying that it had received a complaint about the existence of exaggerated propaganda in the advertisements released by Saphris Eye Drops, and had replied to the consumer in accordance with the procedure: it had not monitored illegal advertisements of Saphris Eye Drops in recent years, and it had not received any notification of illegal advertisements of Saphris Eye Drops from the State General Administration of Administration of Food and Drug Administration of Zhejiang and from other provinces transferred to our province.

In the midst of great concern and questioning, the Zhejiang Provincial Food and Drug Administration suddenly spoke out and responded to social concerns with an affirmative stance, which obviously did not eliminate the outside world's questioning of the efficacy of Saproxil eye drops, but on the contrary, soon, and very soon stirred up the media and other concerns about the matter, and the fire seems to be getting more and more exuberant.

In the evening of December 6, the State Food and Drug Administration issued a notice stating that, in view of the fact that some doctors in the medical profession have questioned the efficacy of Bendazac Lysine Eye Drops (trade name: Saproxis) produced by Zhejiang Saproxis Pharmaceuticals Co, Ltd, the Zhejiang Food and Drug Administration is requested to, in accordance with the "Drug Administration Law of the People's Republic of China" and the relevant provisions on the consistency of the evaluation of the quality and efficacy of generic medicines, urge the enterprise to In accordance with the Drug Administration Law of the People's Republic of China and the relevant provisions of the consistency evaluation of quality and efficacy of generic drugs, Zhejiang Food and Drug Administration should supervise the enterprise to start the clinical efficacy test as soon as possible, and report the evaluation results to the Drug Evaluation Center of the State Food and Drug Administration within three years.

And in response to the widespread concern about advertising, the above notice makes it clear that, in order to prevent misleading consumers, the approved advertisements for the drug should be strictly in accordance with the textual expressions stipulated in the specification of the indications, and there shall be no textual content beyond the specification of the indications.

From the regulatory point of view, at this moment, the State Food and Drug Administration can take the initiative to come forward, and a clear position, which is sound food and drug quality supervision embodied in the performance, but also in relation to the health of patients and the community's major concerns, which is also a reflection of the regulatory responsibility should be given to the commendation, we look forward to scientific, fair and objective evaluation results can come out as soon as possible.

Pharmacist Lee talks about health, to follow please click on the upper right corner!

On December 2, Dr. Ding Xiang's article "The brainwashing drug that sells 750 million dollars a year, please spare the elderly in China" pushed the listed company's cataract treatment "miracle drug" Saproxil to the forefront. As a Chinese pharmaceutical man, the circle of friends on WeChat has been swept by this article or other related articles in the past few days. The State Food and Drug Administration (SFDA) also issued an announcement on December 6, requiring Sapolex to complete a consistency evaluation within three years and not to have a description beyond the scope of the indications in the manual.

There is not much to say about this "miracle drug". Bendazac Lysine is a kind of amino acid nutrients, for ophthalmic diseases cataract has no therapeutic effect. This thing, I've talked to a lot of people around the popularization, today again from the Internet to tell you, first of all, what is a "cataract", there is a tissue in the human eye called the lens, under normal circumstances, it is transparent, the light through it and some refractive interstitial to reach the retina, in order to clearly see the outside world objects. Once the lens is cloudy for some reason, it will affect the retinal imaging, making it difficult to see things. In other words, the clouding of the lens leads to vision loss is cataract. In the human eye structure, in front of the lens, there are a series of structures such as cornea, iris, aqueous humor, etc. Therefore, not only this amino acid eye drops "miracle drug" does not have a therapeutic effect on cataracts, but also any eye drops can't possibly reach the lens and improve the turbid state of the lens, the ultimate and the best treatment for cataracts are --The best way to treat cataracts is to replace the IOL with a surgical procedure, which is now very mature and carries very little risk. Many rural areas in China, the state is free to provide surgery. 30 yuan a "Saproxil"? Saproxil" is not a cataract treatment that can improve the symptoms of cataracts.

Coming back to the issue of consistency evaluation mentioned by the National Bureau, consistency evaluation is a reform initiative put forward by the State Food and Drug Administration (SFDA) in recent years to improve the quality of generic drugs in China, especially for the consistency of dissolution and absorption of conventional oral solid preparations, which is very important for the efficacy of a drug. The so-called consistency evaluation is to require that the pharmacological properties and efficacy of a product are consistent with the original product, and to prove its consistency through relevant research data and clinical data. China is a large country of generic drugs, so the huge difference in the use of generic drugs and foreign original products is also a major problem highlighted by the current social development, therefore, it is imperative to carry out consistency evaluation.

State Bureau of the consistency evaluation of "Saproxil", from the author's point of view, basically announced the "death" of this product. The variety of "original drug" is who? According to the investigation, the product was first approved in 1983 in Italy by the Angelini company by the Bendalina trade name on the market, the product has tried to apply for listing in the United States, but did not get the approval of the FDA. However, the drug's specification shows that its indications are:As an adjunctive therapeutic agent in cataract therapy. And the indication for which Saproxil is approved in this country is "Early age-related cataracts", it is clear that the two indications are worlds apart, if the comparative study of the original research product, and regardless of the quality of the product from the pharmacy has consistency, first of all, the inconsistency of the indications can not be carried out in clinical trials to verify the consistency of the efficacy of the drug. Where does this "consistency assessment" come from?

The emergence of this "miracle drug" phenomenon is not an isolated case, and in the future, there may also be other "miracle drugs" that are pushed into the limelight. There are two main reasons for the emergence of this phenomenon:

1. Problems of the early review and management of the State Drug Administration: Saproxil is a product listed in 1997, according to the history of the State Drug Administration, this product should be approved in the Department of Health of Zhejiang Province in that year, at that time, the approval of the drug was more chaotic, and the research data of the product could not be done comprehensively and sufficiently, this is the inevitable stage of the development of the society and the author does not comment too much, in 2002, the State Drug Administration has carried out a landmark up to the national standard work. In 2002, the State Drug Administration carried out a landmark to national standard work, all the drug symbols collected to the national bureau of management, for the then chaotic drug market, this work is in fact very necessary, but the lack of the state alone is to require enterprises to product-related documents are summarized in the report, but not on all aspects of the product in the evaluation. Of course, with so many varieties and such a heavy task, it was almost impossible to re-evaluate all of them in the historical background at that time. This is also one of the reasons why the Food and Drug Administration now carries out consistency evaluation. Therefore, this "miracle drug" has obtained an indication that should not have been obtained, and has obtained the approval number of the country in a blur.

2. Regulation of drug advertisements: Drug advertisements are still very confusing today, from CCTV to local stations, all kinds of drug advertisements come out one after another, and all kinds of "miracle drugs" are flying all over the place. Moreover, the advertisements are generally bombarded, and all kinds of advertisements are generally broadcasted in a rolling manner. "Saproxil" was listed in 1997, but the real sales are climbing, so as to reach the present amazing "750 million", that is, in recent years, a variety of support for a listed company, indicating that the power of drug advertising is how huge! The State Food and Drug Administration issued a clear document, approved advertising shall not have content beyond the scope of the indications. We all understand very well, this drug advertising spokesman is "Lang guide", but I think, Lang guide has no responsibility for this, Lang guide is not an ophthalmologist, is not a drug expert, people asked her to advertise, the ads so out, but responsible for the review and approval of the Zhejiang Provincial Bureau should bear greater responsibility, you let them do so ads, is it really appropriate? You let them do so ads, really appropriate?

The State Food and Drug Administration is currently on the drug production, supervision, research and development, market supervision of bold reforms, I hope that, for the regulation of drug advertising, for drug publicity, the State Bureau should also be under the great efforts to rectify the management, so as to put an end to the emergence of more "miracle drugs".

Thanks for the invitation! I'm a cardiologist although I don't have a deep understanding of cataracts, but I've seen many experts and professors from the articles posted by Clove Garden have declared that Saproxel is almost ineffective on cataracts, so I firmly believe that this is an exaggerated propaganda to mislead the consumers, and it is irresponsible to the people's health! So it must be investigated and severely punished, this is to seek money and kill people! How did such an ineffective drug pass the audit? How did it bypass doctors and become otc? After so many years of fooling around, what did the regulators do? Really thank the doctors who dared to expose, thanks to the group, in the interests of the people, bravely come forward, as for the Food and Drug Administration to require the start of clinical trials should also be forced by the media and all aspects of the pressure, I hope that the strong regulation, responsible for the people, and I hope that more counterparts bravely come forward to fight counterfeiting! We can risk our lives for the people's health, and I hope you understand us more, support us more, we are the real people's guardians! I hope that the TV media will not dare to broadcast any advertisement, especially medicines, for personal gain! Eucerin sells 800 million bags a year, are all our children sick? Do you have the nerve to say that? If you do whatever it takes to make a profit, you'll die a horrible death! Respect health, respect doctors, we are the guardians of life!

Your health, my wish! Emphasis on science, prevention first! For more professional health knowledge, please pay attention to my headline!

An article titled "Brainwashing miracle drug that wildly sells $750 million a year, please spare China's elderly" has pushed Saproxil in false advertising into the limelight.

On December 6, 2017, the State Food and Drug Administration (SFDA) issued a notice in the evening, stating that in view of the fact that some doctors in the medical profession have questioned the efficacy of Bendazac Lysine Eye Drops (trade name: Saproxis) produced by Zhejiang Saproxis Pharmaceuticals Company Limited, it has requested that the Zhejiang Food and Drug Administration (CFDA), in accordance with the Drug Administration Law of the People's Republic of China and the relevant provisions on the consistency of evaluation of the quality and efficacy of generic drugs Zhejiang Food and Drug Administration in accordance with the "Drug Administration Law of the People's Republic of China" and the quality of generic drugs and the consistency of efficacy evaluation of the relevant provisions, supervise the enterprise as soon as possible to start the clinical effectiveness of the test, and within three years will be the results of the evaluation of the State Food and Drug Administration (CFDA) Drug Review Center.

In order to prevent misleading consumers, the approved advertisements of the drug should be strictly in accordance with the textual expressions specified in the indications of the instruction manual, and should not contain textual contents that exceed the indications of the instruction manual. The rapid response of the drug regulatory authorities this time was praised and expected by the public.

However, for the listed generic drugs, the approval of the market without clinical effectiveness evaluation and confirmation shows that there are still many serious loopholes in the quality of generic drugs on sale in China, which is also the reason why the CFDA resolutely promotes the consistency evaluation of generic drugs.The CFDA in the consistency evaluation of generic drugs requires that the 269 types of generic drugs in the medical insurance catalog need to start the consistency evaluation work on the quality and efficacy of the drugs with those of the originator drugs by the end of 2018, and the drugs can continue to be marketed only after passing the consistency evaluation. Only drugs that have passed the consistency evaluation can continue to be sold on the market.

The consistency evaluation of generic drugs is aimed at enabling the Chinese people to use reliable drugs with efficacy comparable to that of the originator, and eliminating generic drugs whose efficacy does not meet the standard. This is an unprecedented regulatory effort and determination to rectify the situation, a feat for the benefit of Chinese people's lives and safety. It is the duty of the drug regulatory authorities to be strict in the approval of new drugs and review of advertisements, and to be responsible for the safety and health of the people. We believe that strict government regulation will definitely make false pharmaceutical advertisements of "Saproxil" drugs disappear.

The authoritative interpretation of Pharmaceutical Affairs, unauthorized reproduction, plagiarism will be punished.

Did someone say advertising? A willingness to fight is consistent with business practices, and customers should learn to improve their screening skills on their own.

Personally, I feel that the advertisements involving functional foods, health products, medicines and medical treatment should be strictly regulated by the state, and now the management of this area of the country is relatively loose and lagging behind, as long as there is no major mass incident to punish the general thunder, but the rain is small, and often turn a blind eye to the situation. Most of the TV stations, websites, advertising agencies and other media have no professional ethics, and are doing a lot of things that would make a thief cry thief.

The level of civilization, culture and literacy of Chinese individuals varies greatly, especially among the elderly and those in remote and poor areas, who are prone to trust advertisements and recommendations from others. Many advertisers and Internet promoters say that there are too many people in China, and some of them will always believe. Health products, functional foods and medicines that used to be bombarded by TV stations with seemingly vulgar advertisements have become exploding households, such as Sun God, Sanzhu Oral Pills, Brain Platinum, Brain Gold, and so on.

Functional foods, health products and medicines, unlike other advertising products, because of the therapeutic effect, it is easy to mislead and induce customers, which may lead to delays in the prevention and treatment of diseases, with a certain degree of social harm. Therefore, the relevant state departments must strictly control them!

The advertisements for Saproxel portrayed it as a ' miracle drug ' capable of treating all types of eye diseases and claimed that it was highly effective against cataracts. Taking advantage of the overwhelming publicity and brainwashing advertising effects, Saprox reached sales of $750 million in one year in 2016.

Many media outlets and ophthalmologists have written articles questioning the alleged false propaganda and exaggerated efficacy of Sapolex eye drops, misleading cataract patients, especially the elderly, to buy the drug. Zhejiang Sapocephalus Pharmaceutical Co., Ltd. also responded on December 4 that the company's product Sapocephalus Eye Drops is a 'safe and effective anti-cataract drug', 'can slow down the development of senile cataract and improve or maintain vision to a certain extent', and that the content of the advertisements is in line with the relevant regulations. The eye drops were not found to be unqualified in the sampling test", but this has not yet quelled the doubts about the efficacy of the drug.

The State Food and Drug Administration (SFDA) issued a notice stating that, in view of the fact that some doctors in the medical profession have questioned the efficacy of Saproxel, the Zhejiang Food and Drug Administration (SFDA) was requested to supervise the company to start the clinical efficacy test as soon as possible in accordance with the Drug Administration Law of the People's Republic of China (DALC) and the relevant regulations on the consistency evaluation of the quality and efficacy of generic drugs and to report the results of the evaluation to the Center for Evaluation of Medicines (CERM) of the SFDA within three years.

Meanwhile, the notice also said that in order to prevent misleading consumers, the approved advertisements for Saproxil should be strictly in accordance with the textual expressions stipulated in the indications of the manual, and there should be no textual content beyond the indications of the manual.

Take the 30-second video advertisement involving Chinese women's volleyball coach Lang Ping as an example, the advertisement kept repeating "cataracts can't see well Saproxil drops in the eyes", "blurred drops, heavy shadows, black shadows", "a bit of pain Insist on drops " and other advertising slogans. In the subtitle of the advertisement video, the words "early senile cataracts make it difficult to see Saproxil drops" can be seen, in which the font size of "early senile" is obviously reduced. In print advertisements such as the Sapolex online store, more advertisements such as "Preventing and treating senile cataracts, recognize Sapolex" and "Early detection and early treatment of cataracts" can be seen.

I think Saproxis is suspected of deceiving and misleading consumers with this move, "It is not right to not label it obviously or present it through narration, there are various causes of cataracts, including senile, complication, traumatic, metabolic, etc., and only early senile cataracts can be used with the drug, while exploding the sky-high price of the drug, which is not that high in cost at all, and the drug obviously contains false or misleading content." The harm is not only just ineffective, but the main harm is that the exaggerated propaganda and delayed patients to receive the correct treatment.

National requirements for its effectiveness of clinical trials, is a national account, but also a wake-up call for the drug industry, the existence of the entire drug industry sky-high prices, ineffective drugs, fake drugs rampant, the people already do not know who to trust, to the hospital is also a lot of traps, and I hope that the relevant departments to strengthen the rectification of similar behaviors, purify the market so that the people with safe drugs, safe drugs.

Whether the brand protection is in place or not, it is a matter of life and death for the enterprise! Relying only on advertising won't last long after all! I just don't know how the previous clinical trials were done, were the data falsified? Who will be held accountable? Real-time recording of clinical data of various drugs on the blockchain, leaving no chance of tampering with the data at all, may fundamentally solve this problem! Might as well start with drug consistency evaluation? The National Pharmaceutical Industry Blockchain Alliance will surely give its full support!