The benefits of rabies vaccines: the cost of being manipulated

Jiangsu Extension Bio-technology company east.　　(Photo source: Times weekly) May 25, the vaccine industry again "earthquake." Hubei Province Wuhan Institute of Biological Products (WUSHENG) Emergency decision, recall 200905007-3 batches of 10902 people "freeze-dried rabies vaccine (Vero cell)". Xu Gelin, the researcher, confirmed to the time reporter that "there are defects in the seedling, and that the bacterial toxin residue in it is beyond the prescribed standard". This is the fourth rabies vaccine scandal since last year.　　Earlier, Liaoning Golden Port Andy, Jiangsu Jenschen, Hebei Three enterprises in the 18 batches of 540,000-person rabies vaccine because of "actual value" insufficient and has been recalled.　　The scary is, according to Citic Securities market research last year, since 2005, the National Drug Administration issued NO. 327 documents, the implementation of mandatory technology upgrades, the country's rabies vaccine production enterprises reduced to 13, and now, tainted enterprises accounted for 1/4.　　The producer of the problem vaccine, whether it's a barrage of "problem vaccines" or a genuine "bottled saline", has been designed by some as a "profit-driven tool".　　June 1, located in Changzhou, Jiangsu Wu Dadao Biological Technology Co., Ltd. is already empty, only two security guards in the room repeatedly to the Times weekly reporter clarified that the factory is indeed in a comprehensive reorganization, including the swine flu vaccine, rabies vaccine, all the products have been discontinued. According to the two anonymous security recalls, a few weeks ago, a national media in Jiangsu Bureau reporter had to negotiate the name of rabies vaccine business, consulting extension customer service. The unknown operator not only replied "yes", but also enthusiastically forwarded it to the sales department.　　For a time, "the problem of suspected enterprises to return to the news". The Jenschen storm began last December, but it was not until this March that it aroused intense concern.　　At this point, the Shanxi vaccine chaos of the "shock wave" has made vaccine safety has become a worry for the people. May 15, the State administration of medicine to Jiangsu extension of the administrative penalties. The announcement pointed out that 2008 7-October, the enterprise in the production process, the existence of Jerry, fraud, evasion of supervision and other illegal activities, resulting in 4 batches of 179,952 people, "effective price substandard" products to the market.　　At present, this batch of "problem vaccine" has already been Anhui, Guizhou, Henan and other Provinces "digest", difficult to trace. By the State Administration of Pharmacy bulletin also has Hebei Fulcrum Bio-Pharmaceutical Co., Ltd. Last January, Dalian Golden Port Andy Company was also reported "suspected of intentional fraud."　　Now, there is another wusheng on the list. However, the puzzling is that 4 "problem enterprises", in fact, are the industry leading enterprises.　　According to the data of the China Pharmaceutical Products Testing Institute (the Institute), the sales revenue of Andy Di in 2007 was 180 million yuan, the net profit was 80 million yuan, and the market share of two vaccines ranked first in the country. 2008, Jiangsu Jenschen in the country's rabies vaccine batch issued a total of 2086274 people, ranked domestic enterprises four, and accounted forAccording to 11% of the market share.　　In 2009, the State Administration of medicine approved only 8 enterprises of the swine flu vaccine production qualification, "Changzhou star" Jiangsu Extension is ranked among them, but also received 6.3 million orders from the Ministry of Industry. In addition, Hebei Fall 2008 also surrendered the realization of the output value of 130 million yuan, turned over the tax 26.71 million yuan report card, and therefore received the local government a Passat car award, and China Pharmaceutical Group Corporation of Wuhan Institute of Biological Products this year was named Hubei Province innovative Enterprise construction pilot units,　　Enjoy a number of policy concessions by the provincial Science and technology department. "It is very rare for quality enterprises to deliberately counterfeit." Because once discovered, the vaccine production qualification certificate will be revoked. The cost of this risk is too high.　　"Long-term engaged in pharmaceutical manufacturing industry, Guangzhou Mai-Hua Pharmaceutical Co., Ltd., the chief engineer Li Desheng analysis. In his view, the more terrible fraud subject is some outlaws. 2006, the Heilongjiang police have cracked a "rabies vaccine case." In connection with the use of a filling machine, the saline injected into the sealed bottle, labeled "Genuine medicine authentic."　　Each fake vaccine cost only 0.6 yuan, profiteering dumping. In this respect, Li Desheng some indignation: "Whether it is a barrage of" problem vaccine ", or the genuine ' bottled saline ', rabies vaccine has been designed by some people as a" profit-driven tool. "　　"The cost of being manipulated is an indisputable fact among several domestic vaccine manufacturers who can control the cost of raw materials and who can seize the high ground of the market and profits," he said.　　From one point of view, the benefit-driven nature of rabies vaccines is given by policy. According to State Council regulations, China's vaccines are divided into two categories, one is the "first category of vaccines", also known as the "planned immunization vaccine", the other is a "second type of vaccine", that is, "affordable vaccines." The former belongs to the national Immunization Program, which is procured and distributed by central and local finance.　　And the influenza vaccine and the human rabies vaccine belong to the latter, by the CDC, hospitals and other institutions to the vaccine production enterprises to purchase, and the voluntary injection of fees charged. From Jangsujenschen's prospectus, Times weekly reporter found that this is a production of "the second category of vaccines" for the main business enterprise. Among them, the first half of 2007, influenza vaccine and human rabies vaccine income generation 41.2575 million, accounting for 93.7% of the main income.　　In addition, when the Hebei Fulcrum was notified, the rabies vaccine was the only breed in production, and the now defunct Golden Harbor Andy's business scope is the rabies vaccine based on the "affordable vaccine." Changzhou a number of pharmaceutical enterprises Legal Counsel Gao Chunfang told The Times weekly reporter, when rabies vaccine linked to income generation, control costs become the enterprise in the homogeneous competition to maintain a dominant position in one of the effective means.　　But the real problem is that reducing the cost of producing rabies vaccines is not easy. From the production process, a rabies vaccine from raw materials to finished products, at least through cell culture, harvesting, inactivation, purification, canning and so on more than 10 processes. And each ring may be contaminated by bacterial intrusion, with which, the original, vice material scrap, process down again, huge lossLoss is unavoidable. Liaoning Cheng da Biotechnology Co., Ltd. Medical manager Zhang Yizhi to the Times weekly reporter frankly, in order to reduce the "pipeline" by the risk of pollution, enterprises need to continue to introduce technology, improve the process.　　Therefore, half the cost of rabies vaccine is to ensure aseptic production, unless there is technological innovation, it is difficult to significantly reduce. In addition, because of the specificity of the vaccine industry, the country's requirements are much higher than the general injection, protein agent manufacturers. At present, a rabies vaccine production line of the national standard is that the minimum investment of not less than 30 million yuan. Moreover, in order to obtain the rabies vaccine production qualification, spent the research funds is also a "rigid" big expense.　　The number of Jenschen disclosed in the prospectus is as high as 20 million.　　China Newsweek quoted an industry insider as saying that it is an indisputable fact that in some domestic vaccine manufacturers, who can control the cost of raw materials and who can seize the high ground of the market and profits. In order to occupy the interests of the commanding heights, Liaoning Golden Port Andy, Jiangsu Jenschen, Hebei Fulcrum successively put into action. Li Desheng This explains Jenschen's "fake", the rabies vaccine mainly consists of a certain number of rabies virus and related adjuvant. According to the virus culture link, the country establishes the production norm, has the micro-control standard to the viral strain quantity, but the enterprise has the stricter internal control index.　　In the strict sense, the enterprise must use the latter as the investment standard, and the extension of the investment may only reach the lower limit of the micro-control, or even far below this value. In contrast, the Golden Harbor Andy appears "outmanoeuvred".　　Just as melamine can "improve" milk protein content data, golden Port Andy Illegal addition of nucleic acid-like substances, can make "rabies virus not standard" vaccine to deceive, smoothly through the sampling test in the inspection, get put on the market "Zhongsheng". In an interview, Times reporter learned that rabies vaccine raw materials cost about 41.5% of the total cost, of which, the virus strains mainly have two channels of purchase, one is purchased from the Inspection Institute, for example, Jiangsu Jenschen; the second is imported from abroad, for example, Liaoning into a large.　　The price of the former has reached hundreds of thousands of in the past ten years, and the latter is at least 20%. "Our raw material cost itself is higher, if the enterprise peers and then cut corners, a piece of feed divided into two uses, that their profit margin is very large."　　"Zhang Yizhi said. In the reflection of the regulator due to lack of detection means, the only ability to confirm which is "filling saline", which does contain "rabies virus."　　As for the exact valence value, the test is not capable of measuring.　　It is astonishing that companies are being falsified for profit, but the more frightening assumption is that regulators are also involved in the blending of benefits. According to the Hong Kong "Big Bulletin" April 2 reported that the issue of the vaccine is being investigated, the National Drug Administration Drug Registration Division of the Department of Biological products researcher Weiliang was "double regulation", and then "bribery crime" arrested.　　One of the main responsibilities of the Agency is to instruct and supervise the issuance of biological products such as rabies vaccines. Changzhou SquareThe Weiliang has been thought to have been linked to the issue of rabies vaccine. This speculation stems from July 8, 2009, Weiliang has publicly inspected the Jiangsu extension of the swine flu vaccine production. Less than six months, the extension of production, Weiliang arrested.　　Time also basically coincide.　　Although the inevitable link between the two is not confirmed, in some industry, the regulatory network of vaccines is full of loopholes for rent-seeking. Supposedly, rabies vaccine safety has three lines of defense. First of all, the enterprise's own supervision, including the assembly line supervision, inspection Department, and responsible for the quality of the deputy in charge of the "searchlight", the audit of production batches and inspection batches. Second, the government supervision, that is, the drug supervision departments of sampling, submission and inspection of the batch issued. In addition, there are factory monitors throughout the tracking.　　Among them, the management of batch issuance is the lifeline of vaccine safety.　　According to the State administration of medicine, the vaccine before the factory sales, a certificate of competency must be issued, which is the responsibility of the Central Inspection Institute, and seven accredited local drug biologics accreditation departments in Beijing, Jilin, Shanghai, Hubei and Guangdong, which are responsible for the management of on-site sampling of vaccines and the inspection of part of the project. Changzhou Four Pharmaceutical Co., Ltd. a manager who asked not to be named told The Times weekly reporter, because the inspection of all vaccines in control of the "quasi-students" power, do not rule out the possibility of active "public relations" enterprises.　　However, some of the oversight department officials often go to pharmaceutical companies to move around, contact work, is the industry's open secret. At the same time, Zhang Yizhi also provided such information to reporters, earlier, due to the lack of detection means, only the ability to confirm which branch is "filling saline", which does contain "rabies virus." As for the exact valence value, the test is not capable of measuring.　　This time, Shen's rabies vaccine was found to be "inefficient" also benefited from the Wuhan Institute of Biological Research and development of the latest detection methods. According to the Theory of medicine, "valence" is the expected efficiency of the product to achieve its purpose, and it is also one of the indexes that can embody the quality of vaccine.　　And the country's only qualified vaccine quality assessment of the inspection is not capable of detection, which can not help Gao Chunfang lawyers and other industry people confused, really is not detected, or "was" detected? What makes high lawyers question is the role of "factory supervisors". In order to strengthen supervision, in 2007, Jiangsu Province, the provincial Drug Administration to send a supervisor stationed in the extension company.　　In accordance with the design of the system, supervisors, like the "sword" imperial envoys, have the right to supervise the production process, consult the issuing records, and even correct the improper training of personnel. However, high lawyers admitted to reporters that the system itself is a contradiction.　　He explained that if sent to the layman, vaccine production is a technical work, he can not understand; Send insiders, short time, he did not understand the specific situation of the enterprise, until the understanding, he may have been assimilated by enterprises, in addition to increase the possibility of blending interests, the actual regulatory effect is unknown. After the storm in Jiangsu province, "rabies vaccine" became a sensitive topic in Changzhou. When the Times reporter tried to contact the local health Bureau and the FDA,were rejected. Changzhou the former deputy director of Food and Drug Administration Chezhen told The Times weekly Reporter: "Not unwilling to talk, but how to talk." At present, regulators are doing the deepest soul-searching. How to supervise, can promote the whole industry to develop healthily and continuously, this is the question that needs great wisdom. "Corruption of the flow of the wart through the production enterprise and disease control system of the interests of the food, a cost of less than hundred million rabies vaccine, the price has quadrupled."　　This can not help to promote the "can't afford the vaccine" group into the black market, thereby nourishing more production of "bottled saline" outlaws.　　When the rabies vaccine successfully obtains "Zhongsheng", enters the circulation link, the enterprise starts to ponder how the sale profit-driven question. There are many choices in front of Jiangsu Jenschen. Because, June 1, 2005, the State Council promulgated the "Vaccine Circulation and vaccination management regulations." Among them, the core of the 15th article, the vaccine production enterprises can be to disease prevention and control agencies, vaccination units, vaccine wholesale enterprises to sell the production of the second category of vaccines.　　Vaccine wholesale companies can sell the second category of vaccines to disease prevention and control agencies, vaccination units, and other wholesale vaccine companies. Under the regulations, the second category of vaccine enterprises from the original 30 provincial CDC expansion to tens of thousands of provinces, municipalities, county CDC, vaccination units and qualified vaccine wholesale enterprises.　　In the eyes of the outside world, this is tantamount to ending the disease control system monopoly of the era of vaccine circulation. However, the Times weekly reporter in possession of a data show that the extension of rabies vaccine sales by customers are divided into two categories: first, at all levels of the CDC and vaccination units of the professional promotion model, the second is for the qualified distribution of vaccine wholesale enterprises. In comparison to the pros and cons of the two ways, the extension of the view that the former without intermediate links, higher sales prices.　　Although it is necessary to spend a certain amount of sales expenses, but the production enterprises can control this. After this argument, the extension of the selection of professional promotion as the core of the sales method.　　Data show that, in 2004-2006 and in the first half of 2007, income generated from CDC and vaccination units at all levels was 100%, 99%, 94% and 91% per cent of total income. In two categories of vaccine companies are more willing to "higher than the wholesale price of vaccines" to sell at all levels of the CDC, CDC is also very happy to take over the second category of vaccine business.　　Times weekly reporter in Changzhou interview found, and production link "tube is not clear" on the contrary, the channels are clearly tube. According to Changzhou Disease Prevention Center Advocacy Section reclassified Dong Xiuqin, Changzhou City-level, district-level CDC are fully funded by the State, the need for the two types of vaccines completely rely on public bidding, and from top to bottom circulation.　　In recent years the winning bidder has been the largest in the domestic rabies vaccine market share of Liaoning. It can be said that Changzhou's vaccine circulation chain is relatively simple. The longest path from Liaoning to city-level CDC to the district-level CDC to the township, Street hospitals to the vaccination. The regulation has been enacted for more than five years, but the disease control system is still a vaccine circulationThe key subject of the link. "There are so many vaccine safety accidents, the CDC to get the vaccine is more reassuring than those of the wholesale enterprises."　　Changzhou Zhonglou District, a staff member at the hospital, explains.　　There is an inevitable causal link between "Disease control system" and "vaccine safety", but it has a trace of relevance to "benefit". According to the 2007 forecast report by the Yuan Securities Institute, the ex-factory price of the large rabies vaccine in Liaoning province was about 110 yuan in 2009. This value has been recognized by many people in Changzhou industry.　　Then, according to the country's permitted maximum profit margin of 20%, after the longest circulation chain, vaccination of rabies vaccine purchase price should not exceed 228 yuan. However, it is understood that, although the market in Changzhou, the CDC, hospitals, the rabies vaccine prices are not the same, but more than 228 yuan.　　The lowest is the Qishuyan CDC's 300 yuan, the highest reaches the Wujin district CDC's 342 yuan. In this respect, Wujin District CDC staff explained that the Jiangsu Provincial Price Bureau and the Changzhou Price Bureau of Rabies vaccine has not set guidance. Vaccine manufacturers and all levels of CDC have the right to set their own prices, but the CDC will refer to the highest retail price of rabies vaccine. Interestingly, the data was not approved by the authorities, but by the manufacturers themselves.　　At present, the highest retail price recommended by Liaoning Province is 348 yuan. After the production enterprises and disease control system benefits of food, a cost of less than hundred million rabies vaccine, the price has quadrupled.　　This can not help to promote the "can't afford the vaccine" group into the black market, thereby nourishing more production of "bottled saline" outlaws. At a loss, statistics showed that 8376 of the 10902-person rabies vaccine had gone to the country and had been used.　　One night, more people had the same worries about peace and national day.　　At the edge of the profit arena, standing with rabies vaccine as the last line of life of the vaccination. June 1, in Changzhou, Times weekly reporter saw 23-year-old Ping Chun, he is to do not vaccinate rabies vaccine and entanglements. A few hours ago, the pet dog at home bit his finger, but the wound was small.　　He was well aware that only 10% of normal dogs had rabies in their saliva, and that the virus had a latent cycle of up to 10 years, but once it had a 100% mortality rate. Because rabies can be defended and not treatable, the vaccine is the last defensive barrier. However, the reason why the Ping Chun is unwilling to spend the money is that, first of all, the fare increase is too fast. "Five years ago, in Nantong, Jiangsu Province, a man of rabies vaccine, dozen 5 needles, 100 or so; two years ago, in Nanjing, more than 200, now, Changzhou's market prices are more than 300."　　"Ping Chun to the reporter described his experience of the price increase." He agrees with Gao Chunfang's view that imported rabies vaccines, though expensive, are expensive to protect against the safety and potency of vaccines, while China's rabies vaccine is distributed in the interests of manufacturers, disease control systems and wholesale enterprises, sometimesEven at the expense of vaccine quality. In fact, Ping Chun's resistance to "rabies vaccine" mainly by its Shancheng in Guangzhou, Cousin Pingguoqing (alias) influence. Last July, Ping National Day in rural countryside was bitten by dogs, in the local hospital spent more than 300 yuan, played 5-pin rabies vaccine.　　Several months later, because of the headache and went to hospital treatment, he suddenly learned that he was vaccinated unexpectedly is Jangsujenschen problem vaccine. Although Ping National Day in February this year received the CDC's free replant, also saw different medical experts repeatedly affirmed the effectiveness of the replant, but he has been uneasy.　　No one tells him what to do if he or she will be ill and how to treat it. May 15, the National Drug Administration reported the Jenschen, the blessing of the "problem people with rabies vaccine" incident treatment results, including two enterprises are fined 25637905.6 yuan and 5638284 yuan.　　This amount is in accordance with the relevant provisions of drug management, confiscated enterprises illegal production and sale of inferior people with rabies vaccine and illegal income, according to the value of the amount of 3 times times the fine calculated.　　At the same time, the results of the treatment of consumer interests in only one, by the Jenschen, the company to bear the quality of the vaccination of inferior human rabies vaccine replant costs.　　In the view of Ping Chun, the Drug Administration department clearly calculated the profits of enterprises in the process of illegal income, but so far did not understand the vaccination of the "illegal loss." On May 26, when the Wusheng issued a recall order, statistics showed that 8376 of the 10902-person rabies vaccine had been diverted to the country and had been used. One night, more people had the same worries about peace and national day.