Paralysis caused by Shenyao: Ganglioside Injection is safe and effective and is tortured again

 Paralysis caused by Shenyao: Ganglioside Injection is safe and effective and is tortured again

Picture / Photograph by Gan Jun

It has cost 400,000 to 500,000 yuan, and now it cant be cured. It cant be cured. At that time, I had no idea what gangliosides were for. Later, I learned that many diseases of gangliosides were in use. On August 13, 39-year-old Zhang Fan told 21st Century Economic Reporter that he was hospitalized in April 2018 with an injured arm in a car accident, but did not expect to eventually be identified as Guillain-Barre syndrome, which has been paralyzed for more than a year. There are three elderly people and two children in the family to take care of, and now only one wife supports him.

Two months ago, Zhang Fan was pulled into a group of more than 80 patients with Guillain-Barre disease. These patients were exposed to the disease for many reasons. Some were slightly injured in traffic accidents, some were treated for cerebral infarction, and some were just fallen. But they were all injected with gangliosides in hospitals and a few days later. Paralysis within days.

In November 2016, the former State Food and Drug Administration (CFDA) issued an announcement in which it added warning slogans: Postmarket surveillance of drugs at home and abroad found acute inflammatory demyelinating polyneuropathy (also known as Guillain-Barre syndrome) associated with the use of ganglioside products. Case.

Sales of these medicines exceed billions of dollars, but many patients with Guillain-Barre syndrome are not aware of their adverse reactions, and relevant manufacturers have not counted the cases of adverse reactions to the drug, and it is not clear how many victims there are in the country.

However, many patients with Guillain-Barre syndrome who have injected ganglioside have spent a lot of money on the treatment of their diseases. In the 21st century economic reports, the patients interviewed by reporters spent an average of more than 300,000 yuan, some even spent more than 1,000,000 yuan, and many of them are like Zhang Fanyi. Abandoning treatment for economic reasons.

Wang Zhanquns wife, Liu Yun, is also a patient with Guillain-Barre syndrome. She was paralyzed by injections of ganglioside and other drugs during her medical treatment. So far, more than 300,000 yuan has been spent on treatment. There are several patients with Guillain-Barre syndrome near his home.

When the 21st century economic reporter asked whether there was a claim for compensation, Wang Zhanqun said that he had not yet talked about it, and now the first appeal is to cure diseases and save people. But he said that the country is now rectifying the magic pills in the hope that they will disappear completely and not harm more families.

Shenyao is referred to as the cause of paralysis

On April 30, 2018, Zhang Fan himself went to a coal hospital in Shanxi Province because his arm was injured in a traffic accident. But after 5-6 days of injecting ganglioside, his legs and arms felt uncomfortable and weak. Then he returned from Shanxi to Pingshan County, Hebei Province, where he was hospitalized for one day, and the doctor used the medicine again. Aggravated, and then to Hebei Province Second Hospital in intensive care unit, diagnosed with Guillain-Barre syndrome, but the hospital still gave him the drug for a week.

I spent more than 20,000 yuan in Shanxi Hospital, then spent more than 200,000 yuan in the second hospital, and then returned to Pingshan County Hospital for more than 10,000 yuan, and then spent more than 100,000 yuan in the county hospital, because I am a poor household, I can see a doctor before paying money, but now I have been treated for more than a year, I cant get rid of it. There are old and young people in my family, only wives. Zi is doing some small business to make money to support his family. Zhang Fan said helplessly.

Only two months ago, Zhang Fan knew that the biggest cause of Guillain-Barre syndrome, which paralysed him and cost a lot of medical expenses, was the injection of ganglioside. Zhang Fan also entered a group of patients with Guillain-Barre syndrome and found that they had a common feature: they injected ganglioside just like themselves. Lipid drugs, and the paralysis caused by the drug is not known.

On April 30, Wang Zhanquns wife Liu Yun, 46, went to the Eastern Hospital of the Fourth Hospital of Hebei Medical University to undergo thyroidectomy, and everything was normal after the operation. On May 9, Liu Yun recovered basically, but when she got home, Liu Yun had some numbness in her limbs. The next day, her limbs were limited in movement. She was paralyzed in the early morning of May 11. She was later diagnosed as Guillain-Barre syndrome, and was deduced by doctors that ganglioside was the inducement.

On November 29, 2018, Zhang Tianjun, 69, was hospitalized for cerebral infarction, during which his symptoms were controlled, but finally confirmed as Guillain-Barre syndrome, during which he was injected with gangliosides.

There are also several paralysed patients hospitalized with my husband. We communicate with each other. The general situation is that the disease happens in this way. Later, we found the instructions for medication, side effects, symptoms and so on are completely consistent with the situation of these patients. Zhang Tianjun told the 21st Century Economic Reporter that his older husband is a little weak to take care of, including treatment, nursing workers and other expenses in addition to medical insurance reimbursement, a total of more than 300,000 yuan.

Guilan-Barre syndrome, which paralyzes Zhang Fan and Liu Yun, is a demyelinating disease of the spinal and peripheral nerves. In critically ill patients, complete paralysis of the extremities, paralysis of the respiratory and swallowing muscles, resulting in dyspnea, dysphagia and life-threatening.

And they have injected ganglioside. The director of Neurology Department of a third-class A hospital in Beijing introduced to the 21st century economic report reporter that the drug treatment for acute and chronic cerebrovascular diseases such as stroke, Alzheimers disease, craniocerebral trauma, spinal cord injury and other causes of central nervous system injury, in clinical neurology doctor base. Ben didnt use this medicine. There is no valid evidence to prove its efficacy, nor is there any valid evidence to prove its safety.

As early as last century, gangliosides have been removed from shelves by many countries, and have been regarded as experimental drugs by FDA. Gianluca Landi, an Italian scholar, has also published an article reminding us that the use of exogenous gangliosides is closely related to the occurrence of Guillain-Barre syndrome.

In November 2016, the former State Food and Drug Administration (CFDA) issued an announcement in which it added a warning saying: Post-marketing monitoring of drugs at home and abroad has found acute inflammatory demyelinating polyneuropathy (also known as Guillain-Barre syndrome) that may be related to the use of ganglioside products. Case. If the patient has symptoms such as holding disability, limb weakness and flaccid paralysis during the period of medication (usually within 5-10 days after medication), he should consult the doctor immediately.

Although the former State Food and Drug Administration has issued warnings on the use of gangliosides, many patients with Guillain-Barre syndrome interviewed by economic reporters in the 21st century said they did not know before, and the other patients they knew did not even know the doctors who treated them. Taoist countries have revised the instructions for such drugs.

And from the sales point of view, the sales of such drugs are still hot. Clove Garden Insight database shows that ganglioside sales in 2018 approached 4 billion yuan, which is also a ganglioside drug encephaloside inosine, and sales in 2018 reached 2.2 billion yuan.

It is also understood that gangliosides have entered the list of key drug monitoring (auxiliary drugs) in several provinces in order to strengthen rational drug use, effectively control the unreasonable growth of medical expenses and reduce the proportion of drugs.

The first batch of the national edition catalogue lists 20 kinds of Western medicine, focusing on nervous system, immune system and other fields. Statistics from databases of several sample hospitals show that sales of these drugs reached 40 billion to 60 billion yuan in 2018.

Compensation mechanism needs to be improved

The data show that gangliosides are related to Jilin Step Pharmaceutical Company, Qilu Pharmaceutical Company, Jilin Four Rings Pharmaceutical Company, Jilin Yinglian Biopharmaceutical Company and Heilongjiang Harbin Medical University Pharmaceutical Company. The two gangliosides used by Wang Zhanquns wife were produced by Jilin Step Pharmaceutical Company. When asked whether there was a claim for compensation, Wang Zhanqun said that he had not yet talked about it, and now he took curing illness and saving people as his first appeal.

In this regard, the 21st Century Economic Reporter called Stepped Pharmaceutical Securities Office, and the relevant person in charge said that the Stepped Pharmaceutical Ganglioside Pharmaceutical Instructions had been revised, and made relevant prompts. At present, the company has no relevant information on compensation for patients.

It is also known that several manufacturers producing ganglioside drugs have not provided monitoring information on adverse reactions of related drugs after marketing.

The director of the medical device Department of Beijing Eurasian Yongwen Law Firm analyzed to the 21st century economic reporter that this case belongs to the disputes of drug quality in law and can be divided into two categories: drug defects and adverse drug reactions. The relevant provisions of the Product Quality Law and the Tort Liability Law can be applied. If the instructions have indicated the adverse reactions, scope of application and contraindications of drugs, the responsibility of the manufacturers will be reduced, but the hospital also has a certain responsibility, which belongs to the scope of liability investigation for medical errors.

Zhang Fan told 21st Century Economic Reporter that only four or five of his patients are currently entitled to 50% compensation for treatment costs. Even if compensated, it will be a great blow to a family, and doctors say that the disease is life-long affected, many can not be cured.

Zhang Li, a lawyer of Zhejiang Xinmu Law Firm, told the 21st Century Economic Reporter that, in addition to vaccines and drugs, there is no special legislation on the compensation or compensation system for adverse drug reactions in China. Therefore, victims need to claim their rights according to tort liability law, product quality law and so on.

However, due to the premise of the definition of ADR is qualified products, it is difficult for the victims of ADR to obtain compensation from the drug producers within the current legal framework. There are two main reasons. One is that the consequence of damage (Guillain-Barre syndrome) is caused by drugs, which is difficult to prove. Second, the approval of the State Pharmaceutical Supervision Department does not belong to the product quality defect stipulated in the product quality law, and the product quality defect is the premise of personal injury compensation.

From the point of view of tort liability law, if the causal relationship between the consequences of damage (Guillain-Barre syndrome) and drugs can be proved, the victim may consider that the medication risk of ganglioside from medical institutions, such as the existence of damage to Guillain-Barre syndrome, is not done to the patient. Informing damages the patients right to know and to choose, thus advocating the liability for damages.

In Zhang Lis opinion, it is obviously unfair to let patients bear all the risks of drug use. At present, China has established a compensation and compensation system for adverse drug reactions of vaccines. It calls on the state to establish and improve the compensation or compensation system for other adverse drug reactions at the legal level as soon as possible.

As for the problem of compensation for adverse reactions, the president of Beijing Tongren Jingyuan Hospital, Masenbao, also put forward the idea of establishing insurance mechanism to solve this problem. He said that at present, medical accident risk insurance is mainly established for surgery. If adverse drug reactions are included in accident risk insurance, it can reduce the loss of the parties, help to resolve some contradictions and build a more harmonious doctor-patient relationship.

Wang Yue, deputy director of the Department of Health Law, Peking University Medical Department, believes that in the absence of regulations on drug damage compensation, we should learn from the practices of other countries to establish a compensation and relief mechanism for adverse drug reactions as soon as possible and set up a China Fund for Research and Development of Adverse Drug Reactions and Relief to reduce adverse drug reactions. The economic losses and risks of the responding parties without fault. The source of the fund can be three aspects: drug reserve or risk fund for drug manufacturers or importers; government subsidies; and social donations. (All the patients in this article are aliased names, and my intern, Karen Tao, has contributed as well.)

(Editor: Zhang Xing)

Source: Liable Editor of 21st Century Economic Report: Yao Liwei_NT6056