Text/ Wang Chunxiao
Children over 1 year old suffer from a rare epilepsy disease and the family is already overwhelmed. When the young mother, desperate to save her son, bought a drug called Clopazan, she unexpectedly became a "drug dealer".
"How do we keep our children alive?" At the end of November, more than 1,000 parents of children with rare epilepsy sent letters of help, urgently seeking "chloobalcan" and calling for deregulation - whether illegal purchases of overseas drugs can be saved first.
Thousands of parents asked for help under their real names. Photo/Courtesy of respondents
It is understood that clopajan is often used to treat several special types of refractory epilepsy, which can effectively control seizures and has been listed in many countries in Europe and the United States. In China, the drug belongs to the second class of psychotropic drugs and is strictly controlled.
For the parents of these children with epilepsy, they can only buy chlorpachan through purchasing agents or overseas direct mail. However, in recent months, with the development of China's crackdown on drug-related activities in the delivery channel, customs in many places have begun to strictly control and seize the entry of chlorambuzan. Until November, the mother of a child with epilepsy in Zhengzhou was accused of "drug trafficking", which in turn aroused public concern.
After the medicine is not available, more and more children are at risk of discontinuation. In the group of more than 1500 patients, parents can only "continue to live" for their children by borrowing drugs and reducing drugs, but this is not a long-term solution - the most drug margin can only be maintained for two or three months, at the same time, some children have relapsed with epilepsy because of lack of drugs.
After a lack of medication
After writing the letter of help, the anxiety of parents became more and more obvious. In the "Clopazhan Patient Group" with nearly 1,500 people, the largest drug margin can only be maintained for two or three months, and some children have had to reduce and stop drugs.
By December 9, Li Juan (pseudonym) in Wuhan had only a box of half-chlorappa in her hand, enough for her daughter to eat for a month. A few days ago, when the daughter opened the pill box, she accidentally scattered a piece, as usual, the child picked up the "dirty" pill and prepared to throw it away, Li Juan gently stopped it. "It's equivalent of tightening the belt of her pants and living a life, and she (daughter) doesn't know that the medicine she has to take every day is almost gone."
Li Juan's daughter was diagnosed with "infantile spasms" when she was 8 months old. A few years ago, the attending doctor recommended clobats to her, and after the first week of trial, the daughter's condition basically did not see a significant attack, and after a small amount of dosing in the second week, the condition was gradually controlled.
Children are given chlorpazam on the advice of their doctor. Photo/Courtesy of respondents
Today, her daughter is 10 years old, and although the EEG has not completely returned to normal, everything is developing in a good direction under medication and rehabilitation.
Suzhou Lulu's daughter Xiaole suffers from refractory epilepsy, and when the disease occurs, symptoms such as nodding, drooling, and convulsions will occur. After seeking medical treatment in many places, a well-known neurology expert in China also suggested trying clobats, but this drug "can only think of its own way".
Like Lulu, many parents of children use drugs under the advice of doctors, and they also obtain clobats through the children's family members or purchasing agents. Parents said that the price of a box of chlorpagogon is about 300-500 yuan.
A few months ago, however, the life-saving chloebazan suddenly changed. At first, the price rose, and by September, many purchasers removed Chloebazhan from the shelves. Later, the parents of the children themselves found overseas pharmacies and sent them back to China by direct mail, but the package was detained by customs.
According to the information released by the official microblog of the General Office of the General Administration of Customs, since July this year, Luzhou, Jinan, Hohhot, Wuhan and other places have successively seized varying amounts of chlorinated chlorambucan.
A number of parents of the children revealed that similar situations have occurred in various places recently. After receiving the package, some parents were taken to the record by the police on suspicion of "smuggling drugs"; some parents received a notice after the package was detained by customs, asking for a declaration of abandonment.
After 10 days of the letter of help, things still did not go to rest. On the one hand, the drugs are seized by the customs, on the other hand, a large number of children with epilepsy are facing the crisis of drug discontinuation, and the number of families of children following the news is still increasing.
Mei Li (pseudonym), chief physician of the Department of Neurology of a children's hospital in China, told China News Weekly that if the condition can be effectively controlled after taking chlorpachan, once the drug is suddenly stopped because of the discontinuation of the drug, the epilepsy may re-attack, which will not only affect the long-term treatment of the child, but may even aggravate the condition.
In fact, there have been accidents. Some parents posted the video of the child's illness after stopping chlorobazhan to the patient group, and Li Juan looked at it with a heart-wrenching feeling, "In case the drug is stopped, what should my daughter do?" ”
"Irreplaceable"
After the lack of medicines, the families who have no way to buy themselves can only save themselves.
Earlier, Li Juan divided her daughter's chlorappa into a box to the patients in the group, who had completely cut off the drug, and the condition was not very optimistic, and it may convulse for an hour when it is severe. LuLu chose to halve the medication, although this was not the doctor's recommendation, but she really had no way, and there was less than one box of chlorinated baba at home.
After the purchase of chlorpachan was restricted, parents did not think about changing the dressing. There are many domestic anti-epileptic drugs, such as debakin, totalide, kaipurlan, lamotrigine, phenobarbital, prednisolone, etc., but in fact, many children have tried it. "Either it doesn't work, or the side effects are too great," Ms. Li said, before she thought of using chlorpachan.
It is understood that Clopajan was first listed in the Philippines in 1967, and at the end of 2011, Chlorpachan was approved by the US Food and Drug Administration (FDA) and listed in the United States in 2012. The drug is now available in the Uk, France, Germany, India and other countries. At present, in China's Catalogue of Psychotropic Substances (2013 Edition), chlorphazhan belongs to the second class of psychotropic drugs and is strictly controlled.
Mei Li introduced that clobats belong to the benzodiazepine class of drugs, often used to treat several special types of refractory epilepsy, which can effectively control seizures. At present, in the domestic anti-epileptic drugs, there are clonazepam, nizepam, diazepam, etc., but it belongs to the control of the second class of psychiatric drugs, some children have not obtained the desired effect, and improper dosage or method may cause side effects.
Under normal circumstances, when doctors need to use similar drugs in the condition, they usually try other benzodiazepines such as clonazepam and nizepam first, "after the effect is not satisfactory or drug resistance develops, it is recommended that patients go to overseas Hong Kong, Macao, Taiwan or foreign countries, and prescribe the use of clobats after diagnosis and treatment by specialist doctors." In the treatment of some epileptic encephalopathy, Chloebazan can be said to be irreplaceable," Mellie said.
In the year and a half before taking chlorpachan, the doctor prescribed many drugs such as lamotrigine, ciboline, topiramate, and kaipuram for Xiaole, and also tried ketogenic treatment, "The best time was that there was no seizure for half a year, and then it was serious, and there were several seizures in a day." If the center of gravity is unstable, it is easy to fall, and the child is either blue here or swollen there. Lulu said.
Until April 2019, Xiao Le's condition recurred. It was also during this visit that the family learned about Chloebazan. Later, Xiao Le ate chloepazhan for more than a year, and his condition changed visible to the naked eye, gradually controlled, and he could even say one or two more words.
For the effect of clonazepam, Lulu is also deeply impressed. After eating chlorpachan for a while, she changed clonazepam for Xiaole at the suggestion of another doctor, and it wasn't long before the drawbacks appeared: her daughter's body was always soft and soft, and the saliva began to flow continuously, "just like hanging a water bottle, I really can't stand it and change it back to Klobazan."
At present, if clobatazam is exchanged for clonazepam, Lulu does not dare to imagine what the consequences will be.
Mei Li had treated 40 patients with refractory epilepsy in one day, and she found that more than half of the children had taken clobats on the advice of her doctor.
In order to avoid the risk of sudden drug discontinuation, she planned in advance to reduce the drug for these children and switched to clonazepam, "this is no way." Mei Li said that some children were well controlled and could walk freely; after switching to clonazepam, they were weak and had to travel in a wheelchair.
Drugs or life-saving drugs?
For children and families with epilepsy, chlorpazam is a lifesaver, but under existing regulations, clopajan belongs to the second category of controlled psychotropic drugs. There is no formal purchase channel, buying drugs from overseas, and it is possible to become the next "drug trafficking mother" at any time.
In November, after the alleged "drug trafficking" of the mother of a child with epilepsy in Zhengzhou attracted attention, the prosecutor found her guilty of "smuggling, transporting, and trafficking drugs" and refused to prosecute him because the circumstances of the crime were minor. Lu Lu and Li Juan could not understand, "How can the medicine for treating children be related to drugs?" ”
Zeng Wenyuan, associate professor of the Chinese Min public security university and deputy director of the Research Center for Food, Drugs and Environmental Crimes, once mentioned that as a national second-class psychotropic control drug, chlorphazhan is indeed in the category of "drugs" stipulated in the criminal law, "chlorpalocyan is addictive and will make people dependent, which is beyond doubt." ”
However, Wang Xuefeng, executive director of the Chinese Anti-Epilepsy Association and chairman of the Drug Therapy Committee, said in an interview with the Beijing News that clopazan and heroin are not only far different in composition, but also, according to his thirty years of medical experience, chlorpachan's addiction is not strong, and it will not have a negative impact on the mental state of the user. ”
Mei Li also mentioned that in China, clonazepam and phenobarbital are also class II psychoconsiderate drugs and have been legally listed for many years. Doctors strictly limit the amount of medication when prescribing, and only prescribe a maximum of 7 days. "If clobats are drugs, what do other psychotropic drugs say?"
In the view of Wang Hongbing, a lawyer at Beijing Yingke (Guangzhou) Law Firm who focuses on the defense of major drug cases, according to the relevant provisions of the Criminal Law, the Anti-Narcotics Law and the spirit of the Minutes of the National Symposium on the Trial of Drug Crimes in Courts, one of the attributes of drugs is determined to be illegal use. If clobasan is used for medical treatment, it is a drug and does not meet the characteristics of the illicit use of drugs.
"If the purchaser sells the smuggled clobats to the patient's family, rather than to drug addicts or drug offenders, it does not constitute the crime of drug smuggling, because at this time chlorpakan is not a drug, but a drug, which is used to treat diseases." Wang Hongbing said.
After the drugs were detained by the customs, several parents sent out the children's medical records, prescriptions, etc. together with the chlorinated package, they were released, and finally got the medicine; one parent found after the news report that the package, which had been at the customs for many days, suddenly had a logistics progress.
Seeing these news, Li Juan felt envious, but this is only the luck of individuals, for this group is only a drop in the bucket, more people are still facing the risk of drug discontinuation. At the same time, some of the children's families are still under police investigation.
"We buy medicines just to treat our children." Li Juan said that if chlorobazhan needs to be reported and supervised as a control drug, parents are willing to cooperate, but now there is no channel.
After the letters of help from more than 1,000 clobats attracted attention, some patient organizations, hospitals and other organizations also began to appeal. Letting children "live" is their most simple idea.
In 2017, China issued the "Second Batch of Recommendations for Encouraging R&D and Declaration of Children's Drugs", which includes chlorobazan. According to the official website of the Drug Evaluation Center of the State Drug Administration, on November 30, 2020, Yichang Renfu Pharmaceutical's application for imitation of clopazhan tablets has been accepted.
However, when domestic generic drugs can be listed, this still needs to be a question mark.
In addition, it is also possible to solve the urgent need for drugs in the clinic of a rare disease through temporary import channels. For example, in 2019, mitotan tablets officially entered Peking Union Medical College Hospital. This was the first time in China.
Relevant reports mentioned that in the process of one-time import declaration of mitotan tablets, multiple departments of Union Hospital jointly drafted more than ten documents, which were approved under the joint efforts of the national government, health administrative departments and drug supervision departments for nearly 10 months.
Obviously, these methods are difficult to solve the urgent need for children with rare epilepsy to be discontinued. "Our children can't wait that long", at the moment, Li Juan is quite helpless.