Fight for Spinraza
39-year-old Muscovite Vitaly Belenky has been working as a programmer for over 20 years: “I really love my job, for me it is an inexhaustible source of interest.
At first I worked in a small company of seven people, and then it grew to 600 employees.
I had the position of technical director, there was a whole department subordinated to it.
For some reason, including my deteriorating health, in 2016 I decided to switch to freelance.
Now I work as a back-end developer, making technical solutions for a specific business, in my case, online stores. "
Vitaly has a second type of spinal muscular atrophy.
The disease was diagnosed when he was a year and seven months old - parents noticed that their son could not run, walk fast and often fell.
By SMA standards, the young man did not sit in the stroller for a long time.
Only at the age of 15 did he realize that he could no longer walk on his feet.
“I remember how my grandmother in a village in the Altai Territory had a friend who rode a bicycle to the river, but I could not and I was offended.
There were four steps at the entrance to the school, which I could not climb without help.
If there was no one next to me, I myself would change from one step to another.
On September 1, in seventh grade, I was late for all my lessons.
Probably, it was then that I felt the very first limitation due to illness.
I didn't come to school anymore, I studied at home.
I was 13 years old, ”says Belenky.
From the age of 15 to 29, Vitaly's condition was stable, but in 2010, when Moscow was overwhelmed by smog, he lost some important abilities, for example, he could no longer dress on his own.
Since then, the man's health has only worsened, the situation was aggravated by a recent coronavirus infection.
Vitaly learned about the appearance of "Spinraza" - an advanced drug requiring lifelong use, but stopping the progress of the disease - even before the drug was registered in Russia.
He closely followed research and treatment outcomes in other countries.
In 2019, Belenky began collecting documents to receive medicine from the state.
First, he needed to confirm his diagnosis, for this he underwent a genetic examination at the V.I.
Bochkova.
With confirmed SMA, he went to the Research Center of Neurology, where he had to go through a lot of research to get the paper with the appointment of therapy.
Due to the outbreak of the pandemic, Vitaly received a certificate that he was indicated for Spinraza treatment in August 2020.
© Photo from personal archive
After receiving a prescription for the drug, Vitaly turned to a neurologist at the district polyclinic for help in organizing the administration and receipt of Spinraza.
Only in December 2020, the man received a letter from the chief physician of the clinic that he would not be able to inject the drug.
At the same time, Vitaly wrote letters to the Moscow Department of Health with a request to provide him with medicine, and together with a lawyer, they drew up an appeal to the prosecutor's office with a request to understand the situation.
Belenky received a refusal from both departments.
In April 2021, Vitaly filed a lawsuit against the Moscow Department of Health.
The day before the preliminary hearing, he was sent a referral for hospitalization at the City Clinical Hospital.
Veresaev for examination and determination of the schedule for the administration of the drug "Spinraza".
"They said that the treatment is inappropriate"
“I was hospitalized without any problems. The hospital had good conditions, they did massage, exercise therapy, and gave vitamins. They even allowed my mother to be nearby. I was admitted to a non-core department and my doctor was a neurologist, with whom I was the second patient with SMA. The first week I was fully examined. The main study was electromyography, which shows the condition of muscle fibers and the potential in them. The remaining two weeks we waited for a commission and a conclusion, and the day before discharge, the chief freelance neurologist of Moscow came and said that the treatment was inappropriate, ”says Belenky.
There were two reasons for refusal: lack of muscle potential and lack of clinical studies of Spinraza in adults.
At the commission, Vitaly was offered to undergo the tests again, but for people with SMA, even a year matters.
After all, their muscles constantly, every day, lose functionality.
© Photo from personal archive
“I was pretty crippled closer to 30 years old. Then I realized that I would not be able to plan my life in any long term, even at least five years in advance due to my health condition, because I simply cannot rely on my body. I would like to continue to be realized in my career so that I have at least the opportunity to think about children. All this destroys the feeling of life, - says the interlocutor of RT. - If there is a medicine, they don't give it to you, and I don't even know what emotions this situation causes in me. This is not anger, not anger, but rather just misunderstanding. I think every adult with SMA feels about the same thing as me. "
Vitaly wants to find his love.
He has a positive example, which he talks about with great inspiration: his friend with SMA (who is also not given the prescribed medication yet) only moves his neck and fingers, but at the same time he works, provides for his family and plans children with his wife.
Belenky hopes that the situation with the medicine will be resolved, and that the court will be on his side: the next session is scheduled for August 5.
Vitaly does not plan to open a collection for an expensive medicine: “I am not the kind of person to ask for money.
Collecting 20 million each year will be my only occupation in life, but even without treatment I have something to lose. "
"Vicious circle"
Marina Lisovaya moved from Orenburg to Moscow in 2015, when her mother, an English teacher, was offered to transfer to the capital. Marina says that she likes Moscow much more than her hometown, in particular, the abundance of concerts and events that she loves to attend. Now 25-year-old Lisovaya works as a tutor in Russian language and mathematics for primary school students, works with children on Zoom. “It's a lot of fun to work, especially when students get good grades and understand the material better,” she says. She also loves to embroider and collect puzzles.
Marina also has a second type of SMA.
The first signs of the disease appeared when Lisova was ten months old, although the doctors at first told her parents that the girl simply didn’t like to walk, she liked to crawl and had to wait.
Soon Marina's hands began to weaken, she could no longer raise them high.
At the age of 15, the girl underwent an operation in Finland: the curvature of her back was corrected, a metal structure was installed and her body was extended by 15 cm. The authorities of Orenburg helped with the payment for the operation.
Marina says that the surgical intervention not only improved her health, but also added self-confidence, which is sometimes badly lacking in adolescents, and even those with disabilities and disabilities.
Now the girl does not raise her arms, lately her back, neck and pectoral muscles have weakened, and the volume of her lungs is 41% of the norm.
“I followed Spinraza from the very beginning of its appearance on the pharmaceutical market.
Two years ago, when the medicine was registered in Russia, I was still in no hurry, because I knew that the children would be the first to receive the medicine.
In addition, I wanted to see how the families of the patients would pursue the drug.
It turned out that everything is not so simple, this can only be done through the courts.
When the procurement situation more or less stabilized, I turned to my district polyclinic, where they gave me a referral to the federal center of neurology in order to get an appointment for the drug, ”says Lisovaya.
© Photo from personal archive
Vitaly Belenky and Marina Lisova have a similar situation. In March 2020, the girl also began to undergo tests to confirm her diagnosis. And only in November, following the results of the commission, she was given an appointment for the introduction of "Spinraza" for health reasons, attached to it a calculation of doses for correct administration and a schedule. It would seem that Marina only needed to come with an appointment from the federal center to the district clinic - and they would buy a drug for her. But in the clinic, the girl was told that they did not know how to treat adults with SMA, and was given a referral to the chief freelance neurologist of the Department of Health.
In February 2021, Marina came to see a doctor. “I was told about the dangers of lumbar puncture and the side effects of Spinraza for almost an hour. For example, bloating, nausea and dizziness. But it didn't scare me, compared to my illness, such side effects are nothing. As a result, the neurologist wrote to me in the conclusion that because of the danger of the consequences of taking the drug, it would be better for me to contact the federal center. I wrote to there with a request to give me a lumbar puncture, to which they told me that any neurosurgeon or neurologist could do it, and that this should be done on the basis of a municipal or regional medical center. Then some kind of vicious circle began, ”the girl explains.
Marina turned to the Moscow Healthcare Department with a request to buy her a medicine, since the drug was prescribed to her by the neurology center.
There she was told that since she had filed a refusal from the medicine in favor of monetary compensation in the amount of 863 rubles a month, they could not purchase it.
The girl refused payments in the Pension Fund.
But even this did not come close to the purchase of "Spinraza".
In April 2021, Marina filed a lawsuit against the Moscow Department of Health.
The law gives a month for scheduling a hearing, but the deadline was not met for unknown reasons.
"The beginning of the battle"
On May 26, 2021, Marina Lisova received a call from the head of the district polyclinic and said that she had been given a referral for hospitalization at the City Clinical Hospital.
Veresaev for the purpose of examination and clarification of the schedule of administration of the drug "Spinraza".
During the first week, Lisova underwent a full examination.
The second week the girl waited for the council to meet.
“About ten people came to my ward, gathered in a circle around me and began to ask what I do, who I work, whether I receive wheelchairs from the state, whether I underwent rehabilitation,” she says.
- That is, nothing that would concern my health.
Then they looked at my back and left.
In the evening of the same day, it turned out that they could not come to any conclusion. "
Lisovaya asked for a copy of the medical report: “According to the head of the neurosurgical department, my back is suitable for lumbar puncture. He verbally confirmed to me that it is possible and not so scary. As a result of muscle research, it was clear that my muscles are alive and there is potential, and this is a direct indication for drug administration. "
Marina waited another week for the conclusion from the council. At the end of the third week, the chief freelance neurologist of the Department of Health arrived and said that treatment was not advisable. “The first reason was the alleged impossibility of making me a lumbar puncture. I began to explain that I had spoken with a neurosurgeon, he said that it was possible. Then I was told that my muscles were too weak, but research showed that there was potential there. They did not answer me anything, but they added that even if I have a federal appointment for the administration of the drug, the region has its own opinion on this matter and it is inappropriate to treat me. In simple terms, they sent me home to die slowly, ”says Lisovaya.
After the consultation, Marina received the protocol of the medical commission.
In the conclusion of the neurosurgeon, it was written that only a single lumbar puncture is possible, and not regular.
At the same time, says Lisovaya, you can put the pump at the injection site and give an injection through it.
Also in the protocol it was written that pathogenic therapy in the condition of the girl's muscles is inappropriate.
© Photo from personal archive
Another reason for Marina's refusal was the lack of clinical trials in adults, since only children participated in the drug studies, although there are no age restrictions in the instructions for "Spinraza".
Moreover, in the protocol, the doctors wrote that treatment is impossible not only with Spinraza, but also with Evrisdi (this medication for SMA patients is taken orally), although there was no question of the second drug during the examination.
“Why did they have to deny me two drugs at once?
Apparently in advance, ”Lisovaya reflects.
While Marina was in the hospital, the court appointed the first hearing.
Representatives of the Moscow Department of Healthcare did not attend, but the lawyer managed to convey his arguments to the judge.
The next session, scheduled for July 9, had to be postponed due to the judge's illness.
“I have a fighting spirit and I see no reason to give up.
When I went to the hospital, I knew that this was the beginning - either of treatment, or of a big battle, which I have now entered into and will go to the end.
If they don't give me medicine, I can move abroad and seek Spinraza there.
Although I really don't want this, I love my country, I like people and mentality, ”says Marina.
The main goal, the girl continues, is to start treatment and stop losing her skills: “I have many plans for life, I want to master the profession of an editor, after all restrictions have been lifted, go to concerts again, fall in love.
I have the strength, desire and desire for life.
It is important for me to get a cure, because after me other people with SMA will also do it, and a positive example, especially in such a situation, gives strength. "
"Awesome injustice"
Farit Akhmadullin, the president of the To Save and Preserve Association, a lawyer for Marina Lisova and Vitaly Belenky, said that when his clients were routinely hospitalized, he was sure that they would be provided with a drug: council, so there was a discrepancy with the federal opinion.
If we fail to win in the first instance court, then let's move on.
We will submit documents to the European Court of Human Rights for interim measures, because we have expired the procedural period for consideration, and in connection with the violation of the rights of a disabled person, ”the lawyer explained.
According to Olga Germanenko, director of the SMA Family Foundation, adult patients with spinal muscular atrophy in Russia are in the most vulnerable position.
“Most of them are successful people. They work, pay taxes and are full-fledged citizens; they do not just sit and receive a disability pension, but bring benefits. But the regions refuse them to buy medicine. And the refusal to purchase drugs for them, the deprivation of guarantees that are given in accordance with the law is a tremendous injustice, ”she notes.
The big problem, according to Germanenko, is the discrepancy between the federal and regional levels. “When the President of Russia gave instructions in July 2020 to create the Circle of Kindness fund, he set not one task, but two. The first is to organize in the shortest possible time a mechanism that will provide children with serious rare diseases with the help they need. Second, the foundation acts as an additional source of assistance to children. Legislatively, the region still has a duty to provide medicines to children and adults, and, as the President always emphasized, the level of these obligations in this regard should not decrease among the regions, and the funds freed up cannot be used to solve any other problems. "
Today, the situation with adult patients is exactly the same as it was with children before, only multiplied by its catastrophicness at least three times, the director of the fund believes: “Those who are 18 years old are faced with the problem of obtaining medicines, they no longer fall into the category children ”and under the tutelage of the“ Krug of Kindness ”foundation. In addition, the wards of the SMA Family Foundation, who have just turned 18 years old, are forced to interrupt therapy, as it turns out, for the only reason - they just grew up. "