Since the beginning of the year, the state has spent more than a billion rubles on homeopathy and drugs with unproven effectiveness. It is beneficial for large officials

Why is this text. From the author

From the very beginning of the Pandemia of Coronavirus, the Russians read the news that a new, poorly studied disease can be cured with old and well -known drugs. They inspired us: Arbidol showed the effectiveness against coronavirus, "" coronavirus can be cured by the Ural drug "Triazavirin".

People swept these medicines in pharmacies, and Russian hospitals spent budget millions on them.

And no one was embarrassed that most of the advertised drugs did not prove the effectiveness not only for coronavirus, but also for any diseases.

To prove the effectiveness of the drug requires a series of double blind randomized placebo-controlled studies: testing on thousands of people where the effect of the drug will be compared with the effect of the use of a frank dummy-a placebo. The results of these studies, if they are successful, are published in scientific journals and summarized in world -recognized reviews of reviews: Cochrane, literary database of Medline, reference books of the RXLIST type.

The dummy preparations, as a rule, have no such studies and publications.

New Gazeta analyzed the public procurement of drugs since the beginning of 2020. We found that 1,619,295,682 budget rubles were spent on drugs with unproven effectiveness.

How Russians are treated with molecules of milk sugar, who earns in ineffective medicines, and who lobbies them? What do doctors themselves think about using such drugs?

The necessary warning: before applying any drugs, consult a doctor.

Part 1. Viral antiviral

Drug treatment of any viral infections is a distinctive feature of post -Soviet medicine. In Western countries, not only SARS, but also light forms of influenza are recommended to be treated with peace, rinsing and plentiful drink. Effective drugs from “ordinary cold” do not exist, doctors emphasize.

In Russia, antiviral agents are sales leaders in pharmacies. According to the DSMGROUP study, in 2018 two of the ten drugs sold in retail - from SARS: Kagocel (sales volume - 6.7 billion rubles), Ingavirin (6.1 billion rubles). None of these drugs have proven effectiveness for international standards.

In Europe and the USA, no one heard about immunomodulators (antiviral drugs). And in Russia they are purchased not only by patients who hoped for a miracle, but also by state institutions.

So from the beginning of 2020, Russian hospitals spent 46,801,712 rubles on the purchase of Ingavirin . Among the leaders in public procurement are the antiviral drugs " Arbidol" (270 265 857 rubles) and " Kagocel" (30 694 754).

With the beginning of the pandemic, the volume of procurement at the expense of the budget has grown significantly, and not without the help of the state.

Nanima

On March 20, the Moscow Department of Health published a manual for the treatment and prevention of coronavirus infection, in which Kagocel was positioned as a medicine for the prevention of Covid-19. “It is carried out by seven -day cycles. 2 days, 2 tablets once a day, 5 days a break, then repeat the cycle. The duration of a preventive course is from 1 week to several months, ”the manual says.

Following the recommendations of the Department, the hospitals began the purchase of Kagotsel: from March 20, 179 auctions took place for a total of 26,326,608 rubles. At the same time, doctors doubt that the medicine really helps.

- There are no qualitatively conducted randomized studies on Kagocuev. Key work on testing this drug is not published anywhere. In my opinion, it is ineffective in the treatment of not only coronavirus, but also of any other viral infections, ”says Yaroslav Ashikhmin, a doctor-therapist, a medical and general science candidate.

The epidemiologist, Doctor of Medical Sciences and Vice-President of the Society of Evidence Medicine Specialists Vasily Vlasov agrees with him. He notes that there are no data on randomized research (RCTs) of Kagocel in international sources. In Russian magazines, only two RCTs are mentioned, to which there are serious questions:

• There were few participants in the tests - 81 and 60 (3,000 patients usually participate in international standards and more - depending on the research plan);

• The participants knew which drug was tested;

• And in 71% of the first test participants, the temperature normalized on the first day of taking Kagotsel (although the drug is not antipyretic).

According to the epidemiologist of Vlasov, not only the effectiveness of Kagotsel, but also his safety was not proved: “The active substances of Kagotsel - carboximethyl cellulose (CMC) and stateipol. Gossipol in free form is toxic and has the effect of long -term inhibition of spermatogenesis in men.

Kagotsel manufacturers say that the toxicity of this component does not matter, since the drug is not contained in the free, but in a “bound” form. In confirmation, the data of the experiments on the mice are given.

However, it is impossible to extrapolate these data on people. We cannot say that Kagocel is dangerous for a person, but at the same time we have no evidence of his security. ”

According to Yaroslav Ashikhmin, in the case of Kagocel, it is more likely not about the treatment of patients, but about doing business. The manufacturer of the drug, NIARMedik Pharma LLC, is one of the country's largest pharmaceutical companies (revenue in 2019 - 5.35 billion rubles). The company is a member of the NIARMedik group of companies, which is headed by the head of the Department of Immunology of the Research Institute named after N.F. Gamalei of the Ministry of Health of the Russian Federation Vladimir Nesterenko.

Kagotsel has good lobbyists: the effectiveness of the drug in its blog was defended, for example, Rusnano CEO Anatoly Chubais.

The state corporation headed by him in 2011 even bought a share (34.45%) at NIARMedik Pharma for 1.3 billion rubles (in 2013 sold it back to the pharmaceutical companies for 2.3 billion). Nothing personal, only business ...

-The argument of the Moscow Department of Health about the recommendation of Kagotsel is as follows: "We need to treat coronavirus with something." Well, if “something”, then why not a bird drop? - asks Ashikhmin. - The results obtained in the test tube are far from always broadcast on a person. If you tell you that with the help of Kagotzel coronavirus is suppressed in a test tube in chicken embryos, this does not mean that it will be suppressed in people. If you pour soda into chicken embryos, then the coronavirus will also be suppressed on them. But Soda is not a covid cure.

The Moscow Department of Health at the Novaya Gazeta request about the degree of efficiency of Kagotsel under Koronavirus did not answer.

Whose drug is needed

Another drug actively advanced during the pandemic, Arbidol , did not get into the recommendation of the Moscow Department of Health. But he got into the recommendation with a rank above - the Ministry of Health of the Russian Federation. And this is despite the fact that

Back in 2007, the Formolar Committee of the Russian Academy of Medical Sciences recommended that “immediately withdraw it from the list of drugs, as an outdated drug with unproven effectiveness.

In 2020, 270,265,857 rubles were spent from the Russian budget on Arbidol.

- Unlike Kagotsel, Arbidol - the Old drug (invented in 1974 - I.Zh. ), And should be well examined. However, his only serious randomized clinical study was interrupted for some reason, ”says Vasily Vlasov. - It seems that it showed a completely insignificant positive effect of the drug, which cannot be taken into account.

In February-March of this year, in China, on the basis of the eighth people's hospital, Guangzhou conducted an experiment during which 35 patients with coronavirus were given Arbidol, 34-a combination of Lopinavir+Ritonavir, and 17 did not give antiviral drugs. Doctors did not find the significant effect of drugs on the course of the disease: in 23.5% of patients taking Lopinavir+Ritonavir and 8.6% taking “Arbidol”, the disease passed from a moderate form to severe. Among those who did not take antiviral, such patients were 11.8%. At the same time, doctors revealed side effects in patients taking drugs: diarrhea, nausea and a decrease in appetite. In patients who did not take antiviral, there were no such problems.

Both Arbidol and Lopinavir+Ritonavir were included in the recommendations of the Ministry of Health of the Russian Federation for the treatment of coronavirus (the latter was excluded due to inefficiency only on September 3, 2020). At the same time, the recommendations say that there are no reliable data on the effectiveness of these drugs.

“We cannot say that“ Arbidol ”is a dummy, but we can say with confidence that there is no evidence of its effectiveness, and for some reason the manufacturer has not been conducting qualitative studies of the drug for many years,” says Yaroslav Ashikhmin.

The manufacturer of Arbidola (Umifenovir), Otisifarm, in 2013 was allocated from the pharmaceutical giant Farmstandart.

Both enterprises belong to billionaire Viktor Kharitonin, who is associated with a married couple-ex-Minister of Industry Viktor Khristenko and ex-Minister of Health of the Russian Federation Tatyana Golikova (now-Deputy Prime Minister, heads the headquarters to counteract the coronavirus in Russia).

Former Zamim Khristenko Andrei Reus and Andrei Dementiev conduct a joint business (generium JSC) with Kharitonin. When Golikova Minister, Arbidol was included in the list of vital and most important drugs (ZhNVLP). The billionaire himself in an interview with Forbes magazine (the only one in his life) to the question about the connections with Khristenko said: “Viktor Borisovich was the ideologist of the pharma 2020 industry, we, as the largest manufacturers, were involved in development, so we talked and continue to communicate to this day.”

The total net profit of the pharmaceutical companies Viktor Kharitonin in 2019 is 27 billion 070 million 860 thousand rubles.

In the popularization of the Arbidol, even President Putin played its role in the Russian market. In 2010, during a working visit to Murmansk, he, accompanied by journalists, suddenly went into the pharmacy and asked the presence and cost of the Arbidol. After that, the sales of the medicine have grown sharply: if for the whole of 2009 they amounted to 5.5 billion rubles, then for the first half of 2010-7.6 billion.

The Ministry of Health of the Russian Federation did not respond to repeated requests for the "new" on the effectiveness of Arbidol.

So said the governor

The most frank example of lobbying by officials of the drug with unproven effectiveness is the post on Instagram of the Sverdlovsk governor Yevgeny Kuyvashev dated April 28, 2020: “Based on empirical observations and statistical indicators of patients in the Sverdlovsk region, we see differences in the characteristics of the outcome of the disease (coronavirus) with other regions. The only difference is the use of "triazavirin" in all patients of the Sverdlovsk region. I also note that there were no side effects.

In this regard, the Ministry of Health of the region recommended “Tiazavirin” as a preventive agent for doctors in contact with patients <...> today, by my order, 150 thousand packages of “Triazavirin” were purchased for our hospitals. ”

From the beginning of the pandemic, 21,479,289 rubles were spent on the state procurement of the drug.

It is interesting that in his post the governor several times admitted that Triazavirin has no proven effectiveness, but at the same time emphasized: “In war, all means are good.”

To whom is war and to whom and net profit. “Triazavirin” is produced at the Novouralsky Plant “Medsintez”, which is owned by the brothers Denis and Alexander Petrov (the latter through the controlled LLC “Investfarmgroup”).

The father of the owners of the plant is a State Duma deputy from United Russia, a member of the State Duma Committee on Health Protection Alexander Petrov.

"Registered and allowed"

In the preparation of the material, New Gazeta sent 5 requests to various medical institutions, which purchased antiviral agents in 2020 with unproven effectiveness. We were interested in whether these preparations are considered to be working as workers.

Only the head of the medical unit No. 48 of the Federal Penitentiary Service of Russia Andrei Semenov answered. In June of this year, the medical unit purchased Rimantadin for 46,897 rubles (the formular committee of the RAMs in 2007 recommended to withdraw the drug from the sale as “outdated and having unproven effectiveness”).

“The decision to purchase Rimantadin was made due to the fact that this drug is registered in the Russian Federation and is allowed for use for the prevention and early treatment of influenza in adults and children over 1 year old,” said Andrei Semenov.

Part 2. Special medical path

Purely Russian disease

Dysbiosis is a terrible disease that exists only in Russia. In Western countries, they did not hear about him.

The diagnosis is prescribed in the order of the Ministry of Health of the Russian Federation No. 231 of June 9, 2003 “On approval of the industry standard“ Protocol of patients. Intestinal dysbiosis. "

“Doctors who adhere to the principles of evidence -based medicine do not like to affect the topic of microflora, because talking about it, alas, lead to mass purchase by people of probiotics who, it seems, does not work,” says Yaroslav Ashshin. - There is a very serious gap between what is happening in the intestines, between the life of the flora, and that whether we can influence this. The key role for humans is played by the flora that is located between the intestinal villings. It is almost impossible to populate it with probiotics, it is protected by a biofilm.

Despite the unproven efficiency of probiotics, state institutions since the beginning of 2020 purchased them at 112,158,573 million rubles. Leaders - “Biforn” (28 153 069), “Linex” (28 096 686) and “Bifidum” (26 986 050).

- Flora, obviously, greatly affects the immune system. But how exactly this happens is extremely difficult to say. Because to understand the mechanism of influence, it is necessary, roughly speaking, to cut a piece of intestine and get immune cells from there. Cells made of peripheral blood that is taken from the vein in this case are not indicative. It is known that flora can release toxins. Moreover, we learned about some of them recently. For example, trimetlaminoxide - patients with heart attack who have a lot of this toxin, die six times more often than those who have few of it. Flora can affect the vessels. Perhaps it is in it that lies the root of hypertension, atherosclerosis, emotional disorders.

The study of microflora, notes Ashikhmin, is one of the most promising and actively developing areas of modern medicine. But at the moment, it is far from creating effective drugs.

An interesting fact - the official website of the drug "Linex" about dysbiosis says:

“Despite its wide fame, the concept is quite controversial: some mistakenly consider it a disease , others completely deny its existence.”

From everything

Preparations with unproven effectiveness in Russia are used not only for infectious diseases or diseases of the gastrointestinal tract.

On the market of public procurement are popular, for example, hepatoprotectors - medicines for the liver. Since the beginning of the year, 374 million rubles have been spent on the acquisition of Ademetiononin ( Heptral ) from the beginning of the year , 183.5 million rubles on drugs based on essential phospholipids. The interlocutors of Novaya Gazeta in the medical community believe that none of the hepatoprotectors underwent the necessary studies.

Mucolytic’s Russians ( “Bronchipret” , “Gedelix” , “Pertussin” ) do not have proven effectiveness: None of these drugs are recommended, they have not passed serious randomized studies.

With the help of drugs with unproven effectiveness, they try to treat migraines, dementia, herpes, pancreatitis. In 2012, the Minister of Health

Veronika Skvortsova in an interview with Kommersant said that drugs with unproven effectiveness will be removed from the market for two years. In the yard-2020.

Part 3. Dilute the budget

Preparations with unproven effectiveness should be distinguished from drugs that cannot work in principle . For example, from homeopathy. The ineffectiveness of the latter was approved in the memorandum No. 2 of the RAS Commission to Combat the pseudoscience. However, it is naive to think that the state does not spend the money of taxpayers on it.

-CEO of [pharmaceutical companies] "Material Medica" Oleg Epstein, corresponding member of the Russian Academy of Sciences, made a rebranding of homeopathy. He stated that the company's drugs are not homeopathic, but release-active. Although in fact this is the same thing, the same breeding. He simply introduced a new word into everyday life, and it worked in the market, ”says Yaroslav Ashikhmin. -Many scientists advertised the drugs "Materials", including well-known ones-for example, academics of the Russian Academy of Sciences Vladimir Ivashkin and Dmitry Pushkar. “Scientific” articles were produced, which spoke about the effectiveness of release-active drugs.

In October 2019, the RAS Commission to combat the pseudoscience prepared a report on the pseudo-scientific publications of four scientists: in addition to the already mentioned chief freelance specialist-urologist of the Moscow Department of Health Dmitry Pushkar, the Professor of Sechenovsky University Yuri Alyaev, and the subprexus Parfenov, deputy director of the scientific center of neurology Marine Tanashian. У них были обнаружены публикации об эффективности «релиз-активных» препаратов «Импаза» , «Афалаза» и «Диваза» , выпускаемых «Материа-Медика».

В докладе РАН говорилось, что концепция релиз-активности противоречит фундаментальным законам естествознания.

«Разведения столь высоки, что в готовых лекарственных препаратах не остается ни одной молекулы исходного вещества <...> никакое свойство вещества не может проявляться отдельно от его молекул <...>

Концепция «релиз-активности» должна быть безоговорочно отклонена, а разрабатываемые на ее основе лекарственные средства не должны применяться в рамках научно-обоснованной медицины».

The Materials of the Medication was subjected to obstruction of the scientific community before that. In 2018, the Ministry of Education and Science of the Russian Federation awarded the company to the anti -aircraft “for the most harmful pseudoscientific project”.

Однако позиции РАН и Минобразования не остановили расходование бюджета на релиз-активные препараты: с начала 2020 года российские медучреждения потратили на «Ананферон» 1,6 млн рублей, на «Тенотен» — 577 291 рубль, на «Эргоферон» — 1,3 млн.

Получить комментарий «Материа-медика» «Новой газете» не удалось: компания не ответила ни на звонки, ни на письменный запрос. В 2019 году, комментируя РБК выводы комиссии РАН, пресс-служба «Материа-Медика» заявляла: «Позиция комиссии нам хорошо известна. Ее отдельные члены с упорством, достойным искреннего удивления, отрицают подтвержденные многочисленными исследованиями эффекты релиз-активности».

Хотя неэффективность гомеопатии была доказана задолго до появления «релиз-активных» препаратов, лекарства, открыто позиционирующие себя как гомеопатические, также закупаются за счет бюджета.

• «Афлубин» — 3 закупки на 7 320 рублей

• «Стодаль» — 1 закупка на 99 063 рубля

• «Траумель» — 3 закупки на 1 503 498 рублей

• И даже одну упаковку «Оциллококцинума» за 886 рублей в медсанчасть МВД Татарстана купили.

Часть 4. Куда летит «Спутник»?

Благодаря «Арбидолу» и «Кагоцелу» Россия — антивирусный флагман планеты (на Западе простуду, напомним, по старинке лечат покоем и обильным питьем). Поэтому нет ничего удивительного, что страна первой в мире зарегистрировала вакцину от коронавируса — «СпутникV» .

Испытания, по информации с официального сайта, были проведены «на различных видах лабораторных животных, в том числе на 2-х видах приматов». Также в них приняли участие две группы по 38 добровольцев.

«Все добровольцы хорошо перенесли испытания, не было зарегистрировано непредвиденных и серьезных нежелательных явлений, вакцина индуцировала формирование высокого как антительного, так и клеточного иммунного ответа. Ни один участник нынешнего клинического испытания не заразился коронавирусом после введения вакцины», — говорится на сайте. Здесь же говорится о том, что третья фаза испытания вакцины, в которой должны принять участие более 40 тысяч человек, начата 24 августа. Но еще не завершена. Третья фаза обязательна, она должна подтвердить эффективность и безопасность вакцины.

— История с вакциной от коронавируса очень ярко показывает, как у нас появились препараты с недоказанной эффективностью, — утверждает невролог, медицинский директор сети Lahtaclinic Никита Жуков.

— Мы на весь мир говорим: «Вот, мы сделали вакцину». А мир нас спрашивает: «Ребята, а где третья фаза испытаний?» А мы в ответ: «Да ладно вам, у нас вон 300 препаратов есть, которые мы 30 лет без всяких испытаний используем».

О недоказанной эффективности российской вакцины говорили и сами фармацевты: 10 августа Ассоциация организаций клинических исследований обратилась к министру здравоохранения РФ Михаилу Мурашко с просьбой отложить регистрацию вакцины до успешного прохождения ею всех испытаний. «Ускоренная регистрация уже не сделает Россию лидером в этой гонке, она лишь подвергнет ненужной опасности конечных потребителей вакцины, граждан РФ», — заявили в ассоциации.

На следующий день вакцина была зарегистрирована.

Часть 5. Нечего сказать?

Еще 26 июня 2020 года «Новая газета» направила запрос в Минздрав России. Мы привели список лекарств, которые закупаются за счет бюджета, но в эффективности которых сомневаются врачи. И задали следующие вопросы:

• Считает ли Министерство, что перечисленные медицинские препараты имеют недоказанную эффективность? Если да, то как Министерство оценивает факт закупок таких препаратов за счет бюджета?

• Считает ли Министерство оправданными закупки гомеопатических препаратов за счет бюджета?

• В резолюции заседания Президиума Формулярного комитета РАМН от 16.03.2007 года содержится рекомендация об изъятии из перечня лекарственных средств <...> «устаревших препаратов с недоказанной эффективностью»: церебролизина , пирацетама , арбидола , римантадина , валидола , инозина . Почему, несмотря на признание научным сообществом недоказанной эффективности данных препаратов, они продолжают закупаться за счет бюджета?

По прошествии недели, отведенной для ответа Законом о СМИ, в редакцию позвонил представитель Минздрава и попросил об отсрочке: «Препаратов очень много».

Прошел июль, август… Минздрав обещал ответить, но до сих пор не ответил.

Иван Жилин, «Новая газета»

ЧТО ПОКУПАЮТ ЗА СЧЕТ БЮДЖЕТА

Препрараты с недоказанной эффективностью из «расстрельного списка». Table

В 2014 году невролог Никита Жуков составил список препаратов с недоказанной эффективностью , который назвал «расстрельным». С тех пор он неоднократно судился с производителями из этого списка. И ни разу не проиграл.

«Новая газета» публикует перечень госзакупок препаратов из этого списка с 1 января по 3 сентября 2020 года.

При этом подчеркнем, что часть препаратов из выборки была исключена: например, в самом списке говорится, что «Анальгин» обладает доказанной эффективностью, но внесен в перечень из-за своей небезопасности (мы рассматриваем в первую очередь эффективность).

Заметим: недоказанная эффективность не равняется неэффективности. Возможно, указанные препараты работают. Но для того, чтобы доказать это, необходимы исследования.

Условные обозначения в таблице:

РКИ — Рандомизированные плацебо контролируемые клинические исследования, основной способ доказать эффективность препарата

ВОЗ — Всемирная организация здравоохранения

ФК — Формулярный комитет РАМН

«ВОЗ —» ; «ФК —» — ВОЗ и Формулярный комитет не включили препарат в свои пособия, не рекомендуют его

FDA — Агентство Министерства здравоохранения США, занимающееся контролем качества лекарственных препаратов.

Список упомянутых препаратов: Амиксин, Тилорон, Лавомакс, Арбидол, Умифеновир, Арпефлю, Афлюдол, Вобэнзим, Галавит, Глутоксим, Гриппол, Гроприносин, Инозин, Рибоксин, Деринат, Иммунал, Имунофан, Имудон, Бронхо-Ваксом, Бронхо-Мунал, ИРС-19, Ингавирин, Йодантипирин, Кагоцел, Ликопид, Лонгидаза, Неовир, Оксолин, Панавир, Полиоксидоний, Римантадин, Синупрет, Тималин, Триазавирин, Циклоферон, Цитовир-3, Виферон, Генферон, Гриппферон, Кипферон, Глицин, Диметилоксобутилфосфонилдиметилат, Идебенон, Аминалон, Когитум, Кокарбоксилаза, Кокарнит, Кортексин, Мексидол, Мексиприм, Нейрокс, Медомекси, Мексикор, Нооклерин, Пирацетам, Ноотропил, Луцетам, Фезам, Фенибут, Пантогам, Гопантам, Пантокальцин, Гопантеновая кислота, Пикамилон, Семакс, Церебролизин, Адеметионин, Гептрал, Гептор, Лаеннек, Ремаксол, Тиотриазолин, Фосфоглив, Ливолин, Лив 52, Фосфонциале, Эссенциале, Линекс, Бифидумабактерин, Лактобактерин, Бифидум, Бифиформ, Нормобакт, Аципол, Хилак Форте, Бронхипрет, Геделикс, Проспан, Пертуссин, Бронхикум, Валидол, Валокордин, Корвалол, Идринол, Кардионат, Милдронат, Мельдоний, Адаптол, Актовегин, Афобазол, Бендазол, Дибазол, Кавинтон, Винпоцетин, Витапрост, Уропрост, Простатилен, Сампрост, Vitaprost, Гипоксен, Глиатилин, Канефрон, Карипаин, Карипазим, Карсил, Легалон, Гепабене (Расторопша), Ново-Пассит, Персен, Пиаскледин, Реамберин, Рефнот, Танакан, Анаферон, Диваза, Колофорт, Ренгалин, Субетта, Тенотен, Эргоферон, Афлубин, Вибуркол, Оциллококцинум, Стодаль, Траумель, Циннабсин