Of course, Ukraine and the world are groping for the best treatment for this scourge, but we still have no other way.
The Ministry of Health has approved the central protocol for the treatment of patients with COVID-19. This was announced by the new head of the department Maxim Stepanov. The central treatment protocol is long overdue, but with its appearance, a lot of criticism was immediately addressed to the ministry – mainly due to the fact that, if, they say, there is still no scientific basis to confirm it. precisely the effectiveness of the drugs used in the treatment of coronaviruses, so why they were registered in the protocol. However, the developers of the protocol explain: although no panacea for the coronavirus has been found, at least one opportunity must be seized to save a severe patient. And the Minister of Health, meanwhile, announced that within a week, the protocol would be completed with drugs and regimens.
Why is the protocol adopted by the Ministry of Health criticized?
In the approved treatment protocol COVID-19, drugs recommended for use include hydroxychloroquine and chloroquine drugs (antimalarials, although they are also the first to treat rheumatic diseases), as well as lopinavir / ritonavir (both used in combination with HIV), remdesivir (antiviral), tocilizumab (treatment of rheumatic diseases). That is, THESE ARE ALL THESE MEDICINES THAT ARE NOW USED BY MEDICA WORLDWIDE IN THE TREATMENT OF COVID-19 AND THAT HAVE GIVEN A POSITIVE EFFECT. You can find out more about this in the Ukrinform document.
And this is precisely why the Ministry of Health is now criticizing, in particular, the former head of the department, Ulyana Suprun. “While the world is looking for a drug to treat patients with COVID-19 and is very careful to use certain drugs for it, Ukraine has already approved a protocol for the treatment of moderate and severe cases of coronavirus. And this despite the fact that not all of the drugs in the protocol have scientifically based data on the efficacy and safety of use in clinical practice, and now they are only used on an experimental basis. The approval of such a protocol at national level is a very dangerous phenomenon and, on the whole, looks like a mass experiment on Ukrainians. (…) Now, clinical trials are the only way to prove the efficacy and above all the safety of the drug, ”writes Ulyana Suprun. Of course, any drug must undergo extensive clinical trials before being recommended to be put into practice against a specific disease. And these drugs are used as is. But they do not hide the problems. Indeed, for all these procedures, it takes a long time, which, unfortunately, is not available worldwide – people must be saved now.
What do the developers say?
18 experts participated in the development of the protocol, in particular the head of the department of infectious diseases of the National Medical University named after AA Bogomolets Olga Golubovskaya (although the only specialist in infectious diseases on the list) and professor in the Department NMU Anesthesiology and Intensive Care Unit named after Bogomolets Sergey Dubrov. In response to criticism, they commented on the need for a protocol as follows:
“The entire civilized world, realizing that THIS SITUATION CANNOT BE PROOF FOR SUCH A SHORT-TIME APRIORI, has found a mechanism to apply lifesaving regimes for the treatment of patients, including, possibly, prevention serious consequences of the disease … We have managed to do it only now and only thanks to the political will and position of the new minister, “said Olga Golubovskaya.
“There is currently no evidence to recommend specific antiviral therapy for patients with confirmed COVID-19. WHO is conducting an international study that includes the same drugs to assess the effectiveness of COVID-19. This puncture (approved by ordinance 762) was based on clinical guidelines for the treatment of patients with COVID-19 from countries such as Belgium, France, Switzerland, China, Italy, the Netherlands. . THE OBJECTIVE OF THE PROTOCOL PROPOSED BY THE PROTOCOL IS EXAMINED ONLY BY PATIENTS WITH COVERID COVID-19 AND IS IMPLEMENTED AFTER DISCUSSION WITH THAT ONE, OR THE LEGAL REPRESENTATIVE OF COMPLEX COMPLAINTS
Now it seems that we need to do some additional explanatory work that these drugs are only used in complex cases and only as directed by a doctor. Indeed, information is already appearing on the Web that after the publication of the central protocol, the preparations indicated there have started to be dismantled from the shelves of pharmacies without emergency.
It remains to provide a quick update of the protocol
Fedor Lapiy, Associate Professor in the Department of Pediatric Infectious Diseases and Pediatric Immunology at NMAPE named after PL Shupik, Ukrinform in his comment says that the benefit of adopting the COVID-19 treatment protocol is the protection of the doctor during of his decision making.
“But on the other hand, you have to understand that the information on therapeutic approaches to COVID-19 is updated almost daily. By ministerial decree, it is not so quick to respond to scientific information that appears in the world on the confirmation or cancellation of data on the effectiveness of certain drugs. Therefore, the doctor will depend on such a component. Imagine that information appears on the ineffectiveness of the use of hydroxychloroquine (chloroquine), which is listed in the treatment protocol. It turns out that the appointment of this medicine by a doctor can be considered in court. In this case, it will be difficult for a healthcare professional to defend themselves, ”says Fedor Lapiy.
As an example, he cites a publication in the scientific journal New England Journal of Medicine that the drug CALETERA (active substance – LOPINAVIR + RITONAVIR), which is used to treat HIV-infected patients, has been shown to be ineffective. . DAY AFTER THE DEPARTMENT’S ORDER. Therefore, Mr. Lapiy noted that there may be a need for a more flexible approach to the legal regulation of decision making by physicians.
“This is important not only during the coronavirus pandemic, but also for the treatment of patients with other diseases. In the UK, for example, there is a National Institute for Health and Excellence in Aid (NICE) structure, where hundreds of people work to quickly update recommendations for British doctors. If a body at national level decides to recommend a medicine for the treatment of a particular disease, then this recommendation has the same legal value as the instructions. We always retain the supremacy of the instruction on any decision of the authorized bodies ”, explains Fedor Lapiy.
He also added that a separate explanation is required from lawyers regarding obtaining the patient’s informed consent because the document was prepared in the first person. “When we say that the patient is in a critical state, connected to an artificial respiration device, he will not be able to sign anything. And the order does not say that informed consent can be fulfilled by its legal representative. Therefore, it may be necessary to clarify that the right to give informed consent to close relatives or the patient’s spouse, ”notes the infectious disease specialist.
In Vinnitsa, the treatment protocol is almost no different from the central protocol
Just two days before the state-level protocol was adopted in Vinnitsa, without delay, they adopted a local treatment protocol. It is also based on Chinese, Italian, Spanish, American and Korean experiences, reported the health department of the Vinnitsa regional administration. The protocol was developed by the Department of Infectious Diseases of the National Medical University of Vinnitsa and is officially approved at the level of the Ministry of Health.
According to the region’s leading infectious disease specialist, Larisa Moroz, the protocol included a group of antimalarial drugs, as well as drugs used in the treatment of AIDS, because the genome of the coronavirus includes part of the genome of the immunodeficiency virus human. In a comment to Ukrinform, Larisa Moroz said that in terms of antiviral therapy, the state protocol is practically the same and that there is no comment on it. “The only difference is that the central protocol includes remdesivir, which is not currently in the country, as it is still in the clinical trials stage,” said Larisa Moroz.
So while we do not have drugs that have already passed full clinical trials and have proven effective against the coronavirus. Ukraine, like the whole world, is forced to manually search for ways to treat the disease as effectively as possible.
Well, the best method for finding the truth, humanity has yet to find.
Julia Gorban. Kiev
According to the materials: ukrinform.ru