Research on amantadine was planned for a too small number of patients, which will not allow statistical analysis, and thus also drawing binding conclusions, told PAP Prof. Robert Flisiak, member of the Medical Council at Prime Minister Mateusz Morawiecki.
- Clinical trials for the use of amantadine in the treatment of COVID-19 began in April 2021.
- Two projects received nearly PLN 15 million in funding from the Medical Research Agency and are coordinated by centers in Lublin and Silesia
- More information can be found on the Onet homepage.
Prof. Robert Flisiak, who is the president of the Polish Society of Epidemiologists and Doctors of Infectious Diseases, said that, according to his knowledge, for research on amantadine the planned number of patients has not been recruited so far. However, even if it did, it would probably be the number of patients that would not allow scientifically based conclusions to be drawn. Unfortunately, information on the status of both projects is not public. The Medical Research Agency has up-to-date data on this subject, as contractors of all projects financed by it are required to report on the advancement of research on a monthly basis.
- Amantadine against COVID-19? Research in progress. What is already known?
“In my opinion, these studies will not provide any information, even if the effect was positive. Firstly, because the projects were not based on any reliable preliminary data in the literature, and secondly, they were poorly prepared. In effect a lot of money was spent that could have been used much better“- claims prof. Robert Flisiak, head of the Department of Infectious Diseases and Hepatology at the Medical University of Bialystok.
The specialist is a physician with over 20 years of experience in conducting clinical trials in infectious diseases, both as a principal investigator, national coordinator and global leader. He is also the co-author of the recommendations of the Polish Society of Epidemiologists and Doctors of Infectious Diseases regarding the treatment of COVID-19 disease. And also the coordinator of the SARSTer project, which has been allocated 10 times less than research into amantadine.
“The results of research from the SARSTer program are already published in 7 articles in reputable journals, while the results of work on amantadine, even preliminary, have not been disclosed so far and I am afraid that even if they appear, it will be very difficult to publish them in a major journal”- emphasizes the member of the Medical Council at Prime Minister Mateusz Morawiecki. He also cites global literature, which so far has not provided any new information to support the thesis on the usefulness of amantadine in the treatment of COVID-19.
- Polish research on the effectiveness of amantadine in the fight against COVID-19. How’s the work going?
“Each examination and analysis of the obtained data requires a statistical analysis, and it requires some statistical power, mainly generated by the number of patients included in the study. So that you can compare the group receiving the drug with the one that receives a placebo (a dummy drug – PAP) ”- he explains.
In his opinion, the claim of one of the leaders of amantadine research that the drug is safe based on the results of observation of several or even several dozen patients is a mockery of science. In order to confirm the safety of a drug in a given disease, not to mention its effectiveness, several hundred or even several thousand patients need to be examined in three consecutive phases.
“The safety of each SARS-CoV-2 vaccine was assessed based on the observation of tens of thousands of subjects, and then hundreds of millions of people after the vaccines were registered. Despite this, efforts are still being made to question the safety of these vaccinations. Shouldn’t we require equally thorough research in the case of amantadine?“- points out prof. Flisiak.
When asked if it was better to get vaccinated than to count on a drug such as amantadine, the specialist said that for him, as well as for many experts, it was obvious: first of all, you should get vaccinated against COVID-19.
“It’s worth listening to what experts and doctors who care for COVID-19 patients are saying. The opinions of specialists are unambiguous and based not only on the results of research, but also on today’s clinical practice in Poland. The best evidence that the vaccine protects against severe course and death due to COVID-19 is the fact that currently almost exclusively unvaccinated people in Poland suffer from disease. Those who, despite such obvious facts, do not get vaccinated, put their lives and their loved ones at risk, ”he added.
Author: Zbigniew Wojtasiński
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