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Covid-19 vaccine from the point of view of the bioethical principles of human experiment
Written by Prof. Dr. Bardhyl Çipi 23 Qershor 2021
(Continued from the previous issue)
The creation of different types of Covid-19 vaccines, carried out rapidly against this dangerous global pandemic, is also examined from the bioethical point of view, applied in human experiments. As is well known, the human experiment constitutes one of the important topics pertaining to bioethics. According to her, by experimentation, in the general sense of the term, we will mean performing a test to prove a certain hypothesis. P. sh. In medicine, the hypothesis that a drug is or is not effective in a given disease will be verified through so-called "clinical trials" performed on people affected by the disease, in order to prove or not the effectiveness of this drug. These tests should also be performed during the production of Covid-19 vaccines. In principle, human experimentation is not performed immediately on humans.
For their part, according to the American literature, clinical trials are divided into four stages:
• The first phase consists of conducting the first experimental drug trials in volunteers and non-patients, in order to assess the tolerance of the substance as a function of its dose and to verify its pharmacodynamic properties, ie. possible organic or functional modifications caused by the administration of this material.
• The second phase is performed on a small group of patients in order to confirm the therapeutic efficacy of the experimental drug, to assess its interest and risk / benefit ratio. At the same time, during this use, the pharmacological parameters are determined in these patients, in relation to absorption, elimination, in order to determine the best way of taking this drug.
• The third stage is about the methodical comparison of this new medication with the lack of medication, or with the best classic previous medications. In this way it will be possible to demonstrate the therapeutic activity of this drug on a large group of patients, according to a complex and meticulous methodology. In fact, this phase corresponds to the clinical expertise, these actions for obtaining authorizations for the manufacture and marketing of new drugs.
• The fourth phase corresponds to retrospective epidemiological studies, in order to detect rare adverse effects, which may appear later.
These clinical trials, at least the first three phases of them have been carried out so far for Covid-19 vaccines with relevant specifications, but in this case they have been carried out rapidly, even for any of these types of vaccines the phase of their third. In addition, for human experimentation, which may include the many issues pertaining to the Covid-19 vaccine, a number of ethical rules need to be applied, especially in relation to society's responsibility to respect human rights and freedoms through consensus. (approval), which must be given by the person being tested or vaccinated. On this occasion, I want to recall the Nuremberg trial against 20 German doctors who had collaborated with the Nazi regime. Some of them were sentenced to death, others with prison terms of 10 to 20 years. Their experiments were related to the physiological effect of high altitudes, the action of cold on the human body, the action effect of various poisons, antigangrenous serum, artificial hormones, etc. In fact, these so-called experiments, carried out in Nazi concentration camps, without obtaining the consent of the experimented persons, often performed by unprepared persons, from a scientific point of view, most of them were of no value. One of the decisions of this great litigation has been the Nuremberg Code, which is in fact the first international declaration of Medical Ethics. This Code contains 10 points, in relation to the general conditions to be applied in the case of human experiments. In this Code and in other International Declarations:
According to the Nuremberg Code, the consensus of the patient undergoing clinical trial must be conscious. This means that the patient knows what he agrees to give his consent to. With regard to the use of the Covid-19 vaccine, international opinion has recently raised concerns that the use of this vaccine may have been accompanied by a violation of the Nuremberg Code. According to the supporters of those who oppose getting this vaccine, the people who do it should be informed and give conscious consent (approval), without the intervention of force, deception, etc. and not to be told that vaccines are experimental.
But this is not true, because vaccines before their use have been tested, so they are not experimental. Indeed, this confrontation of anti-vaccine propaganda with the principles of medical ethics condemning the Nazi crimes of World War II is used today to misinform people not to use this vaccine. According to Dr. Julian Sheather: "To make a connection between the use of this vaccine and what Nazi doctors did would be morally grotesque." Another argument of those who oppose the use of the vaccine, when its receipt is requested by a state institution or private business, is that even in this case, according to them, the principles of the Nuremberg Code are violated, because people will be obliged to be vaccinated to have the opportunity to do e.g. a trip etc. So in this case their consent will not be not free, but forced. But even this argument is not accepted by the fact that some countries require certifications for vaccinations, e.g. against polio, yellow fever, before travelers are allowed to enter these countries. In addition to the consensus, other ethical principles of human experimentation that also apply to the use of Covid-19 vaccines are those of the risks and benefits as well as the guarantees necessary for conducting human experimental trials. The issue of risks and rewards relates to the fact that experimental testing will only be performed when the potential benefit outweighs the potential risk. In the case of Covid vaccines this is reflected e.g. in case of using AstraZeneca vaccine, for which there have been complaints because in very rare cases severe and sometimes fatal complications have occurred. But on the basis of this principle they have not influenced the measures to be taken for the use and blocking of this vaccine, because the benefits from it to protect against the serious and deadly disease Covid-19, are many times greater than extremely rare adverse effects of this vaccine. The necessary guarantees for conducting experimental tests on humans, which can also be applied to the Covid-19 vaccine, belong to the right to preserve the privacy and dignity of the subject (in this case of those who are vaccinated), so that these rights not to be affected, the obligation that e.g. the vaccine manufacturer to have a high level of technical-scientific qualification, as well as respect for the quality of investigations,
Ky rregull vlen edhe për vaksinën Covid-19 pavarësisht se për prodhimin e saj është vepruar me shpejtësi për shkak të nevojës urgjente, në situatën e rëndë me vdekshmëri të lartë të krijuar nga kjo sëmundje. Përveç kësaj, për sa u përket organizmave që mbikëqyrin respektimin e rregullave etike të një eksperimenti human, po kështu edhe të prodhimit dhe të përdorimit të vaksinës Covid-19, roli i të cilave konsiston për të penguar veprimet e parregullta dhe të dënueshme etj., duhen përmendur në radhë të parë: Komitetet Bioetike, roli i të cilave duhet të jetë i rëndësishëm jo vetëm për çështjet e vaksinave, por edhe për masat e tjera që do përdoren për t’u mbrojtur nga kjo pandemi e rëndë. Për fat të keq, një komitet i tillë që ekziston edhe në vendin tonë, nuk duket që të ketë kryer ndonjë aktivitet të pasqyruar në mediat e vendit tonë, për të ndikuar sadopak sidomos për ata që marrin vendime për qëndrimet që duhen mbajtur ndaj situatave të vështira të krijuara nga kjo pandemi. Më në fund, në trajtimin e problemeve të shumta të Covid-19 dhe vaksinës së tij, si te ne ashtu dhe në vendet tjera, duhet pasur kujdes nga rreziqet e korrupsionit, që pasqyrohen në drejtime të ndryshme, si p.sh. shkelja e rregullave të porosive të prodhimit të vaksinave me firmat private dhe atyre të shpërndarjes së saj në vendet e tjera, përdorimi i vaksinave apo medikamenteve të tjera nën standardin e lejuar apo të falsifikuara etj., për të cilat ka pasur akuza edhe për vendin tonë.
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Në përfundim, nga sa u paraqit, duhet theksuar se:
-përdorimi i vaksinës Covid-19 përbën një nga hapat kryesore që duhet marrë për t’u mbrojtur nga kjo sëmundje e rëndë; hapa të tjera, si përdorimi i maskave mbrojtëse, respektimi i distancimit social, do të ndihmojnë për të pakësuar mundësitë për t’u prekur nga ky virus dhe për të penguar transmetimin e tij personave të tjerë
-njohja e aspekteve bioetike të situatës dramatike të krijuar nga pandemia e rëndë e Covid-19, e cila po mposhtet sot nga përdorimi masiv i vaksinave përkatëse, do të jetë e nevojshme që të merret parasysh nga ata që vendosin për qëndrimet që duhen mbajtur ndaj situatave të vështira të krijuara nga kjo pandemi si dhe nga opinioni publik që të kuptojë edhe më mirë vlerën e këtyre masave.
(Fakulteti i Mjekësisë, Universiteti i Mjekësisë, Tiranë/E-mail: [email protected])