LIST OF ACRONYMS AND ABBREVIATIONS
|AEMEMI||Ecuadorian Association of Expert Physicians in Integrative Medicine|
|CDS||Chlorine dioxide solution|
|COMUSAV||Global Health and Life Coalition|
|COVID-19||From English, Coronavirus disease .|
|SHE||Amyotrophic Lateral Sclerosis|
|FDA||Of English: Food and DPlease Aadministration|
|MMS||Of English: Miracle Mineral Supplement, Miracle Mineral Solution, Master Mineral Solution.|
|NaCl||Sodium chloride (common salt)|
|NaClO||Sodium hypochlorite (bleach - bleach)|
|WTO||World Trade Organization|
|PAHO / WHO / WHO|
From Spanish, Oorganization Mundial da Savalanche.
From Spanish, Oorganization PAmerican of the Savalanche. Of English, World Health Organization
|ppm||Part per million|
|COVID-2||Acute respiratory syndrome coronavirus type 2|
|TCLI||Free and Informed Consent Term|
The recent Covid-19 pandemic shocked the world and has claimed thousands of lives, and as one of the equally complicated consequences, the global economy was compromised. Undoubtedly, this is a problem that requires an urgent solution and the commitment of all, especially the health personnel, to find a prompt solution.
In order to identify a solution for this problem and also based on the scientific evidence already published and clinical experiences of the use of chlorine dioxide (ClO2) by Doctors and Researchers, we made an evaluation of the main information to support our proposal for the use of chlorine dioxide solution (CDS), following the protocol standardized by Andreas Ludwig Kalcker as a safe and effective alternative to combat SARS-COV2 infection (Kalcker 2017-2020; Kalcker & Valladares 2020).
From January to July 2020 a review investigation was carried out on the use of chlorine dioxide in the indexed international literature and as an example, if we only analyze the PubMed website (National Library of Medicine 2020), we note that just using the description 'chlorine dioxide', we have a total of 1.372 documents available dating from 1933 to the date of the investigation in 2020 (A screenshot is shown in Figure 1).
Figure 1 - Number of documents found with the description "chlorine dioxide" in the PubMed scientific database. The first red arrow indicates the description used for the search and the second the number of published documents found on July 24, 2020.
Another important source is the PubChem database (Figure 2), in which it is possible to identify biochemical and toxicological information, among others, and registered patents (which can also be found in Google Patents), among which the following stand out:
- The patent on the disinfection of blood bags (Kross & Scheer, 1991);
- The patent on HIV (Kuhne 1993);
- The patent for the treatment of neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS), Alzheimer's disease and Multiple Sclerosis (McGrath MS 2011);
- Taiko Pharmaceutical's patent (2014) for respiratory viruses, including human coronavirus;
- The patent on a method and composition "for treating cancerous tumors”To treat cancerous tumors (Howard 2018);
- The patent for a pharmaceutical composition for the treatment of internal inflammation. (Kalcker LA, 2017);
- The patent on the pharmaceutical composition for the treatment of acute poisoning (Kalcker LA, 2017);
- The patent of a pharmaceutical compound for the treatment of infectious diseases (Kalcker LA, 2017) and
- The patent on the use of CDS for coronavirus type 2 (Kalcker LA, 2020 - still pending publication: /11136-CH_Antrag_auf_Patenterteilung.pdf).
Figure 2 - Number of documents found with the description «chlorine dioxide»In the scientific database of Pubchem. The first red arrow indicates the description used for the search and the second the number of published documents found on July 24, 2020.
Therefore, only with these initial data, we verify that the research around ClO2 is not something new, that it is a chemical molecule already known for more than 200 years and commercialized for 70 years with various applications, namely : treatment of water for human consumption, treatment of contaminated water, for the control of biofilm in cooling towers and in food and vegetable disinfection processing.
In addition, there are preclinical and clinical studies carried out, as well as studies that allow us to understand its toxicological and safety characteristics, especially for use by humans (Lubbers et al 1984, Ma et al 2017). On the other hand, we verify that clinical trials and the application of chlorine dioxide for health still need more research.
A brief overview of chlorine dioxide
The chemical formula of chlorine dioxide is ClO2 and according to registration in Chemical Abstracts Services (CASE) from Chemical American Society its CAS number is 10049-04-4. In this formula, it is clear that there is one chlorine atom (Cl) and two oxygen atoms (O2) in a molecule of chlorine dioxide. These 3 atoms are held together by electrons to form the ClO2 molecule. It can be used as a saturated gas in distilled water and, therefore, it can be drunk or applied directly to the skin and mucosa, with the appropriate dilutions. Andreas Ludwig Kalcker, Biophysicist and Researcher, standardized a gas saturation in distilled water called chlorine dioxide solution or CDS (CDS: Chlorine Dioxide Solution) (National Library of Medicine 2020).
The discovery of the ClO2 molecule in 1814 is attributed to scientist Sir Humphrey Davy. ClO2 is different from the element chlorine (Cl), both in its chemical and molecular structure and in its behavior. ClO2, as has already been widely reported, can have toxic effects if the necessary care is not observed for its various uses and the appropriate recommendations for human consumption are not respected. It is well known that ClO2 gas is toxic to humans if it is inhaled neat and / or ingested in amounts higher than those recommended (Lenntech 2020, IFA 2020).
ClO2 is one of the most effective biocides against pathogens, such as bacteria, fungi, viruses, biofilms (biofilm) and other species of microorganisms that can cause disease. It works by interrupting the synthesis of the pathogen's cell wall proteins. As it is a selective oxidant, its mode of action is very similar to phagocytosis, in which a mild oxidation process is used to eliminate all types of pathogens (Krogulec 2012, Noszticzius et al 2013, Lenntech 2020). In other words, ClO2, generated by sodium chlorite (NaClO2), is approved by the Environmental Protection Agency in the United States (EPA 2002) and by the World Health Organization for use in water suitable for human consumption. , since it does not leave toxic residues (EPA 2000, WHO 2002).
Many continue to confuse ClO2 with sodium hypochlorite (NaClO - Bleach) and the latter with sodium chlorite (NaClO2), in addition to other chemical compounds, causing frequent inappropriate comments both in the media and among professionals by lack of knowledge of elemental chemistry. NaClO (bleach), for example, is a powerful corrosive agent and the danger of chronic and massive exposure is well known. Symptoms are believed
asthma developed by professionals who work in contact with this substance may be due to continuous exposure to bleach and other irritants. In contact with fats, sodium hydroxide (NaOH) breaks down fatty acids in glycerol and soaps (fatty acid salts), reducing the surface tension of the remaining fat-solution interface. NaClO is responsible for dissolving organic tissue. Thus, it is observed that the main toxicity of the substances generated from the chemical reactions of sodium hypochlorite is the appearance of a hydroxyl NAOH radical, in the various reactions with secretions and the chemical structure of human tissues (Daniel et al. 1990, Racioppi et al 1994; Estrela et al 2002, Medina-Ramon et al 2005, Fukuzaki 2006, Mohammadi 2008, Peck B et al 2011).
Through scientific patents, evidence from available scientific publications demonstrating the efficacy of ClO2 in eliminating different pathogens (Kullai-Kály et al 2020, Kalcker 2017-2020), including SARS-CoV (Taiko Pharmaceutical Patent 2014), as well as work that confirms the safety of the use of chlorine dioxide for the purification of water and, more recently, the aforementioned work of the AEMEMI, we evaluate positively and with great biocidal potential the use of the aqueous solution of ClO2 (CDS) to combat coronaviruses (AEMEMI 2020, EPA 2000, WHO 2005, WHO 2002).
In this context, we are surprised that the mentions that official bodies such as the Ministries of Health, PAHO / WHO (2020), FDA (2020) and regulatory agencies and / or health entities do not recommend the use of ClO2 and all Instead of recommending, they draw attention to its toxicity and danger, but in their speeches, they do not clearly indicate in what form and by which route of administration ClO2 is really toxic. However, everything leads us to understand that they refer to the pure and concentrated form of this gas and not to the standardized formula by Kalcker: the aqueous solution of chlorine dioxide (CDS), at 3.000 ppm.
In this way, to help clarify the concepts, we invite all official bodies to learn about Andreas Kalcker's work with the aqueous solution containing chlorine dioxide gas (CDS). Certainly, after having this knowledge, we believe that definitely, these organisms, who appreciate health, will naturally understand the potential of this solution for human use and from then on, they will be able to review their documents that may be in disagreement with published scientific reality and current medical experiences and perhaps they can offer this information more clearly and assertively in their articles published on official websites or even in their documents.
Therefore, to help clarify the concepts, we invite all official bodies to learn about the work and patents of Scientist Andreas Ludwig Kalcker with the aqueous solution of chlorine dioxide (CDS). Certainly, after having this knowledge, we believe that these organisms, who appreciate health, will naturally understand the potential of this solution for human use, and thereafter they will be able to review their documents that may be in disagreement with published scientific reality and current medical experiences and perhaps can offer this
information in a clearer and more assertive way in your articles published on official sites or even in your documents.
Based on the dissonant and incoherent information when compared with what is really known about the CDS and its potential, it is that we, health professionals in the intention of respectfully giving our contribution so that the health governing institutions review their documentation and officially published guidelines to promote the clearest and most accurate information on the use, efficacy and safety of ClO2 for oral human consumption (CDS), as standardized by Kalcker (2020 - Over evaluation: / 11136- CH_Antrag_auf_Patenterteilung.pdf), we share below a summary of key scientific facts and evidence that CDS is effective against various pathogens, including human coronavirus type 2, the etiologic agent of SARS-COV2. Unfortunately, the way in which information about ClO2 is disseminated raises doubts and, above all, reveals to those who understand the subject under scientific aspects that the misinformation generated is somewhat surprising.
What is Chlorine Dioxide Solution (CDS) and what are the differences from Miracle Mineral Solution (MMS)?
More than 13 years ago, Andreas Ludwig Kalcker started a scientific investigation to study the applicability of ClO2 and its dilutions, so that it can be used safely for human consumption. In these studies, he developed 4 patents, of which 3 are published and one is pending approval (Kalcker 2017-2020). These studies are based on the safe toxicity levels established by the German toxicology database GESTIS (IFA 2020), and take into account other classical scientific studies already published and reference already developed, for example, by the WHO (2000, 2005) and EPA (2000). These studies confirm the non-toxicity of this diluted gas in drinking water.
Much has been said in the media about the risk of MMS use and it is very often confused with CDS. It is important to clarify that MMS is a solution prepared by mixing a few drops of each of the two reagents: sodium chlorite, on the one hand, and an acid that can be citric or hydrochloric, on the other. This mixture is added to a liter of water, placed in a bottle, sealed and consumed orally throughout the day. The problem with this mixture is that none of the reagents is chemically pure and when ingesting this mixture of these two reagents, the impurities of these are also ingested. These impurities or chemical by-products can cause discomfort such as diarrhea, vomiting and other side effects that, although not serious, are irritating, especially when a high dose of these products is drunk due to the limited information that exists in the general public , which, due to the health emergency when trying to prevent or treat COVID-19, leads to not seeking medical advice or consultation and to consuming products that have not been prepared under the supervision of professionals trained for their manufacture.
On the other hand, the other compound known as aqueous chlorine dioxide solution (CDS), only contains chlorine dioxide dissolved in water at a concentration of 3.000 ppm (mg / L) and does not contain
the impurities contained in the preparation called MMS. In the case of CDS, which is an extremely pure compound, during its manufacture, the two substances are placed to react in a container that contains another small container in which the chemical reaction takes place and from which a gas of chlorine dioxide that will saturate the water on the outside of this container. It is important to clarify without any doubt that CDS contains absolutely no sodium chlorite, nor any acid. Another way to produce chlorine dioxide is by electrolysis, in which no acid is used.
Depending on the procedure of its preparation, the CDS solution contains a high degree of purity, since it only contains chlorine dioxide dissolved in water. In summary, MMS contains impurities that can cause discomfort when ingested, but chlorine dioxide in aqueous solution (CDS) contains only chlorine dioxide gas at a concentration of only 0,3 g / L dissolved in water and of which It is considered that only 5 to 10 ml are ingested throughout the day, dissolved in a liter of cold water.
This large difference allows the chlorine dioxide solution (CDS) to be safe and highly tolerable to ingest without causing any discomfort or health risk, when consumed properly.
The lethal dose has been established to be 292 mg / kg (IFA 2020). Therefore, for example, Andreas Kalcker's standard protocol consisting of the use of 10 ml of CDS at 3.000 ppm, diluted in 1.000 ml of water, is being used with great success by clinicians in several countries as one of the protocols to combat SARS-COV2. In this specific recommendation, the maximum consumption of 30 mg / day, divided into 10 doses of 100 ml, is allowed at the end, which constitutes a safe and non-toxic dose based on recognized scientific references (Ma and others 2017). In other words, this amount is equivalent to a dose of 15 to 30 mg / day in adult patients with an average weight of 60 kg, a value that varies from 0,25 to 0,50 mg / kg / day.
The unnecessary controversy and its consequences
Contextualizing the origin of the mistaken controversy that has arisen on the subject of "chlorine dioxide", it is important to clarify:
Historically, a product called "miracle mineral solution" (MMS) has been the subject of much controversy in the media around the world because it is sold as "medicine." We often see news on the Internet that confuse the "miracle mineral solution" (MMS = citric acid + sodium chlorite + water) with the "chlorine dioxide solution" (CDS = chlorine dioxide gas
+ water) and the latter is confused with sodium hypochlorite (bleach). The main differences between the MMS and the CDS can be conferred in table 1:
Table 1 - General characteristics that differentiate the miracle mineral solution (MMS) from the chlorine dioxide solution (CDS).
|ClO2 concentration (part per million - ppm)||Not known||3.000 ppm|
|Waste||Chlorates, chloride||Without residues|
It is very worrying to witness the consequences and the impact of information published in dissonance with reality at a time of global public health emergency, when the lives of many people are in danger. Therefore, it is urgent that all institutions are alert through the previous qualification of the information that is published so that there are no failures in the translation of scientific knowledge, thus generating room for doubts and misinterpretations through the media. communication, with serious consequences and negatively influencing the decision-making of managers.
If we used sodium hypochlorite (NaClO) with hydrochloric acid in the water, the solution would contain Cl2 + NaCl + H2O. Cl2 is a toxic gas that reacts with organic substances, mainly in aqueous media where it can form toxic acids. Although we are clear about the very well established biochemical differences, many continue to confuse some chemicals with ClO2 (Table 2):
Table 2: Summary of the main biochemical characteristics of chlorine dioxide and derived compounds.
|Sodium perchlorate||Sodium chlorate||Chlorite sodium||Hypochlorite of sodium||Sodium chloride||Chlorine||Chlorine Dioxide|
122.44 g / mol
106.44 g / mol
90.44 g / mol
74.44 g / mol
58.44 g / mol
g / mol
67.45 g / mol
Source: Pubchem. Available in: https://pubchem.ncbi.nlm.nih.gov/#query=chlorine%20dioxide. Consultation date: July 24, 2020.
EFFECTIVENESS, SAFETY AND TOXICITY OF CHLORINE DIOXIDE
Action against viruses
Most viruses behave in a similar way because, once they infect the cell, the virus nucleic acid takes over the synthesis of the cell's proteins. Certain segments of the nucleic acid of the virus are responsible for the replication of the genetic material of the capsid, a structure whose function is to protect the viral genome during its transfer from one cell to another and to aid in its transfer between host cells. When ClO2 meets an infected cell, a denaturation process occurs very similar to phagocytosis because it is a selective oxidant (Noszticzius et al 2013).
Preclinical studies exploring the toxicity of ClO2 usually find no adverse effects when animals are exposed to different concentrations of this biocide. Here we will refer to some of the most important ones. Ogata (2007) exposed 15 rats to 0,03 ppm of ClO2 gas for 21 days. Microscopic examination of histopathological samples from the lungs of these rats showed that their lungs were "completely normal." In another preclinical study, Ogata et al. (2008) exposed rats to 1 ppm ClO2 gas for 5 hours a day, 5 days a week for a period of 10 weeks. No adverse effects were observed. They concluded that the “no observed adverse effect level” (NOAEL) for chlorine dioxide gas is 1 ppm, a level that is believed to be non-toxic to humans and exceeds the reported concentration of 0,03 ppm to protect against influenza virus infection.
In studies on rats, Haller and Northgraves (1955) found that long-term exposure (2 years) to 10 ppm of chlorine dioxide does not produce adverse effects. However, rats exposed to 100 ppm showed an increased mortality rate.
Fridliand & Kagan (1971) reported that rats that consumed 10 ppm of ClO2 solution orally for 6 months had no adverse health effects. When the exposure was increased to 100 ppm, the only difference between the treatment group and the control group was slower weight gain in the treatment group. In an effort to simulate the conventional human lifestyle, Akamatsu et al (2012) exposed rats to chlorine dioxide gas at a concentration of 0,05 - 0,1 ppm, 24 hours a day and 7 days. of the week for a period of 6 months. They concluded that whole-body exposure to chlorine dioxide gas of up to 0,1 ppm over a 6-month period is non-toxic for rats.
Larger doses of ClO2 solution (eg, 50-1.000 ppm) can produce hematological changes in animals, including decreased red blood cell count, methemoglobinemia, and hemolytic anemia. Reduced serum thyroxine levels were also observed in monkeys exposed to 100 ppm in drinking water and in rat pups exposed to concentrations up to 100 ppm through the gavage or indirectly through drinking water from their drinking fountains (US Department of health and human service, 2004).
Moore & Calabrese (1982) studied the toxicological effects of ClO2 in rats and observed that when rats were exposed to a maximum level of 100 ppm through drinking water, neither A / J nor C57L / J rats showed any hematological change. It was also found that rats exposed to up to 100 ppm of sodium chlorite (NaCIO2) in their drinking water for up to 120 days could not demonstrate any histopathological change in the structure of the kidneys.
Shi and Xie (1999) indicated that an acute oral LD50 value (expected to result in the death of 50% of the dosed animals) for stable chlorine dioxide was> 10.000 mg / kg in mice. In rats, the acute oral LD50 values for sodium chlorite (NaClO2) ranged from 105 to 177 mg / kg (equivalent to 79-133 mg chlorite / kg) (Musil et al 1964, Seta et al 1991. No Exposure-related deaths were observed in rats given chlorine dioxide in drinking water for 90 days at concentrations resulting in doses up to approximately 11,5 mg / kg / day in males and 14,9 mg / kg / day in women (Daniel et al 1990).
According to the United States Environmental Protection Agency (EPA), the short-term toxicity of ClO2 was evaluated in human studies by Lubbers et al (1981, 1982, 1984a and Lubbers & Bianchine 1984c). In the first study (Lubbers et al 1981, also published as Lubbers et al. 1982), a group of 10 healthy adult men drank 1.000 ml (divided into two 500 ml servings, 4 hours apart) of a solution of 0 or 24 mg / L chlorine dioxide (0,34 mg / kg, assuming a reference body weight of 70 kg). In the second study (Lubbers et al 1984a), groups of 10 adult men received 500 ml of distilled water containing 0 or 5 mg / L ClO2 (0,04 mg / kg day assuming a reference body weight of 70 kg) for 12 weeks. No study found physiologically relevant changes in general health (observations and physical examination), vital signs (blood pressure, pulse rate, respiratory rate, and body temperature), serum clinical chemical parameters (including glucose levels, urea nitrogen and phosphorus), alkaline phosphatase, aspartate, alanine aminotransferase, serum triiodothyronine (T3) and thyroxine (T4), nor the hematological parameters (EPA, 2004).
Michael et al (1981), Tuthill et al (1982) and Kanitz et al (1996) examined the effects of drinking water disinfected with ClO2. Michael et al (1981) found no significant abnormalities in hematological parameters or serum chemistry. Tuthill and colleagues (1982) retrospectively compared the morbidity and mortality data of newborns in two
communities: one that uses chlorine and another that uses ClO2 to purify water. In reviewing this study, EPA found no differences between these communities (US Department of Health and Human Service, 2004).
Two studies conducted at the Ohio State University School of Medicine evaluated the short-term safety of ClO2 in humans. In the first study, 10 healthy adult males drank 1.000 ml (divided into two 500 ml portions, 4 hours apart) of ClO2 0 or 24 ppm solution. In the second study, groups of 10 adult men drank 500 ml of water containing 0 or 5 ppm ClO2 for 12 weeks. None of the studies found any adverse effects.
Haag (1949) exposed groups of rats to ClO2 in drinking water for two years at concentrations that resulted in estimated doses of 0,07, 0,13, 0,7, 1,3, or 13 mg / kg / day. The results indicated no significant difference in mortality between the control group and the treated group up to the highest level of exposure tested. Survival was not significantly decreased in groups of rats exposed to chlorite (such as sodium chlorite) in drinking water for two years at concentrations that resulted in estimated chlorite doses of up to 81 mg / kg / day. In another study, Kurokawa et al. (1986) found that survival was not adversely affected in rats receiving sodium chlorite in drinking water at concentrations resulting in estimated chlorite doses of up to 32,1 mg / kg / day. in males and 40,9 mg / kg / day in females ”.
Exposure of rats to sodium chlorite for up to 85 weeks at concentrations resulting in estimated doses of chlorite up to 90 mg / kg / day has not affected survival (Kurokawa et al. 1986).
According to Lubbers et al 1981, there were no signs of adverse liver effects (evaluated in serum chemistry tests) in adult men who consumed ClO2 in aqueous solution, resulting in a dose of approximately 0,34 mg / kg or in other men adults consuming approximately 0,04 mg / kg / day for 12 weeks. The same researchers administered chlorite to healthy adult men and found no evidence of adverse liver effects after each individual consumed a total of 1.000 ml of a solution containing 2,4 mg / L of chlorite (approximately 0,068 mg / kg) in two doses (4 hours apart), or in other normal or G6PD-deficient men who consumed approximately 0,04 mg / kg / day for 12 weeks (Lubbers et al 1984a, 1984b). No signs of ClO2- or chlorite-induced impairment of liver function were observed among rural villagers who were exposed for 12 weeks via ClO2 in drinking water at weekly concentrations measured from 0,25 to 1,11 mg / L (ClO2) or 3,19 to 6,96 mg / L (chlorite) (Michael et al 1981). In this epidemiological study, the levels of ClO2 in drinking water before and after the treatment period were <0,05 mg / L. The chlorite level in drinking water was 0,32 mg / L before treatment with ClO2. One week and two weeks after stopping treatment, chlorite levels fell to 1,4 and 0,5 mg / L, respectively.
In its official document entitled "Laboratory biosafety manual" (page 93), the WHO (2005) talks about ClO2:
"Chlorine dioxide (ClO2) is a powerful, fast-acting germicide, disinfectant and oxidant which tends to have activity in concentrations lower than those required in the case of chlorine bleach. The gaseous form is unstable and decomposes into chlorine gas (Cl2) and oxygen gas (O2), producing heat. However, the ClO2 It is soluble in water and stable in aqueous solution.
It can be obtained in two ways:
1) By generation in situ, mixing two different components, hydrochloric acid (HCl) and sodium chlorite (NaClO2), Or
(2) ordering the stabilized form, which is activated in the laboratory when necessary.
The ClO2 it is the most selective of the oxidizing biocides. Ozone and chlorine are much more reactive than ClO2 and they are consumed by most organic compounds. In contrast, ClO2 It only reacts with reduced sulfur compounds, secondary and tertiary amines, and other highly reduced and reactive organic compounds. Therefore, with the ClO2 you can get a more stable residue at much lower doses than when using chlorine or ozone. If generated correctly, the ClO2Due to its selectivity, it can be used more efficiently than ozone or chlorine in cases with a higher load of organic matter ”.
Based on the WHO Strategy on Traditional Medicine 2014-2023 (WHO 2013), which recognizes practices related to traditional, complementary and integrative or 'non-conventional' medicine as an important part of health services, a In order to continuously integrate them with the various member countries that are signatories of this initiative, we put here the potential of the aqueous solution of ClO2 (Kalcker 2017) as a potent biocide and, therefore, as a safe complementary alternative to combat SARS-CoV2. ClO2 can fight viruses through the selective oxidation process through denaturation of capsid proteins and subsequent oxidation of the virus's genetic material, rendering it inactive. As there is no possible adaptation of the virus to the oxidation process, it is imposible that develops resistance to ClO2 becomes a promising treatment for any strain of virus.
The LD50 (acute toxicity index) toxicity established by the German GESTIS toxicology database for ClO2 is 292 mg per kilogram for 14 days, when the equivalent in a 60 kg adult would be 18.000 mg for 14 days (IFA 2020). According to the United States Department of Health and Human Services, ClO2 acts quickly when it enters the human body and ClO2 is rapidly transformed into chloride ions, which in turn decompose into chloride ions. The body uses these ions for its physiology. These chloride ions leave the body within hours to days, primarily through urine (EPA 1999).
Ma et al (2017) evaluated the efficacy and safety of an aqueous solution of ClO2 containing
2.000 ppm. Antimicrobial activity was 98,2% at concentrations between 5 and 20 ppm for fungal bacteria and H1N1 viruses. In an inhalation toxicity test, 20 ppm of ClO2 over 24h did not show any abnormalities in clinical symptoms and / or in the functioning of the lungs and other organs. A CLO2 concentration of up to 40 ppm in drinking water did not show any subchronic oral toxicity.
Taylor and Pfohl, 1985; Toth and others, (1990), Orme and others, 1985; Taylor and Pfohl, 1985; Mobley et al. (1990) studied the toxicity of chlorine dioxide, in various organs of the body, at different stages of development of the animal specimens studied, and reported a Minimum Observed Adverse Effect Level (LOAEL) for these effects of 14 mg kg-1 day-1 of chlorine dioxide. While Orme, et al. (1985) identified a No Observed Adverse Effects Level (NOAEL) of 3 mg kg-1 day-1. The clinical experience of Latin American doctors, during the last six months, suggests that the ingestion of 30 mg per day of chlorine dioxide dissolved in one liter of water, and ingested distributed in ten doses throughout the day as a treatment successful for COVID-19, which is 6 times below the NOAEL dose. Therefore, the literature review confirms that the use of chlorine dioxide ingested at a dose of 0,50 mg per kg per day does not represent a risk of toxicity to human health by ingestion, and it does represent a very plausible treatment. for COVID-19.
LEGAL FACTS AND HUMAN RIGHTS
Scientific advances and discoveries are constant, and in the field of health, prompt access to them by health personnel and patients becomes essential and urgent, being logical and obligatory, out of pure humanitarian sense and in accordance with scientific rigor, testing with substances such as Chlorine Dioxide (ClO2) for which there is proven evidence of their efficacy and usefulness. In the history of medicine, the supremacy of the criterion of "compassionate appeal" has been constant over the criterion of "perfectly contrasted appeal.".
Articles 32 and 37 of the Declaration of Helsinki of 1964 allow this in the case of "Unproven Intervention» (INC), «When proven interventions do not exist in the care of a patient or other known interventions have proven ineffective, the physician, after seeking expert advice, with the informed consent of the patient or an authorized legal representative, may be allowed to use unproven interventions, if, in your opinion, this gives some hope of saving life, restoring health or alleviating suffering«.
Doctors, in accordance with the 1948 Geneva Declaration, before patients whose health and life are in danger, have the obligation to use all the means and products at their disposal, which offer indications of effectiveness and, to a greater extent, in a medical emergency, Since in accordance with the duty of fraternity and humanitarian aid, the use of Chlorine Dioxide (ClO2) cannot be limited or denied, whose non-toxicity has been documented and whose efficacy and safety has been demonstrated in the
studies and practices carried out in different countries. To the same extent, States, Institutions and Organizations cannot restrict or prevent its use in the face of existing clinical evidence, otherwise they would fail to comply with the obligations assumed in international and national texts, incurring in the violation of fundamental rights such as the right to life and health, as well as the patient's right to self-determination and professional autonomy and clinical independence.
In accordance with the above, the exercise of the medical profession implies a vocation of service to humanity, with the health and life of the patient being their greatest concern, and must ensure the benefit of the interests of citizens, making knowledge available to them. physicians within the framework of professional autonomy and clinical independence. In the currently existing legal framework, fully applicable and enforceable, the medical profession must have professional freedom without interference in the care and treatment of patients, by having the privilege of using their professional judgment and discretion to make the necessary clinical and ethical decisions .
Physicians are legally conferred a high degree of professional autonomy and clinical independence, so they can make recommendations based on their knowledge and experience, clinical evidence, and holistic understanding of patients, including what is best for them without undue or inappropriate external influence , and take appropriate measures to ensure that effective systems are in place.
Every patient has the right to be treated by a doctor who he knows is free to give a clinical and ethical opinion, without any outside interference. The patient has the right to self-determination and to make decisions freely in relation to his person. Patients in the free exercise of their right to autonomy have the right to dispose of their body, their decisions must be respected, being fully protected to prevent third parties from intervening in their body without their consent, and must be adequately informed about the purpose of the intervention, nature, its risks and consequences.
The right to health requires that governments comply with the obligations they have assumed in the aforementioned agreements, so that health goods and services are available in sufficient quantity, with public access, and of good quality, in accordance with the provisions of the General Comment 14 of the Committee of the Covenant on Economic, Social and Cultural Rights.
All this covered in the provisions that are related and whose essential contents are extracted below;
- Universal Declaration of Human Rights, of December 10,
- American Declaration of the Rights and Duties of Man, Bogotá,
- American Convention on Human Rights, San José (Costa Rica), November 7-22
- International Covenant on Economic, Social and Cultural Rights of December 16, 1966.
- The Convention for the Protection of Human Rights and Fundamental Freedoms, Rome, November 4
- International Covenant on Civil and Political Rights of December 16,
- Agreement for the protection of human rights and the dignity of the human being with respect to the applications of Biology and Medicine of April 4, 1997, Oviedo agreement.
- Nuremberg Code of Ethics of August 19,
- Geneva Declaration of 1948.
- International Code of Medical Ethics of October
- Declaration of Helsinki adopted by the 18th World Medical Assembly of
- Belmont Report of April 18,
- WMA Declaration of Lisbon on the Rights of the Patient of
- Declaration of the WMA on the Independence and Professional Freedom of the Physician of 1986.
- Madrid Declaration of the AMM on the Autonomy and Professional Self-Regulation of
- WMA Seoul Declaration on Professional Autonomy and Clinical Independence of
- Madrid Declaration of the AMM on Professional Regulation of
- WMA Declaration on the relationship between law and ethics of
- UNESCO Universal Declaration on Bioethics and Human Rights de
- International Health Regulations of
The International Covenant on economic, social and cultural rights of December 16, 1966, signed by Ecuador on September 24, 1968 and ratified on June 11, 2010, recognizes the right of everyone to the enjoyment of the highest possible level of health. physical and mental; artº12 «1. The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest possible level of physical and mental health. «and the duty to protect this right by the state through a global health care system, which is available to all, without discrimination and economically accessible, art. 2:
- "Each one of the States Parties to the present Covenant undertakes to adopt measures, both separately and through international assistance and cooperation, especially economic and technical, to the maximum of the resources available to it, to progressively achieve, by all the appropriate means, including in particular the adoption of legislative measures, the full realization of the rights here «
The International Code of Medical Ethics of October 1949, so that articles 36 and 59 of the aforementioned text become effective, among others;
- Article 36 of Chapter VII regarding medical care at the end of
«1. The doctor has the duty to try to cure or improve the patient, whenever possible. When it is no longer so, the obligation to apply the appropriate measures to achieve their well-being remains, even when this may lead to a shortening of life.
- The doctor must not undertake or continue diagnostic or therapeutic actions that are harmful to the patient, without hope of benefits, useless or obstinate. It must withdraw, adjust or not institute a treatment when the prognosis is limited. It must adapt the diagnostic tests and the therapeutic and support measures to the clinical situation of the patient. You must avoid futility, both quantitative and qualitative.
- The doctor, after adequate information to the patient, must take into account his willingness to reject any procedure, including treatments aimed at prolonging the
- When the patient's condition does not allow him to make decisions, the doctor must take into consideration, in order of preference, the indications previously made by the patient, the previous instructions and the opinion of the patient in the voice of his It is the doctor's duty to collaborate with the people who have the mission of guaranteeing compliance with the patient's wishes »
- Article 59 of Chapter XIV relative to medical research;
"1. Medical research is necessary for the advancement of medicine, being a social good that must be fostered and encouraged. Research with human beings must be carried out when scientific progress is not possible by alternative means of comparable efficacy or in those phases of research in which it is essential. 2.- The investigating physician must adopt all possible precautions to preserve the physical and mental integrity of the research subjects. You must take special care in protecting individuals belonging to vulnerable groups. The good of the human being who participates in biomedical research must prevail over the interests of society and science.
- - Respect for the research subject is the guiding principle of the same. Your explicit consent must always be obtained. The information must contain, at least: the nature and purpose of the research, the objectives, the methods, the expected benefits, as well as the potential risks and discomforts that its participation may cause. You must also be informed of your right not to participate or to withdraw freely at any time from the investigation, without being harmed by
- - The medical researcher has the duty to publish the results of his research through the normal channels of scientific dissemination, whether they are favorable or not. It is unethical to manipulate or withhold data, whether for personal or group gain, or for ideological reasons. "
The 1981 WMA Declaration of Lisbon on the Rights of the Patient, «Every patient has the right to be cared for by a doctor who he knows is free to give a clinical and ethical opinion, without any outside interference.
The patient has the right to self-determination and to make decisions freely in relation to his person. The doctor will inform the patient of the consequences of his decision. The mentally competent adult patient has the right to give or deny consent for any examination, diagnosis, or therapy. The patient has the right to the information necessary to make his decisions. The patient must clearly understand what the
purpose of any examination or treatment and what are the consequences of not giving consent »
The Declaration of the AMM on the Independence and Professional Freedom of the Physician of 1986, according to which; «Physicians must enjoy a professional freedom that allows them to care for their patients without interference. The physician's privilege to use his professional judgment and discretion in making the clinical and ethical decisions necessary for the care and treatment of his patients must be upheld and defended. By ensuring the independence and professional freedom for the physician to practice medicine, the community ensures the best medical care for its citizens, which, in turn, contributes to a strong and safe society.«
The 2009 WMA Madrid Declaration on Professional Regulation reaffirms the Seoul Declaration on the professional autonomy and clinical independence of physicians by providing “Physicians are given a high degree of professional autonomy and clinical independence, so they can make recommendations based on their knowledge and experience, clinical evidence and holistic understanding of patients, including the best for them without undue or inappropriate external influence . »
The universal principles that permeate all regulations must comply with respect for humanitarian laws innate in the collective unconscious, as stated in the maxim of the Hippocratic oath «MAINTAIN the greatest respect for human life from the beginning, even under threat, and do not use medical knowledge against the laws of humanity. " Ethical values have primacy over limiting legal provisions, as is well recognized in the WMA Declaration on the relationship between law and ethics of 2003, which provides “When laws and medical ethics are in conflict, doctors should try to change the law. If this conflict occurs, ethical responsibilities prevail over legal obligations. "
When a patient in the face of a disease seeks relief or to save his life and requests to try a therapeutic option of which there are indications of usefulness, such as Chlorine Dioxide (ClO2), it is the doctor's duty to support the patient, acquire knowledge, do studies , and disseminate it in accordance with article 27 of the Universal Declaration of Human Rights of 1948, so that everyone benefits from scientific progress, the information must be freely shared so that it can be disseminated in all countries without restrictions, «Everyone has the right to take part freely in the cultural life of the community, to enjoy the arts and to participate in scientific progress and the benefits that result from it. "
In view of the historical moment that all humanity faces with the Coronavirus pandemic and the urgent need to save lives, the recent events related to the treatment of COVID-19 in both the medical and academic fields, and especially the object of this document, which is to provide the authorities with correct information on chlorine dioxide for correct and safe human use, it is worth considering some fundamental criteria related to human rights and medical practice for reflection:
- Adherence to any treatment depends on the agreement and tacit collaboration between the parties: the doctor and the patient (or their guardian when they are in special conditions that do not allow a conscious choice of medical intervention, for example, memory loss situations , induced or trauma unconsciousness, in boys / girls). This is a free and spontaneous agreement;
- Based on his clinical experience, the doctor is free to prescribe what he considers appropriate for the patient, always communicating the correct way to use a medicine, the possible benefits and risks of a therapeutic intervention. On the other hand, the patient, based on the explanations given, personal beliefs and complementary information, also has the freedom to accept or not any form of indicated treatment;
- Medical practice should always be based, whenever possible, on scientific data that support the diagnostic and therapeutic behaviors used. However, in situations where scientific evidence is not available, or is unreliable, it is up to the Doctor to use his knowledge, previous experience and common sense to conduct the clinical situation in the way that seems most appropriate. In this case, it is important that the doctor ask the patient to sign a Term of Free and Informed Consent (TCLI). For this conduct, the Doctor relies on the Declaration of Helsinki (Art. 37) which tells us:
“In treating an individual patient, when it is established that there have been no interventions or other interventions known to have been ineffective, the physician, after seeking expert advice, with the informed consent of the patient or an authorized representative, may use an unproven intervention if, in the judgment of the clinician, it offers hope of saving lives, restoring health, or alleviating suffering. This intervention should be investigated to evaluate its safety and efficacy. In all cases, the new information must be registered and, where appropriate, made available to the public "
- Respecting the aforementioned aspects, we cannot underestimate the fact that there is still not enough evidence in the scientific literature that indicates the use of CDS for the prophylaxis or for the etiological treatment of COVID-19 cases of any severity, but we do have , for example, from the technical report of AEMEMI doctors confirming an efficacy of 97% in the treatment of patients with COVID-19 for 4 days in Guayaquil / Ecuador (AEMEMI 2020). It is worth mentioning that until now we still have difficulties for the approval of clinical trials and so far, it has not yet been able to begin investigations in many countries because regulatory institutions are sending the wrong message when they consider that chlorine dioxide is toxic;
- In the specific case of ClO2, the information and clinical tests currently available point to the efficacy of this substance in fighting the coronavirus, for example, the observational study made available by the group of Doctors of AEMEMI (2020).
- In view of the above, on the basis of the evidence presented here with evident experience on the part of Scientists and Health Professionals, as well as already well demonstrated in scientific articles already published, we recommend the use of the chlorine dioxide solution ( CDS) according to the standardized by Andreas Ludwig Kalcker (2017), duly diluted and therefore, respecting the safe doses of what is already known as safe according to toxicity studies, which according to reports from doctors from several countries have shown be safe for human consumption and also effective against COVID-19 when consumed correctly following internationally standardized protocols.
As an example of the conscious and compassionate use of chlorine dioxide (CDS), we can cite the Plurinational State of Bolivia, after a prolonged process of debate and resolution within the framework of the exercise of Human Rights and within the framework of the Law on Participation and Social Control, the population has demanded through their departmental and national assembly representatives the Law that allows the authorization of the production, distribution with quality control and compassionate use of the aqueous solution of chlorine dioxide (CDS), as standardized by Andreas Ludwig Kalcker.
- AEMEMI - Ecuadorian Association of Medical Experts in Medicine Chlorine dioxide, an effective therapy for the treatment of SARS-COV2 (COVID-19). May, 2020
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