IVERMECTIN FOR THE PREVENTION OF COVID-19
So WHO is telling the Truth?
This study discusses the case for Ivermectin as a proven preventive treatment for COVID-19.
Ivermectin has been off patent since 1996 when Merck’s patent on Ivermectin expired (WHO, 2020). Here emerges a reasonable question:
Is this the reason for which the pharmaceutical industry is not that interested in Ivermectin for the potential treatment of COVID-19?
The World Health Organization (WHO) has emphasized that to date, there is no specific medicine recommended to prevent or treat the new coronavirus. This documentary research is reporting that several prestigious scientists and physicians around the globe, with hard evidence and successful research results in their hands, are recommending Ivermectin as a preventive treatment.
It was found that Ivermectin, originally introduced as an anthelmintic, to be an effective, safe and an affordable therapeutic option for prevention of COVID-19. It has potential to convert RT-PCR negative quickly. It can be used across the severity of COVID-19 especially in preventive and early viremic phase.
It can be combined with other molecules of interest, like hydroxychloroquine, azithromycin, doxycycline, zinc. Ivermectin is affordable, easily available, and safe without any major side effects.
Right now many lives in the world are at stake. Something to be considered when choosing the right treatment is that many renowned scientists propose Ivermectin, a strong antiviral drug as a therapeutic option in the prevention of COVID-19.
So…WHO is telling the truth?
Ivermectin has been off patent since 1996 when Merck’s patent on Ivermectin expired (WHO, 2020). Here emerges a reasonable question:
Is this the reason for which the pharmaceutical industry is not that interested in Ivermectin for the potential treatment of COVID-19?
The World Health Organization (WHO) has emphasized that to date, there is no specific medicine recommended to prevent or treat the new coronavirus. This documentary research is reporting that several prestigious scientists and physicians around the globe, with hard evidence and successful research results in their hands, are recommending Ivermectin as a preventive treatment.
It was found that Ivermectin, originally introduced as an anthelmintic, to be an effective, safe and an affordable therapeutic option for prevention of COVID-19. It has potential to convert RT-PCR negative quickly. It can be used across the severity of COVID-19 especially in preventive and early viremic phase.
It can be combined with other molecules of interest, like hydroxychloroquine, azithromycin, doxycycline, zinc. Ivermectin is affordable, easily available, and safe without any major side effects.
Right now many lives in the world are at stake. Something to be considered when choosing the right treatment is that many renowned scientists propose Ivermectin, a strong antiviral drug as a therapeutic option in the prevention of COVID-19.
So…WHO is telling the truth?
BUREAUCRACY, COSTS AND NOT ENOUGH PROFITS
The path a drug travels from a lab to our medicine cabinet is very long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. An important use of a drug may also be discovered by accident (FDA, 2020). On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average. The average cost to research and develop each successful drug is estimated to be $2.6 billion (Phrma, 2015).
A patent on a drug holds a lot of importance to the company manufacturing the drug. It means that the company holds exclusive rights to sell the drug (or formulation) throughout the world with no competition for more than 10 years. This encourages the company to market the drug, sell it at a higher price, and reap all the profits for more than a decade. The problem for the company arises when the drug, which has contributed to a large pie of profits, is going off patent. This means that it will face a lot of competition from generic substitutes, which will have a huge impact on its sales (London School of Economics and Political Science, 2007; Harvard Kennedy School, 2010).
Ethics or No Ethics, and Patents
During the time a prescription drug company has a patented product; it has a monopoly on the benefits the prescription drug offers to consumers. When a company has a monopoly on its product it is free from market competition and can therefore charge whatever price the market will pay (Hoen, 2003 in Bodem, 2020). This price is usually the most profitable price as few companies will choose do charge less on the basis that they want to help people who need their medicines for a better, healthier life. This is somewhat of a downside to the patent system in that those who are receiving the newly marketed drugs are only those who can afford them (Bodem, 2020).
There is a conflict between companies who have rights to make profits on innovative new drugs and those who wish to direct companies to innovate new pharmaceuticals for developing countries. (Hoen, 2003 in Bodem, 2020) The amount of new medicines developed over the last 25 years is approximately 1.400.
Only 1% of these new medicines have been for tropical diseases, such as new malaria drugs, that kill thousands of people every year. (Hoen, 2003 in Bodem, 2020) Developing world’s diseases do not represent a profitable venture for pharmaceutical companies and that is why innovative drugs for the people of the developing world are not being developed. (Hoen, 2003 in Bodem, 2020).
Some even say that the patent system is a fault for the lack of prescription drugs available to developing countries. (Sterchx, 2005 in Bodem, 2020) Also, that the patent system is the main contributing factor to the lack of essential drugs in developing countries because the patent system raised drug prices and provides less choice of sources of drugs.
Some would even call the patent system inhuman, as poor people in developing counties are dying because they cannot afford to buy prescriptions drugs they need and the fact that these prices are necessary to ensure pharmaceutical research and development is an unacceptable excuse. (Sterchx, 2005 in Bodem, 2020)
Insuring that sick people have access to the prescriptions that they need should be the goal and because the current patent system does not achieve this for the men, women, and children of developing countries some think that the patent system should be redone and changed so that these people do have access to the prescriptions drugs that they need. (Sterchx, 2005 in Bodem, 2020).
There has been a debate. Is it really the patents given to pharmaceutical companies and the subsequent expensive prescriptions the reason developing countries do not have the prescription medications they need, or is it public policy in developing countries that is to blame? This issue may have to be resolved through politics and government intervention (Bodem, 2020).
Patent expiration leads to the marketing and sales of generic equivalents to the previously patented prescription drugs. This patent expiration represents a loss in profits for pharmaceutical companies who may try to encourage customers to switch to a new and better equivalent of the previously patented prescription.
The generic drug companies have benefited recently from the Hatch-Waxman Act that allows them to put their generics on the market without having to go through costly testing, only proving that their generic is the same as the previously patented brand-name prescription drug (Bodem, 2020).
Ivermectin is a Food and Drug Administration (FDA)-approved antiparasitic drug that is used to treat several neglected tropical diseases, including onchocerciasis, helminthiases, and scabies. It is also being evaluated for its potential to reduce the rate of malaria transmission by killing mosquitoes that feed on treated humans and livestock.
For these indications, Ivermectin has been widely used and has demonstrated an excellent safety profile (NIH, 2020). Ivermectin, approved by the US Food and Drug Administration for parasitic infections, has received renewed attention in the last eight years due to its apparent exciting potential as an antiviral.
The path a drug travels from a lab to our medicine cabinet is very long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. An important use of a drug may also be discovered by accident (FDA, 2020). On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average. The average cost to research and develop each successful drug is estimated to be $2.6 billion (Phrma, 2015).
A patent on a drug holds a lot of importance to the company manufacturing the drug. It means that the company holds exclusive rights to sell the drug (or formulation) throughout the world with no competition for more than 10 years. This encourages the company to market the drug, sell it at a higher price, and reap all the profits for more than a decade. The problem for the company arises when the drug, which has contributed to a large pie of profits, is going off patent. This means that it will face a lot of competition from generic substitutes, which will have a huge impact on its sales (London School of Economics and Political Science, 2007; Harvard Kennedy School, 2010).
Ethics or No Ethics, and Patents
During the time a prescription drug company has a patented product; it has a monopoly on the benefits the prescription drug offers to consumers. When a company has a monopoly on its product it is free from market competition and can therefore charge whatever price the market will pay (Hoen, 2003 in Bodem, 2020). This price is usually the most profitable price as few companies will choose do charge less on the basis that they want to help people who need their medicines for a better, healthier life. This is somewhat of a downside to the patent system in that those who are receiving the newly marketed drugs are only those who can afford them (Bodem, 2020).
There is a conflict between companies who have rights to make profits on innovative new drugs and those who wish to direct companies to innovate new pharmaceuticals for developing countries. (Hoen, 2003 in Bodem, 2020) The amount of new medicines developed over the last 25 years is approximately 1.400.
Only 1% of these new medicines have been for tropical diseases, such as new malaria drugs, that kill thousands of people every year. (Hoen, 2003 in Bodem, 2020) Developing world’s diseases do not represent a profitable venture for pharmaceutical companies and that is why innovative drugs for the people of the developing world are not being developed. (Hoen, 2003 in Bodem, 2020).
Some even say that the patent system is a fault for the lack of prescription drugs available to developing countries. (Sterchx, 2005 in Bodem, 2020) Also, that the patent system is the main contributing factor to the lack of essential drugs in developing countries because the patent system raised drug prices and provides less choice of sources of drugs.
Some would even call the patent system inhuman, as poor people in developing counties are dying because they cannot afford to buy prescriptions drugs they need and the fact that these prices are necessary to ensure pharmaceutical research and development is an unacceptable excuse. (Sterchx, 2005 in Bodem, 2020)
Insuring that sick people have access to the prescriptions that they need should be the goal and because the current patent system does not achieve this for the men, women, and children of developing countries some think that the patent system should be redone and changed so that these people do have access to the prescriptions drugs that they need. (Sterchx, 2005 in Bodem, 2020).
There has been a debate. Is it really the patents given to pharmaceutical companies and the subsequent expensive prescriptions the reason developing countries do not have the prescription medications they need, or is it public policy in developing countries that is to blame? This issue may have to be resolved through politics and government intervention (Bodem, 2020).
Patent expiration leads to the marketing and sales of generic equivalents to the previously patented prescription drugs. This patent expiration represents a loss in profits for pharmaceutical companies who may try to encourage customers to switch to a new and better equivalent of the previously patented prescription.
The generic drug companies have benefited recently from the Hatch-Waxman Act that allows them to put their generics on the market without having to go through costly testing, only proving that their generic is the same as the previously patented brand-name prescription drug (Bodem, 2020).
Ivermectin is a Food and Drug Administration (FDA)-approved antiparasitic drug that is used to treat several neglected tropical diseases, including onchocerciasis, helminthiases, and scabies. It is also being evaluated for its potential to reduce the rate of malaria transmission by killing mosquitoes that feed on treated humans and livestock.
For these indications, Ivermectin has been widely used and has demonstrated an excellent safety profile (NIH, 2020). Ivermectin, approved by the US Food and Drug Administration for parasitic infections, has received renewed attention in the last eight years due to its apparent exciting potential as an antiviral.
Mechanism of Action for the treatment of COVID-19
Ivermectin has been shown to inhibit the replication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in cell cultures. Ivermectin acts by inhibiting the host importin alpha/beta-1 nuclear transport proteins, which are part of a key intracellular transport process that viruses hijack to enhance infection by suppressing the host antiviral response.
Ivermectin is therefore a host-directed agent, which is likely the basis for its broad-spectrum activity in vitro against the viruses that cause dengue, Zika, HIV, and yellow fever profile (NIH, 2020).
Wagstaff et al (2012) have explained that the movement of proteins between the cytoplasm and nucleus mediated by the importin superfamily of proteins is essential to many cellular processes, including differentiation and development, and is critical to disease states such as viral disease and oncogenesis. They developed a high-throughput screen to identify specific and general inhibitors of protein nuclear import, from which Ivermectin was identified as a potential inhibitor of importin α/β-mediated transport. In their study, they characterized in detail the nuclear transport inhibitory properties of Ivermectin, demonstrating that it is a broad-spectrum inhibitor of importin α/β nuclear import, with no effect on a range of other nuclear import pathways, including that mediated by importin β1 alone.
Importantly, they established for the first time that Ivermectin has potent antiviral activity towards both HIV1 and dengue virus, both of which are strongly reliant on importin α/β nuclear import, with respect to the HIV-1 integrase and NS5 (nonstructural protein 5) polymerase proteins respectively.
Ivermectin would appear to be an invaluable tool for the study of protein nuclear import, as well as the basis for the development of antiviral agents.
Ivermectin has the capacity to modulate the immune response. An uncontrolled immune response is partly responsible for the pathophysiology of COVID-19. It exerts anti-inflammatory effect by down regulating the nuclear transcription factor kappa-B and mitogen-activated protein kinase activation pathway, it may inhibit LPS-induced production of inflammatory cytokines by blocking NF-kappaB and MAP-kinase in RAW 264.7 cells (Xinxin C, 2009). Lehrer & Rheinstein (2020) carried out a docking study to determine if Ivermectin might be able to attach to the SARS-CoV-2 spike receptor-binding domain bound with ACE2.
They concluded that the Ivermectin docking that they identified may interfere with the attachment of the spike to the human cell membrane. Other potential mechanisms of action include inhibition of the viral enzyme used to unwind its RNA, the helicase, for which it seems Ivermectin may be effective at much lower concentrations. Interaction with the Nicotinic Acetylcholine receptor that may cause immunomodulation or reduce the expression of ACE-II, the receptor used by the virus to enter the cells (Chaccour, 2020).
It was identified in a high-throughput chemical screen as inhibiting recognition of the nuclear localizing Human Immunodeficiency Virus-1 (HIV-1) integrase protein by the host heterodimeric importin (IMP) α/β1 complex, and has since been shown to bind directly to IMPα to induce conformational changes that prevent its normal function in mediating nuclear import of key viral and host proteins.
Excitingly, cell culture experiments show robust antiviral action towards HIV-1, dengue virus (DENV), Zika virus, West Nile virus, Venezuelan equine encephalitis virus, Chikungunya virus, Pseudorabies virus, adenovirus, and SARS-CoV-2 (COVID-19). Phase III human clinical trials have been completed for DENV, and more that 50 trials currently in progress worldwide for SARS-CoV-2 (Jans and Wagstaff, 2020).
Read the entire article:
http://www.spentamexico.org/v15-n2/A2.15(2)1-30.pdf
Ivermectin has been shown to inhibit the replication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in cell cultures. Ivermectin acts by inhibiting the host importin alpha/beta-1 nuclear transport proteins, which are part of a key intracellular transport process that viruses hijack to enhance infection by suppressing the host antiviral response.
Ivermectin is therefore a host-directed agent, which is likely the basis for its broad-spectrum activity in vitro against the viruses that cause dengue, Zika, HIV, and yellow fever profile (NIH, 2020).
Wagstaff et al (2012) have explained that the movement of proteins between the cytoplasm and nucleus mediated by the importin superfamily of proteins is essential to many cellular processes, including differentiation and development, and is critical to disease states such as viral disease and oncogenesis. They developed a high-throughput screen to identify specific and general inhibitors of protein nuclear import, from which Ivermectin was identified as a potential inhibitor of importin α/β-mediated transport. In their study, they characterized in detail the nuclear transport inhibitory properties of Ivermectin, demonstrating that it is a broad-spectrum inhibitor of importin α/β nuclear import, with no effect on a range of other nuclear import pathways, including that mediated by importin β1 alone.
Importantly, they established for the first time that Ivermectin has potent antiviral activity towards both HIV1 and dengue virus, both of which are strongly reliant on importin α/β nuclear import, with respect to the HIV-1 integrase and NS5 (nonstructural protein 5) polymerase proteins respectively.
Ivermectin would appear to be an invaluable tool for the study of protein nuclear import, as well as the basis for the development of antiviral agents.
Ivermectin has the capacity to modulate the immune response. An uncontrolled immune response is partly responsible for the pathophysiology of COVID-19. It exerts anti-inflammatory effect by down regulating the nuclear transcription factor kappa-B and mitogen-activated protein kinase activation pathway, it may inhibit LPS-induced production of inflammatory cytokines by blocking NF-kappaB and MAP-kinase in RAW 264.7 cells (Xinxin C, 2009). Lehrer & Rheinstein (2020) carried out a docking study to determine if Ivermectin might be able to attach to the SARS-CoV-2 spike receptor-binding domain bound with ACE2.
They concluded that the Ivermectin docking that they identified may interfere with the attachment of the spike to the human cell membrane. Other potential mechanisms of action include inhibition of the viral enzyme used to unwind its RNA, the helicase, for which it seems Ivermectin may be effective at much lower concentrations. Interaction with the Nicotinic Acetylcholine receptor that may cause immunomodulation or reduce the expression of ACE-II, the receptor used by the virus to enter the cells (Chaccour, 2020).
It was identified in a high-throughput chemical screen as inhibiting recognition of the nuclear localizing Human Immunodeficiency Virus-1 (HIV-1) integrase protein by the host heterodimeric importin (IMP) α/β1 complex, and has since been shown to bind directly to IMPα to induce conformational changes that prevent its normal function in mediating nuclear import of key viral and host proteins.
Excitingly, cell culture experiments show robust antiviral action towards HIV-1, dengue virus (DENV), Zika virus, West Nile virus, Venezuelan equine encephalitis virus, Chikungunya virus, Pseudorabies virus, adenovirus, and SARS-CoV-2 (COVID-19). Phase III human clinical trials have been completed for DENV, and more that 50 trials currently in progress worldwide for SARS-CoV-2 (Jans and Wagstaff, 2020).
Read the entire article:
http://www.spentamexico.org/v15-n2/A2.15(2)1-30.pdf
Ivermectin & Orthomolecular Medicine Combination Therapy for COVID-19: Successful Clinical Protocols and A Case Study
| successful_clinical_protocols_and_a_case_study.pdf |
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