BCIIG is advocating for inclusion of Ivermectin in Botswana's Covid-19 treatment protocol
We are Botswana COVID-19 Ivermectin Intervention Group (BCIIG), a group of multidisciplinary scientists, healthcare professionals, and community members with the purpose to educate the public, provide psychosocial counselling and other forms of support to affected families, and advocate for urgent consideration and use of Ivermectin and all other possible therapeutics against COVID-19.
Introduction:
The global community is in a crisis, struggling to contain the COVID-19 pandemic. As of June 2021, a total of ~4 million people worldwide have succumbed to COVID-19, leaving many orphaned or struggling with post-COVID-19 challenges.
While the adverse implications of this pandemic have hit the rich and poor countries alike, the average death toll as a proportion of those infected in poorer countries is generally higher. Two major reasons for the high death toll are a lack of effective treatment options and infection prevention.
There are no newly developed and approved therapeutic agents for COVID-19. Although treatment may vary across nations, combinations of anti virals, antibiotics, corticosteroids, blood thinners, and several other agents that together provide some relief are used.
There is presently no known cure for COVID-19.There has been a race towards the development of vaccines against SARS-CoV-2, and so far, several have been given emergency-use authorisation that has largely benefitted the Western nations.
Access to vaccines in poorer countries is low, and where vaccines are available, their roll-out is slow. With the ever-changing variants, there is presently no indication that there is an end in sight to the pandemic, at least for the developing nations, as each variant seems to spread faster than the previous one.
For Botswana and most of the developing nations, the reality is that current mitigation strategies have, at best, minimal positive impact on infection, hospitalisation, and mortality rates. Given our small population and limited resources, we must urgently search for and accommodate other therapeutic options.
A therapeutic agent that has attracted worldwide attention is Ivermectin as the leading candidate. Ivermectin has been demonstrated to have both antiviral and anti-inflammatory properties, which explains its use against COVID-19, a viral disease associated with heightened inflammation.
There is variability in the quality of studies reported and hence some researchers and institutions, such as USA’s National Institute of Health, Food and Drug Administration, Merck, and World Health Organisation (WHO), have either been neutral to or against the use of Ivermectin on COVID-19patients.
There is, however, a growing body of literature from reputable groups of researchers around the world showing a degree of benefit with the use of Ivermectin in the prevention and treatment of COVID-19. Ivermectin, which is available in tablet form, is relatively cheap and has been widely used as an antiparasitic agent in humans since 1987, with an estimated 4 billion+ prescriptions since then, underlining its safety profile. Indeed, Ivermectin is on the list of essential medicines published by WHO.
What BCIIG has done:
We have so far used a multi-pronged approach, including:
• providing nutritional and dietary assistance and counselling, 29June 20212
• providing socio-economic (COVID-19 supplies and amenities) support,
• providing psycho-social and psycho-therapeutic counselling,
• reviewing scientific literature on COVID-19treatment and preventative drugs, and
• meeting with and formally engaging the Botswana Medical Regulatory Authority, Ministry of Health and Wellness, Presidential Task Force Secretariat, and Technical Committee of the Presidential Task Force over a total of six (6) meetings from March 17 to June 24, 2021.
The following are outcomes from our community engagement and research:
• BCIIG, through its affiliate, Corona Must Fall, has to-date supported at least 1,000families. The feedback has been positive, with families expressing appreciation for help, ability to cope better with their loss, and Covid-related challenges.
• We have identified Ivermectin as a viable treatment and preventative drug.
The following are outcomes from our engagement with authorities:
• We have not received any documented formal response from any authority
• We have been informed that Ivermectin for human use is not registered in Botswana and BoMRA does not initiate drug registration
• BoMRA would consider an application for use of the drug under research conditions, if submitted
• The Ministry of Health and Wellness has not expressed its position on the use of Ivermectin for COVID-19
• The Task Force Secretariat:
O expressed uncertainty about the safety profile for the drug
o suggested that the evidence on the use of Ivermectin is conflicting
o thus, endorsed WHO position that recommends use under research trial conditions
o emphasised that for the drug to be used, all legal and regulatory statutes for Botswana must be followed, thus referring us back to BoMRA
• The Technical Committee of the Presidential Task Force expressed:
O uncertainty about the safety profile for the drug
o that the matter was too technical to be discussed with them
o that they would consult with their scientific experts and revert
Our responses to some of the commonly held objections to the use of Ivermectin against COVID-19
• Uncertainty about Ivermectin safety profile
O Our response: safety is not a valid issue
▪ The drug has been used in humans for over 4 decades, with over 4 billion prescriptions
▪ As ofJune28th, 2021, the drug has at a minimum been used at various doses in approximately 19, 000 humans for the prevention and treatment of COVID-19 without any serious adverse effects reported (see table below for details):https://covid19 criticalcare.com/-accessed on June 28, 2021
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• Conflicting evidence on usefulness of Ivermectin against COVID-19
O Our response:
Even though the evidence is conflicting, overall, majority of studies have shown a degree of benefit.
▪ While studies vary in the level of quality of design, majority of results show a degree of benefit from modest to high reduction in the rate of mortality. A more recent publication from a group of British researchers, for example, shows a 62% reduction in mortality rates (Bryant et al., June 2021 -American Journal of Therapeutics)
▪ The report of conflicting evidence is not sufficient reason not to use the drug, given the severity of the pandemic and a lack of effective alternative treatment.
▪ Remdesivir, which is approved for HIV treatment, is included in our national COVID-19 treatment guidelines despite the absence of evidence that it improves survival and other clinical outcomes in patients with COVID-19.
• Similar to WHO’s advice, the Presidential Task Force Secretariat advises use of Ivermectin against COVID-19 only under conditions of clinical research trials
O Our response:
With the already available evidence and in the face of the pandemic that kills so many people so quickly and knows no limit, available trial data should allow for Ivermectin use.
▪ Future trials will be useful in confirming or refuting the data we currently have.
▪ Proper clinical trials are resource-intensive and would not be prudent to carry out when we are already under severe economic strain
Our Position on the Use of Ivermectin against COVID-19
• Given that Botswana is in a crisis that is destroying the fabric of our society at all levels, we must encourage all willing and able citizens and residents to contribute towards possible solutions.
Unlike most nations, the Government of Botswana has invested heavily in training its citizens in various fields of study and importing skilled labour and thus all should be encouraged and be given the opportunity to address the challenges that have resulted from the current pandemic.
• Furthermore, any other community members or groups should similarly be encouraged to contribute towards the fight against the pandemic.
• We support a comprehensive mitigation strategy that includes all possible preventative and treatment approaches.
• We note with great concern the inclusion of remdesivir in our national COVID-19treatment guidelines, despite WHO’s and others’ recommendations against its use because of its lack of mortality benefit and extremely high cost.
• We recommend the inclusion of Ivermectin in the COVID-19 prevention and treatment protocols in Botswana.
• Given the ongoing severe loss of life, lack of any currently viable treatment, nation’s inability to effectively stem the tide of this disease, slow-paced vaccination programme, and our limited resources, we urge swift registration of Ivermectin.
• We think that there currently is indecisiveness, indifference, misinformation, or disinformation about the adoption of Ivermectin for use againstCOVID-19, globally.
For instance, it is misinformation by some in authority to suggest that Ivermectin’s mechanism of action is unknown.
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• The characterisation of Ivermectin as an animal drug only is misleading. BCIIG does not recommend the animal formulation for human use. However, any use of the injectable form by humans may be an act of desperation.
• BCIIG does not encourage people to take any drug unless it is obtained from a legitimate source and prescribed by a licensed healthcare provider.
• In the interest of saving lives, we respectfully implore His Excellency the President to invoke executive powers and issue a directive for the use of Ivermectin against COVID-19, consistent with President Festus Mogae’s action in the roll-out of anti-retroviral drugs during the HIV-AIDS crisis.
• Our position regarding inclusion of Ivermectin in COVID-19 preventionand treatment protocols is not unique as countries such as Argentina, Czechia, India, Mexico, Peru, South Africa, USA, and Zimbabwe allow some fashion of its use.
SOME KEY REFERENCES
• Bryant A, Lawrie TA, Dowswell T, Fordham EJ, Mitchell S, Hill SR, Tham TC. Ivermectin for Prevention and Treatment of COVID-19 Infection: A Systematic Review, Meta-analysis, and Trial Sequential Analysis to Inform Clinical Guidelines. Am J Ther. 2021 Jun 17. doi: 10.1097/MJT.0000000000001402. Epub ahead of print. PMID: 34145166.
• Singh S, Khera D, Chugh A, Khera PS, Chugh VK. Efficacy and safety of remdesivir in COVID-19 caused by SARS-CoV-2: a systematic review and meta-analysis. BMJ Open. 2021 Jun 24;11(6):e048416. doi: 10.1136/bmjopen-2020-048416. PMID: 34168031.
BCIIG MEMBERS
•Dr. George G. Mokone •Dr. Jean-Leigh Kruger •Ms. Marina Gobagoba •Dr. Maikutlo Kebaetse •Dr. Ludo Badlangana •Dr. Lingani Mbakile-Mahlanza •Ms.Bose Badzile-Stimela •Mr. Gad Bome •Dr.Keikantse Matlhagela •Dr. Mpho S.Mogodi •Dr. Basiamisi Segwagwe •Mr.Kenny Stimela •Prof. Billy Tsima •Dr. Josephine Nkosana •Dr. Segametsi Maruapula •Prof. Maria Nnyepi •Dr. Andrew Ndlovu •Dr. Mighty Kemelo •Dr. Mbako Nnyepi •Dr. Japhter Masunge
