Quality of clinical evidence and political justifications of ivermectin mass distribution of COVID-19 kits in eight Latin American countries
José Antonio Requejo Domínguez, Dolores Mino-León, Dr Veronika J Wirtz
BMJ Global Health, doi:10.1136/bmjgh-2022-010962
Background Several countries in Latin America conducted mass distribution of COVID-19 kits intended to treat mild COVID-19, thereby preventing excess hospitalisations. Many of the kits contained ivermectin, an antiparasitic medicine that was not approved at the time for the treatment of COVID-19. The study objective was to compare the timing of the publication of scientific evidence about the efficacy of ivermectin for COVID-19 with the timeline of distribution of COVID-19 kits in eight Latin American countries and to analyse whether evidence was used to justify ivermectin distribution. Methods We conducted a systematic review of randomised controlled trials (RCTs) published on the efficacy of ivermectin or ivermectin as adjuvant therapy on mortality from, or as prevention for, COVID-19. Each RCT was assessed using the Cochrane Grading of Recommendations, Assessment, Development and Evaluations (GRADE). Information on the timing and justification of government decisions was collected through a systematic search of leading newspapers and government press releases. Results After removing the duplicates and abstracts without full text, 33 RCTs met our inclusion criteria. According to GRADE, the majority had a substantial risk of bias. Many government officials made claims that ivermectin was effective and safe in the prevention or treatment of COVID-19, despite the lack of published evidence. Conclusion All eight governments distributed COVID-19 kits to their populations despite the absence of high-quality evidence on the efficacy of ivermectin for prevention, hospitalisation and mortality in COVID-19 patients. Lessons learnt from this situation could be used to strengthen government institutions' capacities to implement evidenceinformed public health policies.
BACKGROUND In 2020, at least eight countries in Latin America
Competing interests None declared. Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research. Patient consent for publication Not applicable. Provenance and peer review Not commissioned; externally peer reviewed. Data availability statement Data are available in a public, open access repository. No applicable. Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
Supplement 2 Nexis Uni search strategy
Ministry of Health Social Security
Ministry of Health
Ministry of Health
Ministry of Health
Ministry of Health Social Security
Acetaminophen
References
Bryant, Lawrie, Dowswell, 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,
doi:10.1097/MJT.0000000000001402
Camhaji, Gortázar, Santaeulalia, El accidentado viaje de la ivermectina POR América. El País
Campillo, Boussinesq, Bertout, Serious adverse reactions associated with ivermectin: a systematic pharmacovigilance study in sub-Saharan Africa and in the rest of the world, PLOS Negl Trop Dis,
doi:10.1371/journal.pntd.0009354
Chacón, Ivermectin is no longer in COVID-19 treatment kits in Mexico, AP News
Crosby, Crosby, Applying the precautionary principle to personal protective equipment (PPE) guidance during the COVID-19 pandemic: did we learn the lessons of SARS?, Can J Anaesth,
doi:10.1007/s12630-020-01760-y
De, Gobierno envía Los primeros 22.000 tratamientos maíz Y catracho para atender a pacientes de covid-19
De, Paulo, Ministério da Saúde pressiona Manaus e diz ser 'inadmissível' não usar cloroquina contra Covid-19
De, Tomás-López, Álvarez-Medina, A multimodal strategy to reduce the risk of hospitalization/death in ambulatory patients with COVID-19, Arch Med Res,
doi:10.1016/j.arcmed.2022.01.002
Dyer, Domínguez, Covid-19: Mexico City gave ivermectin kits to people with covid in "unethical'' experiment, BMJ Global,
doi:10.1136/bmj.o453
Freelon, Hanbury, Brazil's main COVID strategy is a cocktail of unproven drugs: goats and soda, NPR
Health,
Hellmann, Homedes, An unethical trial and the politicization of the COVID-19 pandemic in Brazil: the case of prevent senior, Dev World Bioeth,
doi:10.1111/dewb.12363
Henrique, COVID-19 vaccination in Brazil is a success, despite the failure of the federal government
Hill, Garratt, Levi, Meta-Analysis of randomized trials of ivermectin to treat SARS-cov-2 infection, Open Forum Infect Dis,
doi:10.1093/ofid/ofab358
Hill, Mirchandani, Pilkington, Ivermectin for COVID-19: addressing potential bias and medical fraud, Open Forum Infect Dis,
doi:10.1093/ofid/ofab645
Kim, Sparks, Liew, A rush to judgment? rapid reporting and dissemination of results and its consequences regarding the use of hydroxychloroquine for covid-19, Ann Intern Med,
doi:10.7326/M20-1223
Kow, Merchant, Mustafa, The association between the use of ivermectin and mortality in patients with COVID-19: a meta-analysis, Pharmacol Rep,
doi:10.1007/s43440-021-00245-z
Lee, Morgan, Chaiyachati, Pulse oximetry for monitoring patients with COVID-19 at home-a pragmatic, randomized trial, N Engl J Med,
doi:10.1056/NEJMc2201541
Lowe, Voo, Lee, Uncertainty, scarcity and transparency: public health ethics and risk communication in a pandemic, Lancet Reg Health Am,
doi:10.1016/j.lana.2022.100374
Machiaco, Vargas, Bolivian city gives out free doses of de-worming drug in Bid to combat coronavirus
Merino, Borja, Lopez, Ivermectin and the odds of hospitalization due to covid-19: evidence from a quasi, SocArXiv
Mt, Prefeitura em MT CRIA kit para tratamento de COVID-19 contendo cloroquina
Nacional, RESOLUÇÃO de DIRETORIA COLEGIADA-RDC no 420, de 1o de SETEMBRO de 2020. DIáRIO OFICIAL dA UNIãO
Nación, Perú dejará de utilizar antiparasitario ivermectina Contra El COVID-19
News, Some Alaska legislators urge easier ivermectin access
Panamericana De La Salud, Ongoing living update of potential COVID-19 therapeutics: summary of rapid systematic reviews
Panamericana De La Salud, Ongoing living update of potential COVID-19 therapeutics: summary of rapid systematic reviews
Peruano, Modifican El documento Técnico: prevencióN, diagnóstico Y tratamiento de personas afectadas POR COVID-19 en El perú-REsolucion Ministerial-N° 270-2020-MINSA-PODER EJECUTIVO-SALUD
República, Coronavirus: ivermectina, antiparasitario animal Y usado Contra rosácea, ES aprobado POR Bolivia para tratar COVID-19
Roman, Burela, Pasupuleti, Ivermectin for the treatment of coronavirus disease 2019: a systematic review and meta-analysis of randomized controlled trials, Clin Infect Dis,
doi:10.1093/cid/ciab591
Saavedra, Cañás, Tratamiento farmacológico para covid-19 en protocolos latinoamericanos: Una revisión narrativa de la eficacia Y seguridad, Visa Em Debate,
doi:10.22239/2317-269x.01741
Shalders, Tratamento precoce': governo bolsonaro gasta quase R $ 90 milhões em remédios ineficazes, MAS ainda não pagou butantan POR vacinas
Tello, Ivermectina e hidroxicloroquina no son recomendables para tratamiento contra la COVID-19
Trigo, Kurmanaev, Cabrera, With officials' backing, dubious virus remedies surge in Latin America. the New York times
Zaidi, Dehgani-Mobaraki, Retracted article: the mechanisms of action of ivermectin against SARS-cov-2: an evidence-based clinical review article, J Antibiot (Tokyo),
doi:10.1038/s41429-021-00430-5