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Quality of clinical evidence and political justifications of ivermectin mass distribution of COVID-19 kits in eight Latin American countries

Requejo Domínguez et al., BMJ Global Health, doi:10.1136/bmjgh-2022-010962
May 2023  
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Ivermectin for COVID-19
4th treatment shown to reduce risk in August 2020
 
*, now with p < 0.00000000001 from 104 studies, recognized in 22 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 75 treatments. c19ivm.org
Authors' claim the first RCT was in August 2020 and did not show a benefit, however the first two RCTs were actually:
Chowdhury et al. in July 2020, showing 46% improved recovery with statistical significance.
Shouman et al., showing over 90% lower cases with very high significance.
Both of these are missing and authors present the third RCT as the first, a trial with 32 hospitalized patients. This is despite the fact that authors claim lower in-hospital mortality is irrelevant: "The remaining 12 studies focused on clinical questions (such as reduction of in-hospital mortality) that were not relevant to deciding to include ivermectin in COVID-19 kits for mass dissemination."
Continuing for 2020: Mahmud et al. in October 2020 is missing, showing statistically significant improvements for progression, recovery, and viral clearance. Niaee et al. in November 2020 is missing, showing statistically significant lower mortality, and Chaccour et al. in December 2020 is missing, showing improvements for symptoms and viral load (hidden in appendix). We did not check 2021/2022 but there are a total of 13 RCTs missing as of the publication date.
Authors' bias analysis is incorrect - for example they claim Reis et al. is low risk of bias. However this trial not only shows very high theoretical risk of bias, but has very high known bias, including reporting data that is impossible to be correct, randomization failure, blinding failure, refusal to release pledged data, and many other issues Reis et al..
Requejo Domínguez et al., 24 May 2023, Peru, peer-reviewed, 3 authors. Contact: wirtz@bu.e.
This PaperIvermectinAll
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
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Available: ' 'https://andina.pe/agencia/noticia-coronavirus-essalud-y-ffaa-preparan-100000-kits-para-atender-pandemia-regiones-807594.aspx ' '[Accessed 11 Aug 2022].'}, { 'key': '2023052408000907000_8.5.e010962.27', 'unstructured': 'Redacción de la Prensa . Minsa entrega kits para pacientes Con covid-19. ' 'La prensa. 2020. Available: ' 'https://www.prensa.com/sociedad/minsa-entrega-kits-para-pacientes-con-covid-19/ ' '[Accessed 10 Aug 2022].'}, { 'key': '2023052408000907000_8.5.e010962.28', 'unstructured': 'Larios B . Gobierno entregará un millón de kits de medicamentos para ' 'pacientes Con COVID-19. Agencia Guatemalteca de Noticias, 2020. ' 'Available: ' 'https://agn.gt/archivo/para-corregir-gobierno-entregara-un-millon-de-kits-de-medicamentos-para-pacientes-con-covid-19/'}, { 'key': '2023052408000907000_8.5.e010962.29', 'unstructured': 'Imprensa Nacional . RESOLUÇÃO de DIRETORIA COLEGIADA-RDC no 420, de 1o ' 'de SETEMBRO de 2020. DIáRIO OFICIAL dA UNIãO. 2020. Available: ' 'https://www.in.gov.br/en/web/dou/-/resolucao-de-diretoria-colegiada-rdc-n-420-de-1-de-setembro-de-2020-275243243 ' '[Accessed 11 2022].'}, { 'key': '2023052408000907000_8.5.e010962.30', 'unstructured': 'Reuters Fact . Fact check-Mexico no longer including ivermectin in home ' 'COVID-19 care kits, contrary to claims on social media. Reuters, 2022. ' 'Available: ' 'https://www.reuters.com/article/factcheck-imssmexico-ivermectin-idUSL1N2U626I'}, { 'key': '2023052408000907000_8.5.e010962.31', 'unstructured': 'Folha de Sao Paulo . Ministério da Saúde pressiona Manaus e diz ser ' '‘inadmissível’ não usar cloroquina contra Covid-19. Folha de Sao Paulo, ' '2021. Available: ' 'https://www1.folha.uol.com.br/colunas/painel/2021/01/ministerio-da-saude-pressiona-manaus-e-diz-ser-inadmissivel-nao-usar-cloroquina-contra-covid-19.shtml'}, { 'key': '2023052408000907000_8.5.e010962.32', 'unstructured': 'Freelon K , Hanbury S . Brazil’s main COVID strategy is a cocktail of ' 'unproven drugs: goats and soda. NPR, 2021. Available: ' 'https://www.npr.org/sections/goatsandsoda/2021/06/15/1006198151/covid-pseudoscience-is-choking-brazil'}, { 'key': '2023052408000907000_8.5.e010962.33', 'unstructured': 'Ministerio de Salud y Deportes de Bolivia . Brigadas de salud ' 'distribuirán 150.000 kits de medicamentos para tratar síntomas de ' 'coronavirus. 2020. Available: ' 'https://www.minsalud.gob.bo/es/4483-brigadas-de-salud-distribuiran-150-000-kits-de-medicamentos-para-tratar-sintomas-de-coronavirus ' '[Accessed 11 Aug 2022].'}, { 'key': '2023052408000907000_8.5.e010962.34', 'unstructured': 'La Nación . Perú dejará de utilizar antiparasitario ivermectina Contra ' 'El COVID-19. 2021. Available: ' 'https://www.lanacion.com.py/mundo/2021/03/28/peru-dejara-de-utilizar-antiparasitario-ivermectina-contra-el-covid-19/ ' '[Accessed 16 Aug 2022].'}, { 'key': '2023052408000907000_8.5.e010962.35', 'unstructured': 'Cruz Walkiria Tello N . Ivermectina e hidroxicloroquina no son ' 'recomendables para tratamiento contra la COVID-19. Caja de Seguro ' 'Social, 2021. Available: ' 'https://prensa.css.gob.pa/2021/12/30/ivermectina-e-hidroxicloroquina-no-son-recomendables-para-tratamiento-contra-la-covid-19/'}, { 'key': '2023052408000907000_8.5.e010962.36', 'unstructured': 'Martínez Chacón M . Ivermectin is no longer in COVID-19 treatment kits ' 'in Mexico. AP News, 2022. Available: ' 'https://apnews.com/article/fact-checking-867018157676'}, { 'key': '2023052408000907000_8.5.e010962.37', 'doi-asserted-by': 'crossref', 'unstructured': 'Lowe AE , Voo TC , Lee LM , et al . Uncertainty, scarcity and ' 'transparency: public health ethics and risk communication in a pandemic. ' 'Lancet Reg Health Am 2022;16:100374. doi:10.1016/j.lana.2022.100374', 'DOI': '10.1016/j.lana.2022.100374'}, { 'key': '2023052408000907000_8.5.e010962.38', 'doi-asserted-by': 'crossref', 'first-page': '1327', 'DOI': '10.1007/s12630-020-01760-y', 'article-title': 'Applying the precautionary principle to personal protective equipment ' '(PPE) guidance during the COVID-19 pandemic: did we learn the lessons ' 'of SARS?', 'volume': '67', 'author': 'Crosby', 'year': '2020', 'journal-title': 'Can J Anaesth'}, { 'key': '2023052408000907000_8.5.e010962.39', 'unstructured': 'Organización Panamericana de la Salud . Ongoing living update of ' 'potential COVID-19 therapeutics: summary of rapid systematic reviews. ' '2020.'}, { 'key': '2023052408000907000_8.5.e010962.40', 'unstructured': 'Organización Panamericana de la Salud . Ongoing living update of ' 'potential COVID-19 therapeutics: summary of rapid systematic reviews ' '(May). 2020.'}, { 'key': '2023052408000907000_8.5.e010962.41', 'doi-asserted-by': 'crossref', 'first-page': '150', 'DOI': '10.22239/2317-269x.01741', 'article-title': 'Tratamiento farmacológico para covid-19 en protocolos latinoamericanos: ' 'Una revisión narrativa de la eficacia Y seguridad', 'volume': '8', 'author': 'Saavedra', 'year': '2020', 'journal-title': 'Visa Em Debate'}, { 'key': '2023052408000907000_8.5.e010962.42', 'doi-asserted-by': 'crossref', 'unstructured': 'Hellmann F , Homedes N . An unethical trial and the politicization of ' 'the COVID-19 pandemic in Brazil: the case of prevent senior. Dev World ' 'Bioeth 2022. doi:10.1111/dewb.12363 [Epub ahead of print 28 Jun 2022].', 'DOI': '10.1111/dewb.12363'}, { 'key': '2023052408000907000_8.5.e010962.43', 'doi-asserted-by': 'crossref', 'unstructured': 'Merino J , Borja VH , Lopez O , et al . Ivermectin and the odds of ' 'hospitalization due to covid-19: evidence from a quasi-experimental ' 'analysis based on a public intervention in Mexico City. SocArXiv ' '[Preprint]. doi:10.31235/osf.io/r93g4', 'DOI': '10.31235/osf.io/r93g4'}, { 'key': '2023052408000907000_8.5.e010962.44', 'unstructured': 'Sarabia D . CDMX gastó 29 MDP en tratamiento Con ivermectina no ' 'autorizado Contra COVID. 2022. Available: ' 'https://www.animalpolitico.com/2022/02/gobierno-cdmx-gasto-tratamiento-covid-ivermectina/ ' '[Accessed 8 Aug 2022].'}, { 'key': '2023052408000907000_8.5.e010962.45', 'unstructured': 'Bertin Henrique AL . COVID-19 vaccination in Brazil is a success, ' 'despite the failure of the federal government. O’Neill Institute. 2022. ' 'Available: ' 'https://oneill.law.georgetown.edu/covid-19-vaccination-in-brazil-is-a-success-despite-the-failure-of-the-federal-government/ ' '[Accessed 16 Aug 2022].'}, { 'key': '2023052408000907000_8.5.e010962.46', 'unstructured': 'Instituto Mexicano del Seguro Social . Algoritmos interinos para La ' 'atención del COVID-19. 2021. Available: ' 'http://educacionensalud.imss.gob.mx/es/system/files/Algoritmos_interinos_COVID19_CTEC.pdf'}, { 'key': '2023052408000907000_8.5.e010962.47', 'doi-asserted-by': 'crossref', 'first-page': '323', 'DOI': '10.1016/j.arcmed.2022.01.002', 'article-title': 'A multimodal strategy to reduce the risk of hospitalization/death in ' 'ambulatory patients with COVID-19', 'volume': '53', 'author': 'Ascencio-Montiel', 'year': '2022', 'journal-title': 'Arch Med Res'}, { 'key': '2023052408000907000_8.5.e010962.48', 'unstructured': 'Shalders A . Tratamento precoce’: governo bolsonaro gasta quase R $ 90 ' 'milhões em remédios ineficazes, MAS ainda não pagou butantan POR ' 'vacinas. BBC News Brasil. 2021. Available: ' 'https://www.bbc.com/portuguese/brasil-55747043 [Accessed 8 Aug 2022].'}, { 'key': '2023052408000907000_8.5.e010962.49', 'doi-asserted-by': 'crossref', 'first-page': '1857', 'DOI': '10.1056/NEJMc2201541', 'article-title': 'Pulse oximetry for monitoring patients with COVID-19 at home-a ' 'pragmatic, randomized trial', 'volume': '386', 'author': 'Lee', 'year': '2022', 'journal-title': 'N Engl J Med'}, { 'key': '2023052408000907000_8.5.e010962.50', 'doi-asserted-by': 'crossref', 'first-page': '584', 'DOI': '10.1001/jama.2021.24352', 'article-title': 'Us insurer spending on ivermectin prescriptions for COVID-19', 'volume': '327', 'author': 'Chua', 'year': '2022', 'journal-title': 'JAMA'}, { 'key': '2023052408000907000_8.5.e010962.51', 'unstructured': 'AP News . Some Alaska legislators urge easier ivermectin access. 2021. ' 'Available: ' 'https://apnews.com/article/coronavirus-pandemic-us-food-and-drug-administration-anchorage-alaska-pandemics-53b41f35cdf640cd3e743482aca565f4 ' '[Accessed 16 Aug 2022].'}, { 'key': '2023052408000907000_8.5.e010962.52', 'unstructured': 'WHO . Who advises that ivermectin only be used to treat COVID-19 within ' 'clinical trials. 2021. Available: ' 'https://www.who.int/news-room/feature-stories/detail/who-advises-that-ivermectin-only-be-used-to-treat-covid-19-within-clinical-trials ' '[Accessed 8 Aug 2022].'}, { 'key': '2023052408000907000_8.5.e010962.53', 'unstructured': 'The Japan Times . Japan to give two masks each to 50 million households ' 'to fight virus. 2022. Available: ' 'https://www.japantimes.co.jp/news/2020/04/02/national/japanese-government-distribute-two-masks-per-household-abe/ ' '[Accessed 16 Aug 2022].'}, { 'key': '2023052408000907000_8.5.e010962.54', 'unstructured': 'FDA . Fda advises patients on use of non-steroidal anti-inflammatory ' 'drugs (NSAIDs) for COVID-19. Available: ' 'https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-patients-use-non-steroidal-anti-inflammatory-drugs-nsaids-covid-19 ' '[Accessed 6 Mar 2023].'}, { 'key': '2023052408000907000_8.5.e010962.55', 'doi-asserted-by': 'crossref', 'first-page': '819', 'DOI': '10.7326/M20-1223', 'article-title': 'A rush to judgment? rapid reporting and dissemination of results and ' 'its consequences regarding the use of hydroxychloroquine for covid-19', 'volume': '172', 'author': 'Kim', 'year': '2020', 'journal-title': 'Ann Intern Med'}, { 'key': '2023052408000907000_8.5.e010962.56', 'unstructured': 'Pan American Health Organization . COVID-19: chloroquine and ' 'hydroxychloroquine research. 2020. Available: ' 'https://iris.paho.org/handle/10665.2/52094 [Accessed 5 Sep 2022].'}, { 'key': '2023052408000907000_8.5.e010962.57', 'unstructured': 'Agencia Guatemalteca de Noticias . Gobierno entregará un millón de kits ' 'de medicamentos para pacientes Con COVID-19. 2020. Available: ' 'https://agn.gt/archivo/para-corregir-gobierno-entregara-un-millon-de-kits-de-medicamentos-para-pacientes-con-covid-19/ ' '[Accessed Aug 2022].'}, { 'key': '2023052408000907000_8.5.e010962.58', 'unstructured': 'González Pinilla J . No hay POR qué temerle a la hidroxicloroquina’, ' 'dice ministro sucre, pese a advertencia de la OPS. La Prensa. 2020. ' 'Available: ' 'https://www.prensa.com/sociedad/no-hay-porque-temerle-a-la-hidroxicloroquina-ministro-sucre/ ' '[Accessed 11 Aug 2022].'}], 'container-title': 'BMJ Global Health', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://syndication.highwire.org/content/doi/10.1136/bmjgh-2022-010962', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2023, 5, 24]], 'date-time': '2023-05-24T15:00:37Z', 'timestamp': 1684940437000}, 'score': 1, 'resource': {'primary': {'URL': 'https://gh.bmj.com/lookup/doi/10.1136/bmjgh-2022-010962'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2023, 5]]}, 'references-count': 58, 'journal-issue': { 'issue': '5', 'published-online': {'date-parts': [[2023, 5, 24]]}, 'published-print': {'date-parts': [[2023, 5]]}}, 'alternative-id': ['10.1136/bmjgh-2022-010962'], 'URL': 'http://dx.doi.org/10.1136/bmjgh-2022-010962', 'relation': {}, 'ISSN': ['2059-7908'], 'subject': ['Public Health, Environmental and Occupational Health', 'Health Policy'], 'container-title-short': 'BMJ Glob Health', 'published': {'date-parts': [[2023, 5]]}}
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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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