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COVID-19 proxalutamide trial in Brazil

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In the wake of the global COVID-19 pandemic, several lines of research targeted the development of a pharmaceutical treatment or cure for the disease. One of those researches involved a clinical trial that took place in Brazil and was led by Brazilian endocrinologist Flávio Cadegiani.

Background

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In the beginning of the pandemic, it was believed that men were generally more prone to the illness than women and as a result of that, some researchers explored human male hormone blockers, also known as antiandrogens, as a treatment.[1] The trial led by Cadegiani looked at the experimental prostate cancer and antiandrogen proxalutamide, and people from the Brazilian region of Amazon were recruited as patients in the study, given the surge in Covid-19 cases in that region in the early months of the COVID-19 pandemic in Brazil which would, according to the study's author, favor the accuracy of the research.[2]

Brazilian president Jair Bolsonaro backed the unproven use of proxalutamide drug to treat Covid-19 as well as he previously did with ivermectin and hydroxychloroquine, both of which are also unproven treatments for the virus.[3][4]

Method

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A total of 645 patients with Covid-19 were administered proxalutamide at nine hospitals in the Brazilian Amazon region. When they were first admitted to hospital, none required mechanical ventilation at the start of the study. The care consisted of medicines such as enoxaparin, colchicine, methylprednisolone, dexamethasone, or antibiotic therapy as necessary and some of them were given unproven Covid-19 treatments drugs such as ivermectin. Altogether, 317 patients received proxalutamide and 328 a placebo. Brazilian National Health Council (CNS) later reported such treatment was prescribed by doctors in a private hospital network as if it were an established medical treatment, despite it was approved only for clinical trial studies. The number of people who were given the drug was also larger than the number approved for the trial.[5]

The trial, which was not peer-reviewed, reported that the 14 day recovery rate of patients was 81.4% with proxalutamide and 35.7% with placebo. Jesem Orellana, an epidemiologist who closely watched the effects of the gamma variant of Covid-19 on the Amazon region at Brazil's leading public health institute Fiocruz, said "the reported results would be a miracle — if they were true" adding that "everything about this trial is suspicious and is anything but clinical and randomised".[6]

Aftermath

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Brazil's National Ethics Commission on Research (CONEP) found that 200 people died after undergoing the study and at least 40 deaths were hidden in the study's conclusions. The consent form handed to the study's patients omitted the risk of birth defects and other potential injuries from the procedures, according to the commission.[7][8] It was later reported that the patients, some of which were hospitalised in intensive care units at the time, trusted the doctors participating in the study because they were desperate for a Covid-19 treatment or cure for their relatives or themselves, as the region was hit the hardest in the world at the time the study was being conducted and the entire local healthcare system had collapsed due to a major surge in Covid-19 cases.[9][10][11][12][13]

After the study's preprint was published in June 2021, several scientists warned it was deeply flawed and a Brazilian research ethics commission opened an investigation into it. Science Magazine also reported that Applied Biology, a Californian hair loss company, where Cadegiani is a clinical director, teamed up with Kintor Pharmaceuticals, proxalutamide's manufacturer based in China.[14] Additionally, UNESCO office for Latin America and Caribbean found the way the study was conducted is "alarming" and that several gross ethics violations were committed. It said the study could be one of the gravest ethical scientific misconduct in the region's history and urged an investigation into the case.[15][16][17][18]

On September 2, 2021, Brazil's health regulator Anvisa suspedend the prescription, usage and importation of proxalutamide in the country, and opened a separate probe about the study.[19] On September 3, 2021, a criminal complaint was filed before Brazil's Public Prosecutor office in order to investigate the actions taken during the study as well as the consequences of it, including the patients deaths.[20]

On June 27, 2022, academic journal Frontiers in Medicine retracted the mentioned study it had initially published in July 2021.[21][22] Similarly, the BMJ Case Reports journal labeled another article based on the same study and authored by Cadegiani as an "expression of concern".[23] On August 25, 2022, Brazilian Federal Police carried out several search and seizure warrants against public officials, doctors and researchers who led proxalutamide trials in the Brazilian southern state of Rio Grande do Sul and elsewhere in the country. Although no names of the suspects targeted by the operation were revealed, Cadegiani said on his social media that his house and clinic were raided by the police.[24][25][26]

In August 2022 Brazilian Federal prosecutors charged two researchers who ran the medical trial in two separate civil lawsuits as well as three hospital officials who reportedly aided them. The defendants can be fined in at least R$10 million (about US$1,917,582) in both suits if convicted.[27][28][29]

See also

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References

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  1. ^ Bwire, George M. (July 2020). "Coronavirus: Why Men are More Vulnerable to Covid-19 Than Women?". SN Comprehensive Clinical Medicine. 2 (7): 874–876. doi:10.1007/s42399-020-00341-w. ISSN 2523-8973. PMC 7271824. PMID 32838138.
  2. ^ Magri, Diogo (2021-10-14). "'Cobaias' da proxalutamida: como o Brasil entrou no que pode ser uma das infrações éticas mais graves da história". El País Brasil (in Brazilian Portuguese). Retrieved 2022-08-27.
  3. ^ Stargardter, Gabriel (2021-05-14). "The man behind Brazil's search for miracle COVID-19 cures". Reuters. Retrieved 2022-08-27.
  4. ^ "Bolsonaro elege proxalutamida, também sem eficácia comprovada contra Covid, como 'nova cloroquina'". Folha de S.Paulo (in Brazilian Portuguese). 2021-07-18. Retrieved 2022-08-27.
  5. ^ Taylor, Luke (2021-11-17). "Covid-19: Trial of experimental "covid cure" is among worst medical ethics violations in Brazil's history, says regulator". BMJ. 375: n2819. doi:10.1136/bmj.n2819. ISSN 1756-1833. PMID 34789508. S2CID 244272450.
  6. ^ Taylor, L. (2021-12-19). "Covid-19: Trial of experimental "covid cure" is among worst medical e…". BMJ (Clinical Research Ed.). 375: n2819. doi:10.1136/bmj.n2819. PMID 34789508. S2CID 244272450. Archived from the original on 2021-12-19. Retrieved 2022-08-25.{{cite journal}}: CS1 maint: bot: original URL status unknown (link)
  7. ^ "Termo enviado para pacientes de estudo da proxalutamida contra a Covid-19 no AM omitiu informações, diz Conep". G1 (in Brazilian Portuguese). 23 November 2021. Retrieved 2022-08-26.
  8. ^ "Estudo com proxalutamida contra a covid omitiu mais de 40 mortes no AM". noticias.uol.com.br (in Brazilian Portuguese). Retrieved 2022-08-25.
  9. ^ "Coronavirus: Disease meets deforestation at heart of Brazil's Amazon". BBC News. 2020-05-04. Retrieved 2022-08-27.
  10. ^ "'Utter disaster': Manaus fills mass graves as Covid-19 hits the Amazon". the Guardian. 2020-04-30. Retrieved 2022-08-27.
  11. ^ Ledur, Júlia. "The arduous path for oxygen to reach the sick in one of Brazil's most remote regions". Washington Post. Retrieved 2022-08-25.
  12. ^ "Coronavirus COVID-19 collapses health system in Manaus, Brazil | MSF". Médecins Sans Frontières (MSF) International. Retrieved 2022-08-25.
  13. ^ "The Amazonian city that hatched the Brazil variant has been crushed by it". Washington Post. ISSN 0190-8286. Retrieved 2022-08-25.
  14. ^ "'Too good to be true': Doubts swirl around trial that saw 77% reducti…". archive.ph. 2022-02-18. Archived from the original on 2022-02-18. Retrieved 2022-08-25.{{cite web}}: CS1 maint: bot: original URL status unknown (link)
  15. ^ "Posible Infracción Ética Gravísima en Brasil". Redbioética/UNESCO. 2021-10-09. Archived from the original on 2021-10-09. Retrieved 2022-08-25.
  16. ^ "Unesco vê possível violação grave em teste com proxalutamida – DW – 11/10/2021". dw.com (in Portuguese). Retrieved 2022-08-25.
  17. ^ Magri, Diogo (2021-10-14). "Cobayas humanas en Brasil: las autoridades investigan 200 muertes en el estudio de un medicamento experimental contra la covid-19". El País (in Spanish). Retrieved 2022-08-25.
  18. ^ "Unesco sobre estudo de proxalutamida contra Covid: "Possíveis graves violações"". Metrópoles (in Brazilian Portuguese). 2021-10-11. Retrieved 2022-08-25.
  19. ^ "Anvisa suspende uso e importação da proxalutamida; entenda". BBC News Brasil (in Brazilian Portuguese). Retrieved 2022-08-25.
  20. ^ "SEI/MS - 0022580072 - Ofício". 2021-10-11. Archived from the original on 2021-10-11. Retrieved 2022-08-25.
  21. ^ Office, Frontiers Editorial (2022). "Retraction: Proxalutamide Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial". Frontiers in Medicine. 9: 964099. doi:10.3389/fmed.2022.964099. ISSN 2296-858X. PMC 9226906. PMID 35755027.
  22. ^ "Revista 'despublica' estudo que sugeria eficácia de proxalutamida contra Covid". Folha de S.Paulo (in Brazilian Portuguese). 2022-06-27. Retrieved 2022-08-25.
  23. ^ Cadegiani, Flavio; Lin, Erica M.; Goren, Andy; Wambier, Carlos G. (2021-02-01). "Expression of concern: potential risk for developing severe COVID-19 disease among anabolic steroid users". BMJ Case Reports. 14 (2): e241572. doi:10.1136/bcr-2021-241572. ISSN 1757-790X. PMC 7919571. PMID 33637513. (Retracted, see doi:10.1136/bcr-2021-241572ret, PMID 37945273,  Retraction Watch. If this is an intentional citation to a retracted paper, please replace {{retracted|...}} with {{retracted|...|intentional=yes}}.)
  24. ^ "Responsáveis por testes com proxalutamida são alvo de busca e apreensão no RS". G1 (in Brazilian Portuguese). 25 August 2022. Retrieved 2022-08-25.
  25. ^ Ventura, Iolanda (2022-08-25). "Médico responsável por estudo com proxalutamida é alvo da PF" (in Brazilian Portuguese). Retrieved 2022-08-27.
  26. ^ "Polícia Federal realiza operação de busca e apreensão contra alvos do caso proxalutamida". O Globo (in Brazilian Portuguese). 25 August 2022. Retrieved 2022-08-27.
  27. ^ "MPF entra com ações contra responsáveis por testes com proxalutamida em pacientes com Covid-19 no RS". G1 (in Brazilian Portuguese). 25 August 2022. Retrieved 2022-12-08.
  28. ^ "MPF entra com ações contra responsáveis por estudo irregular com medicamento experimental em hospitais de Porto Alegre e Gramado (RS)". Ministério Publico Federal (in Brazilian Portuguese). Retrieved 2022-12-08.
  29. ^ NH, Jornal (2022-10-14). "Morte de servidora de Gramado é citada em inquérito sobre pesquisa irregular no São Miguel". Jornal NH (in Brazilian Portuguese). Retrieved 2022-12-08.
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