On the alleged anticancer efficacy of the phosphoethanolamine pill, weakness of scientific evidence and ethical concerns

• Autor(a) principal: Paumgartten, Francisco José Roma
• Data de Publicação: 2016
• Tipo de documento: Artigo
• Idioma: eng; por
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/822
• topic: Estudos Pré-clínicos; Ética em Pesquisa Clínica; Medicamentos Antineoplásicos; Medicamentos Oncológicos; Câncer; Preclinical Studies; Clinical Research Ethics; Anticancer Drug; Oncologic Drugs; Cancer

Anecdotal reports say that cancer patients improved after taking “synthetic phosphoethanolamine” (syn-PEA), anticancer pills produced and distributed by chemists from a Brazilian university. Notwithstanding the fact that syn-PEA pill inventors disseminated in the lay press the information that their drug is effective against different types of malignant tumors, they showed no clinical documentation or case reports to corroborate this statement. Moreover, syn-PEA failed to exhibit a consistent anticancer response in in vitro assays with human and murine cancer cell lines, and in in vivo xenograft tumor rodent assays. Despite the lack of nonclinical and clinical evidence of drug efficacy and safety, a bill authorizing production, prescription and consumption of syn-PEA pill passed the Congress and the president signed it into law (Law 13269/2016) on April 13, 2016. Astonishingly, the National Committee for Ethics in Research approved (April 19, 2016) syn-PEA trials in cancer patients in the absence of scientifically valid indications of a probable efficacy and without an adequate preclinical safety evaluation. It is unlikely that syn-PEA will eventually play a role in cancer therapy. Nonetheless, syn-PEA sad story unavoidably damaged country’s reputation as far as drug regulation and human research ethical standards are concerned.