Abstract
The use of unproven forms of therapy in cancer treatment is very common. In Brazil, the distribution by researchers to patients of an investigational agent called phophoethanolamine (PHOS) has led to a widely publicized scientific scandal. PHOS is a precursor to components of the cell membrane, with some published pre-clinical studies suggesting cytotoxic activity in cancer cells. The willingness of courts and of legislators to guarantee access to PHOS in spite of the lack of any clinical data and against the recommendations of scientific and medical organisations underscores the risks that unproven agents pose to regulatory authorities, health care systems and patients, and bears resemblance to other cases such as the controversy surrounding the approval of zidovudine for AIDS treatment by the FDA.
Highlights
Brazil is a developing nation where a significant portion of the population lacks access to health care [1]
Brazil has struggled since the 1980s to build its public health care system – the Sistema Único de Saúde – and has been able to develop effective policies in certain fields of public health, such as its HIV/AIDS programme [2]
The mixture of a drug developed by Brazilian researchers, questionable theories about why the scientific community rejected the use of PHOS and the dissemination in both regular and social media of interviews with alleged cured patients was the fuel for lay people to spread the news rapidly
Summary
Brazil is a developing nation where a significant portion of the population lacks access to health care [1]. The mixture of a drug developed by Brazilian researchers (nationalism), questionable theories about why the scientific community rejected the use of PHOS and the dissemination in both regular and social media of interviews with alleged cured patients was the fuel for lay people to spread the news rapidly. In Brazil, the courts may grant to claimants access to treatments or procedures not usually available in public hospitals or not yet authorised by ANVISA, but authorised by the FDA or equivalent regulatory authorities in other countries These decisions are commonly based on the ‘right to health’ clause of the Brazilian constitution [41] that defines health as a basic human right that must be guaranteed by the state. The decision by the legislative branch to approve PHOS has challenged the authority of ANVISA and set a worrisome precedent
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