The article entitled Law 13.269/2016: Clamor by Society Trumps the Scientific Method!, published in the issue of June 2016, debated an important question that has repercussions beyond phosphoethanolamine per se ¹1. Alves SMC, Delduque MC, Santos AO. Lei nº 13.269/2016: a comoção da sociedade vence o método científico! Cad Saúde Pública 2016; 32:e00070116.. The issue is use of the scientific method to back public policymakers' decisions.

In the specific case of synthetic phosphoethanolamine (the so-called "cancer pill"), the debate gained public attention because it touched on protection of life, since the substance's principal beneficiaries argued that they had no other alternative for treating their illness. This social clamor was mentioned in a Letter to the Editors as the "medical bandwagon effect", highlighting the fact that public policymakers are not always immune to the pressure and influence of issues with major social repercussions.

The Letter to the Editors also mentions that the ruling by the Brazilian National Commission on Research Ethics (CONEP) approved the clinical protocol to allow testing the substance in human beings to begin without "an adequate set of preclinical safety data", thus disregarding basic ethical principles for research in human subjects. This concern merits attention, since the ruling can be considered a precedent for the approval of other protocols in defiance of this overarching set of principles and standards involved in such a sensitive question.

What is certain is that diseases are not divine punishment and should be viewed and treated in light of science (Hippocrates, 4th century BC) ²2. Littré E. Oeuvres complètes d'Hippocrate. v. I. Paris: J B Bailliere; 1839.. In the post-modern world, the advancement of science should not be pursued by any means or method or at any cost. Humankind has already experienced unreasoned practices and procedures, and to avoid repeating historical episodes, clinical research is based on the Declaration of Helsinki (1964). Science is irreplaceable for guaranteeing the right to health.

The fact is that the Brazilian National Congress passed and the President signed Law 13.269/2016³3. Brasil. Lei nº 13.269, de 13 de abril de 2016. Autoriza o uso da fosfoetanolamina sintética por pacientes diagnosticados com neoplasia maligna. http://www.planalto.gov.br/ccivil_03/_Ato2015-2018/2016/Lei/L13269.htm (accessed on 15/Apr/2016).
http://www.planalto.gov.br/ccivil_03/_At... . Congress argued on the basis of the product's purported low toxicity, "control" of a parallel market, and quality of life for patients. The President justified signing the law as an exception to the prevailing legislation, given the social repercussions, despite acknowledging the need for clinical research. Therefore, neither the Legislative nor the Executive branches honored their Constitutional duty to safeguard the people's health, as duly expressed in article 196 of the 1988 Federal Constitution, i.e., it is the duty of the state to develop public policies to reduce diseases and to promote, protect, and reclaim health.

In light of the above, other arguments were drawn into the debate. The first relates to the expression coined by Dr. Paulo Hoff in the public hearing on health in 2009 in the Brazilian Supreme Court: "hope-based medicine". According to the oncologist, "unproven medications are occasionally used by physicians and patients in desperate situations", as in patients diagnosed with terminal cancer. Still, Hoff (Audiência Pública da Saúde. http://www.stf.jus.br/arquivo/cms/processoAudienciaPublicaSaude/anexo/Marcelo_Hoff.pdf, accessed on 19/Sep/2016) emphasized that "such practice should not be encouraged" and that "expenditures on these medications are difficult to justify in the public system".

In this sense, medication not registered with the Brazilian Health Regulatory Agency (Anvisa), in flagrant violation of Law 6,360/1976⁴4. Brasil. Lei nº 6.360 de 23 de setembro de 1976. Dispõe sobre a Vigilância Sanitária a que ficam sujeitos os Medicamentos, as Drogas, os Insumos Farmacêuticos e Correlatos, Cosméticos, Saneantes e Outros Produtos, e dá outras providências. http://www.planalto.gov.br/ccivil_03/leis/L6360.htm (accessed on 14/Sep/2016).
http://www.planalto.gov.br/ccivil_03/lei... , not only places patients at risk but also compromises resources that would otherwise benefit society as a whole. As the saying goes, both the Legislative and the Executive were "playing to the crowd".

This understanding is reinforced by another Brazilian oncologist, Dr. Raul Cutait, interviewed by a mainstream newspaper, discussing the waiver of registration for phosphoetanolamine. Cutait was incisive in stating that hope should be part of prescriptions in the physician-patient partnership, in the struggle against diseases, but that it should never be offered without scientific validation: "otherwise one runs the risk of promoting quackery" ⁵5. Cutait R. Câncer: esperança e ciência. Folha S. Paulo. http://www1.folha.uol.com.br/opiniao/2016/05/1772719-cancer-esperanca-e-ciencia.shtml. (accessed on 19/Sep/2016).
http://www1.folha.uol.com.br/opiniao/201... .

From this perspective, Supreme Court Justice Marco Aurélio Mello, presiding over the ruling on the injunction discussed in the Letter to the Editor, stated, "The hope invested by society in medicines, especially for treating diseases like cancer, cannot distance itself science" ⁶6. Superior Tribunal Federal. Ação Direta de Inconstitucionalidade nº 5.501 de 2016. http://www.stf.jus.br/arquivo/cms/noticiaNoticiaStf/anexo/adi5501MMA.pdf (accessed on 16/Sep/2016).
http://www.stf.jus.br/arquivo/cms/notici... .

This point highlights the transitory nature of science, whose change must always be subject to analysis. In the case of patient safety and medicines, such analysis is certainly not the responsibility of the National Congress. Safety analysis must be performed by an expert agency, in Brazil's case the Anvisa.

The broader debate at stake here is Anvisa's jurisdiction versus the circulation and consumption of unregistered medicines in the country - having found backing in social clamor, in the lawmaking power of the National Congress, and in a judge's ruling.

The Brazilian Supreme Court is currently reviewing a case dealing with the supply, by government, of medicines not registered with Anvisa (RE 657,718/MG-RG). The presiding judge in the case, Justice Marco Aurélio Mello, in declaring his vote, acknowledged the need for scientific consensus, which according to the legal grounds in Brazilian cases is attested by the product's registration with Anvisa.

Justice Mello stated: "To rule otherwise would mean to allow laboratory experiments for therapies whose clinical benefits and treatment costs escape the control of public authorities. In the ultimate analysis it would mean authorizing pharmaceutical experimentalism at the expense of society, which finances public health through taxes and contributions" ⁷7. Superior Tribunal Federal. Recurso Extraordinário nº 657.718/MG-RG. http://www.stf.jus.br/arquivo/cms/noticiaNoticiaStf/anexo/adi5501MMA.pdf (accessed on 16/Sep/2016).
http://www.stf.jus.br/arquivo/cms/notici... .

The Supreme Court's review of case RE 657,718/MG-RG, which began on September 16, 2016, was temporarily suspended when Justice Luís Roberto Barroso requested a detailed review of the briefs. The situation calls for a state of vigilance concerning future votes on the case and the Supreme Court's final ruling.

May the scientific paradigm prevail!