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The Federal Supreme Court (STF) decided, by majority, that the law passed in 2016 that authorized the use of synthetic phosphoethanolamine – which became known as the “cancer pill” – is unconstitutional for patients diagnosed with the disease.
The law had been challenged in court by the Brazilian Medical Association (AMB). Despite being popularized as a “cancer pill”, alleged anti-cancer effects of the substance have not been tested in tests.
According to the understanding defined in the Supreme Court, the National Congress cannot authorize the distribution of chemical substances that have not been evaluated by the National Health Surveillance Agency (Anvisa). The STF plenary had already suspended the distribution of the pills in a preliminary (provisional) decision.
Cancer Institute of SP concluded in 2017: Phosphoethanolamine doesn’t work
The sentence was made in the virtual plenary session, in which the STF ministers only cast their vote in an electronic system, without reading or oral support. The deadline ended last Friday (23) and the result was published by the Supreme Court on Monday (26).
In reporting on the action, Minister Marco Aurélio Mello defended Anvisa’s authority to allow or prohibit the distribution of chemical substances, in accordance with “scientifically validated protocols.” According to the magistrate, the agency never filed the registration for synthetic phosphoethanolamine.
Without this registration, as the rapporteur pointed out in the vote, a medicine cannot be manufactured, sold or imported for commercial purposes.
Marco Aurélio Mello’s vote was followed by the ministers Alexandre de Moraes, Cármen Lúcia, Ricardo Lewandowski, Luís Roberto Barroso and by the president of the court, Luiz Fux.
Minister Edson Fachin, however, did not agree with arguing that the “cancer pill” could be distributed to terminally ill patients.
“Strictly speaking, the use of phosphoethanolamine is allowed if there is no law prohibiting it […] Anvisa does not have private jurisdiction to authorize the sale of any substance ”, defended Fachin.
The minister’s position was followed by Ministers Dias Toffoli and Gilmar Mendes. With that, the final score was six votes to three due to the unconstitutionality of the law.
Minister Rosa Weber did not vote; at the time of the preliminary decision, he had followed Edson Fachin’s disagreement. The 11th position of the STF has been vacant since Minister Celso de Mello’s retirement on the 13th. His successor, Kassio Marques, is expected to take office next week.
The 2016 law was approved by the National Congress and sanctioned by the then president Dilma Rousseff, with the signature of the then Minister of Health Marcelo Castro.
The bill presented to the Chamber was signed by 18 authors, including Deputy Eduardo Bolsonaro and then Deputy Jair Bolsonaro.
The text predicted that, to receive synthetic phosphoethanolanime, cancer patients must voluntarily adhere to the protocol and sign a term of consent and responsibility.
The law defined the use of the pill as “of public relevance” and allowed, for the duration of the clinical studies, “the production, manufacture, import, distribution, prescription, dispensing, possession or use of synthetic phosphoethanolamine”, regardless of registration sanitary and exceptionally.
In the year following the sanction, in 2017, the São Paulo State Cancer Institute (Icesp) suspended the inclusion of new patients in clinical trials due to the absence of “significant clinical benefit” in the research carried out up to that time .
Phosphoethanolamine testing was discontinued in 2017 due to no benefit
Of the 72 patients in the study, only one, with melanoma, had responded to treatment, a reduction of more than 30% in the size of the tumor lesions.
“Right now, the study has been far behind in terms of response rate. We speak with the commission that accompanies the study at the request of Professor Gilberto [Chierice]. We had extensive internal meetings on what to do with these results at this time and it seemed wiser to suspend the inclusion of new patients in the study, “said Icesp CEO Paulo Hoff in 2017.
