In response to political pressure and popular demand for a drug against cancer largely untested party, Brazilian President Dilma Rousseff signed into law today a measure that allows the compound to renegade phosphoethanolamine -Synthetic be produced and sold legally as a cancer therapy in Brazil.
scientists have poured scorn on the decision, saying it puts patients at risk and undermines the authority of the Brazilian Sanitary Surveillance Agency (the equivalent of the US Food and Drug administration) to regulate research and the approval of new drugs based on safety protocols and internationally recognized efficiency. It was a "political decision inspired by messianic thrust pseudoscience," said Gustavo Fernandes, president of the Brazilian Society of Clinical Oncology in Brasília. "This was the worst possible way to deal with this problem."
The "pill Cancer" sparked a national debate last year after Brazilian media carried stories of patients saying he relieved the symptoms or even cure their cancer. The compound was developed in the early 190s by Gilberto Chierice, an analytical chemist at the University of São Paulo whose lab distributed free to patients for several years without any regulatory approval or clinical monitoring.
apart some studies on mouse models and in cell lines, there is no laboratory evidence that synthetic phosphoethanolamine works as a medicine against cancer. The university tried to stop the operation of Chierice in June 2014, but since then more than 15,000 people sued the university, forcing him to continue to provide the pills. Advocacy groups, meanwhile, lobbied politicians and health authorities to legalize the use of the compound as a drug against cancer. Brazilian Congress passed a bill to do that last month.
Officials from the ministries of health, industry and the science advisable Rousseff to veto the bill, according to O Estado de S. Paulo newspaper. But Rousseff is fighting for his political life, Congress is trying to attack him on allegations of irregularities, its Executive Tax Office has recommended to sign the bill, according to sources.
The law permits the production, prescription and synthetic phosphoethanolamine consumption as a cancer therapy "independently" of the registration with the Brazilian Health Surveillance Agency. To acquire the pills, consumers must submit medical proof that they have a malignant tumor and sign a consent form.
Under the new law, the substance can not be produced and distributed by "licensed agents." On April 1st, the University of São Paulo closed the former research laboratory Chierice, which had hitherto been the production of pills under the orders of the court. The only place where the compound is being produced is a private laboratory contracted by the Government of the State of São Paulo to provide for an upcoming clinical trial. The laboratory prepares the pills according to a proprietary formula by Chierice and six colleagues; they affirm their preparation is different from the synthetic phosphoethanolamine available on the international market as a dietary supplement.
Late last year, the Ministry of Science committed to spending nearly $ 3 million on preclinical studies of synthetic phosphoethanolamine. The first results, released last month, are not promising. According to experiments conducted in four academic and private laboratories, the pills produced by Chierice group contained only 30% synthetic phosphoethanolamine, and the substance failed to kill cancer cells. It does not seem to be toxic.
At a hearing on April 5 at the Federal Senate of Brazil, Chierice charged that the government-sponsored studies are being "bad faith" and said his group is obtaining clinical data from 'overseas. The University of São Paulo in 2015 filed a complaint with the police accusing Chierice of " curandeirismo ," or the illegal distribution of unproven medical treatments. A criminal investigation is underway, according to reports press. "Maybe [Chierice] was well-intentioned, but he did a lot of harm," says Fernandes.
The new law may appeal to desperate cancer patients, but it is an unfortunate move, said biochemist Luiz Fernando Lima Reis, research director at the Sírio-Libanês hospital in São Paulo , where politicians have been treated for cancer, including Rousseff in 09 and former President Luiz Inácio Lula da Silva in 2011. "these types of decisions should be based on scientific evidence," said Reis.
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