Minister of Science, Technology, and Innovation Celso Pansera said Wednesday (Mar. 30) that the government will work to have the sale and legalization of phosphoethanolamine, popularly dubbed “cancer pill,” authorized. “Our proposal is to have it legalized as a food supplement and to remove it from the parallel market—to let it reach the shelves of drugstores and specialized stores,” he said, adding, “If the substance becomes a supplement, it will not supersede any medical treatment with demonstrated effectiveness against the disease.”
The recommendation will be officially made because, Pansera argues, the compound produced by the University of São Paulo (USP) is not toxic. He stated that, since there is a demand for the drug among the population, the best solution is to authorize its sale as a food supplement until the tests on its effectiveness against cancer are concluded.
“People are taking this pill, and I don't know where or how they get it, and that's turning the substance into a myth. Advocates and critics are passionate in their arguments. There's even a law authorizing it—this is how big the debate has become. Our goal is to cast the light of science on the matter,” he said.
According to Pansera, ANVISA, the National Health Surveillance Agency looked into what has been done regarding phosphoethanolamine across the world and found no patent applications or ongoing studies in which the substance is treated as food, food supplement or medication.
He explained that ANVISA follows a specific licensing process for food supplements, and that, should the drug be allowed for use in such a manner, the ministry will seek the laboratory licensed by the São Paulo state government for its production. If the laboratory shows no interest in becoming involved, the minister said an opportunity would be given to some public research institute until the market adjusts to the demand.
Synthesized over 20 years ago, synthetic phosphoethanolamine was studied by Professor Gilberto Orivaldo Chierice, currently retired, when he was a member of USP Analytical Chemistry and Polymer Technology Group, in the São Carlos campus of the university. Some patients were given pills produced by the professor free of charge, but with no authorization from ANVISA. They were taking the pills as medicine against cancer.
In June 2014, an ordinance issued by the USP ruled that all substances being tested should have all its registration processes completed before it is distributed to the population. After the decision, patients who were aware of the research studies being conducted appealed in court in an attempt to have access to the pills.
On March 22, the Senate passed a bill to address this issue and ensure patients with cancer are entitled to the drug even before it is registered and authorized by ANVISA. The piece of legislation is now in the hands of President Rousseff, who can either sign it into law or veto it. Minister Pansera made no remarks on the approval of the bill.
The Brazilian Cancerology Society (SBC) said in a note that it does not support the legalization of the so-called “cancer pill”. ANVISA also uttered an opinion, saying it regards the passing of the bill with concern, since the drug has been used for 20 years illegally and has never been tested in compliance with the scientific methodology internationally adopted to demonstrate safety and effectiveness.
Thus, last year, due to the expectations surrounding the antitumor effect of phosphoethanolamine, the Ministry of Science, Technology and Innovation set up a work group to test the substance. Their goal is to investigate the effects of the drug and ascertain whether or not it is effective in the fight against the disease.
The Health Ministry has $2.76 million to be used in research, of which $554 thousand has already been spent, the minister reported.
The series of in vitro trials carried out to test the pill's toxicity revealed that the compound is 32% phosphoethanolamine, with the remainder consisting of monoethanolamine plus other salts, which are a result of the drug's synthesizing process. None of them is toxic, the minister claims, if administered in the amount set by USP—three 330mg pills a day.
The testing phase with animals has also been concluded and the report with the advanced results are expected to be made public between April 15 and 20, Pansera announced. In this stage, both the compound and the individual substances were tested for pancreatic cancer and melanoma. “Our idea is not to interrupt the studies and move on to pre-clinical and clinical phases with human beings,” he said. “Everything we're doing follows the necessary protocol for the verification of a medication,” he added.
*Additional reporting by Camila Boehm
Translated by Fabrício Ferreira
Fonte: Agência Brasil.