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Synthetic Phosphoethanolamine: Understand What the "Cancer Pill Is"

Synthetic Phosphoethanolamine: Understand What the

The substance known as synthetic phosphoethanolamine also called "USP drug" or "anti-cancer pill" has been highlighted as being a promise of cure for all types of cancer. The substance began to be produced in the laboratory of the Institute of Chemistry of São Carlos (IQSC-USP) and distributed on the campus of the university free of charge to patients who requested it even though it had not been scientifically tested. scientific research is categorical in stating that synthetic phosphoethanolamine can not even be called a "drug" because its benefits for the treatment of cancer have not been proven.

Since 2016 scientific studies have begun to prove the efficacy of phosphoethanolamine in treatment of cancer. The studies are still ongoing and have not yet been finalized. However, as of April 13, 2016, a law was approved that releases the manufacture and distribution of phosphoethanolamine and the use of the substance phosphoethanolamine by patients diagnosed with cancer even before the registration of Anvisa.

The concerns of oncologists on the abuse of the substance are many: since it has not been studied and tested enough, synthetic phosphoethanolamine can cause as yet unknown side effects, in addition the drug can generate a false hope of healing patients and even lead to the abandonment of conventional treatment , putting people's lives at risk.

Phosphoethanolamine is a substance produced naturally by the human body in the cells of some specific muscles and in the liver, but is now reproduced in the USP laboratory. There is little information on how the substance would work in the treatment of cancer. What little is known is that it could act within the carcinogenesis, that is, it could have some influence on the formation of the tumor. Another hypothesis is that synthetic phosphoethalonamine would have anti-inflammatory and apoptotic action, in other words, would be able to "kill" the cancerous cells. However, all these theories have not been proven and are still in the field of supposition.

No evidence

The oncologist Pilar Estevez, coordinator of the clinical oncology service of the Cancer Institute of São Paulo Octavio Frias de Oliveira (Icesp ), explains that the analyzes carried out so far are not sufficient to provide the necessary evidence to prove the safety and efficacy of synthetic phosphoethanolamine. To date, the studies conducted with phosphoethanolamine registered at the Foundation for Research Support of the State of São Paulo (Fapesp) were made exclusively in mice and in some cultures of human cells. "For now, it is a drug, we can not even classify it as a drug. We do not know how effective it is, which tumors would have sensitivity to it, or the dose." There are many questions that need to be answered, "says the specialist.

Clinical and scientific evidence is lacking

The path a new drug makes until it is made available to a patient in the treatment of some disease is long and complex. Until a new cancer drug can finally reach pharmacies, hospitals and health clinics can take more than 10 years, 12 years, sometimes more. "For a drug to be approved and released on the market, it needs to go through very specific testing steps, first in a test tube, using cell and animal cultures, and then if evidence is proven that it can have benefits for patients, it will undergo phase 1 to 4 clinical trials, that is tests performed on humans, "explains clinical oncologist Hezio Jadir Fernandes Júnior, director of the Paulista Institute of Cancerology. Each stage of the tests will evaluate the drug's effectiveness in combating disease, toxicity (safety), dosages and side effects in the short and long term.Oncology drugs are among the greatest cause of side effects and knowing for sure what these effects are is one of the major concerns of oncologists during treatment. "All the drugs we prescribe, either intravenous or oral, cause side effects and we need to be aware of these symptoms in order not to cause complications and more problems to the patient. When we prescribe a treatment we know how this medication will be applied, the indicated dosage and what symptoms patient may present, "explains Fernandes Júnior.

In some cases, the drug has such a high amount of side effects that it is necessary to stop the treatment. "There are some drugs that have not been avenged precisely because of the toxicity.There needs to be a balance between the side effects and the efficiency of the drug.No point is a drug that is promising and not be tolerable," says Pilar. for cancer is unlikely

There are over 200 different types of cancer and the neoplasm can develop in any organ of the body and from almost any type of cell in the body. Therefore, it is important to note that each tumor has its own genetic and biomolecular signature. This makes them respond differently to treatments.

The breakthroughs in the field of oncology medicine concern the discovery of ever more specific and precise treatments for each type of tumor. "That's why it's hard to believe that a single drug can be effective against any type of cancer," says oncologist Volney Soares Lima of Oncocentro Minas Gerais. According to him, even the usual treatments like chemotherapy, radiotherapy and hormone therapy have different compositions to treat a certain type of cancer.

More studies

The experts interviewed by My Life agree that synthetic phosphoethanolamine deserves to be studied rather than studied. rule out that the substance may become a form of cancer treatment. "It may be that in the future it will become an effective cancer drug, but rather it needs to be approved by regulatory bodies and agencies, we need evidence to decide the direction the drug will take," explains the oncologist Volney Soares Lima.

For the clinical oncologist Hezio Jadir Fernandes Júnior, director of the Instituto Paulista de Cancerologia Fernandes Júnior, it takes even more. Cooperation studies involving different entities from different countries are required. "We need to use the globalization of knowledge and pass our discoveries onward, maintain communication with research centers, to obtain different information and detect the benefits and failures of a substance."

The My Life reporting team contacted the chemist Gilberto Orivaldo Chierice, Institute of Chemistry of São Carlos (IQSC-USP) for more information on synthetic phosphoethanolamine.

Understand the case of phosphoethanolamine

Late 1980s

The substance phosphoethanolamine begins to be produced by the chemist Gilberto Orivaldo Chierice, from the Instituto de Chemistry of São Carlos (IQSC-USP) and distributed on the campus of the university free of charge to patients seeking complementary or alternative treatment.

June 2015

USP halts the distribution of phosphoethanolamine and patients are brought to justice

October 2015

The Supreme Federal Court authorizes the distribution of phosphoethanolamine to persons who have filed a petition in court.

At the same time, USP manifests itself through an official communiqué, claiming that "... this substance is not a remedy, it has been studied at USP as a chemical and there is no complete demonstration that it has effective action against the disease."

The Ministry of Science, Technology and Innovation (MCTI) has partnered with six laboratories in the field of pharmaceuticals and medicines to further study phosphoethanolamine.

The scientific journal Nature publishes an editorial highlighting the dangers involved in the distribution of phosphoethanolamine.

January 9, 2016

The Brazilian Ministry of Science, Technology and Innovation, the Brazilian Ministry of Science and Technology, announced that it will carry out tests to prove the efficacy of phosphoethanolamine and be led by the State of São Paulo Cancer Institute (Icesp) The governor of São Paulo, Geraldo Alckmin, announces that the Laboratory PDT Pharma, of Cravinhos, will be the first of its kind in Brazil. responsible for synthesizing the substance phosphoethanolamine for testing in the treatment of cancer. The substance will be analyzed in the treatment of the disease in up to 1,000 volunteers.

The National Cancer Institute (Inca) issues technical advice on synthetic phosphoethanolamine. According to the institution, "any therapeutic decision related to the substance, before conducting controlled research? And only at the end of the pre-clinical and clinical studies, it will be possible to indicate the possibility or not of using the drug as anticancer action."

March 2016

The House of Representatives approves the bill that allows the manufacture, distribution and use of phosphoethanolamine. The bill will be able to use the substance provided there is a medical report proving the disease. In addition, the proposal also allows for the manufacture of synthetic phosphoethanolamine even without a health registry.

Researchers responsible for conducting the first phosphoethanolamine trials report an opinion stating that the medication was low in purity and shows little or no effect on the cells tumor cells. The document also shows that the performance is much lower than that of the substances available for decades in the market.

The chemist who initiated the studies of synthetic phosphoethanolamine Gilberto Chierice and the researcher Durvanei Augusto Maria, connected to the Butantan Institute, enter with a Public Defender of the Union contesting tests that indicated unsatisfactory substance performance.

The Senate approves the House Bill that authorizes cancer patients to use synthetic phosphoethanolamine prior to its registration with Anvisa. The bill was approved by the Social Affairs Commission on March 17 and followed for presidential sanction.

Anvisa recommends that President Dilma Rousseff veto the bill, as it would be a very dangerous precedent to release the substance before the

April 2016

Federal Supreme Court Chief Justice Ricardo Lewandowski determines that USP must provide phosphoethanolamine only while the compound is in stock. After that the distribution could be suspended due to the fact that phosphoethanolamine has no Anvisa registration to be produced and distributed.

President Dilma Rousseff sanctioning law that frees the manufacture, distribution and use of synthetic phosphoethanolamine for cancer patients

The Brazilian Medical Association (AMB) files a direct action of unconstitutionality (ADI) to the Federal Supreme Court to challenge the law that allows the use of synthetic phosphoethanolamine, the cancer pill.

According to the AMB, the "cancer pill" has not passed the clinical tests in humans, which, according to Law 6.360 / 76, are made in three phases before the granting of registration by the National Agency of Sanitary Surveillance (Anvisa). And according to the association, phosphoethanolamine only went through the phase of preclinical research tests required for a substance to be considered a drug, and "permission to use a drug whose toxicity to the human body is unknown undoubtedly poses a serious risk to life and physical integrity of patients, rights protected by the caput of article 5 of the Federal Constitution. "

The Supreme Federal Court (STF) has asked the President of the Supreme Court to explain to the President Dilma Rousseff about Law 13.269, which provides for the suspension of the effectiveness of Law 13.269 / 2016 and, on merit, the declaration of its unconstitutionality. the use of synthetic phosphoethanolamine in Brazil. The decision, pronounced by STF Minister Marco Aurélio Mello was a response to the Direct Action of Unconstitutionality of the Brazilian Medical Association (AMB), which claims that the law releases the use of a substance that has not undergone the clinical tests necessary to prove safety and efficacy

May

The Federal Supreme Court decided on June 19 to suspend the law referred to in April of that year authorizing oncological patients to use synthetic phosphoethanolamine. In addition, judgments requiring the government to provide the substance were also suspended.

June

The Center for Innovation and Pre-Clinical Trials (CIEnP) has completed further testing with synthetic phosphoethanolamine. The analyzes were performed on pancreatic, lung and melanoma cells, in order to check the substance's ability to destroy tumor cells and inhibit their growth. The tests concluded that phosphoethanolamine was not effective against pancreatic tumor cells or melanoma. In lung cancer the substance was able to reduce cell viability by 10.8% and proliferation by 36.1%.

July

The study for the treatment of cancer with synthetic fostoethanolamine, popularly known as " cancer ", began to be tested in humans on July 25, 2016 in São Paulo. The research has been carried out by the Institute of Cancer of the State of São Paulo (Icesp).

Fostoethanolamine began to be produced in the laboratory of the Institute of Chemistry of São Carlos (IQSC-USP) and distributed on the campus of the university free of charge to patients

In the first studies carried out for the Ministry of Science, Technology, Innovation and Communications, animal and laboratory tests had little or no effect on cancer.

The first phase of the research will evaluate 10 patients to define a safe dose that will be used. After the first step, if the drug does not present serious side effects, the research will continue with another 200 people, divided into ten groups of different types of tumor. Each patient should start by taking three tablets a day.

In two months the study will have an evaluation of the result. If every 21 patients have three positive results, there will be another 800 patients in the second phase of the tests and the final number should reach 1,000 volunteers. Researchers believe that in six months they will have the complete analysis to define the effect of the pill.


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