Anvisa: law authorizing the use of phosphoethanolamine can put people at riskThe substance has not undergone any test is able to ensure its safety and efficacy.
A lei da authorizing or use synthetic phosphoethanolamine, sanctioned today (14) by President Rousseff, You can put the Brazilian population health risk because it releases the use of a substance which has not undergone any test is able to ensure its safety and efficacy. The evaluation is the CEO of the National Health Surveillance Agency (Anvisa), Jarbas Barbosa.
In an interview to Brazil, medical health officer noted that the agency was manifesting, repeatedly, concern for the law. Or text, published today in the Official Gazette, authorizes the use of synthetic phosphoethanolamine for patients diagnosed with cancer and sets the permission as public relevance. According to the publication, the option for voluntary use does not preclude the right of access to other forms of cancer treatment.
"Now, with this law, It will be able to be sold, marketed and distributed a substance that is not subject to sanitary inspection. Who will ensure that what's inside the capsule is even phosphoethanolamine, the amount that is written in the box? Who will prevent them from being counterfeited and produced, by unscrupulous pessoas, capsules with flour placed in a box that says is phosphoethanolamine? Will have bula? If so, the bull will be able to say that the person should stop chemotherapy?”, He questioned the director of Anvisa.
For Jarbas Barbosa, the risks posed by the newly enacted legislation are tremendous for placing the synthetic phosphoethanolamine outside the Brazilian regulatory environment, which had been built since 1970 and culminated, in 1999, the agency's creation. Jarbas said he regretted the sanctions and assured that the agency will study legal maneuvers able to cause damage to human health should be minimized.
"I have the greatest respect for Congress, but he is not able to make a technical analysis. And the authorization of a medicine has to be done through a technical analysis based on science and information. The Congress has a political view because it is a political body. That's why, in any civilized place and in any developed country, is the National Congress who authorizes the use of drugs ", said Jarbas Barbosa.
According to the law, intake of synthetic phosphoethanolamine, popularly known as cancer pill, It can be made by free choice of the patient, which must have a medical certificate certifying the diagnosis and sign a consent form and responsibility. Although the possession and use of the substance are authorized, even without registration at Anvisa, laboratories can only make production, manufacture, import, distribution and prescription of synthetic phosphoethanolamine with permission of the agency.
The authorization to use the synthetic phosphoethanolamine established by the text is of exceptional character, while being made clinical studies on the use of the substance.