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Rousseff Sidesteps Regulatory Review for New Cancer Drug

Rousseff Sidesteps Regulatory Review for New Cancer Drug

As the rates of cancer diagnosis rise, so too does public demand for new treatment options. But this demand seems to rise faster than the pace of drug development. Years of testing are required, for both safety and efficacy, before the Brazilian Health Surveillance Agency approves any new therapy. President Dilma Rousseff recently circumvented that process when she signed into law a measure that guarantees access to a new cancer treatment that has not received the full testing and regulatory review required of new drugs.

The drug in question is synthetic phosphoethanolamine, more commonly referred to as “fosfo.” Even though the drug has not been formally tested in humans, many people view it as a cancer cure. The University of São Paolo has manufactured the experimental drug and provided it to some cancer patients for free, though not as part of any clinical trial. Some of the patients who received the drug claimed that it was responsible for their recovery, feeding fosfo’s reputation as a “miracle cure,” Nature explains. Those beliefs have also led to a clash in the courts as patients sue to get access to the drug. Early court orders called upon the university to provide fosfo to people with terminal cancer; subsequent court decisions overturned those orders.

The new Brazilian law that Rousseff signed guaranteeing access to fosfo came just weeks after Brazil’s science minister revealed that laboratory tests of fosfo showed that it was ineffective in fighting cancer. Yet scientific evidence was not the factor driving Rousseff’s decision. Rousseff, who faces her own impeachment trial, a struggling economy, and a restless electorate, was under pressure to sign the bill, Nature explains. Under the new law, anyone with a medical report certifying their cancer diagnosis has the right to acquire the drug without a prescription.

Brazil’s constitution guarantees access to healthcare for all, but the constitution does not guarantee that the state-run healthcare system provide access to all treatments. While there is precedent for patients turning to the courts to obtain drugs, such lawsuits typically involve access to costly drugs, University of Brasilia bioethicist Volnei Garrafa told Nature. Fosfo, however, is different because it is not technically an approved drug.

Critics say that the law undermines the authority of the Brazilian Health Surveillance Agency and could put patients in danger. Gustavo Fernandes, president of the Brazilian Society of Clinical Oncology in Brasília, told Science magazine that the law was a “political decision inspired by a messianic surge of pseudoscience.” The law also sets a new and dangerous precedent. The formal process of testing experimental therapies in clinical trials exists to determine the proper dosing, and then assess any safety risks that may be associated with the drug. The new law means that the state healthcare system is now responsible for providing and paying for a drug that tests have shown do not work. Perhaps more concerning, many cancer patients will receive a drug whose side effects, if any, are unknown.

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