The distribution of a substance called synthetic phosphoethanolamine has divided expert opinions and created controversy between patients. The pill, which would work to combat cancer, was not approved by the Brazilian Health Surveillance Agency (ANVISA). Still, the Federal Supreme Tribunal authorized it for a patient in Rio de Janeiro on October 8th. The case gained repercussion and is feeding the debate over the bureaucracy and ethics involved in the development of medicine. Are there limits imposed on research for new drugs in Brazil? Felipe Ades, oncologist doctor at the Albert Einstein Hospital in Sao Paulo and Antonio Britto, chief executive of Interfarma (Association of the Pharmaceutical Research Industry), discuss the issue.
Behind ‘Ethics’, by Antonio Britto:
Britto writes about the frustration and sadness of doctors in Brazil when the topic is clinical research. Unfortunately, public health experts argue that Brazil cannot support the dream of a universal system, free public health, able to offer treatments and therapies to all, unless it is capable of producing knowledge and innovation at home. The country must reduce its technological and commercial dependency.
Brazil currently holds a mediocre position in clinical research. Scientists write to the President for help in the area, while rich patients opt to go abroad to participate clinical studies elsewhere. With that, the country loses significant scientific and economic opportunities.
Recall that Brazil did put forth a control system for research, under the unforgettable Dr. Adib Jatene. He built a system that included a central unit, the CONEP, responsible for creating standards, accrediting, and overseeing the centers (CEPs), responsible for conducting clinical studies and reviewing decisions, with the main objective of protecting the participant’s interest at heart.
However, corporatism also made victims here. In just a couple years, the system began to generate repeated work, duplication of functions, bureaucracy, and waste of time. As a result, Brazil’s participation in clinical trials slowly began to be cancelled – after all, the world could not wait for Brazil to return to research.
It is a shame to see scientists who could have attended the best universities across the world, who could be leading major research worldwide, being submitted to a petty argument in which corporatism manipulates the idea of ethics to hide an uncomfortable truth, the maintenance power.
It’s sad, but true.