Brazilian Cancer Drug Scandal Provides Valuable Lessons
The widely publicized untested oncology drug scandal could lead to better clinical practice.
A recent scientific scandal in Brazil may provide cancer researchers and patients with valuable lessons that may lead to better clinical practice overall, according to newly published work.
The scandal surrounding the compound phosphoethanolamine (PHOS) began when a retired Brazilian professor taught a salesman how to make the compound. The salesman then began to sell it to cancer patients and, as word spread, patient demand for the compound began to increase.
Unfortunately, PHOS was an untested compound, and selling untested compounds as medication is illegal in Brazil. In a new policy paper published in ecancermedicalscience, researchers addressed the idea of a patient’s right to try any and all treatments, and how the process of cancer drug development is an essential part of clinical research.
“… This question goes much deeper than the patient’s right to try any kind of treatment they feel may help them,” said lead study author Noam Pondé in a press release. “The danger of unproven drugs has wider societal consequences.
The rules and regulations set in place are to protect patients even if cancer patients and advocates grow frustrated with the process.
“I think one of the main messages is that actually, there is no such thing as ‘bureaucracy’ when we talk about drug development,” said Felipe Ades in a press release. “The lab and clinical research phases exist for a very clear and specific purpose, which is to test the real efficacy and safety of a novel drug candidate.”
In the policy paper, researchers divulge into the convoluted legal mess that resulted from the scandal and examined the ethical repercussions. Furthermore, the study authors suggest lessons that the research community can take away.
“When these important clinical research phases are skipped, for any reason, it put[s] patients into dangerous situations,” Ades said. “The resulting decisions about treatment are not based on clinical and scientific evidence — but on fears, and possibly false hopes. I hope that this scandal leads people to understand that miracle cures do not exist for cancer – nor for any other disease. And that good research methods are as important as having good intentions.”