The story of phosphoethanolamine (PHOS) in Brazil, which set off a widely publicized scientific debacle about the dangers of taking unproven compounds as medicines, shows once again that just because some miracle cure is touted in a foreign country doesn't make it real.
This fact is in defiance of anti-science groups convinced of an FDA/Big Pharma conspiracy against cures, but America remains the gold standard for legitimacy, and with good reason. While cancer patients and their advocates may find the process of cancer drug discovery to be opaque or frustrating, the authors of the policy paper argue that the process is an essential part of clinical research.
In the case of phosphoethanolamine, a retired Brazilian professor taught a salesman how to make the compound - and the salesman began to sell it to cancer patients. As word of mouth spread, more and more patients began to demand the compound.
The problem? It isn't legal to sell untested compounds as medicines in Brazil -- and phosphoethanolamine was untested. Even now, as the scandal continues to unfold, it isn't clear exactly what the compound's effects might be.
"When these important clinical research phases are skipped, for any reason, it put patients into dangerous situations," explains Dr. Felipe Ades of the Hospital Israelita Albert Einstein, São Paulo, Brazil. "The resulting decisions about treatment are not based on clinical and scientific evidence -- but on fears, and possibly false hopes."
In the paper, the authors explain the convoluted legal tangle resulting from the fiasco, examine the ethical repercussions, and suggest lessons for the research community to learn.
"Actually, this question goes much deeper than the patient's right to try any kind of treatment they feel may help them," answers lead author Dr Noam Pondé of the Jules Bordet Institute, Brussels, Belgium. "The danger of unproven drugs has wider societal consequences."
"I think one of the main messages is that actually, there is no such thing as 'bureaucracy' when we talk about drug development," says Ades. "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."
Phosphoethanolamine Shows Again Why There Are No Miracle Cures Being Blocked By Drug Companies
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