Understand the controversy of the USP substance that supposedly cures cancer

Imagine you get the devastating news that a loved one has cancer. Wouldn't you do everything in your power to try to find a way to cure this person? And if you found out that there is a revolutionary substance that is supposed to have the power to eliminate the disease, wouldn't you go after it, even if that compound didn't have the necessary records to be legally distributed as a medicine?

This is one of the dilemmas involving phosphoethanolamine, a substance that has been distributed by the University of São Paulo to cancer patients. According to the Institute of Chemistry of São Carlos - IQSC - USP, the compound was studied by Prof. Gilberto Chierice, who was part of the Analytical Chemistry and Polymer Technology Group and is now retired.

Miraculous Substance

According to Prof. Gilberto, phosphoethanolamine makes cancer cells more visible to the immune system, leading the body to attack diseased cells. Research began in the 1980s, and numerous patients reported significant improvements after starting treatment with the substance.

However, although the compound has undergone animal studies and even human cells in the laboratory, research has not progressed further. This means that phosphoethanolamine has never been clinically tested in human patients - and therefore does not have the necessary licenses to be legally provided as a medicine.

Independent Search

According to the IQSC, the research was focused on phosphoethanolamine synthesis and was conducted independently by the professor and other non-university subjects. So, at some point, the professor decided to start producing and donating the substance to cancer patients for those people to use phosphoethanolamine as a medicine.

However, federal law prohibits the production and distribution of compounds for medical use without proper records or licenses issued by the competent authorities - and the substance provided by the teacher does not have any of these documents.

For his part, the professor said he filed several requests with Anvisa to release phosphoethanolamine, but never got a response. Already the agency claimed that never received any notification. But even if it had received it, it could not issue the registration because studies with the substance were never completed.

Still, to meet patient demand, the IQSC continued to provide phosphoethanolamine capsules free of charge, until mid-year last year the institution decided to suspend distribution. The initiative has generated a strong reaction from the thousands of patients who use the substance, and many of them have gone to court to obtain the compound.

Distribution stopped

USP states that it does not have access to the technical and scientific knowledge developed by Prof. Gilberto for the production of phosphoethanolamine, not to mention that the substance is protected by patents. In addition, the institution also stressed that it has no scientific data on the efficacy of the compound in the treatment of cancer, since, as far as is known, there have been no clinical trials with patients using phosphoethanolamine.

The Institute of Chemistry further explained that it has been producing and distributing the substance to meet court orders brought by patients already using phosphoethanolamine. But it added that it does not provide package leaflet or further information about possible side effects and contraindications associated with the use of the compound.

Moreover, while production and distribution are prohibited, there are no restrictions on research conducted with phosphoethanolamine - or any other substance. And if all the legal standards set by federal law are met, studies can advance and involve the participation of animals and humans.

What remains unclear is why a potentially revolutionary compound that could save the lives of millions of people around the world has not yet been properly studied. Instead of fighting so much, wouldn't it be more interesting to focus on developing research that proves the effectiveness of phosphoethanolamine?