scientists of the Industrial University of Santander, UIS, After a year of research, they issued an imminent alert with a drug that is essential in the treatment of acute lymphoblastic leukemia (ALL)what is a cancer that occurs frequently in children.
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The study conducted and released in early February revealed that the drug L- asparaginasa (L- ASNase) that is given to minors in the middle of chemotherapies and, which is supposed to stop cancer cells, is not causing the forceful effect once morest this disease.
In Colombia we are at 60 percent survival, we are well below what children should be cured. One of the hypotheses we have is the quality of the drug,”
That is to say, that this medicine, which comes from India, is not stopping the pathology and this is extremely worrying, since the patients who suffer from this disease and receive such treatment would be excited and hopeful of being able to overcome cancer.
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According to Agustín Contreras Acosta, hematologist, pediatric oncologist and president of the Colombian Association of Pediatric and Hematology, ASHOP, with this medicine, nine out of 10 children are cured in the world.
However, this would not happen in that proportion in Colombia, apparently, because the one that arrives in the country comes from a questioned laboratory in India.
“The drug is part of the chemotherapies for the treatment and in high-income countries the survival of this leukemia is 90 percent. This is the most important and with those, survival rates of 90 percent are achieved. In Colombia we are at 60 percent survival, we are far below those that children with this disease should be cured. There are many factors and within the hypotheses we have is the quality of the drug,” said the expert.
We took six asparaginases and we found ourselves with the unpleasant surprise that three were not working, that is, 50 percent of the study did not work,
This alert was not only generated in Colombia, a while ago in Brazil they realized that this same drug brought from India it was not causing the effect that minors needed and that is why they canceled its distribution for cancer treatments.
Agustín said that, in the investigation between the Industrial University of Santander, UIS, and the Colombian Association of Oncological Hematology, ACHOP, They tested six drugs and three did not cause the effect in the patient.
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“In Brazil they returned to a good quality product and realized that they cured less, unfortunately. We did the study in depth, we caught six asparaginase and we find ourselves with the unpleasant surprise that only two were reaching adequate activity, one intermediate and three were not working, that is, the 50 percent of the study are useless and that medicine is being given to the children”, assured the doctor Contreras Acosta.
What does the medicine do?
It decreases an important substance for cancer cells to multiply, one of the things that changed the history of leukemia was that.
People with leukemia have a substance called Aspargina, what do you need malignant cells to multiply, it is like a kind of food.
According to specialized doctors, what makes the asparaginase is to decrease the levels of cancer cells so that this element disappears from the body and prevents the spread of cancer.
“It decreases an important substance for cancer cells to multiply, one of the things that changed the leukemia story was that, survival before was below 50 percent and one of the drugs that increased survival was asparaginase,” the researcher said.
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This study, which was published in January, was sent to the Ministry of Health a early february and the institution notified the Invima, following three weeks, but so far they have not received any response. However, experts are concerned, since for these health issues they ask for speed, because with each passing day they might be saving the life of a child with leukemia.
“We did the study in vitro, not with patients, we put the bad cells, the medicine and through a device we saw that these bad cells did not disappear as they should disappear, comparing it with the other two products that did show results, since the bad cells disappeared, but with the other three they did not decrease at all”.
The scientists of the UIS They feel that this drug needs to be stopped as soon as possible because it can increase relapse in patients.
This study of the UIS y de ACHOP was published in December last year in an international scientific journal of USA call Pediatric Blood & Cancer, taking into account that these types of articles are very demanding with drug studies.
The questioned drug it is low cost because it comes from india and it is delivered in two phases of the chemotherapy treatment, in induction eight doses are supplied and in reinduction, there would be four doses.
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“Usually the EPS authorizes the medicine and the one that puts the medicine is the IPS. We are sure that mortality has to do with the medicine that is not working.”
According to Claudia Sterling, vice president of corporate affairs at Femsa health-Cruz Verde Colombia, this medicine Invima does not have registration in Colombia and do an import like vital not available and price varies.
“It is time to request authorization from Invima, which is called vital authorizations not availableThe Invima authorizes, it takes a month to approve, and this varies depending on the price of the dollar, but it is approximately between one million or one million two hundred, depending on import costs, it is not a medicine that is obtained in drugstores, it is for institutional medical order, from a doctor or EPS”, said Claudia Sterling.
Reactions from foundations that help people with cancer
The Living Hope Foundation, that helps children with Leukemia and other types of cancer generally indicated that it is alarming this study and it was questioned regarding the quality control that is done in the same medicines that are supplied not only to minors, but also to patients suffering from the disease.
“How is it possible that, if requirements are requested, one of the most important is quality. It must be taken into account that not everything cheap is good, complete studies would have to be done for each drug, where is the pharmacovigilance, What happened? Where is the quality control?” questioned Nury Esperanza Vilalba, creator of the foundation.
He stressed that for months he had been questioning why there had been relapse in children and said that this might be one of the reasons.
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“It would be necessary to review all the ties of the children who received this medication, and see what the response was and if this had an impact on the results and there should be those responsible, they have double constitutional protection,” he concluded.
MELISSA MÚNERA ZAMBRANO
CORREPSONSAL DE EL TIEMPO BUCARAMANGA
TWITTER: @MELYMUNERA
