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An announcement took Venezuelans by surprise on the afternoon of Sunday 25 October. In a live broadcast, President Nicolás Maduro claimed that Venezuelan scientists found a molecule call DR-10, capable of “annihilating” the coronavirus, and that Venezuela aimed to promote it as a drug capable of treating COVID-19.
“Venezuela has got a drug that 100% erases the coronavirus,” Maduro said. The same day, Gabriela Jimenez, Minister of Science and Technology, assured that it all started six months ago, when the Governor of Carabobo, Rafael Lacava, spoke to them about plant with medicinal activities studied by scientists from Puerto Cabello, used against human papillomavirus, Ebola and hepatitis C.
From there, researchers from the Venezuelan Institute of Scientific Research (IVIC) identified the file DR-10 molecule and tested on virus-infected cells SARS-CoV-2, according to Jiménez. But is it possible to say that the country has found a drug against the disease? What else is known so far?
What is known
Jose Esparza, a Venezuelan virologist and professor at the Institute of Human Virology at the University of Maryland School of Medicine (United States), explains to Cocuyo effect that not much is known about the DR-10 molecule. The information was only announced in the state media and has not yet been published in a scientific magazine appropriate, so the results cannot be evaluated.
“Apparently it is a natural product extracted from a plant known to be medicinal, but his identity was not revealed. However, it was said that it was possible to identify the active ingredient (the ‘molecule’) which turns out to be a derivative of ursolic acid, chemically family of triterpenes. Ursolic acid is a known component of many plants known to be medicinal as well as antioxidants like it anti-inflammatory“, Indicates Esparza.
According to the minister, the molecule obtained 100% inhibition of virus replication in vitro. What does this mean? Here’s how Esparza explains it: To multiply, viruses must infect living cells, and researchers can keep these cells alive by growing in laboratory flasks. in vitro (in glass). They insert a small amount of the virus into the cells and within hours or days the virus has multiplied, usually resulting in its destruction or death.
There they measure whether the substance prevents the multiplication of the virus and cell death. But for this they must obtain an adequate dose: one that inhibits multiplication without affecting the viability of the cells.
According to the expert, other laboratories have reported that ursolic acid derivatives may have antiviral activity in vitro. In doing so, he points out that it is possible that the Ivic researchers were able to find a derivative with increased antiviral activity compared to those previously identified, but this is not yet known.
Apparently, the Ivic researchers have achieved two things: one, to demonstrate that very low doses of the product are capable of inhibiting replication. in vitro the coronavirus that causes COVID-19, without causing cell damage; and two, have been able to divide and characterize the specific component present in the plant extract, responsible for the antiviral activity, the molecule they call DR-10 and what we know is a derivative of ursolic acid, ”says former researcher Ivic.
According to the minister, the DR-10 molecule was evaluated in healthy cells without showing toxicity | Photo: @mincyt_ve
When can you talk about medicine?
Gioconda San Blas, a molecular biologist and researcher emeritus at Ivic, points out that the custom in the world of science is to publish the data so that they are then subject to review by other researchers interested in the subject, who can also continue their studies.
“Those of us who work with microorganisms and who have worked with inhibitors or antibiotics at some point, do this kind of experiments regularly. If you have a substance that inhibits a certain virus, in this case, or a fungus, a bacterium or a parasite, the inhibitory effect that this substance can have on the plates occurs, you publish it and then you can continue with the experiments on animals, if they are able to do it, or it is done by another group that has the means, ”he adds.
According to Gabriela Jiménez, Minister of Science and Technology, to date they have the technical-chemical report on the DR-10 molecule, which is “approved by ICI and available to the scientific body of the country and the World Health Organization” to start future activities. However, the country’s scientific societies only know the information that was shared on television by the minister.
San Blas, former president of the Academy of Physical, Mathematical and Natural Sciences (Acfiman), highlights it there are still no medicines As stated by President Nicolás Maduro, because having found inhibition at the laboratory level does not mean that the compound can ultimately be translated into a drug capable of curing COVID-19. To verify this requires resources and time, as these are long and expensive experiments.
“The fact that there is activity in vitro it does not mean that this substance can be effective in vivo in animals or humans, and it would be a very long project to accomplish. First you need to see if it is effective and if it is not toxic in animals. If these two are satisfied, we move on to clinical trials, ”he says.
Only when the product has proven to be safe and effective is it possible to talk about a new medicine | Photo: @mincyt_ve
Jose Esparza, who is also a foreign correspondent member of the National Academy of Medicine of Venezuela, points out that to convert laboratory results to medicine, the first step is develop methodologies reproducibly obtain large quantities of product for preclinical and clinical testing and possibly for use in the human population. He also agrees with Professor San Blas: he has to go through lengthy and expensive stages.
The specialist indicates that a valid product is what can be synthesized in the laboratory of economical and reproducible way. The next step would be animal experiments to determine that the product is safe and, if possible, that it also has an antiviral effect on the animal. Esparza assures that sometimes the products can be toxic, or they cannot be absorbed orally or not reach the necessary concentrations in the tissues. If this does not happen, continue the investigation.
“So the product is introduced in the phases of human experimentation (1-3) to demonstrate that the product is non-toxic, that it has an appropriate absorption and distribution pattern and, finally, that it has a clinical therapeutic effect (step 3). This last stage is complex and usually requires hundreds or thousands of patients where a control group is used to see if the drug has any clinical benefit (faster healing, fewer deaths), ”he says.
In addition, it is possible to measure whether the administration of this product reduces the amount of virus in the patient. “Only when the drug is shown to be truly safe and effective is approval required by regulatory agencies and is when you can talk about having a new medicineAdds the former president of the World Virus Network.
Bioethics and urgency
Gladys velasquez, president of National Center of Bioethics (Cenabi), says that generally developing a new medicine can take years, even when the process is accelerated. So, he claims it is hurried to say that Venezuela has discovered a medicine that treats COVID-19.
“We are talking about years. You can’t claim victory because we have the early stage. It is respectable that this was achieved in our laboratory. IS plausibleBut a process has to go through, and within that process is the fact that these results are published and possibly verified in other laboratories, ”he points out.
The announcement of the DR-10 molecule It has generated alarm among some scientific communities, which have warned that there is no independent National Bioethics Committee registered at Cenabi. However, Velásquez clarifies that the National Bioethics Center, as a civil association, does not act as a regulatory entity but consultant on ethics in health sciences and the protocols developed for research work.
“Bioethics It would only be when you do the experiments in vivo. The experiments in vitro they don’t need bioethics because you don’t work with animals or humans. Those experiments that the minister says were done, being alone in vitroThey don’t have to carry out any bioethical screening, ”adds San Blas.
Experts applaud the initiative and warn it is too early to say that Venezuela has an effective drug | Photo: @mincyt_ve
Velásquez and San Blas say that every institution dedicated to research, including ICI, has a bioethics committee. However, the National Bioethics Center does have a file Independent Bioethics Committee which is regulated by national and international standards for research on living beings. It is also legally registered and meets the requirements of the Rafael Rangel National Institute of Hygiene, an institution they have worked with in the past.
But since the Covid19 pandemic, the authorities of Nicolás Maduro’s administration did not contact the National Bioethics Center. Although the Official Gazette states that any research related to COVID-19 must be approved by the corresponding body’s Research Ethics Committee, Cenabi warns that the studies are therefore only endorsed by the Ministries of Health and Science and Technology themselves.
“This is not an independent committee. They must have a free and autonomous view of the things that are evaluated because in this way the decisions that are made do not generate so much trust ”, adds Velásquez.
However, the discovery of the DR-10 molecule was presented on October 26 before the Pan-American Health Organization, as announced by the vice president of the Nicolás Maduro administration, Delcy Rodríguez, to initiate the “international procedures that correspond to”.
For the experts consulted there is still a long way to go and it is soon to claim that a cure has been found against COVID-19, which has claimed more than 800 lives in Venezuela according to official information.
“It is totally inappropriate when it is said that DR-10 has already been proven to be 100% safe and effective. This information simply does not exist ”, concludes Dr. Esparza.
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