By Carlos Camacho in Caracas.
Venezuelan doctors and the Pan American Health Organization have expressed doubts about a new drug the Nicolas Maduro regime is pushing under the name of a Venezuelan doctor revered as a saint in the crisis-stricken country.
Carvativir is a Thyme-based medication available in drop form, which will be mass-produced since they are “the miraculous little drops of Jose Gregorio Hernandez,” Maduro said on January 24th. Despite the pious invocation, the Pan American Health Organization and the principal medical academic organization in Venezuela questioned the drugs of Maduro.
Maduro’s announcement was so controversial that YouTube censored several news channels (including that of El Pitazo) carrying the item, arguing that the claim has not been scientifically proven. This is the second time YouTube censors Coronavirus claims of Maduro.
“Carvativir passed all studies and has shown 100% effectiveness against the virus. An antiviral from Venezuela, for the Alba (a regional trade and diplomatic bloc formed by Hugo Chavez), for the world,” Maduro said on Sunday.
But both the guild and PAHO are asking for those studies to be made public. Meanwhile, the number of cases is peaking.
Maduro said that Carvativir had been testing in patients with COVID-19 treated at the Periferico de Coche hospital and the Poliedro de Caracas, former music and sports arena where the regime interned 2,500 patients last year. The tests began nine months ago, and the medicine gets based on a compound derived from Thyme (tomillo, in Spanish, a herb commonly used for cooking), also known as Carvacol.
Despite the peaking figures for cases, both the Pan American Health Organization and the Venezuelan Medicine Academy expressed doubts about promised cure from Maduro.
And even if Maduro promised that all laboratories in Venezuela would get on with the manufacturing of Carvativir, only one facility is reportedly manufacturing.
The Academy of Medicine, in a statement, pointed out that it is prudent to wait for more data on the tests performed on Carvativir that are following international protocols, such as the World Health Organization (WHO), which qualify the drug as a candidate to treat patients with COVID-19.
Maduro’s statement about the production of these drops for the disease is contradictory to what even WHO experts maintain: is no yet a therapeutic alternative to prevent or cure the disease, the academy argued.
In Venezuela, the scientific community expects the published results of the studies carried out on the drops that Maduro described as “miraculous.”
Experts doubt the observation of compliance with universal experimentation protocols in humans. Therefore, they ask for evidence to make the right medical decisions without harming patients suffering from respiratory disease.
The study and manufacture of the drops were in charge of Laboratorio Farmacologico de Venezuela (Labfarven). Since October, researchers began testing the drug at the Coche hospital, according to sources consulted. The preliminary studies were published in Scribd by the Venezuelan scientist, Raul Ojeda Rondon, who is part of this laboratory about which there is not much information.
Infectious-disease expert Doctor Jaime Torres from the Institute of Tropical Medicine of the Central University of Venezuela (UCV), told El Pitazo he had questions about the miraculous little drops.
“It gets mentioned that the drops get elaborated with thyme extracts, but we do not know which component of the plant, for example, if it is acid, alcohol, oil, or mixtures. We do not know the doses or the details of the preclinical study. In this panorama, it is difficult to issue an opinion.”
Other questions are whether the product fully complied with the three phases of experimentation and other bioethical protocols to certify that it is suitable for human use and whether it has real effects on the new coronavirus, Dr. Torres said. “It is unknown if this had a peer or specialist evaluation that discriminates the methodology and process of the study,” he added.
Doctor Manuel Figuera, vice-president of the Venezuelan Society of Infectious Diseases, says the doctors approach patients with therapeutic alternatives based on scientific evidence. Figuera questioned Maduro’s affirmation that the product is 100% effective.
“There are levels of evidence that can be ranked to know if a drug is adequate or not. The evidence gets built with randomized controlled clinical studies, administered under placebo effect and with larger and larger groups of people in each phase of the trial,” Figuera points out.
The Pan American Health Organization (PAHO) called Wednesday for the publication of findings and clinical studies on Carvativir, a drug developed in Venezuela that, according to President Nicolas Maduro, is complementary to the fight against COVID-19, EFE reported.
“PAHO, WHO (World Health Organization) do not validate new treatments or known drugs redirected for this case for use for COVID-19,” said the deputy director of PAHO’s Department of Health Emergencies, Sylvain Aldighieri.
The official indicated that this is the responsibility of the national drug regulatory agency in each country.
“What PAHO does is to periodically identify, evaluate and synthesize the available evidence on possible treatments through publications in scientific articles. In this context, he considered it important that researchers, research institutions, publish their findings using randomized clinical studies as a strict methodology to avoid biases,” added the expert.
“In the case of those drugs, molecules, commented by the Venezuelan authorities, we would make the same recommendations of methodology and publication and design of scientific studies,” she complimented.
Maduro assured on Tuesday that “it has been proven that Carvativir is a powerful complementary antiviral for the healing and cure” of COVID-19.