Source: Trial Site News
A new profile of Dr. Hector Carvallo of Argentina is titled “A Lifeline from Buenos Aires,” and it focuses of his use of and advocacy for ivermectin as a treatment for COVID-19. The doctor is a professor of medicine and former director of a large hospital, retired from University of Buenos Aires. TrialSite has followed his ivermectin studies.
By February 2020, our pandemic was already looking dangerous to the world. And later that month, Hector’s wife, Mirta Carvallo, MD, heard that “something’s going on with ivermectin in Australia,” and she informed her husband of this: scientists at Monash University in Australia had shown that ivermectin could fight SARS-CoV-2 in vitro. Hector was intrigued; the anti-parasite medicine had already saved millions of folks in the southern hemisphere from river blindness, known as onchocerciasis.
The doctor and his wife had often prescribed the drug for scabies, rosacea, and other ailments, and he says it is “one of the safest medicines I’ve ever used. ”Considered one of the most important drugs of the 20th century, ivermectin’s creators won the Nobel Prize 2015 for their work on the drug.
Crying for Joy, Then Crying from Frustration
Mere weeks later, prior to any official reporting of the Australian findings, Hector and a colleague conducted the first human trials of ivermectin as a prophylactic preventative against COVID-19. “I am not ashamed to say I cried when we got the results,” Carvallo remembers.
Yet months later, for a very different reason, Hector reports, “I cried again.” This time his emotions were due to the medical authorities in Argentina began an effort to suppress knowledge about ivermectin’s safety and efficacy, question Hector’s results, and even attack his reputation. The doctor is reportedly soft-spoken and gracious personally, and he speaks perfect English partially due to a childhood attachment to TV medical drama, the latter inspired him to be a doctor.
Within days of his wife hearing rumors of ivermectin from down under, Dr. Carvallo met with a top Argentine infectious disease expert, Dr. Roberto Hirsch, to discuss ivermectin.
Not an Animal Drug Only
Little known in North America and Europe except for veterinary use—or perhaps for lice or scabies—ivermectin was reputed to inhibit RNA viruses such as dengue, Zika, and yellow fever in vitro. It is thought that the drug blocks virus’s capacity “to transport from a cell’s watery cytoplasm to its nucleus.”
In early March 2020, Carvallo and his colleague penned a message to the Journal of the American Medical Association. Noting the drugs, “virucidal properties,” the letter offered that ivermectin might be “a safe, potent, widely available and cheap prophylaxis against Covid, urgently in need of swift investigation. ”They also posited that the drug might be effective against active COVID-19 cases, that it could be a treatment as well as a preventative. “But the editor of JAMA said he was not interested. He gave us no good reason,” Carvallo says. “I was surprised. I wrote to say, ‘At least take it as a possibility,’ but we never heard back. So, we decided to form our own trials. We would replicate what the Australians had done in vitro, but we would do it in vivo.”
Observational Studies Show Great Promise
The doctors then proposed an experiment to the ethics committee of Eurnekian Hospital: giving weekly ivermectin to about 100 hospital workers who were often exposed to COVID-19 patients. Another 100 who chose not to take ivermectin functioned as the control group. Carvallo and Hirsh both felt that lengthy RCT’s would be unethical: “If I had to post my hypothesis atop a pile of corpses, that’s criminal,” he said.
Their approach was a “classic” type of research, an observational study. “Elated” by the proposed study, hospital officials, said yes to the idea, and the government health office quickly approved the protocols. The trial started in April, without funding or RCT formality, and utilizing donated medicine.
131 subjects used ivermectin, and 98 did not. The results were stunning: of the 98 who did not use ivermectin, 11 contracted the virus, of the 131 who had gotten the drug, zero cases of COVID-19 were found. “Word spread quickly through the hospital, and the union representing our health care workers demanded the prophylaxis be given to everyone [on staff] who wanted it.
With this large “volunteer pool” available, the doctors started a second and expanded version of the trial. Due to running out of free medicine, this expanded study ended in August 2020. The findings: of 407 folks in the control group, 58.2 were infected with SARS-CoV-2, of 788 patients treated with ivermectin (and carrageenan), zero had contracted the virus.
“Not Allowed to Keep Investigating Ivermectin”
By this point, the doctors had begun a new study of folks already suffering with COVID-19. They signed up 135 outpatients with mild symptoms and 32 in patients with moderate to severe symptoms. All were given ivermectin on a weekly basis. The hospitalized also got steroids and a blood thinner if symptoms warranted. Four weeks later, none of the 135 required going to the hospital.
One inpatient, an 82-year-old with “severe co-morbidities,” died. So, the doctors saw that there was a death rate of 3.2 percent of those using their protocol, far less than the 23.5 percent overall rate for hospitalized patients in Argentina.
Days later, Carvallo got a call at home. The secretary for the health minister was on the line, and “he said I was not allowed to keep investigating ivermectin, or it would put my job in jeopardy. I was baffled. I said, ‘Why?’ and he would give me no answer—And that’s when I cried again, from frustration. I’m not ashamed to say I cried because it’s true.” Now, a year and a half later, “ivermectin still struggles for official recognition as an anti-Covid agent despite the large body of research in its favor.”
Three Phases of Truth
The May 2021 issue of Antibiotics Review, for example, put out a metanalysis of ivermectin which showed that 100% of 36 prophylaxis and early treatment studies showed positive results, and 26 of the studies showed “statistically significant improvements.”
But in August 2021 FDA was “still pounding the same drum it first pounded in June 2020, when the Australian researchers published their findings.” FDA warned, “Taking a drug meant for horses and cattle to prevent or treat COVID-19 is dangerous and could be fatal.”
To Carvallo, this mockery and bad information were “very frustrating.” Next, on September 2, the outlet BuzzFeed put out a lengthy and critical look at the doctor’s work. They reported that the studies “raised questions about how the study’s data was collected and analyzed.”
Carvallo says the ivermectin backlash is “not a matter of ignorance.” He notes that NIH, CDC, and FDA have read the pertinent studies. The doctor feels that a double standard is in place: “The more expensive a compound is, the less quantity of evidence is required to get it approved. “But when a compound is cheap and available,” he opined, “that’s another matter.”
He is confident that eventually, ivermectin will be widely used against COVID-19. “All truth passes through three phases,” he told BuzzFeed. “First it is ridiculed, then it is violently opposed, then it is accepted as self-evident. We are in phase two now.”