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covid-19
In the early months of the COVID-19 pandemic, well before the availability of antiviral medicine such as Paxlovid, many countries struggled with how to respond to this unprecedented crisis and keep the public safe.
Several Latin American countries rushed to distribute mass quantities of COVID kits with medicines that were not approved for COVID-19 treatment by regulatory authorities, including ivermectin, an antiparasitic drug with common side effects such as headaches, muscle pain, cough, vomiting, and more.
The drug received significant attention at the beginning of the pandemic after an in vitro study in April 2020 alleged that ivermectin could fight COVID and prevent deaths, but this study was only conducted in a lab and did not reflect real-world efficacy on humans.
Despite insufficient data to support ivermectin, a new analysis by School of Public Health researchers shows that at least eight Latin American countries conducted mass distribution of ivermectin, even though there was no clinical evidence available to confirm the effectiveness and safety of this drug.
Published in the journal BMJ Global Health, the study found that the governments of Brazil, Honduras, Panama, and Peru distributed ivermectin in 2020 before any randomized controlled trial (RCT) was completed. Honduras led the way in June 2020, and the other countries quickly followed.
The study is the first systematic review to assess the timing, amount, and quality of scientific evidence about the safety and efficacy of this drug at the time that these governments provided federal support of its use and distribution. The findings have several public health implications, but broadly underscore the need for governments to strengthen their ability to implement evidence-informed public health policies, the researchers say.
“While the impulse to ‘do something’ is understandable, there was neither enough evidence nor guidelines or recommendations from recognized international organizations such as the World Health Organization to support ivermectin outside clinical trials,” says study lead author and SPH alum José Antonio Requejo Dominguez (SPH’23), research fellow in the Department of Global Health. “In comparison, governments outside the Americas decided to support their population by including tools for symptom relief, such as ibuprofen, and prevention-oriented devices, such as masks, as was done in Japan. In other words, it was possible for governments to make solid and symbolic gestures through mass distributions based on science without wasting resources and harming the population.”
For the study, Requejo Dominguez and colleagues utilized PubMed and Google Scholar to conduct a systematic search for and review of 33 identified RCTs on the safety and efficacy of ivermectin, available from the start of the pandemic to April 2022.
The findings show that the first RCT of ivermectin was published online in August 2020, and the team labeled it at “risk of bias” with “unfavorable” results. But also in August, Bolivia, El Salvador, and Guatemala distributed the COVID kits with this medicine in mass distribution.
The study also documents national leaders’ vocal support of ivermectin, such as when Bolivian President Jeanine Áñez Chávez said that the COVID-19 kits “are very important to prevent the disease from worsening and also to avoid the saturation of hospitals.”
In addition to potentially endangering hundreds of thousands of people, these actions at the federal level pose many concerns. None of the countries’ medicine regulatory authorities approved market authorization of this drug to treat COVID-19, and many of the most forceful proponents of ivermectin were not healthcare professionals. These repeated claims cast skepticism over federal officials in many of these countries, and the researchers say resources for these efforts could have been applied elsewhere.
“False government claims erode citizen trust, and spending scarce resources on interventions that can potentially be harmful are concerning and affect our ability to promote health,” Requejo Dominguez says.
These federal officials were most likely aware of the adverse effects of ivermectin and were motivated to distribute it anyway to garner political support, he says. “Government officials likely thought they would garner political support, votes, and re-elections if they provided the population with a hand-out in the form of a COVID-19 kit, and used a strategy that many popular leaders have used in the past: ‘Pharmaceutical Messianism,’” Requejo Dominguez says. “This is the populist tendency to offer simple solutions to complex problems in the context of medical populism, and it has been used previously in other epidemics such as HIV in South Africa in the early 2000s and the large Ebola outbreak in 2014-15.”
Requejo Dominguez began this study during his practicum in the MPH program, where he worked closely with study corresponding author Veronika Wirtz, professor of global health. In a follow-up study, the team will delve further to understand more specifically the officials and institutions responsible for this misleading and widespread guidance for people to consume ivermectin to treat COVID-19.
“One question that we are trying to answer is whether national medicines regulatory authorities and institutions developing clinical guidelines, such as health technology assessment institutions, were involved in the decision to distribute COVID-19 kits, or whether they were sidelined by elected political party officials,” says Wirtz. “Were their recommendations in line with other international World Health Organization, and if not, why?”
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