The incidence of invasive fungal infections among hospitalized patients increased significantly during the COVID-19 pandemic, states the World Health Organization (WHO).
The WHO says fungal infections pose a growing threat, due to their increasing resistance to the four available classes of antifungal medications and the lack of alternatives being developed.
Fungal pathogens are ubiquitous and not much of a concern for healthy people. However, serious fungal infections afflict 300 million people worldwide, with 25 million at high risk for death or blindness, according to Global Action for Fungal Infections.
Many fungal infections are opportunistic and occur in patients who are immunosuppressed due to other illnesses. The WHO says those with cancer, HIV/AIDS, chronic respiratory disease, post-primary tuberculosis infection, and organ transplant recipients are at greatest risk.
The WHO released a list of fungal pathogens posing “the greatest threat to human health,” on October 25, 2022. The list includes 19 fungal pathogens prioritized based on unmet research and development needs, and perceived public health importance.
The WHO attributes the sudden rise in fungal infections to climate change and globalization.
“Emerging evidence indicates that the incidence and geographic range of fungal diseases are both expanding worldwide due to global warming and the increase of international travel and trade,” states the WHO.
COVID Connection?
One of the two primary drugs used to treat COVID-19 patients in hospitals is the drug Olumiant (baricitinib), which is a last resort treatment for acute rheumatoid arthritis (RA) and can reduce resistance to fungal infections.
The drug’s information sheet states: “Patients treated with baricitinib are at risk for developing serious infections that may lead to hospitalization or death,” including “invasive fungal infections, candidiasis and pneumocystosis.”
Nearly one million COVID-19 patients have been treated with baricitinib in approximately 15 countries, according to Eli Lilly, the drug’s developer. The WHO and other global health organizations recommended the use of Olumiant for hospitalized COVID-19 patients. The WHO claimed baricitinib “improved survival and reduced the need for ventilation, with no observed increase in adverse effects.”
Experts Question Drug’s Use
The U.S. Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for baricitinib to treat COVID-19 patients in certain circumstances, on November 19, 2020.
The EUA was met with skepticism. Four physicians expressed concerns about the clinical trial used to get the EUA in a December 5, 2020, article published by the website Insider LifeStyles. One researcher quoted, Ilan Schwartz, Ph.D., of the University of Alberta, called baricitinib a “nothing burger.”
“We’re talking about adding a drug that reduces the time to clinical improvement by one day, in a disease that takes weeks to recover,” Schwartz said.
However, Schwartz, now at Duke University, told Health Care News he was mistaken.
“I was very wrong, and I very much regret that comment,” said Schwartz. “The totality of evidence, which is quite robust, supports that baricitinib is lifesaving in carefully selected patients with severe COVID-19.”
Others have found baricitinib to be of minimal therapeutic value in treating COVID-19. For example, a 2021 top-level panel of medical professionals in India investigating the drug for the Indian Council of Medical Research found the clinical evidence unconvincing and recommended against its use, according to a May 14 article in The Economic Times.
In addition, Olumiant‘s high price tag has raised questions about why the drug was given an EUA. Olumiant costs $2,497.20 for a 30-day supply of 2 mg tablets or $4,994.40 for a 30-day supply of 4 mg tablets, according to Eli Lilly.
Stop the Spread?
David Gortler, a pharmacologist, and pharmacist who works as a drug safety epidemiologist and served as a senior advisor to the FDA commissioner from 2019 to and is a scholar and fellow the Ethics and Public Policy, questions the WHO’s push for new fungal infection drugs as well as its earlier recommendation for baricitinib.
“This is not the first time the WHO has given terrible, or flat-out wrong and highly political and wasteful policy advice, which is why the Trump administration correctly cut off their funding after they spread false information about COVID-19,” said Gortler. “While inherent and acquired resistance to antifungals has been reported worldwide, the focus should be on preventing the spread of [fungal] disease—not allowing the disease to spread, then developing a cure for it.”
Drug-resistant fungal infections have emerged in developing countries, says Gortler.
“Extensive public health research shows that these types of drug resistances exist because of inadequate or incompetent public health policies in immunocompromised patients in poorer countries,” said Gortler. “With rampant illegal immigration already a major problem in the United States, and with the end of Title 42 restrictions under Biden, it is almost a certitude fungal resistance will present itself as a major problem to Americans in the United States. Development of emerging antimicrobial drugs could also take away the focus of research into America’s leading causes of death, such as cancer, Alzheimer’s Disease, and heart disease.”
Public health policy should aim at preventing the spread of drug-resistant fungal infections, says Gortler.
“Throwing money at this problem and rushing to develop antifungal drugs, which have all had progressively terrible safety profiles resulting in serious morbidity and mortality, is not a practical solution,” said Gortler. “It will be a no-win situation as long as illegal immigration into the United States exists.”
Kevin Stone (kevin.s.stone@gmail.com) writes from Arlington, Texas. AnneMarie Schieber (amschieber@heartland.org), the managing editor of Health Care News, contributed to this article.