March 15, 2022
RE: Growth of Drug-Resistant Fungi Threatens Health in the U.S.
Dear Members of Congress and health legislative staff:
We write to you out of concern for the growing threat of drug-resistant fungal infections here in the United States and internationally. Recent findings suggest that front-line medications no longer work for certain kinds of fungal infections here in the US and Americans with severe COVID-19 are particularly vulnerable. Fungal drug resistance also contributes to other serious health threats like antimicrobial resistance. When left untreated, invasive fungal disease is nearly always associated with death. Fungal infections are a global threat that is becoming increasingly severe. Annually, over 150 million severe cases of fungal infections occur worldwide resulting in approximately 1.7 million deaths.[1] With these considerations in mind, the federal government should prioritize antifungal and antibiotic drug development as a priority for pandemic preparedness to get ahead of these problems.
The global emergence of antifungal resistance is a growing threat to public health. Research released just before the onset of the COVID-19 pandemic suggest that the threat of drug-resistance for patients with a fungal infection is increasing.[2] This threat is present and all too real in the United States. As an example, the US burden of invasive candidiasis including bloodstream infection is more than 70,000 people, with a global burden of more than 750,000 people.[3] Transplant recipients, diabetes patients, premature infants, and patients in intensive care are at highest risk of contracting these types of infections. About 7% of all Candida blood samples tested at CDC are resistant to the antifungal drug fluconazole; in parallel, resistance to echinocandins (the other class of drug used to treat Candida infections) also appears to be increasing, especially in the species Candida glabrata. Patients with Candida infections that are resistant to both fluconazole and echinocandin drugs have very few treatment options. In particular, concern is rising over the growing threat of the fungus Candida auris in the United States. In fact, roughly 90% of Candida auris samples were found to be resistant to fluconazole and as many as one-third resistant to other drugs that can treat the infection. [4]
We also learned some disturbing news in 2021 that the threat is getting worse.
The CDC released findings in June 2021 that “researchers have for the first-time reported cases of people carrying or infected with strains of the dangerous fungus Candida auris that were resistant to all major classes of antifungal drugs before any treatment. The CDC reported on five cases, three in Washington, D.C., and two in Texas. The agency also reported evidence of some transmission of the strains within health facilities. That there are now so-called pan-resistant cases in people who had never been treated with antifungal drugs is particularly unnerving, experts said.”[5] Late last year, the CDC also released a warning that “people with severe COVID-19, such as those in an intensive care unit (ICU), are particularly vulnerable to bacterial and fungal infections.” In fact, one study found that COVID-19 and influenza patients who are admitted to intensive care or developed acute respiratory distress syndrome are at an increased risk for secondary life-threatening invasive aspergillosis infection. [6] These fungal co-infections are being reported with increasing frequency and can cause severe illness and death.
We, the undersigned, stand united in our efforts to protect American patients from this growing threat. New drug and vaccine development, along with improved diagnostic and other proper stewardship efforts, will be needed to head off what we fear is another emerging pandemic health threat – and should be prioritized by Congress this year. The PASTEUR Act, sponsored by Senator Bennet, Senator Young, Representative Doyle, and Representative Ferguson, would allow us to take a big step forward in the fight against fungal infections, and we urge Congress to prioritize this legislation as part of pandemic preparedness legislative efforts. In addition, the FORWARD Act, sponsored by Representative McCarthy, Representative Bass, Representative Schweikert, Representative O’Halleran, Senator Kelly, Senator Sinema, and Senator Feinstein includes meaningful proposals for desperately needed work on other medically threatening fungi. Taken together, these pieces of legislation represent important and effective actions to address the growing fungal infection crisis.
Sincerely,
Abgenics Life Sciences Pvt Ltd
Acurx Pharmaceuticals
Aequor Inc.
Amgen
AMR.Solutions
Analytika
Antibiotic Resistance Action Center, the George Washington University
Anti-infectives Consulting
Appili Therapeutics, Inc.
Aridis Pharmaceuticals
Arixa Pharmaceuticals
ARM! Antimicrobial Research Matters!
Bactria Pharmaceuticals, LLC
Basilea Pharmaceutica International Ltd
bioMerieux Inc.
Biotechnology Innovation Organization (BIO)
Center for Emerging and Neglected Diseases, UC Berkeley
Centre to Impact AMR
Children’s Memorial Hermann Hospital
Connecting Pharma BV
CUBRC, Inc.
Cystic Fibrosis Foundation
Developing Novel Antibiotics Consultancy
Doctor of Choice
Eastern Michigan University
F2G, Inc.
Felix Biotechnology
Gravitas Therapeutics, Inc.
Hospital Maisonneuve Rosemont
HealthyWomen
Hearts Consulting Group, LLC
Hill Scientific and Public Affairs, LLC
Houston Methodist Hospital
Infectious Diseases Society of America (IDSA)
Institute for Advanced Clinical Trials for Children
Institute for Life Science Entrepreneurship
Instituto de Salud Carlos III
Invitris
JMI Laboratories
Kathera Bioscience, Inc.
KAU
Labcorp
RNA Medicines, LLC
McCarthy Consultants, Inc.
Medical University of Vienna
Memorial Hermann
Midwestern University
Monash University
Mycoses Study Group Education and Research Consortium
Mycovia Pharmaceuticals
National Association of Pediatric Nurse Practitioners
Neoculi Pty Ltd
Northeast Pharmaceutical Services, LLC.
Novo Holdings
NTM Info & Research
Omnix Medical
Partnership to Fight Chronic Disease (PFCD)
Partnership to Fight Infectious Diseases (PFID)
Pediatric Infectious Diseases Society
Peggy Lillis Foundation
Q2Pharma
Rostra Therapeutics Ltd
Rutgers University
Scientific and Medical Affairs Consulting
SCYNEXIS
Sepsis Alliance
Sequella, Inc
Shionogi Inc
SIDR Program
Stochos Therapeutics
Stuart B. Levy Center for Integrated Management of Antimicrobial Resistance at Tufts (Levy CIMAR)
Sydney Institute of Infectious Diseases, University of Sydney
Technical University of Munich
The Gerontological Society of America
The Valley Fever Institute at Kern Medical
UC Davis Health
University College London Hospitals, London, United Kingdom
University of Alabama at Birmingham
University of Kansas Medical Center
University of Leeds; Leeds Teaching Hospitals NHS Trust
University of Michigan-Ann Arbor
University of Nizwa
University of Notre Dame
University of Strathclyde
University of Texas Austin
University of Texas Health Science Center at Houston
University of Wisconsin
University of Queensland, Institute for Molecular Bioscience
US Citizen
VA Boston
Valley Fever Center for Excellence, University of Arizona College of Medicine-Tucson
Valley Fever Solutions
Venatorx Pharmaceuticals, Inc.
Washington University in St. Louis
Zavante Royalty Corporation
Individuals:
Gerard Sheehan
John Freund, former CEO of Arixa Pharmaceuticals
Kelly Wright
Kevin Outterson, Boston University
Peter Pappas, MD FACP
Royce H. Johnson, MD FACP
John Perfect, MD
Greg Basarab
Samuel J. Borgert
[3] Toda M; Williams SR; Berkow EL. et al. Population-Based Active Surveillance for Culture-Confirmed Candidemia — Four Sites, United States, 2012–2016. US Department of Health and Human Services/Centers for Disease Control and Prevention. MMWR / September 27, 2019 / Vol. 68 / No. 8
[6] Rutsaert L, et al. COVID-19-associated invasive pulmonary Aspergillosis. Ann Intensive Care. 2020;10(1):71. https://doi.org/10.1186/s13613-020-00686-4
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