Since Alexander Fleming accidentally discovered penicillin 95 years ago, antibiotics have been a foundational part of medical care and paved the way for much of modern medicine.
These “miracle drugs” have saved countless lives and provided doctors with tools to combat infectious diseases from cholera to pneumonia, which were once among the leading causes of death. But all of this tremendous progress is unraveling, taking us back toward the pre-antibiotic era.
The overuse of antibiotics is decreasing their effectiveness through a phenomenon known as antimicrobial resistance, or AMR. It is spreading fast and is one of the World Health Organization’s top 10 public health threats. By 2050, it’s projected that as many as 10 million people worldwide could die as a result of AMR each year — far outpacing the human impact of the COVID-19 pandemic — with a cost of $100.2 trillion to the global GDP. Drug-resistant infections sicken at least 2.8 million people annually in the United States. In addition to the health threat posed by AMR, the national estimate of health care costs associated with just six of the worst multidrug-resistant infections is reported to be more than $4.6 billion annually.
Beneath every fact and figure about AMR lies very real patients whose lives are in jeopardy. Recently one of us oversaw the care of a child who underwent treatment for cancer and subsequently a bone marrow transplant. He developed serious bacterial and fungal infections — both of which were resistant to all available antimicrobials. His care team attempted off-label combinations of powerful antimicrobials, aiming to make the best use of the tools at our disposal to overcome the antimicrobial resistance. Unfortunately, we did not have adequate tools, and this child did not survive.
Antimicrobial resistance is a complex problem that requires large-scale action from policymakers, pharmaceutical companies, payers, hospitals and health systems. This is a challenge that both Democrats and Republicans share. Drug-resistant infections affect us all, no matter our political leaning, race, gender or geography. As a secretary of Health and Human Services and FDA commissioner in different eras of American politics and for different parties, and as an infectious diseases physician who sees firsthand the devastating effects of AMR on patients, we all agree that combatting AMR must be a policy priority for everyone.
It starts with reforming the way we invest in antibiotic development and pay for the appropriate use of antibiotics.
We’ve hit a wall in developing essential drugs against the spreading risk of resistant organisms over the past few decades, leaving doctors without the tools they need to provide lifesaving care to patients. There are currently less than 50 antibiotics in clinical development worldwide.
America must ignite a second antibiotic development revolution if it hopes to make headway in the fight against AMR. This requires a fundamental rethink about how the federal government pays for novel drug research and development. The traditional model of paying drugmakers for the volume of medicine used doesn’t make sense for antibiotics. These drugs are used for a very short period of time compared to drugs for chronic conditions, and antibiotics must be used very judiciously to protect their effectiveness. Transitioning to a subscription-style business model that assures a needed antibiotic will be there to combat resistance, while providing a predictable return on investment regardless of the volume of antibiotics used, would reduce the economic barriers that currently stymie the creation of new antibiotic treatments.
This is the approach of the bipartisan Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act in Congress.
Importantly, the PASTEUR Act is explicitly designed to deliver truly innovative antibiotics that will provide meaningful clinical benefits for patients and address critical unmet needs. In fact, antimicrobials must meet stringent criteria to demonstrate real-world impact on resistance to fulfill the subscription contract under PASTEUR.
Health care facilities and clinicians also need to use antibiotics appropriately to prevent the development of resistance and ensure antibiotics remain effective for as long as possible. Hospitals and long-term care facilities are already required to have antibiotic stewardship programs, which are programs typically led by experts in infectious diseases to ensure these drugs are used correctly. Unfortunately, many health care facilities don’t have the resources to fully implement stewardship programs. The PASTEUR Act would provide those hospitals with the greatest need additional funds to ensure that all patients can benefit from antibiotic stewardship.
Antimicrobial resistance is taking us back in time to an era when simple injuries or minor illnesses were deadly and when advanced surgeries were unthinkable due to the risk of infection. The threat of antimicrobial resistance is real, and the consequences of inaction will be a devastating blow to modern medicine unless policymakers, public health, health care providers and pharmaceutical companies commit to sustained, collaborative efforts and investment toward solutions.
Donna Shalala served as U.S. secretary of Health and Human Services for eight years. She is currently Trustee Professor of Political Science and Health Policy at the University of Miami.
Dr. Mark McClellan, MD, Ph.D., is a former administrator of the Centers for Medicare & Medicaid Services and former commissioner of the U.S. Food and Drug Administration. He currently is the Robert J. Margolis Professor of Business, Medicine and Policy and founding director of the Duke-Margolis Center for Health Policy at Duke University, as well as independent board member of Alignment Health Care, Cigna, and Johnson & Johnson.
Dr. Lilian Abbo, MD, is currently the associate chief medical officer for infectious diseases at Jackson Health System, and Professor of Clinical Infectious Diseases at the University of Miami Miller School of Medicine and the Miami Transplant Institute.