The U.S. cannot begin to tackle the problem of antimicrobial resistance without first changing the way antibiotics are reimbursed, experts argued during a Senate hearing on Tuesday.
“Antibiotics … are curative life-saving drugs,” said Helen Boucher, MD, of Tufts University School of Medicine in Boston, who spoke on behalf of the Infectious Diseases Society of America at the Senate Health, Education, Labor, and Pensions Subcommittee on Primary Health and Retirement Security hearing.
Their development has transformed modern medicine, enabling advances such as chemotherapy, organ transplants, Cesarean sections and other complex care. These procedures and treatments carry a heightened risk of infection, but antibiotic support makes them possible, explained Boucher.
Yet antimicrobial resistance jeopardizes access to all of these therapies owing to a lack of new antimicrobials, she said, recalling a patient with leukemia who survived multiple rounds of chemotherapy only to come down with an infection for which there were no treatments.
“[T]o watch her go from sitting in the chair to sicker and sicker, and dead in a number of days, is beyond heartbreaking,” she said.
In 2019, antimicrobial resistance was responsible for approximately 1.27 million deaths globally, and it contributed to nearly 5 million deaths worldwide, Boucher added.
Melanie Lawrence, 43, a healthcare advocate and single mother from Fairhaven, Massachusetts, who has cystic fibrosis, has relied on antibiotics her whole life.
Early on, she could trust in a 2-week course of oral antibiotics to keep her safe. But as bacteria in her lungs “began outsmarting the antibiotics,” Lawrence said she came to depend on larger and larger doses of IV antibiotics and longer and longer hospital stays — at the age of 18, as much as 5 weeks.
After 2 decades of this, the threat of antibiotic resistance loomed. And the side effects of so many powerful antibiotics led to bleeding in her lungs, blood clots, kidney damage and tinnitus, as well as a “humbling loss of control, loss of autonomy, and a deep subconscious fear of death,” especially of leaving behind her 12-year-0ld son.
The bacteria in her lungs are currently resistant to almost every antibiotic, except tobramycin — an aminoglycoside antibiotic, which she can’t take because it has already proven toxic to her kidneys and hearing.
“My focus is to manage my symptoms and maintain the best quality of life possible, without the security of effective antibiotics to help me heal,” Lawrence said.
While she hopes to someday see her son graduate college or even become a grandparent, those are dreams she said she doesn’t dare acknowledge because they feel “so out of reach without new antibiotics.”
Subcommittee Ranking Member Roger Marshall, MD, (R-Kan.) said one clear obstacle to developing antimicrobials is that, unlike treatments for diabetes or Alzheimer’s that could be prescribed to millions of patients, these newer antibiotics will only be used only “a handful of times … and it just makes the economics of this next to impossible.”
Christine Anne Miller, CEO of Melinta Therapeutics, agreed.
Public and private partnerships are working to address antimicrobial resistance. For example, global nonprofit CARB-X (Combating Antibiotic Resistance Bacteria Biopharmaceutical Accelerator) has helped by “reinvigorating the pipeline,” she said. However, some of the products are a long way from reaching the market.
There isn’t an innovation problem, nor is there an FDA approval problem, Miller said.
“What we do have is a commercial marketplace problem that is fundamentally unique to antimicrobials, driven by reimbursement and access challenges,” in which biotech companies run out of funding while trying to provide patients access to their life-saving therapies, she said.
Reforming antimicrobial reimbursement can be done by establishing “pull incentives”: new payment mechanisms that de-link payment from the volume of antimicrobials used and instead tie it to value, Miller suggested.
Boucher also supported this approach calling the implementation of pull incentives “the most important thing this subcommittee can do.”
The Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act (PASTEUR) Act of 2021 could provide such incentives through, for example, a subscription model that would pay for treatments based on their value, not their volume, and in doing so drive greater investment in research and development of new antibiotics, Boucher said.
More specifically, the bill would allow a drug company with an FDA-approved antibiotic to request that HHS designate the drug as a “critical need antimicrobial,” which would allow the agency to enter into a subscription contract for that drug.
However, as Marshall noted, “human overuse” is a primary driver of antimicrobial resistance.
While federal legislation has helped to drastically reduce the use of antibiotics in agriculture, “We — meaning physicians, nurse practitioners and PAs [physician assistants] — need to look in the mirror … and pay more attention to this as well,” he added.
In 2016, about half of all hospitalized patients were prescribed antibiotics and about 30-50% of those prescriptions were inappropriate, Boucher said.
In written testimony, Miller noted that new payment mechanisms would also provide support for antimicrobial stewardship programs in rural safety net and critical access hospitals.
Turning to a related issue, both senators and witnesses pointed out the impact of climate change on antimicrobial resistance.
Recalling the “four hottest days on planet Earth ever recorded” just last week, Subcommittee Chairman Ed Markey (D-Mass.) noted that a “warmer planet will turn our coastlines and waterways into petri dishes. Diseases will spread faster and new strains will spread farther.”
“The only answer is to act now,” he added. While he did not mention the bill by name, Markey re-introduced the Protecting Moms and Babies Against Climate Change Act, alongside Rep. Lauren Underwood, MSN, MPH, (D-Ill.) in May.
Another challenge in treating antimicrobial resistance is the shortage of infectious diseases (ID) physicians, she argued.
“Patients with serious infections do better when they are treated by an ID physician,” Boucher said, but four out of five counties lacked access to these specialists in 2022. That same year only 56% of infectious diseases training programs for physicians filled their positions.
Infectious diseases physicians are among the lowest paid across all specialties, Boucher pointed out.
She urged Congress to help to sustain and grow the infectious diseases workforce through improved reimbursement, efforts that address student debt and establishing resources to support training and early career development.
“We need to be able to attract people to do this work, so that our children and their children will be protected,” Boucher said.
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Shannon Firth has been reporting on health policy as MedPage Today’s Washington correspondent since 2014. She is also a member of the site’s Enterprise & Investigative Reporting team. Follow
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