Threat of Drug-Resistant Bacteria Will Grow Unless Congress Steps In, Experts Say

A pharmacy technician counts out a prescription of antibiotic pills in Miami, Fla., on Aug. 7, 2007. Joe Raedle/Getty Images

The increasing public health threat of antimicrobial resistance (AMR) is already putting vulnerable patients at risk, but Congress could step in to help, experts say.

Testifying on July 11 before the Senate Health, Education, Labor, and Pensions Committee, Christine Ann Miller, the president and CEO of Melinta Therapeutics, noted that AMR is a very current concern.

“In the United States, AMR is the third-leading cause of death behind heart disease and cancer,” said Ms. Miller, whose company develops novel antibiotics to treat antibiotic-resistant infections.

“Things have gotten worse since the pandemic in 2020. Hospital-acquired, drug-resistant infections and deaths jumped 15 percent as COVID erased years of progress in the fight against superbugs,” or bacteria that have become resistant to antibiotics.

The source of the dilemma, Ms. Miller stated, isn’t a lack of innovation or the result of regulatory red tape, but rather a commercial marketplace problem that is “fundamentally unique to antimicrobials, driven by reimbursement and access challenges.”

Those roadblocks, she said, often drain biotech companies of their funds even after their products have been approved. However, she added that the federal government could fix the problem by enacting reimbursement reforms and implementing incentives to counter the risks of developing new antibiotic drugs.

Calling on Congress to step in, she added, “Every year we wait to address this crisis is another year more patients are at risk for losing their lives.”

The Fragility of Time

For Melanie Lawrence of Fairhaven, Massachusetts, who is living with cystic fibrosis, the threat of antimicrobial resistance is dire.

A progressive and incurable genetic disease, cystic fibrosis causes the body to produce thick, sticky mucus that can lead to blockages, infections, and damage to affected organs. Those born with the condition today have an estimated life expectancy of 56 years, according to the Cystic Fibrosis Foundation.

That’s why Ms. Lawrence, 43, is determined to live every moment to its fullest.

“Every day, I spend hours taking medications, doing physical therapy, exercise, meditation, breath work, all while raising a very active 12-year-old, trying to create as many meaningful memories with him as I can,” she told committee members.

After years of treatment with various antibiotics, the bacteria in Ms. Lawrence’s lungs have become resistant to nearly all antibiotics—except for tobramycin. Unfortunately, due to hearing and kidney damage that she suffered during a clinical trial, that drug is also off the table.

Now, managing her symptoms and maintaining the best possible quality of life are her goals.

“Without the security of effective antibiotics to help me heal, I find myself living with chronic fear and anxiety about when the bacteria residing in my lungs will act out or when another infection will take me away from truly living,” she said. “On a deeper level, I am often navigating a humbling loss of control, loss of autonomy, and a deep subconscious fear of death—of leaving my son without his primary caregiver, the person who knows him best and loves him without abandon.

“My body is both my biggest ally keeping me alive and fighting off these infections while also being my biggest threat and trying to kill me from the inside. And yet living with CF has been a gift, not a curse. It has opened my eyes to the fragility of time and the importance of connection, and that is a gift we should all be so lucky to receive while we are healthy and able to appreciate it rather than when it’s too late.”

PASTEUR Act

According to the Centers for Disease Control and Prevention (pdf), more than 2.8 million antibiotic-resistant infections occur annually in the United States, killing more than 35,000 people.

In April, members of Congress introduced a bill to address the issue by encouraging the development of new antibiotics, boosting their availability, and improving national reporting on appropriate antibiotic use.

The legislation—the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act—has received bipartisan support in both chambers.

“The PASTEUR Act uniquely values antibiotics for their value, not for their use, so it delinks any incentive to overuse antibiotics, and it focuses on the most needed antibiotics for the most resistant infections,” noted Dr. Helen Boucher, dean and professor of medicine at the Tufts University School of Medicine.

The bill would also establish a subscription-based payment model, offering antibiotic developers upfront payment in exchange for access to their drugs.

“There are clear criteria the developer needs to meet to get this benefit of this subscription reimbursement ... and it’s linked to stewardship, which is very, very important to ensure that we clinicians use the antibiotics in the best way possible so that they’re preserved for as long as possible,” Dr. Boucher said. “And this is felt to be a much-needed first step in getting us back to a healthy economic framework for antibiotics.”

Also voicing her support for the measure, Ms. Miller held that fostering ongoing antibiotic development and innovation would be vital to saving patients’ lives.

And Ms. Lawrence, echoing that sense of urgency, added: “This is a global problem that will affect you at some point in time. So, how proactive do you want to be?”