More Efforts Needed to Combat Antimicrobial Resistance, Lawmakers Told

WASHINGTON -- Antimicrobial resistance remains a serious problem and action is needed on several fronts, including more antimicrobial drugs and diagnostics, and an increase in the infectious disease workforce, witnesses said Friday at a House hearing.

"According to experts, the pipeline of antibiotics in development is insufficient to tackle this growing threat, notably because of the inadequate return on investment for drug companies," Mary Denigan-Macauley, PhD, director of healthcare at the Government Accountability Office, said at a House Energy & Commerce Oversight and Investigations Subcommittee hearing on antimicrobial resistance as an emerging public health threat. "This is concerning because we reported in 2020 that no new classes of antibiotics for human use have been approved since the mid-1980s, despite government incentives."

In addition, improved diagnostics are needed, said Amy Mathers, MD, an infectious disease specialist and associate professor of medicine at the University of Virginia School of Medicine in Charlottesville. "I recently had two unique patients come to [my hospital], both with severe bacterial infections requiring ICU care," she said. "Both were initially prescribed powerful antimicrobials -- we had to guess at the type of infections that each one of them had while waiting for test results."

"One patient was exposed to broad-spectrum antibiotics for almost 3 days before testing showed a more targeted antibiotic would have worked," she continued. "The other patient had a bacteria which was highly resistant and did not get effective antimicrobials for almost 2 days. We need investment in research and rapid diagnostics, and approaches to more quickly reduce antimicrobial overuse and target AMR [antimicrobial resistance] pathogens when needed to treat infections."

Workforce shortages are another problem, according to Amanda Jezek, senior vice president for public policy and government relations at the Infectious Diseases Society of America. "Nearly 80% of U.S. counties lack an infectious disease physician, and only 56% of infectious disease physician training programs [were] filled in 2023," she said.

"Financial barriers pose huge challenges to infectious disease recruitment," Jezek added. "Infectious disease physicians are among the lowest-paid medical specialists, and high levels of medical student debt often drive physicians to higher paying specialties." She recommended that Congress address the student debt issue, increase physician pay, and provide sufficient training resources.

Committee members didn't need much convincing on the problem. Rep. Kathy Castor (D-Fla.), the committee's ranking member, noted that a 2019 CDC report "identified 18 bacteria and fungi that are showing evidence of resistance to currently available treatments. And that trend is expected to rise."

"While we've made some strides in preventing and treating antibiotic resistance, there is ground to regain as we emerge from 3 years of a pandemic that put unprecedented strains on the entire healthcare system and rolled back some of that progress," she said. "The effort to combat antibiotic resistance requires a strong coordinated response involving both private- and public-sector stakeholders." Castor called for "consistent" investment in scientific research, adding, "We need scientists to study these threats to help us prepare against them, and they should be able to do so free of political interference designed to malign or ban certain types of public health research."

Committee chair Morgan Griffith (R-Va.) agreed that antimicrobial resistance places "a heavy burden on our nation's healthcare system," but expressed concerns about the federal government's efforts in this area. "While I'm pleased to see we are addressing this style of pandemic, it is Congress's duty to provide oversight into how dollars are being spent," he said. "Have the various programs found any success yet, and which of these programs are duplicative? As we consider potential solutions to confront these antimicrobials, we must consider the work that has already been done and the dollars already being spent to combat this crisis and look for ways that will yield more successful outcomes."

Committee members also heard from Kevin Outterson, LLM, executive director of CARB-X, an organization supported by the federal government, the U.K., and private organizations that has invested over $400 million in 6 years in companies developing new antibiotics and diagnostics. "We've had 12 therapeutic products that have gone into clinical human trials," and two diagnostic products supported by CARB-X are now on the market in Europe, he said.

The rest of the antibiotic market, however, isn't faring so well. "In the last decade, seven antibiotics have come to the market sponsored by small companies -- seven," he said. "All of those companies, 100% of them, have gone either bankrupt, or are the economic equivalent of their R&D [research and development] -- investors losing their shirts, even after approval from the FDA. No wonder that every expert report agrees that the clinical pipeline of antibiotics is in terrible shape."

Outterson touted the benefits of a "subscription" model for paying for new antimicrobials, in which companies get a periodic payment for their drugs regardless of how much they sell. "If Congress creates a subscription program, Americans will get the new antibiotics we need; they'll be sitting on the shelf ready to go," he said. "The companies will also get what they need, which is not bankruptcy." Outterson added that the PASTEUR Act, introduced in 2021 by Rep. Michael Doyle (D-Pa.) would implement such a model for selected drugs; the bill garnered 65 cosponsors.

Rep. Frank Pallone (D-N.J.), ranking member of the full Energy & Commerce Committee, said he was worried about the declining level of trust in healthcare providers and how it may be affecting adherence to antimicrobial regimens.

Mathers agreed. "Personally, I feel it," she said. "I feel mistrust from patients, and it feels like somebody else is at the bedside -- I don't know if it's social media or who [it is], but there's just a lot of misinformation that's been out there that has impacted trust. That's making it harder to take good care of patients." Because public health messaging on COVID changed course many times, "I think that caused mistrust, because maybe we overpromised and under-delivered in some areas."

Comment