Experts in infectious diseases and antimicrobial resistance (AMR) were on Capitol Hill today to discuss the rising threat of drug-resistant pathogens to the US healthcare system and federal efforts to address the issue.
At a hearing held by the House Energy and Commerce Committee, the experts focused on the need for new antibiotics and antibiotic stewardship, more and better diagnostic tests, more infectious disease (ID) professionals, and better data on the prevalence of AMR in US healthcare facilities.
Lawmakers on the committee also asked about deficiencies in the federal response, duplicative efforts, and whether federal funding for AMR has resulted in any notable achievements.
"While there is no easy solution to the problem of AMR, we are committed to exploring potential solutions to address this public health crisis," Rep. Morgan Griffith (R-Va.), chair of the Subcommittee on Oversight and Investigations, said in his opening comments.
Better data, diagnostic tools needed
Among the witnesses at the hearing was Mary Denigan-Macauley, PhD, of the US Government Accountability Office (GAO), author of a report examining the steps that federal agencies have taken to address AMR since the creation of the National Action Plan for Combating Antibiotic-Resistant Bacteria in 2015. That plan called for federal agencies like the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services to strengthen surveillance, advance the development of new antibiotics and diagnostics, and promote antibiotic stewardship.
The report, which was published in March 2020 and summarized in today's testimony, found that work is needed in all three areas, particularly surveillance. One of the biggest challenges, Denigan-Macauley said, is that the lack of surveillance data means the precise magnitude of the AMR problem is not known.
"While we have estimates that antimicrobial resistance has killed more than a million people worldwide and infected many more, the true extent of the problem is not known because data here in the US and overseas is not complete or timely," she told the panel.
The GAO report noted that while CDC has expanded surveillance of infections for certain antibiotic-resistant bacteria, the agency still faces challenges in obtaining and reporting complete data. As an example, it noted that the CDC's primary surveillance system for drug-resistant gonorrhea, which is considered an urgent AMR threat, represents only 1% to 2% of reported US cases.
In addition, Denigan-Macauley pointed out that reporting of antibiotic-resistant infections to a national database run by the CDC remains optional for most hospitals, with the exception of those run by the Veterans Administration and the Department of Defense.
"That's an area where we need to engage more vigorously on our side," said Rep. Gary Palmer (R-Ala.).
New legislation set to take effect in 2024 that requires certain hospitals that receive money from the Centers for Medicare & Medicaid (CMS) to report data on resistant infections to the CDC will help, Denigan-Macauley said, but more is needed.
"Better data and diagnostic tools are need to understand the magnitude of the problem and monitor progress," she said.
The need for new and better diagnostics was also highlighted by Amy Mathers, MD, an associate professor at the University of Virginia Medical School who focuses on antimicrobial stewardship.
"Improved diagnostics is critical in preventing the continued overuse of antimicrobials, as well as maximizing the treatment of patients with AMR infections," said Mathers, who was also representing the views of the American Society of Microbiology.
That includes tests that can rapidly distinguish bacterial from viral infections as well as those that can more quickly determine the specific bacterial species causing an infection. Current methods to identify bacterial pathogens can take several days.
Better data and diagnostic tools are need to understand the magnitude of the problem and monitor progress.
Mathers cited two recent patients of hers with severe infections caused by unidentified bacteria who were initially prescribed broad-spectrum antibiotics while waiting several days for test results. In one case, the patient had an infection that required a more targeted antibiotic. In the other, the patient was treated for 2 days with the wrong antibiotic because the infection was resistant.
"We need investment and research in rapid diagnostics and approaches to more quickly reduce antimicrobial overuse and target AMR pathogens when needed," she said.
The broken antibiotic market and ID workforce shortages
Kevin Outterson, JD, executive director of the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), spoke to the need for a different payment model to incentivize development of new antibiotics, citing the financial challenges that have led many large pharmaceutical to abandon antibiotic development and resulted in bankruptcies for several smaller companies.
The problem, Outterson explained, is that new antibiotics need to be carefully used to prevent development of resistance, and therefore don't generate much profit.
"It's no wonder that every expert agrees that the clinical pipeline for antibiotics is in terrible shape," Outterson said. "We must change the way that we pay for antibiotics."
Outterson's comments came a day after a bipartisan group of US lawmakers reintroduced the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act, a bill that aims to fix the problem. The bill, which was previously introduced in 2020 and 2021 but has never received a vote, would create a subscription-style payment model, under which the government would pay companies up front for access to critically needed new antibiotics for drug-resistant infections.
In return, the antibiotics would be free for patients covered by federal health programs, and companies would have to support their appropriate use.
Outterson said that paying for the value of antibiotics to the healthcare system, and de-linking companies' profits from the volume of antibiotics sold, will keep developers of new antibiotics from going bankrupt and encourage the development of the type of truly innovative antibiotics that Americans are going to need as AMR rises.
"By restoring some common sense to the market for antibiotics, subscriptions will bend the curve toward innovation," he said.
Outterson's comments were echoed by Amanda Jezek of the Infectious Diseases Society of America, who added that passing the PASTEUR Act would also help antimicrobial stewardship efforts. Jezek said that while many US hospitals can meet CMS stewardship requirements on paper, they frequently lack the resources and staff necessary to "extend the benefits of stewardship to all patients."
Jezek cited the high rate of antibiotic use in COVID-19 patients in 2020—despite the fact that COVID-19 is caused by a virus—as an example of why more resources are needed for antimicrobial stewardship.
Jezek also said the rise of AMR, and the threat it poses to public health, underscores the need for more ID professionals in the United States. She noted that nearly 80% of US counties lack an ID physician, who are among the lowest paid medical specialists.
"The infectious diseases workforce that is needed to care for patients with resistant infections is in crisis," Jezek said. "Congress must take steps to ensure the availability of an expert ID workforce to combat AMR."
Mathers said the need extends beyond ID physicians. "We need infection prevention personnel, epidemiologists, and clinical microbiologists," she said.
The infectious diseases workforce that is needed to care for patients with resistant infections is in crisis.