The health care market is failing to support new antibiotics used to treat some of the world’s most dangerous, drug-resistant “superbugs,” according to a new analysis by University of Pittsburgh School of Medicine
infectious disease scientists.
“New drugs against CRE address a major, previously unmet medical need and are critical to save lives. If the market can’t support them, then that is a chilling commentary on the future of antibiotic development,” said lead author Cornelius J. Clancy, M.D., associate professor of medicine and director of the mycology program and Extensively Drug Resistant Pathogen Laboratory in Pitt’s Division of Infectious Diseases
. “Without antibiotics against increasingly resistant bacteria and fungi, much of modern medicine may become infeasible, including cancer chemotherapies, organ transplantation and high-risk abdominal surgeries.”
Since 2015, five antibiotics against CRE have gained U.S. Food and Drug Administration
approval and trials have so far shown three of them to be more effective and less toxic than the previous first-line antibiotics. One of the developers of the new anti-CRE drugs — the biopharmaceutical company Achaogen — declared bankruptcy in April because of its steep losses.
“The prudent approach when fighting bacteria is to have multiple treatment options in the pipeline so that when resistance is inevitably developed to the current drug, a new antibiotic is waiting in the wings,” said Nguyen. “But we found that market prospects will become even more daunting if more anti-CRE drugs are approved, which is bad news for infectious disease physicians and, more importantly, our patients.”
Clancy and Nguyen propose a combination of “push” and “pull” incentives to encourage sustainable antibiotic development, starting with approval of the bilateral DISARM Act
, which currently is under consideration in Congress. DISARM would assure full Centers for Medicare and Medicaid Services
reimbursement for use of new antibiotics against resistant infections in hospitalized patients, rather than subsuming antibiotic costs into the discounted bundled payment hospitals receive. This would remove the disincentive hospitals face in using more effective but more expensive new agents rather than cheaper, older agents.
There also needs to be a cultural and behavioral change among hospitals and clinicians to encourage faster adoption and appropriate use of new antibiotics, the researchers said. Infectious disease physicians and pharmacists need to take responsibility for educating the wider clinical community about the importance of quickly updating and following guidelines on the best possible antibiotics to be using for their patients.
There was no funding for this study. Clancy and Nguyen report unrelated research funded by various pharmaceutical and medical device companies, detailed in the study manuscript.