Just a couple of months ago, a highly contagious and often deadly fungal infection broke out in a Detroit-area health care facility, forcing the medical center to temporarily turn away all new patients.
The outbreak of Candida auris was extremely dangerous because of its ability to spread easily between hospitalized patients and its resistance to antifungal medications. This strain of C. auris had evolved into a “superbug” — one of an increasing number of strains of bacteria and fungi causing infections that are resistant to currently available antimicrobial treatments. Superbugs were linked to nearly 5 million deaths worldwide in 2019 alone. One of the next great medical crises is upon us.
As an infectious diseases specialist and a consultant to the Michigan Department of Health and Human Services regarding antimicrobial resistance, I have seen firsthand that we are in a race against the clock. The only way out is a speedy and robust response from our nation’s lawmakers to ensure clinicians and patients can fight resistant infections with a sufficient arsenal of antimicrobials. The discovery of antibiotics and other antimicrobials was one of the greatest triumphs in the history of medicine. Yet even as these treatments are saving millions of lives, dangerous pathogens evolve to find ways around them. Each use of an antimicrobial creates the opportunity for a pathogen to grow resistant to it.
Fifty years ago, bacteria took an average of 21 years to become resistant to treatments. Now, it can take just one year. In 2015, for example, the FDA approved a new antibiotic to treat pneumonia and abdominal and urinary tract infections resistant to other antibiotics. Within the same year, researchers discovered a new pneumonia-causing bacterium that was already resistant to the new antibiotic. This could be the story for the foreseeable future. It’s critical that we continuously research and develop new treatments, while managing their use to preserve their effectiveness. We have the technology to stay one step ahead of superbugs. But we don’t have the viable economic ecosystem to guarantee new generations of antimicrobials are developed and make it to patients. That’s what we need to fix.
With most medical treatments, companies can expect to generate a reasonable return on investment and recoup their research funding if the drug is approved by the FDA and the company successfully commercializes the product. In the case of antibiotics, however, widespread use that is associated with high-volume sales is exactly what we’re trying to avoid. Doctors must use all antibiotics judiciously and, at times, keep the newest ones in reserve for complicated infections that don’t respond to current treatments. We need to be careful about prescribing them widely in order to slow down the time it takes for pathogens to develop resistance. That makes it hard for antimicrobial researchers to stay in business. The FDA has approved 15 new antibiotics in the past decade, but the companies behind one-third of those drugs have since gone bankrupt or were sold at a near-zero valuation. A new, unique market model for advanced antimicrobials is necessary.
Congress is now considering the PASTEUR Act, a bipartisan bill that would address challenges specific to antimicrobial development and commercialization. Right now, the federal government reimburses antimicrobial makers based on the quantity of antimicrobials sold. PASTEUR would change this model to a subscription-style mechanism, so that the federal government could pay upfront for access to a new, FDA-approved antimicrobial. This model would stimulate antimicrobial development and help meet a critical public health need. With the support of this new contract from Washington, the antimicrobial maker would manufacture and supply as much of the new treatment as necessary for patients. By making sure that antimicrobial makers don’t have to rely on the volume of drugs sold to recoup their investment, PASTEUR would help reinvigorate the antimicrobial pipeline to ensure a steady supply of new antimicrobials. Importantly, PASTEUR would increase much-needed resources for hospitals to guide appropriate antimicrobial use and prevent the development of resistance and spread of resistant infections. Such a public-private partnership would help us fight superbugs here in Michigan and elsewhere.
Anurag Malani, M.D., is the medical director of antimicrobial stewardship, hospital epidemiology and special pathogens at Trinity Health St. Joseph Mercy Ann Arbor.
Read the full op-ed in The Detroit News here.