Antimicrobial Resistant Infections: The Next Predictable Global Health Catastrophe

The world’s foremost public health experts had been warning for years that a pandemic is a “predictable catastrophe” – one that had had happened so many times in human history it isn’t a matter of if but when the next pandemic would strike. In the early days of what would become the Covid-19 pandemic, one of the first questions scientists knew to ask was: “is this bacterial or viral?”

As we enter 2022, with some public health experts reporting that the SARS-CoV-2 virus is transitioning to a lower-level ‘endemic’ presence in America, we are on the precipice of another predictable catastrophe that public health agencies CDC and WHO have also been warning about for years – this one principally bacterial and caused by antibiotic microbial resistance (AMR).

In 2019, one prominent report estimated that AMR would lead to 10 million deaths annually by 2050 if no action is taken. Worse still, AMR may have been exacerbated during the COVID-19 pandemic as hospitalized patients at high risk for secondary infections from the use of ventilators or weakened immune systems were given large amounts of antibiotics[i]. Initial data suggest that one in seven patients hospitalized with COVID-19 acquired dangerous secondary bacterial infections.[ii]

AMR is a natural process that occurs when bacteria and other pathogens change in ways that neutralize the medicines used to treat them. The most concerning situation is that the pace of emerging multi-drug resistant bacteria and their ability to share the genetic programing to become drug resistant vastly outpaces the world’s collective R&D to keep up. Nearly all the antibiotics used today are derivative of classes of antibiotics discovered more than 30 years ago.

Lilly cares deeply about addressing this global health threat. We helped lead the industry effort to establish the AMR Action Fund which has committed more than $1 billion to bring 2-4 new antibiotics to patients by 2030.

However, industry efforts alone will not be enough to prevent this crisis. Antibiotic R&D presents specific scientific, regulatory, and economic challenges. Novel antibiotics are undervalued relative to the benefits they bring to society. Uptake of new antibiotics is slow since their usage is managed to preserve effectiveness. Overuse of antibiotics increases the risk of spawning AMR. Current reimbursement systems can discourage appropriate use of novel antibiotics, leading to overuse of older antibiotics, heightening the potential for AMR risk.  A new report in Health Affairs quantifies this market failure: of the 17 new antibacterials FDA-approved since 2010, four have bankrupted their sponsors; one was auctioned for pennies; two others severely challenged their companies with little future or making up their R&D costs; and seven have “destroyed or severely damaged economic value.” 

There is broad academic, policy, and industry agreement that market incentives and reimbursement reforms are needed to create a robust and sustainable ecosystem for antimicrobial research, development, and commercialization.

To that end, the bipartisan Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act was introduced in Congress in June 2021. PASTEUR includes needed reforms that will encourage innovative drug development targeting the most threatening infections, improve the appropriate use of antibiotics, and ensure domestic availability when needed. PASTEUR was included in the Cures 2.0 bipartisan legislation that was introduced earlier this week. Cures 2.0 builds on the 21st Century Cures Act of 2016 that accelerated the development of cutting-edge medical treatments, therapies and devices.

The Developing and Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act has been pending for several years and is another helpful bill to improve market conditions by improving Medicare reimbursement for antibiotics.

Enacting these two pieces of complementary legislation would go a long way to create the sustainable antibiotic innovation ecosystem necessary to attenuate the threat AMR poses to human health in the U.S. and around the globe.

Bill Gates was not around the last time the world faced pneumatic plague, but his words should be heeded by our current generation: “In any crisis, leaders have two equally important responsibilities: solve the immediate problem and keep it from happening again.”

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[i] Doctors Heavily Overprescribed Antibiotics early in Pandemic, New York Times, 6/4/2020.

[ii] Fei Zhou, MD, et al. Clinical course ad risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. The Lancet, March 2020.