There is no denying the physical and emotional havoc that the COVID-19 pandemic has wrought in three short years with the Centers for Disease Control and Prevention (CDC) estimating the SARS-CoV-2 virus responsible for 6,202,800 hospitalizations and 1,134,300 deaths in the U.S. through July 10, 2023.
Despite these sobering statistics, a group of prominent health advocates warned last month that antimicrobial resistance could have consequences more devastating than COVID-19.
“The overuse of antibiotics is decreasing their effectiveness through a phenomenon known as antimicrobial resistance, or AMR. It is spreading fast and is one of the World Health Organization’s top 10 public health threats,” wrote Donna Shalala, Dr. Mark McClellan, and Dr. Lilian Abbo in an op-ed published by The Hill.
The trio have distinguished health credentials with Shalala, the former U.S. Secretary of Health and Human Services; Dr. McClellan, former Centers for Medicare & Medicaid administrator, U.S. Food and Drug Administration commissioner, and founding director of the Duke-Margolis Center for Health Policy at Duke University; and Dr. Abbo, the associate chief medical officer for infectious diseases at Jackson Health System.
AMR Could Kill 10 Million People Worldwide by 2050
The trio praise antibiotics and the role they have played in modern medicine – saving countless lives – but they warn that “this tremendous progress is unraveling, taking us back toward the pre-antibiotic era.”
The op-ed paints a stark picture:
“Beneath every fact and figure about AMR lies very real patients whose lives are in jeopardy,” wrote the trio.
The CDC agrees, calling antimicrobial resistance an urgent global public health threat, killing at least 1.27 million people worldwide and associated with nearly 5 million deaths in 2019, according to a report released in The Lancet
“In the U.S., more than 2.8 million antimicrobial-resistant infections occur each year. More than 35,000 people die as a result, according to CDC’s 2019 Antibiotic Resistance (AR) Threats Report. When Clostridioides difficile—a bacterium that is not typically resistant but can cause deadly diarrhea and is associated with antibiotic use—is added to these, the U.S. toll of all the threats in the report exceeds 3 million infections and 48,000 deaths,” reports the CDC.
AMR is a Complex Problem that Requires Large-Scale Action
The op-ed raises the alarm that AMR is a complex problem that requires large-scale action from health systems, hospitals, payers, policymakers, pharmaceutical companies, and other healthcare providers.
The trio says antimicrobial resistance is not a political issue that skews left or right.
“This is a challenge that both Democrats and Republicans share. Drug-resistant infections affect us all, no matter our political leaning, race, gender, or geography,” says the op-ed. “As a secretary of Health and Human Services and FDA commissioner in different eras of American politics and for different parties, and as an infectious diseases physician who sees firsthand the devastating effects of AMR on patients, we all agree that combating AMR must be a policy priority for everyone.”
The trio suggests that the first step is reforming the way we invest in antibiotic development and pay for the use of antibiotics.
Antibiotic Pipeline is Insufficient to Tackle AMR
The World Health Organization (WHO) “2021 Antibacterial Agents in Clinical Development and Preclinical Development: An Overview and Analysis” report found there are fewer than 50 traditional antibacterial agents in the current clinical pipeline.
“Overall, the clinical pipeline and the recently approved antibacterial agents are insufficient to tackle the challenge of increasing emergence and spread of antimicrobial resistance (AMR),” said the report’s key facts.
New antibacterial drugs take time to reach the market with just 12 new antibacterial drugs approved between 2017 and 2021.
“We’ve hit a wall in developing essential drugs against the spreading risk of resistant organisms over the past few decades, leaving doctors without the tools they need to provide lifesaving care to patients,” said the op-ed. “America must ignite a second antibiotic development revolution if it hopes to make headway in the fight against AMR.”
The WHO says there is a delay both in the global availability of newly authorized agents and in development of pediatric indications among authorized products.
Bipartisan Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act in Congress
The op-ed trio favors a subscription-style business model to pay for antibiotic development as laid out in the bipartisan Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act in Congress.
“Millions will continue to die from resistant bacteria because we are out of treatment options. Antibiotics aren't working anymore for most people who contract a superbug. The science is extraordinary, it's the business model that's broken. We desperately need a new way to pay for these drugs - antibiotics, antifungals, and phage therapy. The PASTEUR Act is that rare, bipartisan idea that solves an incredible problem for an affordable price,” said Professor Kevin Outterson, Boston University.
Specifically, the PASTEUR Act would:
- Establish a subscription model to encourage innovative antimicrobial drug development aimed at treating drug-resistant infections. This model will be fully delinked, meaning that participating developers would not receive income, as a part of their subscription payments, based on volume or quantity of sales.
- Subscription contracts would contain terms and conditions including product availability to individuals on a government health insurance plan, supporting appropriate use, and completion of post marketing studies. These contracts could be valued between $750 million and $3 billion.
- Build on existing frameworks to improve usage of the CDC National Healthcare Safety Network, the Emerging Infections Program, and other programs to collect and report on antibiotic use and resistance data.
- Include transition measures such as smaller subscription contracts to support novel antimicrobial drug developers that need a financial lifeline.
- Form a Committee on Critical Need Antimicrobials, consisting of representatives from federal agencies, doctors, patients, and outside experts, to develop and implement necessary guidance regarding infections of concern, and the favored characteristics of potential treatments
The op-ed trio: “The traditional model of paying drugmakers for the volume of medicine used doesn’t make sense for antibiotics. These drugs are used for a very short period of time compared to drugs for chronic conditions, and antibiotics must be used very judiciously to protect their effectiveness. Transitioning to a subscription-style business model that assures a needed antibiotic will be there to combat resistance, while providing a predictable return on investment regardless of the volume of antibiotics used, would reduce the economic barriers that currently stymie the creation of new antibiotic treatments.”
The legislators who introduced the PASTEUR Act urge action before it is too late.
“Right now, we don’t have the tools to address the threat posed by antimicrobial resistance – and infectious disease experts are warning us that it will only get worse,” said Colorado U.S. Senator Michael Bennet. “The bipartisan PASTEUR Act is the strongest bill ever written to strengthen antibiotic development and use. It will fix our market failures, expand the pipeline for next-generation antibiotics, and save lives. We can’t sit on our hands as this public health crisis arrives – we have to act now.”
