With the introduction of multiple highly effective vaccines against COVID-19, we have begun to round a corner on the current pandemic. But another crisis looms — and this one could claim more lives worldwide and change medicine as we know it.
Bacteria and fungi are mutating to resist our current antibiotics: This has always been a fact of evolution. However, in the century since antibiotics were first discovered, widespread use of these drugs in humans and animals has accelerated the natural evolutionary process. Soon, the world may have no effective antibiotics left to fight certain infections. Already, strains of totally drug-resistant tuberculosis and gonorrhea have been isolated from patients. The continued emergence and spread of such strains could result in a deadly pandemic of drug-resistant superbugs, which could kill millions of people a year by 2050, according to one economic analysis.
To win the race against superbugs, we need more interventions, including antibiotics. These can be new generations of existing drugs designed to bypass known resistance mechanisms, and they can also work in completely new ways. However, accomplishing this in a lab is difficult, time-consuming and expensive. And because of their relatively short shelf life compared to drugs used to treat chronic illnesses, many drug companies have opted out of antibiotic research.
How can we reincentivize companies to develop the next generation of antibiotics? A proposal currently working its way through Congress offers a bold new solution.
In most years, drug-resistant superbugs are the fourth-leading cause of death in America, behind only heart disease, cancer and accidents. An estimated 160,000 Americans die from antibiotic-resistant bacterial infections annually.
As Ph.D. student-researchers studying antibiotic resistance in a variety of bacteria, we know this number will continue to rise as antibiotics grow ever less effective.
In our labs, we work to develop new ways to treat infections. But even if we invented the prototype for a wildly effective antibiotic tomorrow, it may not ever reach pharmacy shelves. That’s because Medicare, Medicaid, the VA and private insurers all encourage doctors to prescribe inexpensive, older antibiotics — even though many types of bacteria and fungi are largely resistant to them. And since the typical cost of bringing a new drug to market ranges from $314 million to $2.8 billion, it would be extremely financially risky for most companies to invest in an experimental antibiotic that wouldn’t be widely sold, even if it secures Food and Drug Administration approval after years of clinical trials.
The federal government and nonprofit organizations have tried to combat this problem through increased funding for creative research initiatives. The FDA has even created an expedited approval process for certain antibiotics. Still, most major drug manufacturers have closed their antibiotic research divisions because the economics simply don’t make sense. Novartis recently joined AstraZeneca, Sanofi and Allergan in shuttering their antibiotic programs. A number of smaller startups have gone bankrupt trying to develop antibiotics.
At a time when new antibiotics are needed, fewer are being developed. But by changing how companies are reimbursed for antibiotics, the federal government may help generate a sustainable antibiotic development pipeline.
One option is for the government to pay for the right to access an unlimited amount of antibiotics, rather than paying for individual doses. It’s essentially a Netflix subscription, but for life-saving drugs.
By providing drugmakers a steady stream of income from their antibiotics, a subscription system would incentivize antibiotics R&D while reducing the overuse of the current drugs that fuel antibiotic resistance.
A new bipartisan bill in Congress — recently reintroduced by Sens. Michael Bennet, D-Colo., and Todd Young, R-Ind., and Reps. Mike Doyle, D-Pa., and Drew Ferguson, R-Ga. — has adopted this approach. Under the legislation, known as the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance, or PASTEUR, Act, the federal government would contract with drugmakers to develop and supply new antibiotics. Any beneficiary of a federal insurance program — including Americans covered by Medicare, Medicaid and the VA — would be able to access these drugs as needed.
While we work to defeat antibiotic-resistant bacterial infections in the lab, we can’t do it alone. We need a policy solution that incentivizes the application of new research and development of antibiotics, while limiting the use of existing antibiotics to buy us more time. The PASTEUR Act would do both.
It’s time for Congress to act on the superbug crisis. There’s not a moment to waste.
Francesca Tomasi and Kevin Ma are Ph.D. students in the Department of Immunology and Infectious Diseases at the Harvard T.H. Chan School of Public Health.
Megan McCurry is a Ph.D. student in the Department of Biological Chemistry and Molecular Pharmacology at Harvard Medical School.
All three help lead Harvard Antimicrobial Resistance, a subgroup of the Harvard Infectious Diseases Consortium. The opinions in this op-ed are those of the individual authors and do not represent the views of their departments or institutions.