Halfway through 2023, the United States has already seen alarming reports of serious, even fatal illnesses caused by superbugs — pathogens that have evolved to resist antibiotics, making an increasing number of common infections difficult or impossible to treat.
Eye drops contaminated with resistant bacteria have killed or blinded patients. Federal health authorities raised the alarm about a spike in life-threatening gut infections. And researchers discovered a novel, multidrug-resistant strain of gonorrhea in the U.S.
In the wake of these dangerous developments, the U.S. House of Representatives convened a hearing in April, and the Senate followed with its own hearing in July, to shine a bipartisan light on the growing threat posed by superbugs.
Health officials have been warning for decades that antibiotic resistance is rising quickly across the globe and calling for new and novel antibiotics and antimicrobial drugs that can defeat superbugs. Despite the pressing need, very few of the new antibacterial and antifungal drugs that the world needs are in development.
But Congress can help by passing a bipartisan bill known as the PASTEUR Act, which would stimulate urgently needed antibiotic innovation and support programs that are vital to preserving the effectiveness of existing antibiotics.
Why is this legislation needed? Every Food and Drug Administration-approved antibiotic in clinical medicine is based on a scientific discovery from 1984 or earlier: And major pharmaceutical companies have turned away from developing new antibiotics because research and development of an innovative therapy against superbugs is costly while the return on investment for these lifesaving drugs is low.
Data from a World Health Organization report released in March revealed that of the mere 27 antibiotics now being evaluated in a clinical trial, only six are considered innovative enough to overcome antibiotic resistance, and just two are capable of targeting the most dangerous bacteria. The few companies that remain active in this research arena — mostly small biotech firms and startups — are either struggling to sustain their operations, shutting down research labs after being forced to exit the field outright due to a lack of funding or offering their intellectual property for pennies on the dollar to overseas competitors. The high cost of antibiotic development combined with a low return on investment means that the market for new antibiotics simply doesn’t work.
Compare that number with the incredible scientific and investor focus that’s driving the active development of therapies for cancer patients. We absolutely need new cancer drugs, but because half of all cancer deaths are attributable to infectious disease patients could win the battle against serious illnesses and still lose the war to untreatable infections.
The PASTEUR Act is designed to provide a carefully targeted investment to companies that have promising — and medically important — antibiotics that are good candidates for future development. Under the act’s subscription-based reimbursement model, small companies with innovative products would receive a commitment for future sustainable funding as a strong incentive to develop these lifesaving drugs for the patients who need them. This model involves pharmaceutical companies receiving a fixed “subscription” payment, which provides funding for a limited period of time ranging from 5-10 years, rather than requiring drug manufacturers to rely on sales volume that the private market simply can’t deliver.
It’s a creative approach that would pay only in cases of successful drug discovery and would disconnect drugmaker profit from the need to sell more products, thus aligning market incentives with the careful and selective prescribing practices doctors and health care providers must follow with these valuable drugs.
The act would fund subscription contracts only when a company successfully demonstrates that its drug addresses an unmet medical need and delivers that drug to market. The legislation would also safeguard the development of new drugs by funding antibiotic stewardship programs that preserve the effectiveness of these drugs for years to come, by helping ensure that patients receive antibiotics only when necessary, and are prescribed the right drug at the right dose at the right time for the right duration. Such efforts are key to slowing the spread of resistance.
The central lesson of the COVID-19 pandemic is that preparation for coming health crises is critical. The reauthorization of the pandemic readiness and relief bills in the House and Senate provide the perfect vehicle to fix the broken antibiotics market. Congress should merge these bipartisan bills and include PASTEUR in the final package.
Antibiotics were hailed as miracle drugs when they were first discovered in the early 20th century. They cured once-deadly infections, such as tuberculosis, kept wounded soldiers alive after grave battlefield injuries and today protect patients as they undergo procedures ranging from chemotherapy to hip replacements.
As we mark the 95th anniversary of the discovery of these life-changing drugs, Congress should heed the counsel of the experts it has called, focus on the future and incentivize the development of new miracle drugs. Millions of lives depend on it.
David Hyun, M.D., directs The Pew Charitable Trusts’ antibiotic resistance project.
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