Doctors — and patients — need new antibiotics. But a broken market can't deliver them.

Emily Wheeler: ©Biotechnology Innovation Organization

America's primary care doctors are increasingly encountering bacterial and fungal infections that don't respond to normal treatments. For instance, about one in five urinary tract infections now show reduced susceptibility to standard antibiotics. And over half of U.S. gonorrhea cases are now drug-resistant.

Nationwide, these sorts of antimicrobial-resistant bacteria and fungi — often dubbed "superbugs" — kill tens of thousands of Americans each year. Antibiotic resistance alone plays a role in over 165,000 U.S. deaths annually. Worldwide, the problem is even more severe. Antimicrobial resistance contributes to almost 5 million deaths annually.

The situation is only getting worse. The World Health Organization has already named antimicrobial resistance as one of the top ten global threats to humanity. Unless scientists develop new effective treatments, superbugs will contribute to 170 million deaths worldwide and could reduce global economic output by nearly $2 trillion dollars by 2050.

Antibiotics are also 42% more likely to have shortages than the average medication. According to the American Society of Health-System Pharmacists, antimicrobials are among the top five drug classes currently in active shortage. Amoxicillin, a frontline treatment for pediatric strep throat, has faced ongoing supply issues since October 2022 — as strep cases continued to rise.

Research shows that shortages can leave clinicians to rely on broader-spectrum antibiotics for common infections, which can further complicate efforts to combat resistance.

Physicians, and their patients, desperately need innovative drugs to defend against superbugs. But to get them, they'll have to advocate for policy changes that fix the broken market for antimicrobials.

Unlike treatments for chronic diseases — which patients often need to take for years or even decades — antimicrobials are generally taken only for short periods of time. Physicians are rightly taught to practice good antimicrobial stewardship and prescribe these drugs only when strictly necessary, since every time antimicrobials are used, bacteria and fungi have a chance to evolve and develop resistance.

Low usage, though, means low sales for antimicrobial developers under the standard volume-based sales structure for medicines.

Over the last decade, small biotech firms have brought forward several new antibiotics that received FDA approval. But despite supposedly beating the odds — only 16% of antibiotics that enter clinical trials ever secure regulators' greenlight — nearly every one of those firms has filed for bankruptcy, been acquired at fire sale prices, or shut down operations entirely.

Research and development into new antimicrobials is plummeting because of the uniquely broken marketplace that makes it impossible to create a commercially viable treatment. In the 1980s, 18 major pharmaceutical companies were pursuing new antibiotics. By 2019, that number had fallen to three. And research talent has migrated to more viable fields. Today, there are just 3,000 active AMR researchers in the world, compared to 46,000 for cancer.

Simply put, this broken market is hindering the development of new, lifesaving antimicrobials. Without reform, clinicians will not have the treatments that they need to fight infections.

Fortunately, there's a solution. Under the bipartisan PASTEUR Act, the federal government would adopt a subscription-style model, where it would enter into contracts with biotech companies that successfully develop novel antimicrobials in exchange for using their treatments. Federal health care programs could then use as much, or as little, of the drugs as they need to combat superbugs, and the company would have certainty regarding a return on their investment in R&D.

By giving biotech companies that predictability — without having to rely on high sales volumes of a cutting-edge new treatment that, medically speaking, ought to be held in reserve for the most severe infections — the legislation would incentivize desperately needed investment into antimicrobial R&D.

This model wouldn't be the first of its kind. The United Kingdom already successfully piloted a similar model in 2022 and is currently expanding it.

In the long run, the legislation would more than pay for itself by ensuring that America, and the entire world, has lifesaving new antimicrobials available. One study found that antibiotic resistance added almost $1,400 to the average cost of treating a bacterial infection in the United States. Another found that globally, patients with antibiotic-resistant infections spent an entire additional week in the hospital, compared to patients whose infections didn't involve superbugs.

Doctors see the growing toll that superbugs are taking on patients. Millions of lives, and trillions of dollars in economic activity, depend on our leaders fixing the broken antimicrobial market and incentivizing more R&D. It's the only way to ensure that doctors aren't left defenseless against superbugs today -- and in the coming years.

Emily Wheeler is vice president of infectious disease policy at the Biotechnology Innovation Organization and director of Working to Fight AMR.