World Health Organization Warns That Antibiotic Innovation Still Insufficient

New assessment highlights remaining gaps and concerning trends in fragile global pipeline

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World Health Organization Warns That Antibiotic Innovation Still Insufficient
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The global antibiotic pipeline remains woefully inadequate in the face of increasing antibiotic resistance, according to a recent assessment from the World Health Organization (WHO). The report released in June analyzed antimicrobial drugs that were in global clinical development from 2017 to 2023—as well as the development of other types of “nontraditional” products that help prevent and treat bacterial infection, such as vaccines, bacteriophages, and antibodies. The findings highlight the need for increased innovation and investment in drugs to combat dangerous resistant pathogens.

Antibiotics underpin modern medicine—making everything from cancer treatment to cesarean sections possible—but growing resistance is rendering many of these drugs ineffective. Even common bacteria, such as those that cause urinary tract infections and sexually transmitted infections, are becoming increasingly difficult and sometimes impossible to treat.

Antimicrobial resistance is only getting worse, yet we’re not developing new trailblazing products fast enough to combat the most dangerous and deadly bacteria,” said Dr. Yukiko Nakatani, WHO’s interim assistant director-general for antimicrobial resistance, in a press release.

Among the key findings of the WHO assessment:

  • Of the 97 products currently in clinical development, the majority have limited potential to address the most critical threats posed by antibiotic resistance.
  • Just four of the drugs in development that are considered innovative also have the potential to treat at least one pathogen deemed by WHO as a critical threat, the organization’s most serious level.
  • The pipeline lacks medications for children, oral formulations for outpatient treatment, and antibiotics designed to fight drug-resistant bacteria.
  • Small companies and biotech firms are responsible for 93% of the antibiotics in clinical development.

The report highlights the effects that increasing antibiotic resistance—and a pipeline that cannot keep pace with patient needs—has already had on public health. For example, rates of bloodstream infections caused by resistant E. coli, Salmonella, and Neisseria gonorrhoeae have each increased by at least 15% since 2017, rates that will likely grow without an arsenal of new treatments.

What is resoundingly clear from WHO’s pipeline data is that the new medications the world needs do not exist. That’s because, in part, the antibiotic market is fundamentally broken.

Getting a new antibiotic to market is resource-intensive, and the return on investment is relatively low compared with other therapeutic areas. This stems partly from the public health imperative to use these drugs as little as possible to preserve their effectiveness and to slow the emergence of resistance. As a result, major pharmaceutical companies have backed—and continue to stay—away from antibiotic development in favor of investing in disease areas with a larger and more predictable return on investment. And the small companies and biotech firms responsible for most candidates in the pipeline often lack the resources to sustain operations long enough to bring such drugs to market.

The bipartisan Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act, now awaiting action in Congress, is designed to address the flaws of the antibiotic market and help reinvigorate the pipeline by creating a subscription-style model to provide more predictability—and sustainability—for new products. Specifically, the bill would offer sizable, upfront funding commitments to incentivize the development of innovative, high-priority antibiotics. This approach would delink companies’ revenue from the volume of drugs they sell and instead pay for high-need antibiotics based on their value to public health. Importantly, the act also would support antibiotic stewardship efforts to help preserve the effectiveness of existing antibiotics and slow the spread of superbugs.

Countless medical professionals, public health experts, patient advocates, and research and nonprofit organizations have called on Congress to make the fight against antibiotic resistance a priority. Passing the PASTEUR Act is a critical next step toward delivering and safeguarding the innovative antibiotics needed to meet the significant and growing threat of multidrug-resistant bacteria. Congress should enact this bipartisan legislation before the end of the year. As the latest WHO data makes all too clear, there is no time to waste.

David Hyun, M.D., directs The Pew Charitable Trusts’ antibiotic resistance project.

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