Dec 14, 2021, 11:45 AM ETWebinar, Panel

Antibiotic Resistance and Chronic Disease: Understanding the Challenges and Some Possible Solutions

The webinar, hosted by Faster Cures in partnership with the Infectious Disease Society of America (IDSA), Pew Charitable Trusts, and the Cystic Fibrosis Foundation, addressed the intersection of antimicrobial resistance (AMR), chronic disease, and policy solutions.
The primary objective is to highlight the financial market failure driving the lack of new antibiotic development and advocate for the "Passer Act" (often referred to as the Pasteur Act) to correct this market distortion.
Faster Cures is collaborating with the Milken Institute's Financial Innovation Lab and the UK's Welcome Trust to publish a report on innovative financing solutions for antibiotics in early 2022.
Mark Williams, Associate Director at Faster Cures, emphasized that AMR threatens to undermine modern medical advances, including cancer chemotherapy and organ transplantation, due to the inability to treat secondary bacterial infections.

The CDC estimates at least 2.8 million antibiotic-resistant infections and 35,000 deaths annually in the U.S., figures likely representing conservative estimates of the actual burden.
A study commissioned by IDSA and Pew Charitable Trusts found that six multidrug-resistant pathogens caused $1.9 billion in increased Medicare costs, nearly 12,000 deaths, and 450,000 inpatient days among the Medicare population in a single analysis.
Healthcare data indicates that 40% of deaths associated with six common resistant infections occur in the Medicare population (individuals 65 and older), despite this group comprising only 15% of the U.S. population.
During COVID-19 surges (March–September 2020), hospitals observed a 24% increase in hospital-onset multidrug-resistant infections across 148 facilities in 17 states.
Research suggests that up to 90% of cancer patients in ICUs who die from hospital-acquired infections are infected with multidrug-resistant pathogens.
Health equity disparities are pronounced; Black patients in the U.S. are twice as likely to die from complications of severe infections compared to white counterparts.
A Sepsis Alliance survey revealed a significant awareness gap, with only 45% of Black respondents having heard the term "antimicrobial resistance" compared to 51% of white respondents (global average: 52%).

Cancer Patients: Individuals with cancer have a mortality risk from infection up to three times higher than those without cancer; infections account for approximately 50% of cancer-related deaths.
Sepsis: Sepsis impacts 1.7 million Americans annually, causing 350,000 deaths or hospice discharges; cancer patients face a tenfold increased risk of developing sepsis.
Cystic Fibrosis (CF): Patients with CF face chronic, difficult-to-treat lung infections requiring daily or frequent antibiotic rotation, significantly increasing the risk of developing drug resistance.
Transplant Recipients: Lung transplant patients, many with underlying CF, face recurring infections from drug-resistant pathogens even post-transplant, complicating long-term survival.
Disparities: Racial minorities and individuals living below the poverty line face higher mortality rates and lower awareness regarding sepsis prevention and AMR signs/symptoms.

Current antibiotic pipeline tracking by Pew Charitable Trusts shows approximately 43 antibiotics in development.
Of the 43 candidates, only 15 have the potential to address pathogens labeled as "critical threat" by the World Health Organization.
Historical data indicates a low success rate, with only one out of five antibiotics in the pipeline successfully achieving FDA approval.
The market failure stems from the fact that new antibiotics must be conserved for last-resort use, preventing the high sales volume required to recoup the high R&D costs and ensuring a lack of return on investment for developers.
This economic reality has led to the bankruptcy of small biotech companies following FDA approval of effective antibiotics because they could not sustain revenue models based on low-volume usage.

Core Mechanism: The legislation "delinks" financial reward from the volume of antibiotic sales, allowing the federal government to pay companies a fixed reward for developing drugs that meet high-priority public health needs.
Funding Scope: The proposed financial rewards for approved drugs meeting high-priority needs could total up to $3 billion.
Safeguards: Payments are contingent upon FDA approval and confirmation that the drug addresses specific public health priority areas identified by scientific communities.
Stewardship Provisions: The Act includes grants specifically targeted at rural, critical access, tribal, and safety net hospitals to establish or strengthen antibiotic stewardship programs.
Reporting Requirements: The legislation mandates increased reporting of antibiotic use and resistance data to improve national tracking and combat outbreaks.
Complementary Role: The Act is designed to supplement "push" funding (e.g., from NIH and BARDA) by addressing the missing "pull" incentives for commercialization after FDA approval.

Dr. David Greenberg (IDSA): Noted that resistant infections can delay cancer treatment entirely; a single drug-resistant UTI prevented a multiple myeloma patient from receiving life-saving chemotherapy. He also highlighted that "cousin" antibiotics (slight modifications of existing drugs) are less effective than the need for novel classes.
Tom Heyman (Sepsis Alliance): Described the current situation as a "climate change moment" where data exists but urgency is lacking; emphasized the need for patient stories to drive policy action. He advocated for a centralized "data trust" for sepsis similar to cancer registries.
Jonathan Daniels (Cystic Fibrosis Foundation): Reported that over 80 meetings have been held with Congress to advocate for the Pasteur Act; noted that patients often have only one or two effective options remaining, and some are allergic to the only viable drug.
Kathy Talkington (Pew Charitable Trusts): Stressed that the current crisis requires a dual approach: preserving existing antibiotics through stewardship and jumpstarting new development through the Pasteur Act's market incentives.

Stakeholders are encouraged to submit personal stories to policymakers to illustrate the acute impact of AMR on their constituencies.
An open sign-on letter is being circulated to the House Energy and Commerce Committee urging them to hold a hearing on AMR issues.
The Cystic Fibrosis Foundation and other partners are continuing to fund research and development, with the CF Foundation having committed over $100 million in 2019 to an infection research initiative funding nearly 20 studies.
The webinar recording and the link to the sign-on letter will be made available on the Faster Cures website post-event.