World Health Assembly 2019: As antibiotic pipeline dimishes, time runs out for patients

Science Speaks is inGeneva this week covering the 72nd session of the World Health Assembly, May 20-28. GENEVA - Jonathan was a 27-year-old healthy newlywed when he broke his leg in a skiing accident. Surgery on his leg was followed by bad pain, swelling, and redness. He had a bloodstream infection. Within four days, the infection spread to his brain. His laboratory test results indicated that the bacteria causing his infection were resistant to all antibiotics. At an event here held by the Global Antibiotic Research & Development Partnership onTuesday “Time for Concrete Action: Addressing the global AMR crisis,” Ravina Kullar, PharmD, an infectious diseases specialist in California recounted his story, that of her patient 11 years ago who inspired her to pursue a career combating antibiotic resistance, Jonathan did not survive his infection. The helplessness Kullar felt when she had no antibiotic to offer him continues to be felt by clinicians and patients in growing numbers across the globe, she said, Recent investments by multiple governments have begun to strengthen early stage antibiotic development but are only a partial solution to what happened to Jonathan, Jeremy Knox of Wellcome Trust said at the discussion. The collapse of Achaogen—a small antibiotics company in California that went bankrupt in April 2019 despite securing FDA approval for an important new antibiotic, makes clear that more action is needed to fix the antibiotics market, he noted. Antibiotic development is both costly and risky, GARDP board chair Ramanan Laxminarayan said, adding that an “anchoring bias” means that people are used to paying very little for antibiotics and therefore are unwilling to pay much more. This puts antibiotics at a distinct disadvantage compared to therapeutic areas able to demand much higher prices. Knox asserted that “pull incentives,” which would allow companies to earn a return on investment for antibiotic research and development, are now needed to fully stabilize the antibiotics market and deliver an antibiotic pipeline sufficient to meet public health needs. Laxminarayan countered that the era of pharmaceutical companies developing new antibiotics is coming to an end, and that the public health need for new antibiotics must be met with public dollars, not incentives to encourage pharmaceutical industry or venture capital financing. He argued that new antibiotics must be developed and managed by public private partnerships to ensure that new antibiotics are not only discovered and developed, but also used appropriately and made accessible to those who need them.

All agreed that the need for action is urgent, and that without change, the few remaining antibiotics companies face challenges and risks similar to those forcing Achaogen’s bankruptcy. At the same time the public health need for new antibiotics continues to grow.

While much of the conversation focused on antibiotic research and development, the panelists agreed that comprehensive solutions including increased surveillance, stewardship and better access to antibiotics are all essential. A One Health approach encompassing human health, animal health and the environment panelists said, is necessary.

Improved public understanding of antimicrobial resistance, also, is critical, Dr. Hanan Balkhy, assistant director general for antimicrobial resistance at WHO said. Unlike influenza or Ebola, antimicrobial resistance is not a single pathogen, but a problem that cuts across bacteria and other pathogens, making public communications more challenging. Representatives from South Africa cited multidrug-resistant tuberculosis and treatment-resistant sexually transmitted infections as key challenges. Others called out neonatal sepsis, and still others pointed to infections related to surgeries.

WHO and multiple countries committed to continued efforts to combat antimicrobial resistance, including by developing and implementing national action plans. GARDP Executive Director Dr. Manica Balasegaram noted that GARDP will focus on later stage antibiotic development and access, including partnering with companies on clinical trials, working with manufacturers on formulations that meet public health needs, and asking for significant government support.

Amanda Jezek is senior vice president at the Infectious Diseases Society of America, which produces this blog.