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On Preventing a Post-Antibiotic Era

May 2, 2016

The problem of antibiotic resistance is a problem with many causes, many hurdles, and no single or simple solution—a wicked problem, some might say.

For years, countries and health organizations around the world have reverberated with the question that keeps doctors awake at night: “Will we react in time to prevent a post-antibiotic era?” Last year, Margaret Chan, Director-General of the World Health Organization, warned G7 health ministers that if we don’t fix this problem, common infections could once again kill. In her words, “[t]his will be the end of modern medicine as we know it.”

In light of this growing threat, there are new opportunities and strategies emerging to solve this problem. “We may be at a tipping point,” said Anthony D. So, MD, director of the Johns Hopkins Center for a Livable Future, last Friday when he keynoted the annual J. Douglas Coleman Grand Rounds Lecture for the General Preventive Medicine Residency Program.

The problem of antibiotic resistance is riddled with paradox. “Access and excess,” said Dr. So. “There are people who don’t receive the drugs when they need them, and people who receive too much of the drug when they’re not needed.” Compounded with barriers to accessing existing therapies is a shortfall of novel antibiotics in the R&D pipeline, prompting the question of whether current proposals address the key bottlenecks, or not.

Is there a single culprit holding back the development of drugs? Many like to point their fingers at regulation, suggesting that novel drugs are languishing in a bottleneck of clinical trials and drug approval standards. Others point to financial bottlenecks as pharmaceuticals are at the mercy of market forces. While the revenue margin for antibiotics is relatively low, first-in-class antibiotics have commanded impressive returns, placing them in the top 100 U.S. drugs by sales.

The key bottleneck is scientific, at the drug discovery stage. Dr. So suggested that we overcome this bottleneck to developing new drugs by looking for new families of antibiotic compounds from nature. “What are the potential reservoirs of untapped drugs?” he asked, mentioning the isolation chip, or iChip, a new device for culturing bacteria, which made big news in connection with Teixobactin last year—an allegedly resistance-resistant antibiotic discovered from soil.

De-linkage is a business model that could change the game, said Dr. So. For antibiotics, increased use drives greater resistance. Delinkage seeks to separate returns on industry investment from sales of the product. Dr. So proposed applying the 3Rs—sharing resources, risks and rewards—as a guide to how we might structure such a new business model.

Dr. So also described how antibiotic resistance spans across sectors, requiring solutions across these different areas. This might be done through a One Health approach, recognizing that the health of humans, animals, and the environment are connected. “We need to take an ecosystem approach to tackling it,” he said.

One facet of a systems approach would be to focus on the intensive production of food animals, colloquially referred to as factory farming, in which antibiotics are administered routinely and prophylactically, generating mutations in pathogens that allow the bacteria to become resistant to antibiotics. Dr. So concluded by saying, “…there may be promise in making a bet that antimicrobial resistance may be an important policy lever in reaching the circles of policymakers that should help rethink how our food system might become more sustainable.”

Following his presentation, Dr. John Powers, MD, an infectious disease physician at the National Institutes of Health and George Washington University delved deeper into existing and proposed federal legislation to address the regulatory bottlenecks to antibiotic innovation.

With regard to the misuse of antibiotics in livestock production, Clarence Lam, MD, MPH, a Maryland state delegate, spoke about his work on two bills this past session, HB 1163 and HB 829/SB 607. House Bill 1163 would require a statewide database about antibiotic use; it passed the House but did not get through the Senate. He noted that while there was opposition from industry and farmers in setting up this monitoring system, there was also opposition from those who did not seem to think the bill went far enough.

As Dr. So noted in the Q&A session after the talks, the U.S. is much behind the curve of other European countries who have developed both robust systems to monitoring antibiotic use in food animals but also regulations to curb inappropriate use.

“Perhaps this might be a wake up call,” said Dr. So. “The urgency to act has never been greater.”

—Christine Grillo