Within two decades, many of the antibiotics people use today could become ineffective, and without major changes to the research and development process there will be few replacements, Maryn McKenna writes for WIRED.
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The threat of antibiotic-resistant bacteria
Antibiotics revolutionized medicine in the 20th century and have saved millions of lives, McKenna writes. But the drugs are highly susceptible to bacterial resistance.
Kevin Outterson—a law professor at Boston University and executive director of the nonprofit CARB-X, which helps small firms receive funding to develop antibiotics—said, "[E]very antibiotic we count on now will be destroyed or significantly impaired by resistance" within the next two decades. As a result, researchers have to constantly develop new antibiotics to replace old and ineffective ones.
However, experts in the antibiotics industry note the current pharmaceutical market is not built to sustain the research and development of antibiotics.
Why the current process for developing antibiotics is challenging
Developing new antibiotics is challenging for many reasons. For one, the research and development is costly and few consumers are willing to pay high prices to offset those costs. This has prompted several major pharmaceutical companies—including AstraZeneca, Eli Lilly, Novartis, Pfizer, and Sanofi—to exit the antibiotics market and stop acquiring small companies that focus on antibiotics.
According to McKenna, the market changes has left the small biotech firms that still focus on antibiotic development without access to the funding they need to cover the cost of trials designed to demonstrate the drugs' effectiveness, as well as the packaging, marketing, and distribution abilities of larger firms.
The federal government has made some changes to support smaller firms, such as awarding funding and extending a company's patent exclusivity by five years. But Evan Loh—a physician and president of Paratek Pharmaceuticals, which recently received FDA approval for a new antibiotic called Nuzyra—said most small biotech firms are "basically on [their] own" when it comes to developing antibiotics. The firms seek and use funds from investors to cover the cost of research until the firms can generate a profit from the products, which can take years. Paratek, for example, began work on Nuzyra in 1996, and Loh estimates the company is years away from turning a profit.
How developing antibiotics could be made easier
"Solving this problem isn't just a matter of finding new funding," McKenna writes. "It requires that we change how we think about antibiotics—not as products we purchase but as infrastructure we share."
Outterson explained, "For other big infrastructure things, we have mechanisms. You pay to get across the Golden Gate Bridge. You pay to enter a national park." However, no mechanism exists for antibiotics. He said if people who use antibiotics paid a $5 user fee on every prescription, more than $1 billion a year could be raised and redistributed to cover the costs of antibiotic development.
McKenna suggests the federal government could commission antibiotics in the same way they handle purchases related to national security. McKenna explains purchases of that nature, say for military tanks, go through a bidding process and are viewed as long-term investments. It also gives the buyer control over how the product is sold and distributed.
Under such a system, McKenna writes the government would propose the drug it wants, and companies then would compete to create and deliver that drug—and receive government funding to do it.
That process, McKenna writes, would "mak[e] explicit a thing that has always been true, but never really articulated: The continued availability of antibiotics is as fundamental to the health of society as intact roads and reliable electric generation and robust sewage processing. In effect, they're a component of national security" (McKenna, WIRED, 10/12; Baker, "Vitals," Axios, 10/15).
Learn more: How to eradicate antibiotic overuse
Antibiotic-resistant organisms infect some two million Americans each year. To help confront antibiotic overuse, CMS has indicated it will propose that all hospitals must have an antibiotic stewardship program (ASP) in place by 2017 in order to participate in Medicare. Yet many hospitals still lack fully functional ASPs, especially smaller community hospitals where resource limitations present a major barrier.
Download the slide deck to view case studies and tips from hospitals that have successfully implemented ASPs despite resource challenges.