Kevin Outterson Delivers Kleh Lecture in London
Outterson’s talk focused on the increasing importance of a global effort to combat antibiotic resistance.
On November 3, Professor of Law and N. Neal Pike Scholar in Health and Disability Law Kevin Outterson delivered the annual Kleh Lecture at the Boston University London Academic Centre in England. The Kleh Family Foundation Distinguished Lecture Series is held annually, and made possible through the generosity of Patricia and William H. Kleh (’71), who established the William & Patricia Kleh Visiting Professorship in International Law in February 2011. BU Law also hosts a separate Kleh Lecture at the School each year, given by that year’s William & Patricia Kleh Visiting Professor in International Law.
As the executive director of CARB-X—a new initiative to combat antibiotic-resistant bacteria spearheaded by BU Law—Outterson focused his lecture on the state of antibiotics, and how global public health can be improved through innovative approaches to preventing antibiotic resistance.
Outterson began the lecture by demonstrating how the introduction of antibiotics has steadily increased life expectancy and improved public health over the last 70 years. Without antibiotics, much of what we take for granted within modern medicine—from routine surgery to caesarian sections—would be threatened. “Antibiotics are the safety net for modern medicine,” Outterson said.
To illustrate the importance of reforming how we approach antibiotic resistance, Outterson explained the significant difference between antibiotics and other drugs: “Most drugs are just as good on the billionth dose as it was on the day it was invented. Not so for antibiotics,” he said. “Antibiotics decline in effectiveness with use until they’re worthless. We have to invest in antibiotic R&D just in order to avoid falling behind.”
A second key difference is the expanding research into the microbiome. Outterson explained that past generations “declared war on all microbes” and prompted a push for over-sterilization—a dangerous way to think about the microbial world, most of which is harmless or even beneficial to humans. In the 1940s and 1950s, he said, society’s method of dealing with bacteria was to use wide-spectrum antibiotics to wipe it all out, both good and bad. “We need a more focused, more thoughtful approach, that accounts for both the ecology and evolution of bacteria” Outterson said.
Outterson’s plan to improve the state of antibiotics will require three policies. The first, he said, is to increase access to antibiotics globally. “Today, we have more people dying from bacteria for which we have a generic, inexpensive antibiotic that isn’t getting to them than all current deaths from resistance. Resistance is a looming threat, but inadequate access is killing hundreds of thousands of children today.” Second, we must maintain sustainable use of antibiotics. Antibiotics shouldn’t be wasted, and should be used appropriately to ensure sustainability. The third policy is to promote innovation. The current business model for antibiotics is broken, leading to companies running for the exits.
The key difficulty is that all three of these policies must be pursued simultaneously. For example, access is certainly a problem, but flooding the developing world with cheap antibiotics will undermine sustainable use and innovation incentives. Sustainable use is important, but careful guidelines will make it harder for companies to make a profit and will limit access all the more. Finally, boosting innovation will bring more drugs to the market, but that may make resistance worse as companies feel the need to sell product; and if pricing is too high, these new and expensive antibiotics won’t be available to the rest of the world.
“The way out of this box is ‘de-linkage,’ or ‘market entry rewards,’” Outterson said. With this system, a company would receive a cash prize when they introduce a new drug into the market and give up revenues based on sales volumes. This way, the drug is only used when needed clinically, not to drive sales or revenue.
Outterson also discussed how the law interacts with public health and antibiotic resistance. Primarily, laws can affect both production and conservation of antibiotics. For decades, he said, most of the attention has fallen on patent law, but there are several other domains of law that could interact with and benefit public health, especially in contract (prizes) and regulation (reimbursement).
The lecture closed with a brief discussion of CARB-X. Outterson provided background on the organization, explaining its formation as a “broad and deep effort in the US government to look at the antibiotic problem and to define solutions.” He expressed thanks to many of the primary CARB-X partners, and laid out the partnership’s goals: to accelerate global antibacterial innovation by funding the best ideas around the world, and to generate new ideas and products by joining forces with a wide array of disciplines.
“At the end of the day, this is a global issue,” Outterson said. “It’s not something one country can do alone—we have to do this together.”