Guest Post: Policy Proposals for Combating Antibiotic Resistance

Sep 7, 2010, 2:17 AM, Posted by RWJF Blog Team

By Ramanan Laxminarayan, Director, Extending the Cure

This summer’s media coverage of the NDM-1 gene brought “superbugs” back to the public’s attention. The discovery of NDM-1, which confers resistance to a range of antibiotics, drew comparisons with MRSA and inspired a bold piece by The Guardian on the prospect of a not-so-distant future without antibiotics. But NDM-1 is far from the only resistance mechanism of concern—antibiotic resistance is a growing public health crisis that the World Health Organization now considers an emerging threat to global stability. Although some evolution of resistance is unavoidable, the prevalence of antibiotic-resistant infections is growing at an alarming rate—from 0.02 percent in 1987 to over 20 percent in 2004 (CDC 2005). High-level penicillin resistance in Streptococcus pneumoniae in the United States has experienced a thousand-fold increase in the last 20 years, and that is just one example.

This week, Health Affairs published an article supported by the Public Health Law Research program and Extending the Cure, with grants from the Robert Wood Johnson Foundation. Authors Aaron S. Kesselheim (Brigham and Women’s Hospital, Harvard Medical School) and Kevin Outterson (Boston University College of Law) describe novel policy proposals for combating antibiotic resistance. They identify the many ways in which the health system is currently contributing to the problem—for instance by allowing or even promoting the excessive use of antibiotics while failing to encourage new drug development—and also explore potential solutions for curbing resistance going forward.

Interventions addressing antibiotic resistance typically focus on conserving the use of current antibiotics or on encouraging the development of new drugs. Conservation efforts might aim to better educate doctors in responsible antibiotic dispersal or to develop formal guidelines for prescription practices. Policies to encourage drug development, on the other hand, recognize that antibiotics embody a societal resource. Motivating new antibiotic development using financial incentives such as extended patent terms, “wildcard” patents (patent extensions that can be flexibly applied to other drugs in a company’s portfolio), or even cash prizes can therefore direct research and development in directions that are socially useful (such as toward narrow-spectrum drugs or those that specifically target resistant organisms).

The problem, as Kesselheim and Outterson point out, is that conservation strategies and drug development strategies are often at odds with one other. If pharmaceutical companies are motivated to pursue high-revenue, high-sales opportunities (which the drug development incentives correctly assume), conservation efforts that restrict the distribution of antibiotics and depress drug sales work in direct opposition to those incentives.

How policymakers can reconcile the profit-seeking behavior of drug companies with the need for responsible stewardship of new antibiotics is one of the great stumbling blocks in the policy debate, and it is a focus of research at Extending the Cure. Kesselheim and Outterson echo an important finding of the Extending the Cure report, which points to the need to develop an integrated solution—one that offers financial incentives that are directly tied to public health goals. In other words, simply paying for the development of new antibiotics is likely to delay the problem of resistance to a future time when the costs are almost certain to be far greater than now. We must tie incentives for new drug development to greater responsibility for managing resistance to drugs that emerge from such incentives.

Kesselheim and Outterson suggest two ways to accomplish this goal. First, they propose encouraging antibiotic conservation and infection control by sharing part of the savings resulting from reduced incidence of antibiotic-resistant diseases with drug manufacturers and hospitals. Second, they argue for a system of conservation-based exclusivity, by which the Food and Drug Administration, in consultation with other government agencies, could tie a patent term for a new antibiotic to defined public health goals, such as a reduction in resistance or disease morbidity. So, success in achieving a goal leads to continued market exclusivity for an antibiotic, which in turn results in greater sales revenue.

The paper only begins to sketch how a regulatory program for antibiotics might evolve, but it, along with the Extending the Cure report, recognizes that a solution must address both the supply side and the demand side of antibiotic practices. Antibiotics are a limited resource—much like fish or forests—and an agenda for future research must examine ways to encourage drug development while also promoting conservation. Exploring how financial incentives can be leveraged to achieve important public health goals should be a key part of future policy discussions.

Pioneering Ideas guest blogger Ramanan Laxminarayan directs the Extending the Cure project, a research and consultative effort that frames the growing problem of antibiotic resistance as a challenge in managing a shared societal resource. Extending the Cure is funded in part by the Robert Wood Johnson Foundation through its Pioneer Portfolio.