As officials reel from the news that a “superbug” strain of E-coli resistant to colistin, the antibiotic of last resort, has arrived in the United States, leaders in Europe have issued guidance on policy measures aimed at avoiding this worst-case scenario. Dangerous bacteria are becoming resistant to antibiotics faster than new drugs can hit the market. There are multiple causes, making this a tough problem to solve. Challenges include scientific difficulties keeping up with fast-evolving bacteria, significant financial disincentives for investment in new antibiotics, lack of antibiotics where they are needed, and continuing overuse in health care and agriculture globally.
Gabriela Lavezzari &
As officials reel from the news that a “superbug” strain of E-coli resistant to colistin, the antibiotic of last resort, has arrived in the United States, leaders in Europe have issued guidance on policy measures aimed at avoiding this worst-case scenario.
The U.S. can’t wait any longer, as the United Kingdom and other European countries seem poised to make significant strides, we are running behind.
Dangerous bacteria are becoming resistant to antibiotics faster than new drugs can hit the market. There are multiple causes, making this a tough problem to solve. Challenges include scientific difficulties keeping up with fast-evolving bacteria, significant financial disincentives for investment in new antibiotics, lack of antibiotics where they are needed, and continuing overuse in health care and agriculture globally.
The cost of waiting to find solutions will be huge – according to the Centers for Disease Control and Prevention, antibiotic resistant infections in the U.S. cause an estimated two million infections and 23,000 deaths annually at a direct cost of $20 billion. Globally, experts predict that by 2050, 10 million people a year will die each year from these infections – the equivalent of one person every three seconds – a death toll higher than that of cancer today.
Fortunately, there is global consensus that policies need to change to avoid a future antibiotic crisis and millions of preventable deaths. The recent recommendations from Europe attack the problem from multiple angles: combating resistance and economic incentives to spur development in a therapeutic area dominated by market failure.
Both approaches have been explored in the U.S. with few tangible policy outcomes. The White House, Congress, and regulatory agencies are seeking ways to spur antimicrobial drug development and a few post-approval incentives were introduced through the Generating Antibiotic Incentives Now (GAIN) Act, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 (DISARM Act), and the Limited Population Antibacterial Drug (LPAD) pathway. In 2014, the White House released the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB), and the subsequent National Action Plan for CARB in 2015, which mirrors the goals set out by WHO to generate policy action and coordinate resources across key priority areas, including facilitating discovery and development of new, effective drugs and ensuring their optimal use in the health care system.
The cost of developing any new drug are high and the time it takes is significant. Experts estimate the average cost of development and approval at more than $2 billion and the process often lasts longer than a decade. A drug manufacturer’s return on investment is based on volume of sales; however, new antibiotics must be used sparingly and judiciously in order to preserve their effectiveness and slow the time it takes for bacteria to mutate into resistant strains. Combined, these factors create a disincentive to invest in antibiotics.
To address this challenge, the U.K. government-commissioned Review on Antimicrobial Resistance recommends incentives of around $1 billion for each new antimicrobial drug approved for use by patients – to be provided by a group of countries such as the G20 regardless of the volume of the drug used. These market entry rewards would be subject to certain conditions to ensure that the new compounds are not over-marketed, but are available to those who contract antibiotic-resistant infections.
Market entry rewards are one of four key recommendations that will be brought forward by the international community to the World Health Assembly, G7, G20 and the United Nations as tangible steps to turn discussions and policy proposals on anti-microbial resistance into action. The UK report has much in common with another European Union initiative – DRIVE-AB – advocating for policies that increase awareness of antibiotic overuse in medicine and agriculture, develop more rapid diagnostics to ensure that the right drugs are being used for the right infections at the right time, and create market incentives for drug developers.
The international community is poised to act and the United States must not be left behind. A broad group of stakeholders is committed to implementing policies to protect patients from the potential impact of multi-drug resistant bacteria. The U.S. Healthcare system is complex and unlike any other. Policy research groups, pharmaceutical companies, diagnostic developers, private and public payers and our U.S. policy makers must act to identify the most promising new policies and pave the way toward implementation of some combination of measures to increase research and return on investment while improving access to new antibiotics and combating drug resistance through proper stewardship.