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 2 million infections and 23,000 deaths annually at a direct cost of $20 billion.
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 have been introduced in Congress. In 2014, the White House released the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB), and a subsequent national action plan in 2015 mirrors the goals set out by the World Health Organization 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 drugs is 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 to preserve their effectiveness and slow the time it takes for bacteria to mutate into resistant strains.
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 G-20, 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 overmarketed, 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, G-20 and the United Nations as tangible steps to turn discussions and policy proposals on anti-microbial resistance into action.
The international community is poised to act, and the U.S. 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. health care 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.
Gabriela Lavezzari is a research director at Duke University’s Robert J. Margolis Center for Health Policy, and Gregory Daniel is the deputy director and a clinical professor in the Fuqua School of Business.
(Source – http://www.eastbaytimes.com/opinion/ci_30015005/u-s-must-move-quickly-combat-superbugs-east)