Reinvigorating The Antibiotics Pipeline
Reinvigorating the Antibiotics Pipeline
By Rep. Peter Roskam
Later this month, the President’s Council of Advisors on Science and Technology–commonly known as PCAST–will issue a highly anticipated report on antibiotic resistance, bringing much-needed attention to a growing public health threat that is fast becoming a global crisis.
Each year, the Centers for Disease Control estimates more than 2 million Americans are diagnosed with an infection resistant to virtually all available treatments and 23,000 die as a result. These drug-resistant bacteria, or superbugs, used to be rare even in hospital settings, but the last ten years have seen hard to treat infections like MRSA spreading into communities and other extremely serious infections like CRE developing resistance to all possible treatments. In April, the World Health Organization issued its first global report on antibiotic resistance and found increasingly resistant infections present in every corner of the globe. And for their most recent threat report last fall, the CDC listed superbugs as the number one public health threat facing the United States today.
What do these dire warnings mean in the real world? The rapid increase in antibiotic resistance coupled with the lack of drug treatments currently available or in development has us hurtling into a post-antibiotic era where a simple infection can once again prove deadly and major surgeries we take for granted today become too high-risk because of the threat of untreatable bacterial infections. Twenty years ago, almost 20 pharmaceutical companies had large, active antibiotic research and development programs; today only three large and a handful of smaller companies continue in these efforts to find new and effective treatments. One study suggests only a handful of new drugs are in development to treat multi-drug resistant infections–not nearly enough to keep pace with this rapidly evolving threat.
Recently, I joined with fellow Chicago-area Congressman Danny Davis to introduce the bipartisan DISARM Act, which will spur drug development by updating how our healthcare system views antibiotics. Currently, the federal healthcare program Medicare reimburses hospitals for the use of only one class of antibiotics: the inexpensive, everyday drugs like amoxicillin, penicillin, and azithromycin that cost as little as ten dollars for a course of treatment. However, highly advanced, powerful antibiotics can cost millions to develop and hundreds of dollars to prescribe in the hospital. The financial loss to hospitals–being paid only a fraction of the cost of the drug–means doctors are less likely to use the high-powered antibiotic, and without market demand, companies are reluctant to invest in developing antibiotics that may never reach a patient in need. The short-term, or episodic nature of antibiotics is also partly to blame. While a medication for obesity or high blood pressure may be taken every day for life, antibiotics are meant to be used for only a few days or weeks at a time, with reduces demand. Infectious disease specialists, hospitals and researchers all point to the broken antibiotics market as the central impediment to new drug investment.
DISARM breaks this cycle by adding a new classification for the high-powered antibiotics that treat superbugs. By modernizing how Medicare views these select drugs and reimbursing their use at cost, we can ensure a functioning market for their use and help to reinvigorate the pipeline of new drugs in development. Dr. Emily Landon, the Medical Director of Infection Control and Antimicrobial Stewardship at the University of Chicago described the DISARM Act as the striking the right balance: “Instead of providing an incentive to hospitals to using new and unnecessarily broad drugs, it removes the disincentive from creating them; it removes the obstacles for drug development to happen so that we have these drugs available when we need them, but it doesn’t encourage hospitals and doctors to use them when they aren’t necessarily needed.”
The DISARM Act specifically works to address all four critical recommendations from the CDC’s fall threat report, requiring a multiagency effort to recommend ways the government can streamline processes and cut bureaucratic red tape to better fight antibiotic resistance. It directs hospitals to report drug-resistant bacterial infections and their treatment to the CDC through the National Healthcare Safety Network, the nation’s most widely used healthcare-associated infection tracking system to better monitor and treat superbugs throughout the United States.
The rapid growth of drug-resistant bacteria threatens millions of Americans and could push modern medicine back in time. Combating the threat requires urgent action to modernize our healthcare system and spur the development of critical drugs to fight deadly bacteria. We need to get researchers and scientists back in the business of developing advanced antibiotics, which takes a very long time to produce results. If we don’t start tackling this challenge soon, it will be too late.
Congressman Peter Roskam represents the Sixth District of Illinois and serves on the Ways and Means Committee.