The headlines give us all sorts of scary news. Recently, zombie raccoons walking on their hind feet and dripping saliva have been plaguing an Ohio town. The raccoons are infected with distemper, a disease not affecting humans.
In Madagascar, the black death — the plague responsible for the deaths of as many as 200 million people during the Middle Ages — has returned. So far, the disease, treatable by modern antibiotics, hasn’t crossed the water from the island nation.
But what happens if these diseases or others spread and evolve into antibiotic-resistant strains affecting humans?
The Centers for Disease Control and Prevention has just released a major warning about the spread of antibiotic-resistant bacteria. In the report by its Antibiotic Resistance Laboratory Network, the CDC reported finding 221 instances of bacteria with “unusual” antibiotic resistance genes in 27 states across the United States last year. As the CDC explains, these are bacteria that cannot be killed by all or most antibiotics, are uncommon in a geographic area or the U.S., or have specific genes that allow them to spread their resistance to other bacteria that may be unrelated.
The media – not without good reason – has called these “nightmare bacteria.”
As the CDC notes, antibiotic resistance can spread from people with and without symptoms, between health facilities and between organisms. The CDC report focuses on new and highly resistant bacteria that haven’t yet spread widely and discusses detection and containment as the first line of defense against the further spread of potentially untreatable infections. The CDC’s principal deputy director, Anne Schuchat, noted that 2 million Americans get infections from resistant bacteria, and 23,000 die from these infections each year.
The CDC’s recommendations on aggressive containment are essential, but they are not sufficient to address the problem of antibiotic resistance. As the CDC notes, “the emergence and spread of antibiotic resistance threatens to outpace the development of new antimicrobials.”
The CDC also observes that “germs will continuously find ways to resist new and existing antibiotics; stopping new resistance from developing is not currently possible.” If the “nightmare germs” are evolving continuously, then the antibiotic responses must also evolve continuously. We need a robust drug pipeline of new antibiotics.
As a member of the Infection Diseases Society of America, I supported the organization’s call for “10 x ’20”: the development of 10 new systemic antibacterial drugs by 2020. So far, with only six such drugs, we are a long way from meeting the target with only a short time remaining.
When I began my medical career in the late 1980s at the University of Texas, there were numerous existing antibiotics, and while some bacteria had developed resistance to some of these drugs, the full antibiotic tool chest was adequate to address whatever we encountered. More importantly, there was a steady stream of antibiotics under development, with between 10 and 16 new antibiotics being approved every five years. Now, however, things are completely different.
While the evolution of antibiotic-resistant germs is accelerating, the development of new antibiotic responses is slowing. Today, there are only four companies – including my company, Allergan PLC – responsible for the handful of antibiotics approved by the Food and Drug Administration since 2010.
Unfortunately, other pharmaceutical companies are unlikely to step up to develop new antibiotics without a significant change in the economics of doing so. Developing a new drug can cost billions of dollars for research, clinical testing and FDA approval, and there are significant risks that experiments may fail, a drug may not be approved, or a competitor may beat the developer to market.
So, it’s hardly surprising that pharmaceutical companies target their research budgets to those areas where the potential rewards can offset the risk (e.g., Alzheimer’s drug research where there is a large potential market and the prospect of significant profits during the patent period). In contrast, for new antibiotics, the potential rewards are much more limited. Antibiotics typically have only a short-term use by a patient (e.g., when in the hospital); payers limit reimbursements; and because antibiotic resistance will inevitably develop, the drugs have a peak market life that may be significantly shorter than the patent period.
If we are to avoid a bleak future where tens of millions of people around the world are infected each year by new, untreatable organisms, we need to find a way to improve the economics of undertaking new antibiotic development.
One approach would be to give pharmaceutical companies an incentive to develop treatments for “priority infections or pathogens” identified by the CDC, FDA and leading infectious disease specialists. Companies developing antibiotics for these priority infections could be given a limited extension of exclusivity (up to 12 months) for some other drug that would provide sufficient reward for undertaking the risks of developing the antibiotic. The House Energy and Commerce Committee included this idea in its discussion draft of the 21st Century Cures Act.
Another approach would be to reform the current Medicare reimbursement rules applicable to antibiotics. Under the current regime, reimbursements to a hospital are bundled for various types of patient encounters, with the reimbursement being fixed regardless of the types of drugs that may be administered. This has the effect of discouraging hospitals from using a new, more expensive antibiotic, even when it may be the most appropriate (or only effective) drug.
When considering these infections, as a country, we need to move from focusing on the cost of an individual drug to considering the total cost of care. Utilizing the most effective antimicrobial up front is likely to decrease the total cost of care rather than increasing it. Providing an enhanced reimbursement for high-value antimicrobials — as proposed in H.R. 512 (114th Congress), The DISARM Act — would be a significant improvement.
These are just two ideas focusing on U.S. economic incentives for antibiotic development; there are certainly other good ideas. People in other countries will benefit from the leadership of the United States in developing antibiotics, but that’s not a reason to delay U.S. action while arguing over how to share the risks and costs with the rest of humanity. The bacteria with “unusual” antibiotic resistance that appeared in 27 states last year won’t necessarily be contained, so we need to reinvigorate the antibiotic development pipeline. Soon.
Dr. Gavin Corcoran is the chief medical officer of Allergan PLC.
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