President Joe Biden recently delivered his inaugural address, calling for unity and bipartisanship. One area crying out for cooperation is antibiotic resistance—a health crisis that will last long after the Covid-19 pandemic.
Each year, 162,000 Americans and about 700,000 people globally die from antibiotic-resistant infections. Those numbers will skyrocket as existing antibiotics continue to lose their effectiveness. Rampant overuse is partially culpable, but so is increased reliance due to an aging population. Each time a patient takes an antibiotic, it kills off some bacteria, but those that survive can evolve into treatment-resistant superbugs.
These superbugs threaten to send us back to the medical dark ages. Antibiotics are crucial to preventing infections during procedures ranging from elective surgery to organ transplants to the ventilation of Covid-19 patients.
California doctors are no strangers to the impending superbug crisis. While our state generally takes pride in staying ahead of the curve, leading the country in catheter-associated urinary tract infections—a bacterial infection that’s become increasingly resistant to existing medicine—is not the kind of recognition we’re after.
Scientists have known for years that we desperately need new antibiotics capable of attacking specific drug-resistant bacteria. This pressing information has resulted in some funding for research and development, yet the present commercial market does not support novel FDA-approved antibiotics.
That’s because manufacturing and selling new antibiotics is a money-losing endeavor. Revenues generated from sales are ultimately much less than the cost of entering the market. Why? In the early period of superbug spread, the most resistant infections are rare—perhaps only affecting tens of thousands of patients per year. Additionally, antibiotics provide a rapid cure, often healing patients in seven days or less.
And while there isn’t a formal price cap for a novel antibiotic, the U.S. reimbursement system essentially functions as one. For many serious infections, antibiotics are prescribed intravenously in a hospital, which makes the hospital—not a private insurer or Medicare—responsible for the cost.
Hospitals lose money unless they choose older, less expensive drugs over more appropriate—but more expensive—treatments.
Put plainly, any company that invents a new antibiotic will only sell a limited number of doses at too low a price, which dooms the products to fail. At least four antibiotic start-ups have recently shuttered their doors, despite medical breakthroughs.
The company I cofounded in 2004, Achaogen, was chief among them.
Our California-based biotech firm spent 15 years and $1 billion developing an antibiotic to fight the superbug CRE, or carbapenem-resistant Enterobacteriaceae. But even after we won FDA approval and secured a spot on the World Health Organization’s essential medicines list, the broken market made it impossible for us to sustain our ongoing business let alone return a profit to our investors. Our stock value collapsed and we declared bankruptcy a mere nine months after FDA approval.
Fortunately, last year, House Speaker Nancy Pelosi allocated $500 million towards antibiotic development in a Covid-19 emergency stimulus bill that passed in the House.
It was a step in the right direction.
But in the long term, we need policies that transform the incentive structure for developing new antibiotics, and also encourage responsible stewardship.
The bipartisan Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act fits the bill. The measure would alter Medicare’s reimbursement formula to let it pay hospitals more for using the newest antibiotics when medically appropriate. By helping hospitals afford cutting-edge antibiotics, it would encourage biotech companies to invest more in research and development.
Including the DISARM Act in any upcoming Covid relief bill or health policy legislation would help fundamentally fix the broken market—and stave off a doomsday scenario.
The option stands to take no further action against antibiotic resistance. But we’d have to be comfortable with the ensuing deaths of 10 million people worldwide, each year, by 2050. And, as we’ve learned the hard way from Covid, these are not abstract figures—these could be our family members, our friends, our neighbors.
The onus is on lawmakers to work together and spur the innovation that will save lives.
Ryan Cirz is a microbiologist and a founder of Achaogen Inc. and Revagenix Inc. Opinions are the author’s own and do not necessarily reflect those of San Jose Inside. Send op-ed pitches to [email protected].