Reducing Deaths from COVID-19: What Can We Learn from Rare Disease?

The COVID-19 outbreak has been exposing many of the existing cracks in the foundations of our healthcare system.  But it is not just the lack of equipment, shortage of healthcare workers and hospital beds, and a missing plan for pandemics that are hampering our collective response.  

Some patients are dying not because of the virus itself, but because of antibiotic-resistant bacteria. A Lancet study of 99 COVID-19 patients, found that patients – especially the severely ill – were at risk of co-infection from bacteria, including A. baumannii, an antibiotic-resistant strain that can cause septic shock, organ damage and sometimes death. Populations most vulnerable to infection with multi-drug resistant organisms include those with substantial immunosuppression, including cancer patients and transplant recipients. 

The problem of antibiotic-resistant bacteria is not new. The Centers for Disease Control and Prevention reported on the threat in 2013, but deaths and infections continue to grow. A 2019 CDC report on Antibiotic Resistance Threats in the United States noted that more than 2.8 million drug-resistant infections occur in the U.S. each year, and 35,000 people die as a result. Like COVID-19, antibiotic resistance spreads easily across the globe. The report lists 18 antibiotic resistant bacteria and fungi that are currently considered “urgent and serious” threats. 

Solving this problem requires multiple strategies – including the development of new antibiotics. That’s not happening, at least in part because of the lack of market-incentive. The newest drugs are used as a last resort when other antibiotics fail, which makes sense medically, but means it’s difficult for drug companies to make back their investments.

To incentivize drug companies to develop new antibiotics, it would make sense to learn from rare disease –where small populations are the norm, not the exception. The Orphan Drug Act of 1983 provided incentives for rare disease drug development, including 7 years of market exclusivity, tax breaks for research and development expenses, and a waiver on millions of dollars in fees. The result was a dramatic increase in investment in rare disease. In 2019, 21 of the Center for Drug Evaluation and Research (CDER)’s 48 novel drug approvals (44%) went to orphan drugs to treat rare diseases. 

The Orphan Drug Act has proven that financial incentives save lives.  For small populations, hands off the market just doesn’t work. Using incentives similar to those used for rare disease can help us better prepare to meet the threat of antibiotic-resistant bacteria.   

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