Skydiving instructor Josh Nahum survived a parachuting accident in 2006 only to die eight weeks later from an infection he acquired in the hospital. His killer was a so-called gram-negative pathogen, a bacterium immune to nearly all treatments.
Earlier this year, a Chicago hospital saw the largest outbreak to date of an illness resistant to even “last resort” antibiotics. We desperately need new, more powerful medications to fight these drug-resistant superbugs.
Today, however, our own health care system often stands in the way. Fortunately, with the right financial and regulatory incentives, pharmaceutical companies can develop new antibiotics capable of preempting devastating epidemics.
All antibiotics become less effective over time as pathogens evolve and develop resistance to existing agents. Misuse and overprescription have worsened the problem. A recent study of emerging infectious diseases found drug resistance to be nearly three times greater today than in 1940; in 2013, for the first time, the CDC issued a list of resistant bacteria categorized as a serious or urgent threat.
New drugs are essential. But perversely, antibiotic development is at an all-time low. In the 1980s, the Food and Drug Administration (FDA) approved 30 new antibacterial agents; since the late 1990s, there have hardly been half that number of new approved agents. Our arsenal of effective treatments is emptying rapidly.
Why the drought? Pharmaceutical research is expensive. On average, developing a new medication costs $1 billion. Antibiotics also face special regulatory hurdles, including less-than-optimal FDA guidance in clinical testing and confusing rules for doctors prescribing them.
Because new antibiotics are rarely profitable and pharmaceutical companies have a fiduciary duty to their stockholders, they are forced to concentrate on developing medications that offer a better return on investment. An average neurological drug earns seven times more than the most successful antibiotic, for example. The disparity is greater for antibiotics that target less common threats – like the untreatable gram-negative bacteria that killed Josh Nahum.
Research pharmaceutical companies are in the business of inventing new cures. It’s time to create incentives for them to develop new antibiotics and ensure that indiscriminate prescribing doesn’t cause new problems. The solutions are threefold:
• Doctors need better data and guidance. Increased funding for agencies like the CDC could help better track infections and patterns of drug resistance. Health care agencies and organizations have started to develop clinical treatment guidelines for the use of antibiotics in select infections. However, additional guidelines are needed and emphasis on prescriber adherence to these treatment guidelines is critical.
• Policymakers must ease the regulatory burden on developing new drugs. On its own, the FDA can continue to improve its fast-track approval process. Legislation currently before Congress called the Antibiotic Development to Advance Patient Treatment (ADAPT) Act would create a special approval track at the FDA, building on the success of a 2012 law in creating a better regulatory incentive structure.
• Finally, we must create financial incentives to spur innovative drug research, especially for the rare but lethal superbugs. The European Union already offers tax credits for antibiotic R&D, and in partnership with the pharmaceutical industry, it provides more than $272 million in direct research funding. The United States should follow suit.
The cost of inaction will be enormous. The CDC warns that more than two million illnesses and 23,000 deaths occur each year as a result of antibiotic resistance. As more pathogens develop drug resistance, those numbers will no doubt increase.
One need only glance back in time to imagine a future without strong antibiotics. More soldiers in the Civil War died from illness than battlefield injury. The top three causes of all deaths in 1900 were infectious diseases.
The near elimination of such misery was a crowning achievement of the past century. Unless we take steps today to encourage new drug development, the cost in lives from an epidemic resistant to current antibiotics will be staggering.
Mark W. Garrison is a pharmacy professor at Washington State University.