Antibiotic resistance must be addressed immediately

Without antibiotics, minor injuries could be life threatening and lifesaving therapies and surgeries would be impossible. Yet, we are in the midst of a crisis that threatens to bring us back to an era before these important medications existed. Congress must act now to protect us all from this public health catastrophe.

It is impossible to overstate how antibiotics have transformed our lives. Antibiotics gave doctors the tools to cure a disease, allowing science to focus on developing medical miracles like chemotherapy for cancer, open-heart surgery, organ transplantation and joint replacements. These all seem routine to us today and would be too dangerous if we didn’t have antibiotics to prevent or combat the infections that frequently accompany them.

{mosads}Antibiotics gave us all peace of mind in the face of a cut finger or a baby with a spiking fever. But along the way, peace of mind turned to complacency. Today we are increasingly experiencing what we thought was a relic of history — the minor injury or illness that kills or maims because there is no way to rein in the bacteria running rampant as a result.

The Centers for Disease Control and Prevention’s (CDC) recent report, Antibiotic Resistance Threats in the United States, 2013, conservatively estimates that at least 23,000 Americans will die this year due to antibiotic resistant infections and that these infections cost our healthcare system $20 billion annually.

The actual figures are likely far higher, but our current surveillance and data collection capabilities cannot capture the full burden.

At a time when we desperately need new antibiotics to treat new and evolving superbugs, the pipeline of antibiotics in development is nearly dry. In 1990, according to the CDC report, there were almost 20 pharmaceutical companies with large antibiotic research and development programs; today there are two or three large companies with strong, active programs and a handful of small companies with more limited programs.

There are many reasons for this public health crisis: the antibiotic resistance caused by inappropriate use and overuse of these miracle drugs in humans and animals, the financial and regulatory disincentives for companies to develop more antibiotics, and the way in which microbes cleverly adapt to defend themselves against the effects of antibiotics.

This crisis needs to be addressed now, and legislative action is needed to move us forward:

Fill the drug pipeline

Antibiotics are not moneymakers. They are typically taken for a short period of time, making them a low R&D priority compared to medications to treat chronic conditions such as heart disease or diabetes. We need to provide tax incentives, as proposed by the Infectious Diseases Society of America, which would provide a tax credit to defray the high costs of phase 2 and phase 3 clinical testing.

This would be a much-needed complement to the important first step Congress took in 2012 with passage of the Generating Antibiotic Incentives Now (GAIN) Act as part of the FDA Safety and Innovation Act. GAIN provides additional market exclusivity for new antibiotics that treat serious or life-threatening infections. It’s a start, but it’s not enough.

Get needed drugs to patients efficiently

We need legislation to streamline the process of getting urgently needed new antibiotics to patients who need them. The pathway would allow the Food and Drug Administration to approve certain drugs for narrow use based on smaller clinical trials than required for more widely used antibiotics.

Under the Limited Population Antibacterial Drug approval system, drug companies will still have to show that a drug’s benefits outweigh the risks in patients with serious infections. It would be similar to the successful Orphan Drug Program that encourages the development of drugs for rare disorders. As with orphan drugs, these limited use, powerful antibiotics represent the only hope for patients suffering from drug resistant infections.

Combat resistance

Getting new drugs to market, as urgent as it is, would be time and money wasted if the federal government fails to address the problem of antibiotic resistance. We need federal leadership and coordinated efforts to collect data, track drug resistance and monitor the use of antibiotics in humans. We need improved prevention and efforts to promote appropriate use of the right antibiotics at the right doses for the right reasons.

The Strategies to Address Antimicrobial Resistance (STAAR) Act, introduced in the House by Rep. Jim Matheson (D-Utah), and soon to be introduced in the Senate by Sen. Sherrod Brown (D-Ohio), would improve federal leadership of resistance activities and enhance prevention, surveillance, data collection and research, all in line with the CDC’s recommendations.

We cannot overstate the urgency of this antibiotic crisis. Those of us working in the field of infectious diseases agree: If we don’t act now, the medical treatments, both routine and extraordinary, that save and improve lives every day will become a thing of the past.

Boucher is director of the infectious diseases fellowship program and staff physician at Tufts Medical Center, and associate professor of medicine at Tufts University School of Medicine. She is a member of the Infectious Diseases Society of America’s Board of Directors and Antimicrobial Resistance Committee and serves in advisory roles related to antibiotic development for some pharmaceutical companies.