New measures, legislation aimed at antibiotic resistance: Infections cost millions, end lives ============================================================================================= * Charlotte Tucker Ricky Lanetti was a 21-year-old college football player — strong as an ox, his mother says. But he was helpless against methicillin-resistant *Staphylococcus aureus*, also known as MRSA, which killed him in just a few days in 2003. The doctors in Lanetti’s case could not save him because too little is known about MRSA and drugs to treat infections are simply not available, according to Theresa Drew, Lanetti’s mother. She spoke about the need for more and better research and drugs to treat drug-resistant bacteria during a World Health Day event held in Washington, D.C., in April. “I think it all came down to not knowing about antibiotics and not having new ones and stronger ones to help something like this,” she said. Between 1983 and 1987, the Food and Drug Administration approved 16 new antibiotics for use. But the period between 2008 and 2012 is on track for just two new antibiotic approvals. Several bills to be introduced in Congress shortly are expected to help increase those numbers. Developing new drugs is expensive and time consuming, which has led many pharmaceutical companies to abandon the path. But the dearth of new drugs in the pipeline could have dire consequences as more bacteria become resistant to drugs already on the market, according to public health professionals. Antimicrobial resistance is the outgrowth of overuse and misuse of antibiotics in human health and in animals, among other practices. According to the Infectious Diseases Society of America, MRSA, which killed Ricky Lanetti, kills more Americans every year than emphysema, HIV/AIDS, Parkinson’s disease and homicides combined. Tuberculosis, which kills 2 million people worldwide every year, more than any other infectious disease, is becoming increasingly resistant to antibiotics. The issue is of such growing concern that the World Health Organization dedicated World Health Day, April 7, to the topic, calling for increased attention to antibiotic-resistant bacteria worldwide. The financial costs are great as well, according to the Infectious Diseases Society of America. Two common hospital-acquired infections, pneumonia and sepsis, which are generally the result of antibacterial-resistant pathogens, killed 50,000 Americans and cost the U.S. health care system $8 billion in 2006. The total cost to the health care system of antibiotic-resistant infections is thought to be $21 billion to $34 billion each year. Doctors and hospitals need to develop better infection control methods and diagnostic tools so that patients can avoid catching bugs or be more accurately diagnosed when they do, said Margaret Hamburg, MD, commissioner of the Food and Drug Administration, at the World Health Day event. But even if those efforts are successful, drug-resistant bacteria will emerge, she said. “We need to build on advances in science and harness them into focused research and development efforts,” she said. The Infectious Diseases Society of America released a new paper in April, making recommendations to address the antibiotic resistance problem. Those recommendations include creating incentives for antibiotic research and development, recalibrating and better communicating FDA’s requirements for new antibiotic approvals, supporting research and development for rapid diagnostic tests and creating a fee to help pay for drug development and stewardship. Two bills in the pipeline in the House of Representatives may also provide a way forward. Rep. Phil Gingrey, R-Ga., said he will soon reintroduce the Generating Antibiotic Incentives Now Act. He introduced the bill in September but Congress did not vote on it. The bill provides incentives for the development of “qualified infection disease products,” including five additional years of data exclusivity, six months of additional exclusivity for products with companion diagnostics, priority review by FDA, eligibility for fast-track review by FDA and a requirement for the review and possible revision of FDA guidelines regarding clinical trials and other requirements for approval of antibiotics. “Every day we fail to act, we lose more ground to antimicrobial resistance,” Gingrey said. Rep. Jim Matheson, D-Utah, is also working on a bill aimed at increasing the number and types of antibiotics in the pipeline. At the World Health Day event he said he plans to reintroduce the Strategies to Address Antimicrobial Resistance Act, which he has introduced during previous legislative sessions, in the near future. “This bill is a rare opportunity to bring multiple partners together to address this public health issue through strong surveillance, control and research,” he said. Previous versions of the bill proposed reauthorizing a task force on antimicrobial resistance and establishing an advisory board of experts as well as an office on antimicrobial resistance reporting to the secretary of health and human services. The bill also proposed creating a blueprint for antimicrobial resistance research at federal agencies and collecting available data to allow the government to better assess the antimicrobial resistance problem. The new bill is expected to be similar to previous versions. On a global scale, WHO has identified antimicrobial resistance as one of the three greatest threats to human health. To combat the problem, the Infectious Diseases Society of America debuted its “10 x ’20” initiative last year. The program calls for developing 10 new systemic antibacterial drugs by 2020. The Infectious Diseases Society of America’s policy paper, “Combating Antimicrobial Resistance: Policy Recommendations to Save Lives,” is available at [www.idsociety.org](http://www.idsociety.org). * Copyright The Nation’s Health, American Public Health Association