Growing antimicrobial resistance from indiscriminate use of existing antibiotics and a lack of new ones in development could mean a return to the preantibiotic era of medicine with disastrous consequences.
"We’re in a time of increasing antibiotic resistance and decreasing introduction of new antibiotic drugs ... [this] sets us up for the possibility of returning to the preantibiotic era ... you know historically the devastating consequences that people faced at that time," Dr. James Hughes, president of the Infectious Diseases Society of America, said during a press conference on April 7.
The press conference, sponsored by IDSA, was held to announce the release of the organization’s new policy paper, "Combating Antimicrobial Resistance: Policy Recommendations to Save Lives." The paper is also published in the journal Clinical Infectious Diseases (Clin. Infect. Dis. 2011;52[suppl 5] [doi:10.1093/cid/cir154]).
The incidence of antibiotic-resistant bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), Acinetobacter baumannii, Klebsiella, and others has soared in the past 2 decades. It’s estimated that each year, these infections kill nearly 100,000 U.S. hospital patients. At the same time, while 16 new antibiotics were approved between 1983 and 1987, only 2 have been approved since 2008.
One-third of Acinetobacter and 7% of Klebsiella infections reported to the National Healthcare Safety Network between 2006 and 2008 were resistant to all commonly used antibiotics.
The crisis is so alarming that the World Health Organization has made antibiotic resistance the central focus of this year’s World Health Day, the goal of which is to highlight a global public health issue of critical concern.
FDA Commissioner Margaret Hamburg echoed Dr. Hughes’s concern about the alarming situation posed by antimicrobial resistance. "The problem of antimicrobial resistance is one in which we all have a stake. ... We worry with good cause. Today, antibiotic resistance mechanisms have been reported for virtually all known antibacterial drugs available for clinical use," she said. "It is more than just hypothetical when people like Dr. Hughes talk about a return to the pre-antibiotic era, in which we no longer have effective tools to treat serious infectious disease."
In particular, the IDSA stresses the need for better stewardship of existing antibiotic drugs and to increase incentives for research and development of new antibiotic drugs by drug companies. "We must take action now ... the sad irony is that we’re facing a situation in which tried-and-true drugs are losing their value at the same time that the pipeline of new drugs to treat these diseases is distressingly devoid of innovative drugs," said Dr. Hamburg.
At the national level, two bills already have been introduced to address both of these problems—the Strategies to Address Antimicrobial Resistance (STAAR) Act and the Generating Antibiotic Incentives Now (GAIN) Act.
In the new policy paper, the IDSA also recommends:
• Creating incentives – and removing economic and regulatory disincentives – to encourage drug companies to develop new antibiotics (IDSA has proposed a goal of developing 10 new systemic antibiotics by 2020 – the 10 x ’20 initiative).
• Recalibrating and better communicating the FDA’s requirements for new antibiotic approvals.
• Funding antibiotic research and development efforts under the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority and proposed independent strategic investment firm.
• Supporting research and development for rapid diagnostic tests for use at the point of care to identify the cause of infections more quickly, in order to better use existing antibiotics.
• Designating a leader within HHS to facilitate coordination of federal agencies’ efforts and better utilize outside experts.
• Promoting the judicious use of available antibiotics in all settings – both in humans and in food animals – through better stewardship programs and infection control practices.
• Creating an antimicrobial innovation and conservation fee – charged against the wholesale purchase of antibiotics used in humans, animals, plants, and aquaculture – to help pay for drug development and stewardship.
• Strengthening public health measures – such as surveillance, data collection, and immunization – and research that leads to new interventions to limit the spread of resistant organisms.
• Establishing nonprofit public-private partnerships to invest in bringing new antibiotics to market even though the market may be a small one.
For more information, visit IDSA.