| Special Announcements |
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Hearing Announcement: The Health Subcommittee of the House Energy and Commerce Committee will hold an April 28 hearing on "Antibiotic Resistance and the Threat to Public Health." The hearing will be held at 2:00 p.m. in Room 2123 of the Rayburn House Office Building. Please check the Energy and Commerce Committee website for further details and a witness list.
Briefing Announcement: The Infectious Diseases Society of America (IDSA) will sponsor a congressional briefing, entitled "Antibiotic Resistance and the Dry Antibiotic Pipeline: Saving Patients' Lives and Protecting Public Health," on May 11th from noon to 1:00 p.m. in the Congressional Visitors Center South Committee Meeting Room. View the briefing flyer.
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| Antibiotic Resistance: A Major Public Health Problem Requiring Multiple Solutions |
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Antibiotic-resistant infections kill tens of thousands of Americans each year and have been estimated to cost the U.S. health care system between $21 and $34 billion annually. These infections are painful, difficult to treat, and frequently recur. For nearly a decade, IDSA has raised concerns about the imbalance between the dwindling antibiotic pipeline and the significant clinical need for new antibiotics to treat an increasing number of drug-resistant infections.
A five-point strategy is needed to address the complex, multi-cause antibiotic resistance problem:
- Fix the broken antibiotic drug pipeline by adopting new statutory incentives, assuring a clear regulatory pathway at the Food and Drug Administration (FDA), and potentially creating a new public-private partnership. IDSA's new 10 x '20 initiative provides a measurable goal and a framework for action;
- Pass the Strategies to Address Antimicrobial Resistance (STAAR) Act;
- Stop inappropriate uses of antibiotics on the farm (i.e., growth promotion, feed efficiency, routine disease prevention);
- Promote good antibiotic stewardship practices in both human and veterinary clinical settings; and
- Treat antibiotic resistance as a global health issue.
New funds also are urgently needed. Last month, IDSA testified that an additional $36 million is needed for FDA's antibiotic resistance and antibacterial drug review programs and to support new regulatory science initiatives. IDSA also supports increasing antibacterial resistance and antibacterial drug discovery and development research funding to $500 million at the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH). IDSA objects to the Administration's proposed cut to the Antimicrobial Resistance program at the Centers for Disease Control and Prevention (CDC) and instead favors increasing this program to a total of $40 million.
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| Antibiotic Resistance in Health Care Facilities and Communities: a Growing Problem, but Solvable |
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The Strategies to Address Antimicrobial Resistance (STAAR) Act:
In 1995, the Congressional Office of Technology Assessment said, "The impacts of antibiotic-resistant bacteria can be reduced by preserving the effectiveness of current antibiotics through infection control, vaccination and prudent use of antibiotics, and by developing new antibiotics specifically to treat infections caused by antibiotic-resistant bacteria."
To address these concerns, Congress authorized a federal interagency task force, co-chaired by CDC, NIH and FDA, to examine the antibiotic resistance problem. The task force in 2001 published the Public Health Action Plan to Combat Antimicrobial Resistance. Thirteen key elements (out of a total of 84 elements) highlighted within the Action Plan were deemed critically necessary to address the growing resistance crisis. Unfortunately, due to inadequate coordination of efforts and lack of sufficient oversight and funding, neither the task force nor the Action Plan has accomplished these goals. The Action Plan was revisited in December 2007, but a revised Action Plan still has not been released two and a half years later. Please see IDSA's 2009 letter to the heads of the eleven agencies represented on the interagency task force urging the Action Plan's release and for the inclusion of benchmarks to measure future progress.
Representative Jim Matheson (D-UT) introduced the STAAR Act (H.R. 2400) to address the continued lack of coordination, accountability and progress in federal antibiotic resistance efforts. The legislation strengthens existing federal efforts by establishing an Antimicrobial Resistance Office (ARO) within the Department of Health and Human Services' (HHS') Office of the Secretary. The Director of ARO will serve as the director of the existing interagency task force. The STAAR Act also establishes a Public Health Antimicrobial Advisory Board (PHAAB) comprised of infectious diseases, public health, pharmacy, veterinary and other experts who will provide much needed advice to the ARO director and the task force.
Of importance, the STAAR Act will strengthen existing surveillance, prevention and control, data collection, and research activities to reduce the inappropriate use of antibiotics, and will create new tools to detect, prevent and treat drug-resistant "bad bugs." T he STAAR Act has been endorsed by 26 organizations.
For more in-depth information on the STAAR Act, including Representative Matheson's statement upon the bill's introduction, please see IDSA's STAAR Act webpage.
Antibiotic Resistance in Your State: Antibiotic resistance affects every U.S.
state. For a summary of the problem in your state, go to IDSA's state-by-state map. We also list contact information for your state epidemiologist who can provide more up-to-date information or answer any questions about the problem back home.
Health Care Costs Associated with Antibiotic-Resistant Infections: A new study
in Infection Control and Hospital Epidemiology found that the cost of treating patients with methicillin-resistant Staphylococcus aureus (MRSA) was significantly higher than treating patients with S. aureus that responds to methicillin, known as methicillin-susceptible S. aureus (MSSA). The median cost for six months of treatment of an MRSA infection was $34,657 compared to $15,923 for treatment of an MSSA infection. The higher costs were the result of longer hospital stays, more laboratory and imaging tests, more rehabilitation services, and greater mental, social and spiritual costs. More information on the costs of resistance can be found in the March 2010 Policy Update.
Vancomycin-Resistant Infection Identified in Pennsylvania: A patient in
a Pennsylvania hospital was recently diagnosed with an extremely rare staph infection, known as vancomycin-resistant Staphylococcus aureus or VRSA. This is the 11th known case of VRSA in the United States. VRSA is especially problematic as it is resistant to vancomycin, the powerful antibiotic physicians often use when others fail. Should this dangerous organism spread further, we will be in dire straits. More information on the Pennsylvania case can be found in this Philadelphia Inquirer article.
Another Antibiotic-Resistant Superbug Threatens Hospital Patients: Another
resistant infection receiving increased scrutiny is Clostridium difficile ( C. diff), which can lead to severe diarrhea, ruptured colons, perforated bowels, kidney failure, blood poisoning and death. CDC estimates there are 500,000 cases of C. diff. infection annually in the U.S., contributing to between 15,000 and 30,000 deaths. Elderly hospitalized patients are at especially high risk. An example of the increased visibility of this infection is this story by KDVR in Denver.
Antibiotic Resistance and U.S. Soldiers: Drug-resistant bacteria can cause
serious infections and death in any American, but a specific type of "superbug" is attacking soldiers who have served in Iraq and Afghanistan. Acinetobacter baumannii may be multidrug-resistant, which means it is difficult to treat and difficult to kill once it enters the body. A 2006 study conducted at Walter Reed Army Medical Center in Washington, DC, found that of 75 patients testing positive for the bacteria, 89 percent were resistant to at least three classes of antibiotics and 15 percent were resistant to five classes. The bacteria also are able to live on environmental surfaces in hospitals placing additional soldiers/patients at risk.
Acinetobacter baumannii is commonly found in water and soil in Iraq, Afghanistan and other locations. The bacteria can enter the body through deep combat wounds or burns. Once inside the bloodstream, the bacteria can wreak havoc causing potentially fatal infections, including pneumonia, bloodstream infections and meningitis. This means that even a soldier who is strong enough to survive a combat injury sustained in Iraq or Afghanistan, can sometimes lose the battle against this tiny, but deceptive enemy. A recent article in the Annapolis Capital looks at this devastating infection and the complications involved in treating it.
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| Antibiotic Research and Development (R&D) |
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Prior generations gave us the gift of antibiotics. Today, we have a moral obligation to ensure this global treasure is available for our children and future generations.
The 10 x '20 Initiative: The antibiotic pipeline is nearly empty. The CDC has
recognized this dangerous situation in its new Safe Healthcare blog. The current situation has created very real clinical challenges in physicians' ability to treat infectious diseases. In response, IDSA launched the 10 x '20 initiative; the inaugural statement appears in the April 15th issue of the journal Clinical Infectious Diseases (CID). The goals of this initiative are simple: we need a global commitment by the U.S. government and other governments to create a sustainable antibiotic R&D enterprise, which in the short-term can produce 10 new antibiotics by 2020. To achieve the 10 x '20 goal, it will be necessary to bring together experts from the industrial, medical, scientific, policy, regulatory and financial communities to determine the right combination of incentives that will work.
Regulatory Uncertainty: One key area continually recognized as an impediment
to the development of new antibiotics is lack of regulatory clarity in FDA's drug review process. A new blog, Antibiotics: The Perfect Storm, is focusing on the problematic regulatory issues. |
| Antibiotic Use and Resistance on U.S. Farms |
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Another area of serious concern is the inappropriate use of antibiotics in food animal production.
Antibiotic Resistance and Public Health Briefing: Keep Antibiotics Working
(KAW), the Union of Concerned Scientists (UCS), Pew Campaign on Human Health and Industrial Farming, the American Public Health Association (APHA) and IDSA sponsored an April 14th briefing on antibiotic use on farms and implications for public health. Speakers discussed the alarming increase in human antibiotic-resistant infections and the state of the science linking this phenomenon to non-therapeutic antibiotic use on farms. The panel also discussed the potential trade implications for U.S. farmers associated with antibiotic use. View the presentations.
Former FDA Commissioner Donald Kennedy Speaks Out: In this month's New
York Times, Donald Kennedy, former FDA Commissioner and professor emeritus of environmental science at Stanford, spoke in opposition to the inappropriate use of antibiotics in food animals stating "we don't have the luxury of waiting any longer to protect those at risk of increasing antibiotic resistance."
Pew Charitable Trust Briefing on Alternatives to Antibiotic Use in Food Animals:
Last month, the Pew Charitable Trusts held a briefing on "Alternatives to Routine Antibiotics Use in Food Animals." Bill Niman from Niman Ranch and Steve Ells, the co-CEO of Chipotle, joined other representatives from antibiotic-free farms to discuss their experiences and share their successes in farming without non-therapeutic use of antibiotics in the feed and water of animals that are not sick, stressing that antibiotic-free farming is profitable, marketable, and feasible. View the presentations.
Appropriations Testimony on FDA Funding: The KAW coalition and UCS,
with the support of 108 other organizations, submitted written testimony to the House Subcommittee on Agriculture Appropriations supporting funding for essential research and data collection related to antibiotic-resistance and the non-therapeutic use of antibiotics in animal agriculture. The groups specifically requested the FDA receive an additional $5 million to finish, update, and publish reviews on the safety of antimicrobials important in human medicine currently used for non-therapeutic purposes in food-producing animals, as well as an additional $3 million for the National Antimicrobial Resistance Monitoring System (NARMS) at FDA, CDC and the Department of Agriculture.
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| Antibiotic Stewardship |
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IDSA and the Society for Healthcare Epidemiology of America (SHEA) have developed guidelines containing good antibiotic stewardship practices for use in health care facilities. We are now seeking opportunities to promote the uptake of these practices in collaboration with CDC and other government agencies.
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| Antibiotic Resistance: A Global Problem |
Antibiotic resistance is a serious problem in all parts of the world including the Asia-Pacific region, Latin America, Europe, and North America. Antibiotic-resistant infections do not respect national borders, and infections in one part of the world can quickly and easily spread to other parts of the world—making antibiotic resistance truly a global health problem. U.S. support is essential to address massive gaps in our ability to measure drug-resistant bacteria in developing countries and to prevent virulent new strains from spreading between countries. Better laboratories and rapid new diagnostics are among the vital steps needed to combat this growing global health threat. Because of poor surveillance, antiquated diagnostics, and inadequate lab capacity, the vast majority of people with drug-resistant bacterial infections are never diagnosed or treated. Drug-resistant tuberculosis (TB) is an important example of the global problem, according to a new IDSA Center for Global Health Policy report, " Death by Drug-Resistant TB and How to Stop It."
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