Infectious Diseases Society of America Says Initiatives to Battle Life-Threatening Bad Bugs Must be Implemented Now
[April 7, 2011, WASHINGTON] - To head off a health care disaster, the Infectious Diseases Society of America (IDSA)
has developed a plan to combat deadly antibiotic-resistant "super bugs" and is rolling out the multi-pronged plan today, on World Health Day
Infections are becoming increasingly resistant to existing antibiotics, while the number of new antibiotics being
developed has plummeted. IDSA warns that unless sweeping actions are taken now, the future could resemble the days before these miracle
drugs were developed. People will die of common infections and many medical interventions we take for granted - surgery, chemotherapy,
organ transplantation, and premature infant care - will no longer be possible.
IDSA's new policy paper, "Combating Antimicrobial Resistance: Policy Recommendations to Save Lives," is being released at a
press conference and published in the journal Clinical Infectious Diseases. The paper is
available online .
"The way we've managed our antibiotics for the past 70 years has failed. Antibiotics are a precious resource, like energy,
and we have a moral obligation to ensure they are available for future generations," said IDSA President James M. Hughes, MD, FIDSA. "IDSA
has a comprehensive, multifaceted plan to address this crisis, but time is running out. If such measures are not implemented now by
Congress, federal agencies and health care providers across the country an increasing number of lives will be devastated and lost."
The incidence of antibiotic-resistant bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), Acinetobacter baumannii,
Klebsiella, and others has skyrocketed over the past two decades. Each year, these infections kill nearly 100,000 U.S. hospital patients
and are increasingly affecting healthy people as well. But while 16 new antibiotics were approved between 1983 and 1987, only two have
been approved since 2008. The crisis is so dire, the World Health Organization has made antibiotic resistance the central focus of
this year's World Health Day, a day held each year to highlight a global public health issue of critical concern.
The complex problem is caused by several factors. Antibiotics are becoming less effective due to over-prescription and
improper use (up to half of antibiotic use is unnecessary or inappropriate) as well as bacteria's natural ability to evolve and
develop resistance to antibiotics. Treating these resistant bugs costs the U.S. health care system an estimated $21 billion to
$34 billion annually. Just when we most urgently need new drugs, a market failure coupled with lack of clear guidance from
the Food and Drug Administration (FDA) about how to design studies for new antibiotics has caused research and development
(R&D) efforts to slow to a standstill. Drug companies now are shifting their research dollars to developing drugs that
treat chronic conditions, such as diabetes and high blood pressure. These drugs are less challenging to bring to
market than antibiotics from a regulatory standpoint and are much more lucrative because they are used for
years, rather than days or weeks, as antibiotics are.
In 1990, there were nearly 20 pharmaceutical companies with large, strong and active antibiotic R&D programs. Today, there are just
two, and only a small number of companies have more limited programs.
IDSA supports legislative and administrative action to address the problem, and two bills, the Strategies to Address Antimicrobial
Resistance (STAAR) Act and the Generating Antibiotic Incentives Now (GAIN) Act, are good first steps, but IDSA believes they can do
more. To turn the tide, IDSA recommends:
- Creating incentives (and removing economic and regulatory disincentives) for antibiotic R&D so companies find developing new
antibiotics a viable business endeavor. IDSA's goal is to have 10 new systemic antibiotics by 2020, known as the 10 x '20 initiative.
Since the initiative was launched in April 2010, one new antibiotic has been approved.
- Recalibrating and better communicating FDA's requirements for new antibiotic approvals.
- Funding antibiotic R&D efforts under the Department of Health and Human Services' (HHS) Biomedical Advanced Research and
Development Authority (BARDA) and proposed independent strategic investment firm.
- Supporting R&D for rapid diagnostic tests for use at the point of care to identify the cause of infections more quickly.
- 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 (human and agricultural) through better stewardship programs
and infection control practices.
- Creating an Antimicrobial Innovation and Conservation (AIC) Fee to help pay for drug development and stewardship. The fee would
be charged against the wholesale purchase of antibiotics used in humans, animals, plants, and aquaculture.
- Strengthening public health measures (e.g., surveillance, data collection, immunization) and research that lead to new interventions
to limit the spread of resistant organisms.
- Establishing non-profit Public Private Partnerships to invest in bringing new antibiotics to market even though the market may be a
"Infectious diseases specialists around the country can tell you stories about formerly healthy patients who died because physicians ran
out of antibiotics that worked," said Brad Spellberg, MD, FIDSA, associate professor of medicine at the Geffen School of Medicine at the
University of California at Los Angeles, Los Angeles Biomedical Research Institute. "We're facing a day in the not-too-distant future
where people will be outraged with our inability to treat infectious diseases, and wonder why something wasn't done earlier. The
IDSA plan lays out innovative approaches that can and should be enacted, but they must be done now. The longer we wait, the
bigger and more costly the problem will become both in terms of lives lost and health care expenditures."
Learn more about details of the IDSA Combating Antimicrobial Resistance plan.
The Infectious Diseases Society of America (IDSA) is an organization of physicians, scientists, and other health care
professionals dedicated to promoting health through excellence in infectious diseases research, education, patient care,
prevention, and public health. The Society, which has more than 9,000 members, was founded in 1963 and is based in
Arlington, Va. For more information, see www.idsociety.org .
"Reproduced with permission - "Infectious Diseases Society of America (IDSA)"
Infectious Diseases Society of America (IDSA)