April 07, 2011
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On World Health Day, organizations intensify fight against antibiotic-resistant bacteria

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Despite the surge during the past 20 years in antibiotic-resistant bacteria — including methicillin-resistant Staphylococcus aureus, Acinetobacter baumannii and Klebsiella pneumonia — only two new antibiotics have been approved since 2008, and only one new antibiotic has been approved since the “10 x ’20 initiative” was launched by the Infectious Diseases Society of America in April 2010, according to a press release.

For this reason, members of the IDSA, FDA, CDC, WHO and others came together on this World Health Day to address this year’s focus on antibiotic resistant bacteria and the lack of antibiotics to treat them.

“We face a dual challenge with antibiotic resistance. We talk about antibiotics as a car that is broken, but our road of antibiotic use is also broken,” Arjun Srinivasan, MD, medical director of the CDC’s Get Smart for Healthcare, said during a media telebriefing. “We need new drug development and the way in which we use these new drugs. One of CDC’s major focuses is improving the way we provide antibiotic use in inpatient settings with programs such as Get Smart to help clinicians use antibiotics better. This is a major focus and must be a major strategy. We cannot address one side without addressing the other.”

New policy paper

A new policy paper released today from IDSA and published in Clinical Infectious Diseases, “Combating Antimicrobial Resistance: Policy Recommendations to Save Lives,” addresses the many issues of antibiotic resistance and includes recommendations on:

  • Creating incentives for antibiotic research and development so that companies find developing new antibiotics a viable business endeavor;
  • Recalibrating and better communicating of 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;
  • 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 through better stewardship programs and infection control practices;
  • Creating an antimicrobial innovation and conservation fee to help pay for drug development and stewardship; Strengthening public health measures and research that lead to new interventions to limit the spread of resistant organisms; and
  • Establishing nonprofit public-private partnerships to invest in bringing new antibiotics to market.

“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,” James M. Hughes, MD, FIDSA, president of IDSA, and Infectious Disease News Editorial Board member, said in a press release. “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.”

Legislative action

As previously reported in Infectious Disease News, the IDSA backs legislation currently before Congress, including S.2313/H.R. 3697, Strategies to Address Antimicrobial Resistance (STAAR) Act, and H.R. 6331, Generating Antibiotic Incentives Now (GAIN) Act.

The GAIN Act focuses on stimulating antibiotic and related diagnostic development by extending the exclusivity period for new qualified infectious disease products; gives priority regulatory review to applications for these kinds of products; and requires ongoing review of FDA guidelines for conducting clinical trials for antibiotics, according to the IDSA.

The STAAR Act aims to strengthen federal antimicrobial resistance surveillance, prevention and control, and research efforts, as well as enhance the collection of critical information on the use of antibiotics in humans and animals.

“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,” 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, said in a press release. “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.”

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