The Threat of Antibiotic Resistance

Article September 16, 2013 Read time:

Projects: Antibiotic Resistance

A major report from the U.S. Centers for Disease Control and Prevention, Antibiotic Resistance Threats to the United States, 2013, confirms the growing danger of drug resistance.

Meanwhile, the pace of new antibiotic development continues to lag behind the ability of bacteria to resist new and novel drugs. The problem of antibiotic resistance has become so severe that the World Economic Forum described it as "arguably the greatest risk … to human health."¹

The report provides a snapshot of the complex issue, ranks the severity of public health threats, and emphasizes the need for policies that will foster rapid development and wise use of new antibiotics to combat this problem.

On Sept. 17, the CDC, the Infectious Diseases Society of America, and The Pew Charitable Trusts held a Capitol Hill briefing on the report and a question-and-answer session on the current state of antimicrobial resistance and ways to address it. The event featured the following speakers:

Thomas Frieden, M.D., M.P.H, director, CDC.
Victoria Nahum, founder, Safe Care Campaign, and the mother of Josh Nahum, who died from an antibiotic-resistant infection.
David A. Relman, M.D., president, Infectious Diseases Society of America.
Allan Coukell, senior director, drugs and medical devices, The Pew Charitable Trusts.

In addition, Representatives Gene Green (D-TX), and Phil Gingrey (R-GA) discussed their efforts to change public policy to address drug resistance.

Pew's antibiotics and innovation project actively seeks legislation to deliver antibiotics to the sickest patients more quickly. In January, Pew brought together a diverse group of stakeholders, including the Food and Drug Administration, the Infectious Diseases Society of America, industry representatives, health care providers, and insurers, to discuss the concept of a new regulatory approval pathway for limited-population antibacterial drugs, or LPAD. This pathway would encourage development of antibiotics that address the greatest unmet needs of patients. Read the event proceedings.

After the conference, Pew and the Infectious Diseases Society of America agreed on a set of core principles for LPAD legislation. The principles specify that the pathway would:

Be used to develop antibiotics for serious or life-threatening infections in patients who have few or no other options, probably because they have multidrug-resistant infections.
Create a special designation for these antibiotics that distinguishes them from other drugs.
Maintain the FDA's high standards for safety and efficacy.
Include a mechanism for evaluating how the pathway is used.
Provide for a pre-market review of promotional materials.
Be voluntary and would not restrict the practice of medicine.

In July, Pew and IDSA acknowledged Senator Michael Bennet (D-CO) and Senator Orrin Hatch (R-UT) and Representatives Gingrey and Green for their bipartisan interest in creating the LPAD pathway.

Such efforts call attention to the pressing issue of antibiotic resistance and encourage the development of new and different types of drugs to address it.

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