Incentives urged to spur antibiotic development

Novel drugs are needed to combat lethal, resistant and increasingly widespread infections, says an infectious disease group.

By Susan J. Landers, amednews staff. March 20, 2006.

Washington -- As drug-resistant microbes continue to take a toll on even the youngest and healthiest members of the community, infectious diseases specialists warn that few new and effective antibiotics are in the works.

The Infectious Diseases Society of America released a hit list of six particularly worrisome microbes at a March 1 briefing during which they renewed a plea to Congress to pass legislation that would encourage pharmaceutical companies to develop new, innovative treatments.

Worrisome bugs
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Antimicrobials that go beyond the "me too" drugs are critically needed, the society noted. For instance, drug-resistant pneumonia is a reality even among young children, and it has become increasingly difficult to treat urinary tract and wound infections as they become resistant to more antibiotic classes, according to IDSA.

"In the past, it appeared we were keeping up with the emergence of resistance because the pharmaceutical industry was keeping up," said IDSA President Martin J. Blaser, MD, professor of internal medicine at New York University Medical Center. "But now, the discovery pipeline is drying up, and few new antibiotics are being developed," he said at the briefing.

Market forces are not likely to help, said George H. Talbot, MD, lead author of an article on the issue in the March 1 Clinical Infectious Diseases, also at the briefing. "It's much more profitable for a pharmaceutical company to make a cholesterol drug that you take for a lifetime than an antibiotic you take for a week."

Although there are a few antibiotics on the horizon, they aren't likely to be effective against the infections that are causing the biggest problems, Dr. Talbot said. He and other researchers compiled the IDSA hit list, singling out the bugs that were particularly dangerous, posed unique resistance factors or for which no antibiotics are in development to treat.

IDSA is urging Congress to advance incentives. They include 10 years of market exclusivity for firms that produce antibiotics that represent a significant advance over available drugs and that target serious and life-threatening diseases or conditions -- a concept that has worked in the past for pediatric and orphan drugs. In addition, IDSA is seeking tax credits for facilities that manufacture or develop the new drugs and an independent commission to identify the most serious conditions for which the incentives should apply.

Quick action is necessary, the group said. "Superbugs are not waiting and neither should we," Dr. Blaser added.

ADDITIONAL INFORMATION:

Worrisome bugs

Methicillin-resistant Staphylococcus aureus: Constitute the majority of health care-associated infections, increasing hospital stays, deaths and costs; no longer considered a primarily hospital-acquired infection.

Escherichia coli and Klebsiella species: Major causes of urinary tract, gastrointestinal tract and wound infections; becoming resistant to a number of antibiotic classes; frequency of outbreaks is increasing.

Acinetobacter baumannii: A growing cause of hospital-acquired pneumonia; mortality rates range from 20% to 50%; drug-resistant strains becoming more prevalent; soldiers wounded in Iraq and Afghanistan are returning with highly resistant Acinetobacter wound infections.

Aspergillus: A growing problem among immunocompromised patients such as cancer patients, organ transplant recipients and people with HIV.

Vancomycin-resistant Enterococcus faecium: Major cause of bloodstream infections, infections of the heart, meningitis and intra-abdominal infections; a recent survey of 494 U.S. hospitals found a VRE rate of 10% across all patient groups and as high as 70% among high-risk groups.

Pseudomonas aeruginosa: Causes severe, potentially life-threatening infections, particularly in immunocompromised patients; rates of P. aeruginosa hospital-acquired pneumonia have nearly doubled, from 9.6% in 1975 to 18.1% in 2003; poses particular threat to children with cystic fibrosis.

Source: Clinical Infectious Diseases, March 1