Too few antibiotics in pipeline

April 1, 2005

A public health crisis is brewing, according to a white paper issued by the Infectious Diseases Society of America (IDSA), as two trends converge: the retreat of large and small pharmaceutical companies from antibiotic discovery and development, and the emergence of pathogens with resistance to an increasingly wide spectrum of currently approved antibiotics.

The report Bad Bugs, No Drugs (available at http:// http://www.idsociety.org/) describes the public health consequences of insufficient research and development (R&D) in the field of antibiotics and drug-resistant bacteria.

The IDSA suggests legislative changes that might encourage pharmaceutical and biotechnology companies to reverse these trends.

Project Bioshield provides funding to expedite new research and development in drugs and vaccines that could be used to respond to a biological attack, but the agents targeted by Project Bioshield only include category A bioterrorism agents (anthrax, tularemia, plague, botulism, smallpox and viral hemorrhagic fevers).

Meanwhile, nosocomial bacterial infections in the United States affect approximately 2 million people each year and result in 90,000 deaths, according to the IDSA report.

Emergence of drug resistance The incidence of bacterial resistance to currently available antibiotics continues to increase.

"Practicing dermatologists are seeing a greater number of resistant organisms," says Robert S. Kirsner, M.D., Ph.D., associate professor of dermatology at the University of Miami School of Medicine.

Dr. Kirsner and colleagues reported their findings in a recent publication (J Am Acad Dermatol. 2004;50:845-849).

"Often the original antibiotic prescribed needs to be changed because either a patient fails to respond or the laboratory culture results suggest they might fail to respond," Dr. Kirsner says.

New antibiotics may need to be given intravenously and are frequently more expensive. Consequently, as simple infections become refractory to treatment, hospital stays are longer and more expensive drugs are prescribed, increasing the overall cost of healthcare.

Downside for Big Pharma Why does Big Pharma shy away from antibiotic drug development? Economic considerations generally are cited as the primary reason. Most, if not all, major pharmaceutical companies are shareholder-owned, and cannot afford to ignore the "bottom line."

Most patients are prescribed antibiotics for only a short period of time; by contrast, drugs to treat chronic conditions, such as arthritis or depression, are prescribed for months or years at a time, generating a greater return on investment.

Putting aside the threat posed by increased drug resistance, a pharmaceutical company developing a new antibiotic would face "a crowded and confused marketplace that already has safe and effective antimicrobial agents available at relatively low prices," according to Steven J. Projan, Ph.D., vice president of biological technologies at Wyeth Research in Cambridge, Mass.