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     4. Antibiotic Development Pipeline

4. Antibiotic Development Pipeline

Investment in drug research and production has reached a staggering US $1.2 billion over a 10- to 15-year period (Knowles 2010). The IDSA has as one of its policy foci the drying up of the pipeline of new antibiotics (Spellberg et al. 2004; Boucher et al. 2009). Pharmaceutical companies have found the antibiotics market to be more difficult than and not as profitable as that for drugs to treat chronic illness and lifestyle issues. Approximately 2 million people acquire bacterial infections in the United States and 90,000 die as a result. The IDSA notes that about 70% of those infections are resistant to at least 1 drug. 

The FDA review and approval of new antibiotics has declined 56% during the last 20 years according to a 2004 IDSA assessment. In 2000, 1 in every 10,000 compounds that entered drug discovery was estimated to make it to market, with an average cost for development in excess of US $800 million. Given the high risks associated with new drug development, new financial incentives are needed to encourage the exploration for new therapeutic agents. Government and professional organizations can develop policies and allocated resources to maintain an adequate pipeline of antibiotics and vaccines targeting AMDR. The rate of the arrival to the US market of different antimicrobial drugs is shown in Figure 2. Some of the newer antibiotics, such as tigecycline, have been found to be no better than treatment with standard antimicrobial agents, carry a higher risk of clinical failure and patient mortality, and should not be used as a monotherapy regimen (Yahav et al. 2011; Tasina et al. 2011). 

Please refer to Appendices A and B at the end of the Syllabus to view the classification of the antibiotic drugs and the top 8 most prescribed drugs, currently at risk of becoming ineffective due to AMDR. 

Figure 2. Decadal Release of New Antibacterial Drugs (1910-2010)


Table of Contents

SECTION ONE: The global threat of AMDR
SECTION TWO: Understanding AMDR
    1. Etiology and Epidemiology
    2. Incidence and Prevalence of Microbial Resistance
    3. Major AMDR Pathogens
       a. Acinetobacter baumanii
       b. Clostridium difficile
       c. Escherichia coli
       d. HIV/AIDS and Sexually Transmitted Infection
       e. Influenza virus
       f. Malaria (Plasmodium)
       g. Methicillin-resistant Staphylococcus aureus (MRSA)
       h. Streptococcus pneumoniae
       i. Tuberculosis and MDR-TB
       j. Vancomycin-Resistant Enterococcus (VRE)
SECTION THREE: Control and Prevention of AMDR
    1. Implications of Microbial Resistance
    2. Infections and Chronic Diseases
    3. Policies and Best Practices
       a. Antimicrobial Drug Stewardship
       b. Surveillance
       c. Environmental Decontamination
       d. Infection Control
       e. Patient Education
    4. Antibiotic Development Pipeline
SECTION FOUR: Conclusions
Test Questions
Program Evaluation
Self Assessment

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