AAOS Bulletin - February, 2005

Antibiotic-resistant pathogens increasing

Why “Bad Bugs, No Drugs” should concern orthopaedic surgeons

By the David B. Carmack, MD of the AAOS Infections Committee

The increasing prevalence of antibiotic-resistant pathogenic organisms has and will continue to challenge the medical community in delivering quality care to our patients. Recently, the Infectious Diseases Society of America (IDSA) released a white paper, Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates…a Public Health Crisis Brews, a summary of the problem of emerging antibiotic-resistant pathogenic organisms. The message of this document reinforces the need for appropriate and judicious use of antibiotics, as outlined by the Centers for Disease Control and Prevention (CDC) and their Division of Healthcare Quality Promotion. The AAOS Infections Committee has analyzed the IDSA statement and presents its central points to the fellowship.

Benefits of antibiotics

The development of antibiotics has arguably been one of the most significant advances in medical treatment in the past 70 years.

Antibiotics have saved millions of lives through the prevention and treatment of bacterial infection, thereby improving treatment outcomes for patients of all ages, and increasing longevity. Appropriate use of antibiotics prevents amputations and blindness, advances our ability to perform surgery, enables the use of new cancer treatments and protects the lives of our military men and women.

Antibiotic resistance

The inevitable result of the widespread use of antibiotics is an increase in pathogenic organisms with resistance to these drugs. Approximately 2 million people acquire bacterial infections in U.S. hospitals each year, and 90,000 die as a result. Nearly 70 percent of those infections are with organisms resistant to at least one drug. The increasing numbers of infections with drug-resistant pathogens show no sign of abating. Antibiotic-resistant organisms are not only a public health problem; they are potential national and global security concerns if they are used as agents of biological warfare.

Antibiotic resistance is not a new phenomenon. National surveillance data and independent studies show that drug-resistant, disease-causing bacteria species have multiplied and spread at alarming rates in recent decades. The Institute of Medicine, CDC, National Institutes of Health (NIH) and the Food and Drug Administration (FDA) warn that antibiotic-resistant bacteria are a serious public health threat, especially considering that there are few novel drugs being developed to combat them.

Pharmaceutical development

The pharmaceutical development pipeline of antibiotics is drying up. A recent analysis published in Clinical Infectious Diseases found only five new antibiotics out of more than 506 drugs in the U.S. research and development (R&D) pipeline.1 Pharmaceutical companies have lost interest in the antibiotics market because these drugs simply are not as profitable as drugs that treat chronic conditions and lifestyle issues.

Pharmaceutical R&D is expensive, risky and time-consuming. Bringing just one new drug to market, even with an aggressive R&D program, would require 10 or more years and an investment of between $800 million and $1.7 billion. As a result, a growing number of drug companies appear to be withdrawing from the unprofitable antibiotic drug market.

IDSA has investigated the decline in new antibiotic R&D by interviewing stake holders such as the FDA, the National Institute of Allergy and Infectious Diseases (NIAID), the CDC, pharmaceutical and biotechnology executives, and patients. Their conclusion is that, based upon past successes, the pharmaceutical and biotechnology industries are clearly best situated to take the lead in developing the new antibiotics needed to treat emerging resistant bacterial strains. As such, industry action must become the central focus of an innovative federal public health effort designed to stimulate antibiotic R&D.

Incentives are needed

IDSA’s investigation indicates that the incentives most likely to spur R&D within major pharmaceutical companies include those that provide financial benefits prior to a drug’s approval (such as tax credits for R&D); commence at the time of approval (e.g., wild-card patent extension); reduce the costs of clinical trials (i.e., regulatory flexibility concerning the evidence necessary to demonstrate safety and efficacy; NIAID-sponsored research to develop rapid diagnostic tests, etc.), and reduce companies’ risks through liability protections.

R&D at smaller biotechnology companies could also be stimulated through statutory and administrative changes, such as an increase in the number and amount of Small Business Innovation Research grants from the NIH. Finally, new funding for critical federal public health programs—as well as public and private research efforts—would help to ensure progress and limit the public health impact of antibiotic resistance. In addition to promoting incentives to spur antibiotic R&D, Congress should implement administrative recommendations at FDA and NIAID to facilitate the approval processes for manufacturers of new antibiotics.

Without innovative public policy and additional financial support, fewer and fewer antibiotics will be available to treat the increasing number of drug-resistant and dangerous microbes that threaten Americans and the global community.

References:

1. Spellberg B, Powers JH, Brass EP, et al. Trends in antimicrobial drug development. Clin Infect Dis. 2004; 38: 1279-1286.

The Infections Committee monitors scientific and regulatory developments in the prevention and treatment of infections of concern to orthopaedic surgeons.

Additional Resources

• IDSA white paper Bad Bugs, No Drugs: http://www.idsociety.org/pa/IDSA_Paper4_final_web.pdf (Acrobat Reader required)

• CDC Antimicrobial Resistance home page: http://www.cdc.gov/drugresistance/

• Division of Healthcare Quality Promotion — Preventing antimicrobial resistance among surgical patients: http://www.cdc.gov/drugresistance/healthcare/patients.htm - surgery


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