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**The American College of Chest Physicians (ACCP)**

# and The CHEST Foundation

#### *Comments to Anti-Infectives Drugs Advisory Committee of FDA* 

**PART I:** *Alvin Lever, MA, FCCP(Hon), Executive Vice President & CEO,
ACCP,*

##  Northbrook, IL

Who We Are---The American College of Chest Physicians (ACCP), a Clinical
Society, Founded in 1935 as the Clinical Society for Chest Specialists:

-   A multidisciplinary not-for-profit society of more than 15,500
    members worldwide.

-   Membership includes: pulmonary and critical care physicians,
    cardiologists, thoracic and cardiac surgeons, allergists,
    anesthesiologists, pediatricians, nurses, and allied health
    professionals.

-   ACCP Vision---The College is the leading resource for the
    improvement in cardiopulmonary health and critical care worldwide.

-   ACCP Mission---To promote the prevention and treatment of diseases
    of the chest through leadership, education, research, and
    communication.

The CHEST Foundation---The Philanthropic Arm of the ACCP

-   The CHEST Foundation was founded in 1996.

-   Focus is education and disease prevention in the community and
    public health areas.

-   Emphasis includes smoking cessation and prevention, asthma, and
    end-of-life issues in the critical care environment and awards for
    research and community service.

-   Mission to provide resources to advance the prevention and treatment
    of diseases of the chest.

What We Do---Examples Include:

-   Publish *CHEST*, with the largest worldwide circulation of any
    clinical respiratory journal.

-   Conduct annual national and international scientific assemblies.

-   Offer Continuing Medical Education (CME) to physicians and other
    health care professionals.

-   Develop and distribute Clinical Practice Guidelines and Consensus
    Statements for major clinical concerns such as sepsis. An Example of
    the American College of Chest Physicians/Society of Critical Care
    Medicine (ACCP/SCCM) 1992 Consensus Conference on Definitions of
    Sepsis is available as a reprint from *CHEST* Vol. 101, p. 1644 --
    1655, June 1992 issue.

-   Collaborate with the World Health Organization and others on issues
    concerning the prevention and treatment of respiratory diseases,
    such as chronic obstructive lung diseases, and global controls on
    tobacco and smoking.

-   Consult with government agencies on issues such as new medical
    treatments, prevention of tobacco-related disease, support for
    initiatives, critical care physician's workforce issues, Medicare
    reimbursement, and health care reform.

PART II: *Curtis N. Sessler, MD, FCCP, Professor of Medicine ,Virginia
Commonwealth University Health System, Medical Director of Critical
Care, Medical College*

> *of Virginia Hospitals*

### Incidence and Treatment of Sepsis

-   Every year, severe sepsis strikes an estimated 750,000 people in the
    United States \--killing approximately 215,000 people annually. Its
    incidence is expected to rise to nearly one million annually by the
    end of the decade.

-   Sepsis currently is the leading cause of death in the non-coronary
    ICU.

-   Historically, we have had treatment for severe sepsis. This includes
    antibiotics for direct treatment, fluids (vasopressors) to treat
    components of the derangements caused by severe sepsis and
    supportive therapy such as mechanical ventilation dialysis and
    nutrition.

-   This new class of drugs and novel approach to treatment offers a new
    opportunity to ameliorate the adverse effects of severe sepsis
    through altering its complex pathophysiology.

-   In the course of my medical career, and that of many other
    physicians, I have witnessed hundreds of critically ill patients who
    have had infections and developed severe sepsis. Many such patients
    succumb to the condition of severe sepsis, despite aggressive
    management with conventional tools, including antibiotics, fluids,
    vasopressor, and supportive measures.

-   It is important to emphasize that drotracogin alfa is a novel new
    class of agents which offers a new strategy for the treatment of
    sepsis (combination of anti-inflammatory, anti-coagulant,
    pro-fibrinolytic therapy) that appears to be effective at improving
    the chances of survival in the patient with severe sepsis.

-   We salute the sepsis research that has been done to date and commend
    all involved for their efforts.

-   We encourage you to take these points into consideration as you make
    your recommendation.