stop the clot ™ david henry and tom hogan cardiovascular and renal drugs advisory committee u.s....

Stop the Clot ™ www.stoptheclot.org

David Henry and Tom Hogan

Cardiovascular and Renal Drugs Advisory Committee

U.S. Food and Drug Administration

Adelphi, MD

March19, 2009

Stop the Clot ™ www.stoptheclot.org

NATT

Community-based, patient led, science driven volunteer organization

Committed to prevention and quality treatment of blood clots and clotting disorders

Stop the Clot ™ www.stoptheclot.org

NATT’s Mission. . .

To prevent, diagnose and treat thrombosis and thrombophilia through research, education, support and advocacy

Stop the Clot ™ www.stoptheclot.org

NATT-CDC COOPERATIVE AGREEMENT 2007-2009

Patient Education and Support Health Professional Education Website Development Development of Nationwide Chapter Network

Stop the Clot ™ www.stoptheclot.org

SURGEON GENERAL’S CALL TO ACTION TO PREVENT DVT/PE

Issued September 2008

Spotlights public health urgency posed by DVT/PE

Stop the Clot ™ www.stoptheclot.org

CALL TO ACTION PUBLIC HEALTH THREAT

Surgeon General’s Report

350,000-600,000 Americans have blood clots every year

100,000 deaths

Blood clots are a leading cause of death!

Stop the Clot ™ www.stoptheclot.org

MAYO CLINIC DATA (Heit et al)

900,000 Americans have blood clots every year

300,000 deaths

Blood clots are a leading cause of death!

Stop the Clot ™ www.stoptheclot.org

PRIORITY - REINFORCE EVIDENCE-BASED PREVENTION

Majority of at-risk patients with confirmed DVT were not prophylaxed, despite risk, and availability of evidence-based guidelines

Stop the Clot ™ www.stoptheclot.org

SURGEON GENERAL RECOMMENDATIONS

Encourage development of new pharmaceutical agents with fewer adverse effects of existing agents:

• Faster onset

• Wider therapeutic range

• Fewer food or drug interactions

Stop the Clot ™ www.stoptheclot.org

SURGEON GENERAL RECOMMENDATIONS

Conduct further research on anticoagulants:

• Best or optimal choice for designated populations

• Safest dosing

HIP/KNEE REPLACEMENT TRENDS

2005 < 1 Million

2009 Nearly 1.2 Million

Future Aging Baby Boomers

Stop the Clot ™

Stop the Clot ™ www.stoptheclot.org

NEED TO REINFORCE ESTABLISHED GUIDELINES

Reluctance of orthopedists to implement prophylaxis on patients with knee and hip replacement

• Major Concern: BLEEDING

• A clot is an act of God, whereas bleeding is surgical error

Tom Hogan

Stop the Clot ™

Stop the Clot ™ www.stoptheclot.org

POTENTIAL BENEFITS OF NEW ORAL MEDICATION

No INR monitoring Pill instead of injection Minimal diet concerns (e.g. vitamin K)

Minimal worry about interaction with other medication

Quick action and rapid elimination• (onset-offset)

Stop the Clot ™ www.stoptheclot.org

If potential benefits are realized…

Close to optimal care +

Reduced risks for complications =

Increased acceptance/use for TKR/THR +

Reduced morbidity and mortality

Stop the Clot ™ www.stoptheclot.org

NATT SUMMARY

Supports Surgeon General Call to Action Appreciates the safety and efficacy

review that will be done by committee If approval is recommended, urges

expeditious consideration by FDA