Financial Conflicts of Interest in Medical Research Karen Santoro Deputy Ethics Counselor National Institute of Allergy and Infectious Diseases

Favorable Results Inconclusive Results Negative Results Financial Ties to Sponsor NEJM Vol. 338 (1998) Stelfox

NIH Industry 30% 70% NEJM Vol. 342 (2000) Brodenheimer Clinical Research Support

Industry Support Of Academic Health Centers

Preclinical Testing (~4yr/$2-5MM Investigational New Drug Application Clinical Trials, Phase I (~1.0 year/$5-10MM) New Drug Application (~2.5 years) 1 Approval 100 Discovery Approaches Figure 1. The procedure for gaining FDA approval of a pharmaceutical product based on internal benchmarks Clinical Trials, Phase II (~2.0 year/$25-50MM) Clinical Trials, Phase III (~3.0 year/$ MM) “Genomics and New Technologies as Catalysts for Change in the Drug Discovery Paradigm”) Jeffery Hanke, PhD.

1995 Objectivity in Research Regulations  Disclose “significant” interests  Institution discretion

Stock Publicly Traded Consulting Fees HonorariaResearch Support NIH- funded > $10,000 > $ 10,000 (for profit) > $ 10,000 FDA > $50,000 > $25,000 > $25,000 OGE > $5000Any Any Personally Held NE AHC > $20,000> $10,000 4 x annually > $10,000

Future AAU Report Oct GAO Report Nov AMA Recommendations Jan AAMC Task Force Dec. 2001