Financial Conflicts of Interest in Medical Research Karen Santoro Deputy Ethics Counselor National...

Financial Conflicts of Interest in

Medical Research

Karen SantoroDeputy Ethics CounselorNational Institute of Allergy and Infectious Diseases

0

20

40

60

80

100 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 SupportOf

Academic Health Centers

80%

40%

0102030405060708090

100

1991 1998

199180

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/$250-500MM)

“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

StockPublicly Traded

Consulting Fees

Honoraria Research Support

NIH-funded

> $10,000 > $ 10,000

> $ 10,000 (for

profit) > $ 10,000

FDA > $50,000  > $25,000  > $25,000

> $25,000

OGE > $5000 Any Any Any Personally Held

NE AHC > $20,000 > $10,000

> $10,000

4 x annually

> $10,000

Future

• AAU Report Oct. 2001

• GAO Report Nov. 2001

• AMA Recommendations Jan. 2002

• AAMC Task Force Dec. 2001