financial conflicts of interest in medical research karen santoro deputy ethics counselor national...
TRANSCRIPT
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