financial conflicts of interest: the limits of disclosure and management peter lurie, md, mph public...
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Financial Conflicts of Interest: The Limits of Disclosure
and Management
Peter Lurie, MD, MPH
Public Citizen’s Health Research Group
Presented at:
Conflicts of Interest, Privacy/Confidentiality,
and Tissue Repositories:
Protections, Policies, and Practical Strategies
PRIM&R Conference
Boston, Massachusetts, May 3, 2004
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Conflicts of Interest Affect …
• Study design
• Research ethics
• Publication (or not)
• Data presentation
• Scientific debates
• Regulatory Review
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Placebo-controlled Trials of Acyclovir to Suppress
Recurrent Herpes Genitalis
0
10
20
30
40
50
60
70
80
90
100
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Study Number and Year Published
Perc
ent R
ecur
renc
e-fre
e
Placebo
Acyclovir
Average acyclovir response in 1st 2 studies
Average placebo response in 1st 2 studies
1984 1985 1986 1988 89,91,92,94 1997 1998
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A Drug Company-sponsored Unethical Clinical Trial in Developing Countries
• Discovery Laboratories, Doylestown, PA• Synthetic surfactant (Surfaxin)• 4 surfactants on the market (1st in 1990)• Associated with 34% relative reduction in
neonatal mortality (Cochrane meta-analysis)“Without doubt the most thoroughly studied new therapy in neonatal care” (NEJM review)
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A Drug Company-sponsored Unethical Clinical Trial in Developing Countries
• Title of internal FDA meeting: “Use of placebo-controls in life threatening diseases: is the developing world the answer?”
• Location: Mexico, Peru, Bolivia, Ecuador
• Design: Surfaxin vs. placebo (vs. approved surfactant)
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42 Randomized Trials of Natural and Synthetic Surfactant in the Treatment of Neonatal Respiratory Distress Syndrome
0
1
2
3
4
5
6
7
8
9
1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000
Year of Publication
Num
ber
of tr
ials
No Placebo
Placebo
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A Drug Company-sponsored Unethical Clinical Trial in Developing Countries
• February 2001: Public Citizen writes to HHS Secretary Tommy Thompson
• March 2001: Bolivian health ministry says the study is “totally prohibited” for legal, ethical and social reasons
• April 2001: Discovery announces study changed to compare to known effective surfactant
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April 15, 1997
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Content of Medical School-Industry Multicenter Trial Contracts
10%
1%
0%0%
2%
4%
6%
8%
10%
12%
Data collection andmonitoring
All authors haveaccess to data
Trial results must bepublished
Med
ian
Per
cen
tag
e o
f C
on
trac
ts
Source: NEJM 2002;3471335-41
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Depiction of Alosetron (Lotronex) Efficacy in Lancet
Source: Lancet 2000;355:1035-40
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Public Citizen Depiction of Alosetron (Lotronex) Efficacy
1.97
1.401.24 1.24
1.85
1.33
1.07 1.00
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
0 1 2 3
Month of Treatment
Mea
n P
ain
/Dis
com
fort
Sco
re
Placebo
Alosetron
Source: Lancet 2000;356:2009
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The Debate Over the Safety of Calcium Channel Blockers
60%
37%
96%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Support Neutral Critical
Fin
anci
al R
elat
ion
ship
wit
h S
po
nso
rs
Source: NEJM 1998;338:101-6
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FDA AC Member Recusals in Drug Procuct-Specific Meetings
• 18 recusals (1.5%) in 81 meetings in study period
• Through January 2002: 7 recusals; 0% reason given
• After January 2002: 11 recusals; 36% reason given
• Examples of recusals: Research and consulting on topic of scientific meeting Principal investigator of related clinical trial Research on competing products and consulting on product
at issue Invention of competing product
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Disclosed Conflict Rates for AC Members and Consultants*
*Includes recusals**Percentage of 81 meetings where at least 1 COI was disclosed***Percentage of 1220 AC member or consultant person-meetings disclosing a COI
Through January 2002
After January 2002
Total
Per meeting COI rate** 92% 87% 89%
Per person-meeting COI rate*** 24% 20% 22%
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Value of Particular Conflict Types for AC Members and Consultants,
January 1, 2001-June 30, 2003*
Consulting arrangements (n=114)
10%
73%
18%
No value given
$0-10,000
$10,001-50,000
*Excludes 99 conflicts through January 2002 without any conflict-type details
22%
41%
33%
4%
$0-5,000
$5,001-25,000$25,001-50,000
$50,001-100,000
Investments (n=78)
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Conclusions
• Conflict of interest permeates the entire research process
• Financial conflict of interest, in particular, has an adverse impact upon the public face of science
• Some conflicts are so worrisome that disclosure and “management” will not suffice
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