2. Disclaimer and Disclosure
• Comments do not represent the views of the
IHP, MGH, or HMS
• No relationships of any kind with any firm
whose products or services in any way
relate whatsoever to the life science
research enterprise
• Research funding is from the NIH and the
Greenwall Foundation, IMAP
3. Background: Definition of AIRs
Academic-Industry Relationships (AIRs):
Arrangements in which academic scientists,
administrators and physicians receive industry
resources in exchange for access to intellectual
property, research services, or access to patients,
medical students, residents or other physicians.
Institutional Academic Industry Relationships
(IAIRs): Arrangements when academic
institutions, or any of their senior officials, have a
financial relationship with or a financial interest in
a public or private company
5. Thesis
• Relationships with industry are ubiquitous in all
aspects of academic medicine. These relationships
are not universally bad or good. They have both
risks and benefits. Banning industry relationships
is neither possible or advisable in the current
context. The challenge is to enact new policies and
procedures related to the disclosure and
management of these relationships such that the
benefits are achieved and the risks are limited or
eliminated. Failure to do so could have dire
consequences for the future of medicine.
6. Third-Year Medical Students’ Exposure to Various Types of
Drug Company Interactions AIRs are ubiquitous in the modern
life science enterprise...
26
51
34
42
51
87
89
90
94
97
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Attend workshop
Book donated
Another social event
Drug sample
Dinner
Grand rounds
Snack
Journal reprint
Small, non-ed gift
Lunch
Sierles et al JAMA 2005 294:1034-1042
7. AIRs are ubiquitous......
Academic-based Researchers
6%
24%
32%
21%
18%
1%0%
20%
40%
60%
Research
funding
Consultant Paid Speaker Scientific
advisory
board
Support for
students
Officer/
executive
Campbell, E.G., et al Survey of Academic Faculty 2007
8. AIRs are ubiquitous......
NIH Intramural Scientists and Investigators
17%
8%
16%
2%0%
20%
40%
60%
Research
funding
Consultant Paid Speaker Scientific
advisory
board
Support for
students
Officer/
executive
n/an/a
Campbell, E.G., et al Survey of NIH Intramural Faculty, 2008-9
9. AIRs are ubiquitous in the modern
life science enterprise......
Percentage of IRB Members
2%
10%
14%17%
26%
14%
7%
0%
20%
40%
60%
Research
funding
Pay-Attend
Meetings
Consultant Speakers
bureau
Scientific
advisory
board
Support for
students
Officer/
executive
Campbell, E.G., et al NEJM 2006 355(22):2321-2329
10. AIRs are ubiquitous in the modern
life science enterprise......
Percentage of IRB Chairs
7%
12%
29%
17% 17% 17%
1%0%
20%
40%
60%
Research
funding
Pay-Attend
Meetings
Consultant Speakers
bureau
Scientific
advisory
board
Support for
students
Officer/
executive
Campbell et al, unpublished data
11. AIRs are a fundamental part of the
modern life science enterprise...
Percentage of Department Chair Relationships
9%
14%
21%
28% 27%
27%
19% 16%
0%
20%
40%
60%
Honoraria-
Speaking
Paid
Consultant
Advisory
board
Research
funding
CME speaker Speakers
bureau
Subsidized
travel
Founder of
company
Campbell, E.G., et al JAMA 2007; 298 (15): 1779-1786
12. AIRs are ubiquitous in the modern
life science enterprise......
Percentage of Clinical and Non-Clinical
Departments
19%
36%
65%
51%
37%
30%
3%8%13%2%12%3%
0%
20%
40%
60%
80%
100%
Support for
CME
Food &
Beverage
Support for
residents
Support for
dept
seminars
Support for
travel
Unrestricted
funds
Campbell, E.G., et al JAMA 2007; 298 (15): 1779-1786
Clinical departments
Non-clinical departments
13. AIRs are ubiquitous in the modern
life science enterprise......
Percentage of Physicians
9%
18%
78% 83%
35%
15% 3%
0%
20%
40%
60%
80%
100%
Drug
samples
Food &
Beverage
Reimburse-
Meetings
Consulting
payments
Speakers
bureaus
Advisory
boards
Payments
for enroll
patients
Campbell et al NEJM 2007 356(17):742-750
14. AIRs are ubiquitous in the modern
life science enterprise.....
Percentage with any AIR
94%
60%
43%
36%
53%
0%
20%
40%
60%
80%
100%
Faculty
Researchers
IRB
Members
IRB Chairs Dept. Chairs Physicians
15. AIRs are ubiquitous in the modern
life science enterprise......
Departments with > 1 relationships
67%
80%
43%
0
10
20
30
40
50
60
70
80
90
All Clinical Depts Non-Clinical Depts
Campbell, E.G., et al JAMA 2007; 298 (15): 1779-1786
16. Other Relationships….
• Professional associations
• Guideline committees
• Purchasing agents
• FDA review committees
• Other government officials
• Trustees
• CME
• Other relationships you would not believe… (see
next 3 slides)
17. Background: Other Stuff
• Medtronic and Ms. Kelly
– UCLA dept. chair “like to be taken to Platinum Plus”
– VP clinical affairs made $450,000 charging his OR
time as consulting
– $25,000 to docs to ride on Mardi Gras float
– $15,000 for beads to throw from float
– Trip to “think tank” in Alaska staffed by fishing guides
– Adult companionship
– Helicopter skiing trips
– Fake patent royalties
– Involves more than 100 surgeons nationally
18. • Dr. Charles B. Nemeroff, chair of Emory University's
department of psychiatry:
– Failed to disclose ~ $500,000 he received from GlaxoSmithKline for
giving talks that promoted the company's drugs (The New York Times,
10/04/08)
– As the editor-in-chief of the journal, Depression and Anxiety, wrote a
“Dear Me” letter in 2000, indicating that he was paying himself $3,000 to
write an article to celebrated the 5th anniversary of the introduction of
Effexor, an antidepressant created by Wyeth (Wall Street Journal,
12/18/08)
• Nemeroff also billed Emory for $3,000 for this work, which was paid for
by a grant from Wyeth
• Bristol-Myers Squibb
– Paid over $515 million in 2007 to resolve allegations involving their drug
marketing and pricing practices (Department of Justice, 09/28/07)
• Physician kickbacks included: travel to luxurious resorts, illegal
remuneration (consulting fees, expense payment)
• Retail and wholesaler kickbacks: stocking allowances, price protection
payments, prebates, market share payments and free goods
19. • Pfizer
– Paid over $430 million in 2004 to illegal marketing charges for drug
Neurontin due to activities by Warner-Lambert (acquired by Pfizer in
2000) between 1996-2000 (Department of Justice, 06/2004)
• Paid physicians to attend “consulting meetings” at destinations such as Hawaii,
Florida and the 1996 Olympic Games in Atlanta
• Physicians paid to allow sales reps see patient with them to allow the drug reps to
offer off-label pro-Neurontin treatment advice
• Blackstone Medical
– Paid Arkansas neurosurgeon, Dr. Patrick Chan, (and other physicians) for
bogus consulting contracts, fake research studies and gifts (Boston Globe,
01/08)
• Schering-Plough (New York Times, 06/27/04)
– Sent physicians checks for $10,000 “in exchange for an attached
'consulting' agreement that required nothing other than his commitment to
prescribe the company's medicines”
20. AIRs have benefits...
• Funding to support research ($1.5 billion in 1995)
• Increased academic productivity
• Increased commercial productivity
– Patent applications, patents granted, licenses, start-ups, etc
• Increased access to resources
• Opportunity to participate in application of research
• Offset wage differential between industrial and non-
industrial sectors that will assist in recruitment an
retention of scientists and administrators
• Samples for poor people
21. AIRs have benefits...
• New drugs and medical devices
• Access to newest information
• Address under use of medications and
technology
• Free meals for physicians and staff
• Trips to nice places
• Tickets to sporting events
22. Relationships have risks…..
• Industry funding is limited in amount and short in
focus compared to other funding sources
• Secrecy in science
• Shifting focus of science away from basic research
• Bias in research
• Increased management and negotiation costs
• Perception of being “bought out”
• Conflicts of interest (surgical dept example)
23. Please estimate the effect, if any, of your personal financial
relationships with industry on:
11%
11%
14%
27%
20%
24%
88%
88%
83%
68%
74%
69%
1%
1%
2%
5%
5%
6%
0% 20% 40% 60% 80% 100%
Recruiting new faculty
Retaining current faculty
Securing internal resources
from your institution
Your personal financial status
Your department financial status
Bringing in industry sponosred
research grants & contracts
% Positive
% No effect
% Negative
N=270 Campbell, E.G., et al JAMA 2007; 298 (15): 1779-1786
24. Please assess the relative effects on each of the following types of
industry relationships with respect to a department’s ability to
pursue independent, unbiased research:
10%
18%
17%
7%
8%
21%
28%
12% 72%
45%
48%
72%
0% 20% 40% 60% 80% 100%
More than one of the below
Serves on board(s)
Consults for ≥ 1 company
Substantial ownership/role in
start-up(s)
TypeofRelationship
% Positive
% No effect
% Negative
N=450 Campbell, E.G., et al JAMA 2007; 298 (15): 1779-1786
25. Other things to know …..
• I am entitled to these things…
• Patients don’t care…
• Drug samples are for my poor patients…
• Information provided by drug reps tends to be
biased towards company products…
• We can’t educate medical students and residents
without these……
• Some companies differentially recruit cheerleaders
for drug sales jobs….
26. Manage relationships
• Disclosure
• Review disclosures in context of established institutional policies
and procedures
• Ban some relationships (but not all)
– Research relationships
• PI with equity in clinical trials
• Gifts to individual scientists
– Non research relationships
• No lunches, dinners, sporting tickets….
• Very little contact (if any) between medical students and residents and
industry
• Monitor relationships that need monitoring
• Ignore and pray
27. Failure to do so could have dire
consequences for the future of
the life science enterprise.
• Scandals
• Compromise of key values
– Biased education and research
• Human subjects concerns
• Increased governmental regulation
• Loss of public support for academic science
28. Policy Projections
• Scaling back/bans at medical schools and teaching
hospitals
• More public reporting
• Establishment of institutional level review boards
with external membership
• Companies images with public will continue to
fall
• Companies will become increasingly sly..
– Hotel lunches off campus
– Blurring of accredited and non-accredited CME