Industry Relationships in Medicine and Research

Eric G. Campbell, Ph.D.

Associate Professor

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

Background: Definition of AIRsAcademic-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

Types of Relationships•

Individual Research Relationships– Grants and contracts, – Consulting– Gifts– Equity/ownership positions– Trips– Samples

• Institutional– Discretionary funds– Equipment– Buildings – Programs

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.

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

AIRs are ubiquitous......

Academic-based Researchers

6%

24%

32%

21% 18%

1%0%

20%

40%

60%

Researchfunding

Consultant Paid Speaker Scientificadvisory

board

Support forstudents

Officer/executive

Campbell, E.G., et al Survey of Academic Faculty 2007

AIRs are ubiquitous......

NIH Intramural Scientists and Investigators

17%

8%

16%

2%0%

20%

40%

60%

Researchfunding

Consultant Paid Speaker Scientificadvisory

board

Support forstudents

Officer/executive

n/an/a

Campbell, E.G., et al Survey of NIH Intramural Faculty, 2008-9

AIRs are ubiquitous in the modern life science enterprise......

Percentage of IRB Members

2%10%

14%17%

26%

14%7%

0%

20%

40%

60%

Researchfunding

Pay-AttendMeetings

Consultant Speakersbureau

Scientificadvisory

board

Support forstudents

Officer/executive

Campbell, E.G., et al NEJM 2006 355(22):2321-2329

AIRs are ubiquitous in the modern life science enterprise......

Percentage of IRB Chairs

7%12%

29%

17% 17% 17%

1%0%

20%

40%

60%

Researchfunding

Pay-AttendMeetings

Consultant Speakersbureau

Scientificadvisory

board

Support forstudents

Officer/executive

Campbell et al, unpublished data

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

PaidConsultant

Advisoryboard

Researchfunding

CME speaker Speakersbureau

Subsidizedtravel

Founder ofcompany

Campbell, E.G., et al JAMA 2007; 298 (15): 1779-1786

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 forCME

Food &Beverage

Support forresidents

Support fordept

seminars

Support fortravel

Unrestrictedfunds

Campbell, E.G., et al JAMA 2007; 298 (15): 1779-1786

Clinical departments

Non-clinical departments

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%

Drugsamples

Food &Beverage

Reimburse-Meetings

Consultingpayments

Speakersbureaus

Advisoryboards

Paymentsfor enrollpatients

Campbell et al NEJM 2007 356(17):742-750

AIRs are ubiquitous in the modern life science enterprise.....

Percentage with any AIR

94%

60%43%

36%

53%

0%

20%

40%

60%

80%

100%

FacultyResearchers

IRBMembers

IRB Chairs Dept. Chairs Physicians

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

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)

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

• 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

• 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”

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

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

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)

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 resourcesfrom your institution

Your personal financial status

Your department financial status

Bringing in industry sponosredresearch grants & contracts

% Positive

% No effect

% Negative

N=270 Campbell, E.G., et al JAMA 2007; 298 (15): 1779-1786

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 instart-up(s)

Typ

e o

f R

elat

ion

ship

% Positive

% No effect

% Negative

N=450 Campbell, E.G., et al JAMA 2007; 298 (15): 1779-1786

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….

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

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

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