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The Physician-Pharmaceutical Industry Relationship

The CAGE Questionnaire for Drug Company Dependence

• Have you ever prescribed

C elebrex

TM

?

Do you get

A nnoyed by people who complain about drug lunches and free gifts?

• Is there a medication lo

G o on the pen you're using right now?

Do you drink your morning

E ye-opener out of a Lipitor

TM coffee mug?

If you answered yes to 2 or more of the above, you may be drug company dependent.

Levels of Interactions:

• Clinicians

– gifts

– promotional information

• Researchers

• Professional societies; medical journals

• Continuing medical education (CME)

Case

It is a busy day in the office, but you have agreed to speak for a minute to a pharmaceutical representative who has stopped by to drop off some samples of a new quinolone antibiotic, called Ubiquinone. Knowing your interest in golf, he has brought you golf balls emblazoned with the letter “U,” and also invites you to a round of golf at the country club this weekend.

Would you accept the golf balls?

Would you accept the invitation?

(From: “Really difficult Problems in Medical Ethics”)

Attitudes and Practices

Are gifts from pharmaceutical companies ethically problematic? A survey of physicians

• Survey of 42 residents and 52 faculty at a university-based IM training program.

• 21 item questionnaire. 4 point Likert scale.

• 90% response rate (105/117 residents).

• 93% of residents, 73% faculty responded.

Arch Intern Med. 2003;163:2213-2218

Are gifts from pharmaceutical companies ethically problematic? A survey of physicians

Resident and faculty responses

$40 textbook

$40 golf balls

Free Lunch +rep

Free Lunch -rep

Happy Hour +rep

Happy Hour -rep

P=.05

P=.88

P=.10

P=.34

P=.08

P=.04

0 1 2 3

Arch Intern Med. 2003;163:2213-2218

4

Residents faculty

Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical promotions

• Survey of 117 1st and 2nd year residents at a university-based IM training program.

• Attitudes towards 9 types of promotion assessed.

• 90% response rate (105/117 residents).

Am J Med 2001;110:551

Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical promotions

Percent Who Consider Appropriate

100

80

60

40

20

0

Very appropriate

Somewhat appropriate abx guide conf.

lunch

Am J Med 2001;110:551 dinner lect.

article pen social text CME luggage

Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical promotions

Practices Among Residents Who Consider Promotion Appropriate

Percent who did or would have participated

100

90

80

30

20

10

0

70

60

50

40 abx guide conf.

lunch

Am J Med 2001;110:551 dinner lect.

article pen social text CME luggage

Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical promotions

Practices Among Respondents Who Consider Activity Inappropriate

Percent who did or would have participated

100

90

80

70

60

50

40

30

20

10

0 abx guide conf.

lunch dinner lect.

Am J Med 2001;110:551 article pen social text CME luggage

Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical promotions

Perceived influence of pharmaceutical reps on Prescribing Practices

A lot

1%

A Lot

33%

A little

38%

“You”

Am J Med 2001;110:551

None

16%

None

61%

A Little

51%

“Other Physicians”

P<.0001

Pharmaceutical branding of Resident Physicians

• Survey of 181 primary care residents; 164

(91%) responded.

First asked to complete survey, then asked to empty pockets of white coats.

98% had eaten drug company-sponsored meal within the past year.

97% of residents were carrying at least one item with pharmaceutical insignia.

JAMA 2001;286:1024

Pharmaceutical Branding of Resident Physicians

Frequency of items found in residents' white coats

100

95

80

60

58

41

40

20

28

0

C al cu la to r

C al ip er s

R efl ex

h am m er

Ste th os co pe

ta g

R efe re nc e

b oo k

JAMA 2001;286:1024

93

98

P en

P en lig ht

51

Pharmaceutical Branding of Resident Physicians

Frequency of items found in residents' white coats

100

80

60

85

55

40

20

14

31

0

C al cu la to r

JAMA 2001;286:1024

C al ip er s

R efl ex

h am

Ste m er th os co pe

ta g

R efe re nc e

b oo k

90

79

P en

P en lig ht

45

Patient Attitudes

A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts

• Survey of physicians and patients at 2 tertiary care medical centers (1 military, 1 civilian).

• 196 patients and 268 physicians completed survey.

54% of patients were aware that pharmaceutical industry gave gifts to physicians.

Does your own doctor accept gifts? 27% yes, 20% no, 53% unsure.

J Gen Int Med 1998;13:151

A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts

Percentage that considered gift inappropriate

40

30

20

10

0

80

70

60

50

Patients

Physicians

Pen Mug Lunch Dinner

J Gen Int Med 1998;13:151

Trip

P<.004 for all except mug, p=.24)

A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts

Percentage that considered gift influential

60

50

40

30

20

10

0

31

8

31

8

29

12

48

24

56

42

Patients

Physicians

Pen Mug Lunch Dinner

J Gen Int Med 1998;13:151

Trip

P<0.0001 for all except trip, p=0.0017

Professional Guidelines

American Medical Association

Council on Ethical & Judicial Affairs

• “Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value.”

• “Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging, or personal expenses of the physicians who are attending the conferences and meetings . . .”

• “No gifts should be accepted if there are strings attached.”

JAMA 1991;261:501

American College of Physicians

Guidelines on Physician-Industry Relations

The acceptance of individual gifts, hospitality, trips, and subsidies of all types from industry by an individual physician is strongly discouraged.

The acceptance of even small gifts can affect clinical judgment and heighten the perception (as well as the reality) of a conflict of interest..

The dictates of professionalism require the physician to decline any industry gift or service that might be perceived to bias their judgment, regardless of whether a bias actually materializes.

Ideally, physicians should not accept any promotional gifts or amenities, whatever their value or utility, if they have the ability to cloud professional judgment and compromise patient care.

Annals of Internal Medicine 2002;136:396-402.

American College of Physicians

Guidelines on Physician-Industry Relations

Acceptable industry gifts:

Inexpensive gifts for office use (pens and calendars).

Low cost gifts of an educational or patient-care nature (such as textbooks).

Modest refreshment.

Annals of Internal Medicine 2002;136:396-402.

PhRMA Code on interactions with healthcare professionals

Items primarily for the benefit of patients may be offered to healthcare professionals if they are not of substantial value ($100 or less).

Items of minimal value may be offered if they are primarily associated with a healthcare professional’s practice.

• Items intended for the personal benefit of healthcare professionals (CDs, tickets to a sporting event) should not be offered.

www.PhRMA.org, April 2002

PhRMA Code FAQs

Question:

Under the Code, may golf balls and sports bags be provided if they bear a company or product name?

Answer:

No.

www.PhRMA.org, April 2002

PhRMA Code FAQs

Question:

Under the Code, may healthcare professionals be provided with gasoline for their cars if they are provided with product information at the same time?

Answer:

No.

www.PhRMA.org, April 2002

PhRMA Code FAQs

Question:

Under the Code, may items such as stethoscopes be offered to healthcare professionals?

Answer:

Yes www.PhRMA.org, April 2002

“That stuff doesn’t influence me at all.

I don’t even know what drug is on my pen. I just go for the food.”

--Fill in your name here?

Pharmaceutical industry

Spending on Promotion

Promotional spending on prescription drugs, l996-2002

25

21

20

17.8

15.7

15 13.9

12.5

11

10

9

5

0

Source: NIHCM, 2001

1996 1997 1998 1999 2000 2001 2002

Promotional spending on prescription drugs, 2002

Hospital detailing

4.1%

$861 million

Journal ads 2%

$480 million

Detailing to doctors 25.3%

$5.3 billion

Samples 56.1%

$11.78 billion

DTC ads 12.5%

$2.63billion

Source: IMS Health

Total spending: $21 billion

Direct to consumer advertising on prescription drugs,l996-2000

3

2.5

2.5

2

1.85

1.32

1.5

1

0.5

0.791

0

1996

Source: NIHCM, 2001

1.07

1997 1998 1999 2000

Direct to consumer advertising spending in the U.S., 2000

180

160

140

120

100

80

60

40

20

0

125

146

161

169

Source: NIHCM, 2001

Pepsi Budweiser Vioxx GM Saturn

Comparison of median revenue dedicated to R&D, profits, and marketing/administration, Fortune 500 drug companies, 2000 (n=11)

60%

50%

40%

30%

20% 17%

12%

10%

0%

R&D as % of revenue Profits as % of revenue

Source: Public Citizen, 2001

30%

Marketing & administration as % of revenue

Main task of drug company employees, 2000

Distribution,

Other

2%

Administration

11%

Production,

Quality Control

26%

Marketing

39%

R&D

22%

Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar

Drug company jobs in marketing and research, 1995-2000

100,000

87,810

80,000

Marketing

Research

# Jobs

60,000

55,348

49,409

40,000

48,527

20,000

0

1995 1996 1997 1998 1999 2000

Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar

Profitability of drug industry, l993-2000

20%

18%

16%

14%

12%

10%

8%

6%

4%

2%

0%

11%

2.8%

18.7%

5%

1992 1993 1994 1995 1996 1997 1998 1999 2000 drug industry median profit as % revenue other industry median profit as % revenue

•Source: Public Citizen update of Stephen W. Schondelmeyer calculation, Competition and Pricing Issues in the Pharmaceutical Market , PRIME Institute, University of Minnesota based on data found in Fortune magazine, 1958 to 1999; Fortune magazine, April 2000, Fortune 500 (www.fortune.com).

Fortune 500 drug company profitability compared to all other Fortune 500 companies, 2000

50%

45%

40%

35%

30%

25%

20%

15%

19%

10%

4.9%

5%

0%

Profits as % of revenues

Source: Public Citizen, 2001

18%

3.9%

Profits as % of assets

29%

15.8%

Profits as % of equity

Drug industry median

All Fortune 500 industries median

Sources of increased drug expenditures, 2000-2001

Increased cost of drugs

37%

Shift to more expensive drugs

24%

39%

Increased number of

Rxs

Source: NIHCM, 2002

Total increase: $22.5 billion

“Gifts are just a form of promotion or advertising, and advertising is a part of our society, like it or not.”

Gifts:

• Cost money (like other advertising).

• Influence behavior (like other advertising).

• Create obligation, need to reciprocate (unlike advertising). Conflict of interest

• Create sense of entitlement (unlike advertising).

• Erode professional values; demean profession (probably unlike advertising).

Conflict of interest

Set of conditions in which judgement concerning a primary interest tends to be unduly influenced by a secondary interest.

NEJM 1993;329:573-6

Conflict of interest?

“I have never been bought, I cannot be bought. I am an icon, and I have a reputation for honesty and integrity, and let the chips fall where they may.” “It is true that there are people in my situation who could not receive a million-dollar grant and stay objective.

But I do.”

“That stuff doesn’t influence me at all.

I don’t even know what drug is on my pen. I just go for the food.”

--Fill in your name here?

Should doctors be held to different

(higher) standards?

The physician-patient relationship is a fiduciary relationship.

Characteristics of a Fiduciary:

• Has specialized knowledge or expertise

• Holds the trust of others

• Held to high standards of conduct

• Avoids conflicts of interest

• Is accountable or obligated (ethically and legally)

“That stuff doesn’t influence me at all.

I don’t even know what drug is on my pen. I just go for the food.”

--Fill in your name here?

Influence

The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns

Pharmacy records reviewed 22 months before and 17 months after two pharmaceutical company-sponsored symposia on two medications:

Drug A: New intravenous antibiotic

Promotion: All-expenses-paid trip to “luxurious resort on West Coast” (n=10 travelling MDs)

Drug B: New intravenous Cardiac drug

Promotion: All-expense-paid trip to island resort in the Caribbean (n=10 travelling MDs)

Chest 1992;102:270

The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns

Drug "A" Usage

450

400

350

300

250

200

150

100

50

0

Jan

M ar

M ay

Ju l

S ep t

N ov

Jan M ar

M ay

Ju l

S ep t

Index Institution Major Medical Centers

Chest 1992;102:270

N ov

Physicians' Behavior and their Interaction with

Drug Companies

• Case-control study at a University Hospital

Cases: 40 physicians who had requested formulary additions.

Controls: 80 physicians who had made no such requests.

• Information regarding interaction with drug companies obtained by survey instrument.

JAMA 1994;271:684

Physicians' Behavior and their Interaction with

Drug Companies

Physicians who had requested formulary changes were more likely to have accepted money from drug companies to attend or speak at symposia.

(OR=5.1, 95%CI, 2.0 - 13.2)

Physicians were more likely to have requested additions of drugs made by companies with whose reps they had met (OR=4.9, 95%CI, 3.2 - 7.4).

JAMA 1994;271:684

Scientific versus commercial sources of influence

• Telephone questionnaire of 85 randomly selected internists in Boston area

• Questioned about two classes of drugs:

Propoxyphene analgesics

Cerebral and peripheral vasodilators.

Am J Med 1982;273:4

Scientific versus Commercial Sources of Influence

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

62%

68%

4% 4%

Scientific papers Drug ads

Very important Minimally important

Am J Med 1982;273:4

Scientific versus Commercial Sources of Influence

100%

80%

60%

40%

20%

0%

71%

32%

49%

Impaired cerebral blood flow major cause of dementia

Vasodilators useful in managing

"confused geriatric patients"

Propoxyphene more potent than aspirin

Am J Med 1982;273:4

Scientific versus Commercial Sources of Influence on the Prescribing behavior of Physicians

Were physicians who believed these drugs to be effective more likely to rely on commercial than scientific sources?

Vasodilators: Yes (p=0.006)

• Propoxyphene: No

Am J Med 1982;273:4

A Physician Survey of the Effect of Drug Sample

Availability on Physicians’ Behavior

Setting: University-based clinics at an academic medical center.

Participants: 131 of 154 general medicine and family physicians.

79 residents, 52 attendings.

Questionnaire.

• Three hypothetical clinical scenarios: Patient with uncomplicated urinary tract infection, hypertension, depression.

J Gen Int Med 2000;15:478

A physician survey of the effect of drug sample availability on physicians’ behavior

HTN scenario:

• 92% said they would prescribe a diuretic or b

-blocker as initial therapy.

When samples were made available, 32 of the 35 physicians who said they would give a drug sample selected a drug that differed from their preferred choice.

J Gen Int Med 2000;15:478

A physician survey of the effect of drug sample availability on physicians’ behavior

HTN “follow-up” scenario:

Patient now has health insurance, blood pressure controlled on drug sample

69% said they would write a prescription for the sampled medication rather than switch therapy.

• 88% of sample users would have written a prescription for a drug that differed from their preferred choice.

J Gen Int Med 2000;15:478

Physicians, Pharmaceutical Sales Representatives, and the Cost of Prescribing

Questionnaire on attitudes toward and use of information provided by pharmaceutical representatives.

Mailed to all primary care adult medicine practitioners in

Kentucky (n=1603)

Main outcome measure: Relative cost of prescribing, based on responses to treatment choices for clinical scenarios.

36% response; 446 questionnaires suitable for analysis.

Arch of Fam Med 1996;5:201

Physicians, Pharmaceutical Sales Representatives, and the Cost of Prescribing

% of physicians that used information provided by reps in their clinical practice

Yearly

14%

Never

1%

Daily

5%

Weekly

31%

Arch of Fam Med 1996;5:237

Monthly

49%

Physicians, Pharmaceutical Sales Representatives, and the Cost of Prescribing

3 case scenarios: acute bronchitis, mild HTN, and uncomplicated UTI.

Positive correlation found between physician cost of prescribing and:

– perceived credibility of information provided by pharmaceutical reps (p<.01).

– Frequency of use of reps as information source (p<.001)

• Physician age, years since graduation, hours worked per week was not correlated with cost of prescribing

Arch of Fam Med 1996;5:237

Bias in promotional materials

Pharmaceutical Advertisements in Leading Medical

Journals: Experts’ Assessments

• “Peer review” of all ads from 10 journals during

January, 1990.

109 advertisements were analyzed by 113 experienced physician peer reviewers and 54 clinical pharmacists.

71% of reviewers had received money from the drug industry within the past 2 years; 53% had received more than $5000.

Ann Int Med 1992;116:912

Pharmaceutical Advertisements in Leading Medical

Journals: Experts’ Assessments

FDA regulations specify that ads are false, lacking in fair balance, or otherwise misleading if:

They make claims about relative safety and efficacy or about the populations in which the drug is useful that are not supported by the current literature.

Use literature or references inappropriately to support claims in the advertisement.

• Use statistics erroneously.

Use headlines, sub-headlines, or pictorial or other graphic material in way that is misleading.

Ann Int Med 1992;116:912

Pharmaceutical Advertisements in Leading Medical

Journals: Experts’ Assessments

100

90

80

70

60

50

40

30

20

10

0

30

44

Disagreed with DOC claim

Ad would lead to proper prescribing

Ann Int Med 1992;116:912

57

Little or no educational value

92

Not in compliance with 1 or more FDA criteria

The Quantity and Quality of Scientific Graphs in

Pharmaceutical Advertisements

• Review of all pharmaceutical ads in from 10 leading American journals in 1999.

498 unique advertisements (3,185 total).

• 74 unique graphs

JGIM 2003;18:294-297

The Quantity and Quality of Scientific Graphs in

Pharmaceutical Advertisements

• 36% of graphs contained “numeric distortion.”

• 66% of graphs contained “chart junk.”

54% reported intermediate outcomes.

JGIM 2003;18:294-297

Logical Fallacies in Pharmaceutical Promotion

[Sample Ads available on request from No Free Lunch]

JGIM, 1994; 9:563

Logical Fallacies in Pharmaceutical Promotion

Argumentum ad populum

Appeal to popularity

Logical Fallacies in Pharmaceutical Promotion

Argumentum ad verecundiam

Appeal to authority

Logical Fallacies in Pharmaceutical Promotion

Argumentum ad celebritam

Appeal to celebrity

Logical Fallacies in Pharmaceutical Promotion

Fallacy of ignoratio elenchi

(or fallacy of irrelevant conclusions, or fallacy of ignoring the issue or the non-sequitur)

Logical Fallacies in Pharmaceutical Promotion

Appeal to emotion

The Academic-Industry Relationship

Scope and Impact of Financial Conflicts of

Interest in Biomedical Research

Systematic review of studies on relationships between investigators and industry.

144 studies identified in Medline and other sources.

37 studies met inclusion criteria.

JAMA 2003;289:454

Scope and Impact of Financial Conflicts of

Interest in Biomedical Research

JAMA 2003;289:454

Pharmaceutical industry sponsorship and research outcome and quality: systematic review

• Systematic review of studies that compared pharmaceutical company-sponsored research to non-industry-sponsored research.

Searched Medline, Embase, Cochrane register; contacted experts.

30 studies were included in analysis.

BMJ 2003;326:1167-1170

Pharmaceutical industry sponsorship and research outcome and quality: systematic review

Drug company-sponsored research was less likely to be published than research sponsored by other sources.

Drug company sponsored Pharmacoeconomic studies were more likely to report results favoring the sponsor's product than studies with other sponsors.

• 13 of 16 studies found that clinical trials and meta-analyses sponsored by drug companies favored the sponsor’s product.

Methodological quality of industry-sponsored studies was as good as or better than non-industry sponsored studies.

BMJ 2003;326:1167-1170

Association between competing interests and authors' conclusions

• Randomized clinical trials published in the BMJ from January 1997 to June 2001. 159 trials.

• Gathered data on authors' conclusions, competing interests, methodological quality, sample size, type of intervention, and type of control.

• Competing interest: “Anything that may influence professional judgment.”

BMJ, 2002:325:249

Association between competing interests and authors' conclusions

159 trials:

65 trials competing interests declared:

– 27 funding by for profit organizations.

19 funding by both for profit and non-profits.

– 19 “Other.”

BMJ, 2002:325:249

BMJ, 2002:325:249

Relationships between authors of clinical practice guidelines and the pharmaceutical industry

Authors of CPGs endorsed by North American and European societies on common adult diseases published between 1991-99.

Identified through MEDLINE search, reference lists, interviews with experts.

44 CPGs with 192 authors were included.

Survey instrument evaluated interactions with pharmaceutical industry.

100 (52%) authors participated.

JAMA 2002;287:612

Relationships between authors of clinical practice guidelines and the pharmaceutical industry

100

87

80

64

60 53

38

40

20

0

A ny re lat ion sh ip

Sp eak in g

H on or ar iu m

JAMA 2002;287:612

T rave l f un di ng

E m pl oye e/

C on su ltan t

E qu ity

6

Relationships between authors of clinical practice guidelines and the pharmaceutical industry

Do relationships influence treatment recommendations?

70

60

50

40

30

20

10

7

0

Personal Recommendations

JAMA 2002;287:612

19

Colleague Recommendations

Relationships between authors of clinical practice guidelines and the pharmaceutical industry

Declarations contained within guidelines regarding authors' interactions (n=44)

50

40

30

20

10

0

42

1

No declaration Declared no sponsorship

1

Declared industry support received

JAMA 2002;287:612

Dealing with conflicts of interest

• Prohibition

• Divestiture

• Abstention

• Mediation

• Disclosure

NEJM 1993;329:573

Epilogue: Do doctors need drug reps?

• Medical Letter (www.medicalletter.com)

• Therapeutics Initiative (Canada)

(www.ti.ubc.ca)

• Drug and Therapeutics Bulletin (UK)

(www.which.net/health/dtb)

• Prescrire.org (France)

• etc.

Conclusion

• The patient-physician relationship is a fiduciary relationship.

• Fiduciaries have an obligation to avoid conflicts of interest.

• Gifts from the pharmaceutical industry, whether large or small, create conflicts of interest.

• Physicians should not accept any gifts from the pharmaceutical industry.

Just say no to drug reps

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