1. Pharmaceutical Industry Marketing and Influence
Dean Haxby, Pharm.D.
Associate Professor of Pharmacy
Oregon State University, College of Pharmacy
To receive 1.5 AMA PRA Category 1 Credits™, you must review this progam and pass the CME quiz at the end.
Release Date: January Expiration Date: January 2012

2. Attachments
The attachments tab contains documents that supplement the presentation.
The slides are available as an attachment to print out to use as a handout for the presentation.
“Show Me the Evidence” has a list of additional resources on evidence-based drug information and industry marketing.

3. Program Funding
This work was made possible by a grant from the state Attorney General Consumer and Prescriber Education Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin.

4. Continuing Education Sponsors
Continuing Medical Education for the following activity titled “Pharmaceutical Industry Marketing and Influence”, is jointly sponsored by The University of Texas Southwestern Medical Center and the Federation of State Medical Board’s Research and Education Foundation.

5. CME Information Program Speaker/Author: Dean Haxby, PharmD
Course Director: Barbara S. Schneidman, MD, MPH
Federation of State Medical Boards Research and Education Foundation, Secretary
Federation of State Medical Boards, Interim President and Chief Executive Officer
Program Directors: David Pass, MD
Director, Health Resources Commission, Oregon Office for Health Policy and Research
Dean Haxby, PharmD
Associate Professor of Pharmacy Practice, Oregon State University College of Pharmacy
Daniel Hartung, PharmD, MPH
Assistant Professor of Pharmacy Practice, Oregon State University College of Pharmacy
Target Audience: This educational activity is intended for health care professionals who are involved with medication prescribing.
Educational Objectives: Upon completion of this activity, the participants should be able to: describe the purpose and expenditures for various marketing strategies and the impact on prescribing; outline techniques pharmaceutical representatives use to influence clinicians; identify strategies clinicians can use to reduce impact of marketing; describe the role of samples in marketing and the impact of samples on prescribing; identify drug sample regulatory requirements and options to improve sample use; summarize research findings on the impact of direct-to-consumer advertising of prescription drugs; identify potential conflicts of interest.
CME Information

6. CME Policies
Accreditation: This activity has been planned and implemented in accordance with the Essential Areas & Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of The University of Texas Southwestern Medical Center and the Federation of State Medical Boards Research and Education Foundation. The University of Texas Southwestern Medical Center is accredited by the ACCME to provide continuing medical education for physicians.
Credit Designation: The University of Texas Southwestern Medical Center designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
Conflict of Interest: It is the policy of UT Southwestern Medical Center that participants in CME activities should be made aware of any affiliation or financial interest that may affect the authors presentation. Each author has completed and signed a conflict of interest statement. The faculty members’ relationships will be disclosed in the course material.
Discussion of Off-Label Use: Because this course is meant to educate physicians with what is currently in use and what may be available in the future, “off-label” use may be discussed. Authors have been requested to inform the audience when off-label use is discussed.

7. DISCLOSURE TO PARTICIPANTS
It is the policy of the CME Office at The University of Texas Southwestern Medical Center to ensure balance, independence, objectivity, and scientific rigor in all directly or jointly sponsored educational activities.
Program directors and authors have completed and signed a conflict of interest statement disclosing a financial or other relationship with a commercial interest related directly or indirectly to the program.
Information and opinion offered by the authors represent their viewpoints. Conclusions drawn by the audience should be derived from careful consideration of all available scientific information. Products may be discussed in treatment outside current approved labeling.
FINANCIAL RELATIONSHIP DISCLOSURE
Faculty Type of Relationship/Name of Commercial Interest(s)
David Pass, M.D. None
Dean Haxby, Pharm.D Employment/CareOregon
Daniel Hartung, Pharm.D., MPH None
Barbara S. Schneidman, MD, MPH None

8. Learning Objectives
Describe the purpose and expenditures for various marketing strategies and the impact on prescribing
Outline techniques pharmaceutical representatives use to influence clinicians
Identify strategies clinicians can use to reduce impact of marketing
Describe the role of samples in marketing and the impact of samples on prescribing
Identify drug sample regulatory requirements and options to improve sample use
Summarize research findings on the impact of direct-to-consumer advertising of prescription drugs
Identify potential conflicts of interest

9. Important Contributions by the Pharmaceutical Industry
Development of new treatments that improve health and well-being
Make substantial contributions to educational, health care and professional organizations
Provide indigent care programs

10. Pharmaceutical Manufacturers
Are for-profit companies
Primary mission is to increase share holder value
This is accomplished by:
developing new products
successfully marketing those products
having an effective lobby to protect and advance their interests

11. 2007 Fortune 500 Profits J & J 21% Pfizer 37% Merck 20% Abbott 8%
Wyeth
BMS 9%
Eli Lilly
17%
Amgen
Schering
11%

12. Pharmaceutical Industry
One of the most profitable industries in the US
Industry advocates argue these profits are justified because:
Required to support R & D
Tremendous value of medications
High risk of the industry
A report by Tufts University says it costs $802 million to bring a drug to market

13. Industry Critics Profits are excessive
Drug development cost figures grossly inflated
exclude tax deductions/credits, include capital opportunity cost (1/2 of total), skewed sample of drugs, industry figures not verifiable
Government funds much of critical research on new drugs
Uninsured cannot afford medications
Public Citizen

14. Pharmaceutical Industry Marketing
A key to industry profitability
Highly effective
Very sophisticated
Multi-pronged campaigns targeting clinicians and patients

15. Pharmaceutical Industry Promotion & Marketing
Source: N Engl J Med 2007;357:
2005 Dollars

16. Annual Increase in US Prescription Drug & Total Health Expenditures
Annual % Change
Rx Drugs
Health

17. Expenditures by Type of Marketing 2004 ($ Billions)
IMS
CAM
Total
Percent
Samples
15.9
6.3
28%
Detailing
7.3
20.4
36%
DTCA 4 7%
Meetings
No data 2 3%
E-promo.
0.3 0%
Journals
0.5 1%
Unmonitored
14.4
25%
27.7
47.9
$57.5
Gagnon MA, Lexchin J. PLoS Medicine 2008;5:1-5

18. Pharmaceutical Representatives
Still the major focus of pharmaceutical marketing
Approximately 100,000 reps in 2005 vs 38,000 in 1995
1 rep per 6 MDs in US and 1 rep per 2.5 targeted MDs
6 million detail visits annually
Cost estimate $12 - $13 thousand per MD on detailing (IMS data)
PhRMA:”serves an essential function in the health care delivery system”

19. Characteristics of Representatives
Presentability/appearance
Outgoing personality
Excellent interpersonnal skills
Assertive

20. Representative Training
How to be observant and assess clinician personalities
How to adjust approach based on reactions and profile information
How to gather and use personal information to establish a connection
How to monitor impact of various marketing strategies on prescribing
Plos Medicine 2007;4(4):

21. How Representative Can Tailor Approach
Friendly clinician
Skeptical clinician
High prescribers
Frame interactions as gesture of friendship
Use literature, humility, appeal to their “high intellect”
Make best effort to establish personal connection, best gifts
Plos Medicine 2007;4(4):

22. How Representaive Can Tailor Approach
Find out why, try to capture a niche
Try to work through office staff, can get useful information
Friendly thought leaders groomed for speaking circuit. Monitor impact of local talks and their allegience
Clinician prefers competing product
Refuses to see reps
Thought leaders
Plos Medicine 2007;4(4):

23. Targeted Clinicians High volume prescribers
Specialists: scripts they initiate can continue for years by PCPs
Opinion leaders
Low volume, non-influential clinicians receive much less attention

24. Physician Rating of Rep Information Usefulness
Kaiser Family Foundation Report March, 2002

25. Physician Rating of Accuracy of Representative Information
Kaiser Family Foundation March, 2002

26. Stages of Rep/Provider Interactions
Acknowledgement of relative status
Valuable time, opinion leader
Find out what is known
Outline benefits of product
Expert name drop
Provider resistance
Reinforcement of role
Compliments, sympathy
Closure: ensure opportunity for return, gifts, obligation
BMJ 2001;323:

27. Benefits to Provider Pleasant respite from workday demands
Someone who is “impressed” with their “superior knowledge”
Can be object of flattery and sympathy
Psychological benefits
Receipt of gifts
Can present themselves as skeptic
Questions information, doesn’t agree to prescribe
Can feel like they were in control
BMJ 2001;323:

28. Representative Goals Develop positive relationship
Opportunity for future contact
Create a sense of obligation
Control agenda
Promoting product appears secondary in many interactions

29. Influence on Prescribing
Studies show that prescribing is influenced by industry representatives
Higher cost, less rational prescribing is associated with:
Frequency of use of representatives as an information source
Perceived credibility of representative
Even a few minutes of contact can impact prescribing
Arch Fam Med 1996;5:237
Soc Sci Med 1988;26:1183

30. Perceived Influence of Pharmaceutical Reps
Am J Med 2001;110:551

31. Physician/Drug Representative Meetings
Specialty Meetings/Month Family Physicians 16 Internal Medicine 10 Cardiology 9 Pediatrics 8 Surgeons 4 Anesthesiology 2
N Engl J Med 2007;356:

32. Physician Industry Relationships
Benefits % Reporting Samples 78% Gifts 83% Travel/CME funding 35% Payments 28% Any Relationship 95%
N Engl J Med 2007;356:

33. Physician Factors Associated With Receipt of Payments
Practice with < 25% Medicaid/uninsured
Private practice
Less likely in hospital/HMO setting
University/Medical School
Role as a preceptor
Developer of clinical guidelines
Cardiology specialty (of the six specialties studied)
N Engl J Med 2007;356:

34. Physician Interactions With Detailers
Physicians are aware of potential conflicts
Interactions are welcomed
Reps described as:
Pleasant
Friendly
Helpful
J Gen Intern Med 2007;22:184-90

35. Methods to Deal With Potential Conflict of Interest
Eliminate the conflict
Can be difficult and painful
Rationalization
“Its educational”
“Patients need samples”
Denial
“It doesn’t influence me”
“I take it with a grain of salt”
J Gen Int Med 2007;22:184-90

36. Clinician Marketing Data
One of best market research systems in the world
Manufacturers have extensive data
Collect information from pharmacies, PBM’s, AMA and Government
Can track impact of different strategies
Profiles help target efforts
Ann Intern Med 2007;146:742-8

37. AMA Master File Has been sold to industry for decades
Contains physician identifier data that can be linked to other prescribing data
Generated 16% of AMA revenue in 2005
Due to member concerns, a new “opt out” option allows individual physicians to request that companies not share their individual data with representatives
Most doctors do not know about the program and few have signed up (<1%)
Ann Intern Med 2007;146:751-2

38. How to “Opt-out”
Physicians can enroll by going to the following website:
Purchasers of the data must agree to restrict prescriber profiling by reps for those who have opted out
Must be renewed every three years and manufacturers have 90 days to comply after requesting the opt-out
Ann Intern Med 2007;146:742-48

39. Conclusions on Representative Marketing
Industry invests billions on detailing
Most prescribers meet with representatives
Representatives are skilled at developing relationships with and influencing clinicians
Meetings with representatives are associated with less rational prescribing and increased costs
Most physicians feel they are not influenced

40. What Can Clinicians Do?
Reduce or eliminate contact with industry representatives
“Just say no”
Identify and use unbiased and independent sources of prescribing information
Medical letter, prescribers letter, cochrane data-base of systematic reviews, Oregonrx.gov
See the document in attachments for sources of evidence-based drug information
Opt-out to limit use of AMA master profile

41. Drug Samples A major marketing strategy
An estimated $18 billion (retail value) distributed in 2005
Estimated use: 10-20% of patient encounters
Primary industry goals :
Influence prescribing habits/get patients on med
Representative access, a reason to visit

42. Trends in Retail Value of Sample Distribution

43. Arguments for Samples A source of medications for the indigent
Reduces cost to patient
Provider can test effectiveness and tolerability before committing patient to long term use
Prescribers can gain experience with a product

44. Arguments for Samples Can start therapy immediately
A way around formulary or PA requirements
Can assist with patient instruction
Improves patient satisfaction
Enhances patient-provider relationship / gift giving

45. Arguments Against Samples
Loss of pharmacist review/counseling
Clinician unfamiliarity may increase chance of medication errors
Sub-optimal treatment choices may be made
Labeling/documentation is often deficient
Storage concerns
Environment
Security

46. Arguments Against Samples
Estimated that only about half reach patients
Ethical concerns with personal use by providers
Only branded expensive drugs are sampled which increases overall cost of care
Inconsistent supplies for indigent patients

47. Survey of Sample Use 12% of Americans received samples
13% of patients with insurance received samples
10% of the uninsured received samples
72% of sample users were above 200% of the federal poverty level
82% of sample users had health insurance the entire year while 18% were uninsured at least part of the year
Am J Public Health 2008;98:284-9

48. Sample Use in Pediatrics
4.9% of children received samples in 2004
10% of those receiving a prescription medication received samples
84% went to patients with insurance the whole year
Over 500,000 children received drugs that were subsequently subject of serious safety concerns
Pediatrics 2008;122:736-42

49. Samples Influence on Prescribing
Randomized 29 Internal Medicine residents to a no sample and sample group
No sample group was:
Less likely to use an advertised brand drug
Trend towards less expensive drugs
Am J Med 2005;118:881-4

50. Samples Influence on Prescribing
Studied 32 family medicine resident and faculty physicians prescribing for hypertension before and after a ban on samples
Prescribing of first-line agents increased from 38% to 61%
Impact was greatest on residents
Fam Med 2002;34:729-31

51. Other Research on Sample Use
In a physician survey of the effect of sample availability on prescribing, it was concluded that sample availability influences choice of drug and can lead to suboptimal drug selection (J Gen Int Med 2000;15:478-83)
Samples are frequently used by clinicians or their family members; and by office staff: in one clinic the retail cost of samples taken was $10,000 (JAMA 1997;278:141-3)

52. Sample Impact on Cost and Continuation
Patient out-of-pocket costs increased 47% (p<0.001)
Total Rx costs increased 38% (p< )
The odds of continuing the same medication was dramatically lower after receipt of a sample than a prescription: OR, 0.22 (CI 0.08 – 0.65)
Medical Care 2008;46:

53. Conclusions on Drug Samples
Samples are a major marketing tool
Reps gain access
Sample use can lead to higher costs for both patients and the health care system
Sample use may compromise the quality of prescribing
Samples are less likely to go to the uninsured

54. Prescription Drug Marketing Act (PDMA)
Due to abuse, sample regulations were implemented in 1987 (PDMA)
Applies to manufacturers
Manufacturers must keep records of sample distribution
Requires signed requests by prescribers
Requires appropriate storage conditions

55. JCAHO Sample Requirements
Applies to hospitals and health-systems
Same standards as non-sample medications
Written policies and procedures
Proper, secure storage, regular inspections
Labeled and dispensed like other meds
Documentation same as other orders
An effective recall mechanism

56. Strategies to Improve Sample Use
Apply JCAHO requirements
Develop sample formulary
Consider use of generic samples
Clinics can ban samples
No Free Lunch has developed a patient education leaflet entitled “Why we don’t have free samples”
It is available for download free of charge at
Helps to support clinics that choose not to accept samples

57. Direct to Consumer (DTC) Advertising
Advertising directly targeting consumers
In 1997, the FDA relaxed regulations
Eliminated requirement to list all side-effects
Allowed referral to another source of information such as a toll free number or website
The US and New Zealand are the only developed countries to allow DTC advertising for Rx drugs

58. Trends in DTC Advertising

59. Type of DTC Advertising
Print Advertising
Magazines
Newspapers
Television
Radio
Internet

60. Direct-to-Consumer Expenditures
Nexium (AstraZeneca)
$224 Million (2005)
Lunesta (Sepracor)
$214 Million (2005)
Vytorin (Merck/SP)
$155 Million (2005)
Coke Classic
$146 Million (2004)*
Bud Light
$136 Million (2003)**
Source: Donohue JM. NEJM ;357:673-81; *WSJ Oct 7, 2005; **WSJ Apr 16, 2004

61. PhRMA Position on DTC Ads
Serves to improve public health
Prompts people to seek care
Promotes informed discussions
Provides useful information to consumers
Improves compliance
Physicians are in control, thus it won’t lead to inappropriate prescribing

62. Public Citizen Position on DTC
Promotion not education
Ads increase demand for newer more expensive products, thus increase costs
Physician gate-keepers susceptible to marketing
Can stimulate inappropriate use
Can harm doctor-patient relationship
FDA is grossly understaffed to regulate

63. Systematic Review of DTCA
Patients who request a drug are 16x more likely to get it
DTCA campaigns significantly increase trend of Rx volume of targeted drugs
DTCA campaigns can increase new diagnoses
Concern about risks of treating minor conditions
To date no studies of patient satisfaction or health outcomes
Qual Saf Health Care 2005;14:246-50

64. Kaiser Family Foundation Study
30% of adults have talked to their doctor as a result of seeing a drug ad
44% of these individuals were prescribed the drug they asked about
Showed TV ads for Nexium, Lipitor and Singulair
Kaiser Family Foundation November, 2001

65. Kaiser DTC Study Results
Ads prompt patients to talk with their provider
Those with greatest health needs most likely to take action
25% without condition would discus further
Educational ability is mixed
Patients can identify condition, drug name, and need to see doctor; but most felt they knew little or nothing more about the condition or drug
Many subjects could not recall side effects or where to get additional information
Kaiser Family Foundation November, 2001

66. Clinician Response to DTCA Based Medication Requests
Survey of PCPs comparing clinician responses to a request for more information based on DTC ad vs. a reference book
Requests based on DTC adds:
Were more likely to become annoyed
Less likely to answer questions
Less likely to provide written information
Arch Intern Med 2003;163:

67. Survey Respondents Response to a Hypothetical Denied Request
46% thought they would be disappointed
25% would try to change prescribers mind
24% might try a different doctor
15% thought they would switch to a new doctor
Health Affairs 2000;19(2):

68. Influence of Patient Requests on Antidepressant Prescribing
298 physician visits by standardized pts
Patients presented with symptoms of two conditions: major depression, adjustment disorder
Divided into three groups
Asked about Paxil
Asked about antidepressants in general
No mention of drug therapy
JAMA 2005;293:

69. Influence of Patient Requests on Antidepressant Prescribing
Major Depression %Rx % Rx Paxil
Asked about Paxil 53% 52%
Asked about antidep. 76% 3%
No med inquiry 31% 13%
Adjustment Disorder
Asked about Paxil 55% 67%
Asked about antidep 19% 26%
No med inquiry 5% 0%
JAMA 2005;293:

70. DTC Model Advertising increases awareness of condition and treatment
Awareness motivates patients to seek care or treatment
Requests lead to increased prescribing
DTC essentially adds patients to the manufacturers sales force

71. Common Patient Misperceptions
Many think DTC ads are reviewed and approved by the FDA before an add is released
Some patients think DTC advertised drugs are completely safe and only highly effective agents are advertised

72. DTC Advertising Conclusions
DTCA works to increase sales
There is a substantial return on investment for manufacturers
While DTCA can increase the rate of treatment, research shows there is potential for increases in both appropriate and inappropriate treatment
Policies are needed to mitigate risks of DTCA in the US

73. Common Techniques Used in Ads
Drug touted as unique, new or first
Appeal to authority
Bandwagon appeal
Appeal to celebrity
Appeal to fear

74. Slide Courtesy of NoFreeLunch.org

75. Selling Sickness by Moynihan and Cassels
Disease Mongering
Strategies to expand markets
Promotional campaigns change the way people think about common ailments
Menopause becomes hormone deficiency
Shyness becomes social anxiety disorder
Acid indigestion becomes gastroesophageal reflux disease
Lowering thresholds for treating common conditions
The US has 5% of the worlds population yet accounts for 50% of drug consumption
For an entertaining video that provides a hypothetical example, go to and search for motivational deficiency disorder. Click on a new epidemic.
Selling Sickness by Moynihan and Cassels

76. Regulation of Marketing
FDA responsible for oversight, not Federal Trade Commission (FTC)
Research suggests journal ads often do not meet all FDA requirements
FDA does not have adequate staff
FDA’s power is limited
Impossible to regulate what reps say

77. Industry Sponsored CE Programs
Industry invests heavily in educational programs as part of their overall marketing plan
$2.4 billon spent on CME in 2006
712,163 hours of education
61% supported by commercial sources
It may be very difficult to critically evaluate information provided

78. Assessing Bias in Commercially Supported CME
Disclosure: Required whether COI present or not
Branding
Ideally should present levels of evidence
Favorable presentation of data, especially using low level evidence
Watch out for verbiage suggesting weak evidence: “its possible”, “may be”, “in my experience”
Unapproved use of products
Off-label drug use must be clearly identified

79. Questions to Ask Why am I attending?
Are there better sources of information?
Will I be able to critically evaluate this information?

80. Conclusions
The primary mission of a pharmaceutical company is to generate profit and increase shareholder value
Effective marketing helps companies achieve their mission
Enormous amounts are expended in the marketing of prescription drugs, primarily for detailing, samples and DTCA
Industry marketing is sophisticated, influential and impacts health professionals decision making

81. Conclusions Industry marketing can lead to sub-optimal prescribing
Current marketing practices are controversial and opinions vary depending on ones perspective
Clinicians can make choices to avoid undue influence
Using unbiased and evidence-based sources of drug information and avoiding commercial sources as much as possible is an important step
Consider signing up for the AMA opt-out program to prevent detailers from using your individual prescribing data at

82. Thank you
This work was made possible by a grant from the state Attorney General Consumer and Prescriber Education Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin.

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