Pharmaceutical Industry Marketing and Influence

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 2009 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. 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 FacultyType of Relationship/Name of Commercial Interest(s) David Pass, M.D.None Dean Haxby, Pharm.DEmployment/CareOregon Daniel Hartung, Pharm.D., MPHNone Barbara S. Schneidman, MD, MPHNone

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

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 IndustryPromotion & Marketing Source: N Engl J Med 2007;357:673-81. 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) 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):0621-25

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):0621-25

22. How Representaive Can Tailor Approach • Clinician prefers competing product • Refuses to see reps • Thought leaders • 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 Plos Medicine 2007;4(4):0621-25

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;323:1481-84

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;323:1481-84

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 SpecialtyMeetings/Month Family Physicians16 Internal Medicine10 Cardiology 9 Pediatrics 8 Surgeons 4 Anesthesiology 2 N Engl J Med 2007;356:1742-50

32. Physician Industry Relationships Benefits% Reporting Samples78% Gifts83% Travel/CME funding35% Payments28% Any Relationship95% N Engl J Med 2007;356:1742-50

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;356:1742-50

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: • www.ama-assn.org/go/prescribingdata • 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

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