The Physician-Pharmaceutical Industry Relationship

1. The Physician-Pharmaceutical Industry Relationship

2. The CAGE Questionnaire for Drug Company Dependence • Have you ever prescribed CelebrexTM? • Do you get Annoyed by people who complain about drug lunches and free gifts? • Is there a medication loGo on the pen you're using right now? • Do you drink your morning Eye-opener out of a LipitorTM coffee mug? If you answered yes to 2 or more of the above, you may be drug company dependent.

3. Levels of Interactions: • Clinicians • gifts • promotional information • Researchers • Professional societies; medical journals • Continuing medical education (CME)

4. 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”)

5. Attitudes and Practices

6. 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

7. Are gifts from pharmaceutical companies ethically problematic? A survey of physicians P=.08 P=.04 P=.05 P=.88 P=.10 P=.34 Arch Intern Med. 2003;163:2213-2218

8. 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

9. Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical promotions Am J Med 2001;110:551

10. Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical promotionsPractices Among Residents Who Consider Promotion Appropriate Am J Med 2001;110:551

11. Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical promotionsPractices Among Respondents Who Consider Activity Inappropriate Am J Med 2001;110:551

12. Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical promotionsPerceived influence of pharmaceutical reps on Prescribing Practices “You” “Other Physicians” P<.0001 Am J Med 2001;110:551

13. 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

14. Pharmaceutical Branding of Resident Physicians JAMA 2001;286:1024

15. Pharmaceutical Branding of Resident Physicians JAMA 2001;286:1024

16. Patient Attitudes

17. 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

18. A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts J Gen Int Med 1998;13:151 P<.004 for all except mug, p=.24)

19. A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts J Gen Int Med 1998;13:151 P<0.0001 for all except trip, p=0.0017

20. Professional Guidelines

21. American Medical AssociationCouncil 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

22. American College of PhysiciansGuidelines 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.

23. American College of PhysiciansGuidelines 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.

24. PhRMA Codeon 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

26. 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

27. 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

28. PhRMA Code FAQs Question: Under the Code, may items such as stethoscopes be offered to healthcare professionals? Answer: Yes www.PhRMA.org, April 2002

29. “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?

30. Pharmaceutical industry Spending on Promotion

31. Promotional spending on prescription drugs, l996-2002 Source: NIHCM, 2001

32. Promotional spending on prescription drugs, 2002 Total spending: $21 billion Source: IMS Health

33. Direct to consumer advertising on prescription drugs,l996-2000 Source: NIHCM, 2001

34. Direct to consumer advertising spending in the U.S., 2000 Source: NIHCM, 2001

35. Comparison of median revenue dedicated to R&D, profits, and marketing/administration, Fortune 500 drug companies, 2000 (n=11) Source: Public Citizen, 2001

36. Main task of drug company employees, 2000 Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar

37. Drug company jobs in marketing and research, 1995-2000 # Jobs Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar

38. Profitability of drug industry, l993-2000 2.8% • 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).

39. Fortune 500 drug company profitability compared to all other Fortune 500 companies, 2000 Source: Public Citizen, 2001

41. Sources of increased drug expenditures, 2000-2001 37% 39% 24% Total increase: $22.5 billion Source: NIHCM, 2002

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

43. Gifts: • Cost money (like other advertising). • Influence behavior (like other advertising). • Create obligation, need to reciprocate (unlikeadvertising). Conflict of interest • Create sense of entitlement (unlike advertising). • Erode professional values; demean profession (probably unlike advertising).

44. 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

45. 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.”

46. “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?

47. Should doctors be held to different (higher) standards?

48. The physician-patient relationship is a fiduciary relationship.

49. 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)

50. “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?