The CAGE Questionnaire for Drug Company Dependence

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. Case You are an overworked, under-appreciated physician in a large hospital-based practice and while going through the mail find an invitation to a lecture on a new diabetes drug. The lecture, sponsored by the manufacturer, takes place in a restaurant at New York City’s Madison Square Garden, and is preceded by dinner. Following the lecture, the invitation reads, you will be escorted to your seat to watch a basketball game between the Knicks and the Raptors. “A free Knick game sounds pretty good,” you think to yourself, “and that lecture doesn’t sound half-bad either.” Would you accept the invitation?

4. American Medical AssociationCouncil on Ethical & judicial Affairs(JAMA, Jan 23/30, 1991) • “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.”

5. American College of PhysiciansPhysicians and the Pharmaceutical IndustryPosition Statement (Ann Int Med, April 15, 1990) “Gifts, hospitality, or subsidies offered to physicians by the pharmaceutical industry ought not to be accepted if acceptance might influence or appear to others to influence the objectivity of clinical judgement. A useful criterion in determining acceptable activities and relationships is: Would you be willing to have these arrangements generally known?”

6. Canadian Medical Association Policy SummaryPhysicians and the Pharmaceutical Industry(CMAJ, Feb 1, 1992) • “Practicing physicians should not accept personal gifts from the pharmaceutical industry or similar bodies” • “Practicing physicians may accept patient-teaching aids appropriate to their area of practice provided these aids carry only the logo of the donor company and do not refer to specific therapeutic agents.”

7. The Royal College of PhysiciansThe Relationship between physicians and the pharmaceutical industry(J Royal Coll Phys London, October 1986) • “A physician should not accept inordinate or excessive hospitality from any pharmaceutical company. The borderline of acceptability is not easy to define. The provision of modest refreshment at a conference should be construed as reasonable; a lavish private dinner party at a restaurant should not. A pharmaceutical company should not be expected to extend hospitality to the spouse of a physician.” • “ . . . A useful criterion of acceptability may be ‘would you be willing to have these arrangements generally known?’”

8. “A useful criterion in determining acceptable activities and relationships is: Would you be willing to have these arrangements generally known?” (ACP)____________ [Image of flyer]

9. Distinguish? • Pens, notepads, stethoscope tags • Sponsored conferences/lunch • Unrestricted grants from • Dinners • Happy hours • Sporting events

10. But Gifts: • Create relationship, obligation. • Erode professional values, damage image of profession. • Cost money -- patients pay? • Influence behavior. (Chren, Landefeld, Murray, JAMA ‘89)

11. Pharmaceutical industry promotion, pharmaceutical industry profits

12. Farmaceutical Facts: • The pharmaceutical industry spent $15.7 billion dollars in 2000 on promotion, up from $ 13.9 billion in 1999. • Most of this was spent on promoting products to doctors and free drug samples. • Sixty million “details” were made by 83,000 reps in the year 2000. $7.2 billion dollars worth of free samples were distributed. • The “Research-based” pharmaceutical industry spends more on promotion and administration than it does on research and development.

13. Promotional spending on prescription drugs, in billions of dollars, l996-2000 . Source: NIHCM

14. Promotional spending on prescription drugs 2000 Total spending: $l5.7 billion dollars Source: IMS Health

15. Pharmaceutical Industry Profits • 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).

16. Pay, Profits, and Spending by Drug Companies: • All of the 9 U.S. drug companies that market the top-selling 50 drugs for senior citizens spent more money on promotion and administration than on research and development in FY 2000. • 6 of these 9 companies made more money in net profits than they spent on R&D. • For the highest-paid executive in each of the 9 companies, the average compensation was almost $19,000,000. Source: Families USA

17. Source: Public Citizen analysis of company annual reports; Fortune magazine, April 2001

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

19. Farmaceutical Facts: • 2.9 billion prescriptions were written in 2000, an average of 10.4 prescriptions per person. • Drug costs increased 18.8% to $131.9 billion dollars in 2000 • 42% of increase attributed to increase #prescriptions • 36% to a shift to more expensive drugs • 22% to an increased price of drugs • The best selling category of drugs in 2000 was anti-depressants

20. Prescription drug expenditures, in billions of dollars, l993-2000 . Source: IMS Health

21. Drug costs increased 18.8% in 2000 Source: NIHCM

22. Farmaceutical Facts: • $2.5 billion dollars were spent on advertising to consumers in 2000; $468 million dollars were spent on journal ads. • Increases in the sales of the 50 drugs most heavily advertised to consumers in 2000 were responsible for almost half (47.8%) of the $20.8 billion increase in spending on drugs that year. • Over 40% of DTC spending was concentrated on ten products, among them Claritin, Prilosec, Viagra, Paxil, and Meridia. Source: NIHCM

23. Ideal Direct to Consumer Ad Target?

24. Farmaceutical Facts In 2000, Merck spent $161 million on advertising for Vioxx. That is: • More than Pepsico spent advertising Pepsi. ($125 million) • More than Anheuser-Busch spent advertising Budweiser. ($146 million) The increase in VioxxTM sales in 2000 accounted for 5.7% of the 1 year increase in drug spending!

25. Pharmaceutical promotion in clinical practice. Why is this important? A matter of: • Ethics • Good medical practice • Medical education • Cost

26. “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?

27. Evidence that: • Physicians don’t believe promotion influences their own behavior. • Promotion does influence behavior. • Promotion is often biased and inaccurate. • Promotion may lead to inappropriate prescribing.

28. What’s the Evidence?

29. Pharmaceutical companies spent $15.7 billion dollars in 2000 on drug promotion in the U.S. . .

30. The Evidence • Attitudes and Practices • Influence of promotion on behavior • Bias in promotion • The use of pharmaceutical samples

31. Attitudes and Practices

32. Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical promotions. Steinman MA, Am J Med, 110, 2001. • Survey of 117 1st and 2nd year residents at a university-based IM training program • Attitudes towards 9 types of promotion assessed . Promotions categorized on basis of cost (inexpensive, < $10) and educational value • 90% response rate (105/117 residents)

33. Attitudes Toward PR PromotionsPercent Who Consider Appropriate

34. Practices Among Residents Who Consider Promotion Appropriate

35. Practices Among Respondents Who Consider Activity Inappropriate

36. Perceived Influence of PRs on Prescribing Practices p <.0001

37. Interactions with the pharmaceutical industry: experiences and attitudes of psychiatry residents, interns, and clerks. Hodges B, CMAJ, 153 (5); 1995 • Survey of 105 residents, interns, and clerks rotating through 7 teaching hospitals in Toronto, Canada. • Self-report questionnaire • 70% response rate

38. Interactions with the pharmaceutical industry: experiences and attitudes of psychiatry residents, interns, and clerks. Hodges B, CMAJ, 153 (5); 1995 • The mean estimate of the value of gifts received was $60, range $0 to $800. • 37% reported attending dinners, 43% reported receiving books. • The number of promotional items received was positively correlated with the belief that discussions with reps have no impact on prescribing behavior.

39. Interactions with the pharmaceutical industry: experiences and attitudes of psychiatry residents, interns, and clerks. Hodges B, CMAJ, 153 (5); 1995 • 34% said discussions with reps do not impact prescribing behavior. • 56% said accepting promotional items does not impact prescribing. • 42% disagreed with the statement “I would maintain the same degree of contact with reps if no gifts were distributed.”

40. The pharmaceutical industry’s influence on chief medical residents.Adler, L, Muller D, Bao P, Lan J, Haddow S.JGIM. 1999; 14[supplement 2]:128. • National survey of chief medical residents. 84 responded. • 100% reported that their programs participated in pharmaceutical company-sponsored theatre or sporting events; 67% had personally participated in such events. • Thirty per-cent said that the reps were more likely to get access to the housestaff if they left gifts; 27% asked for gifts. • One in four chief residents never asked for references when discussing products with reps; one in ten ranked the drug reps above the medical literature, their attendings, and their peers as sources of information about new drugs.

41. Is there free lunch? Resident and faculty perceptions at the turn of the century.Hulgan TM, Wilson MC, Applegate WB. JGIM. 2000; 15[supplement 1]:35. • Questionnaire at academic medical center • 83/84 housestaff, 90/103 faculty responded • 60% of faculty and 37% of housestaff felt that interaction with reps could influence prescribing patterns of other physicians • 44% of faculty and 22% of housestaff felt their own decisions had ever been influenced by these interactions. • 13% of faculty and 54% of housestaff felt that overnight/weekend trips for conferences sponsored by drug companies were acceptable gifts.

42. Patient Perceptions of Physician Acceptance of Gifts from the Pharmaceutical Industry Mainous lll AG, Hueston WJ, Rich EC.. Arch Fam Med. 4; 1995: 335-9. Telephone survey of 649 adult patients in Kentucky Response rate 55% 82% were aware that physicians received gifts that were of potential value to patients. 32% were aware that physicians received personal gifts.

43. Influence

44. Physicians' Behavior and their Interaction with Drug CompaniesChren MM, Landefeld CS. JAMA. 1994;271:684-689. 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.

45. Physicians' Behavior and their Interaction with Drug Companies (continued) • Case and control physicians were similar with respect to age, academic rank, tenure status, and number of publications indexed in MEDLINE. • Case physicians were more likely to be male.

46. Physicians' Behavior and their Interaction with Drug Companies (continued) • 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). • These results were consistent in multivariate analysis adjusting for potential confounders.

48. The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns. Orlowski JP, Wateska L Chest 1992 Jul;102(1):270-3 Pharmacy records were reviewed 22 months before and 17 months after two pharmaceutical company sponsored symposia on two medications: Drug A: New intravenous antibiotic; all-expenses-paid trip to “luxurious resort on West Coast (n=10) Drug B: New intravenous Cardiac drug; all-expense-paid trip to island resort in the Caribbean (n=10)

49. The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns. (continued) • The majority of participating physicians interviewed did not believe the free trip would influence their prescribing patterns. • There was a statistically significant increase in prescribing of both medications following the meeting (p<.001). • This increase differed form national prescribing patterns at similar hospitals during this period.

50. The effects of pharmaceutical firm enticements on physician prescribing patterns.Orlowski JP. Chest 1992; 102: 270-3.