1. Separating the Wheat from the Chaff Obtaining Useful Information from Pharmaceutical Representatives

3. 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. Source: www.NoFreeLunch.org

4. Drug Rep Bashing

5. Pharmaceutical Advertising “The best defense the physician can muster against (misleading) advertising is a healthy skepticism and a willingness... to do his (sic) homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial... and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new” P.R. Garai, 1964

6. Drug Advertising The goal of advertising is to inform, remind, or persuade the target audience The difference? A select group (clinicians) controls consumption for millions (patients) 3

7. Drug Advertising Information alone rarely changes behavior Provides information, but has to generate an emotional response to work –Pride, fear, anger, ego gratification – all work Target audience considers themselves rational and critical, requiring special techniques

8. Other Sales Forces: Patients Mukherjee D, Topol EJ. Am Heart J 2003;146:563-4.

9. Other Sales Forces: Patients Goal of DTC advertising: create a sales force of patients Effective: 40% of patients get prescriptions for the drugs they ask for!

10. Other Sales Forces: Colleagues Wall Street Journal: “At small meetings, these physician- pitchmen tell their peers about diseases and the drugs to treat them, often pocketing $750 or more from the sponsor.” 2004; 237,000 physician-led meetings Speaker training – the new sales method Trusted colleagues = good sales –Merck: Return on investment twice as high with MD-led discussion groups Hensley S, Martinez B. Wall Street Journal, July 15, 2005

11. The Evidence Increased prescribing with increased contact –more costly prescribing –more nonrational prescribing –new drug prescribing –decreased use of generic drugs More requests for formulary additions –“dose-related” increase with sponsored meals Wazana A. JAMA 2000;283:373-80.

12. The Evidence Company-sponsored speakers: –increased residents’ inappropriate treatment decisions –occurred even in residents who could not remember the speakers’ affiliations (“under the radar”) CME: increases prescribing of sponsors’ drugs Wazana A. JAMA 2000;283:373-80.

13. Pharmaceutical Representatives Excellent source for “Patient-Oriented Evidence that Matters,” especially with an active approach Experts on drugs they sell- indications, dose, side effects, pharmacokinetics Cannot provide information on when or for whom

14. Usefulness Score Validity: Moderate Relevance: Moderate. Much irrelevant info. Work: Low If validity or relevance is zero, usefulness is zero

15. The “Appeals Process” Correct InformationCorrectReasoning + Correct Conclusion See: Johnson RH, Blair JA. Logical Self-Defense. 2 nd ed. Toronto: McGraw-Hill Ryerson Limited. 1991.

16. Appeals- Rational/Non Rational Rational: All relevant information, true facts, sound reasoning connecting facts to conclusion Non-rational: Fallacy of Logic

17. Non-Rational Appeal “Cefawhatzitcalled” is effective against 98% of bacteria causing sinusitis “Cefawhatzitcalled” is the best drug for treating sinusitis You should use my drug for your patient

18. Non-Rational Appeal A major journal releases a supplement focusing on strep throat, co-authored by well-respected academicians (guess who sponsored the supplement?). Conclusion: Second and third generation cephalosporins are the drug of choice for strep throat. What are the facts and what is the reasoning?

19. Non Rational Appeal Facts: –Second and third generation cephalosporins given once or twice daily for 5 days eradicate strep from pharynx –Patients are more compliant with once or twice daily meds for short periods –Best drugs to treat strep throat, right?

20. The Rest of the Story... May NOT be more compliant if much more expensive (real world vs free study, 60% of patients on statins stop after one year) What about generic azithromycin for 5 days, or chewable amoxicillin 750mg daily for 5 days with morning cereal? Do we even need to really treat for 10 days or even treat at all?

21. Facts vs Reasoning Less work to focus first on reasoning instead of facts What outcomes truly matter?

22. Appeal to Authority “Dr. ____ from ____ University uses this drug” The fallacy: basing a decision on an authority’s decision, not on the authority’s reason for making the decision

23. Bandwagon Effect “This is the most prescribed ____ in the U.S.” The fallacy: –A derivative of the appeal to authority –Not knowing reasons why the drug is the most prescribed –The Ford Escort is the best selling car in the world...

24. Red Herring This drug: –Has a unique carboxyl group on the terminal chain –Is safer in the event the patient also overdoses on acetaminophen (Tylenol) –Penetrates the bacterial cell wall better The fallacy: interesting (or not) but irrelevant information

25. Appeal to Pity “Can’t you help me out by trying...” “Doesn’t every patient deserve a trial...” The fallacy: Basing a decision on emotions (pity, wishful thinking), rather than evidence

26. Appeal to Curiosity “Let me show you this brief demonstration of how our drug works” “Our antibiotic is a zwitterion...” The fallacy: Similar to the red herring appeal, the demonstration or highlighting of a non-clinical uniqueness captivates the mind

27. Error of Omission “I’m glad you asked me that question...” The fallacy: Omitting information necessary for making a totally informed decision –STEPS: Safety, Tolerability, Effectiveness, Price, Simplicity

28. Other Techniques Testimonial –Experts –Self-testimonial 6

29. Other Techniques Testimonial Relationship building –“Face-time” is crucial 6

30. Other Techniques Testimonial Relationship building Reinforcement –Message comes in “under the radar” –Pens, pads, trinkets –Office survey for reinforcers Shaughnessy AF. JAMA 1988;260:926. 6

31. Other Techniques Testimonial Relationship building Reinforcement Food –More receptive to messages while eating Janis I. J Pers Soc Psychol 1965;1:181-6. 6

32. Other Techniques Testimonial Relationship building Reinforcement Food Gifts 6

33. Acceptance establishes relationship with attendant obligation Culturally programmed to return “gift” Goal of advertising- “emotional response” Chren MM, Landefeld CS, Murray TH. doctors, drug companies, and gifts. JAMA 1989;262:3448-3451.

34. Sunshine Policy “What would my patients think if they knew they were paying for this (Cruise on the river, dinner at the Clifton, box seats) ?” AMA Opinion E-8.061 Gifts to Physicians from Industry

35. What Can We Do? Identifying non-rational does not ensure protection Common (mis)belief: “can receive... and not be influenced” “... implies lack of judgment...” The more unaware, the more vulnerable Visceral response, not intellectual

36. Taking the right “STEPS” when evaluating new information S = Safety T = Tolerability look for “pooled drop-out rates” E = Effectiveness -- Studies showing that the new drug is better than your current choice examples: aspirin vs tPA in acute stroke, adequate vitamin D dose to prevent fractures. P = Price S = Simplicity of use Preskorn SH. Advances in antidepressant therapy: the pharmacologic basis. San Antonio: Dannemiller Memorial Educational Foundation, 1994

37. STEPS- Clinical Example Should ezetimibe be used to treat hypercholesterolemia? Safety: No safety issues No  rhabdomyolysis in comb. with statins

38. STEPS- Clinical Example Tolerability: No particular issues Pooled dropout rate 5% (= placebo)

39. STEPS- Clinical Example Effectiveness:  LDL-C 18-25% when used alone Ezetimibe + 10 mg simvastatin:  LDL-C to same degree as higher doses of simvastatin alone But... –No research showing its effectiveness in  death, stroke, CV disease –No research in patients with other illnesses

40. STEPS- Clinical Example Price: $75/month Less than simvastatin, atorvastatin Simv. 10 mg + ezetimibe > simvastatin 40 mg (at least now) Simplicity QD No dosage adjustments Can be given with or without food

41. Information Mastery Rely on PR for data, not decisions Look for “Patient-Oriented Evidence that Matters”, the reasons to choose one drug over another –STEPS Take responsibility for validity Take active approach, teach PR your needs 4

42. Roll Tape