Show Me the Evidence!

1. Show Me the Evidence! Identifying the Truth about Rx Drugs Enter event/location May 19, 2008

2. Faculty Disclosure Your Name Here, MD Dr. Your Name Here reports that he has No Conflict of Interest with this presentation. In accordance with the requirements of the Standards for Commercial Support of the Accreditation Council for continuing Medical Education adopted by the AMA and the Oregon Medical Association, each instructor is asked to disclose any affiliations with, or financial interests in, companies whose products are discussed in his/her presentation. Event/Location of Lecture CME Presentation May 19, 2008

3. Learning Objectives • Recognize cost and health impact of inappropriate or excessive utilization of prescription drugs • Increase awareness of biased information and pharmaceutical industry marketing practices. • Describe strategies that can reduce the influence of biased information.

4. Learning Objectives, con’t. • Describe how evidence-based approaches can be used to guide prescribing decisions. • Provide reliable sources of unbiased prescribing information and practice guidance. • Provide educational resources for more in-depth information regarding pharmaceutical industry marketing and use of evidence-based methods to make prescribing decisions.

5. US Health Spending in 2006 $2.1 trillion or $7,026 per person Health care inflation generally outpaces increase in GDP. When health care costs rise faster than the overall economy, affordability and range/quality of benefits decrease. Health Affairs 2008;27(1):14-29

6. Healthy Life Expectancy & Per Person Medical Expenses: 22 Developed Countries HealthLifeExpectancy Per Person Annual Medical Expenses

7. Trends in health care

8. Rx Costs Are a Large Part of Overall Health Care Spending Source: 2007 DMAP class 07/11 expenditures (total fund, excludes rebates) http://www.oregon.gov/DHS/aboutdhs/budget/07-09budget/index.shtml (accessed 6/10/08) http://www.oregon.gov/DAS/BAM/GRB0709.shtml (accessed 6/10/08)

10. Prescription Drug Expenditures Increased at a faster rate than any other area of health care over the last 15 years Major contributor to rising health care costs Responsible for a large portion of insurance cost increases Costs increased because of Increased utilization (prescribing rate) Increased price per prescription

11. Factors Driving Utilization Increase in prescription drug coverage Marketing Aging population More chronic conditions Impact of Medicare Coverage

12. Increased Price Per RX Price increases for existing drugs exceed inflation Largest driver of increased Rx spending Newer drugs replace older less expensive agents Shorter approval time Marketing of newer agents drives market share

13. Premiums, Earnings & Inflation Source: Kaiser/HRET Survey of Employer-Sponsored Health Benefits

14. Implications of Current Trends Health care affordability continues to deteriorate Health costs, including Rxs, expected to rise faster than economy Increased consumer out-of-pocket costs  increased premium share, deductibles, co-insurance, and co-payments State & Federal budget deficits Increased rate of uninsured/underinsured

15. Conclusions About Costs Currently, the US spends more per capita on health care than any other developed country, yet is ranked near the bottom in terms of quality. Continuing on the current path has huge societal implications. How much more can we spend? The alternative is to spend more wisely. Payers are looking at all options to contain health care and pharmaceutical costs, and to get better value. This creates a great opportunity for prescribing physicians.

16. Quality of care issues with prescription drugs • Over-medicalization (disease mongering) • Treatment of non-disease or trivial entities • Premature intervention in less severe conditions • Poly-pharmacy • Increasing med side effects leading to more medications • Unpredictable interactions and greater potential for errors • Off-label use

17. Disease Mongering US has 5% of the worlds population but 50% of drug consumption 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 Selling Sickness by Moynihan and Cassels

19. What the FDA does • Approves new drugs and devices based on: • The medicine or device is “effective” • Endpoint may be a surrogate such as lowering cholesterol as opposed to longer life • Usually 2 RCTs required to prove clinical efficacy for drugs • The medicine or device is “safe” • Charged with oversight of DTC materials • Small number of DTC materials are actually reviewed • Regulatory letters are often delayed and marginally effective.

20. What the FDA doesn’t do! Does not assess cost vs benefit for a drug or device. Does not determine whether one drug is better than another. Does not approve every use to which a product may be put. Does not require large trials that will identify all potentially rare complications.

21. Important Contributions by the Pharmaceutical Industry • Development of new treatments that improve health and well-being • Substantial contributions to educational, health care and professional organizations • Provide samples and free meds to many patients • …but, their main goal is to make profits for their shareholders and they spend enormous amounts to influence all involved, including legislators, providers, patients, and the general public, to help them maintain or increase those profits.

22. 2007 Fortune 500 Profits

23. Pharmaceutical Industry Methods for Increasing Market Share • Marketing expenditures • Drug reps • DTC advertising • Journal ads • Prescriber data • What can be done?

24. Promotional Spending and Advertising, 2005 Total spending: $29 billion (Source: IMS Health, in Donohue, NEJM 2007)

25. Socolar D, Sager A. Pharmaceutical marketing and research spending: the evidence does not support PhRMA’s Claims. http://dcc2.bumc.bu.edu/hs/sager/pdfs/120601/DrugIndustryMarketingStaffSoarswhileReserchStaffingStagnates5Dec01.pdf; Accessed 3/6/08

26. Pharmaceutical Representatives • Remains the major marketing focus • ~ 100,000 reps in 2005 vs 38,000 in 1995 • 1 rep/6 MDs in US and 1 rep/2.5 targeted MDs • 6 million detail visits annually • Cost estimate $12-$13K/MD for detailing • Industry spends $150K annually/primary care rep and $330K/specialty rep* *Med Ad News 2004;23(3):1

27. Docs’ Perception vs. Brutal Reality • Studies consistently show physicians do not believe that promotion affects their prescribing habits*, but… • Studies consistently show drug promotion increases prescribing of targeted drugs** *Sigworth SK et al. JAMA. 2001;286(9):1024-5.McKinney WP et al. JAMA 1990;264(13):1693-7 **Chren MM et al. JAMA 1994 Mar 2;271(9):684-9; Lurie N et al. J Gen Int Med 1990;5:240-243; Wazana A. JAMA 2000 Jan 19;283(3):373-80. .

28. Details of Detailing: Impact on Prescribing & Costs • Increased likelihood of formulary requests for targeted drugs • Increased awareness, preference and rapid prescribing of new drugs • Higher prescribing costs • Less use of lower cost, but equally effective, generics • Less rational prescribing (Wazana A, JAMA 2000)

29. Direct to Consumer (DTC) Ads • Directly target consumers & general public • 1997: FDA relaxed regulations • Eliminated requirement to list all side-effects by simply referring to additional sources of information, e.g., 1-800 number or website • As of 2005, the US and New Zealand only developed nations with DTC Rx advertising

30. DTC Expenditures Are Huge… • $4.5 billion spent on DTC in 2005* • 296.4% increase from 1997-2005* • 14% of total industry marketing for DTC** • Hoechst spent $580K on 60-second Allegra ad*** • Merck spent $161M advertising on 1 drug, Vioxx, whereas total annual ad budgets: Dell ($160M), Budweiser ($146M), Pepsi ($125M) or Nike ($78M)**** *Shuchman, NEJM, 2007 **Donohue et al. NEJM, 2007 ***Eaton, Stanford University Press, 2004 ****Gellad et al. Amer J Med, 2007

31. But, DTC Ads Pay Off • 1998-1999: 25 most advertised drugs account for 43% growth in Rx sales compared to 13.3% for all other drugs* • 1998: Claritin, Allegra, and Zyrtec increase sales by 32%, 50% and 56%* • 2002: >53M patients discuss DTC-advertised meds with their doctors** *Eaton, Stanford University Press, 2004 **Rosenthal, NEJM, 2002

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34. The Quantity and Quality ofScientific Info in Journal Ads 1999 review of pharm ads from 10 US journals: • 498 unique ads (3,185 total) • 74 unique graphs • 36% of graphs: “numeric distortion” • 66% of graphs: “chart junk” • 54% list intermediate outcomes JGIM 2003;18:294-297

35. Big Brother (Pharma) Knows What You Are Doing • Industry has access to AMA managed databases that track prescribing patterns of most practicing providers • Such data is used to more precisely target specific providers with specific types of products or messages • AMA has an “opt out” option

36. But You Can “Opt-out” • Physicians can enroll at: 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 opt-out is exercised. Ann Intern Med 2007;146:742-48

37. What Clinicians Can Do To Reduce Marketing Impact? • Reduce or eliminate contact with industry representatives • “Just say no” • Identify/use unbiased and independent sources of prescribing information • Opt out of use of your data in the AMA master profile

38. CME: Incentives and Gifts • Free Meals • Payment for attendance at lectures and conferences • Stipend • Time • Travel • Registration fees

39. Industry Support of Continuing Medical Education • In 2006, half of the $2 billion dollars spent on CME came from industry sponsorship • Medical Education and Communication Companies (MECCs) • Organize meetings, find speakers for grand rounds and symposia, develop written materials • About 76% income from industry • Medical Schools • Industry provides almost two thirds (62%) of CME income to medical schools (ACCME) Source: ACCME, Annual Report Data 2006

40. Does this Affect Prescribing? • Attending drug company–sponsored CME • 5-19% increase in rate of prescription of sponsor’s drug vs. competitor’s drug (P<.05) • Funding for travel or lodging to attend educational symposia • Increased formulary requests for the sponsor's drug • Increased rate of prescribing of sponsor’s drug • Impacted hospital prescribing practices 2 years later (Wazana A, JAMA 2000)

41. Does the Source of Funding Affect the Content of CME? • Content analysis of two different CME courses sponsored by two different drug companies, each discussed 3 calcium channel blockers • Drug company–sponsored CME preferentially highlighted the sponsor's drug(s) compared with other CME programs • 2.5-3 times more likely to mention positive effects of sponsor’s drug and negative or equivocal effects of competitor’s (P<.05) (Bowman MA, Mobius1986)

42. Deal With Conflicts of Interest • Eliminate the conflicts whenever possible • Can be difficult and painful, especially with friendly reps • Even the perception of conflicts create credibility problems • Recognize tendency to rationalize • “It’s an educational dinner” • “patients need samples” • Denial • “It doesn’t affect my prescribing decisions” • “I take it with a grain of salt” J Gen Int Med 2007;22:184-90

43. Sage Advice “The best defense the physician can muster against (misleading) advertising is a healthy skepticism... cultivate a flair for spotting the logical loophole, the invalid clinical trial . . . and the unlikely claim. Above all, develop greater resistance to the lure of the fashionable and the new.” P.R. Garai, 1964

44. Conclusions About Marketing • Industry marketing is very influential and definitely impacts decision making • Marketing can lead to ineffective prescribing • Current marketing practices are controversial and opinions vary • Health professionals can make choices to avoid undue influence

45. Need for evidence “First of all, do no harm” (Hippocratic Oath) 2008 version: Never offer treatment to a patient without convincing evidence that it will provide more help than harm. Shouldn’t we also consider help/harm to the patient’s family & overall community in this equation?

46. Principles of Evidence-based Medicine (EBM) Decision making in clinical practice What is EBM? What EBM is not

47. Decision Making in Clinical Practice Unfortunately, many decisions are made based on unreliable “evidence” Expert opinion plays a heavy role in medical decision making Personal observation or anecdotal experience can frequently overcome clear evidence to the contrary

48. Clinical Decision Making Guidelines Knowledge Ethics Mulrow: Ann Intern Med, Vol 126(5) 3/1/97, pp 389-91

49. What is EBM? EBM is "the conscientious, explicit and judicious use of best current evidence in making decisions about the care of individual patients.” -David Sackett

50. What is EBM? Evidence based medicine requires the integration of the best research evidence with our clinical expertise and our patient’s unique values and circumstances. Sharon E. Straus: Evidence Based Medicine 3rd Edition