1. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Eric J Topol MD Provost and Chief Academic Officer Chairman, Department of Cardiovascular Medicine The Cleveland Clinic Foundation Cleveland, Ohio Robert M Califf MD Professor of Medicine Associate Vice Chancellor for Clinical Research Director, Duke Clinical Research Institute Duke University Medical Center Durham, North Carolina

2. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Special Guest Commentator Thomas Lee MD M Sc Associate Professor of Medicine, Harvard Medical School Boston, Massachusetts

3. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Hot topic Rosenthal MB, Berndt ER, Donohue JM, et al. Promotion of prescription drugs to consumers. N Engl J Med 2002;346:498-505. Wolfe SM. Direct-to-consumer advertising -- education or emotion promotion? N Engl J Med 2002;346:524-6. Holmer AF. Direct-to-consumer advertising -- strengthening our health care system. N Engl J Med 2002;346:526-8. Lee TH, Brennan TA. Direct-to-consumer marketing of high- technology screening tests. N Engl J Med 2002;346:529-31. Mintzes B, Barer ML, Kravitz RL, et al. Influence of direct to consumer pharmaceutical advertising and patients' requests on prescribing decisions: two site cross sectional survey. BMJ 2002; 324: 278-279.

4. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Rosenthal MB, et al. N Engl J Med 2002;346:498-505. Direct-to-consumer advertising

5. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Consumer culture We're in a consumer's culture, people want information to make their own choices. "However, I think it [DTC advertising] can do a lot of damage to medicine in general. It's jacking up the prices, the amount of money being spent on drugs, as well as radiology." Lee

6. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising EBCT It doesn't seem to add information beyond a typical clinical risk score. Some people believe it works, some do not and are just doing this for money. "My feeling is, it's a great technology, it's an interesting technology, but it just has not been shown to be useful yet." Lee

7. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Three counter arguments Three points to consider Those who make medical products or diagnostic technology are obligated to inform patients about them The real issue isn't medical product advertising, it's professionalism of doctors It is critical to separate out reimbursement from the issue of people choosing to use a particular diagnostic technology Califf

8. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Rosenthal MB, et al. N Engl J Med 2002;346:498-505. Pharma advertising: 2000 2467 13 421

9. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Consumer choice "I would not advocate […] having insurance cover it. But if someone wants to pay out of their pocket and they make their own choice to do that, more power to them. From my perspective, that's the American way and I'm all for it." Califf We must separate proven technologies from those which are still questionable

10. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Flip side of consumerism "You know, ma'am, this isn't a grocery store and I'm not a waiter in a restaurant. You can't just come in and tell me what you want." Lee The flip side of consumerism is the patient demanding the tests they want because they can pay for them.

11. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Drugs with most DTC advertising:2000 Rosenthal MB, et al. N Engl J Med 2002;346:498-505.

12. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Ads for statins Source: Merck

13. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Patient information "The problem really is that health systems and doctors have not created their own information which informs patients adequately […] about what their options are and what their risks and benefits are." Califf

14. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising VIGOR 0.1%0.4%MI Event 0.2% CV death 0.4%0.5%Mortality Naproxen 1000 mg Rofecoxib 50 mg Bombardier CA, et al. N Engl J Med 2000;343:1520-28

15. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Doctors need to give information "If you survey patients, they would much rather get information from their doctors than from anyone else. "They're not getting their information from the doctors or the doctors don't have time or the systems aren't set up so that it's easy for them to get information related to medical products or therapeutics." Califf

16. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Where to spend the money? "Do you think that it's appropriate that a quarter of a billion dollars is spent on television advertising, when there's important issues that haven't been studied appropriately?" Topol "I don't think we have the right to tell people they can't advertise if they have a product which is in a market, which is being used by a lot of people." Califf

17. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Different rules What if it is the wrong message? FDA is understaffed to monitor ads The rules are different for advertising sneakers than for advertising drugs There will always be a tendency to make the downside appear as small as possible Califf

18. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising "The reason I get so upset [about EBCT] is that our own colleagues are doing the things that upset us when the drug companies do them." Lee Physicians hawking unproven tests for patients paying out of pocket is a violation of professional ethics. Professional ethics

19. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising How do we prioritize? "We live in a society where we spend more on potato chips then we do on the treatment of cancer." Califf We shouldn't control the problem through regulation. We don't know enough yet on the CT score.

20. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Professionalism "I would err less on the side of regulating or eliminating the things and err more on the side of working harder in medical schools to teach doctors what they need to know." Califf Professionalism is the key.

21. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Rising costs Everything rising faster than doctors' salaries is a possible area of waste Radiology costs increasing 25-30% annually Pharmacy costs increasing 15-20% annually Tests must be tied to better outcomes for the patients Lee

22. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Discretionary income "People's discretionary income, they can spend it on a new car, or they can spend it on a CT scan." Califf "When the patient spending his or her own bucks affects the rest of the health care system, I do think it's fair game for us to talk about it as a profession." Lee

23. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Ads for Viagra® Source: Pfizer

24. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Rosenthal MB, et al. N Engl J Med 2002;346:498-505. Direct-to-physician advertising: 2000 7.95 4.04

25. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Drugs with most DTC advertising:2000 Rosenthal MB, et al. N Engl J Med 2002;346:498-505.

26. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising "Just because some good things may happen from something like advertising, it doesn't mean that I want to support that as the main way of making those good things happen." Lee The drug companies have not proven able to regulate themselves. Good from advertising

27. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Rosenthal MB, et al. N Engl J Med 2002;346:498-505. Direct-to-physician advertising

28. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising "It's hard enough to learn what you need to learn just to take care of people without having to worry about weeding out the stuff that doesn't add any value." Lee Learning

29. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Eroding trust in doctors Public trust in physicians has eroded Rise in the use of alternative medicines The use of the internet for information Direct-to-consumer advertising The ability to order their own tests Topol Physicians have to practice evidence-based medicine to regain the trust of patients.

30. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising Physician education "Don't you think that the medical schools have been an abject failure in this regard of really training physicians to be prepared to practice as opposed to serving as farm schools for basic science laboratories?" Califf "If there aren't any checkpoints in this […] then it's quite dangerous." Topol

31. Thumbs up/Thumbs down – March 2002 Direct-to-consumer advertising "The last thing I would say is that if physicians don't do it, someone is going to do it for us and that will not be pretty." Lee Physicians have to practice evidence-based medicine to regain the trust of patients. Drawing a line