Bennison Comment:
In 2001, pharmaceutical companies spent $2.7 billion or 2% of revenues on DTC advertising.²⁰ Recent research shows that physician response to this advertising is mixed: 40% believe it has a positive effect on their patients and practice, 30% say it has a negative effect, and 30% say it has no effect at all.⁴⁰

There are two types of advertising content: informational and persuasive. In health care, marketing that seeks to raise awareness among consumers by discussing disease states or health conditions or by promoting screening, but does not mention or make a claim about a drug, is viewed as encouraging patients to seek medical attention for treatment. Such communications are not regulated by the Food and Drug Administration.

Persuasive advertising mentions specific drugs with balanced discussion of risks and benefits and encourages patients to try the medication. These advertisements are regulated by the FDA.

In another study, 60% of physicians said DTC advertising helps educate patients about treatments.⁴¹ Fifty percent agreed that DTC ads increase patient compliance and that 25% of the patients who asked about an advertised drug resulted in a new diagnosis.⁴¹

Former FDA commissioner Lester Crawford has said: "DTC advertising is supposed to get patients who need the medication to know about the drug so they can ask their physician about it. Direct-to-consumer advertising, correctly done, is a great health tool."⁴²

Prescribers need to know about new medications or indications before DTC advertising is launched. This type of advertising increases awareness of disease states and products. It is also designed to increase product market shares and expands the overall disease state market by raising awareness.

Both Sides Now: In Conclusion
Crigger:

When it comes to the pharmaceutical industry's relationship with prescribers, both of the primary participants must recognize the danger to professional integrity that occurs if we embrace the types of business relationships that profane and erode societal trust. There are two extreme views of how to handle the promotional activities by drug companies: the "egoistic" view, in which the provider accepts all promotional gifts and activities, and the "ethically sensitive" view, in which the provider rejects any form of gift or program.

A provider who takes the egoistic view has no concern for conflict of interest or just distribution of benefits. All gifts and promotional activities are acceptable. A provider with a pure ethically sensitive view refuses to accept any gift or promotional programs, no matter how small, because of the potential conflict of interest and the ultimate cost to the patient and society.

Bennison:

The pharmaceutical industry is one of the most regulated in this country. The PhRMA code disallows unethical product promotion or creation of conflicts of interest by pharmaceutical representatives. Pharmaceutical representatives should be considered part of the health care team, since they often possess critical knowledge and information that can help patients and health care professionals. Medical education for representatives can help reestablish this relationship. Professionalism and integrity are necessary attributes for representatives.

For pharmaceutical companies to survive, the product pipeline must be full, and research must be productive. The cost of research and development is high, and if revenues don't provide for these endeavors, new product development and medical breakthroughs will slow or cease. The pharmaceutical industry must have fair regulations for pricing, promotional activities, generics, patent protection and managed health care.

I believe regulated pharmaceutical promotions, including detailing, advertising, educational programs and gifts, are all part of doing business in our free enterprise system. I also believe that because of their medical knowledge and clinical experience, prescribers are able to select the most relevant and reliable pharmaceutical information. Our interaction with providers can have a positive impact on patient care when it is understood that we are able to provide a service and bring value.

Putting It Into Practice
Although we (the authors) differ in our views on particular problems, we agree that pharmaceutical industry promotions offer benefits to the patient and health care provider - but that they also present difficult ethical challenges for prescribers. The PhRMA guidelines have reduced certain challenges, but inappropriate activities and promotions still call into question the strategies of the pharmaceutical industry. Providers are advocates for the benefits obtained through their relationships with the pharmaceutical industry but are obligated to identify and stop participation in the promotional activities that negatively affect patients.

Nancy Crigger is a family nurse practitioner and nurse ethicist who has a PhD in nursing and a master's degree in philosophy. She is an associate professor at William Jewell College in Liberty, Mo. Larry Bennison is a senior professional health care consultant, master level, for Pfizer Inc. and lives in Lafayette, Ind. He has a degree in marketing and was recently inducted into the Pfizer Hall of Fame.

References
1. Sherrid P. Fewer doc freebies. U.S. News & Word Report. 2002;132(21):46.

2. Tsai AC. Policies to regulate gifts to physicians from industry. JAMA. 2003;290(13):1776.

3. Angell M. The Truth About Drug Companies: How They Deceive Us and What to Do About It. New York: Random House; 2004.

4. Rothman SM, Rothman DJ. The Pursuit of Perfection. New York: Patheon Books; 2003.

5. Davis M. Conflict of interest. Business and Professional Ethics Journal. 1982;1(4):17-27.

6. Castledine G. Nurses must be immune to product promotions. Br J Nurs. 2003;12(13): 827.

7. Levit K, et al. Trends in U.S. health care spending, 2001. Health Affairs. 2003;22(1):154-164.

8. Iglehart JK. Medicare and drug pricing, New Engl J Med. 2003;348(16):1590-1597.

9. Packheiser M, et al. Should nurses engage in noneducational activities sponsored by pharmaceutical companies? MCN Am J Matern Child Nurs. 2003;28(4):26-227.

10. Sharpe VA. Science, bioethics and the public interest. Hastings Cent Rep. 2002;32(3):23-26.

11. ACOG committee opinion. Guidelines for relationships with industry. Obstet Gynecol. 001;98(4):703-706.

12. Collier J, Iheanacho I. The pharmaceutical industry as an informant. Lancet. 2002;360(9343):1405-1409.

13. Bonk RJ, et al. Drug expenditures in a balanced strategy for healthcare policy. Pharmacoeconomics. 1995;7(6):534-542.

14. Weber J. Drug prices: so much for restraint. Business Week. 1996;March 4:40.

15. Lee TH. "Me-too" products - friend or foe? New Engl J Med. 2004;350(3);211-212.

16. Moynihan R. The making of a disease: female sexual dysfunction. BMJ. 2000;326(7379);45-47.

17. Weber LJ, et al. Health care professionals and industry: reducing the conflicts of interest and established best practices. Arch Phys Med Rehabil. 2001;82(12 suppl 2):s20-s24.

18. Rosenthal MB, et al. Promotion of prescription drugs to consumers. New Engl J Med. 2002;346(7):498-505.

19. Bureau of Census. Statistical Abstract of the United States, 2002. Washington, D.C.; Bureau of the Census; 2002.

20. Pharmaceutical Research and Manufacturers of America. Pharmaceutical Industry Profile 2003. Washington, D.C.:PhRMA; 2003: 76.

21. Lichtenberg FR. Pharmaceutical knowledge, capital accumulation and longevity. In: Corrado C, et al, eds. Measuring Capital in the New Economy. Chicago: University of Chicago Press; 2005.

22. DiMasi JA, et al. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22(2):151-158.

23. Kaitin KI, DiMasi JA. Measuring the pace of new drug development in the user fee era. Drug Information Journal. 2000;34(3):673-680.

24. Research 2000 Sustaining Pfizer's leadership. USPG Team News. 1996;2(5):2-5.

25. Schere FM. The link between gross profitability and pharmaceutical R&D spending. Health Affairs. 2001;20(5):216-220.

26. Kumar P, Zaugg AM. Steady but not stellar. IMS Health Business Watch. 2003;May:50-63.

27. Boston Consulting Group. The contribution of pharmaceutical companies: What's at stake for America? Ann NY Acad Sci. 1994;729:111-126.

28. Katz D, et al. All gifts large and small. Toward an understanding of the ethics of pharmaceutical industry gift-giving. Amer J Bioethics. 2003;3(3):39-47.

29. Chren M, et al. Doctors, drug companies, and gifts. JAMA. 1989;262(24):3448-3451.

30. Ruffle J. Gift giving with emotions. J Econ Behav Org. 1999;39(4):399-420.

31. Holmes DR, et al. Conflict of interest. Am Heart J. 2004;147(2):228-237.

32. Morin K, Morse LJ. The ethics of pharmaceutical gift-giving: the role of the professional association. Am J Bioethics. 2003;3(3):54-55..

33. Khushf G, Gifford R. Understanding, assessing and managing conflicts of interest. In: McCullough L, et al, eds. Surgical Ethics. New York: Oxford Press; 1998: 342-366.

34. Pfizer Inc. Data on file, 2005.

35. Steinman MA, et al. Of principles and pens: attitudes and practices of medicine house staff toward pharmaceutical industry promotions. Am J Med. 2001;110(7):551-557.

36. Caudill TS, et al. Physicians, pharmaceutical sales representatives, and the cost of prescribing. Arch Fam Med. 1996;5(4):201-206.

37. Chatham-Showalter PE. Why I welcome drug reps. Medical Economics. 2003;80(20):80.

38. McCormick BB, et al. Effect of restricting contact between pharmaceutical company representatives and internal medicine residents on posttraining attitudes and behavior. JAMA. 2001;286(16):1994-1999.

39. Weissman JS, et al. Physicians report on patient encounters involving direct to consumer advertising. Health Affairs. 2004;23(2):219-233.

40. Robinson A, et al. Direct-to-consumer advertising: physician and public opinion and potential effects on the physician-patient relationship. Arch Intern Med. 2004;164: 427-432.

41. Aikin KJ. The impact of direct to consumer prescription drug advertising on the physician-patient relationship. Available at: http://www.fda.gov/cder/ddmac/globalsummit2003. Accessed Dec. 5, 2006.

42. Berndt ER. To inform or persuade? Direct to consumer advertising of prescription drugs. New Engl J Med. 2005;352(4):325-328.