By: Amer K. Ardati, MD Editor: Amy Shaheen, MD, Assistant Professor of Clinical Medicine

The Doc, The Drug Rep and The Ward RoundsOr everything you wanted to know about pharmaceutical marketing but was afraid to ask. By: Amer K. Ardati, MD Editor: Amy Shaheen, MD, Assistant Professor of Clinical Medicine Duke University Medical Center

Them Introductions • Pharmaceuticals as a business • Detailing Drugs to Docs • Costs of detailing to docs • Influence of detailing on docs • Perception of physicians and patients about drug detailing • What the academy and industry has to say about drug detailing. • Conclusions and Questions

The Business of Drugs • Pharmaceutical companies are for profit entities with a fiduciary responsibility to obtain profits for their shareholders. • The drug industry is highly profitable when compared to others. • The drug industry invests more in marketing than in research and development.

The Business of Drugs Source: Public Citizen 2002: http://www.citizen.org/documents/Pharma_Report.pdfaccessed 9/1/05

The Business of Drugs Source: Public Citizen 2002:http://www.citizen.org/documents/Pharma_Report.pdfaccessed 9/1/05

The Business of Drugs Source: PhRMA, Industry Profile 2001. Calculations by Sager and Socolar

Detailing Drugs to Docs • More than $11 billion is spent each year by pharmaceutical companies in promotion and marketing, $5 billion of which goes to sales representatives. It has been estimated that $8000 to $13,000 is spent per year on each physician. • The money is well spent and does influence prescribing patterns. JAMA 2000: 283;373

Detailing Drugs to Docs • Unlike advertising, gifts and hospitality promote a sense of obligation towards the gift giver and encourages reciprocation of the gesture. This creates a conflict of interest.

Detailing Drugs to Docs • Physicians recognize that gifts influence other doctors but not themselves. • Patients perceive drug gifts as a form of bribe against their interests regardless of whether or not the bribe is effective.

Detailing Drugs to Docs • From a review of 29 studies evaluating physician-industry interactions: • Most physicians meet with drugs reps 4 times a month. • Most physicians believe that drug representatives provide accurate information. JAMA 2000: 283;373

Detailing Drugs to Docs • From a review of 29 studies evaluating physician-industry interactions: • Most physicians deny that interactions influence their behavior. JAMA 2000: 283;373

Detailing Drugs to Docs • In a survey of 102 medical residents, most respondents felt that they were immune to drug representative marketing, while their colleagues were vulnerable. Am J Med: 2001: 110; 551

Detailing Drugs to Docs Am J Med: 2001: 110; 551

Detailing Drugs to Docs • In a case control study of physicians requesting formulary additions at an academic hospital, physicians who met with pharmaceutical representatives were more likely to have requested addition of drugs made by those companies OR=4.9, 95%CI, 3.2 - 7.4 JAMA 1994;271:684

Detailing Drugs to Docs • In a survey of 468 physicians (both academic and community) a significant positive correlation was foundbetween physician cost of prescribing and perceived credibility,availability, applicability, and use of information provided bypharmaceutical representatives. Arch Fam Med 1996: 5;201

Detailing Drugs to Docs • In a survey of 196 patients and 268 physicians at two tertiary care centers, 54% of patients were aware that doctors received gifts from drug representatives, but only 27% thought that their doctors received gifts. • Patients were more likely than physicians to feel that gifts influenced medical practice. JGIM 1998; 13:151

Detailing Drugs to Docs JGIM 1998; 13:151

Detailing Drugs to Docs • Drug detailing is an orchestrated endeavor. Here is an example of a drug detailing training manual from Merck that was obtained by the House Committee on Government Reform hearing on Rofecoxib (Vioxx): Harper’s 2005; 311: 16

Detailing Drugs to Docs • The Merck Manual: • “Health Education Learning [HEL] Situation: • Physician Says: What a great football game yesterday. Did you see how effective Drew Bledsoe was in the fourth quarter? That guy is amazing. • Possible rep response: Bledsoe is effective on so many levels. He’s a leader, you feel safe with him carrying the ball, and he’s a proven winner. You know who else he sounds like? Zocor, a market leader with an eight-year safety record, proven to save lives of your patients…” Harper’s 2005; 311: 16

Detailing Drugs to Docs • Policy Recommendations and Guidelines

Detailing Drugs to Docs • The AMA Position: • “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.” JAMA 1991: 261;501

Detailing Drugs to Docs • The ACP position: • The acceptance of individual gifts, hospitality, trips, and subsidies of all types from industry by an individual physician is strongly discouraged. • Physicians should not accept gifts, hospitality, services, and subsides form industry if acceptance might diminish or appear to others to diminish the objectivity of professional judgment. Annals 2002: 136; 396

Detailing Drugs to Docs • The ACP position: • Acceptable Industry Gifts: • Inexpensive gifts for office use (pens and calendars). • Low cost gifts of an educational or patient-care nature (such as textbooks). • Modest refreshment. Annals 2002: 136; 396

Detailing Drugs to Docs • AMSA’s Position: • BELIEVES that practicing physicians should maintain an independent financial posture vis-a-vis the pharmaceutical industry to avoid the potential of conflict of interests in prescribing for and treating their patients • URGES all physicians, residents and medical students not to accept as end recipients any promotional gifts from the pharmaceutical industry. • URGES all hospitals and residency programs to discontinue the practice of pharmaceutical company-funded lectures and lunches. http://www.amsa.org/about/ppp/pharm.cfm, accessed 8/31/05

Detailing Drugs to Docs • AMSA’s Position: • URGES all physicians not to accept honoraria on behalf of pharmaceutical companies for speaking at educational conferences and not to accept compensation for token consulting or advising. • SUPPORTS including curricula in medical school education concerning the ethics of physician-industry interactions, particularly in relation to pharmaceutical research and marketing. http://www.amsa.org/about/ppp/pharm.cfm, accessed 8/31/05

Detailing Drugs to Docs • PhRMA’s (The pharmaceutical industry) Position: • Items primarily for the benefit of patients may be offered to healthcare professionals if they are not of substantial value ($100 or less). • Items of minimal value may be offered if they are primarily associated with a healthcare professional’s practice. • Items intended for the personal benefit of healthcare professionals (CDs, tickets to a sporting event) should not be offered. http://www.phrma.org/publications/policy//2004-01-19.391.pdf, accessed 8/31/05.

Detailing Drugs to Docs • The Duke Position: • Representatives may sponsor or attend educational conferences with Duke faculty, trainees… upon prior approval by the program director, clinic director or conference organizer. • Promotional materials (e.g. all branded office supplies, personal items such as coffee mugs, bags, calendars, note pads) and other devices will not be distributed within Duke Hospital, Duke Clinics or the PDC clinics. http://pharmacy.mc.duke.edu/pt/index.htm, accessed 8/31/05.

Detailing Drugs to Docs • The Duke Position: • No advertisements should be posted on walls, doors, windows, and cabinets or placed in reception area(s). • Financial support directly to housestaff, fellows and students is prohibited. http://pharmacy.mc.duke.edu/pt/index.htm, accessed 8/31/05.

Conclusions • The pharmaceutical industry is in the business of selling drugs to make money. • Drug marketing influences the way we treat our patients. • Our patients know that drug marketing exists and that it affects the way we care for them.

Conclusions • Academic societies have recognized this conflict of interest and have made varying attempts to manage this conflict. • As a group we need to be more cognizant of the power of marketing to cloud our judgment.

Question 1 • Congrats! You have been elected chief medical resident and have to manage noon conference lunches for the next year. During last year as a GI fellow you got to know the Astra Zeneca Drug Rep while at the AGA meeting. She calls and asks if she could sponsor a talk in Peptic Ulcer Disease to your residents. She offers to bring lunch, pens, mugs, and a stack of tickets to go see Justin Timberlake at the RBC Center in Raleigh.

Question 1 (cont.) • Based on what you know about Duke’s Rules you decide to tell her: A) Sure come on down, the interns are hungry, my ACR stole all my pens, and Justin is dreamy. B) Thanks, but I can’t have you do the talk or pass out gifts. If you want to buy us lunch we may be able to work things out with my boss. C) No way! After Janet Jackson’s wardrobe malfunction, I wouldn’t feel Justified. Besides, couldn’t you use that money to pay for Malaria drugs in Africa?

Answer 1 • The answer is B. According to Duke rules, the drug rep cannot bring gifts. She may sponsor lunch, if the program director and chair agree. Wouldn’t it be nice if the $11 billion spent by drug companies to advertise to us were spent on saving lives?

Question 2 • Your have just graduated from your Allergy and Immunology fellowship and finally have to work for a living. You move to Columbus, OH where the Buckeye Allergens are high enough to support your career in treating allergic rhinitis. The Schering representative drops by your office and notices that your golf clubs are looking kind of ratty. He offers to hook you up with a new set of clubs and a membership at the Country Club in exchange for your advice on the advantages of Clarinex.

Question 2 (cont.) • Based on what you know about the ACP and PhRMA’s guidelines on drug marketing you tell him: A) Could you please arrange for a 3PM tee time Monday-Friday I like to get a game in after a hard day in the office. B) My golf game is kind of weak, could you throw in a couple of lessons. C) Sorry I can’t take your bribe, ahem, gift.

Answer 2 • The answer is C. • Gifts should be of an educational nature and should benefit patient care. PhRMA’s voluntary guidelines recommend that the value of gifts not exceed $100. The ACP says that docs “should not accept gifts, hospitality, services, and subsides form industry if acceptance might diminish or appear to others to diminish the objectivity of professional judgment.”

Questions 3, 4, and 5 background • You’ve just finished Gen Med Duke as an intern and have CAD and 9090 to look forward to. As you try to figure out how much of your well earned paycheck to invest in PfizerMerckSchering and Co, you try to remember how these companies spend their money.

Questions 3, 4, and 5 • Match the following numbers with the correct description: • $11bnAmount of total revenue spent on • Research and Development • 14%Amount of total revenue • that is diverted to profits • 17%Amount of total revenue • spent on advertising drugs

Answers 3, 4, and 5 Answers • $11Bn is spent on marketing drugs each year • 14% of drug company revenue is spent on research and development • 17% is spent on profits Be sure to complete the evaluation (next slide)!!!

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By: Amer K. Ardati, MD Editor: Amy Shaheen, MD, Assistant Professor of Clinical Medicine