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Medicine and Industry: An Ethical Dilemma

Family Medicine Clinical Clerks Discussion 2008. Medicine and Industry: An Ethical Dilemma. Jeff Susman, MD Professor and Chair Department of Family Medicine University of Cincinnati susmanjl@uc.edu. Revised, June 2, 2008. Case 1.

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Medicine and Industry: An Ethical Dilemma

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  1. Family Medicine Clinical Clerks Discussion 2008 Medicine and Industry: An Ethical Dilemma Jeff Susman, MD Professor and Chair Department of Family Medicine University of Cincinnati susmanjl@uc.edu Revised, June 2, 2008

  2. Case 1 It is a busy day in your preceptor’s office, but you have agreed to speak for a minute to a pharmaceutical representative who has stopped by to drop off some samples of a new quinolone antibiotic, called Ubiquinone. He offers you golf balls emblazoned with the letter “U,” and invites you to a round of golf at the country club this weekend. Would you accept the golf balls? Would you accept the invitation? From: “Really difficult Problems in Medical Ethics”

  3. Are gifts from pharmaceutical companies ethically problematic? A survey of physicians P=.08 P=.04 P=.05 P=.88 P=.10 P=.34 Arch Intern Med. 2003;163:2213-2218

  4. Attitudes of residents toward pharmaceutical promotions Am J Med 2001;110:551

  5. Attitudes and practices of residents toward pharmaceutical promotionsPerceived influence of pharmaceutical reps on prescribing practices “You” “Other Physicians” Am J Med 2001;110:551 P<.0001

  6. A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts J Gen Int Med 1998;13:151 P<.004 for all except mug, p=.24)

  7. A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts J Gen Int Med 1998;13:151 P<0.0001 for all except trip, p=0.0017

  8. Conflict of interest? “I have never been bought, I cannot be bought. I am an icon, and I have a reputation for honesty and integrity, and let the chips fall where they may.” “It is true that there are people in my situation who could not receive a million-dollar grant and stay objective. But I do.”

  9. Disclosures • Editor for JFP, owned by a privately held, for profit • Medical Co-editor UpToDate • STFM Industry Strike Force • Medical malpractice work • Pharma stock • Paid consultant to Pfizer, Forest, Wyeth, Neurocrine • I’ve ghost-written, participated in symposia, done paid CME talks, even ate food from a dine and dash... • Now, do I have your attention?

  10. What do Professional Organizations Advise?

  11. American Medical AssociationCouncil on Ethical & Judicial Affairs • “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

  12. AMA Opinion E-8.061 (2005) “Gifts to Physicians from Industry” Many gifts given to physicians by companies in the pharmaceutical, device, and medical equipment industries serve an important and socially beneficial function. For example, companies have long provided funds for educational seminars and conferences. However, there has been growing concern about certain gifts from industry to physicians. Some gifts that reflect customary practices of industry may not be consistent with the Principles of Medical Ethics. To avoid the acceptance of inappropriate gifts, physicians should observe the following guidelines [.]

  13. AMA Opinion, 2005 • No gifts should be accepted if there are strings attached. For example, physicians should not accept gifts if they are given in relation to the physician’s prescribing practices. • Individual gifts of minimal value are permissible as long as the gifts are related to the physician’s work (e.g. pens and notepads) • Revision in June 2008?

  14. American College of PhysiciansGuidelines on Physician-Industry Relations • The acceptance of individual gifts, hospitality, trips, and subsidies of all types from industry by an individual physician is strongly discouraged. • The acceptance of even small gifts can affect clinical judgment and heighten the perception (as well as the reality) of a conflict of interest.. • The dictates of professionalism require the physician to decline any industry gift or service that might be perceived to bias their judgment, regardless of whether a bias actually materializes. • Ideally, physicians should not accept any promotional gifts or amenities, whatever their value or utility, if they have the ability to cloud professional judgment and compromise patient care. Annals of Internal Medicine 2002;136:396-402.

  15. American College of PhysiciansGuidelines on Physician-Industry Relations 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 of Internal Medicine 2002;136:396-402.

  16. American Association of Medical Colleges (AAMC) • Gifts should not be accepted • Drug samples should be distributed centrally • Sales reps only by appointment and outside patient care areas • No food except at CME events • Speakers’ bureaus should not include faculty • Ghost-writing not permitted • Travel payment should not be accepted Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council, June 18-19, 2008

  17. PhRMA Codeon interactions with healthcare professionals • 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. www.PhRMA.org, April 2002

  18. PhRMA Code FAQs Question: Under the Code, may golf balls and sports bags be provided if they bear a company or product name? Answer: No. www.PhRMA.org, April 2002

  19. PhRMA Code FAQs Question: Under the Code, may healthcare professionals be provided with gasoline for their cars if they are provided with product information at the same time? Answer: No. www.PhRMA.org, April 2002

  20. PhRMA Code FAQs Question: Under the Code, may items such as stethoscopes be offered to healthcare professionals? Answer: Yes www.PhRMA.org, April 2002

  21. Case 2 • You sit in on a discussion at your preceptor’s office about whether to continue to see pharmaceutical representatives. Your preceptor asks your opinion. • You respond by saying: A. Let me get back to you on that one. • I may not like them, but patients need those free drugs • No way—it’s about time medicine banned pharmaceutical representatives • Everyone needs to make a living...

  22. “I learn a lot from the drug reps” When was the last time a drug rep gave you an article unfavorable to their drug? Lancet 2002; 359: 1648

  23. Typical problems with drug rep info • Single, favorable clinical trial vs systematic review • Disease endpoints vs patient oriented outcomes • The review articles and monographs are funded and may lack peer review • Never, never, NEVER give unfavorable info

  24. 13 noon-time talks by drug reps • 106 statements made by drug reps during their presentations • 11% were inaccurate – all of these inaccurate statements were about the rep’s drug and made it look better. • All 15 statements about competing drugs were accurate, but they were also all negative • Only 7 of 27 physicians noted any inaccuracies at all

  25. What do we know? • Physicians deny bias but think their colleagues are probably influenced • Patients feel same way • Studies show that interaction with drug reps and other pharma interactions: • Affect prescribing (for the worse) • Increase drug costs • Create work for practices • Affect formulary decisions Am J Med 2001; 110: 551 J Gen Intern Med 1998; 13: 151

  26. “I need the samples to help my patients…” • Nexium (esomeprazole) 40 mg samples vs omeprazole 40 mg prescription • Nexium 40 mg: copay $30, actual cost $140/month • Omeprazole 40 mg: copay $10, actual cost $30/month

  27. Patient cost

  28. Societal cost - $1320/year

  29. Your pharmaceutical rep?

  30. Case 3, Continued • After a lengthy debate about pharmaceutical reps, your preceptor asks, does the University have a policy in place? Your respond by: • Getting another helping of pizza • Paging yourself • Mumbling something about a H and P that needs completed • “Yes, I’m glad you asked that question”

  31. Health Alliance Policy • “It is mandatory that representatives schedule appointments... • Loitering or wandering to spontaneously deliver product information is not deemed appropriate.” • “Food may be only be provided if scheduled in advance... in • conjunction with an informational presentation. Take-out meals • and meals to be eaten without the company of the representative • being present (e.g. “Dine and dash” programs) do not facilitate • the transfer of quality information and as such are prohibited • in the Health Alliance.”

  32. University COM Policy • Comprehensive addressing research and scholarly activity; clinical training and patient care; and consulting, collateral employment and entrepreneurial affairs/technology transfer • Incorporates external standards (e.g., International Committee of Medical Journal Editors; ACCME Standards for Commercial Support; University Rules • Site Access controlled • Gifts or Compensation • Anything of value provided by or on behalf of Industry, including but not limited to food, beverages, pharmaceutical or device samples, or travel related expenses

  33. University COM Policy (II) • Unacceptable Gifts and Compensation • Incentives for prescribing or for changing a patient's prescription to a specific medication • Incentives for recommending or utilizing a specific diagnostic or therapeutic device • “It is expected that no form of Gift or Compensation from Industry will be accepted by Personnel of the University of Cincinnati College of Medicine under any circumstances, except as reasonable compensation for bona fide services.” • Other training sites’ policies are honored if they are more restrictive than those in the COM Policy • Industry Interactions Committee established • Training opportunities for faculty, staff and students

  34. What do you think of the COM Policy?

  35. It’s a National Issue: State Legislative Initiatives 1993 Minnesota 2002 West Virginia 2002 Vermont 2003 Maine, District of Columbia 2004 California 2006 Florida, New Hampshire, South Carolina

  36. Scope of Pharmaceutical Industry Support

  37. Promotional spending on prescription drugs, 2002 Total spending: $21 billion Source: IMS Health

  38. Our Journals: Pure and Unadulterated?

  39. Case 4 • You are reading a new study in the NEJM on the effectiveness of a new antibiotic that concludes cefakilital is more effective than high dose amoxicillin for the treatment of otitis media. You... • Begin prescribing cefakilital for all your patients with otitis • Prescribe cefakilital only for patients who fail amoxicillin • Treat otitis media with antibiotics? • Buy stock in the firm publishing the study

  40. Drug company jobs in marketing and research, 1995-2000 # Jobs Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar

  41. Physicians Link Journals to Advertising

  42. Physicians View Journals as Important Sources of Information 76.3% of physicians rated journals as most important source of information

  43. How Can We Do Better?

  44. “The Unprepared Drug Rep.” (Haiku) Imagine my shock when the rep asked to borrow my pen. Ironic. Metkus TS. Ann. Int. Med. 147(11) 818 (December 4, 2007)

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