Rebuttal From Drs Greenberg and Vender

Rebuttal From Drs Greenberg and Vender

distorts how individuals weigh arguments. Students are also concerned. A single-center study reported that of the 81 residents (69.2%) and 196 faculty...

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distorts how individuals weigh arguments. Students are also concerned. A single-center study reported that of the 81 residents (69.2%) and 196 faculty (75.7%) who responded to an anonymous survey, . 60% in each group felt that annual industry income ,$10,000 could influence teaching by an attending physician.15 Another single-institution study reported that even after COI disclosures 72% of first-year and second-year medical students felt that medical school educators who had financial relationships with industry were more likely to recommend those companies’ products during a learning session.16 The American Medical Student Association evaluates COI policies at all 158 allopathic and osteopathic medical schools in the United States. A model policy prevents participating in speakers’ bureaus. The number of schools complying with this policy in 2013 is 44 compared with four in 2008.17 Some argue that speakers’ bureaus systems are peer selling18 whereas proponents of speakers’ bureaus claim that ethical physicians avoid such traps. Every physician I know who is a member of a speakers’ bureau is ethical and would cringe at the thought of being viewed as a salesperson. However, this debate is not about ethics; it is about trust. In my opinion, the evidence shows that physicians participating in speakers’ bureaus unwittingly imperil their credibility for their most important audiences. The growing number of AMCs restricting the participation of the faculty in speakers’ bureaus dictates that we find better ways than speakers’ bureaus to engage good teachers and recapture some of our lost credibility. Just imagine how refreshing it would be for our patients, students, and colleagues to truly believe a teacher who says, “Trust me…I’m a doctor.”

References 1. Boyd EA, Bero LA. Assessing faculty financial relationships with industry: a case study. JAMA. 2000;284(17):2209-2214. 2. Campbell EG, Gruen RL, Mountford J, Miller LG, Cleary PD, Blumenthal D. A national survey of physician-industry relationships. N Engl J Med. 2007;356(17):1742-1750. 3. Campbell EG, Weissman JS, Ehringhaus S, et al. Institutional academic industry relationships. JAMA. 2007;298(15):1779-1786. 4. Institute of Medicine. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; 2009. http://www.iom.edu/Reports/2009/Conflict-of-Interestin-Medical-Research-Education-and-Practice.aspx. Accessed April 10, 2014. 5. Dubovsky SL, Kaye DL, Pristach CA, DelRegno P, Pessar L, Stiles K. Can academic departments maintain industry relationships while promoting physician professionalism? Acad Med. 2010; 85(1):68-73. 6. Chimonas S, Evarts SD, Littlehale SK, Rothman DJ. Managing conflicts of interest in clinical care: the “race to the middle” at US medical schools. Acad Med. 2013;88(10):1464-1470.

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7. Stossel TP. Regulating academic-industrial research relationships— solving problems or stifling progress? N Engl J Med. 2005;353(10): 1060-1065. 8. Lo B. Serving two masters—conflicts of interest in academic medicine. N Engl J Med. 2010;362(8):669-671. 9. Boumil MM, Cutrell ES, Lowney KE, Berman HA. Pharmaceutical speakers’ bureaus, academic freedom, and the management of promotional speaking at academic medical centers. J Law Med Ethics. 2012;40(2):311-325. 10. Pew Prescription Project. Consumer survey. Disclosure of industry payments to physicians. The Pew Charitable Trusts website. http:// www.pewhealth.org/reports-analysis/issue-briefs/consumer-surveydisclosure-of-industry-payments-to-physicians-85899367979. Accessed April 10, 2014. 11. Orlowski JP, Wateska L. The effects of pharmaceutical firm enticements on physician prescribing patterns. There’s no such thing as a free lunch. Chest. 1992;102(1):270-273. 12. Robertson C, Rose S, Kesselheim AS. Effect of financial relationships on the behaviors of health care professionals: a review of the evidence. J Law Med Ethics. 2012;40(3):452-466. 13. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283(3):373-380. 14. Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA. 2003;290(2):252-255. 15. Watson PY, Khandelwal AK, Musial JL, Buckley JD. Resident and faculty perceptions of conflict of interest in medical education. J Gen Intern Med. 2005;20(4):357-359. 16. Kim A, Mumm LA, Korenstein D. Routine conflict of interest disclosure by preclinical lecturers and medical students’ attitudes toward the pharmaceutical and device industries. JAMA. 2012;308(21):2187-2189. 17. American Medical Student Association. AMSA PharmFree Scorecard 2013. Conflict of interest policies at academic medical centers. American Medical Student Association website. http:// www.amsascorecard.org. Accessed April 10, 2014. 18. Reid L, Herder M. The speakers’ bureau system: a form of peer selling. Open Med. 2013;7(2):e31-e39.

Rebuttal From Drs Greenberg and Vender Steven B. Greenberg, MD; Jeffery S. Vender, MD, MBA, FCCP; Evanston, IL

Dr Nathanson1 acknowledges the potential value of the physician-industry relationship. However, he is concerned that even the most ethical academic physicians involved in speaker bureaus might market rather than inform and teach. His predominant concern is the loss of trust from patients, other providers, and community due to this premise.1 Although abuses of the current relationships exist, should we eliminate or restrict participation by qualified physicians in speaking to colleagues while supported by industry?2,3 Physician involvement in speaker bureaus is prevalent.1 In spite of this fact, there are no definitive data supporting a lack of trust of physicians who are engaged in educational activities. A recent Gallup poll rated medical doctors in the top five of all professions when referring

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to honesty and ethical standards.4 Furthermore, Kawczak and colleagues5 reported in a prospective analysis of the continuing medical education (CME) data that no definitive evidence supported the notion that commercial support resulted in perceived bias in CME activities. The premise that physician societal trust has been reduced by physician speaker bureau participation has not been clearly validated. Dr Nathanson stated that paid physician speakers often promote off-label uses of pharmaceutical products at speaker bureau-related events.1 Paid physician speakers must comply with all federal statutes and their presentations should reflect both the perceived benefits and risks of new products. In accordance with US Food and Drug Administration (FDA) regulations, speakers (including physicians) may only present and discuss FDA-approved indications for the drug.6 Major pharmaceutical companies such as Merck & Co, Inc; GlaxoSmithKline; Eli Lilly and Co; AstraZeneca; Pfizer, Inc; Johnson & Johnson Services, Inc; and Cephalon (Teva Pharmaceuticals, Inc) have repeatedly reported their clear stance on all speaker bureau-related information being in accordance with FDA regulations.6 Compliance with statutes and safety standards only improves the quality of presentations and their relevance. Speaker bureau opponents support eliminating industry relationships irrespective of its potential value. If these contrarians wish to do away with speaker bureaus, then it would seem that other physician-industry relationships will be next on the hit list. Should industry sponsorship at national meetings

AFFILIATIONS: From Critical Care Services (Dr Greenberg), Evanston Hospital, the Department of Anesthesia/Critical Care Services (Dr Vender), and Physician & Programmatic Development (Dr Vender), NorthShore University HealthSystem; and the Department of Anesthesia and Critical Care (Drs Greenberg and Vender), University of Chicago Pritzker School of Medicine, Chicago, IL. FINANCIAL/NONFINANCIAL DISCLOSURES: The authors have reported to CHEST the following conflicts of interest: Dr Greenberg serves as a consultant for CAS Medical Systems, Inc FORE-SIGHT cerebral oximetry (2010-present) and received funds from Cadence Medical Partners/Cadence Health to perform the phase 3 randomized controlled trial: Efficacy of Intravenous Acetaminophen During the Perioperative Period of Neurosurgical Patients Undergoing Craniotomies (period of support, November 2011-present). Dr Vender serves as a consultant for PharMEDium Services, LLC and Covidien. CORRESPONDENCE TO: Steven B. Greenberg, MD, NorthShore University Health Systems, Evanston Hospital, 2650 Ridge Ave, Evanston, IL 60201; e-mail: [email protected] © 2014 AMERICAN COLLEGE OF CHEST PHYSICIANS. Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details. DOI: 10.1378/chest.14-0686

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be revoked? What about industry-funded research? Approximately 75% of clinical trials are funded by pharmaceutical companies.7 Others report that pharmaceutical companies account for nearly twice as much funding as the US federal government.8 What about other industry-backed CME activities? What about industry advertising in medical journals? Do we really believe it will be a benefit to medical education and research to eliminate industry relationships? If not, where do we draw the line? Physicians have lived by the Hippocratic Oath for centuries. Eliminating speaker bureaus will have no effect on physician adherence to ethical and moral teachings of the Oath taken in medical school. Largely unsubstantiated fear of ethical compromise by speaker bureau involvement should not lead to elimination of this activity that has served as an important resource for education and collaboration. Elimination of speaker bureaus would most likely strain the coveted physicianindustry relationship that Dr Nathanson confesses should continue. Academic physician speakers should be permitted to disseminate scientific and clinical advice based on their expertise and understanding of the medical literature. All information must be accurate and source material should be disclosed, while “selling of products” condemned and reprimanded. With the appropriate disclosure of conflicts of interest, the audience can make an educated decision on what they believe to be biased. Physicians engaged in fraudulent activities should be disciplined. In our opinion, there continues to be a clear need for collaboration of physician speakers (experts) and industry. Don’t throw out the baby with the bath water!9

References 1. Nathanson I. Counterpoint: should academic physicians lecture as members of industry speaker bureaus? No. Chest. 146(2): 252-254. 2. Reid L, Herder M. The speakers’ bureau system: a form of peer selling. Open Med. 2013;7(2):e31-e39. 3. Boumil MM, Cutrell ES, Lowney KE, Berman HA. Pharmaceutical speakers’ bureaus, academic freedom, and the management of promotional speaking at academic medical centers. J Law Med Ethics. 2012;40(2):311-325. 4. Honesty/ethics in professions. Gallup, Inc website. http://www. gallup.com/poll/1654/honesty-ethics-professions.aspx. Published December 8, 2013. Accessed March 28, 2014. 5. Kawczak S, Carey W, Lopez R, Jackman D. The effect of industry support on participants’ perceptions of bias in continuing medical education. Acad Med. 2010;85(1):80-84. 6. Ornstein C, Weber T. Drug companies retain tight control of physicians’ presentations. New York, NY: ProPublica; December 9, 2010. 7. Bodenheimer T. Uneasy alliance—clinical investigators and the pharmaceutical industry. N Engl J Med. 2000;342(20):1539-1544.

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8. Dorsey ER, de Roulet J, Thompson JP, et al. Funding of US biomedical research, 2003-2008. JAMA. 2010;303(2):137-143. 9. Ammer C. Throw out the baby with the bath water. In: The American Heritage Dictionary of Idioms. Boston, MA: Houghton Mifflin Harcourt; 1997.

Rebuttal From Dr Nathanson Ian Nathanson, MD, FCCP; Maitland, FL

In defense of allowing academic physicians to be members of speakers’ bureaus, Drs Greenberg and Vender1 make the case that the real enemy is bias. They even state that humans are innately biased, and the “real problem is with those providers who allow their beliefs to inappropriately affect clinical care, which is based on sound evidence.”1 I agree that when bias trumps sound evidence we have major problems in any field, including medicine. However, what puzzles me is the leap that because we are biased it is somehow okay for academic physicians to use slides and other materials supplied by marketing divisions. Do Drs Greenberg and Vender honestly believe that marketing divisions select speakers solely based on their expertise? In her book Our Daily Meds, investigative reporter Melody Petersen2 points out that marketing guru George Silverman stated that “your entire sales force making calls for an entire year may not be as effective as one trusted expert recommending your product at a conference. Companies spur prescriptions by getting a physician to tell his peers about the benefits of a new drug.” In October 2007, Daniel J. Carlat, MD, testified before the Massachusetts State House and recounted his experiences as a member of speakers’ bureaus. He described his “lunch and learn” sessions, rationalizing that he was there to educate and not sell. He further testified that a district manager promptly visited him, inquiring as to why he was not enthusiastic about a product when he revealed “less than glowing information about a company drug.”3 In 2005, the

AFFILIATIONS:

From Humana.

The author has reported to CHEST that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article. CORRESPONDENCE TO: Ian Nathanson, MD, FCCP, Humana, 838 Lake Catherine Court, Maitland, FL 32751; e-mail: [email protected] © 2014 AMERICAN COLLEGE OF CHEST PHYSICIANS. Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details. DOI: 10.1378/chest.14-0688 FINANCIAL/NONFINANCIAL DISCLOSURES:

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US Justice Department testified before Congress that it had launched 180 separate investigations of marketing practices of pharmaceutical companies. In 2010, cardiologists published a point/counterpoint about the role of industry-sponsored education, but both sides agreed that speakers’ bureaus should be avoided.4,5 Although the missions of industry and academic medical centers differ, I think academic-industry collaboration is essential. I do not oppose industry support of physician education provided appropriate firewalls are in place. The value of such oversight cannot be underestimated to protect physicians from becoming mouthpieces for industry, which is what a physician becomes when employed by a company’s marketing division. Drs Greenberg and Vender link the physicianindustry relationship being under fire with the mandated financial disclosures required by the Physician Payments Sunshine Act of 2010. Perhaps the message is that the most powerful regulatory body in the United States no longer trusts us to ensure that we always have our patients’ best interests at heart. Finally, Drs Greenberg and Vender assert that “it is simply too difficult to regulate ethics and morality.”1 I agree with this assertion, but, as I wrote, ethics is not the issue; the issue is trust. We cannot ignore that patients, students, and colleagues are wary of our ability to separate ourselves from a cozy relationship with industry, particularly the marketing divisions. When professional societies, coalitions of academic centers,6 lawmakers, proponents of strong academicindustry relationships, students, and colleagues suggest that we avoid speakers’ bureaus, maybe we should listen.

References 1. Greenberg SB, Vender JS. Point: should academic physicians lecture as members of industry speaker bureaus? Yes. Chest. 146(2): 250-252. 2. Petersen M. Our Daily Meds. New York, NY: Sarah Crichton Books, Farrar, Straus and Giroux; 2008. 3. National Legislative Association on Prescription Drug Prices. Testimony of Daniel J. Carlat, M.D. NLARx website. http://www. reducedrugprices.org/av.asp?na=347. Accessed April 10, 2014. 4. Avorn J, Choudhry NK. Funding for medical education: maintaining a healthy separation from industry. Circulation. 2010;121(20):2228-2234. 5. Harrington RA, Califf RM. There is a role for industry-sponsored education in cardiology. Circulation. 2010;121(20):2221-2227. 6. Association of American Medical Colleges. Industry Funding of Medical Education. Report of an AAMC Task Force. AAMC website. https://members.aamc.org/eweb/upload/Industry%20Funding%20 of%20Medical%20Education.pdf. Published June 2008. Accessed April 10, 2014.

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