Report

Conflicts-of-Interest Policies for Academic Medical Centers
Recommendations for Best Practices


Quick Summary

In 2012, The Pew Charitable Trusts convened an expert task force on conflicts of interest in medicine to assist academic medical centers in identifying best practices to incorporate into their conflict-of-interest policies. The task force formulated recommendations in 15 areas in order to protect the integrity of education and training and the practice of medicine within the academic medical center while not standing as an impediment to research and scientific inquiry.
Conflicts-of-Interest Policies for Academic Medical Centers
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Background

Many medical schools and medical centers have adopted conflict-of-interest  policies banning various industry inducements to influence students, trainees, and faculty clinical practice. The Pharmaceutical Research and Manufacturers of America, the trade association for drug companies, has also recommended that its member drug companies stop providing noneducational gifts and certain types of free meals to physicians.

It remains unclear, however, how widespread and effective these changes have been. The Institute on Medicine as a Profession, which maintains a comprehensive database of medical school conflict-of-interest policies,5 reported that the percentage of medical schools with strict policies increased from 10 percent in 2008 to 27 percent in 2011 but that there are still areas that need to be addressed, such as ghostwriting;  free samples; continuing medical education, or CME; consulting; honoraria; and speakers’ bureaus.6

In 2008, the American Medical Student Association, or AMSA, with support from The Pew Charitable Trusts, created a medical school “scorecard” that annually assigns a letter grade to institutions based on how fully they comply with the Association of American Medical Colleges’ recommendations, which included restrictions or prohibitions on a number of practices, such as industry gifts and meals, speakers’ bureaus, and the presence of pharmaceutical sales reps on campus.7  According to the scorecard, the percentage of medical schools that have adopted policies consistent with the Association of American Medical Colleges’ recommendations, corresponding to an A grade, increased from 4.7 percent in 2009 to 25.3 percent in 2012.8

The policy provisions with the most dramatic improvements in grades have been those banning outright payments and gifts from industry. Conversely, relatively few schools have implemented policies restricting promotional speaking, eliminating industry support of accredited continuing medical education, and banning access to the institution by pharmaceutical sales representatives. In addition, even when schools have adopted well-crafted policies, compliance is not assured. One recent survey of medical schools, for example, found that up to half of medical students and residents reported receiving gifts from pharmaceutical companies, even in schools graded highly on the AMSA scorecard.9 Thus, while institutions can set guidelines and provide a level of oversight and enforcement, it is not clear that these are sufficient to change an individual’s behavior, much of which can occur outside of the institution’s purview. 

Date added:
Dec 10, 2013
Project:
Pew Prescription Project
References:
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References:

1 Office of Inspector General (2003), OIG Compliance Program Guidance for Pharmaceutical Manufacturers, Fed. Reg. 68: 23731-23743.
2 U.S. Senate Committee on Finance, Use of Educational Grants by Pharmaceutical Manufacturers, 110th Cong., 1st sess., (Washington: U.S. Government Printing Office, 2007).
3 Michael A. Steinman, Lisa A. Bero, Mary-Margaret Chren, C. Seth Landefeld, “Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents,” Annals of Internal Medicine 145 (2006): 284-293.
 “Code on Interactions With Health Care Professionals,” Pharmaceutical Research and Manufacturers of America, accessed March 4, 2013, http://www.phrma.org/code-on-interactions-with-healthcare-professionals.
5 “Conflicts of Interest Overview,” Institute on Medicine as a Profession, accessed March 4, 2013, http://www.imapny.org/conflicts_of_interest/conflicts-of-interest-overview.
6 Susan Chimonas, Lisa Patterson, Victoria H. Raveis, David J. Rothman, “Managing Conflicts of Interest in Clinical Care: A National Survey of Policies at U.S. Medical Schools,” Academic Medicine: Journal of the Association of American Medical Colleges 86 (2011): 293-99, doi:10.1097/ACM.0b013e3182a2e204. Susan Chimonas, Susanna D. Evarts, Sarah K. Littlehale, David J. Rothman, “Managing Conflicts of Interest in Clinical Care: The ‘Race to the Middle’ at U.S. Medical Schools,” Academic Medicine: Journal of the Association of American Medical Colleges 88, no. 10 (2013): 1464-7, doi: 10.1097/ACM.0b013e3182a2e204.
7 “AMSA PharmFree Scorecard 2013,” American Medical Student Association, accessed Aug. 13, 2013, http://www.amsascorecard.org.
8 AMSA PharmFree Scorecard.
9  Kirsten Austad et al., “Changing Interactions Between Physician Trainees and the Pharmaceutical Industry: A National Survey,” Journal of General Internal Medicine 28, no. 8 (2013): 1064-71, doi:10.1007/s11606-013-2361-0.
10 Ashley Wazana, “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” Journal of the American Medical Association 283, no. 3 (2000): 373-380, doi:10.1001/jama.283.3.373.
11 Jason Dana and George Loewenstein, “A Social Science Perspective on Gifts to Physicians From Industry,” Journal of the American Medical Association 290 (2003): 2, doi:10.1001/jama.290.2.252.
12 Frederick  S. Sierles et al., “Medical Students’ Exposure to and Attitudes About Drug Company Interactions: A National Survey,” Journal of the American Medical Association 294 (2005): 1034-1042.
13 Samuel M. Keim, Mary Z. Mays, and David Grant, “Interactions Between Emergency Medicine Programs and the Pharmaceutical Industry,” Academic Emergency Medicine 11 (2004): 1, doi:10.1197/j.aem.2003.07.016.
14 C.K. Varley, M.D. Jibson, M. McCarthy, and S. Benjamin, “A Survey of the Interactions Between Psychiatry Residency Programs and the Pharmaceutical Industry,” Academic Psychiatry 29 (2005): 40-46.
15 Accreditation  Council for Continuing Medical Education, ACCME Annual Report Data—2007 (2008), http://www.accme.org/sites/default/files/null/Annual_report_2007_20090109.pdf.
16  “AMSA PharmFree Scorecard.”
17 Colleen Walsh, “Medical School Revises Conflict  of Interest Policy,” Harvard Gazette, July 21, 2010,  http://news.harvard.edu/gazette/story/2010/07/medical-school-revises-conflict-of-interest-policy.
18 Azalea Kim, Lawrence Mumm, and Deborah Korenstein, “ Routine Conflict of Interest Disclosure by Preclinical Lecturers and Medical Students’ Attitudes Toward the Pharmaceutical and Device Industries,” Journal of the American Medical Association 308 (2012):  21, doi:10.1001/jama.2012.25315.
19 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 502(f); 21 U.S.C. § 352(f); and 21 C.F.R. 201.100(c)(1).
20 “For the Record: Our Work With the U.S. Healthcare and Nonprofit Communities,” GlaxoSmithKline, accessed Nov. 19, 2013, http://fortherecord.payments.us.gsk.com/funding.html.
21 ACCME Annual Report Data 2007.
22 M.A. Bowman and D. L. Pearle, “Changes in Drug Prescribing Patterns Related to Commercial Company Funding of Continuing Medical Education,” Journal of Continuing Education in the Health Professions 8, no. 1 (1988): 13-20.
23 J.P. Orlowski  and L. Wateska, “The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns: There’s No Such Thing as a Free Lunch,” Chest 102, no. 1 (1992): 270-3.
24 M.E. Dieprink and L. Drogemuller, “Industry-Sponsored Grand Rounds and Prescribing Behavior,” Journal of the American Medical
Association 285 (2001): 1443-44.
25 Harvey P. Katz, Stephen  E. Goldfinger, and Suzanne W. Fletcher, “Academia-Industry Collaboration in Continuing Medical Education: Description of Two Approaches,” Journal of Continuing Education in the Health Professions 22(205): 1, doi:10.1002/chp.1340220106.
26 Ronald M. Cervero and Jiange He, “The Relationship Between Commercial Support and Bias in Continuing Medical Education Activities: A Review of the Literature,” Accreditation Council on Continuing Medical Education (2008). 
27 Council on Ethical and Judicial Affairs, “Financial Relationships with Industry in Continuing Medical Education,” American Medical Association, 1-A-11, (2011).
28 Association of American  Medical  Colleges, “The Scientific Basis of Influence and Reciprocity: A Symposium,” 2008.
29 “Sunshine Act Prompts Pharma Companies To Alter Grant Contracts.” The Pink Sheet Daily, October 24, 2013.
30 “UM Medical School Plans Changes to Continuing Medical Education Funding,” University of Michigan Medical School (2010), accessed
Nov. 15, 2013, http://www.uofmhealth.org/u-m-medical-school-plans-changes-continuing-medical-education-funding.
31 Steve Willis, associate dean for continuing medical education at East Carolina University Brody School of Medicine, personal communication to Daniel Carlat, 2013.
32 Federal Food, Drug, and Cosmetic Act.
33 Scott H. Podolsky and Jeremy A. Greene, “A Historical Perspective of Pharmaceutical Promotion and Physician Education,” Journal of the American Medical Association 300 (2008): 7, doi:10.1001/jama.300.7.831.
34 Geoffry Spurling, et al., “Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians’ Prescribing: A Systematic Review,” PLOS Medicine 7 (2010): 10, doi:10.1371/journal.pmed.1000352.
35 B. Mintzes, et al., “Pharmaceutical Sales Representatives and Patient Safety: A Comparative Prospective Study of Information Quality in Canada, France and the United States,” Journal of General Internal Medicine 10: 1368-75, doi:10.1007/s11606-013-2411-7.
36 Alex Berenson, “Eli Lilly Said to Play Down Risk of Top Pill,” New York Times, Dec. 17, 2006, http://www.nytimes.com/2006/12/17/business/17drug.html?_r=0.
37 T. Isaac, J. Zheng,  and A. Jha, “Use of UpToDate and Outcomes in U.S. Hospitals,” Journal of Hospital Medicine 7 (2012): 2, doi:10.1002/jhm.944.
38 A.E. Carroll,  R.C. Vreeman, J. Buddenbaum, T.S. Inui, “To What Extent Do Educational Interventions Impact Medical Trainees’ Attitudes and Behaviors Regarding Industry-Trainee  and Industry-Physician Relationships?” Pediatrics 120 (2007): 6, e1528-1535.
39 “Financial Conflict of Interest,” National Institutes of Health, accessed Jan. 14, 2013, http://grants.nih.gov/grants/policy/coi.
40 “AMSA PharmFree Scorecard.”
41 Myrle Croasdale, “Drug Firms to Fund Residency Slots in Dermatology Pilot Program,” American Medical News, July 18, 2005, http://www.amednews.com/article/20050718/profession/307189971/2.
42  Bridget M. Kuehn, “Pharmaceutical Industry Funding for Residencies Sparks Controversy,” Journal of the American Medical Association 293(2005): 13, doi:10.1001/jama.293.13.1572.
43  Alfred Lane M.D., professor of dermatology and pediatrics, Stanford University School of Medicine, and member of the committee of the American Academy of Dermatology that selected residents for the pilot program in 2006, personal communication to Daniel Carlat, Nov. 19, 2013.
44  “NREF Post-Residency Clinical Fellowship Program,” American Association of Neurological Surgeons, accessed Aug. 30, 2013, http://www.aans.org/Grants%20and%20Fellowships/NREF%20Post-Residency%20Clinical%20Fellowship.aspx.
45  Joseph S. Ross, et al., “Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents from Rofecoxib Litigation,” Journal of the American Medical Association 299 (2008): 15, doi:10.1001/jama.299.15.1800.
46 Adriane Fugh-Berman,”The Haunting of Medical Journals: How Ghostwriting Sold ‘HRT,’ ” PLOS Medicine 7 (2010): 9, doi:10.1371/journal. pmed.1000335.
47 “Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of Research: Authorship and Contributorship,” International Committee of Medical Journal Editors, accessed Aug. 30, 2013, http://www. icmje.org/ethical_1author.html.
48 Proclamation No. 92N-0434, 62 Fed. Reg. 64093-64100 (Dec. 3, 1997); and U.S. Food and Drug Administration,  The Prescription and Drug Marketing Act (1987), http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/ignificantAmendmentstotheFDCAct/PrescriptionDrugMarketingActof1987.
49 R.F. Adair  and L.R. Holmgren, “Do Drug Samples Influence Resident Prescribing Behavior? A Randomized Trial,” American Journal of Medicine 118 (2005): 881-84.
50 Sarah L. Cutrona, et al., “Characteristics  of Recipients of Free Prescription Drug Samples: A Nationally Representative Analysis,” American
Journal of Public Health 98(2008): 2, doi:10.2105/AJPH.2007.114249.
51 G.C. Alexander,  J. Zhang,  and A. Basu, “Characteristics of Patients Receiving Pharmaceutical Samples and Association Between Sample Receipt and Out-of-Pocket Prescription Costs,” Medical Care 46 (2008): 4, doi:10.1097/MLR.0b013e3181618ee0.
52  D.L. Coleman, et al., “Guidelines for Interactions Between Clinical Faculty and the Pharmaceutical Industry: One Medical School’s Approach,” [In eng]. Acad Med 81, no. 2 (2008): 154-60. Community Catalyst, “Conflict of Interest Policy Guide for Medical Schools and Academic Medical Centers,” accessed December 2, 2013, http://www.communitycatalyst.org/initiatives-and-issues/initiatives/prescription-reform/conflict-of-interest-policy-guide

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