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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Overview

Principled scientific collaboration between physicians and the drug and medical device industries has contributed to many of the medical advances of the past century—penicillin and implantable cardiac pacemakers, to name just two. Industry marketing efforts, however, have increasingly slipped into the educational and clinical programs of academic medical centers. 

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COI-report-table-thumbTable: Task Force Recommendations on Relationships With Industry
Out of concern that certain industry relationships can threaten the integrity of academic medical centers and bias physicians’ therapeutic choices and clinical practices, a number of medical schools have adopted conflict-of-interest policies for their faculty and medical centers that ban many industry inducements to influence students, trainees, and faculty.*

In addition, pressure from the U.S. Office  of the Inspector General,1 congressional hearings,2 and lawsuits alleging deceptive marketing practices3 led the Pharmaceutical Research and Manufacturers of America to recommend that member companies cease providing noneducational gifts and certain types of free meals to physicians.4

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 panel reviewed the literature and consulted experts in order to create an updated list of recommendations to those established by the Association of American Medical Colleges in 2008. 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.

The best-practice recommendations are:

  1. Acceptance of gifts and meals: No gifts or meals of any value should be accepted by clinical faculty members and staff, medical students, residents, clinical fellows, or other clinical trainees from the pharmaceutical, biotechnology, medical device, or medical diagnostics industries or their sales representatives.
  2. Disclosing conflicts of interest: Faculty should be required to disclose to their institutions all industry relationships that relate to their academic activities in teaching, research, patient care, and institutional service.
  3. Industry-funded speaking: Faculty should not accept industry funding for speaking engagements directed toward other faculty, medical students, trainees, patients, community physicians, health professionals, or the public.
  4. Continuing medical education: In general, continuing medical education should not be supported by industry.
  5. Attendance at industry-sponsored lectures and meetings: Faculty, students, and trainees should not attend promotional or educational events that are supported directly by industry.
  6. Pharmaceutical sales representative presence in academic medical centers: Pharmaceutical sales representatives should not be allowed access to any faculty, students, or trainees in academic medical centers or affiliated entities. 
  7. Medical device representative presence in academic medical centers: The access of medical device representatives to patient care areas should be limited to in-service training and technical assistance on devices and other equipment already purchased and then only by appointment and with disclosure to and consent from the patients who would be involved.
  8. Curriculum on conflict of interest: Conflict-of-interest education should be required for all medical students, residents, clinical fellows, and teaching faculty.
  9. Extension of institutional conflict-of-interest policies to community educational settings: Conflict-of- interest policies established by academic medical centers should apply to all faculty members regardless of the nature of their relationship to the institution—paid or voluntary, full time or part time, on-site or off-site— and to affiliated institutions participating in the academic medical center’s educational and training programs.
  10. Industry-supported clinical fellowships: In general, clinical fellows, residents, and medical students may not accept industry-sponsored fellowships earmarked specifically for clinical training but may compete for industry fellowships awarded for scientific training.
  11. Ghostwriting and honorary authorship: Academic medical faculty and trainees should follow the International Committee of Medical Journal Editors standards for authorship and contributorship. Ghostwriting and honorary authorship are strictly prohibited.
  12. Consulting relationships  for research and scientific activities: Faculty and trainees should be permitted to engage in consulting relationships with pharmaceutical and device companies about research and scientific matters.
  13. Consulting relationships  for marketing (excluding scientific research and speaking): Academic medical faculty and trainees should be prohibited from engaging in consulting relationships that are solely or primarily for commercial marketing purposes.
  14. Pharmaceutical samples: An academic medical center should not accept samples unless it determines that there are compelling circumstances to do so. In these cases, it should implement mechanisms for accepting samples that prevent their use as marketing tools.
  15. Pharmacy and therapeutics  committee:  Ideally, voting members of these committees should not have a financial relationship with industry. In circumstances when this standard cannot be achieved, members with such relationships should be recused from any discussion of, or voting on, a related product, whether the product is manufactured by the company, is a competitor of that product, or is in the same class as that product. All committee members should disclose financial relationships with pharmaceutical and medical device companies, as should practitioners  requesting changes or additions to the institution’s formulary.

This report will discuss these best-practice recommendations and provide the reasoning behind their formation. Included will be case studies at academic medical centers and examples of conflict-of-interest policies that are currently in place.

* The term “conflict-of-interest policies” refers to policies regulating the financial relationships between health care companies and academic medical center staff and trainees in the areas of medical education and clinical care. These are also known as “clinical conflicts of interest.” Policies relating to conflicts of interest in medical research are not addressed in this report.

A shorter version of these best practice recommendations can be found in the December 2013 issue of the Journal of the American Medical Association.

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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