Virtual Mentor. July 2003, Volume 5, Number 7.
Suggested Reading and Resources
Resources on Medicine and Industry
Related Opinions from the AMA's Code of Medical Ethics
- Opinion 5.075 Confidentiality: Disclosure of Records to Data Collection Companies. American Medical Association. Code of Medical Ethics 2008-2009 Edition. Chicago, IL: American Medical Association; 2008:173-174.
- Opinion 8.051 Conflicts of Interest under Capitation. American Medical Association. Code of Medical Ethics 2008-2009 Edition. Chicago, IL: American Medical Association; 2008:220-222.
- Opinion 8.054 Financial Incentives and the Practice of Medicine. American Medical Association. Code of Medical Ethics 2008-2009 Edition. Chicago, IL: American Medical Association; 2008:223-225.
- Opinion 8.06 Prescribing and Dispensing Drugs and Devices. American Medical Association. Code of Medical Ethics 2008-2009 Edition. Chicago, IL: American Medical Association; 2008:228-230.
- Opinion 8.061 Gifts to Physicians from Industry. American Medical Association. Code of Medical Ethics 2008-2009 Edition. Chicago, IL: American Medical Association; 2008:230-243.
- Opinion 8.062 Sale of Non-Health-Related Goods from Physicians' Offices. American Medical Association. Code of Medical Ethics 2008-2009 Edition. Chicago, IL: American Medical Association; 2008:243.
- Opinion 8.063 Sale of Health-Related Goods from Physicians' Offices. American Medical Association. Code of Medical Ethics 2008-2009 Edition. Chicago, IL: American Medical Association; 2008:243-245.
- Opinion 9.011 Continuing Medical Education. American Medical Association. Code of Medical Ethics 2008-2009 Edition. Chicago, IL: American Medical Association; 2008:290-292.
- Accreditation Council for Continuing Medical Education. Accreditation policy: commercial support. Available at: www.accme.org/incoming/pol_03_comm_sup_08_22_2000.pdf. Accessed May 15, 2003.
- Accreditation Council for Continuing Medical Education. Income and expense for all ACCME accredited providers--2001. Available at: www.accme.org/incoming/125_2001_Annual_Report_Data.pdf. Accessed May 15, 2003.
- Accreditation Council for Continuing Medical Education. Standards for commercial support of continuing medical education. Available at: http://www.accme.org/dir_docs/doc_upload/68b2902a-fb73-44d1-8725-80a1504e520c_uploaddocument.pdf. Accessed May 15, 2003.
- Accreditation Council for Graduate Medical Education. Principles to guide the relationship between graduate medical education and industry. Available at: http://www.acgme.org/acWebsite/positionPapers/pp_GMEGuide.pdf Accessed March 24, 2003.
- Adams C. Student doctors protest largess of drug makers. Wall Street Journal. June 24, 2002;B1.
- ALLHAT - So What? J Inform Pharmacother 2003;12:1.
- American College of Physicians. Physicians and the pharmaceutical industry. Ann Intern Med. 1990; 112:624-626.
- American Medical Association Council on Ethical and Judicial Affairs. Gifts to physicians from industry. JAMA. 1991;265:501.
- American Medical Association. National task force on CME provider/industry collaboration. Available at: /2005/01/toc7-0501.html Accessed July 1, 2003.
- American Medical Association. Principles of medical ethics. Available at: http://www.ama-assn.org/ama/pub/category/2512.html. Accessed: May 27, 2003.
- American Medical Student Association. AMSA PharmFree Campaign. Available at: www.amsa.org/prof/pharmfree.cfm. Accessed May 31, 2003.
- American Medical Student Association. Revitalizing professionalism. Available at: www.amsa.org/prof/. Accessed May 31, 2003.
- Barzansky B, Etzel SI. Educational programs in US medical schools, 2000-2001. JAMA. 2001;286:1049-1055.
- Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research. JAMA. 2003;289:454-65.
- Best Pharmaceuticals for Children Act (21 USC 505) (BPCA).1997.
- BIO. Biotechnology industry statistics. Available at: http://www.bio.org/speeches/pubs/er/statistics.asp. Accessed: May 27, 2003.
- Blood Pressure Lowering Trialists' Collaboration. Effects of ACE inhibitors, calcium antagonists, and other blood-pressure-lowering drugs: results of prospectively designed overviews of randomized trials. Lancet. 2000;356:1955.
- Bodenheimer T. Uneasy alliance: clinical investigators and the pharmaceutical industry. N Eng J Med. 2000;342:1539-44.
- Bowman MA, Pearle DL. Changes in drug prescribing patterns related to commercial company funding of continuing medical education. J Contin Educ Health Prof. 1988;8:13-20.
- Bowman MA. The impact of drug company funding on the content of continuing medical education. Mobius.1986;6:66-69.
- Boyd EA, Bero LA. Assessing faculty financial relationships with industry: a case study. JAMA. 2000;284:2209-14.
- Brody H. A matter of influence. Health Affairs. March/April 2002;21:232-234.
- Cho MK, Bero LA. The quality of drug studies published in symposium proceedings. Ann Intern Med. 1996;124:485-89.
- Chobanian AV, Bakris GL, Black HR, et al and the National High Blood Pressure Education Program Coordinating Committee. The seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure: The JNC report. JAMA. 2003;289:2560-2572.
- Chren M-M, Landefeld CS, Murray TH. Doctors, drug companies, and gifts. JAMA. 1989; 262:3448-51.
- CONSORT. Available at: http://www.consort-statement.org/.
Accessed June 27, 2003.
- Council on Ethical and Judicial Affairs. E-Addendum II: Council on Ethical and Judicial Affairs clarification of gifts to physicians from industry (E-8.061). June 2002. Available at: http://www.ama-assn.org/ama/pub/education-careers/continuing-medical-education/cme-credit-offerings/ama-cme-courses/ethical-guidelines-gifts-physicians-industry/ethical-opinions-guidelines/opinion-e8061-clarifying.shtml. Accessed May 31, 2003.
- Council on Scientific Affairs and Council on Ethical and Judicial Affairs, American Medical Association. Conflicts of interest in medical center/industry research relationships. JAMA. 1990;263:2790.
- Coyle SL. Physician-industry relations. Part 1; Individual physicians. Ann of Intern Med. 2002;136:396-402.
- Coyle SL. Physician-industry relations. Part 2: Organizational issues. Ann of Intern Med. 2002;136:403-406.
- DuBois JM, Burkemper J. Ethics education in US medical schools: A study of syllabi. Acad Med. 2002;77:432-437.
- Ethics Manual: Fourth Edition. Ann of Intern Med. 1998;128:576-594.
- Ferguson RP, Rhim E, Belizaire W, et al. Encounters with pharmaceutical sales representatives among practicing internists. Am J Med. August 1999;107:149-152.
- Frankel M. Perception, reality, and the political context of conflict of interest in university-industry relationships. Acad Med. 1996;71:1297-1304.
- Frohlich ED. Treating hypertension. What are we to believe? N Engl J Med. 2003;348:639-641.
- Gibbons RV, Landry FJ, Blouch DL, et al. A comparison of physicians' and patients' attitudes toward pharmaceutical industry gifts. J Gen Intern Med. 1998; 13:151-154.
- Goldhammer A. Current issues in clinical research and the development of new pharmaceuticals. Accountability in Research. 2000;8:283-91.
- Goodman B. No free lunch. Available at: www.nofreelunch.org. Accessed May 31, 2003.
- HHS Office of Inspector General. Compliance program guidance for pharmaceutical manufacturers. April 2003. Accessed June 25, 2003.
- HHS Office of Inspector General. Medicare and state health care programs: Fraud and abuse; OIG anti-kickback provisions. 56 Federal Registrar 3592.
- HHS Office of Inspector General. OIG compliance program guidance for pharmaceutical manufacturers. 68 Federal Registrar 23731.
- Hyman DJ, Pavlik VN. Self-reported hypertension treatment practices among primary care physicians: blood pressure thresholds, drug choices, and the role of guidelines and evidence-based medicine. Arch Intern Med. 2000;160:2281-6.
- IMS Health Incorporated. Total
US promotional spending by type. March 2003. Accessed May 28, 2003.
- Jung P. No free lunch. Health Affairs. April 2002;21:226-231.
- Kelcher S, Brownoff R, Meadows LM. Structured approach to pharmaceutical representatives. Canadian Family Physician. 1998;44:1053-1060.
- Kopelman L. Children as research subjects: a dilemma. Journal of Medicine and Philosophy. 2000;25:745-64.
- Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003;326:1167-70.
- Makoff D. Science agencies get most of what they want, finally. Science 2003; 299:1160-61.
- McCormick BB, Tomlinson G, Brill-Edwards P, Detsky AS. Effect of restricting contact between pharmaceutical company representatives and internal medicine residents on posttraining attitudes and behavior. JAMA.
- Monaghan MS, Galt KA, Turner PD, et al. Student understanding of the relationship between the health professions and the pharmaceutical industry. Teaching and Learning in Medicine. 2003;15:14-20.
- Moser M. Results of ALLHAT. Is this the final answer regarding initial antihypertensive drug therapy? Arch Intern Med. 2003;163:1269-1273.
- Moses H, Martin JB. Academic relationships with industry: a new model for biomedical research. JAMA. 2001;285:933-35.
- NIH. Questions and answers about the NIH. Available at: http://www.nih.gov/about/FAQ.htm.
Accessed: May 27, 2003.
- Objectivity in Research, 60 Federal Register 35810 (1995) (codified at 45 CFR, 94).
- Orlowski JP, Wateska L. The effects of pharmaceutical firm enticements on physician prescribing behavior: there's no such thing as free lunch. Chest.1992; 102:270-273.
- Orphan Drug Act (ODA) (Public Law 97-414). 1983.
- Pahor M and colleagues. Health outcomes associated with calcium channel antagonists compared with other first-line antihypertensive therapies: a meta-analysis of randomized controlled trials. Lancet. 2000;356:1949.
- Pearson S-A, Rolfe I, Smith T. Factors influencing prescribing: an intern's perspective. Medical Education. August 2002;36:781-787.
- Pharmaceutical Research and Manufacturers of America. PhRMA: Industry Profile 2003 (Chapter 2). Accessed June 30, 2003.
- PHRMA. Intellectual property. Available at: http://www.phrma.org/index.php?option=com_content&task=view&id=123&Itemid=109&cat=Intellectual+Property/. Accessed: May 27, 2003.
- PHRMA. Research and development. Available at: http://www.phrma.org/innovation/. Accessed: May 27, 2003.
- Pritchard MS. Conflicts of interest: conceptual and normative issues. Acad Med.1996;71:1305-13.
- Pritchett HS. Introduction. In: Flexner A, ed. Medical Education in the United States and Canada: A Report to the Carnegie Foundation for the Advancement of Teaching. Reprint. New York: Arno Press Inc; 1972:xiii-xiv.
- Razack S, Arbour L, Hutcheon R. Proposed model for interaction between residents and residency training programs, and pharmaceutical industry. Annals of the Royal College of Physicians and Surgeons of Canada. March 1999;32:93-96.
- Resnik D. Developing drugs for the developing world: an economic, legal, moral and political dilemma. Developing World Bioethics. 2001;1:11-32.
- Resnik D. Setting biomedical research priorities: justice, science, and public participation. Kennedy Institute of Ethics Journal. 2001;11:181-204.
- Romano M. Student rally. Modern Healthcare. May 13 2002;32:24-25.
- Rothman DJ. Medical professionalism: focusing on the real issues. New Engl J Med. 2000;342:1284-1286.
- Santana S. AAMC executive council sets guidelines on industry marketing to residents. Association of American Medical Colleges. Available at: www.aamc.org/newsroom/reporter/april03/executivecouncil.htm. Accessed May 27, 2003.
- Smith R. Beyond conflict of interest. BMJ. 1998;137:291-2.
- Tauer C. Ethical dilemmas on research on children. Accountability in Research. 2002;9:127-42.
- The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angtiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the antihypertensive and lipid-lowering treatment to prevent heart attack (ALLHAT). JAMA. 2002;288:2981-2997.
- The sixth report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. Arch Intern Med. 1997;157:2413-46.
- Thompson DF. Understanding financial conflict of interest. N Engl J Med. 1993;329:573-576.
- Thomson AN, Craig BJ, Barham PM. Attitudes of general practitioners in New Zealand to pharmaceutical representatives. B J Gen Pract. 1994; 44:220-223.
- US Food and Drug Administration. FDA: Final guidance on industry-supported scientific and educational activities. 62 FR 64074.
- Wazana A. Is a gift ever just a gift? A critical review of the interaction between physicians and the pharmaceutical industry. JAMA. 2000;283:373-380. Wazana A, Primeau F. Ethical considerations in interactions between residents and the pharmaceutical industry. Psychiatric Clin N Amer. Fall 2002.
- Wazana A, Primeau F. Ethical considerations in the relationship between physicians and the pharmaceutical industry. Psychiatric Clinics of North America. 2002;25:647-663.
- Wilkes MS, Hoffman JR. An innovative approach to educating medical students about pharmaceutical promotion. Acad Med. 2001;76:1271-1277.
- Wing LMH, Reid CM, Ryan P, et al for the Second Australian National Blood Pressure Study Group. A comparison of outcomes with angiotensin-converting-enzyme inhibitors and diuretics for hypertension in the
elderly. N Engl J Med. 2003;348:583-592.
- Wolfe SM. The destruction of medicine by market forces: teaching acquiescence or resistance and change? Acad Med. 2002;77:5-7.
- Wolfsthal SD, Beasely BW, Kopelman R, et al. Benchmarks of support in internal medicine residency training programs. Acad Med. 2002;77:50-56.
- Ziegler MG, Lew P, Singer BC. The accuracy of drug information from pharmaceutical representatives. JAMA. 1995;273:1296-1298.
Legal and Regulatory Resources
- 42 USC sec 1320a-7b(b)(2).
- 46 CFR sec 164.508(a)(3)(ii).
- D.A.B. v Brown, 570 NW2d 168 (Minn Ct App 1997).
- US v Brown, 108 F3d 863 (8th Cir 1997).
- US v Perlstein, 632 F2d 661 (Mich Ct App 1980).
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