UCSF Marketing of Medicines Course
Principal Investigator: Lisa Bero, PhD
List of References
UCSF CME: Marketing of Medicines
1. Overview: L. Bero
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Bero, LA., Galbraith, A., and Rennie, D. The publication of sponsored symposiums in
medical journals. New England Journal of Medicine, 1992; 327: 1135-1140.
Bero, L., Oostvogel, F., Bacchetti, P., and Lee, K. Factors associated with findings of
published trials of drug-drug comparisons: Why some statins appear more efficacious
than others. PLOS Medicine, 2007: 4: 6: e184 doi:10.137/journal.pmed.0040184.
Moynihan R, Cassels A. Selling sickness : how the world's biggest
pharmaceutical companies are turning us all into patients. New York, NY: Nation
Books; 2006.
Rising, K, Bacchetti, P, and Bero, L. Reporting bias in drug trials submitted to
the Food and Drug Administration: A review of publication and presentation.
PLoS Medicine, 2008; 5 (11) e217 doi:10.1371/journal.pmed.0050217.
Sierles FS, Brodkey AC, Cleary LM, et al. Medical students' exposure to and
attitudes about drug company interactions: a national survey. JAMA
2005;294(9):1034-42.
Sigworth SK, Nettleman MD, Cohen GM. Pharmaceutical branding of resident
physicians. JAMA 2001;286(9):1024-5.
Steinman MA, Bero LA, Chren MM, Landefeld CS. Narrative review: the
promotion of gabapentin: an analysis of internal industry documents. Annals
Intern Med 2006;145(4):284-93.
Website for accessing drug company documents: http://dida.library.ucsf.edu .
Yank, V. Rennie, D, and Bero, L. Financial ties and concordance between results and
conclusions in meta-analyses: retrospective cohort. BMJ, 2007; 335: 1202-1205.
2. Industry-sponsored research and marketing: T. Newman
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Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and
conclusions in randomized drug trials: a reflection of treatment effect or adverse
events? JAMA. Aug 20 2003;290(7):921-928.
Andersen M, Kragstrup J, Sondergaard J. How conducting a clinical trial affects
physicians' guideline adherence and drug preferences. JAMA 2006;295(23):275964.
Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest
in biomedical research: a systematic review. JAMA. Jan 22-29 2003;289(4):454465.
Dong BJ, Hauck WW, Gambertoglio JG, et al. Bioequivalence of generic and
brand-name levothyroxine products in the treatment of hypothyroidism. JAMA
1997;277(15):1205-13.
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UCSF Marketing of Medicines Course
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Principal Investigator: Lisa Bero, PhD
Echt DS, Liebson PR, Mitchell LB, et al. Mortality and morbidity in patients
receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression
Trial. N Engl J Med. Mar 21 1991;324(12):781-788.
Ferreira-Gonzalez I, Busse JW, Heels-Ansdell D, et al. Problems with use of
composite end points in cardiovascular trials: systematic review of randomised
controlled trials. BMJ (Clinical research ed 2007;334(7597):786.
Gerstein HC, Miller ME, Byington RP, et al. Effects of intensive glucose
lowering in type 2 diabetes. N Engl J Med. Jun 12 2008;358(24):2545-2559.
Gilbody S, Bower P, Sutton AJ. Randomized trials with concurrent economic
evaluations reported unrepresentatively large clinical effect sizes. J Clin
Epidemiol. Aug 2007;60(8):781-786.
Hay J, Ernst R, Meisner H. Respiratory syncytial virus immune globulin: a costeffectiveness analysis. Am J Manag Care. 1996;2:851-861.
Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S. Why olanzapine
beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine:
an exploratory analysis of head-to-head comparison studies of second-generation
antipsychotics. Am J Psychiatry. Feb 2006;163(2):185-194.
Hjalmas K, Arnold T, Bower W, et al. Nocturnal enuresis: an international
evidence based management strategy. J Urol. Jun 2004;171(6 Pt 2):2545-2561.
Horton R (2004) The dawn of McScience. New York Rev Books 51(4):7–9.
Johansen HK, Gotzsche PC. Problems in the design and reporting of trials of
antifungal agents encountered during meta-analysis. JAMA. Nov 10
1999;282(18):1752-1759.
Kamm MA, Muller-Lissner S, Talley NJ, et al. Tegaserod for the treatment of
chronic constipation: a randomized, double-blind, placebo-controlled
multinational study. Amer J Gastroentero 2005;100(2):362-72.
Kearney PM, Baigent C, Godwin J, Halls H, Emberson JR, Patrono C. Do
selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal antiinflammatory drugs increase the risk of atherothrombosis? Meta-analysis of
randomised trials. BMJ Clinical research ed 2006;332(7553):1302-8.
Krzyzanowska MK, Pintilie M, Tannock IF. Factors associated with failure to
publish large randomized trials presented at an oncology meeting. JAMA
2003;290(4):495-501.
Moore TJ. Deadly medicine : why tens of thousands of heart patients died in
America's worst drug disaster. New York: Simon & Schuster; 1995.
Morrell MJ, McLean MJ, Willmore LJ, et al. Efficacy of gabapentin as adjunctive
therapy in a large, multicenter study. The Steps Study Group. Seizure
2000;9(4):241-8.
Newman TB, Industry-sponsored "expert committee recommendations for acne
management" promote expensive drugs on the basis of weak evidence. Pediatrics
2007 Mar;119(3):650.
Newman TB. Industry-sponsored "expert committee recommendations for acne
management" promote expensive drugs on the basis of weak evidence. Pediatrics.
Mar 2007;119(3):650; author reply 650-651.
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UCSF Marketing of Medicines Course
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Principal Investigator: Lisa Bero, PhD
Pahor M, Psaty BM, Alderman MH, et al. Health outcomes associated with
calcium antagonists compared with other first-line antihypertensive therapies: a
meta-analysis of randomised controlled trials. Lancet 2000;356(9246):1949-54.
Pizarro D, Posada G, Sandi L, Moran JR.Rice-based oral electrolyte solutions for
the management of infantile diarrhea. N Engl J Med. 1991 Feb 21;324(8):517-21.
Psaty BM, Furberg CD. Rosiglitazone and cardiovascular risk. New Engl J Med
2007;356(24):2522-4.
Psaty BM, Rennie D. Clinical trial investigators and their prescribing patterns:
another dimension to the relationship between physician investigators and the
pharmaceutical industry. JAMA. Jun 21 2006;295(23):2787-2790.
Psaty BM, Weiss NS, Furberg CD. Recent trials in hypertension: compelling
science or commercial speech? JAMA 2006;295(14):1704-6.
Psaty BM, Weiss NS. NSAID trials and the choice of comparators--questions of
public health importance. N Engl J Med. Jan 25 2007;356(4):328-330.
Riggs BL. A new option for treating osteoporosis. New Engl J Med
1990;323(2):124-5.
Rochon PA, Gurwitz JH, Simms RW, et al. A study of manufacturer-supported
trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis.
Archives Intern Med 1994;154(2):157-63.
Smith R. Medical journals are an extension of the marketing arm of
pharmaceutical companies. PLoS Med 2005;2(5):e138.
Spruance SL, Rea TL, Thoming C, Tucker R, Saltzman R, Boon R. Penciclovir
cream for the treatment of herpes simplex labialis. A randomized, multicenter,
double-blind, placebo-controlled trial. Topical Penciclovir Collaborative Study
Group. JAMA. May 7 1997;277(17):1374-1379.
Trouiller P, Olliaro P, Torreele E, Orbinski J, Laing R, Ford N. Drug development
for neglected diseases: a deficient market and a public-health policy failure.
Lancet. Jun 22 2002;359(9324):2188-2194.
Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective
publication of antidepressant trials and its influence on apparent efficacy. N Engl
J Med. Jan 17 2008;358(3):252-260.
Zaenglein AL, Thiboutot DM. Expert committee recommendations for acne
management. Pediatrics 2006;118(3):1188-99.
Zaenglein AL, Thiboutot DM. Expert committee recommendations for acne
management. Pediatrics. Sep 2006;118(3):1188-1199.
Zimmerman M, Chelminski I, Posternak MA. Exclusion criteria used in
antidepressant efficacy trials: consistency across studies and representativeness of
samples included. J Nerv Ment Dis. Feb 2004;192(2):87-94.
Zimmerman M, Chelminski I, Posternak MA. Generalizability of antidepressant
efficacy trials: differences between depressed psychiatric outpatients who would
or would not qualify for an efficacy trial. Am J Psychiatry. Jul 2005;162(7):13701372.
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UCSF Marketing of Medicines Course
Principal Investigator: Lisa Bero, PhD
3. Industry-sponsored education and marketing: K. Lee
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Accreditation Council for Continuing Medical Education (ACCME). ACCME
Standards for Commercial Support: Standards to Ensure the Independence of
CME Activities. Accessed on 9/21/07. Available at www.accme.org.
Accreditation Council for Continuing Medical Education (ACCME). Annual
Report Data 2006. Accessed on 9/21/07. Available at www.accme.org.
American Medical Student Association. AMSA’s 2007 PharmFree Scorecard.
Accessed on 9/21/07. Available at www.amsa.org.
Bowman MA. The impact of drug company funding on the content of continuing
medical education. Mobius. 1986;6:66-69.
Brennan TA, Rothman DJ, Blank L, Blumenthal D, Chimonas SC, Cohen JJ, et al.
Health industry practices that create conflicts of interest: a policy proposal for
academic medical centers. JAMA. 2006;295:429-33.
Donohue JM, Cevasco M, Rosenthal MB. A decade of direct-to-consumer
advertising of prescription drugs. N Engl J Med. 2007;357:673-81.
Fugh-Berman A, Ahari S. Following the script: how drug reps make friends and
influence doctors. PLoS Med. 2007;4:e150.
Gagnon MA, Lexchin J. The cost of pushing pills: a new estimate of
pharmaceutical promotion expenditures in the United States. PLoS Med.
2008;5:e1.
Goldberg M, Davenport B. In sales we trust: the survey reveals a shift toward
sales volume-and away from training competencies-as performance metrics.
Pharm Exec 2005, January. Accessed on 9/21/07 at
http://www.pharmexec.com/pharmexec/PE+Features/In-Sales-WeTrust/ArticleStandard/Article/detail/146596.
Kaiser Family Foundation. National Survey of Physicians Part II: Doctors and
Prescription Drugs. 2002. Accessed on 9/21/07 at www.kff.org.
Ma J, Stafford RS, Cockburn IM, Finkelstein SN. A statistical analysis of the
magnitude and composition of drug promotion in the United States in 1998. Clin
Ther. 2003;25:1503-17.
MedAdNews. Hard Sell. 2004;23:1.
Peters SM, Peters VF. Selling to specialist physicians. Downington,
Pennsylvania: Black Dog Publishing Company; 2004.
Preskorn SH. Advances in antidepressant therapy. Dannemiller Memorial
Education Foundation, San Antonio, Texas, 1994.
Reidy J. Hard Sell: the evolution of a Viagra salesman. Andrews McMeel
Publishing, Riverside, NJ, 2005.
United States Senate Committee on Finance Report 2007. Accessed on 9/21/07.
Available at
http://www.senate.gov/~finance/press/Bpress/2007press/prb042507a.pdf
Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift?
JAMA. 2000 Jan 19;283(3):373-80.
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UCSF Marketing of Medicines Course
Principal Investigator: Lisa Bero, PhD
4. Direct-to-consumer marketing: E. Boyd
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Bell RA, Wilkes MS, Kravitz RL. Advertisement-induced prescription drug
requests: patients' anticipated reactions to a physician who refuses. J Fam Prac
1999;48(6):446-52.
Donohue JM, Cevasco M, Rosenthal MB. A decade of direct-to-consumer
advertising of prescription drugs. New Engl J Med 2007;357(7):673-81.
Eaton, ML. Ethics and the business of bioscience. Stanford, CA: Stanford
University Press; 2004.
Gellad ZF, Lyles KW. Direct-to-consumer advertising of pharmaceuticals. Amer J
Med 2007;120(6):475-80.
Holmer AF. Direct-to-consumer prescription drug advertising builds bridges
between patients and physicians. JAMA 1999;281(4):380-2.
Ingelfinger FJ. Advertising: informative but not educational. New Engl J Med
1972;286(24):1318-9.
Kravitz RL, Epstein RM, Feldman, MD, Franz, CE, Azari, R, Wilkes, MS,
Hinton, L, Franks, P. Influence of patients’ requests for Direct-to-Consumer
advertised antidepressants. JAMA 2005: 293(16): 1995-2002.
Perri M, 3rd, Shinde S, Banavali R. The past, present, and future of direct-toconsumer prescription drug advertising. Clin Ther 1999;21(10):1798-811;
discussion 7.
Rosenthal MB, Berndt ER, Donohue JM, Frank RG, Epstein AM. Promotion of
prescription drugs to consumers. New Engl J Med 2002;346(7):498-505.
Shuchman M. Drug risks and free speech — can Congress ban consumer drug
ads? New Engl J Med 2007; 356: 2236-39.
US House of Representatives Committee on Government Reform, FDA
Enforcement Actions Against False and Misleading Prescription Drug
Advertisements Declined in 2003. Washington, DC; 2004.
Wilkes MS, Bell RA, Kravitz RL. Direct-to-consumer prescription drug
advertising: trends, impact, and implications. Health affairs (Project Hope)
2000;19(2):110-28.
Woloshin S, Schwartz, LM, Tremmel, J, Welch, HG. Direct-to-consumer
advertisements for prescription drugs: what are Americans being sold? Lancet
2001: 358: 1141-1146.
5. Effects of marketing on prescribing: L. Bero
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Avorn J, Chen M, Hartley R. Scientific versus commercial sources of influence
on the prescribing behavior of physicians. Amer J Med 1982;73(1):4-8.
Bero L, Oostvogel F, Bacchetti P, Lee K. Factors associated with findings of
published trials of drug-drug comparisons: why some statins appear more
efficacious than others. PLoS Med 2007;4(6):e184.
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UCSF Marketing of Medicines Course
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Principal Investigator: Lisa Bero, PhD
Bero, LA., and Rennie, D. Influences on the quality of published drug studies.
International Journal of Technology Assessment in Health Care, 1996; 12 (2):
209-237.
Cho MK, Bero LA. The quality of drug studies published in symposium
proceedings. Annals Intern Med 1996;124(5):485-9.
Chren MM, Landefeld CS. Physicians' behavior and their interactions with drug
companies. A controlled study of physicians who requested additions to a hospital
drug formulary. JAMA 1994;271(9):684-9.
Dana J, Loewenstein G. A social science perspective on gifts to physicians from
industry. JAMA 2003;290(2):252-5.
De Las Cuevas C, Sanz EJ, De La Fuente JA. Variations in antidepressant
prescribing practice: clinical need or market influences? Pharmacoepid Drug Saf
2002 Sep;11(6):515-22.
Glaser BE, Bero LA. Attitudes of academic and clinical researchers toward
financial ties in research: a systematic review. Science and engineering ethics
2005;11(4):553-73.
Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry
sponsorship and research outcome and quality: systematic review. BMJ (Clinical
research ed 2003;326(7400):1167-70.
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):270-3.
Smith R. Medical journals are an extension of the marketing arm of
pharmaceutical companies. PLoS Med 2005;2(5):e138.
Steinman MA, Harper GM, Chren MM, Landefeld CS, Bero LA. Characteristics
and impact of drug detailing for gabapentin. PLoS Med 2007;4(4):e134.
doi:10.1371/journal.pmed.0040134.
Steinman MA, Shlipak MG, McPhee SJ. Of principles and pens: attitudes and
practices of medicine housestaff toward pharmaceutical industry promotions.
Amer J Med 2001;110(7):551-7.
Stryer, D., and Bero, L. Characteristics of materials distributed by drug
companies. Journal of General Internal Medicine, 1996; 11: 575-583.
Stryer DB, Lurie P, Bero LA. Dear doctor ... regarding calcium channel blockers.
JAMA 1996;275(7):517-9.
Zipkin DA, Steinman MA. Interactions between pharmaceutical representatives
and doctors in training. A thematic review. J Gen Intern Med 2005;20(8):777-86.
To opt-out of AMA Masterfile sales of your personal and license information for
marketing purposes:
(Masterfile includes even non-AMA members, physicians need to renew opt-out
every 3 years) Physician Data Restriction Program (PDRP): http://www.amaassn.org/ama/pub/category/12054.html
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