Hostname: page-component-586b7cd67f-dlnhk Total loading time: 0 Render date: 2024-11-24T03:58:59.141Z Has data issue: false hasContentIssue false
  • English
  • Français

DTC Advertising Harms Patients and Should Be Tightly Regulated

Published online by Cambridge University Press:  01 January 2021

Peter Lurie
Get access Rights & Permissions [Opens in a new window]

Extract

Like all interventions in health care, direct-to-consumer (DTC) advertising should be evaluated by comparing its risks to its benefits, in the context of the available or potentially available alternatives. The objective, of course, is to realize any unique benefits while minimizing the risks. On balance, the adverse effects of DTC advertising outweigh the still-undemonstrated benefits of the advertising.

DTC advertising must be seen in the context of overall pharmaceutical company expenditures on advertising. In 2005, the industry spent $29.9 billion dollars on promotions (up from $11.4 billion in 1996), of which a relatively small fraction, $4.2 billion (14.2%), was spent on DTC advertising. The percentage spent on DTC advertising has been relatively constant this decade. Promotions to professionals (24.2%) and samples (61.8%) accounted for far larger percentages of total promotional spending in 2005.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 37 , Issue 3 , Fall 2009 , pp. 444 - 450
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Donohue, J. M., Cevasco, M. and Rosenthal, M. B., “A Decade of Direct-to-Consumer Advertising of Prescription Drugs,” New England Journal of Medicine 357, no. 7 (2007): 673–681.CrossRefGoogle Scholar
“Guidance for Industry: Consumer-Directed Broadcast Advertisements”, Food and Drug Administration, August 1999, available at <http://www.fda.gov/cder/guidance/1804fnl.htm> (last visited May 21, 2009).+(last+visited+May+21,+2009).>Google Scholar
Toop, L. and Mangin, D., “Industry Funded Patient Information and the Slippery Slope to New Zealand,” British Medical Journal 335, no. 7622 (2007): 694–695.CrossRefGoogle Scholar
Hollon, M. F., “Direct-to-Consumer Advertising: A Haphazard Approach to Health Promotion,” Journal of the American Medical Association 293, no. 16 (2005): 2030–2033.CrossRefGoogle Scholar
National Institute for Health Care Management, “Prescription Drugs and Mass Media Advertising, 2000”, 2001, available at <http://www.nihcm.org/∼nihcmor/pdf/DTCbrief2001.pdf> (last visited May 22, 2009).+(last+visited+May+22,+2009).>Google Scholar
Graham, D. J., Campen, D. and Hui, R. et al., “Risk of Acute Myocardial Infarction and Sudden Cardiac Death in Patients Treated with Cyclo-Oxygenase 2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs: Nested Case-Control Study,” The Lancet 365, no. 9458 (2005): 475–481.CrossRefGoogle Scholar
Spence, M. M., Teleki, S. S., Cheetham, T. C., Schweitzer, S. O. and Millares, M., “Direct-to-Consumer Advertising of COX-2 Inhibitors: Effect on Appropriateness of Prescribing,” Medical Care Research and Review 62, no. 5 (2005): 544–559.CrossRefGoogle Scholar
Bradford, W. D., Kleit, A. N., Nietert, P. J., Steyer, T., McIlwain, T. and Ornstein, S., “How Direct-to-Consumer Television Advertising for Osteoarthritis Drugs Affects Physicians' Prescribing Behavior,” Health Affairs 25, no. 5 (2006): 1371–1377.CrossRefGoogle Scholar
Galderma website, available at <http://www.differin.com/teens/index.shtml> (last visited May 21, 2009).+(last+visited+May+21,+2009).>Google Scholar
Wolfe, S. M., Letter to FDA Urging Action on Misleading CRESTOR Advertising by AstraZeneca (HRG Publication 1712), available at <http://www.citizen.org/publications/release.cfm?ID=7347> (last visited May 21, 2009).Google Scholar
Smith, C. H., Division of Drug Marketing, Advertising and Communications, Letter to Mark R. Szewczak, AstraZeneca, Food and Drug Administration, December 21, 2004, available at <http://www.fda.gov/cder/warn/2004/12779.pdf> (last visited May 22, 2009).+(last+visited+May+22,+2009).>Google Scholar
Saul, S., “Drug Ads Raise Questions for Heart Pioneer,” New York Times, February 7, 2008, at A1; Saul, S., “Pfizer to End Lipitor Ads by Jarvik,” New York Times, February 26, 2008, at C1.Google Scholar
Gollust, S. E., Hull, S. C. and Wilfond, B. S., “Limitations of Direct-to-Consumer Advertising for Clinical Genetic Testing,” Journal of the American Medical Association 288, no. 14 (2002): 1762–1767.CrossRefGoogle Scholar
CyGene Direct website, available at <https://cygenedirect.com/athletic-performance/dna-testing-athletic-performance.html> (last visited May 22, 2009.)+(last+visited+May+22,+2009.)>Google Scholar
Suracell website, available at <http://www.suracell.com/faqs/#1> (last visited May 22, 2009).+(last+visited+May+22,+2009).>Google Scholar
General Accounting Office, “Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising has Limitations”, GA0-03-177, October 2002, available at <http://www.gao.gov/new.items/d03177.pdf> (last visited June 12, 2009).+(last+visited+June+12,+2009).>Google Scholar
Bell, R. A., Kravitz, R. L. and Wilkes, M. S., “Direct-to-Consumer Prescription Drug Advertising and the Public,” Journal of General Internal Medicine 14, no. 11 (1999): 651–657.CrossRefGoogle Scholar
Aikin, K. J., Swasy, J. L. O. and Braman, A. C., “Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs — Summary of FDA Survey Research Results”, Center for Drug Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services, November 19, 2004, available at <http://www.fda.gov/cder/ddmac/researchka.htm> (last visited May 22, 2009).+(last+visited+May+22,+2009).>Google Scholar
Id.Google Scholar
Kravitz, R. L., Epstein, R. M. and Feldman, M. D. et al., “Influence of Patients' Requests for Direct-to-Consumer Advertised Antidepressants: A Randomized Controlled Trial,” Journal of the American Medical Association 293, no. 16 (2005): 1995–2002.CrossRefGoogle Scholar
Mintzes, B., Barer, M. L. and Kravitz, R. L. et al., “How Does Direct-to-Consumer Advertising (DTCA) Affect Prescribing? A Survey in Primary Care Environments With and Without Legal DTCA,” Canadian Medical Journal 169, no. 5 (2003): 405–412.Google Scholar
National Institute for Health Care Management, Prescription Drugs and Mass Media Advertising, September 2000, available at <http://www.nihcm.org/∼nihcmor/pdf/DTCbrief.pdf> (last visited May 22, 2009).+(last+visited+May+22,+2009).>Google Scholar
Henry J. Kaiser Family Foundation, “Impact of Direct-to-Consumer Advertising on Prescription Drug Spending”, 2003, available at <http://www.kff.org/rxdrugs/6084-index.cfm> (last visited May 22, 2009).+(last+visited+May+22,+2009).>Google Scholar
See General Accounting Office, supra note 16.Google Scholar
See Aikin, , supra, note 18.Google Scholar
Gilbody, S., Wilson, P. and Watt, I., “Benefits and Harms of Direct to Consumer Advertising: A Systematic Review,” Quality & Safety in Health Care 14, no. 4 (2005): 246–250.CrossRefGoogle Scholar
See Kravitz, , supra, note 20.Google Scholar
Pharmaceutical Research and Manufacturers Association, “PhRMA Guiding Principles: Direct to Consumer Advertisements about Prescription Medicines”, 2005, available at <http://www.phrma.org/mediaroom/press/releases/02.08.2005.1195.cfm> (last visited May 22, 2009).+(last+visited+May+22,+2009).>Google Scholar
Sasich, L. D. and Wolfe, S. M., “Deficiencies in Patient Information Leaflets Concerning Gastrointestinal Complications of Nonsteroidal Anti-Inflammatory Drugs,” Journal of General Internal Medicine 12, Supplement (1997): 79 (abstract); Bradley, L. R. and Sasich, L. D., “The Information Content of Patient Medication Information Leaflets: Examination of Five Fluoroquinolone Antibiotics,” Journal of the American Pharmaceutical Association 38, no. 2 (1998): 278-279 (abstract); Wolfe, S. M. and Sasich, L. D., “Comments before FDA Hearing on Current Status of Useful Written Prescription Drug Information for Consumers, July 31, 2003 (HRG Publication #1672), available at <http://www.citizen.org/publications/release.cfm?ID=7269> (last visited March 13, 2008).Google Scholar
Ingelfinger, F. J., “Advertising: Informational but Not Educational,” New England Journal of Medicine 286, no. 24 (1972): 1318–1319.CrossRefGoogle Scholar
Food and Drug Administration, “Guidance for Industry: Consumer-Directed Broadcast advertisements,” Division of Drug Marketing, Advertising and Communications, 1999, available at <http://www.fda.gov/cder/guidance/1804fnl.htm> (last visited May 21, 2009); Food and Drug Administration, “Guidance for Industry: “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms”, Division of Drug Marketing, Advertising and Communications, 2004, available at <http://www.fda.gov/cder/guidance/6019dft.htm) (last visited May 22, 2009); Food and Drug Administration, “Guidance for Industry: Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements,” Division of Drug Marketing, Advertising and Communications, 2004, available at <http://www.fda.gov/cder/guidance/guidance.htm> (last visited May 22, 2009).+(last+visited+May+21,+2009);+Food+and+Drug+Administration,+“Guidance+for+Industry:+“Help-Seeking”+and+Other+Disease+Awareness+Communications+by+or+on+Behalf+of+Drug+and+Device+Firms”,+Division+of+Drug+Marketing,+Advertising+and+Communications,+2004,+available+at++(last+visited+May+22,+2009).>Google Scholar
See General Accounting Office, supra note 16.Google Scholar
Anon, , “FDA Enforcement Actions Against False and Misleading Prescription Drug Advertisements Declined in 2003”, Minority Staff of United States House of Representatives Committee on Government Reform, 2004, available at <http://www.democrats.reform.house.gov/story.asp?ID=440&Issue=Prescription+Drugs> (last visited May 22, 2009).+(last+visited+May+22,+2009).>Google Scholar
Division of Drug Marketing, Advertising and Communications, “Warning Letters and Notice of Violation Letters to Pharmaceutical Companies”, Food and Drug Administration, available at <http://www.fda.gov/cder/warn/index.htm> (last visited May 22, 2009).+(last+visited+May+22,+2009).>Google Scholar