The Info List - Direct-to-consumer

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Direct-to-consumer advertising (DTC advertising) usually refers to the marketing of pharmaceutical products but also applies to the direct marketing of medical devices, consumer diagnostics and sometimes financial services. This form of advertising is directed toward patients, rather than healthcare professionals. The rhetorical objective of direct-to-consumer advertising is to directly influence the patient-physician dialogue in order to increase sales of a particular pharmaceutical drug.[1] The Food and Drug Administration is responsible for regulating DTC advertising in the United States. The FDA's latest version of guidelines, though still in draft form, for pharmaceutical drug advertising was updated in 2009.[2] Forms of DTC advertising include TV, print, radio and other mass and social media. There are ethical and regulatory concerns regarding DTC advertising, specifically the extent to which these ads may unduly influence the prescribing of the prescription medicines based on consumer demands when, in some cases, they may not be medically necessary.


1 Countries permitting DTC 2 History 3 Pros

3.1 Economic 3.2 Public health

4 Cons

4.1 Economic 4.2 Doctor-Patient Relationship 4.3 Drug Safety 4.4 Medicalization 4.5 References

5 Further reading 6 External links

Countries permitting DTC[edit] To date four nations permit DTC in the pharmaceutical industry:[3][4]

New Zealand (1981) United States (1985)[4][5] Brazil (2008) – In 2008 a new resolution from ANVISA (Control Agency for Sanitary Vigilance), Resolution 96 from December 17 was released, with focus on medication advertisement. It allows direct-to-consumer advertising of non-prescription medication, with restrictions on the type of drug and words and images that can be used, among other things.[6] Advertisements for prescription medications can only appear in scientific, medical, or health professional journals.[7] Hong Kong (1953)[8]

History[edit] Direct-to-consumer pharmaceutical advertising (DTCPA) laws and regulations in the United States have gradually become more relaxed since they were first introduced in the 1960s.  Consequently, expenditures on advertisements for prescription drugs in the United States have grown to approximately $4.5 billion per year.[9] In 1962 Congress gave the Food and Drug Administration (FDA) the authority to regulate prescription drug labeling and advertising, but the FDA did not establish implementing regulations until 1969.[9][10] Pharmaceutical companies shifted the focus of their marketing efforts to licensed medical doctors in the 1970s, as the FDA mandated that only doctors could prescribe medicine.[10] After a series of Patient Rights campaigns in the 1970s persuaded a large segment of the population to be actively involved in their own medical care, the drug company Pfizer launched the first pharmaceutical direct-to-consumer campaign in 1980, promoting its brand but not marketing any prescription medication.[9]  In 1981, Boots aired the first targeted drug advertisement for the drug Rufen, promoting the pain killer as a cheaper alternative to leading brands. Soon after Merck launched a campaign promoting its pneumonia vaccine.[10] DTC marketing significantly increased starting in 1997, after the FDA suggested ways pharmaceutical companies could meet what had previously been a legally vague regulatory provision; the FDA also exempted certain types of advertisements from providing a full summary of major side effects and contraindications of a drug's effectiveness.[10] In 2004, the FDA further relaxed DTCPA regulations to require only a brief description of the drug and its side effects – provided that consumers could access full summary information elsewhere.[9] In 2002, the Secretary of Health and Human Services began requiring all draft FDA regulatory letters, including letters related to advertising violations, to be reviewed and approved by the FDA's Office of Chief Counsel before they are issued.[11] On 2 August 2005, Pharmaceutical Research and Manufacturers of America released its Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines, with the intent to stop congressional action to end industry self-regulation.[12] This great amount of advertising has been successful in raising the prescription rate of DTC drugs by 34.2% from 1998 to 1999, compared to only a 5.1% increase in other prescriptions during the same time.[13] The apparent commercial success of DTC advertising drew criticism from public health officials and physicians.[14] On 17 November 2015, the American Medical Association called for a ban on all U.S. prescription drug and medical device advertising directly to consumers. Representatives of the leading physician's association argued that such commercial broadcasts encourage patients to take medications unnecessarily and to choose more expensive drugs. However, such a ban would require authorization by the United States Congress.[15] On 4 March 2016, Senator Al Franken introduced a bill to Congress that would eliminate tax breaks for pharmaceutical companies advertising directly to consumers. In a similar move, representative Rosa DeLauro called for a three-year moratorium on advertising of newly approved prescription drugs. Such bans on advertising have faced substantial criticism by the pharmaceutical industry. Representatives from Pharmaceutical Research and Manufacturers of America (PhRMA) stated that drug advertising campaigns are aimed at providing consumers with information to become actively involved in their own health care.[16] Pros[edit] Economic[edit] Supporters of DTCPA argue that advertisements increase competition which leads to lower prescription drug prices and new development, citing, for instance, that between 1997 to 2001, spending on research and development in the US increased 59% while spending on promoting drugs directly to patients increased 145%. However, other experts have asserted that funding for R&D is determined by several other factors.[17][9] Public health[edit] Arguments in favor of DTCPA assert that advertising informs consumers of new treatment options, generating new doctor visits and thereby reducing the rate of undiagnosed illnesses.  DTC advertising, among other patient education initiatives, can educate consumers and patients about therapeutic options that may not have been proactively mentioned by their healthcare professional. Proponents of DTCPA claim this provides a vital opportunity for the public to be aware of what is available to them and to engage in an educated discussion with their doctor. According to one study, every additional $28 spent on DTCPA prompts one patient visit within the following 12 months. Another study observes that DTCPA promotes communication between patients and their doctors about medications. Thirty percent of Americans indicate they talk with their doctor about a medicine they saw on TV.[18] In addition, surveys show that increased advertising has had a positive impact on the degree to which people adhere to a given course of treatment – but only among those who were already on medication prior to exposure to DTCPA. Among this population, a 10% increase in exposure to drug advertising increases the rate of adherence between 1% and 2%.[19] Cons[edit] Economic[edit] Some studies have asserted that DTCPA misleads patients into demanding heavily-advertised drugs, leading to superfluous or sub-optimal treatment.  For example, the Centers for Disease Control and Prevention have determined that 47% of all antibiotics prescribed in the United States are unnecessary, imposing significant additional costs on affected households.[20]  Another study found that young people living in West Palm Beach, Florida found that a 10% increase in advertising expose increased the total number of prescriptions by 5%; a higher percentage change than in Denver, Colorado – where DTCPA expenditures per person are lower.[21] Critics also argue that resources spent on DTCPA could otherwise be spent on developing new drugs and medical therapies.  Nine of the 10 largest pharmaceutical companies worldwide spend more money on sales and marketing than on research and development.[22] US pharmaceutical companies are estimated to have spent 5.2 billion dollars on prescription drug advertising in 2015 most of which was spend on television advertising.[23] Doctor-Patient Relationship[edit] When consumers approach their doctor with a health concern, or to request a change in medication for a condition they already have, often their first and most persuasive source of information was a pharmaceutical advertisement.  This leads consumers to direct their doctors’ visits from the start by prompting a conversation about a certain drug or course of treatment.  Doctors may be more likely to prescribe the medicine patients requested even when it may not be the most cost-effective, medically sound or safe course of treatment.  Of those patients who sought medical treatment because of an advertisement, 44% report their doctor prescribed the medication that they requested.[19] 47% of doctors expressed feeling pressured to prescribe a drug because their patient requested it by name.[24] When new drugs are marketed directly to patients, the use of these drugs accelerates, even though trials and testing may not have yet had enough time to identify long-term side effects or rare reactions to the drug. Recently-released drugs usually are only tested in small pre-marketing clinical trials.[25] New demand for a particular drug can also create adverse public health harm.  A higher rate of antibiotic consumption – driven in part by DTCPA – is creating anti-biotic resistant infection strains that in turn pose a public health hazard.[20] DTCPA has contributed to illicit drug use of certain pharmaceutical drugs, as drug addicts seek out prescriptions based on their greater knowledge of drugs available on the market.[19] Drug Safety[edit] DTCA can lead to patients using newer drugs. Drug advertisements predominately advertise new drugs.[26] Advertisements generally begin within a year of drugs entering the market.[26] Newer drugs have had less time to be studied. This can result in drugs being withdrawn from the market after initial approval. From 1997 to 2001, 10 drugs were removed from the U.S. market.[27] Medicalization[edit] Pharmaceutical companies' desire to make a profit can lead to marketing more drugs to more people. The bounds for what is considered ill may broaden. Advertisements display “unfortunate facts of life” like wrinkling or baldness as a disease to be treated with drugs.[24] References[edit]

^ Mogull, Scott A.; Balzhiser, Deborah (September 2015). "Pharmaceutical Companies Are Writing the Script for Health Consumerism". Commun. Des. Q. Rev. 3 (4): 35–49. doi:10.1145/2826972.2826976. ISSN 2166-1200.  ^ Research, Center for Drug Evaluation and. "Guidances (Drugs) - Advertising". www.fda.gov.  ^ Bulletin of the World Health Organization. Direct-to-consumer advertising under fire. The World Health Organization (WHO). Retrieved 4 January 2017. ^ a b Mogull, Scott A. (2008). "Chronology of Direct-to-Consumer Advertising Regulation in the United States". AMWA Journal. 23: 3.  ^ "WHO - Direct-to-consumer advertising under fire". www.who.int.  ^ "RESOLUÇÃO-RDC Nº 96, DE 17 DE DEZEMBRO DE 2008" (PDF). Retrieved August 13, 2017.  ^ "Advertising Regulation for Medication in Brazil". The Brazil Business. Retrieved 2018-02-21.  ^ "Drug Office - Undesirable Medical Advertisements Ordinance".  ^ a b c d e Ventola, C. Lee (2011). "Direct-to-Consumer Pharmaceutical Advertising". Pharmacy and Therapeutics. 36 (10): 669–684. ISSN 1052-1372. PMC 3278148 . PMID 22346300.  ^ a b c d Donohue, Julie (2006). "A History of Drug Advertising: The Evolving Roles of Consumers and Consumer Protection". The Milbank Quarterly. 84 (4): 659–699. doi:10.1111/j.1468-0009.2006.00464.x. ISSN 0887-378X. PMC 2690298 . PMID 17096638.  ^ Donohue, J. M.; Cevasco, M.; Rosenthal, M. B. (2007). "A Decade of Direct-to-Consumer Advertising of Prescription Drugs". New England Journal of Medicine. 357 (7): 673–681. doi:10.1056/nejmsa070502. PMID 17699817.  ^ Arnold, Matthew (2006-10-01). 40 years of DTC. MMM, 1 October 2006. Retrieved from http://www.mmm-online.com/40-years-of-DTC/article/35502/ ^ Sheehan, Kim. Controversies in Contemporary Advertising; Sage Publications, Thousand Oaks, CA, 2003; pp 209-215. ^ Kerber, Ross. Doctors Criticize Sleeping-Pill Ad (Lunesta from Sepracor Inc.). Boston Globe, Boston, Aug. 18, 2005, p HS05. ^ E Silverman (2015). "American Medical Association wants to ban drug ads to consumers". STAT (Pharmalot). Retrieved 4 January 2017. ^ E Silverman (2016)."Lawmaker seeks to end tax breaks for consumer drug ads". STAT (Pharmalot). Retrieved 4 January 2017. ^ Hollon, Matthew F. (2004-02-01). "Direct-To-Consumer Marketing of Prescription Drugs". CNS Drugs. 18 (2): 69–77. doi:10.2165/00023210-200418020-00001. ISSN 1172-7047.  ^ Iizuka, Toshiaki; Jin, Ginger Zhe (2005-09-01). "The Effect of Prescription Drug Advertising on Doctor Visits". Journal of Economics & Management Strategy. 14 (3): 701–727. doi:10.1111/j.1530-9134.2005.00079.x. ISSN 1530-9134.  ^ a b c McKinlay, John B.; Trachtenberg, Felicia; Marceau, Lisa D.; Katz, Jeffrey N.; Fischer, Michael A. (April 2014). "Effects of patient medication requests on physician prescribing behavior: results of a factorial experiment". Medical Care. 52 (4): 294–299. doi:10.1097/MLR.0000000000000096. ISSN 1537-1948. PMC 4151257 . PMID 24848203.  ^ a b "CDC Press Releases". CDC. Retrieved 2017-08-12.  ^ "Cause and Effect: Do Prescription Drug Ads Really Work? - Knowledge@Wharton". Knowledge@Wharton. Retrieved 2017-07-28.  ^ Anderson, Richard (2014-11-06). "Pharmaceutical industry gets high on fat profits". BBC News. Retrieved 2017-08-12.  ^ Orelli, Brian (June 9, 2017). "6 Reasons Why Prescription Drug Prices Are Extremely Expensive -- The Motley Fool". The Motley Fool. Retrieved 2017-08-12.  ^ a b Metzl, Jonathan. “Selling Sanity Through Gender.” Ms Magazine, Fall, 2003. ^ Lyles, Alan (2002-05-01). "Direct Marketing of Pharmaceuticals to Consumers". Annual Review of Public Health. 23 (1): 73–91. doi:10.1146/annurev.publhealth.23.100901.140537. ISSN 0163-7525.  ^ a b Donohue, Julie, Marisa Cevasco, and Meredith Rosenthal. “A Decade of Direct-to-Consumer Advertising of Prescription Drugs.” The New England Journal of Medicine, 357:7 (August 16, 2007): 673-681. ^ Fisher, Jill A, and Ronald, Lorna. “Sex, Gender, and Pharmaceutical Politics: From Drug Developing to Marketing.” Gender Medicine, 7:4 (August 2010): 357-70.

Further reading[edit]

Frosch, D. L.; Krueger, P. M.; Hornik, R. C.; Cronholm, P. F.; Barg, F. K. (2007). "Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-to-Consumer Advertising". The Annals of Family Medicine. 5: 6–13. doi:10.1370/afm.611. PMC 1783924 . PMID 17261859.  Kornfield, R.; Donohue, J.; Berndt, E. R.; Alexander, G. C. (2013). "Promotion of Prescription Drugs to Consumers and Providers, 2001–2010". PLoS ONE. 8 (3): e55504. doi:10.1371/journal.pone.0055504. PMC 3587616 . PMID 23469165. 

External links[edit]

Educating the Consumer about Advertising: Some Issues – from the Education Resources Information Center Clearinghouse on Reading and Communication Skills, Bloomington, Indiana. 40 years of DTC by Matthew Arnold/Medical Marketing and Media Catch the New Pharmaceutical Marketing Wave: Trends & Strategies for Reaching Today's Healthcare Consumer

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Unnecessary health care


Direct-to-consumer advertising Overscreening Overdiagnosis Fee-for-service Defensive medicine Unwarranted variation Overmedication Disease mongering Political abuse of psychiatry

Overused health care

Caesarean delivery on maternal request Antibiotic misuse Polypharmacy treatment of incidentaloma

Works about unnecessary health care

Overtreated The Treatment Trap Selling Sickness