Consumer Advertisements for Psychostimulants in the United States:
A Long Record of Misleading Promotion
By Jeffrey R. Lacasse, PhD and Jonathan Leo, PhD |
February 26, 2009
Dr Lacasse is assistant professor at the School of Social Work in the College of Public Programs at Arizona State University in Phoenix. His research examines psychiatric treatment provided to vulnerable populations, such as state hospital inpatients and children living in poverty. Dr Leo is assistant dean of students and associate professor of neuroanatomy at Lincoln Memorial University-DeBusk College of Osteopathic Medicine in Harrogate, Tenn. He is co-editor, with Dr Sami Timimi, of the forthcoming book, Rethinking ADHD: From Brain to Culture, to be published in March 2009 by Palgrave Macmillan. He recently served as a peer reviewer for the 2008 NICE guidelines on ADHD. Drs Lacasse and Leo have collaborated on several papers, including an analysis of consumer advertisements for SSRI antidepressants published in PLoS Medicine.
This chain of events raises several important issues. First, we wonder how many parents have been “driven to the doctor” and made the difficult decision to medicate their child under the influence of misleading advertising. However, there is a larger problem. There were few (if any) dissenting voices raised from rank-and-file academic psychiatrists who objected to these misleading advertisements. How is it that over the past 3 years, we have not seen strong public objections to the widespread dissemination of obviously inaccurate information? Beyond academia, practicing child psychiatrists and pediatricians who treat patients with ADHD must also be aware of the disconnect between these highly visible advertisements and the scientific evidence.
While we have focused here on Adderall, for years we have also noted questionable promotional materials for several other ADHD medications.10 Yet, the voice of mainstream practicing and academic psychiatrists has seemingly been silent. Why?
It is easy—perhaps too easy—to blame the FDA for inefficient regulation, but at least the agency has finally acted. This is in stark contrast to the many professional societies and representative bodies made up of physicians who study ADHD or who treat affected patients, from which we have seen no public objections. Certainly, a public outcry from prominent academic psychiatrists could have influenced the FDA to act sooner. Is it possible that the flow of money from the pharmaceutical companies to influential academic psychiatrists (a situation now being investigated by Congress)14 has brought with it a certain willingness to remain silent?
Intriguingly, a recent federally funded, controlled long-term study found the clinical utility of psychostimulants to be limited,15 and recent evidence-based treatment guidelines in the United Kingdom now recommend their prescription only for children with the most severe behaviors.16 A recent study found that stimulants are prescribed at a rate 3 times higher for children in the United States than for their counterparts in Germany and the Netherlands.17 According to the researchers, DTCA is one likely reason for the higher rate of drug use in the United States. Obviously, advertisements that exaggerate the efficacy of stimulants are intended to increase sales, and therefore, the rate at which we medicate our children.
Children with behavioral disorders are a vulnerable population. Certainly, their welfare—and the science behind our efforts to help—should come before commercial interests. The policies, practices, and advocacy of the medical profession should clearly demonstrate a preference for evidence-based information over commercial advertising.
1. Mintzes B. Disease mongering in drug promotion: do governments have a regulatory role? PloS Med. 2006;3:e198. http://medicine.plosjournals.org/ archive/1549-1676/3/4/pdf/10.1371_journal. pmed.0030198-L.pdf. Accessed January 21, 2009.
2. Morgan S. Direct-to-consumer advertising and expenditure on prescription drugs: a comparison of experiences in the United States and Canada. Open Med. 2007;1:1. http://www.openmedicine.ca/article/view/23/26. Accessed January 21, 2009.
3. Lacasse JR, Leo J. Letter to T. Abrams, Director, Food and Drug Administration Division of Drug Marketing, Advertising, and Communications. http://www.public.asu.edu/~jlacass1/3_To_FDA_Sep_2005.pdf. Accessed January 26, 2009.
4. Food and Drug Administration. 21 CFR 202 Guidance for Industry: Consumer-Directed Broadcast Advertisements. Washington, DC: Food and Drug Administration; 1997.
5. Murphy JC. Letter to J Lacasse and J Leo: Promotional materials for Adderall XR® CII Capsules. http://www.public.asu.edu/~jlacass1/5_FDA_Response_Sep_2005.pdf. Accessed January 26, 2009.
6. Food and Drug Administration, Division of Drug Marketing, Advertising and Communications September 2008. [Warning letters issued to 5 manufacturers of psychostimulants]. http://www.accessdata.fda.gov/scripts/wlcfm/date.cfm?MONTH=9&YEAR=2008. Accessed January 26, 2009.
7. American Academy of Pediatrics. Clinical practice guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics. 2001;108:1033-1044. http://aappolicy.aappublications.org/cgi/reprint/pediatrics;108/4/1033. Accessed January 21, 2009.
8. Shire Pharmaceticals. Adderall XR™ Prescribing Information. http://www.fda.gov/cder/foi/label/2004/ 021303s005lbl.pdf. Accessed January 21, 2009.
9. Shire Pharmaceuticals. Direct-to-consumer advertisement for Adderall XR™ [published in People magazine, August 22, 2005]. http://www.public.asu.edu/~jlacass1/Adderall_advertisement_2005.jpg. Accessed January 26, 2009. [see also http://www.public.asu.edu/~jlacass1/Adderall_advertisement_2_2005.pdf.]
10. Leo J, Lacasse JR. Consumer advertisements for ADHD. In: Timimi S, Leo J, eds. Rethinking ADHD: From Brain to Culture. New York: Palgrave Macmillan.In press.
11. Lacasse JR, Leo J.. Letter to G Flexter, Executive Vice-President and General Manager, North America, Shire Pharmaceuticals. http://www.public.asu.edu/~jlacass1/11_To_Shire_9_2005.pdf. Accessed January 26, 2009.
12. Casby J. Letter to J Lacasse and J Leo: Adderall XR™ Consumer Advertisements. http://www.public.asu.edu/~jlacass1/12_Shire_Response.pdf. Accessed January 26, 2009.
13. Food and Drug Administration. Warning Letter to Shire Pharmaceuticals. http://www.fda.gov/cder/ warn/2008/AdderallXR_Letter.pdf. Accessed January 26, 2009.
14. Harris G, Carey B. Researchers fail to reveal full drug pay. New York Times. June 8, 2008. http://www.nytimes.com/2008/06/08/us/08conflict.html?fta=y. Accessed January 26, 2009.
15. Jensen PS, Arnold LE, Swanson JM, et al. 3-year follow-up of the NIMH-MTA study. J Am Acad Child Adolesc Psychiatry. 2007;46:989-1002.
16. National Institute for Health and Clinical Excellence. Attention deficit hyperactivity disorder: diagnosis and management of ADHD in children, young people and adults. http://www.nice.org.uk/guidance/index.jsp?action=byID&o=12061. Accessed January 26, 2009.
17. Zito JM, Safer DJ, Berg LT, et al. A three-country comparison of psychotropic medication prevalence in youth. Child Adolesc Psychiatry Ment Health. 2008;2:26. http://www.capmh.com/content/pdf/ 1753-2000-2-26.pdf. Accessed January 21, 2009.