Manufacturing Consensus
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Abstract
The Food and Drug Administration (FDA) has declared that it would be illegal to advertise as or in any way claim your drug to be superior to competitors on the market, which are up to 30 times cheaper. How does a pharmaceutical company market such a product? The answer is to enlist academics to form expert panels to construct guidelines and algorithms, or participate in Delphi panels and other exercises, which can be expected to prove that newer, more costly drugs produce cost savings. These academics do so on the basis of the existing clinical trial evidence—which supposedly the FDA has used to come to its verdict that the newer compound is no better than its competitors. However, where the FDA has seen the raw data, academics later see the published data. In between intervenes a medical writing exercise, which produces the first and most important piece of advertising for any pharmaceutical product—the randomized controlled trial infomercial. This paper explores how pharmaceutical companies manufacture an apparent academic consensus and, in so doing, gives a case study of the recent controversies surrounding the marketing of selective serotonin reuptake inhibitor (SSRI) drugs for adolescent depression.
Keywords
adolescent depression FDA manufacturing consensus pharmaceutical marketing SSRIReferences
- Alderman J., Wolkow R., Chung M., Johnston H.F. (1998) Sertraline Treatment of Children and Adolescents with OCD or Depression: Pharmacokinetics, Tolerability, and Efficacy. Journal of the American Academy of Child and Adolescent Psychiatry 37:386–394CrossRefGoogle Scholar
- Ambrosini P.J., Wagner K.D., Biederman J., Glick I., Tan C., Elia J., Hebeler J.R., Rabinovitch H., Lock J., Geller D. (1999) Multicenter Open Label Sertraline Study in Adolescent Outpatients with Major Depression. Journal of the American Academy of Child and Adolescent Psychiatry 38:566–572CrossRefGoogle Scholar
- Applbaum Kalman (2004) The Marketing Era. Routledge, New YorkGoogle Scholar
- Carpenter, D.J., G.J. Emslie, B. Birmaher et al. 2001 Safety of Paroxetine in the Treatment of Children and Adolescents with OCD. Presented at the 40th annual NCDEU meeting, abstract 58Google Scholar
- Chiles J.A., Miller A.L., Crismon M.L. et al. (1999) The Texas Medication Algorithm Project: Development and Implementation of the Schizophrenia Algorithm. Psychiatric Services 50:69–74Google Scholar
- Eccleston, D. 1993 The Economic Evaluation of Antidepressant Drug Therapy. British Journal of Psychiatry 163: Supplement 20.Google Scholar
- Emslie G.J., Heligenstein J.H., Wagner K.D., Hoog S.L., Ernest D.E., Brown E., Nilsson M., Jacobson J.G. (2002) Fluoxetine for Acute Treatment in Children and Adolescents: A Placebo-Controlled Randomized Clinical Trial. Journal of the American Academy of Child and Adolescent Psychiatry 41:1205–1215CrossRefGoogle Scholar
- Emslie, G., J.J. Mann, W. Beardslee, J. Fawcett, A. Leon, H. Meltzer, F. Goodwin, D. Shaffer, K. Wagner, and N. Ryan 2004 ACNP. Preliminary Report of the Task Force on SSRIs and Suicidal Behavior in Youth. January 21.Google Scholar
- Emslie G.J., Rush A.J., Weinberg A.W., Kowatch R.A., Hughes C.W., Carmody T. (1997) A Double-Blind, Randomized Placebo Controlled Trial of Fluoxetine in Depressed Children and Adolescents. Archives of General Psychiatry 54:1031–1037Google Scholar
- Flanagin A., Carey L.A., Fontanarosa P.B., Phillips S.G., Pace B.P., Lundberg G.D., Rennie D. (1998) Prevalence of Articles with Honorary Authors and Ghost Authors in Peer-Reviewed Medical Journals. Journal of the American Medical Association 280:222–224CrossRefGoogle Scholar
- Garland E. Jane (2004) Facing the Evidence: Antidepressant Treatment in Children and Adolescents. Canadian Medical Association Journal 170:489–491CrossRefGoogle Scholar
- Geller, D.A., K.D. Wagner, G.J. Emslie, T. Murphy, D. Gallagher, C. Gardiner, and D.J. Carpenter 2002 Efficacy and Safety of Paroxetine in Pediatric OCD: Results of a Double-Blind Placebo Controlled Trial. Presented at the 42nd Annual NCDEU Meeting, Session III–16. (Also presented at the APA annual meeting, Philadelphia, May 2002, NR 349.)Google Scholar
- Gilbert D.A., Altshuler K.Z., Rego W.V., Shon S.P., Crismon M.L., Toprac M.G., Rush A.J. (1998) Texas Medication Algorithm Project: Definitions, Rationale, and Methods to Develop Medication Algorithms. Journal of Clinical Psychiatry 59:345–351Google Scholar
- Guest J.F., Hart W.M., Cookson R.F., Lindstrom E. (1996) Pharmacoeconomic Evaluation of Long-Term Treatment with Risperidone for Patients with Chronic Schizophrenia. British Journal of Medical Economics 10:59–67Google Scholar
- Healy David (1998) The Antidepressant Era. Harvard University Press, Cambridge, MAGoogle Scholar
- Healy David (2003a) Let Them Eat Prozac. Lorimer, Toronto (Linked Web site: ttp://www.healyprozac.com)Google Scholar
- Healy David (2003b) Lines of Evidence on SSRIs and Risk of Suicide. Psychotherapy and Psychosomatics 72:71–79CrossRefGoogle Scholar
- Healy David (2004) Shaping the Intimate. Influences on the Experience of Everyday Nerves. Social Studies of Science 34: 219–245Google Scholar
- Healy David, Cattell Dinah (2003) The Interface between Authorship, Industry and Science in the Domain of Therapeutics. British Journal of Psychiatry 182:22–27CrossRefGoogle Scholar
- Healy David, Nutt DavidJ. (1998) British Association for Psychopharmacology Consensus on Statement on Childhood and Learning Disabilities Psychopharmacology. Journal of Psychopharmacology 11:291–294Google Scholar
- Herxheimer Andrew, Mintzes Barbara (2004) Antidepressants and Adverse Effects in Young Patients: Uncovering the Evidence. Canadian Medical Association Journal 170:487–489CrossRefGoogle Scholar
- Hughes C.W. (1999) The Texas Children’s Medication Algorithm Project: Report of the Texas Consensus Conference Panel on Medication Treatment of Childhood Major Depressive Disorder. Journal of the American Academy of Child and Adolescent Psychiatry 38:1442–1454CrossRefGoogle Scholar
- Keller M.D., Ryan N.D., Strober M., Klein R.G., Kutcher S.P., Birmaher B., Hagino O.R., Koplewicz H., Carlsson G.A., Clarke G.N., Emslie G.J., Feinberg D., Geller B., Kusumakar V., Papatheodorou G., Sack W.H., Sweeney M., Wagner K.D., Weller E., Winters N.C., Oakes R., McCafferty J.P. (2001) Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial. Journal of the American Academy of Child and Adolescent Psychiatry 40:762–772CrossRefGoogle Scholar
- Khan Arif, Khan Shirin R., Leventhal Robyn, Brown Walter A. (2001) Symptom Reduction and Suicide Risk in Patients Treated with Placebo in Antipsychotic Clinical Trials. American Journal of Psychiatry 158:1449–1454CrossRefGoogle Scholar
- Kuslak, V. 2003 Letter to Physicians. Wyeth Pharmaceuticals, August 22. Available at: http://www.rphlink.com/wyethpharmaceuticals.html
- Mandoki M.W., Tapla M.R., Tapla M.A., Sumner G.S., Parker J.L. (1997) Venlafaxine in the Treatment of Children and Adolescents with Major Depression. Psychopharmacology Bulletin 33:149–154Google Scholar
- March J.S., Biederman J., Wolkow R., Safferman A., Mardekian J., Cook E.H., Cutler N.R., Dominguez R., Ferguson J., Muller B., Riesenberg R., Rosenthal M., Sallee F.R., Wagner K.D., Steiner H. (1998) Sertraline in Children and Adolescents with OCD: A Multicenter Randomized Controlled Trial. Journal of the American Medical Association 280:1752–1758CrossRefGoogle Scholar
- Mortimer, A., D. Healy, R. Gray, R. Peveler, P. Pratt, T. Sharma, and T. Turner 1998 Consensus Statement on Schizophrenia Standards in Care for Maintenance Therapy and Poorly Responding/Treatment Intolerant Patients. CINP meeting, Glasgow. International Journal of Neuropsychopharmacology 1:Abstracts Supplement.Google Scholar
- Mosholder, Andrew 1993 Review and Evaluation of Clinical Data. Application NDA 20–272, 11 May. (Cited in J. Whitaker and R. Whitaker 2002. Mad in America. Boston: Perseus: 277).Google Scholar
- National Institute for Clinical Excellence (NICE) 2002 Guidance on the Use of Newer (Atypical) Antipsychotic Drugs for the Treatment of Schizophrenia. Technology Appraisal Guidance 43, June. Available at: http://www.nice.org.uk.
- Newsweek 2002 Depression. 3 Million Kids Suffer From It. What You Can Do. Newsweek, October 7:52–61.Google Scholar
- Petersen, Melody 2004 Making Drugs, Shaping the Rules. Big Pharma Is Eager to Help States Set Medication Guidelines. New York Times, February 1:3–1, 3–10.Google Scholar
- Rosenheck R., Perlick D., Bingham S., Mares W.L., Collins J., Warren S., Leslie D., Allan E., Campbell C., Caroff S., Corwin J., Davis L., Douyon R., Dunn L., Evans D., Frecska E., Grabowski J., Graeber D., Herz L., Kong K., Lawson W., Mena F., Sheikh J., Smelson D., Smith-Gamble V. (2003) Effectiveness and Cost of Olanzapine and Haloperidol in the Treatment of Schizophrenia. A Randomized Controlled Trial. Journal of the American Medical Association 290:2693–2702CrossRefGoogle Scholar
- Sharav Vera Hassner (2003) The Impact of FDA Modernization Act on the Recruitment of Children for Research. Ethical Human Sciences and Services: An International Journal of Critical Inquiry 5:83–108Google Scholar
- Sheldon T.A. and Smith G.D. (1993) Consensus Conferences as Drug Promotion. Lancet 341:100–102CrossRefGoogle Scholar
- Wagner K.D., Ambrosini P., Rynn M., Wohlberg C., Yang R., Greenbaum M.S., Childress A., Donnelly C. and Deas D. (2003) Efficacy of Sertraline in the Treatment of Children and Adolescents with Major Depressive Disorder: Two Randomized Controlled Trials. Journal of the American Medical Association 290:1033–1041CrossRefGoogle Scholar
- Wagner, K.D., E. Wetherhold, D.J. Carpenter, S. Krulewicz, and A. Bailey 2002 Safety and Tolerability of Paroxetine in Children and Adolescents: Pooled Results from Four Multi-center Placebo Controlled Trials. Presented at the 42nd Annual NCDEU Meeting, Session II–61.Google Scholar
- Walkup J.T., Labellarte M.J., Riddle M.A., Pine D.S., Greenhill L., Klein R., Davies M., Sweeney M., Fu C., Abikoff H., Hack S., Klee B., McCracken J., Bergman L., Piacentini J., March J., Compton S., Robinson J., O’Hara T., Baker S., Vitiello B., Ritz L. and Roper M. (2001). Fluvoxamine for the Treatment of Anxiety Disorders in Children and Adolescents. New England Journal of Medicine 344:1279–1285CrossRefGoogle Scholar
- World Health Organization 2003 Technology Appraisal Programme of the National Institute for Clinical Excellence. Geneva: WHO. Available at: http://www.nice.org.uk.