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Pharmacoeconomics and clinical trials in multiple sclerosis: baseline data from the European Union

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Abstract

Aim

One of the contemporary debates between science and economics is concerned with why, and to what extent, financial cost and economic efficiency considerations affect scientific inquiry into possible solutions to human illnesses. This study inquires into clinical drug trials for multiple sclerosis (MS) in the European Union to determine the validity of a prevailing claim, advanced in the medical community, that the clinical efficacy of these drugs is undermined by cost and efficiency considerations.

Subjects and methods

The first part of the study is devoted to a review of pharmacoeconomic literature (2000–2012) on clinical drug testing for MS, particularly in the member countries of the European Union. The second part presents survey results of discontinued clinical trials that we gathered from European Union registries.

Results

The study finds that cost and efficiency considerations exist in a limited number of trials in the European Union. Specifically, about 1/5 of MS drugs do not reach the pharmaceutical markets even if there may be some supporting efficacy data, or negative safety data is absent, during testing/experimentation. Their direct and controlling impact on decisions to withdraw suspend or prematurely terminate (as well as initiate) clinical testing and efficacy data collection for MS does not appear to be consistent. However, these could extend prevailing theoretical debates about the proper scope of clinical drug efficacy in MS.

Conclusion

The study suggests that pharmacoeconomic approaches to clinical efficacy help broaden and enhance our understanding and choices of disease management options for MS sufferers, their families and health care providers in the European Union and elsewhere. Finally, there is some empirical evidence to indicate an inverse relationship between transaction costs and drug marketability: The higher the transaction costs of clinical testing, the lower is the drug's potential for funding and eventual marketing

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References

  • Baumhackl U, Kappos L, Radue EW, Freitag P, Guseo A, Daumer M, Mertin J (2005) A randomized, double-blind, placebo controlled study of oral hydrolytic enzymes in relapsing multiple sclerosis. Mult Scler 11:166–168

    Article  CAS  PubMed  Google Scholar 

  • Bryant J, Clegg A, Milne R (2001) Systematic review of immunomodulatory drugs for the treatment of people with multiple sclerosis: is there good quality evidence on effectiveness and cost? J Neurol Neurosurg Psychiatry 70:574–579

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  • CAMMS223 Trial Investigators, Coles AJ, Compston DA, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK (2008) Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med 359:1786–1801

    Article  PubMed  Google Scholar 

  • Chilcott J, McCabe C, Tappenden P, O’Hagan A, Cooper NJ, Abrams K, Claxton K (2003) Modelling the cost effectiveness of interferon beta and glatiramer acetate in the management of multiple sclerosis. BMC 326:522–526

    Article  Google Scholar 

  • Coase R (1937) The nature of the firm. Economica 4:386–405

    Article  Google Scholar 

  • Couzin J (2005) Drug discovery: magnificent obsession. Science 307:1712–1715

    Article  CAS  PubMed  Google Scholar 

  • Curtiss FR (2007) Pharmacoeconomic modeling of drug therapies for multiple sclerosis: are we building houses on sand? J Manag Care Pharm 13:245–261

    Google Scholar 

  • Dahlman CJ (1979) The problem of externality. J Law Econ 21:141–162

    Article  Google Scholar 

  • European Union Clinical Trials Register, https://www.clinicaltrialsregister.eu/ctr-search/search?query=multiple+sclerosis. Accessed February 24, 2012

  • Fuller GN, Bone I (2001) Disease modifying treatment in multiple sclerosis. J Neurol Neurosurg Psychiatry 71:i20–ii21

    Google Scholar 

  • Hauser S (1994) Multiple sclerosis and other demyelinating diseases. In: Isselbacher KJ, Martin JB, Fauci AS (eds) Harrison’s principles of internal medicine. McGraw-Hill, New York, pp 2287–2295

    Google Scholar 

  • Holmoy T, Celius EG (2008) Cost-effectiveness of natalizumab in multiple sclerosis. Expert Rev Pharm Outcomes Res 8:11–21

    Article  Google Scholar 

  • Kendrick M, Johnson KI (2000) Long-term treatment of multiple sclerosis with interferon may be cost effective. PharmacoEconomics 18:45–53

    Article  CAS  PubMed  Google Scholar 

  • Kleinschnitz C, Meuth SG, Wiendl H (2008) The trials and errors in MS therapy. Int MS J 15:79–90

    PubMed  Google Scholar 

  • MacLean HJ, Freedman MS (2001) Immunologic therapy for relapsing-remitting multiple sclerosis. Curr Neurol Neurosci Rep 1:277–285

    Article  CAS  PubMed  Google Scholar 

  • Maggon K (2010) Daclizumab (Biogen, Abbott) Review: multiple sclerosis. http://knol.google.com/k/daclizumab-biogen-abbott-review-multiple-sclerosis#Clinical_trials. Accessed July 11, 2011

  • National Institute of Neurological Disorders and Stroke (NINDS) Multiple sclerosis information page. http://www.ninds.nih.gov/disorders/multiple_sclerosis/multiple_sclerosis.htm. Accessed May 13, 2007

  • O’Connor PS, Goodman AD, Kappos L, Lublin FD, Miller DH, Polman CH, Rudick RA, Forrestal F, Jurgensen S, Panzara MA, Sandrock AW (2009) Return of disease activity after cessation of natalizumab. Mult Scler 15:S240

    Google Scholar 

  • Pugliatti M, Rosati G, Carton H, Riise T, Drulovic J, Vecsei L, Milanov I (2006) The epidemiology of multiple sclerosis in Europe. Eur J Neurol 13:700–722

    Article  CAS  PubMed  Google Scholar 

  • Ryan M (2008) Multiple sclerosis. In: Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM (eds) Pharmacotherapy a pathophysiologic approach. McGraw Hill, New York, pp 431–441

    Google Scholar 

  • Sorensen PS, Mellgren SI, Svenningsson A, Elovaara I, Frederiksen JL, Beiske AG, Myhr KM, Søgaard LV, Olsen IC, Sandberg-Wollheim M (2009) NORdic trial of oral Methylprednisolone as add-on therapy to Interferon beta-1a for treatment of relapsing-remitting multiple sclerosis (NORMIMS study): a randomised, placebo-controlled trial. Lancet Neurol 8:519–529

    Article  CAS  PubMed  Google Scholar 

  • Tan IL, Lycklama à Nijeholt GJ, Polman CH, Adèr HJ, Barkhof F (2000) Linomide in the treatment of multiple sclerosis: MRI results from prematurely terminated phase-III trials. Mult Scler 6:99–104

    Article  PubMed  Google Scholar 

  • Weinshenker BG, Noseworthy JH (2001) Multiple sclerosis: study design, sample sizes and pitfalls. In: Guiloff RJ (ed) Clinical trials in neurology. Springer, London, pp 371–386

    Chapter  Google Scholar 

  • Wiendl H, Hohlfeld R (2002) Therapeutic approaches in multiple sclerosis: lessons from failed and interrupted treatment trials. BioDrugs 16:183–200

    Article  CAS  PubMed  Google Scholar 

  • Wiendl H, Neuhaus O, Kappos L, Hohlfeld R (2000) Multiple sclerosis: current review of failed and discontinued clinical trials of drug treatment. Nervenarzt 71:597–610

    Article  CAS  PubMed  Google Scholar 

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Correspondence to Roger Lee Mendoza.

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Mendoza, R.L. Pharmacoeconomics and clinical trials in multiple sclerosis: baseline data from the European Union. J Public Health 22, 211–218 (2014). https://doi.org/10.1007/s10389-013-0561-z

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