Skip to main content
SpringerLink
Log in
Book cover

Uncertainty in Pharmacology pp 451–470Cite as

Sex, Drugs, and How to Deal with Criticism: The Case of Flibanserin

  • Chapter
  • First Online:

Part of the book series: Boston Studies in the Philosophy and History of Science ((BSPS,volume 338))

Abstract

In 2015, the US Food and Drug Administration made the controversial decision to approve flibanserin as the first drug against problems of low female sexual desire. This approval has encountered many criticisms; in particular, it has been condemned as an exemplary instance of medicalization and disease-mongering, as lacking sufficient evidential support, and as targeting a highly problematic diagnosis (Hypoactive Sexual Desire Disorder). In this paper, we review these complaints and show that many of the issues in the flibanserin case stem from a failure to properly deal with criticism. We argue that a principle of uptake of criticism can help preventing bias in research and drug regulation and can be secured by institutional measures.

This is a preview of subscription content, log in via an institution.

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   119.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD   159.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD   159.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

Notes

  1. 1.

    Nevertheless, it is highly unlikely that HSDD is a purely biological problem and its evaluation as harmful and treatworthy unaffected by commercial interests as well as value-laden assumptions about what “normal” female sexuality looks like, or should look like (cf. also Sect. 20.3 on the definition of HSDD as a diagnostic category).

  2. 2.

    Sexual intercourse, oral sex, masturbation, and genital stimulation by the partner counted as sexual events.

  3. 3.

    We thank an anonymous reviewer for pointing this out.

  4. 4.

    We thank an anonymous reviewer for pointing this out.

  5. 5.

    Two of the authors worked as consultants for Pfizer and other pharma companies; the conflicts of interest were “inadvertently omitted” in the original paper, but disclosed later on.

  6. 6.

    In contrast to the heavy industry links of a lot of other works on HSDD, the DSM-5 adopted a policy that not only made conflicts of interests transparent but also limited them (APA 2008).

  7. 7.

    We see an additional issue regarding the uptake of criticism here, namely, how the FDA deals with dissent inside it’s committees and boards. However, it is beyond the scope of this paper to analyze this in more detail.

References

  • American Psychiatric Association (APA). (1994). Diagnostic and statistical manual of mental disorders (DSM-IV) (4th ed.). Washington, DC: APA.

    Google Scholar 

  • APA. (2008). Principles for DSM-5 Task Force and Work Group Members. http://web.archive.org/web/20120404114422/http://www.psych.org/MainMenu/Research/DSMIV/DSMV/BOTPrinciples.aspx. Assessed 8 Aug 2016.

  • APA. (2013). Diagnostic and statistical manual of mental disorders (DSM-5) (5th ed.). Washington, DC: APA.

    Google Scholar 

  • Balon, R., & Clayton, A. H. (2014). Female sexual interest/arousal disorder: A diagnosis out of thin air. Archives of Sexual Behavior, 43, 1227–1229.

    Article  Google Scholar 

  • Basson, R. (2000). The female sexual response: A different model. Journal of Sex and Marital Therapy, 26, 51–64.

    Article  Google Scholar 

  • Boehringer Pulls the Plug on “Pink Viagra”. (2010, October 8). https://www.reuters.com/article/us-boehringer-flibanserin/boehringer-pulls-the-plug-on-pink-viagra-idUSTRE6970TN20101008. Accessed 13 Sept 2017.

  • Bradford, A. (2012). Listening to placebo in clinical trials for female sexual dysfunction. The Journal of Sexual Medicine, 10, 451–459.

    Article  Google Scholar 

  • Brotto, L. A. (2010). The DSM diagnostic criteria for hypoactive sexual desire disorder in women. Archives of Sexual Behavior, 39, 221–239.

    Article  Google Scholar 

  • Brotto, L. A., et al. (2011). Should sexual desire and arousal disorders in women be merged? A response to DeRogatis, Clayton, Rosen, Sand, and Pyke (2010). Archives of Sexual Behavior, 40, 221–225.

    Article  Google Scholar 

  • Brotto, L. (2015). Flibanserin. Archives of Sexual Behavior, 44(8), 2103–2105.

    Google Scholar 

  • Bueter, A. (2017). Androcentrism, feminism, and pluralism in medicine. Topoi, 36, 521–530.

    Article  Google Scholar 

  • Clayton, A. H. (2010). The pathophysiology of hypoactive sexual desire disorder in women. International Journal of Gynecology & Obstetrics, 110, 7–11.

    Article  Google Scholar 

  • De Angelis, C., Drazen, J., Frizelle, F., Haug, C., Hoey, J., Horton, R., Kotzin, S., Laine, C., Marusic, A., Overbeke, A., Schroeder, T., Sox, H., & Van Der Weyden, M. (2004). Clinical trial registration. A statement from the International Committee of Medical Journal Editors. New England Journal of Medicine, 35, 1250–1251.

    Article  Google Scholar 

  • DeRogatis, L. R., et al. (2011). Should sexual desire and arousal disorders in women be merged? Archives of Sexual Behavior, 40, 217–219.

    Article  Google Scholar 

  • DeRogatis, L., Komer, L., Katz, M., & et al. VIOLET Trial investigators. (2012). Treatment of hypoactive sexual desire disorder in premenopausal women: Efficacy of flibanserin in the VIOLET study. The Journal of Sexual Medicine, 9(4), 1074–1085.

    Article  Google Scholar 

  • Dreifus, C. (Ed.). (1978). Seizing our bodies: The politics of women’s health. New York: Vintage Books.

    Google Scholar 

  • Ehrenreich, B., & English, D. (1978). For her own good: 150 years of the experts’ advice to women. New York: Anchor Books.

    Google Scholar 

  • FDA briefing document. (2015). http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM449088.pdf FDA. Accessed 5 June 2016.

  • Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women with Hypoactive Sexual Desire Disorder. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00996164. Accessed 4 Aug 2016.

  • Forbes, M., Baillie, A., & Schniering, C. (2014). Critical flaws in the female sexual dysfunction index and the international index of erectile dysfunction. The Journal of Sexual Research, 57, 485–491.

    Article  Google Scholar 

  • Frühauf, S., et al. (2013). Efficacy of psychological interventions for sexual dysfunction: A systematic review and meta-analysis. Archives of Sexual Behavior, 42, 915–933.

    Article  Google Scholar 

  • Gellad, W., Flynn, K., & Alexander, G. (2015). Evaluation of Flibanserin. Science and advocacy at the FDA. JAMA, 314(9), 869–870.

    Article  Google Scholar 

  • Graham, C. A. (2010). The DSM diagnostic criteria for female sexual arousal disorder. Archives of Sexual Behavior, 39, 240–255.

    Article  Google Scholar 

  • Graham, C. A., Brotto, L. A., & Zucker, K. J. (2014). Response to Balon and Clayton (2014): Female sexual interest/arousal disorder is a diagnosis more on firm ground than thin air. Archives of Sexual Behavior, 43, 1231–1234.

    Article  Google Scholar 

  • Howick, J. (2011). Philosophy of evidence-based medicine. Oxford: BMJ Books/Wiley-Blackwell.

    Book  Google Scholar 

  • Jaspers, L., Feys, F., Bramer, W., Franco, O., Leusink, P., & Laan, E. (2016). Efficacy and safety of Flibanserin for the treatment of hypoactive sexual desire disorder in women. A systematic review and meta-analysis. JAMA Internal Medicine, 176(4), 453–562.

    Article  Google Scholar 

  • Joffe, H. (2015). Division director review. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022526Orig1s000SumRedt.pdf. Accessed 6 June 2016.

  • Jutel, A. (2010). Framing disease: The example of female hypoactive sexual desire disorder. Social Science & Medicine, 70, 1084–1090.

    Article  Google Scholar 

  • Katz, M., Derogatis, L., Ackerman, R., & et al. Begonia Trial Investigators. (2013). Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial. The Journal of Sexual Research, 10(7), 1807–1815.

    Article  Google Scholar 

  • Laumann, E. O., Paik, A., & Rosen, R. C. (1999). Sexual dysfunction in the United States: Prevalence and predictors. JAMA, 281, 537–544.

    Article  Google Scholar 

  • Longino, H. (1990). Science as social knowledge: Values and objectivity in scientific inquiry. Princeton: Princeton University Press.

    Google Scholar 

  • Lundh, A., Lexchin, J., Mintzes, B., Schroll, J. B., & Bero, L. (2017). Industry sponsorship and research outcome. Cochrane Database of Systematic Reviews, 2, MR000033. https://doi.org/10.1002/14651858.MR000033.pub3.

    Article  Google Scholar 

  • Masters, W. H., & Johnson, V. E. (1966). Human sexual response. Boston: Little, Brown.

    Google Scholar 

  • McCabe, M. P., & Goldhammer, D. L. (2013). Prevalence of women’s sexual desire problems: What criteria do we use? Archives of Sexual Behavior, 42, 1073–1078.

    Article  Google Scholar 

  • McClimans, L. (2013). The role of measurement in establishing evidence. The Journal of Medicine and Philosophy, 38(5), 520–538.

    Article  Google Scholar 

  • McClimans, L., & Browne, J. (2011). Choosing a patient-reported outcome measure. Theoretical Medicine and Bioethics, 32, 47–60.

    Article  Google Scholar 

  • Meixel, A., Yanchar, E., & Fugh-Berman, A. (2016). Hypoactive sexual desire disorder: Inventing a disease to sell low libido. Journal of Medical Ethics, 41, 859–862.

    Article  Google Scholar 

  • Merton, R. K. (1942). The sociology of science: Theoretical and empirical investigations. Chicago: University of Chicago Press.

    Google Scholar 

  • Moynihan, R. (2005). The marketing of a disease: Female sexual dysfunction. British Medical Journal, 330, 192–194.

    Article  Google Scholar 

  • Moynihan, R., & Mintzes, B. (2010). Sex, lies, + pharmaceuticals: How drug companies plan to profit from female sexual dysfunction. Vancouver: Greystone Books.

    Google Scholar 

  • Park, K., Goldstein, I., Andry, C., Siroky, M. B., Krane, R. J., et al. (1997). Vasculogenic female sexual dysfunction: The hemodynamic basis for vaginal engorgement insufficiency and clitoral erectile insufficiency. International Journal of Impotence Research, 9, 27–38.

    Article  Google Scholar 

  • Payer, L. (1992). Disease-mongers: How doctors, drug companies, and insurers are making you feel sick. New York: Wiley.

    Google Scholar 

  • Popper, K. R. (1959). The logic of scientific discovery. London: Routledge.

    Google Scholar 

  • Shifren, J. L., et al. (2008). Sexual problems and distress in United States women: Prevalence and correlates. Obstetrics & Gynecology, 112, 970–978.

    Article  Google Scholar 

  • Simon, J., et al. (2005). Testosterone patch increases sexual activity and desire in surgically menopausal women with hypoactive sexual desire disorder. The Journal of Clinical Endocrinology & Metabolism, 90, 5226–5233.

    Article  Google Scholar 

  • Sismondo, S. (2008). How pharmaceutical industry funding affects trial outcomes: Causal structures and responses. Social Science & Medicine, 66(9), 1909–1914.

    Article  Google Scholar 

  • Sismondo, S., & Doucet, M. (2010). Publication ethics and the ghost management of medical publications. Bioethics, 24(6), 273–283.

    Article  Google Scholar 

  • Stegenga, J. (2015). Measuring effectiveness. Studies in History and Philosophy of Biological and Biomedical Sciences., 54, 62–71.

    Article  Google Scholar 

  • Tavernise, S (2016) ‘Female Viagra’ Only Modestly increase sexual satisfaction, study finds. The New York Times. February 29.

    Google Scholar 

  • Thorp, J., Simon, J., Dattani, D., & et al. DAISY Trial Investigators. (2012). Treatment of hypoactive sexual desire disorder in premenopausal women: Efficacy of flibanserin in the DAISY study. Journal of Sexual Medicine, 9(3), 793–804.

    Article  Google Scholar 

  • Tiefer, L. (2006). Female sexual dysfunction: A case study of disease mongering and activist resistance. PLoS Medicine, 3, e178.

    Article  Google Scholar 

  • Wilholt, T. (2006). Design rules: Industrial research and epistemic merit. Philosophy of Science, 73(1), 66–89.

    Article  Google Scholar 

  • Woloshin, S., Schwartz, L. M., Frankel, B., & Faerber, A. (2014). US food and drug administration and design of drug approval studies. JAMA, 312, 2163–2165.

    Article  Google Scholar 

  • Woloshin, S., & Schwartz, L. M. (2016). US food and drug administration approval of flibanserin: Even the score does not add up. JAMA Internal Medicine, 176, 439–442.

    Article  Google Scholar 

  • Young, N., Ioannidis, J., & Al-Ubaydli, O. (2008). Why current publication practices may distort science. PLoS Medicine, 5(10), e201. https://doi.org/10.1371/journal.pmed.0050201.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Leibniz University Hannover, Hannover, Germany

    Anke Bueter

  2. Bielefeld University, Bielefeld, Germany

    Saana Jukola

Authors
  1. Anke Bueter
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Saana Jukola
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Anke Bueter .

Editor information

Editors and Affiliations

  1. School of Pharmacy, The University of Queensland, St Lucia, QLD, Australia

    Adam LaCaze

  2. Department of Biomedical Sciences and Public Health, Polytechnic University of the Marche, Ancona, Italy, Munich Center for Mathematical Philosophy, Munchen, LMU, Munich, Germany

    Barbara Osimani

Rights and permissions

Reprints and permissions

Copyright information

© 2020 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Bueter, A., Jukola, S. (2020). Sex, Drugs, and How to Deal with Criticism: The Case of Flibanserin. In: LaCaze, A., Osimani, B. (eds) Uncertainty in Pharmacology. Boston Studies in the Philosophy and History of Science, vol 338. Springer, Cham. https://doi.org/10.1007/978-3-030-29179-2_20

Download citation

Publish with us

Policies and ethics

Search

Navigation