Skip to main content
SpringerLink
Log in

EMA’s reflection on placebo does not reflect patients’ interests

  • Point of View
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

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

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  1. Committee for Medicinal Products for Human Use (2011) Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available. EMA/759784/2010. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/01/WC500100710.pdf. Accessed 17 May 2011

  2. Garattini S, Bertele’ V (2007) Non-inferiority trials are unethical because they disregard patients’ interests. Lancet 370(9602):1875–1877. doi:10.1016/S0140-6736(07)61604-3

    Article  PubMed  Google Scholar 

  3. World Medical Association (1964–2008) (2008) The Declaration of Helsinki. Available at: http://www.wma.net/en/30publications/10policies/b3/. Accessed 18 July 2011

  4. DHHS Food and Drug Administration. 21 CFR part 312 (2008) Human subject protection; foreign clinical studies not conducted under an investigational new drug application. Final rule 28 April 2008, effective, October 27 2008. Available at: http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=0900006480537f08. Accessed 18 July 2011

  5. Barbui C, Cipriani A, Lintas C, Bertele’ V, Garattini S (2007) CNS drugs approved by the centralised European procedure: true innovation or dangerous stagnation? Psychopharmacology (Berl) 190(2):265–268. doi:10.1007/s00213-006-0629-3

    Article  CAS  Google Scholar 

  6. Garattini S, Bertele’ V (2002) Efficacy, safety, and cost of new anticancer drugs. Br Med J 325(7358):269–271

    Article  Google Scholar 

  7. Joppi R, Bertele’ V, Garattini S (2005) Disappointing biotech. Br Med J 331(7521):895–897. doi:10.1136/bmj.331.7521.895

    Article  Google Scholar 

  8. Motola D, De Ponti F, Poluzzi E, Martini N, Rossi P, Silvani MC, Vaccheri A, Montanaro N (2006) An update on the first decade of the European centralized procedure: how many innovative drugs? Br J Clin Pharmacol 62(5):610–616. doi:10.1111/j.1365-2125.2006.02700.x

    Article  PubMed  Google Scholar 

  9. Hrobjartsson A, Gotzsche PC (2010) Placebo interventions for all clinical conditions. Cochrane Database Syst Rev (1): CD003974. doi:10.1002/14651858.CD003974.pub3

Download references

Acknowledgments

We thank Judith Baggott for editing. This study was supported by internal institutional funds from the Mario Negri Institute and the Copenhagen Trial Unit.

Conflict of interests

The authors declare that they have no conflict of interest.

Author information

Authors and Affiliations

  1. Mario Negri Institute for Pharmacological Research, Via La Masa 19, 20156, Milan, Italy

    Vittorio Bertele’, Rita Banzi & Silvio Garattini

  2. Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark

    Christian Gluud

Authors
  1. Vittorio Bertele’
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Rita Banzi
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Christian Gluud
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Silvio Garattini
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Vittorio Bertele’.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Bertele’, V., Banzi, R., Gluud, C. et al. EMA’s reflection on placebo does not reflect patients’ interests. Eur J Clin Pharmacol 68, 877–879 (2012). https://doi.org/10.1007/s00228-011-1175-4

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00228-011-1175-4

Keywords

Search

Navigation