Skip to main content
SpringerLink
Log in

Availability and quality of illegitimate somatropin products obtained from the Internet

  • Research Article
  • Published:
International Journal of Clinical Pharmacy Aims and scope Submit manuscript

Abstract

Background Growth hormones are widely available on the Internet for those who want to enhance their physical performance and improve body satisfaction. Illegitimate websites market somatropin injections without medical prescription and encourage misuse. Customers potentially put their health at risk when purchasing parenteral medications online. Objective The objective of our study was to evaluate the online market of no-prescription somatropin products and to analyse and document Internet pharmacy characteristics, distribution and pharmaceutical quality. Setting Websites indexed in Google promoting somatropin for sale direct to patients. Method Websites promoting the sale of growth hormone products were identified and analysed from June to August 2014. Internet vendor sites were evaluated to identify possible patient and medication safety concerns. Website characteristics, delivery time, storage conditions, packaging and attached product information were assessed. Investigation of the somatropin content was achieved using capillary electrophoresis with UV detection and electrospray ionization mass spectrometry. Main outcome measure Accessibility and quality of somatropin injections. Results Seventeen individual Internet vendor websites distributed somatropin products directly to patients, majority (94%) did not require a valid medical prescription before dispensing the products. Majority (70%) of Internet pharmacies displayed no medical information and none (0%) of the vendors displayed any regulatory body logo. All online samples had significantly (p < 0.001) lower somatropin concentration than labelled. Conclusion Our results clearly illustrate that prescription only biologic drugs are widely available online and can be easily accessed by anyone. Unprofessional distribution and handling is likely to cause degradation and possible patient safety concerns.

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

Fig. 1

Similar content being viewed by others

References

  1. McVeigh J, Evans-Brown M, Bellis MA. Human enhancement drugs and the pursuit of perfection. Adicciones. 2012;24(3):185–90.

    Article  PubMed  Google Scholar 

  2. Fittler A, Bősze G, Botz L. Evaluating aspects of online medication safety in long-term follow-up of 136 Internet pharmacies: illegal rogue online pharmacies flourish and are long-lived. J Med Internet Res. 2013;15(9):e199.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Graham MR, Ryan P, Baker JS, Davies B, Thomas NE, Cooper SM, et al. Counterfeiting in performance- and image-enhancing drugs. Drug Test Anal. 2009;1(3):135–42.

    Article  CAS  PubMed  Google Scholar 

  4. Jiang H, Wu SL, Karger BL, Hancock WS. Mass spectrometric analysis of innovator, counterfeit, and follow-on recombinant human growth hormone. Biotechnol Prog. 2009;25(1):207–18.

    Article  CAS  PubMed  Google Scholar 

  5. Sheridan C. Bad medicine. Nat Biotechnol. 2007;25(7):707–9.

    Article  CAS  PubMed  Google Scholar 

  6. United States Pharmacopeia. Somatropin for injection. In United States Pharmacopeia 37, National Formulary 32. Rockville: United States Pharmacopeial Convention Inc.; 2014. p. 4730–2.

    Google Scholar 

  7. European Pharmacopoeia, 7.0-1 ed. Somatropin for injection. Supplement 535th ed.; 2005. p. 3619–21. European Directorate for Quality of Medicines and Health Care. Strasbourg, France; 2014.

  8. Catai JR, Sastre Toraño J, Jongen PM, de Jong GJ, Somsen GW. Analysis of recombinant human growth hormone by capillary electrophoresis with bilayer-coated capillaries using UV and MS detection. J Chromatogr B Biomed Sci Appl. 2007;852(1–2):160–6.

    CAS  Google Scholar 

  9. Arcelloni C, Fermo I, Banfi G, Pontiroli AE, Paroni R. Capillary electrophoresis for protein analysis: separation of human growth hormone and human insulin molecular forms. Anal Biochem. 1993;212(1):160–7.

    Article  CAS  PubMed  Google Scholar 

  10. Orizio G, Merla A, Schulz PJ, Gelatti U. Quality of online pharmacies and websites selling prescription drugs: a systematic review. J Med Internet Res. 2011;13(3):e74.

    Article  PubMed  PubMed Central  Google Scholar 

  11. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf Accessed 21 Aug 2016.

  12. Malik NN, Khan Y. Personalized medicine: potential impact on the biopharmaceutical industry. Drug Discovery Today. 2010;15(21–22):881–3.

    Article  PubMed  Google Scholar 

  13. IMS Institute for Healthcare Informatics. Increasing numbers of innovative new medicines and orphan drugs are expected to be launched. In: The Global Use of Medicines: Outlook through 2017. IMS Institute for Healthcare Informatics. 2017. https://www.imshealth.com/files/web/IMSH%20Institute/Reports/The_Global_Use_of_Medicines_2017/global%20use%20of%20meds%202017%20right5%20Global_Models_New_Molecular_Entities.pdf Accessed 21 Aug 2016.

  14. Kinch MS, Haynesworth A, Kinch SL, Hoyer D. An overview of FDA-approved new molecular entities: 1827–2013. Drug Discovery Today. 2014;19(8):1033–9.

    Article  CAS  PubMed  Google Scholar 

  15. Foster KA. Biologics: a new approach needed? Drug Discovery Today. 2010;15(3–4):81–3.

    Article  PubMed  Google Scholar 

  16. Tsiftsoglou AS, Ruiz S, Schneider CK. Development and regulation of biosimilars: current status and future challenges. BioDrugs. 2013;27(3):203–11.

    Article  CAS  PubMed  Google Scholar 

  17. Gohil K. Long-acting therapies will expand growth hormone deficiency market. Pharm Ther. 2015;40(11):772–3.

    Google Scholar 

  18. Høybye C, Cohen P, Hoffman AR, Ross R, Biller BM. Christiansen JS; Growth Hormone Research Society. Status of long-acting-growth hormone preparations—2015. Growth Hormon IGF Res. 2015;25(5):201–6.

    Article  Google Scholar 

  19. Navarro R, Dunn JD, Lee PA, Owens GM, Rapaport R. Translating clinical guidelines into practice: the effective and appropriate use of human growth hormone. Am J Manag Care. 2013;19(15 Suppl):s281–9.

    PubMed  Google Scholar 

  20. Jung FM. Counterfeit protein drugs: how to discover and how to prevent? Eur J Hosp Pharm Pract. 2007;13(3):61–3.

    Google Scholar 

  21. Casali PG. Executive Committee of ESMO. The off-label use of drugs in oncology: a position paper by the European Society for Medical Oncology (ESMO). Ann Oncol. 2007;18(12):1923–5.

    Article  CAS  PubMed  Google Scholar 

  22. Generali JA, Cada DJ. Recombinant human growth hormone: HIV-related lipodystrophy. Hosp Pharm. 2014;49(5):432–4.

    Article  PubMed  PubMed Central  Google Scholar 

  23. U.S. Food and Drug Administration. Drug database. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm Accessed 21 Aug 2016.

  24. European Medicines Agency. Drug database. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124 Accessed 21 Aug 2016.

  25. National Institute of Pharmacy and Nutrition. Drug database. https://www.ogyei.gov.hu/drug_database/ Accessed 21 Aug 2016.

  26. Hardin DS. Treatment of short stature and growth hormone deficiency in children with somatotropin (rDNA origin). Biologics. 2008;2(4):655–61.

    CAS  PubMed  PubMed Central  Google Scholar 

  27. Svensson J, Johannson G. Long-term efficacy and safety of somatropin for adult growth hormone deficiency. Treat Endocrinol. 2003;2(2):109–20.

    Article  CAS  PubMed  Google Scholar 

  28. Holt R, Erotokritou-Mulligan I, Sönksen PH. The history of doping and growth hormone abuse in sport. Growth Hormon IGF Res. 2009;19(4):320–6.

    Article  CAS  Google Scholar 

  29. Samaras N, Papadopoulou MA, Samaras D, Ongaro F. Off-label use of hormones as an antiaging strategy: a review. Clin Interv Aging. 2014;23(9):1175–86.

    Article  Google Scholar 

  30. Dresser R, Frader J. Off-label prescribing: a call for heightened professional and government oversight. J Law Med Ethics. 2009;37(3):476–86, 396.

  31. Rennie MJ. Claims for the anabolic effects of growth hormone: a case of the emperor’s new clothes? Br J Sports Med. 2003;37(2):100–5.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  32. Liu H, Bravata DM, Olkin I, Nayak S, Roberts B, Garber AM, et al. Systematic review: the safety and efficacy of growth hormone in the healthy elderly. Ann Intern Med. 2007;146(2):104–15.

    Article  PubMed  Google Scholar 

  33. Cittadini A, Berggren A, Longobardi S, Ehrnborg C, Napoli R, Rosén T, et al. Supraphysiological doses of GH induce rapid changes in cardiac morphology and function. J Clin Endocrinol Metab. 2002;87(4):1654–9.

    Article  CAS  PubMed  Google Scholar 

  34. Birzniece V, Nelson AE, Ho KK. Growth hormone and physical performance. Trends Endocrinol Metab. 2011;22(5):171–8.

    Article  CAS  PubMed  Google Scholar 

  35. Krug O, Thomas A, Walpurgis K, Piper T, Sigmund G, Schänzer W, et al. Identification of black market products and potential doping agents in Germany 2010–2013. Eur J Clin Pharmacol. 2014;70(11):1303–11.

    Article  PubMed  Google Scholar 

  36. Kimergård A, McVeigh J, Knutsson S, Breindahl T, Stensballe A. Online marketing of synthetic peptide hormones: poor manufacturing, user safety, and challenges to public health. Drug Test Anal. 2014;6(4):396–8.

    Article  PubMed  Google Scholar 

  37. Perls TT, Reisman NR, Olshansky SJ. Provision or distribution of growth hormone for “antiaging”: clinical and legal issues. J Am Med Assoc. 2005;294(16):2086–90.

    Article  CAS  Google Scholar 

  38. Perls TT. Anti-aging quackery: human growth hormone and tricks of the trade—more dangerous than ever. J Gerontol A Biol Sci Med Sci. 2004;59(7):682–91.

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

The present scientific contribution is dedicated to the 650th anniversary of the foundation of the University of Pécs, Hungary.

Funding

This research received no external funding.

Conflicts of interest

The authors declare no conflict of interest.

Author information

Authors and Affiliations

  1. Department of Pharmaceutics and Central Clinical Pharmacy, Faculty of Pharmacy, University of Pécs, 3 Honvéd Street, Pecs, 7624, Hungary

    Róbert György Vida, András Fittler, Ivett Mikulka, Eszter Ábrahám & Lajos Botz

  2. Institute of Bioanalysis and Szentágothai Research Centre, Medical School, University of Pécs, 1 Honvéd Street, Pecs, 7624, Hungary

    Viktor Sándor & Ferenc Kilár

Authors
  1. Róbert György Vida
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. András Fittler
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Ivett Mikulka
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Eszter Ábrahám
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Viktor Sándor
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Ferenc Kilár
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Lajos Botz
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Róbert György Vida.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (DOCX 304 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Vida, R.G., Fittler, A., Mikulka, I. et al. Availability and quality of illegitimate somatropin products obtained from the Internet. Int J Clin Pharm 39, 78–87 (2017). https://doi.org/10.1007/s11096-016-0398-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11096-016-0398-y

Keywords

Search

Navigation