• Tim Ken Mackey 1. Institute of Health Law Studies, California Western School of Law 2. Dept. of Anesthesiology, University of California, San Diego, School of Medicine
  • Bryan A Liang UCSD



stem cells, regenerative medicine, direct-to-consumer advertising, stem cell clinics, medical tourism, stem cell tourism, online pharmacies, Internet pharmacies


Stem cell-based therapies represent a potential pathway for a new era of 21st century regenerative medicine. In support of this new form of treatment, a global multibillion-dollar research endeavor is currently underway in an effort to establish a scientific evidence base for safe and effective clinical use of stem cells. At present, due to its early stages, only a few stem cell therapies are approved for use. Yet despite very limited evidence-based data, a proliferation of questionable and often illegal stem cell providers around the world are now offering unfettered access to largely experimental stem cell treatment claiming cures for virtually any disease or condition. These stem cell clinics promote their services globally to patients using unregulated Internet and forms of direct-to-consumer advertising. In this paper we examine marketing characteristics of these questionable stem cell clinics and discuss pathways of access through the globalization of medical tourism. We conclude with an examination of the similarities between unproven stem cell therapy access and illicit online pharmacies and explore possible lessons that can be learned to inform future global regulation and policymaking in this arena.

Author Biographies

Tim Ken Mackey, 1. Institute of Health Law Studies, California Western School of Law 2. Dept. of Anesthesiology, University of California, San Diego, School of Medicine

Department of Anesthesiology, University of California, San Diego-School of Medicine; and San Diego Center for Patient Safety, University of California, San Diego-School of Medicine, San Diego.

Bryan A Liang, UCSD

Department of Anesthesiology, University of California, San Diego School of Medicine; San Diego Center for Patient Safety, University of California, San Diego School of Medicine; and, the Program on Health Policy & Law, University of California, San Diego.


Bernard Lo LP. (2009) Ethical Issues in Stem Cell Research. Endocrine Reviews. 30(3):204–13.

Singec I, Jandial R, Crain A, Nikkhah G, Snyder EY. (2007) The Leading Edge of Stem Cell Therapeutics. Annu. Rev. Med. Annual Reviews. 58(1):313–28.

Elliott MJ, De Coppi P, Speggiorin S, Roebuck D, Butler CR, Samuel E, et al. (2012) Stem-cell-based, tissue engineered tracheal replacement in a child: a 2-year follow-up study. The Lancet. 380(9846):994–1000.

Children's Hospital of Illinois. (2013) Trachea Transplant at Children's Hospital of Illinois Gives Korean Toddler New Windpipe. Children's Hospital of Illinois Website Apr. 30. Accessed May 30, 2013.

Knoepfler PS. Deconstructing Stem Cell Tumorigenicity: A Roadmap to Safe Regenerative Medicine. (2009) Stem Cells. (5):1050–6.

Liang BA, Mackey TK. (2012) Stem cells, dot-com. Science Translational Medicine. 4(151):151cm9.

Cyranoski D. (2010) Korean deaths spark inquiry. Nature. 468(7323):485–5.

Amariglio N, Hirshberg A, Scheithauer BW, Cohen Y, Loewenthal R, Trakhtenbrot L, et al. (2009) Donor-Derived Brain Tumor Following Neural Stem Cell Transplantation in an Ataxia Telangiectasia Patient. PLoS Med. 6(2):e1000029.

Lyn TE. (2011) China stem cell therapies offer heartbreak for many. Reuters Sept. 21. Accessed May 28, 2013.

Mendick R, Hall A. (2011) Europe's largest stem cell clinic shut down after death of baby. The Telegraph May 8. Accessed May 28, 2013.

Fitzpatrick D, Griffin D. (2012) Florida suspends doctor accused of illegal stem cell therapy. CNN Health Mar 8. Accessed May 28, 2013.

Lau D, Ogbogu U, Taylor B, Stafinski T, Menon D, Caulfield T. (2008) Stem Cell Clinics Online: The Direct-to-Consumer Portrayal of Stem Cell Medicine. Cell Stem Cell. 3(6):591–4.

Liang BA, Mackey T. (2011) Direct-to-consumer advertising with interactive internet media: global regulation and public health issues. JAMA. 305(8):824–5.

Mackey T, Liang B. (2012) Globalization, Evolution and Emergence of Direct-to-Consumer Advertising: Are Emerging Markets the Next Pharmaceutical Marketing Frontier. J Commer Biotechnol. 18:58–64.

Einsiedel EF, Adamson H. (2012) Stem Cell Tourism and Future Stem Cell Tourist: Policy and Ethical Implication. Dev World Bioeth. 12(1):35–44.

Horowitz MD, Rosensweig JA, Jones CA. (2007) Medical Tourism: Globalization of the Healthcare Marketplace. Medscape General Medicine 9(4):33.

Liang BA, Mackey T. (2011) Reforming direct-to-consumer advertising. Nat. Biotechnol. 29(5):397–400.

Liang BA, Mackey TK. (2011) Prevalence and Global Health Implications of Social Media in Direct-to-Consumer Drug Advertising. J. Med. Internet Res. 13(3):e64.

Mackey TK, Liang BA. (2013) Global Reach of Direct-to-Consumer Advertising Using Social Media for Illicit Online Drug Sales. J. Med. Internet Res. 15(5):e105.

Mintzes B. (2008) Direct to consumer advertising of prescription drugs. BMJ. 337:a985.

Liang BA, Mackey T. (2009) Searching for safety: addressing search engine, website, and provider accountability for illicit online drug sales. Am J Law Med. 35(1):125–84.

Forman RF, Block LG. (2006) The Marketing of Opioid Medications without Prescription over the Internet. Journal of Public Policy & Marketing 25:133–46.

Liang BA, Mackey TK. (2012) Vaccine shortages and suspect online pharmacy sellers. Vaccine 30(2):105–8.

Liang BA, Mackey TK. (2012) Online availability and safety of drugs in shortage: a descriptive study of internet vendor characteristics. J. Med. Internet Res. 14(1):e27.

Liang BA, Mackey TK, Lovett KM. (2012) Suspect online sellers and contraceptive access. Contraception 86(5):551–6.

Liang BA, Mackey TK. (2012) Sexual medicine: Online risks to health-the problem of counterfeit drugs. Nat Rev Urol. 9(9):480–2.

Mackey TK, Liang BA. (2011) The global counterfeit drug trade: patient safety and public health risks. J Pharm Sci. 100(11):4571–9.

Deasy BM, Anderson JE, Zelina S. (2013) Regulatory Issues in the Therapeutic Use of Stem Cells. Andrades JA (Ed.) InTech. Accessed May 28, 2013.

Knox R. (2010) Offshore Stem Cell Clinics Sell Hope, Not Science. NPR Website July 26. Accessed May 28, 2013.

Caplan A. (2011) Stem cell clinics ripping off patients. NBC News July 18. Accessed May 28, 2013.

CBSNews. (2010) 21st Century Snake Oil. CBSNews Sept 9;lst;3. Accessed May 28, 2013.

The darker side of stem cells. Nature. 483(7387):5–5.

Food and Drug Administration. (2012) Consumer Updates - FDA Warns About Stem Cell Claims. FDA Website Jan 6. Accessed May 28, 2013.

van Burik JA, Brunstein CG. (2007) Infectious complications following unrelated cord blood transplantation. Vox Sang. 92(4):289–96.

Almyroudis NG, Fabian J, Hahn T, Segal BH, Wetzler M, McCarthy PL. (2009) Late infectious complications after cord blood stem cell transplantation. Eur J Clin Microbiol Infect Dis. 28(11):1405–8.

Zarzeczny A, Rachul C, Nisbet M, Caulfield T. (2010) Stem cell clinics in the news. Nat. Biotechnol. 28(12):1243–6.

Brenner J. (2013) Pew Internet: Social Networking (full detail). PewInternet Feb 14. Accessed May 28, 2013.

Gottlieb S. (2013) FDA Wants to Regulate Drug Firms on the Internet and It's Targeting Facebook 'Likes.' Forbes Feb 27. Accessed May 28, 2013.

Deloitte. (2008) Medical Tourism: Consumers in Search of Value. Deloitte Center for Health Solutions. Accessed May 28, 2013.

The Economist. (2010) Stem cells in China: Wild East or scientific feast? The Economist Jan 14. Accessed May 28, 2013.

Cyranoski D. (2012) China’s stem-cell rules go unheeded. Nature. 484(7393):149–50.

Liang BA, Mackey TK, Lovett KM. (2013) Illegal “no prescription†internet access to narrow therapeutic index drugs. Clin Ther. 35(5):694–700.

Forman RF, Woody GE, McLellan T, Lynch KG. (2006) The availability of web sites offering to sell opioid medications without prescriptions. Am J Psychiatry. 163(7):1233–8.

Liang BA, Mackey TK, Archer-Hayes5 AN, Shinn LM. (2013) Illicit online marketing of lorcaserin before DEA scheduling. Obesity. [in press].

National Association of Boards of Pharmacy. VIPPS. Accessed May 28, 2013.

National Association of Boards of Pharmacy. Not Recommended Sites - National Association of Boards of Pharmacy. Accessed May 28, 2013.

Ledford H. Stem-cell scientists grapple with clinics. (2011) Nature. 474(7353):550.