Advanced-economy nations top global distribution of businesses marketing stem cell therapies
A structured search by a team from Japan and Australia has indicated that the direct-to-consumer-advertized stem cell therapy market has moved from developing to higher-income countries such as the USA, Ireland, Australia and Germany, presenting challenges for regulators, bioethicists and prospective patients.
A large-scale study of number of clinics engaging in direct-to-consumer marketing of stem cell therapies has concluded that advanced-economy nations, led by Ireland, Singapore, Australia, Germany, Italy, Japan and the USA, have the highest per capita.
Although the prevalence of clinics in certain places such as the USA was reasonably well know, online-advertised ‘stem cell tourism’ was generally considered to mainly take place in countries in South East Asia, Russia and Eastern Europe. However, this and other recent studies (such as into clinics in Japan and the USA) are disproving this theory.
“In the early days of this under-regulated industry, clinics were typically located in developing economies, where weak laws or lax enforcement enabled these businesses to operate with relative impunity,” explained Professor John Rasko (the University of Sydney, Australia), the study’s senior author. “More recently, richer countries such as Australia, Germany, Italy, Japan, and the United States have seen clinics take advantage of real or imagined gaps in regulation.”
Key results
The highest number of clinics undertaking direct-to-consumer marketing per country was as follows: 187 clinics in the USA; 35 in India; 28 in Mexico, 23 in China; 19 in Australia; and 16 in the UK.
Taking into account the population (per 10-million citizens), some of the highest among high-income countries were Australia (8.1), Ireland (11.2) and Singapore (10.0).
With regard to the types of therapies on offer, 83% of the identified websites advertised adult stem cell-based therapies, 13% stem cells of unspecified type, 8% embryonic, induced pluripotent or fetal, and finally 1% amniotic stem cells. Furthermore, 52% did not specify the donor source of cells.
Websites frequently advertised anti-aging/skincare indications (47%), rather than strictly medical applications.
Details on the medical conditions for which the interventions were being offered were frequently vague, and terminology or categories of diseases across sites was inconsistent.
Regulatory loopholes
The claims with direct-to-consumer marketing of stem cell therapies are not always supported by independent clinical trials or regulatory authority authorization, raising concerns for the wellbeing of patients paying for these therapies. Furthermore, the authors comment that some regulatory agencies do not have sufficient laws, allowing companies to exploit loopholes and therefore administer costly, unproven and potentially dangerous stem cell therapies.
In June this year, an Australian coroner found that a 75-year-old woman, died from blood loss after undergoing an experimental liposuction stem cell procedure for her severe dementia. The procedure was performed by a cosmetic physician at a private facility and Drysdale died shortly after arriving home.
The Coroner, Hugh Dillon, stated that the death “highlights the vulnerability of elderly sick people and their families”. He stated that he recommend the Australian authorities consider how best to manage and regulate the provision of ‘experimental’ or ‘innovative’ medical or surgical procedures that have not yet been approved following clinical trials or other recognized peer-reviewed evaluation processes.
The study authors believe the WHO should also develop a policy to ensure guidelines are consistent between countries.
Sources: Berger I, Ahmad A, Bansal A, Kapoor T, Sipp D, Rasko JE. Global distribution of businesses marketing stem cell-based interventions. Cell Stem Cell 19(2), 158—1562 (2016); http://medicalxpress.com/news/2016-08-advanced-economy-nations-high-online.html; http://www.ncbi.nlm.nih.gov/pubmed/27494673