In the September 2009 issue of Nature Biotechnology, Jane Qiu reports on a thriving trade in nonvalidated stem cell interventions for incurable illnesses (“Trading on Hope”). The article provides numerous examples of overseas clinics that cater primarily to North American and European clientele in offering pricey, unproven stem cell transplants for incurable conditions like spinal cord injury, Parkinson’s disease, and autism. Many of these clinics make extravagant claims in their promotion materials.
Encouragingly, policy makers are beginning to take notice. China, for example, has issued new regulations on clinical application of novel interventions; it requires licensing for clinics that provide unproven stem cells. India has issued guidelines on stem cell research and therapy. As noted previously in this blog, the scientific society ISSCR issued guidelines urging clinicians to offer nonvalidated stem cell interventions to patients only in the context of clinical trials designed to test safety and efficacy. Problem is (according to the article), guidelines are sporadically enforced, if that.
I think there is much more that governments and professional societies can and should do to stem this unethical conduct. Though most of these clinics are located outside of North American and Europe, some overseas clinics have reputable, North American / European scientists and clinicians on their advisory board or have partnerships with biotechnology companies that are based in North America / Europe. Examples include Stemedica (which includes several Stanford and UCSD faculty on its advisory board), and Theravitae (which has involved close collaboration with University of Pittsburgh clinicians), and Vescell (which includes Nobelist Aaron Ciechanover on its scientific advisory board). All of these companies offer stem cell interventions to large numbers of patients outside trials, and make claims that their interventions are effective when, in fact, they remain unproven.
1- Research ethics policies should condemn scientist-clinicians who travel or collaborate abroad in delivering nonvalidated, potentially risky interventions overseas outside the context of a clinical trial. Policies should state clearly the imperative of subjecting nonvalidated interventions to systematic study.
2- Institutions should not allow these clinics to trade on their reputations, and should sanction faculty members who are involved in such activities.
3- professional societies in medical fields (e.g. cardiology) and research areas (stem cells, gene transfer) should steward the standing and credibility of their research field by developing policies and standards that discourage inappropriate activities– through social pressure– by providing a benchmark against which the conduct of scientists and clinicians can be judged.
@Manual{stream2009-84,
title = {Quack You! Medical Tourism and Stem Cells},
journal = {STREAM research},
author = {Jonathan Kimmelman},
address = {Montreal, Canada},
date = 2009,
month = sep,
day = 23,
url = {https://www.translationalethics.com/2009/09/23/quack-you-medical-tourism-and-stem-cells/}
}
MLA
Jonathan Kimmelman. "Quack You! Medical Tourism and Stem Cells" Web blog post. STREAM research. 23 Sep 2009. Web. 22 Oct 2024. <https://www.translationalethics.com/2009/09/23/quack-you-medical-tourism-and-stem-cells/>
APA
Jonathan Kimmelman. (2009, Sep 23). Quack You! Medical Tourism and Stem Cells [Web log post]. Retrieved from https://www.translationalethics.com/2009/09/23/quack-you-medical-tourism-and-stem-cells/
After scandals involving tainted toothpaste, poisonous pet food, adulterated milk, contaminated heparin, and counterfeit medicines, and a thriving trade in organs, one shudders to imagine how well human subjects are protected in drug studies performed in China. Apart from an occasional report in the medical literature, there is little easily accessible information about Chinese human protections: the regulations and laws, compliance and enforcement, and professional standards. This information would be interesting in its own right; however, it is all the more essential given trends towards trans-national trials.
A recent report issued the Medical Research Council (UK) provides some indication of China’s system of human protections, and how researchers in countries like UK might proceed when locating trials in China. The executive summary finds that Chinese regulations substantially parallel those of the International Committee on Harmonization (ICH). Informed consent and independent ethics review is required for any study. However, the UK and China “differ greatly in their approaches to enforcing guidelines for the conduct of research at the national level. In China, although there is some scrutiny of clinical trials, there is comparatively little inspection or review of compliance.” Other intriguing mentions are concerns about undue inducement in China: “the high costs of healthcare and medicines, and the dependence on local providers means that particular attention [for UK researchers pursuing studies in China] must be given to potential inducements to participate in research. Collaboration with China may offer attractive opportunities for large-scale recruitment, but potential UK collaborators must be alert to the risk that unethical inducements may be offered to potential participants. … given the high cost of accessing health care in China, a ‘free health check’ may be a relatively greater inducement than it would be deemed to be in the UK.”
A perusal of the Chinese regulations- at least the ones provided in this report- indicate the following:
• China places heavy emphasis on procedure (e.g. IRB review) and informed consent, rather than substance (e.g. prohibitions on certain practices; definitions of minimal risk; categories of patients)
• China seems to take a very permissive stand (like ICH) on the use of placebos. Indeed, there is no mention of studies involving placebo.
• There is no mention of justice considerations- for example, post-trial access or responsiveness.
@Manual{stream2009-87,
title = {Everything You Always Wanted to Know About Clinical Research in China, But Were Afraid to Ask},
journal = {STREAM research},
author = {Jonathan Kimmelman},
address = {Montreal, Canada},
date = 2009,
month = aug,
day = 20,
url = {https://www.translationalethics.com/2009/08/20/everything-you-always-wanted-to-know-about-clinical-research-in-china-but-were-afraid-to-ask/}
}
MLA
Jonathan Kimmelman. "Everything You Always Wanted to Know About Clinical Research in China, But Were Afraid to Ask" Web blog post. STREAM research. 20 Aug 2009. Web. 22 Oct 2024. <https://www.translationalethics.com/2009/08/20/everything-you-always-wanted-to-know-about-clinical-research-in-china-but-were-afraid-to-ask/>
APA
Jonathan Kimmelman. (2009, Aug 20). Everything You Always Wanted to Know About Clinical Research in China, But Were Afraid to Ask [Web log post]. Retrieved from https://www.translationalethics.com/2009/08/20/everything-you-always-wanted-to-know-about-clinical-research-in-china-but-were-afraid-to-ask/
In the September 2009 issue of Nature Biotechnology, Jane Qiu reports on a thriving trade in nonvalidated stem cell interventions for incurable illnesses (“Trading on Hope”). The article provides numerous examples of overseas clinics that cater primarily to North American and European clientele in offering pricey, unproven stem cell transplants for incurable conditions like spinal cord injury, Parkinson’s disease, and autism. Many of these clinics make extravagant claims in their promotion materials.
