STEM CELL: ISTOCKPHOTO, DRA_SCHWARTZ; AIRPORT: DREAMSTIME.COM, ANA SOUSA
As with many new areas of technological advancements, stem cell research has received its fair share of hype. Though much of the excitement is warranted, and the potential of stem cells promising, many have used that hype for their own monetary gain. Some market beauty products containing the rejuvenation powers of stem cells and vitamins that claim to boost adult stem cell function while others have established stem cell clinics offering treatments for major diseases and injuries. Although creams and vitamins may (hopefully) be relatively benign, the same is not true for stem cell treatments. Young and elderly patients have died from receiving illegitimate stem cell treatments; others have developed tumors following stem cell transplantations.
In some cases, physicians’ medical licenses have been revoked and investigations of misconduct have been pursued, but the number of fraudulent clinics are vast and growing, offering...
The International Society for Stem Cell Research (ISSCR) has developed translational guidelines for researchers, a patient’s handbook on stem cell therapies, and a website chock-full of information about real and fraudulent stem cell treatments. Yet the question remains whether this educational information reaches patients, and whether it deters them from seeking snake oil abroad. How many scientific societies or patient advocacy groups must provide sufficient educational materials for this to be a truly effective effort?
From analysis of patient blog sites, our research team at the University of Alberta’s Health Law and Science Policy Group learned that many patients, or family members of patients, seem distraught with the pace at which new treatments are approved because they believe that our regulatory system merely adds red tape. This may encourage some to travel abroad to receive therapies that they expect will be approved in the United States in the coming years. Perhaps then it may be necessary to educate patients on translational research and why translation and the regulatory process are lengthy.
International guidelines could also help by encouraging countries to develop laws and regulations ensuring that clinics offering treatments receive ethics approval and have received regulatory oversight for the products and procedures they intend to use on patients. But the development of international guidelines is an extremely demanding, controversial, and lengthy process. Moreover, international guidelines may not carry sufficient weight as some countries will not adopt them or will choose to ignore them.
Clearly, something more needs to be done. Scientists are uniquely positioned to help quell stem cell tourism because of their knowledge and control over stem cell materials. We propose that scientists could use existing contracts called MTAs (material transfer agreements) to share materials and reagents only with responsible scientists. This would require researchers to evaluate the requestor’s CV, supplementary documentation, a clinical protocol, and website before providing reagents such as stem cell lines, nucleic acid sequences, growth factor enriched cocktails, or purified proteins to others. Those requesting materials would have to sign an MTA, which would outline the intended purposes of the materials. For example, MTAs for sharing stem cells that are not clinical grade or are not being used to develop clinical grade cells should stipulate that the cells are to be used for non-clinical research purposes only.
Although our proposal places limits on scientific openness and sharing, we believe it is necessary to have such restrictions in this situation in order to prevent greater harms—potentially worsening the condition of patients who receive fake treatments and the possibility of reducing public trust and undermining legitimate stem cell research. Our proposal also adds additional time and resource burdens to stem cell researchers, but again, this is a necessary inconvenience to stop the growing illegitimate stem cell industry. There is also concern that MTAs themselves will be ineffective, says Robin Lovell-Badge, a renowned stem cell scientist at the MRC National Institute for Medical Research in London. His contention is that rogue clinics can themselves derive embryonic stem cells from embryos, create induced pluripotent stem cells from patients, or simply not transfer anything into a patient, providing nothing more than a placebo (Robin Lovell-Badge, EuroStemCell, 2011). These are definitely valid concerns and we agree that MTAs, by themselves, will not stop stem cell tourism. But if they can deter some irresponsible stem cell therapy and research, why not use them? As with education and international policies, control of materials is simply one strategy in the scientist’s arsenal that can help mitigate the use of bogus stem cell remedies.
Zubin Master, PhD is a Research Associate at the University of Alberta’s Health Law and Science Policy Group. Master has published numerous research articles on stem cell ethics and policy, genethics, the responsible conduct of research, and the ethics of research involving humans.
David Resnik, JD, PhD is a Bioethicist and IRB Chair at the National Institute for Environmental Health Sciences, National Institutes of Health. Resnik has published over 170 articles and 7 books on various topics in philosophy and bioethics, serves on several editorial boards, and is an Associate Editor of the journal Accountability in Research.