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In February 2014, an appeals court upheld the Food and Drug Administration’s (FDA) ability to regulate manipulated stem cells as drugs. However, this may not put a stop to "stem cell tourism," in which patients often pay thousands of dollars for unhelpful treatments, says R. Alta Charo, JD, Warren P. Knowles professor of law and bioethics at University of Wisconsin Law School in Madison, WI. Charo served as senior policy advisor in the Office of the Commissioner of the FDA between 2009 and 2011.
"The primary ethical concern with stem cell tourism is the potential for fraud," says Charo.
Many responsible medical practices have used adult stem cells for years to treat a limited range of conditions. There are a growing number of well-designed, properly overseen clinical trials to test the use of these cells for a wider range of conditions, or to test the use of other kinds of stem cells, notes Charo.
"Unfortunately, there are also a growing number of clinics around the world advertising therapeutic applications that have not been subjected to well-controlled trials, nor appear to be overseen by any regulatory authority," says Charo.
Patients are enticed to spend large sums of money but are not getting what they believe was advertised, she explains. "Giving the impression to patients that these treatments are regulated, proven, and safe will, in many cases, be a form of misrepresentation," says Charo.
"Stem cell tourism" is most prevalent outside the United States. "There are some limited examples of domestic clinics that offered therapies that were subject to FDA regulation but which had not been submitted to FDA for the required review and approval before being offered to the public," says Charo.
A major ethical concern is that patients can be harmed physically by unproven interventions, says Zubin Master, PhD, assistant professor at the Alden March Bioethics Institute at Albany (NY) Medical College. "There have been reports of tumors and even deaths," he adds. "We don’t know the full extent of harm, because we are relying largely on anecdotal information."
People are also being harmed financially and emotionally by clinics, says Master, as patients sometimes have to collect money from community donations or take out loans to pay for expensive treatments.
"We are also starting to see research reporting that some patients are skeptical about unproven stem cell interventions," he reports.1
Unethical practices of clinics are likely to add to the public’s confusion about stem cell treatments, according to Master.
"Right now, there are a handful of established stem cell therapies," he says. "While much research is in clinical stages, the majority of research is still in pre-clinical stages being done in the laboratory."
As stem cell research is being translated into clinical applications, patients may have a hard time distinguishing what is an established therapy, what is legitimate clinical research, and what are unproven and potentially fraudulent interventions. "It’s a complicated landscape," says Master. "Patients may just see someone in a white coat who is trying to help them and not be able to distinguish a registered clinical trial from an unproven intervention."
Public concerns about reported deaths from fraudulent stem cell interventions could become more prevalent and have a chilling effect on legitimate clinical research, adds Master. "To some degree, the clinics are playing on hype over stem cell research," he says. "It’s really the premature selling of science."
Master also adds that the term "stem cell tourism" itself is misleading because it suggests a parallel to "medical tourism." "Getting a treatment in another country may be fine if a treatment is legitimate and they are following good practices," he says. "With people travelling for stem cell treatments, most of these things are just complete scams."
It is a basic doctrine of law and bioethics that patients should have an opportunity to give informed consent. "But where there is confusion about whether a treatment has been developed or offered in full accordance with legal requirements, a patient’s consent cannot be informed," says Charo.
If a treatment option is simply not reasonable, it really doesn’t make any difference how well the provider informs the patient, says Master.
"It has to be based on scientific evidence," he says. "If there is no evidence that something will work, then you just ought not to be offering it to patients."
Bioethics can educate physicians by encouraging them to talk with their patients openly about unethical practices involving stem cell treatments, suggests Master.
"While educating patients and the public is likely to help them make better informed decisions, it is unclear whether patients will change their minds about seeking unproven interventions," says he adds.
Patient advocacy groups can get involved by sending similar messages about stem cell tourism’ to their patient population. "Bioethicists can continue to conduct research and develop better ways of curtailing this practice," says Master.