Many “cures” are problematic and unsustainable

Stem cell scientists appear to have oversold their product. In debates a decade ago, scientists, foundations and patient advocacy groups spoke glibly of cures for chronic diseases which would come after embryonic stem cell research was legalised. They made a rod for their own back.

The cures have been slow in coming, but not the hucksters, charlatans and snake-oil salesmen. According to a paper in BMC Medical Ethics by Kirstin Matthews, of Rice University, and Ana Iltis, of Wake Forest University, disillusioned patients, tired of waiting for the cures they were promised, are seeking unproven stem cell-based treatments that are causing more harm than good.

The continued marketing and use of experimental stem cell-based interventions inside and outside the United States is problematic and unsustainable.

The rise in stem cell tourism is a recent phenomenon, write Matthews and Ilitis. Scientists have long envisioned their stem cell research would lead to cures in the near future. In 2004, patient-advocate groups were major players in helping pass and implement significant public policy and funding initiatives in stem cells and regenerative medicine. In the following years, advocates were also actively engaged in Washington DC, encouraging policymakers to broaden embryonic stem cell research funding, which was ultimately passed after President Barack Obama came into office. After waiting more than 10 years, many of these same patients are now approaching clinics around the world that are offering experimental stem cell-based interventions instead of waiting for scientists in the US to complete clinical trials.

Central problems of stem cell tourism include the lack of patient protection, US liability standards, regulation of clinical sites and clinician licensing, the authors said. “These interventions have insufficient evidence of safety and efficacy; patients may be wasting money and time, and they may be forgoing other opportunities for an intervention that has not been shown to be safe and effective,” they write. “Current practices do not contribute to scientific progress because the data from the procedures are unsuitable for follow-up research to measure outcomes. In addition, there is no assurance for patients that they are receiving the interventions promised or of what dosage they are receiving. Furthermore, there is inconsistent or nonexistent follow-up care.”

Using HIV, AIDS and breast cancer advocate cases as examples, Matthews and Iltis identify key priorities and goals for a policy effort to combat stem cell tourism.

“Policy should be aimed at bringing patients home and fostering responsible scientific research as well as access for patients,” they wrote. “This will require discussions about alternative approaches to the design and conduct of clinical trials as well as to how interventions are approved by the Food and Drug Administration.”

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Michael Cook

Michael Cook edits BioEdge, a bioethics newsletter, and MercatorNet, an on-line magazine whose focus is human dignity. He writes from Sydney, Australia.

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