Hastings Center News

Stem Cell Treatments: Assessing the Evidence

Should the Food and Drug Administration regulate some or all stem cell interventions? What standards of evidence should be used for making claims that stem cell interventions are safe and effective? The answers are not as straightforward as they may seem, write Hastings Center scholars Karen Maschke and Michael Gusmano in a new article in the Journal of Health Politics, Policy and Law.

The article discusses the politics of the FDA’s authority over the governance of stem cell technologies and examines the “evidence question” regarding the assessment of any new biomedical technologies. Disputes about evidence include legitimate scientific disagreements about the type and amount of evidence for making claims about a technology’s risks and benefits, but they are also influenced by values, interests, and ideology. “Many patients want access to interventions they think will help them, even if there is a limited evidence base about their safety and effectiveness,” Maschke and Gusmano write. Their reasons include a sense of desperation and the feeling that they have nothing to lose.

Maschke and Gusmano point out that the dispute about patient access to stem cell interventions reflects a failure to reach political and social consensus about evidentiary standards for health technology assessment and the role of government in that effort. They are working on a book on the politics of evidence-based medicine.