Balancing Safety and Innovation

Leaders in stem cell guidelines development urge compassion, caution
Insoo Hyun (left) and George Daley. Photo: Lipofsky.com

With the first audience question, Ethical Frontiers in Biotechnology got immediate and real. The questioner was a father who had come to the September seminar, “Clinical Trials and Stem Cell Tourism,” hopeful of gaining knowledge as he considers stem cell therapy to treat his child’s autism. But what he heard from Insoo Hyun and Harvard Medical School Dean George Daley was disappointing for the father and hopeful only for parents in the distant future.

Such is the tension between the therapeutic promise of stem cells and their unproven effectiveness. This is the tension between what Hyun, faculty at the HMS Center for Bioethics, terms therapeutic hope and spiritual distress. Or, in Daley’s words, “between the scientific pursuit of generalizable knowledge and the desire for medical innovation.”

Part of the challenge is this: Clinical trials first seek to determine maximum tolerable dose – that is, safety. And stem cells, though used successfully in bone marrow transplantation, don’t lend themselves to such a test: “How do you do that for a cellular product?” Daley said. “We lack tools for tracing the fate of cells as they find their way into their niche.”

Faced with the urgency of a suffering and desperate patient and family, it’s easy to view a clinician’s caution as anything but patient-centered. And yet news reports of harms to patients done by clinicians providing unproven therapies—at $5,000 to $20,000 a pop—are easy to find.

For example, health care journalist Karen Weintraub recently wrote about a Beverly Hllls plastic surgeon with a thriving business (more than 100 clinics) “treating” everything from knee pain to congestive heart failure with stem cell injections. The surgeon no longer injects stem cells into his patients’ eyes, however – after reports of patients going blind.

What are current and future students at Harvard Medical School to make of this? Or, as Daley said, “How do you teach ambition and humility?”

The guidelines for the study of stem cells, which both Hyun and Daley were involved in creating, are available from the International Society for Stem Cell Research.

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