“If stem cells didn't work, we would go back to our day jobs,” Berman said. “It's a disruptive technology. We are the black swan.”
Cosmetic surgeon Dr. Mark Berman explains how he started working with other surgeons to use stem cells taken from patient's liposuction procedures to treat their other conditions. (Youtube/Cell Surgical Network)
But the disruptive technology might itself face disruption. The FDA, which has taken a mostly hands-off approach toward the rapidly proliferating stem-cell clinics, is signaling that some of the treatments should be regulated as new drugs, which require advance approval. That entails a lengthy process, with extensive safety and effectiveness data, and a potential cost of millions of dollars.
The issue has ignited a fierce debate among physicians, patients, scientists and politicians about whether the agency should crack down on therapies that critics deride as snake-oil but that some patients swear by. And it is fueling a broader, longer-term debate over how cellular therapies should be regulated.
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