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out of options," McCormack says. "So it's natural that they would turn to wherever they can fi nd hope." Diffi cult to Track Determining how many people undergo stem cell treatments is challenging. Oversight of the industry is negligible in many countries, and in the United States, treatments can skirt the FDA approval process by means of an exemption for procedures that involve only minimal manipulation of cells. In the case of structural tissue, minimal manipulation of "human cells and tissues, and cellular and tissue-based product (HCT/P) … means that the processing of the HCT/P does not alter the original relevant characteristics of the tissue relating to the tissue's utility for reconstruction, repair, or replacement," the FDA stated in a recently released draft document provid- ing its latest thinking on the subject. "For cells or nonstructural tissues, minimal manipulation means that the processing of the HCT/P does not alter the relevant biological characteristics of cells or tissues." "An awful lot of people are using that loophole to be able to offer stem cells," McCormack says. "When you hear about professional athletes, football players, get- ting a stem cell therapy for their knees or their neck or some other injury, that's typi- cally what's being done. They're getting their own stem cells that have been taken from their fat and getting them reintroduced." The FDA's draft guidelines clarify that the agency has oversight regarding the use of stem cells derived from fat tissue, says R. Alta Charo, Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin Law School and Medical School. "Even though those [guidelines] tech- nically are not legally binding, they are extremely infl uential," Charo says. "And they certainly set kind of a presumption of what the standard in the fi eld should be." However, determining whether clinics that furnish unregulated treatments are taking that guidance to heart is a struggle. They often decline to release data on patient numbers or outcomes, McCormack notes. "The problem is, we don't know what's going on," he says. "None of this is reported." Charo is equally troubled by the lack of transparency. The FDA must base regula- tions on evidence, she says, so there is a "chicken-and-egg problem" when evidence is lacking. "I can't emphasize enough that there's no system for collecting this data," Charo says. "It's so frustrating … for those of us who are trying to come up with a solution to the problem." To estimate the number of people undergoing unregulated treatments, she adds, researchers often rely on highly inexact methods such as making inferences based on how many people on patient advocacy websites state that they have obtained treatments. Stemming the Tide While the Federal Trade Commission can take action against misleading or untruthful ads, Charo says, lack of data about stem cell treatments makes it diffi cult for the agency to prioritize scrutiny of those types of ads over others. However, search engines such as Google and Yahoo, as well as online marketplaces such as Amazon, are positioned to evaluate such ads and take voluntary action on their own, she says. She also urges medical organizations to educate members about unsubstantiated medical claims. Master recommends that physicians not be dismissive when patients express interest in stem cell treatments, or they may seem unresponsive to patients' needs. Rather, he says, physicians should provide trustworthy resources on the topic that will make it clear the physicians are empathetic. "Patients want to have hope," Master says. "When anyone kills a hope or takes that hope away, that becomes an issue." ■ "It just would sadden me immensely to have somebody waste months or years on [stem cell treatments] that have never really been thoroughly vetted, instead of immediately enrolling in one of the clinical trials that have already been approved because there is some reason to believe they have a possibility of truly helping." — R. Alta Charo, Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin Law School and Medical School M D N E W S . CO M ■ MD NEWS Minnesota | 1 3

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