School of Biological & Health Systems Engineering, Arizona State University, Tempe, AZ 85287, USA.
School of Biological & Health Systems Engineering, Arizona State University, Tempe, AZ 85287, USA; School for the Future of Innovation in Society, Arizona State University, Tempe, AZ 85287, USA.
Stem Cell Reports. 2021 Dec 14;16(12):2852-2860. doi: 10.1016/j.stemcr.2021.10.007. Epub 2021 Nov 11.
Hundreds of businesses across the United States offer direct-to-consumer stem-cell-based interventions that have not been approved by the Food and Drug Administration. Here, we characterize the types of evidence used on the websites of 59 stem cell businesses in the Southwest United States to market their services. We identify over a dozen forms of evidence, noting that businesses are less likely to rely on "gold-standard" scientific evidence, like randomized clinical trials, and instead draw substantially on forms of evidence that we identify as being "ambiguous." Ambiguous evidence has some scientific or medical basis, but its interpretation is highly context-dependent. These findings highlight the interpretive responsibility placed on prospective patients. We identify actions for regulators and professional societies to assist with evaluating evidence, but caution that focusing on the (in)validity of particular evidence types is unlikely to eliminate demand for stem-cell-based treatments in this complex marketplace.
美国数以百计的企业提供未经食品和药物管理局批准的直接面向消费者的基于干细胞的干预措施。在这里，我们描述了美国西南部 59 家干细胞企业网站上用于推销其服务的证据类型。我们确定了十几种形式的证据，注意到企业不太可能依赖“金标准”科学证据，如随机临床试验，而是大量依赖我们称之为“模糊”的证据形式。模糊证据具有一定的科学或医学基础，但对其的解释高度依赖于具体情况。这些发现强调了对潜在患者的解释责任。我们确定了监管机构和专业协会采取的行动来协助评估证据，但警告说，关注特定证据类型的（不）有效性不太可能消除在这个复杂市场中对基于干细胞的治疗的需求。
