2023-11-28 バッファロー大学(UB)
◆デューク大学のIkonomou准教授は、この問題に対処するための戦略を提案するガイドの主著者であり、FDAがこれらのクリニックに送っている手紙を監視している。彼は経済的利益が主な動機であり、これらの治療法は高価なプラセボに過ぎないと指摘している。
◆直販ビジネスの濫用が特にカリフォルニア、フロリダ、テキサス、アリゾナで顕著であり、これに対する規制と法制度の強化が必要としている。
<関連情報>
- https://www.buffalo.edu/news/releases/2023/11/unproven-stem-cell-therapy.html
- https://www.isct-cytotherapy.org/article/S1465-3249(23)00064-6/fulltext
国際細胞・遺伝子治療学会のポジションペーパー: 証拠に基づいた細胞・遺伝子治療を支持し、証明されていない製品のマーケティングに反対するための重要な考慮事項 International Society for Cell & Gene Therapy Position Paper: Key considerations to support evidence-based cell and gene therapies and oppose marketing of unproven products
Laertis Ikonomou,Natividad Cuende,Miguel Forte,Bambi J. Grilley,Aaron D. Levine,Megan Munsie,John E.J. Rasko,Leigh Turner,Hamid R. Bidkhori,Rachele Ciccocioppo,Felix Grignon,Alok Srivastava,Daniel J. Weiss,Patricia Zettler,Bruce L. Levine
Cytotherapy Accepted: March 6, 2023
DOI:https://doi.org/10.1016/j.jcyt.2023.03.002
Abstract
The field of regenerative medicine, including cellular immunotherapies, is on a remarkable growth trajectory. Dozens of cell-, tissue- and gene-based products have received marketing authorization worldwide while hundreds-to-thousands are either in preclinical development or under clinical investigation in phased clinical trials. However, the promise of regenerative therapies has also given rise to a global industry of direct-to-consumer offerings of prematurely commercialized cell and cell-based products with unknown safety and efficacy profiles. Since its inception, the International Society for Cell & Gene Therapy Committee on the Ethics of Cell and Gene Therapy has opposed the premature commercialization of unproven cell- and gene-based interventions and supported the development of evidence-based advanced therapy products. In the present Guide, targeted at International Society for Cell & Gene Therapy members, we analyze this industry, focusing in particular on distinctive features of unproven cell and cell-based products and the use of tokens of scientific legitimacy as persuasive marketing devices. We also provide an overview of reporting mechanisms for patients who believe they have been harmed by administration of unapproved and unproven products and suggest practical strategies to address the direct-to-consumer marketing of such products. Development of this Guide epitomizes our continued support for the ethical and rigorous development of cell and cell-based products with patient safety and therapeutic benefit as guiding principles.
