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Show drugs work before selling them

Regulation makes economic sense, argue Douglas Sipp, Christopher McCabe and John E. J. Rasko.

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Correspondence to Douglas Sipp.

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Competing interests

J.E.J.R. is Director of Pathology and a shareholder at the IVF company Genea. He has a management/advisory relationship with the Cure The Future Foundation (honorary Board Member), FSHD Global Research Foundation (honorary Scientific Patron) and New Directions in Leukaemia Research (honorary Scientific Committee member). He is President-Elect 2016–18 of the International Society for Cellular Therapy, which may have links to companies and affiliations with interests in medical technology development. He chairs the RPA Hospital Institutional Biosafety Committee and has chaired the federal Gene Technology Technical Advisory Committee of the Office of the Gene Technology Regulator, Australian Government, for the past ten years. His Department of Cell & Molecular Therapies is involved in clinical development of gene-modified cells, often in collaboration with companies such as Miltenyi, Terumo, Sillajen, Athersys, Cynata and Novartis. Some or all of these are covered by confidential disclosure agreements. He has had paid consulting relationships and/or travel support, as follows: (i) Honoraria for speaking and/or as part of clinical trials by GSK, Spark, Novartis, bluebird bio; (ii) Rarecyte (past scientific consultant, stocks in lieu); (iii) Imago (scientific consultant). His employer, Sydney Local Health District, NSW Government, assisted with travel as part of his salary package for training education and service leave.

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Boom in unproven cell therapies intensifies regulatory debate 2016-Sep-07

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Sipp, D., McCabe, C. & Rasko, J. Show drugs work before selling them. Nature 543, 174–175 (2017). https://doi.org/10.1038/543174a

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