FinkD. W., “FDA Regulation of Stem Cell-based Products,”Science324, no. 5935 (2009): 1662–1663.
2.
DiMasiJ. A.HansenR. W.GrabowskiH. G., “The Price of Innovation: New Estimates of Drug Development Costs,”Journal of Health Economics22, no. 2 (2003): 151–185.
3.
McKneallyM. F., “Ethical Problems in Surgery: Innovation Leading to Unforeseen Complications,”World Journal of Surgery23 (1999): 786–788; McKneallyM. F.DaarA. S., “Introducing New Technologies: Protecting Subjects of Surgical Innovation and Research,”World Journal of Surgery27 (2003): 930–935; AgichG. J., “Ethics and Innovation in Medicine,”Journal of Medical Ethics27 (2001): 295–296; ReitsmaA. M.MorenoJ. D., “Ethical Regulations for Innovative Surgery: The Last Frontier?”Journal of the American College of Surgeons194 (2002): 792–801; ReitsmaA. M.MorenoJ. D., “Ethics of Innovative Surgery: US Surgeons' Definitions, Knowledge, and Attitudes,”Journal of the American College of Surgeons200 (2005): 103–110.
Cook-DeeganR., The Gene Wars: Science, Politics and the Human Genome (New York: Norton and Co., 1996).
6.
See Geron, Geron Receives FDA Clearance to Begin World's First Human Clinical Trial of Embryonic Stem Cell-Based Therapy, Press Release, January 23, 2009.
7.
KeirsteadH. S.NistorG.BernalG.TotoiuM.CloutierF.SharpK.StewardO., “Human Embryonic Stem Cell-Derived Oligodendrocyte Progenitor Cell Transplants Remyelinate and Restore Locomotion after Spinal Cord Injury,”Journal of Neuroscience25, no. 19 (2005): 4694–705.
8.
See Geron, Geron and FDA Reach Agreement on Clinical Hold, Press Release, October 30, 2009.
9.
EmanuelE. J.WendlerD.GradyC., “What Makes Clinical Research Ethical?”JAMA283, no. 20 (2000): 2701–2711.
10.
MooreF. D., “Three Ethical Revolutions: Ancient Assumptions Remodeled Under Pressure of Transplantation,”Transplantation Proceedings20, 1Suppl. 1 (1988): 1061–7; MooreF. D., “The Desperate Case: CARE (Costs, Applicability, Research, Ethics),”JAMA261, no. 10 (1989): 1483–1484.
11.
AgrawalM.EmanuelE. J., “Ethics of Phase I Oncology Studies: Reexamining the Arguments and Data,”JAMA290, no. 8 (2003): 1075–1082.
KingN. M.HendersonG. E.ChurchillL. R.DavisA. M.HullS. C.NelsonD. K.Parham-VetterP.C.RothschildB. B.EasterM. M.WilfondB. S., “Consent Forms and the Therapeutic Misconception: The Example of Gene Transfer Research,”IRB27 (2005): 1–8.
14.
KimmelmanJ.LevenstadtA., “Elements of Style: Consent Form Language and the Therapeutic Misconception in Phase I Gene Transfer Trials,”Human Gene Therapy16, no. 4 (2005): 502–508.
15.
Id.
16.
See King, supra note 13.
17.
Please note: The author is a member of the CDHP Advisory Committee and drafted the guidelines concerning clinical trials.