xxviii
Advantages of Personalized Medicine ...................................................... 651
Limitations of Personalized Medicine ...................................................... 652
References ................................................................................................. 65421 Ethical Aspects of Personalized Medicine ............................................. 655
Introduction to Ethical Issues .................................................................... 655
Ethical Issues of Pharmacogenetics .......................................................... 655
Ethical Aspects of Genetic Information .................................................... 656
Ethical Issues of Whole Genome Analysis ........................................... 656
Ethical Aspects of Direct-to-Consumer Genetic Services .................... 657
Privacy Issues in Personalized Medicine .............................................. 658
Genetic Information Nondiscrimination Act in the US ........................ 659
Genotype-Specifi c Clinical Trials ......................................................... 659
Social Issues in Personalized Medicine .................................................... 660
Race and Personalized Medicine .............................................................. 660
Gene Patents and Personalized Medicine ................................................. 663
References ................................................................................................. 664
22 Regulatory Aspects of Personalized Medicine ...................................... 665
Introduction ............................................................................................... 665
FDA and Personalized Medicine .............................................................. 666
Regulatory Aspects of Pharmacogenetics ............................................. 666
FDA and Pharmacogenomics ................................................................ 667
FDA and Validation of Biomarkers ....................................................... 669
FDA and Predictive Medicine ............................................................... 671
FDA Regulation of Multivariate Index Assays ..................................... 672
Evaluation of Companion Diagnostics/Therapeutic ................................. 674
CLSI Guidelines for RNA Controls in Gene Expression Assays ............. 676
Regulation of Direct-to-Consumer Genetic Testing ................................. 676
Need for Regulatory Oversight of DTC ................................................ 677
References ................................................................................................. 680
23 Economics of Personalized Medicine .................................................... 681
Introduction ............................................................................................... 681
Perceived Financial Concerns ................................................................... 681
Personalized Medicine and Orphan Drug Syndrome ................................ 682
Commercial Aspects of Pharmacogenomics ............................................. 682
Cost of DNA Testing ............................................................................. 682
Lowering the Cost of Sequencing the Human Genome ........................ 683
Cost of Genotyping ............................................................................... 684
Cost of Pharmacogenomics-Based Clinical Trials ................................ 685
Personalized Medicine and the Rising Healthcare Costs in the US ...... 686
Genetic Testing and Cost of Healthcare ................................................ 687
Reducing Healthcare Costs by Combining Diagnostics
with Therapeutics .................................................................................. 687
Costs of Pharmacogenetic Testing ........................................................ 688
Contents