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Medical Utopias: The Promise of Emerging Technologies

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Medical utopias are often about good health, absence of suffering, and even delaying of the aging process. The last two decades have seen a tremendous increase in emerging medical technologies to achieve these utopias. The completion of the sequencing of the human genome sets the stage for the next step of genetic and molecular advances. The increase in computing power, storage capacity, connectivity, and the Internet has opened avenues of new diagnostic and therapeutic modalities. The perfecting of sustaining cell growth in vitro and cell nucleus transfer has opened the way to cloning, stem cell harvesting, and a new field of regenerative medicine. However, these emerging technologies bring with them a large number of bioethical concerns that need to be addressed. These concerns involving tissue engineering, bioelectronics, new genetics, cloning, gene therapy, germ-line genome modifications are only the tip of the iceberg. In this paper I will reflect on three areas of concern. Firstly, the emergence of the digital patient will be considered. This digital patient will be deeply formed and informed by health information technology (IT), the social media, and issues involving privacy, confidentiality and data security. Secondly, the direct to customers (DTC) genetic screening tests will be discussed. The ethical issue of buccal swabs taken at home and be tested for genetic diseases and future prediction of other illnesses which is marketed directly to the consumers will be examined. Finally, the development of new pharmaco-therapeutics will be explored. There have been changes in the way new drugs are tested and these changes do raise some ethical concerns. The examination of these ethical issues will be done in the framework of respect for autonomy, beneficence, non-maleficence, and justice.

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Medical Utopias: The Promise of Emerging Technologies

  1. 1. Medical Utopias Ethical Reflections about Emerging Medical Technologies Dr Alex Tang MD PhD Consultant Paediatrician KPJ Johor Specialist Hospital
  2. 2. • Living without pain, diseases or even dying • No more fertility or reproductive problems • Delaying or defying the aging process • Personalized genomic medicine (P4 Medicine) • Optimize and enhance normal abilities Medical Utopias
  3. 3. Emerging Technologies Consumer Expectation Healthcare providers Healthcare professionals Medical Utopias and Emerging Technologies
  4. 4. Respect for Autonomy Beneficence Non-maleficence Justice Biomedical Ethics Framework Beauchamp and Childress; Principles Biomedical Ethics, OUP, 5th edition 2001
  5. 5. 1. Already in clinical applications (include phase 3 trials) 2. Research fields at preclinical stages 3. Research fields at purely theological stages Ethical areas of concern
  6. 6. 1. Already in clinical applications (include phase 3 trials) – tissue engineering, bioelectronics, health IT, genetic tests, drugs testing 2. Research fields at preclinical stages - reproductive cloning, germ line genome modification, interventions in biological aging process 3. Research fields at purely theological stages – nanotechnology, virtual digital patient Ethical areas of concern
  7. 7. 1. The emergence of the digital patient (to be or not be be) 2. The direct to customer (DTG) genetic screening (to know or not to know) 3. The development of new pharmaco-therapeutics (to treat or not to treat) Ethical Reflections on Emerging Medical Technologies
  8. 8. Medical Utopias Ethical Reflections about Emerging Medical Technologies 1. The Emergence of the Digital Patient
  9. 9. Health IT and patient care Ethical Reflection on the Digital Patient
  10. 10. Use and Characteristics of Electronic Health Record Systems Among Office-based Physician Practices: United States, 2001–2013 NCHS Data Brief Number 143, January 2014 http://www.cdc.gov/nchs/data/databriefs/db143.htm Percentage of office-based physicians with EHR systems: United States, 2001–2013 HITECH Medicare and Medicaid EHR Incentive Programs
  11. 11. Health IT Administrative Functionality Health Management Functionality Medical Device Functionality Ethical Reflections: Digital Patient FDASIA Health IT Report April 2014
  12. 12. • Is health IT the key to better healthcare? Ethical reflection
  13. 13. • One quarter of the hospitalizations (937 admissions) had at least 1 ADE • 9% resulted in serious harm, 22% in additional monitoring and interventions, 32% in interventions alone, and 11% in monitoring alone • Errors associated with ADEs: 61% ordering, 25% monitoring, 13% administration, 1% dispensing, and 0% transcription Nebeker JR, Hoffman JM, Weir CR, Bennett CL, Hurdle JF. High Rates of Adverse Drug Events in a Highly Computerized Hospital. Arch Intern Med. 2005;165(10):1111-1116. doi:10.1001/archinte.165.10.1111. Adverse Drug Events (ADEs) in a Highly Computerized Hospital (20 week period)
  14. 14. Technology People ProcessOrganisation External Environment Health IT Sociotechnical System FDASIA Health IT Report April 2014
  15. 15. • Poorly designed health IT new hazards in an already complex system of health care delivery • Individual health IT components may meet their stated performance requirements, yet the system as a whole may yield unsafe outcomes • Problematic events involving complex systems often cannot be ascribed to a single causative factor • Poor human-computer interactions can contribute to serious injury and death Issues in health IT Sociotechnical System
  16. 16. • e-iatrogenesis • e-iatrogenic Issues in health IT Sociotechnical System
  17. 17. • Is health IT the key to better healthcare? • Data interoperability – will it ever be resolved? Ethical reflection
  18. 18. Health IT is a practical tool not a replacement for quality patient care Ethical reflection Norman Rockwell, Saturday Post Archives
  19. 19. Health IT and patient care Privacy, Confidentiality, Security Ethical Reflection on the Digital Patient
  20. 20. Ethical reflection
  21. 21. • Most patients not aware of their right to privacy and confidentiality • Cheaper and faster to develop non-privacy aware health IT software solutions • Healthcare provider consolidation • Hackers Privacy, confidentiality, security: how safe is the data? Employers Insurance companies Law
  22. 22. • Is our healthcare providers keeping their data secure? • Are we educating our patients on their privacy rights? • Do we allow patient to access their own medical records? • Data Protection Regulation Ethical reflection
  23. 23. Medical Utopias Ethical Reflections about Emerging Medical Technologies 2. Direct to Customers (DTC) genetic screening
  24. 24. Direct To Consumer (DTC) Screening Tests
  25. 25. • Scientific accuracy, clinical validity and utility of genetic tests • Absence of and/or quality of pre- and post-test counselling • Absence of individualized medical supervision • Lack of adequate consent procedures • Respect for privacy and confidentiality Direct To Consumer (DTC) Screening Tests
  26. 26. • What is to be done about direct to consumer (DTC) genetic screening tests? • Role of regulating direct to consumer medical tests? Ethical Reflections
  27. 27. Medical Utopias Ethical Reflections on Emerging Medical Technologies 3. Development of new pharmacotherapeutics
  28. 28. Ethical Concerns on Pharmacotherapeutics Testing for carcinogenicity Pharmacogenomics
  29. 29. • Test for carcinogenicity – Short term in vitro mutagenicity test – Lifespan in vivo tests in rodents (two species) • 12-24 months • expensive Testing of new drugs
  30. 30. • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) approved using genetic engineered rats for one species short term lifespan studies in 1997 • The validation was done in the 2000s by International Life Sciences Institute (ILSI) Short term lifespan rodent studies
  31. 31. • How accurate are these studies using genetically engineered rats? • How safe are the new drugs? Ethical Reflections
  32. 32. Ethical Concerns on Pharmacotherapeutics Testing for carcinogenicity Pharmacogenomics
  33. 33. • Design of clinical trails • Cost as a barrier to access • Professional standards of care Ethical Concerns on Pharmacogenomics
  34. 34. Emerging Technologies Consumer Expectation Healthcare providers Healthcare professionals Medical Utopias and Emerging Technologies Beauchamp and Childress; Principles Biomedical Ethics, OUP, 5th edition 2001 Respect for Autonomy Beneficence Non-Maleficence Justice
  35. 35. Ethical Reflections

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