Current Pharmacogenomics and Personalized Medicine, Dec 1, 2009
ABSTRACT Nanotechnology and personalized medicine are two of the most rapidly emerging areas of b... more ABSTRACT Nanotechnology and personalized medicine are two of the most rapidly emerging areas of biomedical research, as well as two of the most promising technologies for improving health care and health outcomes. They are also rapidly converging in numerous current and future clinical applications. Examples include the use of nanotechnology for im-proved DNA sequencing and SNP analysis, the development of nano-therapeutics that can target specific cell and tissue types, biosensors for specific proteins and other molecules in vivo, and point-of-care molecular diagnostic devices enabled by nanotechnology. Nanotechnology offers many advantages for personalized medicine applications, including a size that matches the scale of the molecular substrates of personalized medicine, an increased sensitivity in detecting and binding with target molecules, and flexibility in the design and function of therapeutics and diagnostics at the nano scale. Yet, at the same time, the utilization of nanotechnology in personalized medicine may create uncertainties or risk relating to po-tential toxicity. In addition to describing the scientific and technical opportunities and challenges in applying nanotech-nology to personalized medicine, this article also addresses some of the policy, legal and ethical issues raised by the con-vergence of nanotechnology and personalized medicine.
6073 Background: The adoption of new genetic technologies into clinical practice has been much sl... more 6073 Background: The adoption of new genetic technologies into clinical practice has been much slower than many predicted. Though many factors underlie this delay, the current gap between public expectations and actual practice makes physicians extraordinarily vulnerable to medical malpractice lawsuits. Courts are beginning to take a lead role in setting the standards for genetic testing within the medical field. Because physicians' responsibilities related to genetics are still in flux and rapidly evolving, the expectations placed on them are unclear and remain largely dependent on a case's judge, jury, and jurisdiction. METHODS A search of a legal case database (Westlaw) for all federal and state cases involving liability relating to genetic testing was conducted. All cases involving malpractice claims against physicians or other health professionals for alleged negligence in recommending, conducting, or reporting genetic tests were included. The basis for litigation and outcomes of the cases were summarized. RESULTS Over 50 cases were identified in which health care providers-mainly physicians-were sued for their negligence in using and applying genetic testing methods. Of these, only three cases related to a hereditary cancer, though the causes of action recognized by the courts in other cases apply to hereditary cancers as well. Physicians were held liable for failing to: take an adequate family history, recommend the appropriate testing, refer to a geneticist or genetic counselor, interpret the test results correctly, interpret the test results in a timely manner, recommend the appropriate risk mitigation strategies, and failing to disclose their patients' test results to at-risk family members. CONCLUSIONS Though drug manufacturers, hospitals, and pharmacists have all been the subject of lawsuits related to genetic technologies, physicians appear to be the most vulnerable group. Courts are willing to require the use and understanding of genetic information even before the medical community itself is ready and able to do so. The number of lawsuits physicians will face in the future is likely to mushroom as the field of genetics continues to grow and public expectations continue to be fed by an optimistic media.
Artificial Intelligence (AI) is positioned to be a foundational technology in most industrial sec... more Artificial Intelligence (AI) is positioned to be a foundational technology in most industrial sectors, societal interactions, as well as in many other technological advantages. AI is rapidly evolving with the promise of bettering our businesses, keeping us safer, and transforming us into a better society. At the same time, we know there will be concerns, some anticipated, and many that will develop alongside the technology itself. Its ubiquitous nature and rapid pace of development make traditional governance structures difficult to impose. However, there are a number of “soft-law” or non-legally binding tools that offer the flexibility needed to foster innovation safely.
The process of risk assessment has the potential to improve the factual component of health risk ... more The process of risk assessment has the potential to improve the factual component of health risk decision making in several forums (e.g. regulatory agencies, courts, workers compensation boards, etc.). However, the use of RA as evidence for decision making must be consistent with forum rules which govern the admissibility and value of scientific evidence. Risk assessment is a analytical tool utilized quantitatively to estimate public health risks. By its nature, there are definite weaknesses is using the process as evidence for risk decision making. The information database in RA is not complete; it involves uncertainty due to limited data available and from unresolved methodological issues which together create areas of conflict where scientific judgments or policy decisions must be made.
A growing body of scientific evidence suggests that some otherwise toxic agents may have a health... more A growing body of scientific evidence suggests that some otherwise toxic agents may have a health protective effect at very low concentrations. The regulatory and legal implications of these findings of "hormesis" are just now beginning to be evaluated systematically, and Professor Frank Cross has provided a valuable "first cut" of these issues. As Cross and others have noted, regulators have, to date, been resistant to incorporating hormesis into regulatory decision making, although there have been few, if any, specific regulatory proceedings in which hormesis arguments have been squarely and fully presented. At least four conditions are necessary for hormesis to have significance in regulatory decision making. First, there must be credible scientific evidence of a hormetic effect for the specific agent being regulated. Second, hormesis must be relevant to the regulatory decision in that the regulatory outcome might be different if hormesis is considered. Third, the agency's statutory authority must not preclude consideration of hormesis. Fourth, the regulatory agency must be receptive to considering hormesis. This commentary addresses only the last of these four conditions by evaluating whether agencies are likely to be amenable to considering hormesis, and how reluctant agencies may be forced to consider valid hormesis evidence through the mechanism of judicial review. Specifically, this commentary dis-
Are consumers entitled to full disclosure about what is in their food? The authors contend that m... more Are consumers entitled to full disclosure about what is in their food? The authors contend that mandatory GM labeling laws actually harm consumers by pushing GM foods off the market.
Current Pharmacogenomics and Personalized Medicine, Dec 1, 2009
ABSTRACT Nanotechnology and personalized medicine are two of the most rapidly emerging areas of b... more ABSTRACT Nanotechnology and personalized medicine are two of the most rapidly emerging areas of biomedical research, as well as two of the most promising technologies for improving health care and health outcomes. They are also rapidly converging in numerous current and future clinical applications. Examples include the use of nanotechnology for im-proved DNA sequencing and SNP analysis, the development of nano-therapeutics that can target specific cell and tissue types, biosensors for specific proteins and other molecules in vivo, and point-of-care molecular diagnostic devices enabled by nanotechnology. Nanotechnology offers many advantages for personalized medicine applications, including a size that matches the scale of the molecular substrates of personalized medicine, an increased sensitivity in detecting and binding with target molecules, and flexibility in the design and function of therapeutics and diagnostics at the nano scale. Yet, at the same time, the utilization of nanotechnology in personalized medicine may create uncertainties or risk relating to po-tential toxicity. In addition to describing the scientific and technical opportunities and challenges in applying nanotech-nology to personalized medicine, this article also addresses some of the policy, legal and ethical issues raised by the con-vergence of nanotechnology and personalized medicine.
6073 Background: The adoption of new genetic technologies into clinical practice has been much sl... more 6073 Background: The adoption of new genetic technologies into clinical practice has been much slower than many predicted. Though many factors underlie this delay, the current gap between public expectations and actual practice makes physicians extraordinarily vulnerable to medical malpractice lawsuits. Courts are beginning to take a lead role in setting the standards for genetic testing within the medical field. Because physicians' responsibilities related to genetics are still in flux and rapidly evolving, the expectations placed on them are unclear and remain largely dependent on a case's judge, jury, and jurisdiction. METHODS A search of a legal case database (Westlaw) for all federal and state cases involving liability relating to genetic testing was conducted. All cases involving malpractice claims against physicians or other health professionals for alleged negligence in recommending, conducting, or reporting genetic tests were included. The basis for litigation and outcomes of the cases were summarized. RESULTS Over 50 cases were identified in which health care providers-mainly physicians-were sued for their negligence in using and applying genetic testing methods. Of these, only three cases related to a hereditary cancer, though the causes of action recognized by the courts in other cases apply to hereditary cancers as well. Physicians were held liable for failing to: take an adequate family history, recommend the appropriate testing, refer to a geneticist or genetic counselor, interpret the test results correctly, interpret the test results in a timely manner, recommend the appropriate risk mitigation strategies, and failing to disclose their patients' test results to at-risk family members. CONCLUSIONS Though drug manufacturers, hospitals, and pharmacists have all been the subject of lawsuits related to genetic technologies, physicians appear to be the most vulnerable group. Courts are willing to require the use and understanding of genetic information even before the medical community itself is ready and able to do so. The number of lawsuits physicians will face in the future is likely to mushroom as the field of genetics continues to grow and public expectations continue to be fed by an optimistic media.
Artificial Intelligence (AI) is positioned to be a foundational technology in most industrial sec... more Artificial Intelligence (AI) is positioned to be a foundational technology in most industrial sectors, societal interactions, as well as in many other technological advantages. AI is rapidly evolving with the promise of bettering our businesses, keeping us safer, and transforming us into a better society. At the same time, we know there will be concerns, some anticipated, and many that will develop alongside the technology itself. Its ubiquitous nature and rapid pace of development make traditional governance structures difficult to impose. However, there are a number of “soft-law” or non-legally binding tools that offer the flexibility needed to foster innovation safely.
The process of risk assessment has the potential to improve the factual component of health risk ... more The process of risk assessment has the potential to improve the factual component of health risk decision making in several forums (e.g. regulatory agencies, courts, workers compensation boards, etc.). However, the use of RA as evidence for decision making must be consistent with forum rules which govern the admissibility and value of scientific evidence. Risk assessment is a analytical tool utilized quantitatively to estimate public health risks. By its nature, there are definite weaknesses is using the process as evidence for risk decision making. The information database in RA is not complete; it involves uncertainty due to limited data available and from unresolved methodological issues which together create areas of conflict where scientific judgments or policy decisions must be made.
A growing body of scientific evidence suggests that some otherwise toxic agents may have a health... more A growing body of scientific evidence suggests that some otherwise toxic agents may have a health protective effect at very low concentrations. The regulatory and legal implications of these findings of "hormesis" are just now beginning to be evaluated systematically, and Professor Frank Cross has provided a valuable "first cut" of these issues. As Cross and others have noted, regulators have, to date, been resistant to incorporating hormesis into regulatory decision making, although there have been few, if any, specific regulatory proceedings in which hormesis arguments have been squarely and fully presented. At least four conditions are necessary for hormesis to have significance in regulatory decision making. First, there must be credible scientific evidence of a hormetic effect for the specific agent being regulated. Second, hormesis must be relevant to the regulatory decision in that the regulatory outcome might be different if hormesis is considered. Third, the agency's statutory authority must not preclude consideration of hormesis. Fourth, the regulatory agency must be receptive to considering hormesis. This commentary addresses only the last of these four conditions by evaluating whether agencies are likely to be amenable to considering hormesis, and how reluctant agencies may be forced to consider valid hormesis evidence through the mechanism of judicial review. Specifically, this commentary dis-
Are consumers entitled to full disclosure about what is in their food? The authors contend that m... more Are consumers entitled to full disclosure about what is in their food? The authors contend that mandatory GM labeling laws actually harm consumers by pushing GM foods off the market.
Globally, citizens exist for sustained periods in states of aging-related disease and multimorbid... more Globally, citizens exist for sustained periods in states of aging-related disease and multimorbidity. Given the urgent and unmet clinical, health care, workforce, and economic needs of aging populations, we need interventions and programs that regenerate tissues and organs and prevent and reverse aging-related damage, disease, and frailty (1). In response to these challenges, the World Health Organization (WHO) has called for a comprehensive public-health response within an international legal framework based on human rights law (1). Yet for a clinical trial to be conducted, a disease to be diagnosed, intervention prescribed, and treatment administered; a corresponding disease classification code is needed, adopted nationally from the WHO International Classification of Diseases (ICD). Such classifications and staging are fundamental for health care governance among governments and intergovernmental bodies. We describe a systematic and comprehensive approach to the classification and staging of organismal senescence and aging-related diseases at the organ and tissue levels in order to guide policy and practice and enable appropriate interventions and clinical guidance, systems, resources, and infrastructure.
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Papers by Gary Marchant