Genetic technologies and the regulation of reproductive decision-making in Australia

This article provides a critical analysis of the current Australian regulatory landscape at the interface between genetics and reproductive decision-making. The authors argue that a comparative analysis with other countries and international law and a contextual examination of the way law regulates concepts such as disease and health, abnormality and normality is necessary before we can develop appropriate policy and legislative responses in this area. Specific genetic testing technologies are considered including prenatal genetic testing, preimplantation genetic diagnosis and inheritable genetic modification. An increasing number of members of the Australian community are using genetic testing technologies when they decide to have a baby. The authors argue that as concepts of disease and health vary among members of the community and the potential to test for traits other than illness increases, a new tension arises between an ethic of individual choice and a role for government in regulating reproductive decision-making.     

The science, studies and sociology of the abortion breast cancer link

This article explains the breast physiology and epidemiologic criteria supporting the abortion breast cancer link and the sociologic factors that cause this risk to remain largely unknown to both medical professionals and the public. Abortion increases breast cancer risk through multiple mechanisms. Pregnancy exposes women to high levels of estrogen acting as a mitogen and genotoxin, and induced abortion then leaves their breasts with more places for cancers to start. They have a higher risk of subsequent premature deliveries that further increase their risks of breast cancer. Rampant breast cancer seen in ever younger women will not allow this issue to be suppressed.     

Natural Settings Trials — Improving the Introduction of Clinical Genetic Tests

Approaches to genetic testing differ in the research setting and the clinical setting. More data are needed to develop approaches that will best facilitate the use of new genetic tests in the clinical setting, especially settings where genetic testing has not been widely used, such as in primary care. Furthermore, data are needed to establish the clinical utility of new genetic tests in the general practice setting. Natural setting trials are proposed as a strategy to develop this information. While natural setting trials are clinical research studies and will expose participants to some degree of risk, the risks are different, and arguably less than the risks those same individuals would otherwise face if the test went directly into clinical practice. Ultimately, clinical practice and safety of new genetic tests can be improved by adding the evaluation provided by natural setting trials.     

Race, Money and Medicines

Taking notice of race is both risky and inevitable, in medicine no less than in other endeavors. On the one hand, race can be a useful stand-in for unstudied genetic and environmental factors that yield differences in disease expression and therapeutic response. Attention to race can make a therapeutic difference, to the point of saving lives. On the other hand, racial distinctions have social meanings that are often pejorative or worse, especially when these distinctions are cast as culturally or biologically fixed. I argue in this essay that we should start with a presumption against racial categories in medicine, but permit their use when it might prolong lives or meaningfully improve health. Use of racial categories should be understood as an interim step; follow-up inquiry into the factors that underlie race-correlated clinical differences is important both to improve the efficacy of clinical care and to prevent race in itself from being misunderstood as a biological determinant. If we pursue such inquiry with vigor, the pernicious effects of racial categories on public understanding can be managed. But perverse market and regulatory incentives create the danger that use of race will be "locked-in," once drugs or other therapies are approved. These incentives should be revisited.     

Legal considerations of sleep deprivation among resident physicians

Medical training in the United States often takes the form of a grueling endurance test in which patients are often those most at risk. This Article discusses sleep deprivation among resident physicians in the United States with an eye towards resolving the problem through legal channels. It analyzes the effects of sleep deprivation on resident physicians, with subsequent discussion of the implications for patient care and medical training. Next, it makes comparisons to medical training in other developed nations, as well as regulations that exist in the airline and trucking industries, where public safety is a principal concern. Furthermore, this Article discusses proposals to mend the dilemmas created by sleep-deprived resident physicians through statutory and regulatory reform, deterrence by way of tort law, and unionization or collective bargaining.     

Whom do physicians work for? An analysis of dual practice in the health sector

This article presents a thorough analysis of dual practice among physicians who work in both the public and private sectors. A conceptual framework is presented to help the reader understand dual practice and the contexts where it takes place. The article reviews the existing theoretical and empirical literature on this form of dual practice among physicians. It analyzes the extent of this phenomenon, the underlying factors that motivate physicians to engage in dual practice, and the main implications of their decision to do so. It also examines and discusses current policies that address dual practice. In this regard, the article provides some qualified support for the use of "rewarding" policies to retain physicians in the public sectors of more developed countries, while "limiting" policies are recommended for developing countries - with the caveat that the policies should be accompanied by the strengthening of institutional and contracting environments. The article highlights the lack of quality evaluative evidence regarding the consequences of dual practice on the delivery of health care services. It concludes that the overall impact of dual practice remains an open question that warrants more attention from researchers and policy makers alike.     

Displaced agendas: current regulatory strategies for germline gene therapy

Recent developments in biotechnology are radically affecting the nature of reproduction and the manner in which we approach disease. In particular, germline gene therapy, or the insertion of genetic material into cells while they are developing and dividing, offers the promise of eradicating genetic defects in humans during embryonic development. In this article, the authors argue that the social and ethical implications of the developments in the field of germline gene therapy have not yet received adequate consideration. Unlike previous technologies which targeted already-developed cells, germline gene therapy can potentially correct and eliminate genetic deficiencies at the developmental stages of a cell. This raises issues of genetic enhancement beyond the therapeutic applications of this technology. However, the authors submit that an established pattern of subordinating social and ethical issues to technical and scientific debate in the regulatory arena is repeating itself in the case of discussions over germline gene therapy. The authors suggest that the American scientific regulatory process fails to fully meet the challenges of this technology, particularly because social and ethical issues are not formally considered in the existing process. They therefore suggest that American regulatory agencies should look to the approach taken by Europe with regard to germline gene therapy as an emerging technology, and that it may be necessary to incorporate effective public debate over social and ethical concerns into a regulatory process which is primarily concerned only with the efficacy of new technologies.     

The ethics of managed care: a dose of realism

This article examines the ethics of medical practice under managed care from a pragmatic perspective that gives physicians more useful guidance than existing ethical statements. The article begins by stating the authors' starting premises and framework for constructing a realistic set of ethical principles: namely, that bedside rationing in some form is permissible; that medical ethics derive from physicians' role as healers; that actual agreements usually trump hypothetical ones; that ethical statements are primarily aspirational, not regulatory; and that preserving patient trust is the primary objective. The authors then articulate the following concrete ethical guides: financial incentives should influence physicians to maximize the health of the group of patients under their care; physicians should not enter into incentive arrangements that they would be embarrassed to describe accurately to their patients or that are not in common use in the market; physicians should treat each patient impartially, without regard to source of payment, and in a manner consistent with the physician's own treatment style; if physicians depart from this ideal, they must tell their patients honestly; and it is desirable, although not mandatory, to differentiate medical treatment recommendations from insurance coverage decisions by clearly assigning authority over these different roles and by having physicians to advocate for recommended treatment that is not covered.     

Underwhelmed: hyperbole,regulatory policy,and the genetic revolution

Rapid advances in the field of genetics in recent years have caused some commentators to suggest the emergence of a "genetic revolution." Such advances have been both praised as the "future of medicine" and condemned for encouraging the acceptance in society of laissez-faire eugenics. Yet the effect of technological advances flowing from the science of genetics appear somewhat overstated as few products of the genetic revolution, particularly in the areas of gene therapy and genetic testing, have managed to satisfy scientists' expectations to date. Furthermore, misdirected regulation of such advances can exacerbate the social, legal, and ethical problems associated with genetics, particularly in the context of health care, where issues of human cloning and the use of premature genetic testing technologies dominate current public debate. In this article, the author criticizes the hyperbolic rhetoric surrounding the genetic revolution and calls for a more balanced and informed approach to the development of genetic policies and regulations. Such an approach should include substantial interdisciplinary debate and an active role on the part of government in the identification and communication of accurate information relating to the effects of recent technological advances in the field of genetics.     

Incidental findings and future testing methodologies: potential application of the ACMG 2013 recommendations

Reactions to the first clinical recommendations for the return of incidental findings (IFs) from genomic sequencing published by the American College of Medical Genetics and Genomics (ACMG) were polarized and resolute. Exploring the three main points of controversy: mandatory testing, testing children for adult conditions, and selection of conditions to be reported on, illuminates concerns for and conservation of bioethical principles—specifically, autonomy and non-directiveness. With the historical context of genetic testing in mind, this article studies the potential application of the ACMG recommendations to embryonic testing in the form of preimplantation genetic diagnosis. Theoretical extension of the current recommendations assists in the identification of bioethical dilemmas and possible societal impacts. The recommendations make a statement on the importance of diagnosis and intervention for specific genetic conditions, setting a precedent for disease classification and patient autonomy. In the extreme, the clinical application of such recommendations prenatally may result in discarded embryos, and less societal tolerance of specific conditions. Skilled professionals, such as genetic counselors, researchers, and lawmakers must work together to maintain patient autonomy, providing care in the best interest of each patient.     

Public sector primary care and Medicaid: trading accessibility for mainstreaming

Facilities operated by public and nonprofit agencies have become increasingly important sources of primary care for Medicaid patients. These facilities are particularly important sources of care in segregated, competitive urban areas, where they are more geographically accessible than many private physicians and expand the availability of care to Medicaid patients rather than substituting for care provided by private physicians. In rural areas, in contrast, the availability of care from public facilities appears to reduce the level of care Medicaid patients receive from private physicians in the counties where these facilities are located. These findings suggest that policymakers can expand urban Medicaid patients' access to care by spending on public care, but at the cost of increasing the segregation of Medicaid patients into a two-tier system of care.     

The national residency exchange: a proposal to restore primary care in an age of microspecialization

Healthcare deficiencies in the United States have long been perpetuated by a shortage of primary care providers. A core purpose of the Patient Protection and Affordable Care Act (PPACA) is to provide health insurance for America's approximately fifty million uninsured. Implementation of universal health insurance, however, does not mean sufficient healthcare access for all, since the supply of physicians does not and will not meet demand. For reasons reviewed in this Article, the current physician shortage mainly impacts primary care providers. This shortage is particularly troubling because increased provision of primary care relative to specialty care has been associated with improvement in health outcomes, disease prevention, cost effectiveness, and coordination of care. This Article highlights provisions in the PPACA that impact primary care physicians. Finally, this Article proposes the creation of a universal primary care loan repayment program and a national residency exchange designed to alleviate the U.S. primary care crisis by facilitating optimal distribution of resident physicians in each medical specialty based on community need.     

Investigating genetic discrimination in the Australian life insurance sector: the use of genetic test results in underwriting, 1999-2003

A major component of the Genetic Discrimination Project (GDP), an Australia-wide study to examine the advantages and disadvantages for individuals of having genetic information and cases of alleged genetic discrimination, is the analysis of insurers' use of genetic test results. The peak life insurance body, IFSA, had collected data through the Australian Institute of Actuaries (AIA) for the period June 1999-May 2003 from life insurance companies in Australia regarding their use of genetic test results in insurance underwriting. The GDP negotiated with IFSA and the AIA for access to this data for independent analysis. Applications from 288 individuals who had disclosed a genetic test result included products for cover for death, trauma/crisis, income protection/disability and total and permanent disablement. A total of 81% (234/288) contained usable data for analysis. These cases involved the genetic conditions haemochromatosis (71%), Huntington disease (12%) and breast/ovarian cancer (6%). In 49% of cases, the genetic test result was described as the only influencing factor and of these, 32% involved a "positive" genetic test result. Whilst underwriting in most cases appeared to be reasonable, the article highlights several cases involving disclosure of a positive predictive test result for breast/ovarian cancer that required further investigation.     

Silicone gel-filled breast prostheses; silicone inflatable breast prostheses: patient risk information--FDA. Notice

The Food and Drug Administration (FDA) is issuing a notice to promote the dissemination of information on risks associated with silicone gel-filled breast prostheses and silicone inflatable ("saline-filled") breast prostheses to women considering having the devices implanted. This notice addresses an important public health issue presented by the continued marketing and implantation of these unapproved devices. FDA has identified significant deficiencies in premarket approval applications for silicone gel-filled breast prostheses. FDA will regard breast prostheses as misbranded under the Federal Food, Drug, and Cosmetic Act (the act) if their labeling does not provide adequate written information to patients on the risks associated with these devices. Such information should be written so as to be easily comprehensible to most patients and should be provided to patients prior to scheduling implantation, so that patients have sufficient time to review the information and discuss it with their physicians. To satisfy the requirements of the act, such patient risk information must set out the known, suspected, and potential risks associated with implantation of these devices. This notice includes suggested patient risk information sheets as guidance.     

Contract health care services; reimbursement and Medicare allowable rates--Bureau of Prisons, Dept. of Justice. Notice

The Bureau of Prisons is issuing this Statement of Policy to inform the public that when it becomes necessary to supplement the direct delivery system of health care the Bureau provides to persons committed to its custody, the Bureau ordinarily will contract to purchase health services only with those hospitals, physicians and other health care providers which agree to accept, as payment in full, reimbursement at rates no higher than the prevailing Medicare allowable rates (including deductibles and co-payments). This encompasses those rates established by the Health Care Financing Administration as "sole community providers" or "regional referral centers". The Bureau will phase this policy into the administration of its contract health services program.     

Preserving human potential as freedom: a framework for regulating epigenetic harms

Epigenetics is a rapidly evolving scientific field of inquiry examining how a wide range of environmental, social, and nutritional exposures can dramatically control how genes are expressed without changing the underlying DNA. Research has demonstrated that epigenetics plays a large role in human development and in disease causation. In a sense, epigenetics blurs the distinction between "nature" and "nurture" as experiences (nurture) become a part of intrinsic biology (nature). Remarkably, some epigenetic modifications are durable across generations, meaning that exposures from our grandparents' generation might affect our health now, even if we have not experienced the same exposures. In the same vein, current exposures could affect the health of not only individuals currently living but also future generations. Given the relative novelty of epigenetics research and the multifactorial nature of human development and disease causation, it is unlikely that conclusive proof can be established showing that particular exposures lead to epigenetic risks that manifest into specific conditions. Using the Capabilities Approach ("CA") developed by Amartya Sen and Martha Nussbaum, this article argues that epigenetic risk is not merely a medical issue, but that it more generally implicates the underlying fairness and justice of our social contract. For instance, how we develop mentally or physically has a tremendous impact upon our inherent capabilities and our set of life options. The CA prompts us to ask questions such as: (1) what impact do particular epigenetic risks have on our ability to exercise free choices; (2) are these risks avoidable; and (3) how are these risks distributed across society? Due to the complex nature of epigenetic risk, tort law is predictably incapable of addressing this harm. Further, while regulatory agencies possess the statutory authority to begin addressing epigenetic harms, currently these agencies are not attuned to measure or to respond to this type of harm. This article argues that it is imperative to initiate a regulatory framework to address epigenetic risk from specific substances even if conclusive proof of disease causation cannot be established. Shifting the burden of generating epigenetic risk data to producers of suspected harmful substances serves as a start. As information concerning epigenetic risks accrues, the regulatory response should evolve concurrently. As part of a dynamic policy-making approach our goals need to encompass the following: (i) promotion of knowledge in the scientific, legal, and public domains; (ii) assessment and modification of current regulations to address preventable risk; and (iii) an overarching commitment to protect human capabilities in an equitable manner.     

The Federal Trade Commission, clinical integration, and the organization of physician practice

This article examines Federal Trade Commission (FTC) policy--in particular, the agency's controversial 1996 statements on clinical integration--toward joint negotiations for nonrisk contracts with health plans by physicians organized into independent practice associations (IPAs) and (with hospitals) into physician-hospital organizations (PHOs). The article concludes that the policy is consistent with anti-trust principles, consistent with current thinking on the use of organized processes to improve medical care quality, specific enough to provide guidance to physicians wanting to integrate clinically, and general enough to encourage ongoing innovations in physician organization. The FTC should consider stronger sanctions for IPAs and PHOs whose clinical integration is nothing more than a sham intended to provide cover for joint negotiations, should give the benefit of the doubt to organizations whose clinical integration appears to be reasonably consonant with the statements, and should clarify several ambiguities in the statements. Health plans should facilitate IPA and PHO efforts to improve care by rewarding quality and efficiency and by providing clinically integrated organizations with claims information on individual patients. Though creating clinically integrated organizations is difficult and expensive, physicians should recognize that clinical integration can help them both to gain some negotiating leverage with health plans and to improve the quality of care for their patients.     

Genetic testing,genetic medicine,and managed care

As modern human genetics moves from the research setting to the clinical setting, it will encounter the managed care system. Issues of cost, access, and quality of care will affect the availability and nature of genetic testing, genetic counseling, and genetic therapies. This Article will explore such issues as professional education, coverage of genetic services, privacy and confidentiality, and liability. It will conclude with a series of recommendations for the practice of genetic medicine in the age of managed care.     

Balancing regulatory controls and incentives: toward smarter and more transparent oversight in long-term care

Government oversight of long-term care involves inspections of patients' records, limited observations of patients and care practices, reviews of policies and procedures, and distribution of publicly available information. Although many providers bemoan the stifling consequences of excessive regulation, oversight in this area remains a highly legitimate endeavor for the public, though the public has limited trust in the existing regulatory regime. This distrust stems from many sources, not least of which includes considerable variation, both within and across states, in the way government oversight occurs. Reforming the current regulatory structure requires that we regulate "smarter" and more consistently. This means improving and maximizing use of the data already being collected, but it also means explicitly rationalizing the regulator's responsibility to review performance and apply sanctions when necessary. Oversight should more closely resemble consultancy, with regulators sharing information with providers about how to improve quality. Ideally, there needs to be an iterative process in which state inspectors identify performance problems and the nation's quality improvement organizations then help providers design quality improvement interventions to ameliorate the problems identified. The benefits of a revised regulatory approach are especially apparent in the aftermath of Hurricane Katrina, where more effective oversight would have identified nursing home residents at risk for low-quality care before the disaster occurred while better identifying those in need of evacuation or assistance afterward.     

The legal status of clinical and ethics policies, codes, and guidelines in medical practice and research

This article examines the legal status of "soft law" in the fields of medicine and medical research. Many areas of clinical practice and research involve complex and rapidly changing issues for which the law provides no guidance. Instead, guidance for physicians and researchers comes from what has often been called "soft law"--non-legislative, non-regulatory sources, such as ethics policy statements, codes, and guidelines from professional or quasi-governmental bodies. This article traces the evolution of these "soft law" instruments: how they are created, how they are adopted within the professional community, and how they become accepted by the courts. It studies the relationship between soft law instruments and the courts. It includes an examination of the approaches to judicial analysis used by the courts in theory and in practice. The authors then examine the jurisprudence to see how courts will adopt professional norms as the legal standard of care in some circumstances and not others. They consider the legal concerns and ethical issues surrounding the weight attached to professional practices and norms in law. The authors demonstrate how practices and policies that guide professional conduct may ultimately bear weight as norms recognizable and enforceable within the legal sphere.