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Biomedical subjects

Franklin G Miller

Publications and source records attributed to Franklin G Miller.

At least 19 recordsLinked to original sources
PubMed2006

Justice and fairness in the Kennedy Krieger Institute lead paint study: the ethics of public health research on less expensive, less effective interventions.

The Kennedy Krieger lead paint study stirred controversial questions about whether research designed to develop less expensive interventions that are not as effective as existing treatments can be ethically warranted. Critics questioned the social value of such research and alleged that it sanctions a double standard, exploits participants, and is complicit in perpetuating the social injustice. In response, we demonstrate the propriety of conducting research on interventions that can be extended to the population in need by stipulating the limited conditions in which it is ethically warranted and providing fair terms of participation. We contend that the failure to conduct such research causes greater harm, because it deprives disadvantaged populations of the benefits of imminent incremental improvements in their health conditions.

Baltimore↗
PubMed2006

The nature and power of the placebo effect.

Progress in understanding the placebo effect and its clinical significance depends on conceptual clarification of this elusive phenomenon and critical appraisal of research bearing on the influence of placebo interventions on clinical outcomes. Here we locate the placebo effect within a typology of modes of healing, distinguish between the observed placebo response in randomized controlled trials and the placebo effect, and examine critically a recent meta-analysis of clinical trials that challenges the reality of the placebo effect.

Analgesia↗
PubMed2005

The relevance of empirical research in bioethics.

Empirical research related to ethical issues in clinical research has grown dramatically in recent years. However, little attention has been devoted to the ethical relevance of the findings from this research. In order to examine the value and limitations of ethics-related empirical research, we discuss 3 case studies involving research with stored biological samples, placebo-controlled trials, and the idea of the therapeutic misconception.

Bioethics↗
PubMed2005

Research with stored biological samples: what do research participants want?

BACKGROUND: There is widespread disagreement about the type of consent needed for research with stored biological samples. Many believe consent for each future use is required to respect individuals. Others worry this approach may block important research. METHODS: We analyzed 1670 consent forms signed by research participants at the Warren G. Magnuson Clinical Center, National Institutes of Health, between January 1, 2000, and May 31, 2002, that offer options for future research with participants' biological samples. The research participants were healthy volunteers, family members of affected individuals, and individuals with a broad range of medical conditions enrolled in clinical research studies with and without the prospect of direct medical benefit. RESULTS: Overall, 87.1% of research participants given the option chose to authorize future research on any medical condition. More than 85% permitted unlimited future research with their stored biological samples regardless of sex, age, geographic location, or whether the individual was affected by the disease being studied or a healthy volunteer. Only 6.7% of those given the option to refuse all future research did so. Although African Americans were less likely to permit future research, 75.0% of African Americans still authorized unlimited future research with their samples. CONCLUSIONS: Most research participants authorize the unlimited future research use of their biological samples when given the opportunity to do so. These findings suggest that providing research participants with a simple binary choice to authorize or refuse all future research might allow individuals to control use of their samples, simplify consent forms, and allow important research to proceed.

Biological Specimen Banks↗
PubMed2005

Ethical issues in surgical research.

Higher standards of evidence for surgical procedures are likely to be demanded in the future by health insurance providers. Consequently, more formal and rigorous surgical research, including RCTs, will become more prevalent. Facing the ethical challenges of surgical research requires understanding of the ethically significant differences between surgical practice and research and the ways in which the ethical standards appropriate for the design and conduct of clinical research differ from the ethics of clinical care.

Ethics, Clinical↗
PubMed2005

Viewpoint: what is the best and most ethical model for the relationship between mainstream and alternative medicine: opposition, integration, or pluralism?

Despite radical improvements in medicine over the past 60 years, patients maintain multiple health care pathways that include high utilization of unconventional treatments. The authors examine three possible relationships between mainstream and alternative medicine: opposition, integration, and pluralism. Opposition, the traditional ethical position that the medical profession must eradicate unconventional medicine for the good of the patient, has withered away. Integration of mainstream and alternative medicine is increasingly advocated in tandem with hospital-based programs that amalgamate the use of conventional and alternative therapies. While advocates of integrative medicine often speak of "evidence-based" complementary and alternative medicine (CAM), integration fosters double standards for validating conventional and unconventional treatments. Integration also ignores unbridgeable epistemological beliefs and practices between mainstream and alternative medicine. Pluralism, which has been relatively ignored, calls for cooperation between the different medical systems rather than their integration. By recognizing the value of freedom of choice in medical options, pluralism is compatible with the principle of patient autonomy. Nonetheless, the pluralistic model does not amount to a relativistic stance according in which there would be no objective standards for comparing the therapeutic merit of conventional and CAM treatments. As an ethical model, pluralism realizes that physicians must be prepared to disagree with patient choices to pursue alternative therapies, and urge patients not to forgo medically indicated treatment. Pluralism encourages cooperation, research, and open communication and respect between practitioners despite the possible existence of honest disagreement, and preserves the integrity of each of the treatment systems involved.

Clinical Medicine↗
PubMed2005

Viewpoint: professional integrity in industry-sponsored clinical trials.

Evidence-based medicine (EBM) relies on accurate data derived from well-designed, clinically relevant randomized controlled trials (RCTs). Most randomized trials, however, are conducted by industry sponsors aiming at licensing and marketing drugs, which may weaken the usefulness of the findings to EBM. Disturbing evidence has emerged of widespread biases in industry-sponsored trials, including publication bias, selective reporting of findings, and distorted interpretation of results. These practices compromise the professional integrity of physician-investigators who contribute to them. In turn, the well-being of patients participating in RCTs may be jeopardized, and the evidence base upon which EBM is practiced may be corrupted. Regulatory reform alone will be inadequate to resolve these problems; attention must also be paid to physicians' professionalism. The authors recommend a change in the culture of academic medicine whereby physician-investigators who maintain professional integrity are rewarded or recognized. Educational interventions promoting integrity in clinical research may be one part of affecting such change.

Advertising↗
PubMed2005

Principles of early stopping of randomized trials for efficacy: a critique of equipoise and an alternative nonexploitation ethical framework.

Recent controversial decisions to terminate several large clinical trials have called attention to the need for developing a sound ethical framework to determine when trials should be stopped in light of emerging efficacy data. Currently, the fundamental rationale for stopping trials early is based on the principle that equipoise has been disturbed. We present an analysis of the ethical and practical problems with the "equipoise disturbed" position and describe an alternative ethical framework based on the principle of nonexploitation. This framework acknowledges the need for balancing the dual ethical obligations of clinical research, the protection of human subjects and the generation of new medical knowledge. Based on this framework, we put forward a proposal to make early stopping guidelines more stringent under specified conditions. The temporary withholding of apparent benefits in certain circumstances is justified by achieving a fair contract with the research participants, one that protects them from undue harm and exploitation while reducing the many uncertainties surrounding new investigational treatments that arise when trials are stopped prematurely.

Endpoint Determination↗