Tai Chi and Qigong are traditional Chinese exercises that are widely practiced for their health benefits and as martial arts. Evidence suggests that these practices may be effective at treating a ...range of physical health conditions, and at improving health-related quality of life. There is growing interest in the use of Tai Chi and Qigong to treat mental disorders, because they are noninvasive, exercise-based therapies, and because patients with mental disorders frequently use complementary and alternative medicine. Evidence is promising that these treatments may be effective in reducing depressive symptoms, stress, anxiety, and mood disturbances.
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a ...novel use for which such evidence is currently lacking. This "extrapolation" issue arises in the medicines context when an approved drug or device that is already being marketed is being considered (1) for new conditions (such as off-label diagnostic categories), (2) for new patients (such as new subpopulations), (3) for new dosages or durations, or (4) as the basis for approving a related drug or device (such as a generic or biosimilar drug). Although the logic of preapproval testing and the precautionary principle—first, do no harm—would counsel in favor of prohibiting extrapolation approvals until after traditional safety and efficacy evidence exists, such delays would unreasonably sacrifice beneficial uses. The harm of accessing unsafe products must be balanced against the harm of restricting access to effective products. In fact, the Food and Drug Administration's (FDA's) current regulations in many ways reject the precautionary principle because they largely permit individual physicians to prescribe medications for off-label uses before any testing tailored to those uses has been done. The FDA's approach empowers physicians, but overshoots the mark by allowing enduring use of drugs and devices with insubstantial support of safety and efficacy. This Article instead proposes a more dynamic and evolving evidence-based regime that charts a course between the Scylla and Charybdis of the overly conservative precautionary principle on one hand, and the overly liberal FDA regime on the other. Our approach calls for improvements in reporting, testing, and enforcement regulations to provide a more layered and nuanced system of regulatory incentives. First, we propose a more thoroughgoing reporting of off-label use (via the disclosure of diagnostic codes and "detailing" data) in manufacturers' annual reports to the FDA, in the adverse event reports to the FDA, in Medicare/Medicaid reimbursement requests, and, for a subset of FDA-designated drugs, in prescriptions themselves. Second, we would substantially expand the agency's utilization of postmarket testing, and we provide a novel framework for evaluating the need for postmarket testing. Finally, our approach calls for a tiered labeling system that would allow regulators and courts to draw finer reimbursement and liability distinctions among various drug uses, and would provide the agency both the regulatory teeth and the flexibility it presently lacks. Together, these reforms would improve the role of the FDA in the informational marketplace underlying physicians' prescribing decisions. This evolutionary extrapolation framework could also be applied to other contexts.
Everything Is Obvious Abbott, Ryan
UCLA law review,
01/2019, Letnik:
66, Številka:
1
Journal Article
Recenzirano
For more than sixty years, “obviousness” has set the bar for patentability. Under this standard, if a hypothetical “person having ordinary skill in the art” would find an invention obvious in light ...of existing relevant information, then the invention cannot be patented. This skilled person is defined as a non-innovative worker with a limited knowledge-base. The more creative and informed the skilled person, the more likely an invention will be considered obvious. The standard has evolved since its introduction, and it is now on the verge of an evolutionary leap: Inventive machines are increasingly being used in research, and once the use of such machines becomes standard, the person skilled in the art should be a person using an inventive machine, or just an inventive machine. Unlike the skilled person, the inventive machine is capable of innovation and considering the entire universe of prior art. As inventive machines continue to improve, this will increasingly raise the bar to patentability, eventually rendering innovative activities obvious. The end of obviousness means the end of patents, at least as they are now.
Clinicians still employ a "trial-and-error" approach to optimizing treatment regimens for late-life depression (LLD). With LLD affecting a significant and growing segment of the population, and with ...only about half of older adults responsive to antidepressant therapy, there is an urgent need for a better treatment paradigm. Pharmacogenetic decision support tools (DSTs), which are emerging technologies that aim to provide clinically actionable information based on a patient's genetic profile, offer a promising solution. Dozens of DSTs have entered the market in the past 15 years, but with varying level of empirical evidence to support their value. In this clinical review, we provide a critical analysis of the peer-reviewed literature on DSTs for major depression management. We then discuss clinical considerations for the use of these tools in treating LLD, including issues related to test interpretation, timing, and patient perspectives. In adult populations, newer generation DSTs show promise for the treatment of major depression. However, there are no primary clinical trials in LLD cohorts. Independent and comparative clinical trials are needed.
The efficacy of providing self-acupressure educational materials in reducing stress and improving health-related quality of life (HRQOL) is uncertain. Evidence-based data to recommend for or against ...self-acupressure as an intervention for reducing stress and improving HRQOL is needed.
The Self-Acupressure for Stress (SAS) trial evaluates whether providing self-acupressure educational materials would reduce stress and improve HRQOL among health care providers (HCPs).
Randomized behavioral clinical trial.
The entire study took place remotely.
One hundred fifty-nine adult HCPs with no prior experience or training in acupressure.
The intervention group received self-acupressure educational materials.
Primary outcomes were perception of stress measured by the Perceived Stress Scale (PSS), as well as scores on the physical and mental components of the 12-item Short Form Health Survey version 2 (SF-12v2).
From the baseline to midpoint evaluations, the intervention group significantly reduced their PSS score (P ≤ .001) and increased their SF-12v2 Mental score (P = .002) but not their SF-12v2 Physical score (P = .55). These findings persisted at the final follow-up (both PSS and SF-12v2 Mental changes from baseline P < .001). However, the control group also significantly improved their SF-12v2 Mental from baseline to midpoint (P = .01) which was maintained at final follow-up (P = .02), whereas PSS and SF-12v2 Physical did not significantly change from baseline at either mid or final. Finally, the intervention group improved by significantly more than the control group from baseline to final follow-up for both PSS (P = .007) and SF-12v2 Mental (P = .02) HRQOL measures.
The trial was not blinded.
Among HCPs during the coronavirus disease 2019 (COVID-19) pandemic, the provision of self-acupressure educational materials safely improved self-reported assessments of perception of stress and mental health. Self-acupressure represents a promising intervention for other populations. The study findings support the use of self-acupressure to reduce stress and improve HRQOL.
ClinicalTrials.gov: NCT04472559.
While the use of complementary, alternative and integrative medicine (CAIM) is substantial, it continues to exist at the periphery of allopathic medicine. Understanding the attitudes of medical ...students toward CAIM will be useful in understanding future integration of CAIM and allopathic medicine. This study was conducted to develop and evaluate an instrument and assess medical students' attitudes toward CAIM. The Complementary, Alternative and Integrative Medicine Attitudes Questionnaire (CAIMAQ) was developed by a panel of experts in CAIM, allopathic medicine, medical education and survey development. A total of 1770 CAIMAQ surveys (51% of US medical schools participated) were obtained in a national sample of medical students in 2007. Factor analysis of the CAIMAQ revealed five distinct attitudinal domains: desirability of CAIM therapies, progressive patient/physician health care roles, mind-body-spirit connection, principles of allostasis and a holistic understanding of disease. The students held the most positive attitude for the “mind-body-spirit connection” and the least positive for the “desirability of CAIM therapies”. This study provided initial support for the reliability of the CAIMAQ. The survey results indicated that in general students responded more positively to the principles of CAIM than to CAIM treatment. A higher quality of CAIM-related medical education and expanded research into CAIM therapies would facilitate appropriate integration of CAIM into medical curricula. The most significant limitation of this study is a low response rate, and further work is required to assess more representative populations in order to determine whether the relationships found in this study are generalizable.
The rising popularity of complementary and alternative medicine (CAM) in child and adolescent psychiatry raises unique ethical and legal concerns for psychiatrists and other conventional health care ...providers. This article explores these concerns and provides clinical advice for promoting patient health and safety while minimizing the psychiatrist's risk. Although any departure from the conventional standard of care is a potential risk, the risk of malpractice liability for practicing integrative medicine in child and adolescent psychiatry is low. CAM is most safely recommended from a legal standpoint when there is some published evidence of safety and efficacy.
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