Patent Punting: How FDA and Antitrust Courts Undermine the Hatch-Waxman Act to Avoid Dealing with Patents

Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing than FDA to address the merits of the underlying patent infringement actions, preferring to rely on misleading proxies such as the existence of a “reverse payment” in the settlement agreement. Antitrust litigation is, at best, a belated and awkward mechanism for correcting the effects of improperly delayed generic entry. But FDA is well-positioned to make timely determinations of which patents meet the statutory criteria for deferring generic entry. With proper staffing and resources, FDA could use its expertise in drug regulation to make rough assessments of the relationship between particular patents and the scope of FDA approval in NDAs and ANDAs quickly and cheaply, while leaving patent infringement remedies intact. Only those patents that FDA decides could reasonably be asserted against an unauthorized generic would lead FDA to stay approval of the generic pending litigation of the infringement action. The result would be a reduction in incentives to pursue dubious patent infringement claims, with a corresponding reduction in opportunities for anti-competitive settlements

Patent Punting: How FDA and Antitrust Courts Undermine the Hatch-Waxman Act to Avoid Dealing with Patents

Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing than FDA to address the merits of the underlying patent infringement actions, preferring to rely on misleading proxies such as the existence of a “reverse payment” in the settlement agreement. Antitrust litigation is, at best, a belated and awkward mechanism for correcting the effects of improperly delayed generic entry. But FDA is well-positioned to make timely determinations of which patents meet the statutory criteria for deferring generic entry. With proper staffing and resources, FDA could use its expertise in drug regulation to make rough assessments of the relationship between particular patents and the scope of FDA approval in NDAs and ANDAs quickly and cheaply, while leaving patent infringement remedies intact. Only those patents that FDA decides could reasonably be asserted against an unauthorized generic would lead FDA to stay approval of the generic pending litigation of the infringement action. The result would be a reduction in incentives to pursue dubious patent infringement claims, with a corresponding reduction in opportunities for anti-competitive settlements

What defines mindfulness-based programs?:The warp and the weft

There has been an explosion of interest in mindfulness-based programs (MBPs) such as Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy. This is demonstrated in increased research, implementation of MBPs in healthcare, educational, criminal justice and workplace settings, and in mainstream interest. For the sustainable development of the field there is a need to articulate a definition of what an MBP is and what it is not. This paper provides a framework to define the essential characteristics of the family of MBPs originating from the parent program MBSR, and the processes which inform adaptations of MBPs for different populations or contexts. The framework addresses the essential characteristics of the program and of teacher. MBPs: are informed by theories and practices that draw from a confluence of contemplative traditions, science, and the major disciplines of medicine, psychology and education; underpinned by a model of human experience which addresses the causes of human distress and the pathways to relieving it; develop a new relationship with experience characterized by present moment focus, decentering and an approach orientation; catalyze the development of qualities such as joy, compassion, wisdom, equanimity and greater attentional, emotional and behavioral self-regulation, and engage participants in a sustained intensive training in mindfulness meditation practice, in an experiential inquiry-based learning process and in exercises to develop understanding. The paper's aim is to support clarity, which will in turn support the systematic development of MBP research, and the integrity of the field during the process of implementation in the mainstream

Mindfulness-based cognitive therapy (MBCT) reduces the association between depressive symptoms and suicidal cognitions in patients with a history of suicidal depression.

Objective: In patients with a history of suicidal depression, recurrence of depressive symptoms can easily reactivate suicidal thinking. In this study, we investigated whether training in mindfulness, which is aimed at helping patients “decenter” from negative thinking, could help weaken the link between depressive symptoms and suicidal cognitions. Method: Analyses were based on data from a recent randomized controlled trial, in which previously suicidal patients were allocated to mindfulness-based cognitive therapy (MBCT), an active control treatment, cognitive psychoeducation (CPE), which did not include any meditation practice, or treatment as usual (TAU). After the end of the treatment phase, we compared the associations between depressive symptoms, as assessed through self-reports on the Beck Depression Inventory–II (Beck, Steer, & Brown, 1996), and suicidal thinking, as assessed through the Suicidal Cognitions Scale (Rudd et al., 2001). Results: In patients with minimal to moderate symptoms at the time of assessment, comparisons of the correlations between depressive symptoms and suicidal cognitions showed significant differences between the groups. Although suicidal cognitions were significantly related to levels of symptoms in the 2 control groups, there was no such relation in the MBCT group. Conclusion: The findings suggest that, in patients with a history of suicidal depression, training in mindfulness can help to weaken the association between depressive symptoms and suicidal thinking, and thus reduce an important vulnerability for relapse to suicidal depression

Impact of Mindfulness-Based Teacher Training on MBSR Participant Well-Being Outcomes and Course Satisfaction

Growing interest in mindfulness-based programs (MBPs) has resulted in increased demand for MBP teachers, raising questions around safeguarding teaching standards. Training literature emphasises the need for appropriate training and meditation experience, yet studies into impact of such variables on participant outcomes are scarce, requiring further investigation. This feasibility pilot study hypothesised that participant outcomes would relate to teachers' mindfulness-based teacher training levels and mindfulness-based teaching and meditation experience. Teachers (n = 9) with different MBP training levels delivering mindfulness-based stress reduction (MBSR) courses to the general public were recruited together with their course participants (n = 31). A teacher survey collected data on their mindfulness-based teacher training, other professional training and relevant experience. Longitudinal evaluations using online questionnaires measured participant mindfulness and well-being before and after MBSR and participant course satisfaction. Course attendees' gains after the MBSR courses were correlated with teacher training and experience. Gains in well-being and reductions in perceived stress were significantly larger for the participant cohort taught by teachers who had completed an additional year of mindfulness-based teacher training and assessment. No correlation was found between course participants' outcomes and their teacher's mindfulness-based teaching and meditation experience. Our results support the hypothesis that higher mindfulness-based teacher training levels are possibly linked to more positive participant outcomes, with implications for training in MBPs. These initial findings highlight the need for further research on mindfulness-based teacher training and course participant outcomes with larger participant samples

Skeletal muscle AMPK is essential for the maintenance of FNDC5 expression

Fibronectin type III domain‐containing protein 5 (FNDC5) expression is controlled by the transcriptional co‐activator, peroxisome proliferator‐activated receptor gamma, coactivator 1 alpha (PGC1α). FNDC5 expression has been shown to be increased in muscle in response to endurance exercise in some but not all studies, therefore a greater understanding of the mechanisms controlling this process are needed. The AMP‐activated protein kinase (AMPK) is activated by exercise in an intensity dependent manner and is an important regulator of PGC1α activity; therefore, we explored the role of AMPK in the regulation of FNDC5 using AMPK β1β2 double muscle‐null mice (AMPK DMKO), which lack skeletal muscle AMPK activity. We found that FNDC5 expression is dramatically reduced in resting muscles of AMPK DMKO mice compared to wild‐type littermates. In wild‐type mice, activating phosphorylation of AMPK was elevated immediately post contraction and was abolished in muscle from AMPK DMKO mice. In contrast, PGC1α was increased in both wild‐type and AMPK DMKO mice 3 h post contraction but FNDC5 protein expression was not altered. Lastly, acute or chronic activation of AMPK with the pharmacological AMPK activator AICAR did not increase PGC1α or FNDC5 expression in muscle. These data indicate that skeletal muscle AMPK is required for the maintenance of basal FNDC5 expression

The Mississippi delta health collaborative medication therapy management model: Public health and pharmacy working together to improve population health in the Mississippi delta

© 2020. Introduction The Mississippi Delta has high rates of chronic disease and is known for its poor health outcomes and health disparities. University of Mississippi School of Pharmacy (UMSOP) and the Mississippi State Department of Health partnered in 2009 through the Mississippi Delta Health Collaborative to reduce health disparities and improve clinical outcomes by expanding the UMSOP\u27s evidence-based medication therapy management (MTM) initiative, focused in Mississippi\u27s 18-county Delta region, to federally qualified health centers (FQHCs) in 4 of those counties. Methods Between January 2009 and August 2018, the MTM initiative targeted FQHC patients aged 18 years or older with a diagnosis of diabetes, hypertension, and/or dyslipidemia. Pharmacists initially met face-to-face with patients to review all medications, provide education about chronic diseases, identify and resolve drug therapy problems, and take appropriate actions to help improve the effectiveness of medication therapies. Clinical parameters evaluated were systolic blood pressure (SBP), diastolic blood pressure (DBP), total cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and hemoglobin A1c (HbA1c). Results The analysis included 335 patients with hypertension (n = 287), dyslipidemia (n = 131), and/or diabetes (n = 331). Significant mean reductions occurred in the following metrics: SBP (7.1 mm Hg), DBP (6.3 mm Hg), LDL cholesterol (24.9 mg/dL), triglycerides (45.5 mg/dL), total cholesterol (37.7 mg/dL), and HbA1c (1.6% [baseline ≥6%] and 1.9% [baseline ≥9%]). Conclusion Despite the cultural and environmental disadvantages present in the Mississippi Delta, the integrated MTM treatment program demonstrated significant health improvements across 3 chronic diseases: hypertension, dyslipidemia, and diabetes. This model demonstrates that a partnership between public health and pharmacy is a successful and innovative approach to care

Accessibility and implementation in UK services of an effective depression relapse prevention programme - mindfulness-based cognitive therapy (MBCT): ASPIRE study protocol

notes: PMCID: PMC4036706types: Journal Article© 2014 Rycroft-Malone et al.; licensee BioMed Central Ltd.Mindfulness-based cognitive therapy (MBCT) is a cost-effective psychosocial prevention programme that helps people with recurrent depression stay well in the long term. It was singled out in the 2009 National Institute for Health and Clinical Excellence (NICE) Depression Guideline as a key priority for implementation. Despite good evidence and guideline recommendations, its roll-out and accessibility across the UK appears to be limited and inequitably distributed. The study aims to describe the current state of MBCT accessibility and implementation across the UK, develop an explanatory framework of what is hindering and facilitating its progress in different areas, and develop an Implementation Plan and related resources to promote better and more equitable availability and use of MBCT within the UK National Health Service.NIHRHS&D

3D Selection of 167 Substellar Companions to Nearby Stars

© 2022. The Author(s). Published by the American Astronomical Society. This is an open access article distributed under the Creative Commons Attribution License, to view a copy of the license, see: https://creativecommons.org/licenses/by/4.0/We analyze 5108 AFGKM stars with at least five high-precision radial velocity points, as well as Gaia and Hipparcos astrometric data, utilizing a novel pipeline developed in previous work. We find 914 radial velocity signals with periods longer than 1000 days. Around these signals, 167 cold giants and 68 other types of companions are identified, through combined analyses of radial velocity, astrometry, and imaging data. Without correcting for detection bias, we estimate the minimum occurrence rate of the wide-orbit brown dwarfs to be 1.3%, and find a significant brown-dwarf valley around 40 M Jup. We also find a power-law distribution in the host binary fraction beyond 3 au, similar to that found for single stars, indicating no preference of multiplicity for brown dwarfs. Our work also reveals nine substellar systems (GJ 234 B, GJ 494 B, HD 13724 b, HD 182488 b, HD 39060 b and c, HD 4113 C, HD 42581 d, HD 7449 B, and HD 984 b) that have previously been directly imaged, and many others that are observable at existing facilities. Depending on their ages, we estimate that an additional 10–57 substellar objects within our sample can be detected with current imaging facilities, extending the imaged cold (or old) giants by an order of magnitude.Peer reviewe