Food Oppression in a Pandemic.

COVID-related racial disparities represent a spectrum of injustices and inequalities. Focusing on food oppression, this essay argues that racism infuses food law and policy in ways that contribute to racially disparate COVID deaths and severe illnesses. USDA nutrition program participants were at a nutritional disadvantage when COVID hit. Yet, government responses focused on food insecurity, not nutritional quality. Racism against a predominantly Black and brown labor force of essential food workers - from fields to meat plants to grocery stores - created tolerance for the administration's failure to protect or compensate some of the country's most vulnerable workers. When COVID-driven supply issues threatened to narrow white people's activities and choices, the favored response was to keep their options open by sacrificing Black and brown workers. A food oppression lens - understanding how corporate interests drive food policy - is necessary to achieve food equality in this pandemic and beyond.

Patient Satisfaction With Medications for Opioid Use Disorder Treatment via Telemedicine: Brief Literature Review and Development of a New Assessment.

Telemedicine is increasingly being used to treat patients with opioid use disorder (OUD). It has particular value in rural areas of the United States impacted by the opioid crisis as these areas have a shortage of trained addiction medicine providers. Patient satisfaction significantly impacts positive clinical outcomes in OUD treatment and thus is of great clinical interest. Yet little is known regarding patient satisfaction with the increasingly important platform of telemedicine-delivered medications for opioid use disorder (tMOUD). The goal of this review is to provide a summary of the existing literature regarding patient satisfaction with tMOUD. We also submit a novel survey based on an existing framework designed to assess tMOUD satisfaction, and present pilot data (N = 14) acquired from patients engaged in rural tMOUD care. Telemedicine provides a feasible method for delivering MOUD in rural areas, and our survey provides a useful assessment to measure patient satisfaction with tMOUD. In light of the pressing need for innovative and technology-driven solutions to the opioid epidemic (especially in light of the COVID-19 pandemic), future research should focus on the development and refinement of tools to assess the important implementation goal of patient satisfaction.

Multivariate analysis as a method to understand variability in a complex excipient, and its contribution to formulation performance.

A key part of the Risk Assessment of excipients is to understand how raw material variability could (or does) contribute to differences in performance of the drug product. Here we demonstrate an approach which achieves the necessary understanding for a complex, functional, excipient. Multivariate analysis (MVA) of the certificates of analysis of an ethylcellulose aqueous dispersion (Surelease) formulation revealed low overall variability of the properties of the systems. Review of the scores plot to highlight batches manufactured using the same ethylcellulose raw material in the formulation, indicated that these batches tend to be more closely related than other randomly selected batches. This variability could result in potential differences in the quality of drug product lots made from these batches. Manufacture of a model drug product from Surelease batches coated using different lots of starting material revealed small differences in the release of a model drug, which could be detected by certain model dependent dissolution modeling techniques, but they were not observed when using model-independent techniques. This illustrates that the techniques are suitable for detecting and understanding excipient variability, but that, in this case, the product was still robust.

Pre-operative self-efficacy education vs. usual care for patients undergoing joint replacement surgery: a pilot randomised controlled trial.

BACKGROUND: Hip and knee replacement is a major surgical procedure performed worldwide. Despite 20 or so years of clinical research and care guidelines, the management of acute postoperative pain continues to be a concern. A growing number of self-efficacy strategies are being included in education programs for patients to enable then to have a central role in managing their illness and symptoms. AIMS AND OBJECTIVES: The purpose of this pilot study was to evaluate the feasibility of testing an education intervention to improve self-efficacy in patients undergoing hip or knee replacement. METHODS: A single-blinded, parallel, pilot randomised control trial design was used. Ninety-one patients undergoing hip or knee replacement surgery were randomly assigned to an intervention or control group. Intervention group participants were given a DVD demonstrating self-efficacy activities to undertake four times before admission. Feasibility criteria related to recruitment, protocol adherence and missing data were assessed. Participants were assessed for pain, anxiety, self-efficacy and healthcare utilisation. RESULTS: In relation to recruitment, 55% of screened patients were eligible and of these 81% enrolled (n = 91). Exclusion following randomisation was 10% with missing data ranging from 0 to 20.7%. Nineteen per cent of participants were lost to follow up in the control group and 20% lost to follow up in DVD group. Protocol adherence to components of the intervention varied. Both groups were generally satisfied with pain management during hospitalisation, and there were no differences in groups on clinical outcome measures. CONCLUSIONS: Preliminary evidence for the benefits of self-efficacy-based education for patients undergoing hip or knee replacement was identified. Additional findings included a need to strengthen the intervention and reducing the number of data collection points to improve the protocol, missing data and numbers lost to follow up before a larger trial is undertaken.

A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma.

This multicenter, open-label, randomized phase 2 study evaluated 2 dose regimens of lenalidomide for relapsed, refractory myeloma. Seventy patients were randomized to receive either 30 mg once-daily or 15 mg twice-daily oral lenalidomide for 21 days of every 28-day cycle. Patients with progressive or stable disease after 2 cycles received dexamethasone. Analysis of the first 70 patients showed increased grade 3/4 myelo-suppression in patients receiving 15 mg twice daily (41% versus 13%, P = .03). An additional 32 patients received 30 mg once daily. Responses were evaluated according to European Group for Blood and Marrow Transplantation (EBMT) criteria. Overall response rate (complete, partial, or minor) to lenalidomide alone was 25% (24% for once-daily and 29% for twice-daily lenalidomide). Median overall survival in 30-mg once-daily and twice-daily groups was 28 and 27 months, respectively. Median progression-free survival was 7.7 months on once-daily versus 3.9 months on twice-daily lenalidomide (P = .2). Dexamethasone was added in 68 patients and 29% responded. Time to first occurrence of clinically significant grade 3/4 myelosuppression was shorter in the twice-daily group (1.8 vs 5.5 months, P = .05). Significant peripheral neuropathy and deep vein thrombosis each occurred in only 3%. Lenalidomide is active and well tolerated in relapsed, refractory myeloma, with the 30-mg once-daily regimen providing the basis for future studies as monotherapy and with dexamethasone.

New oral linguiform projections and their associated neurons in the third-stage infective larva of the parasitic nematode Oesophagostomum dentatum.

The infective larvae (L3i) of the nematode parasite of swine, Oesophagostomum dentatum, are passively ingested by their hosts. The L3i exhibit certain behaviors that are probably selected to increase the likelihood of ingestion, by strategic positioning in the environment. The larvae show positive geotactic behavior and respond to temperature variations in their environment, as shown by their behavior on a thermal gradient. To investigate neuronal control of this behavior, we initiated a study of the structure of the amphidial neurons of this parasite. The same number and types of neuronal dendritic processes are found in the amphids of the O. dentatum L3i as in those of its close relatives Haemonchus contortus and Ancylostoma caninum. Well-developed dendritic processes of wing cells are located in the amphidial sheath cells, these being similar to wing cells AWA in the free-living nematode Caenorhabditis elegans but actually more extensive. Similar to its close relatives just mentioned, and C. elegans as well, O. dentatum L3i has prominent finger cell processes, the finger cell neurons being the thermoreceptors in all 3 of the preceding species. However, unlike the arrangement seen in H. contortus and A. caninum, where the microvilli-like "fingers" of these neurons lie dorsal to the amphidial channel and occupy a very large portion (>50%) of the anterior end of the larva, the dendritic process of the finger cells in O. dentatum extends into unusual linguiform projections that, in turn, extend into the lumen of the mouth tube, a complex structural arrangement that has not been described for any other nematode.

Thalidomide for patients with relapsed multiple myeloma after high-dose chemotherapy and stem cell transplantation: results of an open-label multicenter phase 2 study of efficacy, toxicity, and biological activity.

OBJECTIVES: To determine the progression-free survival at 12 weeks, to evaluate the toxic effects, and to analyze the biological activity of thalidomide in patients with relapsed multiple myeloma (MM) after high-dose chemotherapy and stem cell transplantation. PATIENTS AND METHODS: From 1999 to 2001, we performed a multicenter prospective phase 2 study in patients with MM that relapsed after high-dose chemotherapy and stem cell transplantation to evaluate the efficacy of oral thalidomide, with dose escalation from 200 to 600 mg/d over 12 weeks and a subsequent maintenance phase of 200 mg/d for up to 1 year. Outcome was correlated with serum and plasma levels of vascular endothelial growth factor and serum levels of tumor necrosis factor alpha, soluble intercellular adhesion molecule 1, interferon gamma, interleukin (IL) 2, and IL-6 during treatment. RESULTS: Thirty patients were treated (19 men and 11 women; median age, 58 years). The median number of prior therapies was 5, and the median duration from diagnosis of MM to study enrollment was 4.3 years. The 12-week progression-free survival rate was 67% (95% confidence interval [CI], 48%-86%). The observed response rate (partial response plus minor response) was 43% (95% CI, 28%-60%) with a median duration of 6 months. Attributable toxicities included constipation, fatigue, rash, and neuropathy, which was dose limiting in 8 patients (27%). Dose escalation from 200 to 600 mg/d was achieved in 50% of patients. Although responses were observed with lower doses, possibly eliminating the need to escalate the dose, responses were also seen in patients who completed the dose escalation. Some patients had disease progression while receiving the maintenance dose of 200 mg/d. Analysis of biomarker assays did not identify any biomarker associated with greater response, but a significant increase in levels of soluble intercellular adhesion molecule 1, IL-2, and interferon gamma was seen with thalidomide therapy. CONCLUSION: The optimal thalidomide dose varies, and adverse effects can be dose limiting. The dose of thalidomide therapy should be based on the individual patient to ensure that it is well tolerated and that a response is achieved.

Endoparasites of western lowland gorillas (Gorilla gorilla gorilla) at Bai Hokou, Central African Republic.

A coprologic study of free-ranging western lowland gorillas (Gorilla gorilla gorilla) at Bai Hokou, Dzangha-Ndoki National Park, Central African Republic (2 degrees 51'34''N, 16 degrees 28'03''E) was conducted from October 1999 to November 2000. All 75 fecal samples examined were positive for endoparasites, and each contained at least two species. Parasites present included two genera of amoebae, entodiniomorph ciliates, including Prototapirella gorillae, Troglodytella spp., and Gorillophilus thoracatus, a Balantidium-like organism, strongyle/trichostrongyle eggs (including a presumptive Mammomonogamus sp. and several other genera), Strongyloides sp., Probstmayria sp., a spirurid, a trichuroid, and several unidentified trematodes. Flagellates and cestodes were not found. Despite the presence of a variety of parasite genera, in general, levels of parasitism were low. These data provide baseline parasitologic data for this population as part of a comprehensive health-monitoring program. With the advent of ecotourism in this study area, continued monitoring is indicated for insuring the health of both gorillas and humans in the Bai Hokou study area.

Amphidial structure of ivermectin-resistant and susceptible laboratory and field strains of Haemonchus contortus.

The development of anthelmintic resistance by nematode parasites is a growing problem for veterinarians, pet owners, and producers. The intensive use of the macrocyclic lactones for the treatment of a variety of parasitic diseases has hastened the development of resistance to this family of parasiticides. As a result, resistance to ivermectin, moxidectin, nemadectin, and doramectin by Haemonchus contortus has been documented throughout the world. Sensory neurons located in the cephalic end of nematodes are in close contact with the external environment. Through these neurons, important chemical and thermal cues are gathered by the parasite. Examination of serial electron micrographs of ivermectin-susceptible and ivermectin-resistant H. contortus allows for comparison of neuronal structure, arrangement of neurons within the amphidial channel, and distance of the tip of the dendritic processes to the amphidial pore. The latter of these characteristics provides a useful means by which to compare the association between the neurons and the external environment of the worm. Comparison of parental laboratory strains of ivermectin-susceptible strains of H. contortus with related selected, ivermectin-resistant strains and with a wild-type ivermectin-susceptible field strain of H. contortus from Louisiana reveal that the ivermectin-resistant worms examined have markedly shorter sensory cilia than their ivermectin-susceptible parental counterparts. Additionally, the amphidial neurons of ivermectin-resistant worms are characterized by generalized degeneration and loss of detail, whereas other neurons outside of the channels, such as the labial and cephalic neurons, are normal in structure. These findings raise a number of questions regarding the relationship between amphidial structure and ivermectin resistance as well as the role of amphids as a means of entry for ivermectin. While shortened amphidial sensilla are associated with ivermectin resistance, it remains unclear if such a structural modification facilitates survival of nematodes exposed to macrocyclic lactones.

Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma.

Thalidomide (Thal) can overcome drug resistance in multiple myeloma (MM) but is associated with somnolence, constipation, and neuropathy. In previous in vitro studies, we have shown that the potent immunomodulatory derivative of thalidomide (IMiD) CC-5013 induces apoptosis or growth arrest even in resistant MM cell lines and patient cells, decreases binding of MM cells to bone marrow stromal cells (BMSCs), inhibits the production in the BM milieu of cytokines (interleukin-6 [IL-6], vascular endothelial growth factor [VEGF], tumor necrosis factor-alpha [TNF-alpha]) mediating growth and survival of MM cells, blocks angiogenesis, and stimulates host anti-MM natural killer (NK) cell immunity. Moreover, CC-5013 also inhibits tumor growth, decreases angiogenesis, and prolongs host survival in a human plasmacytoma mouse model. In the present study, we carried out a phase 1 CC-5013 dose-escalation (5 mg/d, 10 mg/d, 25 mg/d, and 50 mg/d) study in 27 patients (median age 57 years; range, 40-71 years) with relapsed and refractory relapsed MM. They received a median of 3 prior regimens (range, 2-6 regimens), including autologous stem cell transplantation and Thal in 15 and 16 patients, respectively. In 24 evaluable patients, no dose-limiting toxicity (DLT) was observed in patients treated at any dose level within the first 28 days; however, grade 3 myelosuppression developed after day 28 in all 13 patients treated with 50 mg/d CC-5013. In 12 patients, dose reduction to 25 mg/d was well tolerated and therefore considered the maximal tolerated dose (MTD). Importantly, no significant somnolence, constipation, or neuropathy has been seen in any cohort. Best responses of at least 25% reduction in paraprotein occurred in 17 (71%) of 24 patients (90% confidence interval [CI], 52%-85%), including 11 (46%) patients who had received prior Thal. Stable disease (less than 25% reduction in paraprotein) was observed in an additional 2 (8%) patients. Therefore, 17 (71%) of 24 patients (90% CI, 52%-85%) demonstrated benefit from treatment. Our study therefore provides the basis for the evaluation of CC-5013, either alone or in combination, to treat patients with MM at earlier stages of disease.