scholarly journals ‘Lines in the sand’: an Australian qualitative study of patient group practices to promote independence from pharmaceutical industry funders

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e045140
Author(s):  
Lisa Parker ◽  
Quinn Grundy ◽  
Alice Fabbri ◽  
Barbara Mintzes ◽  
Lisa Bero
Keyword(s):  
Pharmaceutical Industry ◽  
Patient Group ◽  
Undue Influence ◽  
Industry Funding ◽  
Group Practices ◽  
Ability To Act ◽  
Brand Marketing ◽  
Qualitative Interview Study ◽  
Patient Groups ◽  
Participant Role

ObjectivesTo study how patient groups that accept pharmaceutical industry money perceive and manage the risk of undue influence from their sponsors.DesignEmpirical ethics approach using a qualitative interview study.SettingThe Australian patient group sector.Participants27 participants from 23 patient groups, purposively recruited for diversity of group characteristics (degree of pharmaceutical industry funding, health focus, location) and participant role (staff, board members).AnalysisInterview data were transcribed and read repeatedly to identify concepts and patterns in the data. These were grouped into conceptual categories that described and explained the findings. We used an inductive analytical approach to identify important themes and concepts in the data.ResultsParticipants in this study described how the patient group sector receives pressure from pharmaceutical company funders to act in ways that prioritise company interests. Groups worked to try and protect their credibility and ability to act in ways of their own choosing using practical rules or ‘lines in the sand’ about industry funding activities. They were grouped around the dominant topics of: sponsor exclusivity, brand marketing, agenda setting, advocacy and content of group activities. Lines in the sand were largely experience-driven and ethically informed; they varied between groups. There was also variable transparency among groups about financial interactions with pharmaceutical companies.ConclusionsIt is important to know about patient group practices around pharmaceutical industry funders as this allows public scrutiny about the adequacy of such practices. Inadequate strategies may mean that funders can influence patient groups activities in ways that do not necessarily prioritise the interests of members. We found that groups differed in their approach, with little independent external guidance to inform responses to commonly encountered types of influence. Inadequate transparency limits the ability of the public to make informed assessments about the risk of bias over the activities of groups that accept industry funding.

scholarly journals “Asset exchange”—interactions between patient groups and pharmaceutical industry: Australian qualitative study

BMJ ◽  
2019 ◽  
pp. l6694 ◽  
Author(s):  
Lisa Parker ◽  
Alice Fabbri ◽  
Quinn Grundy ◽  
Barbara Mintzes ◽  
Lisa Bero
Keyword(s):  
Pharmaceutical Industry ◽  
Patient Group ◽  
General Health ◽  
Exchange Interactions ◽  
New Drugs ◽  
Industry Funding ◽  
Industry Sponsorship ◽  
Health Consumer ◽  
Qualitative Interview Study ◽  
Patient Groups

AbstractObjectiveTo understand and report on the nature of patient group interactions with the pharmaceutical industry from the perspective of patient group representatives by exploring the range of attitudes towards pharmaceutical industry sponsorship and how, why, and when interactions occur.DesignEmpirical qualitative interview study informed by ethics theory.SettingAustralian patient groups.Participants27 participants from 23 Australian patient groups that represented diverse levels of financial engagement with the pharmaceutical industry. Groups were focused on general health consumer issues or disease specific topics, and had regional or national jurisdictions.AnalysisAnalytic techniques were informed by grounded theory. Interview transcripts were coded into data driven categories. Findings were organised into new conceptual categories to describe and explain the data, and were supported by quotes.ResultsA range of attitudes towards pharmaceutical industry sponsorship were identified that are presented as four different types of relationship between patient groups and the pharmaceutical industry. The dominant relationship type was of a successful business partnership, and participants described close working relationships with industry personnel. These participants acknowledged a potential for adverse industry influence, but expressed confidence in existing strategies for avoiding industry influence. Other participants described unsatisfactory or undeveloped relationships, and some participants (all from general health consumer groups) presented their groups’ missions as incompatible with the pharmaceutical industry because of fundamentally opposing interests. Participants reported that interactions between their patient group and pharmaceutical companies were more common when companies had new drugs of potential interest to group members. Patient groups that accepted industry funding engaged in exchanges of “assets” with companies. Groups received money, information, and advice in exchange for providing companies with marketing, relationship building opportunities with key opinion leaders, coordinated lobbying with companies about drug access and subsidy, assisting companies with clinical trial recruitment, and enhancing company credibility.ConclusionsAn understanding of the range of views patient groups have about pharmaceutical company sponsorship will be useful for groups that seek to identify and manage any ethical concerns about these relationships. Patient groups that receive pharmaceutical industry money should anticipate they might be asked for specific assets in return. Selective industry funding of groups where active product marketing opportunities exist might skew the patient group sector’s activity towards pharmaceutical industry interests and allow industry to exert proxy influence over advocacy and subsequent health policy.

How do health consumer organisations in Australia manage pharmaceutical industry sponsorship? A cross-sectional study

2019 ◽  
Vol 43 (4) ◽  
pp. 474 ◽  
Author(s):  
Edith Lau ◽  
Alice Fabbri ◽  
Barbara Mintzes
Keyword(s):  
Pharmaceutical Industry ◽  
Trade Association ◽  
Corporate Sponsorship ◽  
Undue Influence ◽  
Industry Funding ◽  
Cross Sectional ◽  
Health Consumer ◽  
Financial Transparency ◽  
Consumer Organisations ◽  
Corporate Funding

Objective The aim of this study was to investigate how health consumer organisations manage their relationships with the pharmaceutical industry in Australia. Methods We identified 230 health consumer organisations that received pharmaceutical industry support from 2013 to 2016 according to reports published by Medicines Australia, the industry trade association. A random sample of 133 organisations was selected and their websites assessed for financial transparency, policies governing corporate sponsorship and evidence of potential industry influence. Results In all, 130 of the 133 organisations evaluated received industry funding. Of these 130, 68 (52.3%; 95% confidence interval (CI) 43.4–61.1%) disclosed this funding. Nearly all (67; 98.5%) reported the identity of their industry donors, followed by uses (52.9%), amount (13.2%) and proportion of income from industry (4.4%). Less than one-fifth (24/133; 18.0%; 95% CI 11.9–25.6%) had publicly available policies on corporate sponsorship. Six organisations (7.2%; 95% CI 2.7–15.1%) had board members that were currently or previously employed by pharmaceutical companies, and 49 (36.8%; 95% CI 28.6–45.6%) had company logos, web links or advertisements on their websites. Conclusion Industry-funded health consumer organisations in Australia have low transparency when reporting industry funding and few have policies governing corporate sponsorship. Relationships between health consumer organisations and the industry require effective actions to minimise the risks of undue influence. What is known about this topic? Pharmaceutical industry funding of health consumer organisations is common in the US and Europe, yet only a minority of such organisations publicly disclose this funding and have policies regulating their relationships with industry. What does this paper add? Industry-funded health consumer organisations in Australia have inadequate financial transparency and rarely have policies addressing corporate funding. Organisations that have received more industry funding are more likely to report it publicly. What are the implications for practitioners? Robust policies addressing corporate sponsorship and increased transparency are needed to maintain the independence of health consumer organisations. Governments may also consider regulating non-profit organisations to ensure public reporting of funding sources.

scholarly journals Definitely Maybe: New Governance of Uncertainty and Risk in Patient Group Involvement with UK Guidance on Testing for Lyme Disease

2021 ◽  
pp. 097172182096024
Author(s):  
Alex Faulkner ◽  
Kate Bloor ◽  
Vahsti Hale
Keyword(s):  
Lyme Disease ◽  
Patient Group ◽  
New Governance ◽  
Difficult Patient ◽  
Consultation Process ◽  
Diagnostic Uncertainty ◽  
Policy Actors ◽  
Patient Groups ◽  
Evidence Review ◽  
The Uk

States that claim responsibility for citizens’ healthcare try to deal with knowledge uncertainties while preserving a duty of care. Production of clinical guidelines in disputed medical conditions or where uncertainty is high, is difficult. Patient groups may advocate non-credentialed evidence, contribute to debates and form alliances with established policy actors. In this context, Lyme disease, especially highly contested ‘chronic’ Lyme disease is a good case with which to examine how official governance institutions are managing diagnostic uncertainty and evidence for tests. The healthcare state has been provoked to develop extensive policy for Lyme disease. In the UK, national Health Technology Assessment agency, NICE, began a consultation process in 2016. NICE and other policy actors are moving towards more participatory modes of decision-making. The article analyses NICE’s recently published guidelines and consultation documents; patient groups’ contributions; observations of consultations and of evidence review processes; and recent Department of Health systematic reviews, including patient group participation. We draw on concepts of participatory governance, patient group activism and guideline involvement. We find an increased level of participation by patient groups in recent policy and evidence review processes, and hence legitimation of them as ‘stakeholders’, alongside a strengthened state position on pre-existing diagnostic and testing standards.

scholarly journals Oxygen Consumption of Erythrocytes from Patients with Various Thyroid Conditions Related to Their Respective Serum Protein—Bound Iodine Concentrations

Blood ◽  
1954 ◽  
Vol 9 (10) ◽  
pp. 953-958 ◽  
Author(s):  
LUIS ANGELONE ◽  
DAVID H. WATKINS ◽  
CLIFFORD A. ANGERER
Keyword(s):  
Oxygen Consumption ◽  
Serum Protein ◽  
Patient Group ◽  
Phosphate Solution ◽  
Exponential Order ◽  
Group A ◽  
Patient Groups ◽  
The Mean ◽  
Cent Change

Abstract Blood was obtained from patients who were divided into four groups: (A) euthyroid, (B) untreated hyperthyroid, (C) iodine-treated hyperthyroid and (D) hypothyroid. The erythrocytes from each patient group were washed and resuspended in Krebs-phosphate solution for study by the Warburg respirometric technic. When the erythrocytes obtained from patient groups B, C and D are compared with group A (control), a +92 per cent, +23 per cent and -15 per cent change is noted, respectively, in their mean QOO2 values when QOO2 values for erythrocytes for each patient in each patient group (excluding group C) are plotted relative to their respective serum PBI concentration (µg. per cent), a curve of exponential order appears to be the curve of best probable fit for these data. The mean QOO2 value for the iodine-treated hyperthyroid group falls on the ordinate of this curve (fig. 1) between the euthyroid and untreated hyperthyroid groups, though the mean serum PBI value (abscissa), of course, has no meaning for this group.

Clinically relevant concentrations of opioids for in vitro studies

2016 ◽  
Vol 12 (5) ◽  
pp. 313 ◽  
Author(s):  
Jason W. Boland, FRCP, PhD ◽  
A. Graham Pockley, PhD
Keyword(s):  
Patient Group ◽  
Clinical Setting ◽  
Clinical Studies ◽  
Large Range ◽  
In Vitro Studies ◽  
Clinical Effects ◽  
Clinical Context ◽  
Patient Groups

Objectives: Numerous in vitro studies have evaluated the influence of opioids on many biological and immunological processes. The concentrations that have been used in these studies span a large range and often do not reflect levels that are present in the relevant patient groups. This article reviews the literature concerning the concentrations of opioids that are detected in patients so that the concentrations of opioids that are used for in vitro studies can better reflect those that are present clinically. This will enable scientists and clinicians to more effectively model and interpret potentially relevant clinical effects from in vitro studies.Methods: Data on the concentrations of six commonly used opioids from clinical studies in adults were collected by searching PubMed (Medline).Results: A total of 42 relevant studies were included in the review. Concentrations of the opioids from previous clinical studies were mostly between 1 and 10 ng/mL for buprenorphine, 1 and 10 ng/mL for fentanyl, 50 and 500 ng/mL for methadone, 25 and 250 ng/mL for morphine, 10 and 100 ng/mL for oxycodone, and 100 and 1,000 ng/mL for Tramadol and were dependent on the patient group and indication under investigation.Conclusions: Concentrations of opioids used in vitro should include those that are present in the relevant clinical setting if the effects of opioids detected in vitro are to be of potential relevance to the clinical setting. Therefore, it is essential that these concentrations in the relevant clinical context(s) are known.

Differential Expression Of TREM-1 In Myelogenous Leukemia Cells

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4951-4951 ◽  
Author(s):  
Huiyu Li ◽  
Wenying Li ◽  
Xiaoling Yi ◽  
Shiang Huang ◽  
Wei Liu ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Complete Remission ◽  
Patient Group ◽  
Peripheral Blood ◽  
Myelogenous Leukemia ◽  
Leukemia Cells ◽  
Control Group ◽  
Healthy Controls ◽  
Significant Difference ◽  
Patient Groups

Abstract Objectives Triggering receptor expressed on myeloid cells (TREM) -1 is a receptor as a member of the immunoglobulin superfamily expressed on the cell-surface of neutrophils, monocytes and macrophages. This receptor amplifies the inflammatory response, activating the signaling pathway. TREM-1 expression is associated with mature myeloid cell development. TREM-1 is shed from the membrane of activated macrophages without the transmembrane and intracellular domains, and can be found as soluble TREM (sTREM)-1. Soluble TREM-1 is thought to negatively regulate TREM receptor signaling. Some studies currently reported that TREM-1 regulates the malignant behavior of cancer cells in lung cancer and HCC. However, no related studies about the role of TREM-1 in leukemia have been carried out. The aims of this study was investigated the TREM-1 expression in myelogenous leukemia cells. Methods Thirty-five patients with AML, twenty-five patients with CML and a control group of eleven healthy people were subjected to the study. TREM-1 expressions on the surfaces of leukemia cells were measured by flow cytometry. Plasma sTREM-1 levels were measured by ELISA. Results In this study, our results provide the first evidence that TREM-1 was differentially expressed in myelogenous leukemia cells. The TREM-1 mean ratio of median fluorescence intensity (mean ratio of MFI) was 3.13±0.88 and 2.52±0.40 in CML and AML patients, respectively. The TREM-1 mean ratio of MFI was 3.03±1.40 in myelogenous leukemia cell lines (K562, HL60, THP-1). The TREM-1 mean ratio of MFI was 5.37±0.88 in healthy controls. Compared to healthy controls, myelogenous leukemia cells had decreased TREM-1 expressions (P<0.001). The TREM-1 mean ratio of MFI was 4.89±0.60 in patients who are in complete remission after Novartis's Gleevec therapy. Compared with CML patient groups, patients who are in complete remission after Gleevec therapy had rising TREM-1 expressions (P<0.01). TREM-1 expressions of patients who are in complete remission after Gleevec therapy were slightly lower than the healthy controls, but this did not reach significance. No significant difference in TREM-1 expressions was seen between AML and CML patient groups, male and female patient groups, and cells derived from peripheral blood and bone marrow of the same leukemia patients (p>0.1). In addition, the plasma sTREM-1 levels were measured by ELISA. sTREM-1 levels was 48.54±57.63pg/mL for AML group and 43.72±23.93pg/mL for CML group. Results indicated that plasma sTREM-1 levels significantly higher in AML and CML patients than that in healthy controls (P<0.01). However, there was no significant difference in plasma sTREM-1 levels observed in AML patient group compared with CML patient group, male patients group compared with female patients group, and plasma from peripheral blood compared with plasma from bone marrow of the same leukemia patients (p>0.1). An ongoing project focuses on the relationship between the function of TREM-1 and occurrence, progression and prognosis of myelogenous leukemia, advances will be reported in time. Conclusion TREM-1 expression on leukemia cells was significantly lower in patients with AML and CML than those in healthy controls and patients in complete remission had increased TREM-1 expression. Patients with AML and CML had increased plasma soluble TREM-1. The TREM-1 expression on leukemia cells had an inverse correlation with plasma sTREM-1 level in AML and CML patients. Disclosures: No relevant conflicts of interest to declare.

Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development

2020 ◽  
Author(s):  
Brian Perry ◽  
Carrie Dombeck ◽  
Jaye Bea Smalley ◽  
Bennett Levitan ◽  
David Leventhal ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Product Development ◽  
Patient Group ◽  
Medical Product ◽  
Structured Interviews ◽  
Web Based ◽  
Research Activities ◽  
Development Lifecycle ◽  
Patient Groups ◽  
Group Engagement

Patient group engagement is increasingly used to inform the design, conduct, and dissemination of clinical trials and other medical research activities. However, the priorities of industry sponsors and patient groups differ, and there is currently no framework to help these groups identify mutually beneficial engagement activities. Methods: We conducted 28 qualitative, semi-structured interviews with representatives from research sponsor organizations (n=14) and patient groups (n=14) to determine: 1) how representatives define benefits and investments of patient group engagement in medical product development and, 2) to refine a list of 31 predefined patient group engagement activities. Results: Patient group and sponsor representatives described similar benefits: engagement activities can enhance the quality and efficiency of clinical trials by improving patient recruitment and retention, reduce costs, and help trials meet expectations of regulators and payers. All representatives indicated that investments include both dedicated staff time and expertise, and financial resources. Factors to consider when evaluating benefits and investments were also identified as were suggestions for clarifying the list of engagement activities. Discussion: Using these findings, we refined the 31 engagement activities to 24 unique activities across the medical product development lifecycle. We also developed a web-based prioritization tool (https://prioritizationtool.ctti-clinicaltrials.org/) to help clinical research sponsors and patient groups identify high priority engagement activities. Use of this tools can help sponsors and patient groups identify the engagement activities that they believe will provide the most benefit for the least investment and may lead to more meaningful and mutually beneficial partnerships in medical product development.

scholarly journals Comparison Of Stress Response Performing Endotracheal Intubation By Direct Laryngoscopy, Fibreoptic Intubation And Intubation By The Glidescope Laryngoscope

2008 ◽  
Vol 62 (4-5) ◽  
pp. 176-181
Author(s):  
Nataļja Jakušenko ◽  
Uldis Kopeika ◽  
Māris Mihelsons ◽  
Dace Nagobade ◽  
Aina Vija Putniña ◽  
...  
Keyword(s):  
Stress Response ◽  
Endotracheal Intubation ◽  
Patient Group ◽  
Direct Laryngoscopy ◽  
Fibreoptic Intubation ◽  
Macintosh Laryngoscope ◽  
Fibreoptic Bronchoscope ◽  
Amylase Level ◽  
Intubation Time ◽  
Patient Groups

Comparison Of Stress Response Performing Endotracheal Intubation By Direct Laryngoscopy, Fibreoptic Intubation And Intubation By The Glidescope Laryngoscope Stress response is regulated by two primary neuroendocrine systems—the hypothalamuspituitary- adrenocortical (HPA) and sympathetic adrenomedullary (SAM) systems. Salivary alphaamylase (AA) levels can be used as an index of the SAM activity, and serum cortisol as an index of HPA activity. The aim of the study was to compare patient stress response to different intubation techniques. Sixty adult patients, ASA I-III, scheduled for elective abdominal surgery were included in this study, with median age of 54±18 years. Patients were prospectively randomly divided into three groups-intubation with a GlideScope (GS), Macintosh laringoscope (ML) and PENTAX fibreoptic bronchoscope (FB). After preoxygenation for 3 min anaesthesia was induced with fentanyl 2 mkg/kg, mivacuronium 0.2 mg/kg and propofol 2 mg/kg, injected intravenously over 20 seconds. Intubation was started 2 min after mivacuronium injection. Anaesthesia was maintained with sevoflurane 1-2 vol% and fentanyl 1 mkg/kg as needed. Intubation time (IT) was measured, blood and saliva samples were collected before and shortly after intubation. Haemodynamic response was recorded. Intubation time was statistically significantly longer in the FB group (120±65 s) versus the ML group (29±5 s) and GS group (26±9 s), P < 0.05. In the three patients groups the initial AA level was similar (54±20 KU/ml, P > 0.05). In GS patients the alpha amylase level after intubation significantly decreased (42±15 KU/ml, P < 0.05), but in ML and FB patients—significantly increased (68±24 KU/ml and 73±32 KU/ml, respectively, P < 0.05). After intubation, blood cortisol did not differ between the ML (377±181 U/ml) and GS (484±61 U/ml) patient groups, but was significantly higher (P < 0.05) in the FB group (530±79 U/ml). Both heart rate and blood pressure increased during intubation, the difference between groups was not significant. All intubations were successful, but in the FB patient group IT was significantly longer than in the ML and GS patient group. IT in the GS and FB patient groups did not statistically significantly differ. In our opinion, shorter and more confident intubations with a GlideScope produce less nociceptive stimulus and less stress to the patient. Intubations using GlideScope videolaryngoscope causes lesser stress response in comparison to intubation with a Macintosh laryngoscope or fibreoptic bronchoscope.

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